On May 21, 2008, President Bush signed into law the Genetic Information Nondiscrimination Act of 2008 (GINA). The purpose of the legislation is to establish a national and uniform standard to protect the public from genetic discrimination, and to encourage individuals to take advantage of genetic testing, technologies, research, and new therapies.
GINA amends broad legislation including the Employee Retirement Income Security Act (ERISA), the Public Health Security Act (PHSA), the Internal Revenue Code, the Social Security Act relating to medigap, and the Health Insurance Portability and Accountability Act (HIPAA). These amendments affect group health plan, individual, and Medicare supplemental policy issuers from discriminating based on genetic information. Significantly, GINA covers the vast majority of health insurance plans, but as yet does not apply to other common types of insurance, including disability, life, and long-term care insurance issuers. Finally, while GINA is directed at the insurance industry and employers, its broad scope may affect health care providers as well.
Core Prohibitions
GINA prohibits health insurance issuers from:
- requesting or requiring an individual to undergo a genetic test, subject to certain exceptions
- collecting genetic information for underwriting purposes or prior to plan enrollment
- adjusting premium or contribution amounts on the basis of genetic information
Impact on Health Care Providers
The Secretaries of Labor, Health and Human Services, and Treasury are required to issue regulations in compliance with GINA by May 21, 2009. Much of GINA’s impact will be determined as these regulations are put into place. However, GINA already presents several questions to health care providers.
- Broad application. GINA’s definition of “genetic information” gives it broad reach. Specifically, “Genetic information” encompasses information about an individual’s genetic tests, the genetic tests of family members, and the manifestation of a disease or disorder in family members of such individual. Furthermore, “genetic information” includes any request for, or receipt of, genetic services or participation in clinical research, including genetic services by an individual or any family member.
- Protection of information. GINA amends HIPAA by providing that “genetic information” is to be treated as “health information.” Consequently, it may be that revised HIPAA regulations will require health care providers to provide genetic information with special protection or to segregate it from other types of health information.
- Enforcement. Violators face financial penalties, largely at the discretion of the Secretary. There is, however, a safe harbor provision that affords violators 30 days to remedy inadvertent violations and to avoid the imposition of penalties.
For a more detailed summary of GINA, click here.