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Frequently Asked Questions

General Questions
Q. What does GINA do?
Q. When will GINA take effect?
Q: How do I know whether my information is protected by GINA? [Definitions]
Q. What are some examples of protected tests?
Q. Is family history considered genetic information?
Q. What are some examples of protected genetic services?
Q. What is not covered by GINA?

Health Insurance Protections
Q. What health insurance protections does GINA create?
Q. Can my health insurer ask about my genetic tests?
Q. I had breast cancer and genetic testing. Can my health insurer deny me coverage?
Q. Can higher risk for colon cancer be considered a pre-existing condition exclusion?
Q. I have two employees who are related and one has cancer. Will my premiums go up?
Q. Can my insurer require my genetic test results to prove my need for preventive treatment?
Q. Can my insurer force me to take a genetic test to prove my need for preventive treatment?
Q: Does GINA mean that insurers must pay for genetic testing, or for medical care that is indicated by a genetic test?
Q. What part of the federal government enforces GINA health insurance protections?
Q. How do GINA health insurance protections work with existing state laws?
Q. When are states supposed to make their laws conform to new federal GINA standards?
Q. I am self-employed and buy my own health insurance policy. Whom should I call if I think I have been discriminated against?
Q. I get my health benefits through work. Whom should I call if I think my group health plan is discriminating against me?
Q. When do GINA's health insurance provisions take effect?
Q. Does GINA protect me when I buy life insurance or long-term care insurance?

Employment Discrimination Protections
Q. What are GINA's protections against genetic discrimination in employment?
Q. How will GINA's employment provisions be enforced?
Q: What employment discrimination is not covered by GINA?
Q. Does GINA put any new limitations on existing federal law?
Q. Are there exceptions to the rule against employer collection of genetic information?
Q. I'm an employer and when I asked our receptionist how he was, he mentioned that his brother is being treated for colon cancer. Am I in trouble under GINA?
Q. I'm afraid that my employer will share what she knows about my family history with others outside the office. What is the rule against disclosure of genetic information?
Q. What procedures must an employer follow if he or she does obtain genetic information about an employee?
Q. What if my employer discriminates against me not because of my genetic information but because I spoke up about a GINA-related violation by my employer?
Q. Are disparate impact claims authorized under GINA?
Q. How do GINA employment provisions interact with state employment law?
Q. I have a new job offer, but the employer wants to hire me without benefits because of my genetic information. Does GINA prohibit this?

Transcript of GINA Q & A session, December 3, 2008


General Questions

Q. What does GINA do?
A: GINA prevents health insurers from denying coverage, adjusting premiums, or otherwise discriminating on the basis of genetic information. Health insurers also may not request that an individual undergo a genetic test. Similarly, employers are prohibited from using genetic information to make hiring, firing, compensation, or promotion decisions. The law also sharply limits a health insurer's or employer's right to request, require, or purchase someone's genetic information.

Q. When will GINA take effect?
A: All provisions of GINA are in effect as of November 21, 2009 (18 months after the bill's signing on May 21, 2008). The health insurance provisions went into effect earlier, depending on when a company's "plan year" begins. (See FAQs on GINA and health insurance for details.)

Q: How do I know whether my information is protected by GINA?
A: The key terms in GINA are "genetic information," "genetic services," and "genetic test."

The term "genetic information" means information about your genetic tests, the genetic tests of your family members, and the manifestation of a disease or disorder in your family members (sometimes referred to as "family history.") It also includes any request for, or receipt of, genetic services, or participation in clinical research that includes genetic services, by you or your family members.

"Genetic information" does not include information about your sex or age.

"Genetic services" may include any of the following: a genetic test, genetic counseling (including obtaining, interpreting, or assessing genetic information), or genetic education.

The definition of "genetic test" in GINA is very specific and technical. The law says that "genetic test" means an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, to detect genotypes, mutations, or chromosomal
changes.

However, according to the health insurance provisions of the law, "genetic test" does not include

"(i) an analysis of proteins or metabolites that
does not detect genotypes, mutations, or chromosomal
changes; or"
"(ii) an analysis of proteins or metabolites that
is 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."

It is important to note that (ii) does not appear in the employment section of the law, so in the workplace, this exception to the definition of genetic test would not apply. In other words, GINA does not prohibit insurers from underwriting based on information that reveals information about current health status. However, employers may not use that same information to make employment decisions.

Q. What are some examples of protected tests?
A. Examples of protected tests are:

  • 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 the Huntington disease mutation
  • Carrier screening for conditions such as cystic fibrosis, sickle cell anemia, spinal muscular atrophy, and fragile X syndrome

During congressional consideration of GINA, a group of scientists and health care providers looked at the definition of genetic test in the bill and compared it to a list of the most-frequently-ordered laboratory tests to make sure they were not accidentally swept into the bill's definition. Routine tests such as complete blood counts (CBC, or blood panel), cholesterol tests, and liver-function tests are not protected under GINA. Also not protected are analyses, including DNA analysis, of infectious agents such as bacteria, viruses, and fungi. An HIV test, for example, is not covered. Although 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.

Further clarification about the scope of these definitions is available from federal regulations.

Q. Is family history considered genetic information?
A. Yes. The definition of genetic information specifically includes the manifestation of a disease or disorder in a family member. "Family member" is defined as a first-, second-, third-, or fourth-degree relative. This means that family history about diseases and disorders of, for example, your mother, grandmother, great-grandmother, and great-great grandmother is protected information under GINA.
 
Q. What are some examples of protected genetic services?
A. One example would be a woman who seeks BRCA testing (genetic testing for breast cancer risk) and learns that she has a mutation that significantly raises her risk of getting breast cancer and ovarian cancer. Typically, this woman would seek genetic counseling before and/or after genetic testing from a doctor and/or genetic counselor who would tell her the risks and benefits of testing and what the test results mean, explain her lifetime risks of developing breast or ovarian cancer, and review clinical options that can reduce those risks. These options would include earlier and more frequent mammograms and preventive measures (such as taking tamoxifen or having preventive surgery to remove the ovaries or breasts). After discussing these options with the patient, the doctor may recommend the best screening and prevention strategy. This genetic counseling would be protected by GINA.

Q. What is not covered by GINA?
A. Currently, long-term care insurance, life insurance, and disability insurance are not covered by GINA. Also, the United States military (or the Tricare military health system), veterans' health care administered by the Veterans' Administration, the Federal Employees Health Benefits Plan, or the Indian Health Service are not included in GINA. However, these health systems have their own policies related to the use of genetic information.


Health Insurance Protections

Q. What health insurance protections does GINA create?
A. Health insurance companies (including those that sell group policies to employers, non-group policies to individuals and families, and Medicare supplemental policies to Medicare enrollees) are not allowed to:

  • determine eligibility (including continued eligibility) for coverage based on genetic information,
  • charge higher or lower premiums based on genetic information, or
  • consider genetic information as a pre-existing condition.

In addition, health insurers are prohibited from asking about genetic information as part of the application process. Once a person is covered, insurers may not ask about or use that person's genetic information for "underwriting purposes" -- for example, to determine whether to raise premiums when an individual renews his or her coverage, or in a wellness program Health Risk assesment if thereis a penalty or benefit associated with answering the questions.

Q. I am applying for an individual health insurance policy. The first question on the application asks whether I've had any lab tests in the past year. I just had genetic testing for colon cancer. Is the insurer allowed to ask me about that?
A. GINA prohibits insurers from asking for, seeking, or obtaining genetic information about applicants before they enroll in coverage. The insurer should modify questions on its application to make clear that it does not intend to ask you about genetic tests or any other genetic information.

Q. I was diagnosed with breast cancer and then took a genetic test to see if that was the reason I got cancer. Can health insurers deny me coverage?
A. Insurance companies cannot discriminate against you based on your genetic information. However, GINA does not prevent discrimination based on your "manifest disease." Because you already have breast cancer, insurers may refuse to sell you a policy. However, there are two things to keep in mind:

  1. Your state insurance laws may offer additional protections. In some states, health insurance companies are prohibited from discriminating against anyone based on his or her health status. Check with your state insurance department for more information. In addition, the new federal health care reform law is likely to improve access to health insurance for individuals with diagnosed conditions.
  2. The manifestation of breast cancer in you also constitutes genetic information about your family members. Health insurers are not allowed to discriminate against your sisters, daughters, granddaughters, or other relatives - no matter where in the United States they may live based on this family history/genetic information.

Q. I learned I have a genetic mutation that increases my risk of getting colon cancer, though I am healthy today. I'm about to enroll in a new health insurance policy. I'm worried if I develop colon cancer down the road, the insurer might say it's a pre-existing condition and exclude coverage for treatment. Can they do that?
A. No. Genetic information can never be used by insurers as the basis for imposing a pre-existing condition exclusion period.

Q. I own a small business with eight employees, including two women (Ann and Alice) who are sisters. One of the sisters (Ann) has breast cancer. Can our group health insurance plan premiums go up at renewal as a result?
A. Although GINA's employment provisions do not apply to employers with fewer than 15 employees, this situation involves GINA's health insurance provisions and thus you and your employees fall under GINA's reach. GINA does not prevent the health insurer from raising your premium based on the manifestation of a disease or disorder in Ann (cancer). However, most states have laws that either limit or prohibit health insurers from adjusting small employer premiums based on the health status of group members.

Ann's cancer is, however, genetic information about her sister, Alice. GINA prohibits the insurer from further increasing your group premium because of Alice's family history of cancer. And if Ann or Alice were to take a genetic test to determine their risk of cancer in the future, the results of the test could not be used as a basis for premium adjustment by the insurer.

Q. My doctor has recommended that I have prophylactic (preventive) surgery to remove my ovaries because a genetic test indicated I am at higher risk of getting ovarian cancer. My health insurance company wants verification of my genetic information before it will pay for the surgery. I thought GINA prevents insurers from asking about my genetic information. Is this allowed?
A. GINA does not prohibit a health insurer from obtaining and using the results of a genetic test in making a determination regarding payment for a claim when that information is necessary to proving that the care is medically necessary. However, the insurer may only request the minimum amount of information necessary to accomplish the intended purpose, proving that the surgery is medically necessary. If your medical record documents that you are at higher risk for ovarian cancer based on your own personal history or family history of cancer, you and your provider may make the case to your insurer that that information is sufficient to justify the medical necessity of your planned surgery.

Like your genetic test results, any family history information is considered "genetic information" under GINA, and thus the insurer may not use it for underwriting purposes.

Q. My doctor has recommended that I have prophylactic (preventive) surgery to remove my ovaries because I have a strong family history of breast and ovarian cancer. My health insurance company wants me to have a genetic test to confirm that I am at higher risk before it will pay for the surgery. I thought GINA prevents insurers from requiring people to undergo genetic testing. Is this allowed?
A. In your case, the insurer may not require testing but may view a positive test result as the best way to justify paying for the procedure. GINA does not prohibit a health insurer from obtaining and using the results of a genetic test in making a determination regarding payment for a claim. The insurer may only request the minimum amount of information necessary to accomplish the intended purpose. Thus if your medical record documents that you are at higher risk for ovarian cancer based on your own personal history or family history of cancer, you may be able to make the case that your family history is sufficient, in the absence of a genetic test, to justify the medical necessity of your planned surgery. Some women with a strong family history of breast and ovarian cancer may have a negative BRCA test result and nevertheless choose to pursue prophylactic surgery.

Like your genetic test results, any family history information would be considered "genetic information" under GINA and thus the insurer may not use it for underwriting purposes.

Q: Does GINA mean that insurers must pay for genetic testing, or that they must pay for the medical care indicated after a patient receives a particular result from a genetic test?
A: No, GINA does not mandate coverage for any particular tests or treatments.

Q. What part of the federal government enforces GINA health insurance protections?
A. Several federal agencies are involved. The U.S. Department of Labor (DOL) has primary jurisdiction over employer health benefit plans. Questions about genetic discrimination in your job-based health insurance coverage can always be directed to DOL. The Secretary of Labor has authority to fine employer-sponsored health benefit plans that do not comply with GINA. In addition, the Internal Revenue Service (IRS) has authority to assess tax penalties on employer-sponsored health benefit plans that do not comply with GINA.

The U.S. Department of Health and Human Services (HHS) has jurisdiction over health insurers and the policies they sell to individuals and employers. HHS also has jurisdiction over Medigap supplemental policies sold to Medicare beneficiaries. However, states (which traditionally are the primary regulators of health insurance) are allowed to adopt and enforce standards that are at least as protective as those required by GINA. The Secretary of HHS will enforce GINA protections when states fail to do so.

Q. How do GINA health insurance protections work with existing state laws?
A:
GINA mandates a minimum level of protection for genetic information. It does not disturb state laws that are more protective; for example, those that prohibit medical underwriting on the basis of any health status factors. Be sure to check with your state health insurance regulator to learn about your protections under state law.

Q. When are states supposed to make their laws conform to new federal GINA standards?
A.
States health insurance regulations must conform by GINA's effective date, which is May 21, 2009. After that date, if state protections do not meet GINA standards, federal enforcement can be triggered.

Q. I am self-employed and buy my own policy. I think my health insurance company may be discriminating against me based on my genetic information. Whom should I call?
A.
Start with your state insurance department. States are authorized to enact provisions identical to those in GINA and enforce the standards of the law themselves. If states fail to enact or enforce one or more GINA protections, federal "fallback" enforcement is triggered and the Secretary of HHS is supposed to enforce these protections and fine the health insurer. Regulations issued by the federal government should provide more information about how coordination between state and federal enforcement will take place.

Q. I get my health benefits through work and I think my group health plan may be discriminating against me based on my genetic information. Whom should I call?
A.
You should contact the U.S. Department of Labor and Department of Health and Human Services, which administer and enforce the laws relating to health insurance. If there is evidence that your employer is directing the health insurer to behave in a discriminatory factor, it is possible that you also should contact the Equal Employment Opportunity Commission. Cases such as these are complex, but may be clarified once the federal agencies issue final regulations implementing GINA.

Q. When do GINA health insurance provisions take effect?
A. The date depends on the type of health coverage you have.

  • For employer-sponsored group health insurance plans, the health insurance protections of GINA took effect for plan years beginning or renewing after May 21, 2009.
  • For non-group health insurance policies, GINA protections took effect on May 21, 2009 and apply to all non-group policies, including those that have already been purchased and are in effect.
  • For Medicare supplemental policies, GINA protections took effect on the earlier of:
    • the date your state adopts GINA protections for its Medigap market
    • May 21, 2009
    • In states that fail to enact GINA protections for the Medigap market, July 1, 2009.

Q. Does GINA protect me when I buy life insurance or long-term care insurance?
A. GINA health insurance protections currently do not apply to the life insurance market or the long-term care insurance market. If you buy these types of coverage on your own, federal law does not protect you. However, some state laws may apply to these types of coverage. Check with your state insurance department for more information.


Employment Discrimination Protections

Q. What are GINA's protections against genetic discrimination in employment?
A.
GINA prohibits discrimination in all aspects of the employment relationship, including hiring, firing, compensation, and any other aspect of employment. Any act by an employer that deprives or tends to deprive any employee of an employment opportunity or otherwise adversely affects that employee because of his or her genetic information is prohibited.

Q. How will GINA's employment provisions be enforced?
A.
 The law will be enforced by the Equal Employment Opportunity Commission (EEOC). All employers must be in compliance by November 21, 2009. Your employer must employ at least 15 employees in order to be liable for a GINA violation.

If you believe that you have a claim for discrimination you first must file a claim with the EEOC in order to later file a claim in state or federal court. The EEOC will then assign an investigator to your case, contact your employer, and attempt to resolve the situation through mediation. If the EEOC finds reasonable cause, it will attempt to resolve the matter through informal conciliation. The EEOC may give you a Right to Sue letter so that you can pursue your rights in court at any time during the process. If at the end of the process a meritorious claim is found to exist, the EEOC will give you a notice of Right to Sue or may actually file a civil suit on your behalf. As with other civil rights laws, compensatory and punitive damages are capped - depending on the size of the employer - at a maximum of $300,000 per offense.

Q: What employment discrimination is not covered by GINA?
A.
GINA covers health insurers and employers (including employment agencies, labor organizations and training programs). Currently, long-term care insurance, life insurance, and disability insurance are not covered by GINA. However, there may be cases in which the refusal to provide these benefits as part of an employment benefits package may constitute genetic discrimination by the employer. In addition, GINA does not cover employers with fewer than 15 employees, and it does not apply to the U.S. military.

Q. Does GINA put any new limitations on existing federal law?
A.
GINA puts new limitations on the Americans with Disabilities Act (ADA) with regards to collection of genetic information.

Given that most individuals' medical files include family history and may even have genetic test information, employers who require access to such records must take measures to avoid improperly collecting genetic information. Collection of medical information that is currently allowed in order to meet a request for reasonable accommodation under the ADA will need to be in compliance with GINA. Similarly, under the ADA there virtually is no limit on the scope of medical evaluations that are permitted after a conditional offer of employment has been made. Under GINA, however, an employer is not permitted to collect genetic information as part of this process.

Q. Are there exceptions to the rule against employer collection of genetic information?
A.
Employers are generally barred from collecting genetic information about an employee or an employee's family member, whether by request, mandatory disclosure, or purchase from a third party. Information about an individual's existing disease or condition, whether or not it has a genetic basis, does not come under the protection of the new law.

Several narrow exceptions do exist that permit employer collection of genetic information; these generally require prior, knowing, voluntary, and written authorization by the affected employee. Such programs include toxic exposure monitoring, wellness programs, and federal and state Family and Medical Leave Act compliance. Employers may view some publicly available documents containing family medical history, such as newspapers and magazines, but employer access to family medical history in medical databases and court records is prohibited. Employers also are protected in cases where they may have made "inadvertent" requests for family medical history.

Q. I'm an employer and when I asked our receptionist how he was, he mentioned that his brother is being treated for colon cancer. Am I in trouble under GINA? What is the "inadvertent" request exception?
A.
An employer who unintentionally asks for family medical history is protected from liability under GINA. (Note this exception applies to family medical history, not genetic information (such as test results) more broadly.) It is meant to protect an employer who is spontaneously offered family medical history or who obtains such as a result of an innocent question. This applies in cases such as yours, or when an employee asks to leave early on a particular day to attend to a mother stricken with breast cancer. This exception is narrow and does not apply to incidents where an employer knows or should know that a request will lead to collection of family medical history.

Q. I work in an office of 18 people and we know a lot about each others' health and families. I'm afraid that my employer will share what she knows about my family history with others outside the office. What is the rule against disclosure of genetic information?
A.
GINA sets strict limits on employer disclosure of genetic information
to third parties. Permitted disclosures are limited to the written request of the employee for themselves or a family member, or for health research, Family and Medical Leave Act certification compliance, and in rare cases when a public health agency requests information about a manifested disease or disorder in a family member that poses imminent hazard of death or life-threatening illness. Disclosure also is permitted in response to a court order (though not a subpoena or discovery request), but the employer must notify the employee of the disclosure if the court order was issued without the employee's knowledge.

Q. What procedures must an employer follow if he or she does obtain genetic information about an employee? For example, where aspects of the employee's medical record were provided to the employer as part of a request for reasonable accommodation under the Americans with Disabilities Act or request for leave under the Family and Medical Leave Act?
A.
As with other medical information obtained by an employer, GINA requires an employer to maintain genetic information as part of a confidential medical record in accordance with the Health Insurance Portability and Accountability Act.

Q. What if my employer discriminates against me not because of my genetic information but because I spoke up about a GINA-related violation by my employer?
A.
GINA prohibits retaliation by an employer against an employee who has opposed a practice made unlawful by GINA.

Q. Are disparate impact claims authorized under GINA?
A.
Disparate impact means an employer may be held liable based on the discriminatory impact of a policy, even if the policy or practice is "facially neutral" - i.e., does not appear to be discriminatory on its face, but is discriminatory in its application or effect. GINA does not authorize disparate impact claims, but does create a bipartisan commission to study this issue and make recommendations.

Q. How do GINA employment provisions interact with state employment law?
A.
GINA does not disturb state laws that are more protective. Plaintiffs may bring a claim under either GINA or their state genetic discrimination law or both. Thirty-four states have enacted genetic nondiscrimination in employment laws to date. Of these, 21 states allow for a private right of action. While most state genetic discrimination laws offer fewer protections than GINA, a number allow for greater monetary recovery.

Q. I have a new job offer, but the offer does not include the same benefits offered to other employees. I think the employer knows that I am at increased risk for cancer and wants to hire me but not provide me with benefits they believe are likely to be costly. Is this legal under GINA?
A.
If your employer provides life or disability insurance as part of your employment benefits and you are discriminated against by the employer in the way these benefits are provided or administered, then you would have a cause of action against the employer (but not against the insurance provider). If your employer offers health insurance as part of the standard package of benefits but is not offering those benefits to you, it is possible you could have a claim against both the employer and health insurer. You should consult an attorney and/or the federal agencies charged with enforcement of GINA.

Transcript of GINA Q & A session, December 3, 2008