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Long-awaited federal regulations implementing the landmark Genetic Information Nondiscrimination Act (GINA) of 2008 are nearly complete, and will go into effect by the end of this year.
GINA prevents health insurers from denying coverage or adjusting premiums on the basis of genetic information, or requesting that an individual undergo a genetic test. Employers are prohibited from using genetic information to make hiring, firing, or promotion decisions. The law also sharply limits an employer's right to request, require, or purchase an employee's genetic information.
Interim final rules developed by the Departments of Health and Human Services, Labor, and Treasury, were published in the Federal Register on Oct. 7, 2009. The proposed regulations spell out steps to be followed by insurers to ensure that they don’t collect genetic information that could be used in underwriting. Specific measures include:
* Insurers are prohibited from collecting genetic information, except if that collection is “incidental”. A request for medical records must explicitly state that genetic information, including family history, should not be provided.
* Underwriting is prohibited. This includes not only rating and pricing insurance policies, but also offering financial incentives for participating in health risk assessments or wellness programs. An insurer may collect family history or genetic information as part of a health risk assessment or wellness program from people already enrolled in insurance, as long as no rewards are provided.
* An insurer may request but not require than an individual undergo a genetic test as part of a research study, if strict conditions are met.
Public comments on the regulations are being accepted through Jan. 5, 2010, but the rules become effective on December 7, 2009. The agencies can change the rules after that date, to reflect information in the public comments.
The Office of Civil Rights at HHS also issued regulations on Oct. 7, in order to make the Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant with GINA. The OCR has extended the prohibition on use and disclosure of genetic information for underwriting to all entities covered by HIPAA. These rules are open for public comment through Dec. 7, 2009, with a final rule expected after that date.
GINA regulations related to employment are on a different timetable, as they are overseen by the Equal Employment Opportunity Commission. Final regulations should be issued soon, as GINA requires that employment-related prohibitions be in effect by Nov. 21, 2009.
The Genetics and Public Policy Center continues to monitor the GINA regulatory process closely, in order to provide current information to consumers, patients, insurers, employers, providers and researchers on how the new law will affect genetic privacy in health insurance, the workplace, and the laboratory. - Susannah Baruch
