On May 21, 2008, in an effort to protect individuals from discrimination on the basis of their genetic information, President Bush signed into law the Genetic Information Nondiscrimination Act (“GINA”) (H.R. 493). One of the primary goals of GINA is to promote genetic research by reducing fears that an individual’s genetic information may be used against him or her in health insurance coverage or in employment. GINA is significant for group health plans, health insurers and employers because it restricts their use of genetic information and will require changes in how they collect this information.

Overview

Recognizing the impact of GINA first requires an understanding of the scope of information protected under the law and whose genetic information is at issue.

GINA is intended to protect an individual from the use of “genetic information” against him or her. “Genetic information” is defined under GINA as

• a genetic test of an individual or his or her family members (a genetic test includes analyses of DNA, RNA, chromosomes, proteins or metabolites that detect genotypes, mutations or chromosomal changes); and
• the manifestation of the disease or disorder in an individual’s family members. Under GINA, family medical histories and genetic services, such as genetic counseling and education, are deemed to contain genetic information.

GINA protects individuals from discrimination through the use of genetic information of any of the following:

• first, second, third and fourth degree relatives (e.g., mother, grandmother, great-grandmother and great-great-grandmother);
• the fetus of a pregnant individual; or
• the embryo legally held by an individual or family member who used assisted reproductive technology.

With these definitions in mind, the following explains how GINA will affect group health plans and health insurers and employers. We note that the Department of Labor and the Treasury Department are expected to issue regulations regarding the implementation of GINA by May 21, 2009.

Impact on Group Health Plans and Health Insurers

Title I of GINA applies to group health insurance plans and health insurers. It expands on the protections already available under the HIPAA nondiscrimination rules by placing four additional restrictions on group health plans and health insurers with respect to genetic information.

First, GINA prohibits plans and insurers from adjusting premiums or employer contribution amounts for the group as a whole based on genetic information. This provision, however, would not bar a plan or insurer from increasing the premium for a group if a covered individual’s genetic information is manifested as a disease or disorder.

Second, GINA prevents plans and insurers from requiring or requesting any individual or family member to undergo genetic testing. We note that GINA does not specify the types of tests that would or would not be considered “genetic tests.” Any such clarification in the implementing regulations would be welcome — for example, that routine blood and cholesterol tests are not “genetic tests.”

We note that the genetic testing provision does not place any limits on a health care professional’s authority to request genetic testing. Moreover, the provision does not bar plans and insurers from using the results of any genetic test to make claims payment determinations. To the extent that such information is integral to a payment determination, however, GINA requires that plans and insurers only request the minimum amount of genetic information necessary to make the determination.

Third, GINA restricts the collection of genetic information. Plans and insurers may not request, require or purchase such information for underwriting purposes or for any individual’s enrollment in the plan. Underwriting is defined to include rules for benefit eligibility determinations, the computation of premiums or contributions, the application of preexisting condition exclusions and any other activity related to creation, renewal or replacement of health benefits.

This restriction should have a significant impact on health risk assessments (“HRA”) that are used for underwriting or enrollment purposes. Under GINA, HRAs cannot include questions related to the manifestation of a genetic disease or disorder of family members. For example, questions about an individual’s family medical history of heart disease or cancer would need to be eliminated because they would require the employee to disclose his or her genetic information. Plans and insurers should review their HRA forms to determine whether any of the information requested would constitute the collection of genetic information. We note that the incidental collection of genetic information by a plan or insurer would not constitute a violation of GINA (e.g., if an employee voluntarily discloses his or her family medical history to the employer).

Finally, GINA requires the Secretary of Health and Human Services to amend the HIPAA privacy regulations to:

• treat genetic information as “protected health information;” and
• prohibit the use or disclosure of such information for underwriting purposes.

Plans and insurers should review and amend their HIPAA privacy and security policies to reflect these new rules.

Enforcement

Violations of GINA by plans and insurers come at a significant cost. The Department of Labor may assess penalties of $100 per day per affected individual beginning on the first day the violation occurred and ending on the date the violation is corrected. If a violation is not corrected following receipt of a notice of violation from the Department of Labor, a minimum penalty of $2,500 may be imposed for de minimus violations, and $15,000 for significant violations. Unintentional violations are capped at the lesser of 10% of the amount paid by the employer for its group health plans during the prior year or $500,000. There is no cap on violations resulting from willful neglect or intentional misconduct.

Impact on Employers

Title II of GINA prohibits employers from using genetic information to discriminate against an individual with respect to the terms and conditions of that individual’s employment (e.g., in hiring or firing decisions or in determining compensation). Employers are also prohibited from retaliating against employees based on their genetic information. Finally, employers are generally prohibited from collecting an employee’s genetic information subject to certain exceptions. For instance, an employer may request genetic information to administer leaves protected by the Family Medical Leave Act, to monitor toxic substances in the workplace or when offering health or genetic services (as part of a wellness program, for example). Such information may only be collected pursuant to an employee’s written authorization and only if it is disclosed to the employer in an aggregated format that does not identify any individual employees.

Next Steps

Title I of GINA, which impacts all group health plans and health insurers, becomes effective on May 21, 2009, while the employment discrimination provisions of Title II of GINA become effective on December 21, 2010. Although regulations are expected within a year, health plans, insurers and employers should begin reviewing their policies and procedures relating to the treatment and collection of genetic information now to ensure timely compliance. If you would like assistance to review your policies and procedures, please contact our office.