Genetic Information Nondiscrimination Act of 2008 – Almost a Reality
May 19, 2008
Michael J. "Mike" Ranallo- Chicago
On May 1, 2008, the U.S. House of Representatives passed the Genetic Information Nondiscrimination Act (GINA or the Act) by a vote of 414-1. A week earlier, the Senate had passed the Act by a 95-0 vote. This legislation, prohibiting health insurance and job discrimination based on one’s genetic makeup, now moves to President Bush, who has already said that he will sign it when it reaches his desk.
Title I of GINA deals with health insurance discrimination and Title II addresses employment discrimination.
Title I of GINA
Title I prevents all health insurers, including employer-sponsored group health plans and individual health insurance issuers, from basing eligibility or premium determinations on genetic information. The Act broadly defines “genetic information” to include not just the genetic test results of an individual and his/her family members, but also the manifestation of a disease or disorder in an individual’s family members. In a clarification sought by the insurance industry, the term genetic information does not include a “manifested disease” in an individual as distinguished from a disease suffered by family members. This clarification allows insurers to continue to underwrite health insurance coverage based on existing illness.
GINA also prohibits health insurers from requesting or requiring an individual to take a genetic test. The term “genetic test” is broadly defined in Title I of GINA. Indeed, the definition is much broader than the definition of “genetic test” under most state laws prohibiting genetic discrimination. Specifically, the definition in GINA states that a genetic test is not limited to those that detect mutations or chromosomal changes predictive of disease.
Nonetheless, GINA specifically states that the prohibition on genetic testing shall not interfere with the delivery of health care services. For example, GINA does not prevent a doctor from requesting that an individual or family member undergo a genetic test, nor does it prevent a doctor employed by or affiliated with a group health plan from notifying an individual about genetic tests or providing information about a genetic test if the doctor takes these actions in connection with a bona fide wellness program. However, the legislation does prevent a doctor from requiring that an individual undergo a genetic test.
Existing law already protects the use and disclosure of all individually-identifiable health information, including genetic information. These protections are included under the medical privacy regulations of the Department of Health and Human Services (HHS). However, these regulations allow such health information to be used for health insurance underwriting – a practice that inherently discriminates based on an individual’s medical history. GINA, however, expressly prohibits the use, disclosure, or collection of genetic information for underwriting purposes. Under the Act, health insurers also may not request, require or purchase genetic information prior to an individual’s enrollment in the plan.
The enforcement provisions in Title I expand existing penalties under the Employee Retirement Income Security Act of 1974 (ERISA) to enable the secretary of labor to impose fines of $100 per day on noncompliant health plans. The minimum penalty is $2,500 unless the violation was corrected before the health plan received notice that it was out of compliance. The minimum penalty is $15,000 in cases in which the violations are more than de minimus. There is language in the Act minimizing penalties when a health plan would not have identified the violation through the exercise of due diligence or when the plan corrects the violation quickly. The maximum penalty for unintentional violations is $500,000.
In addition to monetary fines and penalties, GINA also authorizes the Department of Labor (DOL) to sue for equitable relief. In addition, the Act states that with respect to a group health plan, a participant or beneficiary can bypass administrative remedies with the DOL if the time involved in administrative proceedings would cause irreparable harm to the participant’s health. When a participant or beneficiary obtains equitable relief for a genetic discrimination violation, a court may reinstate coverage retroactive to the date of the violation and can award a penalty to the participant.
GINA’s enforcement mechanism for violations of the privacy provisions in Title I is the same as that created by the Social Security Act for the HHS privacy regulations. The secretary of HHS may impose civil monetary fines of $100 per violation, up to $250,000, and up to 10 years in prison for violations committed for commercial advantage, personal gain, or malicious harm.
Title II of GINA
Turning to Title II, GINA broadly prohibits employers, labor unions and employment agencies from using genetic information to discriminate against an individual through hiring, firing, compensation, or other employment decisions. The Act also generally prohibits employers from requesting, requiring, or purchasing genetic information of employees. In addition, Title II bars employers from classifying employees based on genetic status in ways that affect their employment or promotion opportunities.
The genetic information protections under Title II of GINA extend to the employee, his or her spouse and all of their blood relatives, as well as adopted children. Employers who obtain genetic information about their employees inadvertently, either through compliance with the Family and Medical Leave Act, the Americans with Disabilities Act, or other laws, or through employee wellness programs or monitoring of the effects of toxic substances in the workplace, will not be penalized under the Act unless they use such information to discriminate against employees.
Title II of GINA also regulates how employers, labor unions and employment agencies must maintain and disclose genetic information. Specifically, the Act requires that genetic information be maintained on separate forms and in separate medical files. The information must be treated confidentially. Generally, employers will comply with GINA’s confidentiality requirements if they treat genetic information as they do other medical information under the Americans with Disabilities Act.
Employers may not disclose genetic information regarding an employee except to that employee, health researchers, or in compliance with federal or state law. For example, an employer can disclose genetic information in connection with its compliance efforts under the Family and Medical Leave Act.
The enforcement provisions of Title II of GINA are borrowed from Title VII of the Civil Rights Act of 1964, as amended. Thus, the Equal Employment Opportunity Commission (EEOC) has jurisdiction over enforcement. Employees who believe they have been discriminated against in violation of the Act must file a charge with the EEOC or the appropriate state agency. The EEOC will investigate the charge and may bring suit on behalf of the employee if it finds evidence of a violation. In cases where the EEOC chooses not to bring suit, the employee may file suit individually in federal district court. The same remedies available under Title VII are available under Title II of GINA. An aggrieved employee may seek reinstatement, back pay, injunctive relief, equitable relief, and attorneys’ fees and costs. The damages caps of Title VII that are tied to the number of an employer’s employees also apply under Title II of GINA. One significant difference between Title VII and Title II of GINA, however, is that disparate impact claims are not allowed under GINA. However, the Act directs that a commission be formed six years after enactment to report on the possibility of allowing disparate impact claims.
We will continue to monitor this new legislation once it is enacted and will report of significant developments in upcoming newsletters and alerts.
For more information, email Michael J. Ranallo at michael.ranallo@hklaw.com or call toll free, 1.888.688.8500.