GINA Basics

As genetic testing for predisposition to such diseases as cancer, Alzheimer’s, and others has become more widely used, legislators like the late Senator Ted Kennedy (D-MA) wanted to encourage people to take advantage of the technologies. But lawmakers feared that test results would be used unfairly: For example, an employer or insurer learns that a participant has a high genetic risk of developing an illness and uses that information to deprive the person of benefits—or to refuse to hire him or her. GINA’s purpose, then, is to prevent the spread and misuse of such information.

A genetic test is defined as one involving analysis of DNA, RNA, chromosomes, proteins, or metabolites. Blood tests, tests for viral infection, cholesterol level, or the like don’t count—nor does information that an individual currently has a disease, his or her age or gender, or data regarding a test for drug or alcohol abuse.

Who Is Covered, and What Should They Do?

GINA’s employer requirements apply to all of these: Private employers with 15 or more employees, certain public-sector employers, and employment agencies and labor organizations. Those affected need to be ready for November 21 in two ways: First, update your equal employment opportunity policies to reflect the ban against discrimination with respect to genetic and family medical history information as defined by GINA. Second, never ask potential hires who may have a disability anything about their family medical history or require them to undergo genetic testing.

Under the Americans with Disabilities Act, however, you can require medical exams of all applicants after you have offered them positions. Some observers have pointed out that GINA and ADA requirements should be clearly distinguished from each other. That is, the disabilities of some candidates are readily discernable or can be revealed, while those same individuals’ genetic histories or predispositions will not be visible. We can hope that the final regulations will make this distinction. We also assume that the Equal Employment Opportunity Commission will modify its poster requirements to include information about GINA, so covered employers will be required to post that along with changes from January 2009 to the Family and Medical Leave Act poster.

A notable rule exception for employers: If a health plan participant wants a medical procedure that requires a genetic test, either the employer or the insurer may request information about the test to OK the procedure.

GINA’s Adverse Impact on HRAs

GINA contains the latest generation in rules meant to protect the privacy of health information. Observers have noted since the law’s enactment in 2008 that the disclosure of individuals’ private genetic information is not anything close to widespread—yet. But lawmakers were concerned that the number of frequently conducted genetic tests will increase exponentially in the near future, and they were thinking ahead.

In the meantime, as GINA’s rules are currently written, they directly collide with another, perhaps equally valuable, growing trend. Increasingly, health-risk assessments (HRAs) are a vital part of forward-thinking employers’ wellness programs. And GINA makes such assessments much more difficult.

According to the ERISA Industry Committee (ERIC), the success of wellness programs depends on HRAs, which typically include questions about participants’ family medical histories. After all, when combined with any individual’s current health, his or her risk of predisposition toward a life-threatening illness is key to determining what kinds of behavior changes might offer protection. And, ERIC says, wellness programs are employers’ only tools for containing runaway healthcare costs.

But here’s the problem: If providing all requested information on an HRA, including family medical history, would lead to any kind of incentive or reward for participants, proposed regulations for GINA prohibits the arrangement. The idea seems to be that “bribing” employees with a reduction in premium or deductible if they provide private genetic information is unacceptable. So how do employers save their wellness programs?

ERIC and employment attorneys have some advice. First, understand that family-medical-history questions cannot be asked if any sort of participation in the wellness program can lead to a reward—even if the reward has nothing to do with filling out the HRA. Clearly, then, employers have two choices: Ask the questions—and get them answered—but offer no rewards for program participation. Or, remove all family-medical-history questions from your HRA and include planned incentives and rewards for program participation.

Or, says ERIC, break the process into two parts: Design an assessment/program that includes genetic information but not rewards, and one that does not include genetic information but does offer rewards. Still another alternative: Offer a financial incentive, but separate it completely from the health plan/wellness program, and make it taxable. Unfortunately, employers have too little time to revise their plans to comply. But we all knew that HR is never easy, didn’t we?

Employers Have a Bit of Wiggle Room

As detailed above, many provisions of GINA really hem employers in. But even such a strict law has some loopholes, so here’s a sampling of escape clauses that might come in handy.

• Regarding collecting family medical history in health-risk-assessments for wellness programs, some experts stress that collecting the information before employees are officially enrolled in your health plan means it could be used for “underwriting” purposes—a big no-no. So some have suggested that if you collect it after open enrollment—and don’t tie it to a health plan reward—you may be in compliance.
• But remember the rule that a wellness program that offers no incentives/rewards usually garners 50 percent participation, while one that does contain rewards boosts participation to 80 percent.
• If you gain an employee’s genetic information totally by accident—you overhear a conversation, the employee discloses it when you didn’t ask for it, the information comes to you as part of an accommodation request, and other instances—you’re off the hook.
• You’re also in the clear if you must ask for—or you inadvertently receive—family medical history when processing a request for leave under state or federal family and medical leave laws.
• You cannot be liable if you acquire such genetic information in the course of a law enforcement or forensic investigation.
• If there are toxic substances in your workplace (or you believe their might be), you can use such private data for genetic monitoring of the biological effects of the substances, provided you notify employees in writing.