GINA Questions and Answers

A companion to New Genetic Nondiscrimination Law Applies to Employers and Health Insurers, this question and answer format is a convenient reference regarding definitions, exceptions and penalties for noncompliance with these requirements.

When is GINA effective?

• Amendments to ERISA are effective for plan years beginning after May 21, 2009 (Jan. 1, 2010 for calendar year plans).
• Amendments to Title VII are effective Nov. 21, 2009.
• Regulations (other than HIPAA privacy) are due by May 21, 2009.

What does genetic information include?

• Genetic tests, e.g., DNA analysis or test that detects genotypes, mutations or chromosomal changes.
  • Individual—includes fetuses and embryos
  • Family member—up to the 4th degree, e.g., great, great-grandparents and their descendents
  • For example, a plan must not discriminate against a pregnant woman's fetus that has been genetically tested for Down syndrome on the basis of the genetic test.
• Genetic services, e.g., counseling, education and genetic information interpretation
  • Individual
  • Family member
  Manifestation of a disease or disorder
  • Family member (not including an individual's own manifestation of disease or disorder). This includes family medical history.
• Genetic information does not include
  • Blood tests not designed to detect genotypes, mutations or chromosomal changes
  • Cholesterol tests
  • Liver-function tests
  • Sex
  • Age

Who is affected by GINA?

• Health Insurance
  • Small and Large Group Health Plans
  • Church Plans
  • Non-federal Government Plans
  • Individual Insurers
  • Medicare Supplement Insurers
• Employment
  • Employers
  • Employment Agencies
  • Unions
  • Apprenticeships

How does GINA impact employers?

• Employers must not discriminate in terms and conditions of employment based on genetic information. For example, an employer must not deny a job to someone because he or she has a family history of cancer.
• Employers must not segregate, limit or classify employees based on genetic information.
• Employers must not retaliate based on opposition to actions or practices prohibited by GINA.
• Employers must not request, require, purchase or disclose genetic information about employees. For example, a health risk assessment requesting family medical history will no longer be allowed, unless an exception applies.

What exceptions exist regarding employment discrimination under GINA?

• Inadvertent exception
  • An employer does not violate the law by inadvertently obtaining genetic information through casual conversation with employees or similar means.
• FMLA exception
  • Employers may collect information required to satisfy the Family and Medical Leave Act (FMLA). For example, employers may require an employee to disclose that she is taking FMLA leave because her mother has breast cancer, even though her mother's breast cancer is genetic information of the employee.
• Wellness exception
  • This elaborate exception applies to wellness programs and requires that:
    • The employee provide prior, knowing, voluntary and written authorization;
    • Any individually identifiable genetic information is provided only to a health care professional; and
    • Employers may obtain only aggregated genetic information.
  • If all of these criteria are met, employers may have health risk assessments that request family medical history.
• Publicly available exception
  • Employers may obtain genetic information from commercially and publicly available sources such as newspapers, magazines, periodicals and books.
• Toxic workplace substances exception
  • Employers may test for the effect of toxic workplace substances. This exception requires that:
    • The employer provides written notice of the testing;
    • The employee provides prior, knowing, voluntary and written authorizations;
    • Testing is required by law; and
    • Testing is conducted in compliance with the Department of Labor's Occupational Safety and Health Act, Federal Mine Safety and Health Act and Atomic Energy Act regulations.
  • Employers may obtain aggregated genetic information only.
• Law enforcement exception
  • Employers may request genetic information of employees to maintain quality control of samples in a forensic lab or for purposes of identifying human remains.

What exceptions exist regarding employer disclosure of genetic information under GINA?

• Employee consent exception
  • Employers may disclose genetic information if the employee has provided a written request for disclosure.
• Occupational health researcher exception
  • Employers may disclose genetic information to a health researcher if they do so in compliance with Department of Health and Human Services regulations regarding Protection of Human Research Subjects.
• Court order exception
  • The disclosure of genetic information by court order must be limited to the genetic information expressly authorized by the order.
  • The employer must notify the employee of the court order and contents of the disclosure.
  • This exception does not include subpoenas or discovery requests without a court order.
• Government official investigation exception
  • Employers may disclose genetic information to any government official investigating compliance with GINA.
• FMLA exception
  • Employers may disclose genetic information to comply with the certification process of the FMLA.
• Public health agency exception
  • Employers may disclose genetic information regarding a contagious disease that poses an imminent threat to public health agencies, if the employee is given notice of the disclosure.

What are the consequences for employers violating GINA?

• Damages may include:
  • Front pay,
  • Back pay,
  • Compensatory,
  • Emotional distress and
  • Punitive damages.
• Disparate impact theory is not available.

How does GINA impact health insurers (including group health plans)?

• Health insurers must not request or require genetic testing based on genetic information.
• Health insurers must not adjust premiums or contributions for a covered group based on genetic information.
• Health insurers must not request, require or purchase genetic information for underwriting or prior to enrollment.
• Does not include increasing premium for an individual with a manifested disease or disorder.

What exceptions exist regarding health insurer discrimination under GINA?

• Health care professionals exception
  • Health care professionals may continue to require or request genetic information of an individual.
• Payment exception
  • Health insurers may request the least amount of genetic information needed in determining whether to pay claims. For example, a plan that covers cancer screening every 10 years could authorize more frequent testing based on requested genetic information.
• Research exception
  • This elaborate exception applies to research. The research must:
    • Be voluntary;
    • Be requested in writing;
    • Be compliant with Department of Health and Human Services regulations regarding Protection of Human Research Subjects;
    • Not affect enrollment, premiums or contributions;
    • Not result in the information collected being used for underwriting purposes; and
    • Include notification regarding the research by the plan or insurer to the Secretary of Labor.
  • If all of these criteria are met, health insurers and plans may conduct genetic research.

What are the consequences for health insurers violating GINA?

• Penalties and taxes (same as COBRA taxes under Internal Revenue Code § 4980B):
  • No penalties if reasonable diligence used or if failure due to reasonable cause,
  • No penalties if failure is corrected within a 30-day grace period,
  • Minimum penalty of $2,500 per person, per day for de minimus, uncorrected failures—increases to $15,000 per person, per day for more than de minimus violations,
  • Maximum for unintentional violations of less than $500,000 or 10% of the amount paid for group health plans in preceding taxable year and
  • The Secretary of Labor has discretion to waive penalties.

What is GINA's effect on state law?

• State law is not preempted, so more protective state laws must still be followed.