On May 21, 2008, President Bush signed the Genetic Information Nondiscrimination Act of 2008 (GINA). After having been introduced in Congress for the past 13 years, the bill received near-unanimous Congressional support in this most recent effort. Although its title may cause many to dismiss the bill as acutely focused, GINA has a broad impact affecting health insurers and employers.
The Congressional findings listed in GINA include both the promise of the emerging science of genetic testing and the concern of entering into the field without standardized protections. The findings cite historical examples of State legislatures discriminating against groups of people with genetic "defects," including State sterilization laws, as compelling the need for Congressional action. For further support, GINA references modern examples of genetic discrimination in the workplace and Americans' apprehensions of potentially negative consequences from receiving genetic testing. The aim is to establish a basic standard of protection, "thereby allowing individuals to take advantage of genetic testing, technologies, research, and new therapies."
Impact on Health Insurers
GINA regulates discrimination based on genetic information in the health insurance industry by amending several pieces of already existing federal legislation, including: (1) The Employee Retirement Income Security Act of 1974 (ERISA); (2) The Public Health Service Act; (3) The Internal Revenue Code of 1986; and, (4) The Social Security Act. Through these amendments GINA regulates health insurers offering group health plans or insurance, individual health insurance, and Medicare supplemental policies (commonly referred to as "Medigap policies"). Conversely, GINA does not regulate long-term care insurers, life insurers, or health care providers.
The genetic information of an individual includes the genetic tests of that individual or his or her family members, and the manifestation of a disease or disorder in family members of the individual. Reference to an individual or family member includes fetuses and embryos. Genetic information does not include the sex or age of any individual.
At its core, the legislation makes it unlawful for health insurers to use genetic information for enrollment screening or underwriting purposes. It prohibits a health insurer, whether a group or individual insurer, from requesting, requiring, or purchasing genetic information of an individual or an individual's family member for such purposes. In other words, an insurer cannot require an applicant to submit to a genetic test, nor require disclosure of genetic information, before determining eligibility for enrollment in a plan. Also, genetic information cannot constitute a pre-existing condition for a policy. If an individual is already covered by a policy, an insurer cannot thereafter make similar requests in an effort to adjust premium or contribution payments.
Genetic information is different from a manifested illness or condition. Insurers are not prevented from denying coverage, limiting pre-existing conditions, or adjusting premiums based upon a manifested illness or condition, whether genetically caused or otherwise. However, when a policy includes members of the same family, the manifestation of a condition in one member cannot be used to raise premiums based on a likelihood of other members carrying the genes for that same condition. For example, a group health insurer can raise premiums when a member is diagnosed with colon cancer; however, that insurer cannot further raise premiums because that member's brother is also in the group and proportionately more likely to also be diagnosed.
There are, however, exceptions to the blanket prohibition. For example, an insurer may request a beneficiary undergo a genetic test if it is done as part of research. If so, there are several requirements the insurer must meet, including making clear compliance with the request is voluntary, not using the information for underwriting purposes, and notifying appropriate authorities of the research. Also, an insurer may obtain and use the results of a genetic test in making a determination regarding payment, e.g., a determination of medical necessity. In that instance, the insurer is limited to requesting only the minimum amount of information necessary to accomplish that purpose. Finally, if genetic information incidentally comes with the request, requirement, or purchase of other information, it is not deemed a violation unless that genetic information gets used for underwriting purposes.
GINA amends Title XVIII of the Social Security Act to apply the above prohibitions specifically to insurers offering Medigap policies. It also includes genetic information under the confidentiality requirements for health information for purposes of HIPAA, prohibiting its use or disclosure for underwriting purposes. If a health care professional is providing health care services, the Act clearly expresses noninterference with requests by that professional for an individual to undergo a genetic test.
Impact on Employers
Title II of GINA applies to employers, employment agencies, and labor organizations. It adopts the definitions used in Title VII of the Civil Rights Act of 1964 for those entities, meaning it generally applies to employers with fifteen or more employees.
All of the above entities are prohibited from discriminating on the basis of genetic information. The prohibitions for employers cover the entire range of ways in which an employee could claim discrimination, from hiring decisions to employee status. The requirements of agencies and labor organizations differ only in ways related to their functions, e.g., agencies cannot discriminate in their referrals for employment, and organizations cannot discriminate in membership.
Each of the entities is also prohibited from requesting, requiring, or purchasing genetic information with respect to an employee/member or his or her family member. However, a list of exceptions applies nearly uniformly to each, as long as the information is not then used to discriminate. For example, it is not a violation to inadvertently request or require a family medical history, or to obtain that information in order to comply with the certification provisions of the Family Medical Leave Act (FMLA). If an employer offers health services, an employee can consent to receiving genetic services as long as it remains confidential and any information the employer receives is not identifiable to the specific employee. Also, it is not illegal for an employer to purchase commercially available documents, not including medical databases or court records, which contain family medical history. An employer may have in place a program for genetic monitoring of effects of exposure to toxic substances. If so, the program is allowed if several requirements are met. Finally, an employer may conduct DNA analysis in compliance with law enforcement.
If an employer, agency, or organization does possess genetic information of an individual, it must be maintained in confidential medical records. Disclosure of that information is limited to specific circumstances. Addressing a Congressional concern, GINA does not require employers to keep separate medical files solely for genetic information. Rather, genetic information can be maintained with general health information, and the confidentiality of the aggregate is governed by HIPAA.
Implementing Compliance With GINA
Title I, dealing with health insurance, begins affecting policies for plan years after May 21, 2009. Title II, for employers, agencies, and labor organizations, has an effective date of November 21, 2009. Further, 41 states already have genetic anti-discrimination laws, and GINA does not displace any federal or state statute that provides equal or greater protection to an individual. Therefore, an insurer or employer visiting policies in light of GINA should also review its compliance with any relevant state statutes.
Policy changes in light of GINA could include the following: adding genetic information to all non-discrimination policies; revisiting procedures for maintaining confidential medical records; and, ensuring any questionnaires or other information collection does not touch potential genetic information. Insurers and employers should eliminate any inquiries into family medical histories. Even if an employer is making the inquiry to comply with FMLA certification, it should carefully limit the scope of the process.