The Employee Benefits Security Administration (the “EBSA”) has issued guidance, in the form of FAQs, on the Genetic Information Nondiscrimination Act (“GINA”). The following are some of the more interesting points.
GINA applies generally to group health plans. Unlike Title I of HIPAA, there is no exception for very small health plans, e.g., those with less than two participants. The statutory provisions of GINA are effective for plan years beginning on or after May 21, 2009, and regulations on GINA, issued on October 7, 2009, apply to plan years beginning on or after December 7, 2009. Therefore, for calendar year plans, the statute and regulations apply as of January 1, 2010.
GINA contains the following specific protections:
–GINA provides that group health plans cannot determine or adjust a participant’s premiums or contributions based on any participant’s genetic information. However, premiums or contributions may be increased for participants based on the manifestation of a disease of any participant.
–GINA generally prohibits group health plans from requesting or requiring an individual to undergo a genetic test. However, a health care professional providing health care services to an individual ( such as a physician, nurse, physician’s assistant, or technician) is permitted to request a genetic test. The plan may request the results of a genetic test to determine whether a claim for benefits should be paid, but only the minimum amount of information needed to make this determination.
–GINA prohibits a group health plan from collecting genetic information (including family medical history) from an employee prior to or in connection with his or her enrollment in the plan, or at any time for underwriting purposes. A “collection” includes any request, requirement, or purchase. Under GINA, “underwriting purposes” includes rules for determining eligibility for benefits and the computation of premium and contribution amounts. Thus, under GINA, the plan is generally prohibited from offering rewards in return for the provision of genetic information. GINA includes an exception for incidental collection of genetic information, provided the information is not used for underwriting purposes. However, this exception is not available if it is reasonable for the plan to anticipate that health information will be received in response to the collection, unless the collection explicitly states that genetic information should not be provided.
For these purposes, “genetic information” generally means information about: (1) an individual’s genetic tests, (2) the individual’s family members’ genetic tests, (3) the manifestation of a disease or disorder in the individual’s family members, or (4) any genetic services (including those provided during clinical research), rendered to the individual or his or her family members. In the case of a pregnant woman (or a family member of the woman), genetic information includes genetic information about the fetus and, with respect to an individual using assisted reproductive technology, genetic information about the embryo. Genetic information does not include information about the sex or age of any individual.
A “genetic service” is a genetic test, genetic counseling, or genetic education. A “genetic test” is an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, if the analysis detects genotypes, mutations, or chromosomal changes. A genetic test does not include an analysis of proteins or metabolites directly related to a manifested disease, disorder, or pathological condition. A “manifested disease” is a disease, disorder, or pathological condition for which an individual has been or could reasonably be diagnosed by a health care professional. A disease is not manifested if a diagnosis is based principally on genetic information.
A point about mamograms-if the plan normally covers mammograms for participants starting at age 40, but covers them at age 30 for individuals with a high risk of breast cancer, the plan may require an individual under 40 to submit genetic test results or family medical history as evidence of high risk of breast cancer (limited to the minimum amount of information needed), in order to have a claim for a mammogram paid.