Thursday, November 26, 2009

Genetic Nondiscrimination

The Genetic Information Nondiscrimination Act of 2008 (GINA) is an extremely important anti-discrimination law. GINA prohibits employers from requesting genetic testing or considering someone's genetic background in hiring, firing, or promotion. The implementation of GINA exists to facilitate the collection and analysis of patient genetic information that is necessary to make personalized medicine and companion diagnostics standard medical care practice.

My company is involved in technology that empowers personalized medicine and companion diagnostics. These fields of activity work to tailor medical therapies to the individual patient, taking into account the individual's genetics. Application of our microarray technology is part of the growing effort that empowers healthcare providers to move from a one-size-fits-all approach to one that identifies the most effective treatment for each individual patient. The discovery and validation of the biomarkers used in microarray assays requires careful planning and the analysis of correctly identified patient sample populations and medical histories. Implementation of GINA as a law in the United States will help facilitate the collection of such information because the act protects patient confidentiality!! Something we take very seriously.

GINA was signed by President George W. Bush on May 22, 2008 it reads...

establish ... a national and uniform basic standard [that] is necessary to fully protect the public from discrimination and allay their concerns about the potential for discrimination, thereby allowing individuals to take advantage of genetic testing, technologies, research and new therapies.

Under the Ombama Administration, on October 7, 2009, the U.S. Department of Health & Human Services (HHS) and other agencies sought to strengthen patient protection provided under GINA. The HHS, U.S. Department of Labor and the U.S. Department of the Treasury, proposed to modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to

(1) explicitly provide that genetic information is health information for purposes of the rule and

(2) prohibit health plans from using or disclosing protected health information (PHI), which would include genetic information, for underwriting purposes.

In addition, while GINA's prohibition on using or disclosing genetic information for underwriting purposes currently applies only to certain health plans, HHS clarifies in the Rules that such prohibitions apply to all health plans that are subject to HIPAA.

So basically this means that your insurance company can't use the results of a genetic test against you, which looked at in another way means that it can only help. To quote, Kathleen Sebelius, HHS Secretary, "...by protecting Americans undergoing genetic testing from having the results of such tests used against them..."

These are very good rules, genetic testing is here to help people. The genetic information should only help diagnose and treat diseases, not do harm in anyway. Genetic information empowers medical reseachers with important information that leds to new medicines, treatments, and therapies. In some cases it empowes the early diagnosis and treatment of certain diseases, an area that Arrayit is keenly working on.

It is important to note it is illegal for group health plans and health insurance issuers to request, require, or buy genetic information for underwriting purposes or prior to and in connection with enrollment in a health insurance plan. Insurance companies cannot increase premiums, deny coverage, or have pre-existing condition exclusions based on genetic information! Health plans and issuers also are generally prohibited from asking individuals (or family members) to undergo genetic testing, but in my opinion in most cases it's better know the information. It is my hope that this privacy protection will promote participation in genetic research and therapies by insureds who might otherwise avoid them for fear that results could be adverse to their health insurance premiums and coverage.

So next time if you are presented the opportunity to participate in a genetic study, or need a genetic test, have the confidence to go ahead with it. On an upcoming post I will be putting up photographs of my experience providing my personal fibroblast sample to the Parkinson's Institute.

Todd Martinsky
todd@arrayit.com