General Purpose of the Legislation

Question:

What additional protection or purpose would be served by further legislation to safeguard individuals from the improper use of genetic information not already addressed by current federal law or regulations?

Discussion:

Numerous provisions of current federal law and regulation already protect individuals from improper use of genetic information. For example, the Health Insurance Portability and Accountability Act (HIPAA) already prohibits employer group health plans from imposing enrollment restrictions or charging higher rates based on genetic information or other health status information. In addition, the Equal Employment Opportunity Commission (EEOC) has taken the position that the Americans with Disability Act (ADA) should be interpreted to already preclude discriminatory behavior based on genetic information. Finally, the Department of Health and Human Services (HHS) has issued regulations that, when finalized, will protect the privacy of an individual's "personally-identifiable health information", including genetic information.

If additional legislation is determined to be required, what gaps need to be addressed that are not already adequately covered by current federal requirements? If flaws are found in existing federal standards, a better solution would be to correct those problems in current law rather than develop a separate set of requirements that would apply only to genetic information.

Need for Precise Definitions of "Genetic Tests" and "Genetic Information"

Question:

Is it possible to define key terms such as "genetic tests" and "genetic information" specifically enough so any legislation is properly focused in its scope and would not apply to other activities that require more ordinary or routine information on an individual's health care condition?

Discussion:

The legislation appears to include quite broad and general definitions especially for the term "protected genetic information", which is defined to include "information about the occurrence of a disease or disorder in family members". The legislation does attempt to include a more specific definition of what constitutes a "genetic test", but even this definition could be open to much broader interpretation by subsequent regulations issued by federal agencies or decisions by state or federal courts. Imprecise or overly broad terms could lead to far-reaching, unintended consequences. For example, information on family health history is vital in the successful employee wellness and disease management programs that many employers and health plans offer to individuals who need better management of their high blood pressure, diabetes, risk of heart disease, or cancer condition. Similarly, it is important that any definition of "genetic test" be highly specific so no ambiguity remains about whether other more routine health care screenings or lab tests are restricted by any new statutory requirements.

Possibility of Unlimited Damages

Question:

Why should a new federal law on genetic nondiscrimination be enforced with the possibility of unlimited damages when other federal nondiscrimination laws protecting an individual's basic civil rights or discrimination on the basis of a disability are limited to no more than $300,000 in punitive damages?

Discussion:

The proposed legislation would impose no limit on the damages a court might award for violations of the new statutory requirements. Other comparable nondiscrimination statutes such as the Americans with Disabilities Act and Title VII of the 1964 Civil Rights Act limit punitive damages for large employers to $300,000. A far preferable approach would be to provide for an effective enforcement mechanism through fines that could be imposed by an appropriate federal agency rather than by encouraging costly litigation through the prospect of attorneys seeking unlimited damages.

Conflicting Standards under Separate State Laws

Question:

Why should separate state laws that contain conflicting or inconsistent standards continue to apply if federal standards are enacted?

Discussion:

Under the legislation, separate state laws that set higher standards on genetic information would not be preempted. This could create several significant problems. For employers and health plans that operate in multiple states, this framework would create the prospect of being subject to multiple and conflicting requirements governing the same subject matter and activities. Further, state laws establishing "higher" standards could easily undermine federal objectives. For example, if it were the intent of Congress to carefully apply standards only to a set of well-defined activities that involved genetic tests and information, state efforts to broaden these definitions or requirements could lead to the unintended consequences Congress specifically intended to avoid. Further, the multiplicity of federal and state standards governing employee benefit practices undercuts the federal objective of encouraging the establishment of health benefit plans and providing valuable health care services to more Americans.

American Benefits Council
September 2001