Who Is GINA? And Why Should I Care?

GINA is not a "who," but a "what": The Genetic Information Non-Discrimination Act. Signed into law on May 21, 2008, the initial regulatory and health insurance-related provisions become effective on May 22, 2009, some 2 weeks hence. The various agencies involved are required to have regulations in place by this month. The employment components of the law take effect in November 2009.

The provisions of the law are as follows: In general, GINA prohibits discrimination with regard to health insurance or employment based on genetic information. In combination with existing HIPAA provisions, the law prohibits health insurers or plan administrators from requesting or requiring any genetic data from any individual or family members, or using such data for any decisions regarding insurance coverage or rates, or the diagnosis of preexisting conditions. Additionally, GINA prohibits (most) employers from using any genetic information for decisions regarding hiring, firing, or promotion.

There are exceptions: The law does not apply to life or disability insurance (the former would seem to me to be of particularly significant consequence). GINA does not require insurance coverage for genetic testing, nor does it prohibit insurers from using genetic data in determining payment for claims. The employment provisions do not apply to small companies with less than 15 employees. Also, certain exceptions apply for research done by health plans.

So, what does this have to do with neurology? From a neurologic standpoint, the most likely immediate impact is with regard to Huntington's Disease (HD). Genetic testing is already in common use for HD, as well as Fragile X syndrome, the most common inherited cause of mental retardation. Such testing is also commonly used to detect certain inherited disorders (e.g. Factor V Leiden) which are important causes of stroke, especially in younger persons. Other disorders where GINA will be germane include Parkinson's disease, autism, and Tourette's syndrome, as well as less common but genetically well characterized disorders such as myotonic dystrophy. In future, people with migraine and others may appreciate the manifestations of this new law, as the genetic bases of such problems become clearer. Relevant non-neurologic situations include the BRCA gene and associated breast cancer, as well as the FDA required package labeling changes regarding genetic testing and warfarin dosing.

There are opposing viewpoints on the value of this legislation. Advocates note that the law adds discrimination protection for genetic information to protections from existing laws. One organization opines that: "When GINA takes effect in November 2009, all Americans will be free to use genetic information in health management."

Some opponents of the law criticize the absence of a "direct threat" provision. As a result, employers cannot use genetic information in decisions regarding job qualifications for positions which produce a threat to the public (such as seizures in a person driving a commercial vehicle.) Another cited concern is that individual insurance will be priced by pooling people who both have and do not have conditions associated with high medical expenses. Consequently, people who have test data indicating the absence of such conditions will be paying considerably more than their individual risk justifies. They may then not purchase such insurance, creating an adverse selection bias. Furthermore, it is not at all clear that this legislation is solving an existing problem. There is no evidence that genetic discrimination is widespread. Apparently the intent is to prevent harm which has not yet occurred, and, indeed, might not occur.

I tend to get somewhat nervous when Congress, a body comprised largely of lawyers, and with scant knowledge of science, gets involved in matters medical. Nevertheless, this is now the law, and the initial provisions will take effect soon. The benefits and unintended consequences will become clearer in the months to come.