New Genetic Nondiscrimination Law Applies to Employers and Health Insurers

The Genetic Information Nondiscrimination Act of 2008 (GINA), signed by President Bush on May 21, amends several statutes regarding employment and health insurance, including Title VII of the Civil Rights Act of 1964 (Title VII), the Employee Retirement Income Security Act of 1974 (ERISA) and the Internal Revenue Code of 1986 (Code). GINA's stated intent is "to prohibit discrimination on the basis of genetic information with respect to health insurance and employment." Sections of the law related to health insurance will take effect for plan years beginning after May 2009 (January 1, 2010 for calendar year plans). Employment-related changes will take effect in November 2009.

According to GINA's supporters, many Americans have declined genetic testing and services for fear that information about genetic findings could affect their health insurance and employment. GINA is designed to relieve these fears by protecting the public from discrimination based on genetic information. GINA is, however, unique in the history of nondiscrimination law, in that it was written primarily to be proactive, rather than as a reaction to pervasive discrimination. Without such a history of past discrimination, it is particularly difficult to predict GINA's impact either on health insurance or employment.

See "GINA Questions and Answers" (page 8) for a convenient reference to GINA's requirements as well as exceptions to the new law.

Genetic Information

GINA broadly defines "genetic information" to include the results from or information about "genetic tests" or "genetic services" for an individual or "family member" and the manifestation of a disease or disorder in a "family member." Genetic information does not, however, include an individual's age or sex. "Genetic tests" generally include analysis of DNA and chromosomes to detect genotypes, mutations or chromosomal changes. (See "GINA Questions and Answers" for examples.) Covered "family members" include fourth-degree relatives, such as great-great-grandparents and their descendants.

GINA also protects the genetic information of fetuses and embryos. For example, a health care 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.

Amendments to Title VII

GINA amends Title VII to prohibit employers, among others, from discrimination in the terms and conditions of employment based on genetic information. The rights, procedures and remedies for GINA are the same as for Title VII. GINA does not allow a cause of action based on disparate impact, but GINA contemplates that such a cause of action could exist. The statute establishes a commission—beginning six years from enactment of GINA—to study developments in genetic technology and consider the application of the disparate impact theory to genetic information.

Employers must not fail to hire, discharge or classify employees on the basis of genetic information, and must not request, require or purchase genetic information, unless an exception applies. (See "GINA Questions and Answers" for a discussion of exceptions.) Finally, employers must not retaliate against an individual based on the exercise of rights created by GINA.

Genetic information, whether lawfully or inadvertently collected by employers, must be kept in a separate file from the employee's personnel file. Employers must not disclose employees' genetic information, unless an exception applies. (See "GINA Questions and Answers" for a discussion of exceptions.)

Amendments to ERISA and Other Statutes

GINA amends ERISA and the Code to impose penalties and taxes for discrimination in health insurance on the basis of genetic information. Group health plans, among others, must not request or require genetic information for underwriting or enrollment purposes, unless an exception applies. (See "GINA Questions and Answers" for a discussion of exceptions.) GINA also prohibits health insurers from increasing premiums on a group basis based on genetic information.

GINA required the U.S. Department of Health and Human Services to issue final regulations to include "genetic information" in the definition of "private health information."

While GINA itself does not impose any notice obligations on health insurers or employers, future regulations may create such obligations.

Regulations

GINA requires that regulations be published by May 21, 2009. Many issues are left to be addressed in these regulations, including:

• Whether a disease or disorder of family members has to be a genetic disease or disorder—and specific examples of genetic tests;
• If the "bona fide occupational qualification" defense, which may be used by employers in defense of some other cases under Title VII, may be used by employers in cases of genetic discrimination;
• Whether there is any exception to GINA for employers requesting information for non-FMLA leaves such as paid leaves of absence or bereavement leaves, or for providing reasonable accommodations required under the Americans with Disabilities Act; and
• How the maximum penalty for health insurers will be calculated.

Regulations addressing those and many other issues will to a large extent determine GINA's ultimate impact. The agencies responsible for the GINA health insurance regulations have requested comments from the general public regarding health insurance issues under GINA. These comments are due by December 9, 2008.

GINA Questions and Answers

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 any test that detects genotypes, mutations or chromosomal changes for:
• Individuals—includes fetuses and embryos
• Family members—up to fourth-degree relatives (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 the interpretation of genetic information for:
• Individuals
• Family members
• Manifestation of a disease or disorder by:
• Family members (not including an individual's own manifestation of disease or disorder). Family medical history is included
• 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 affect 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 provides 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 the above 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 authorization;
• 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 affect 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 prohibit 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 Code Section 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 percent of the amount paid for group health plans in preceding taxable year

The Secretary of Labor has discretion to waive penalties.

What is GINA's effect on state law?