After more than a decade of effort, supporters of the Genetic Information Nondiscrimination Act (GINA) were finally granted their wish. Passed overwhelmingly by the Senate (95-0) and House (414-1), GINA was signed into law today, May 21, 2008, by President Bush. Title I prohibits genetic discrimination in the area of health insurance while Title II ensures nondiscrimination in the employment arena.
Employers have plenty of time to bring their plans and workplaces into compliance. The Act’s group health plan provisions are effective for plan years beginning one year after enactment. The employment provisions become effective 18 months after enactment – November 21, 2009.
Health Plan/Health Insurance Highlights
The Act amends ERISA, the Public Health Service Act, and the Internal Revenue Code to prohibit group health plans and health insurance issuers from (a) adjusting group premium or contribution amounts on the basis of genetic information or (b) requesting, requiring or purchasing genetic information for underwriting purposes or with respect to any individual before that individual’s enrollment in a health plan. Except under limited circumstances involving voluntary participation in research studies, the Act also prohibits group health plans and health insurance issuers from requesting or requiring individuals or family members to undergo genetic tests.
Notwithstanding the Act’s prohibitions, group health plans and health insurance issuers can still adjust health plan premiums based on diseases or disorders that have already manifested themselves. Also, the Act does not prohibit group health plans or health insurance issuers from obtaining genetic information incidental to a request, requirement or purchase of other information that does not involve a request, requirement or purchase of genetic information for underwriting purposes.
Violations of the Act by any group health plan sponsor or health insurance issuer can result in penalties of $100 per day per affected participant or beneficiary. If violations are not corrected before the enforcing agency notifies the plan sponsor or health insurance issuer of the violation, minimum penalties can range from $2,500 to $15,000. No penalties attach, though, if the person otherwise liable did not know and, exercising reasonable diligence, would not have known of a violation or if a violation due to reasonable cause is corrected within a certain time period.
The Departments of Labor, Health and Human Services, and Treasury must issue regulations or other guidance to carry out the Act within one year of its enactment. In addition, the Secretary of Health and Human Services must publish revisions to HIPAA’s privacy regulations in the Federal Register not later than 60 days after enactment. These revisions will be effective upon publication and will provide that genetic information is to be treated as “protected health information” and that a covered entity that is a group health plan or health insurance issuer may not use or disclose genetic information for underwriting purposes.
Employment Discrimination Highlights
From the perspective of private employers, GINA draws heavily on Title VII. It not only expressly adopts Title VII’s definitions for terms like “employee,” “employer,” “employment agency” and “labor organization” but also uses Title VII’s remedial and enforcement structure. Thus, allegations of genetic discrimination will begin with a charge of discrimination and investigation by the Equal Employment Opportunity Commission before ending, possibly, with a lawsuit in federal court. And, those discriminated against based on their genetic information will have the same federal relief available as those discriminated against because of their race, color, sex, religion or national origin.
In essence, "genetic information with respect to the employee" becomes a new protected classification upon which employers, employment agencies, and labor organizations may not discriminate. "Genetic information" is defined as:
"with respect to any individual, information about –
(i) such individual’s genetic tests,
(ii) the genetic tests of family members of such individual, and
(iii) the manifestation of a disease or disorder in family members of such individual.
The phrase also includes “any request for, or receipt of, genetic services, or participation in clinical research which includes genetic services” but, significantly, does not include information about the sex or age of any individual.
The term "family member" is then defined to include a "dependent" as that term is defined by section 701(f)(2) of ERISA and first through fourth degree relatives of such dependents. "Genetic services" are broadly defined to include tests, counseling (including obtaining, interpreting, or assessing genetic information) and education, while "genetic test" means "an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, that detects genotypes, mutations, or chromosomal changes."
In contrast with Title VII, GINA expressly provides that "disparate impact" based on genetic information is not now actionable. Six years following its enactment, however, GINA creates a Genetic Nondiscrimination Study Commission "to review the developing science of genetics and to make recommendations to Congress regarding whether to provide a disparate impact cause of action under this Act." The EEOC is also charged with adopting regulations to implement the Act within one year, which will be 6 months before its effective date in the employment arena.
In addition to prohibiting discrimination based on genetic information, GINA makes it an unlawful employment practice for a covered entity "to request, require, or purchase genetic information with respect to an employee or a family member of the employee" except in limited circumstances. Where covered entities possess genetic information, they must maintain it on separate forms, keep it in separate files and treat it as confidential medical information. Compliance with the requirements for confidential medical records under the Americans With Disabilities Act will also satisfy GINA’s confidentiality provisions.
Employers and group health plan sponsors should consider the following steps as they prepare for GINA’s implementation:
- Review current policies and practices relating to medical information to determine whether changes are required to comply with GINA;
- Monitor the issuance of regulations to determine whether certain requests for family medical history by group health plans, including employer-sponsored wellness programs, will result in violations of GINA;
- Confirm compliance with HIPAA and the ADA; and
- Consider what training may be required for human resources personnel, occupational health and safety personnel, or others to ensure compliance.