United States: Genetic Non-Discrimination Bill Signed Into Law

After thirteen years of consideration, legislation prohibiting health insurance companies and employers from discriminating against individuals based on genetic information was signed into law on May 21, 2008.

The Genetic Information Nondiscrimination Act (H.R. 493) (GINA) balances the benefit of using genetic information for medical advances and care management with the potential for harm that could be caused by the misuse of genetic information. Through a bipartisan effort, Congress reduced the potential for harm by creating Federal standards for prohibited and permitted uses by insurers and employers of an individual's genetic information.

An individual's genetic information is defined in GINA as "information about (i) such individual's genetic tests, (ii) the genetic tests of family members of such individual, and (iii) the manifestation of a disease or disorder in family members of such individual." It also includes "any request for, or receipt of, genetic services, or participation in clinical research which includes genetic services, by such individual or any family member of such individual." Additionally, genetic information related to an individual or family member of an individual includes the genetic information of any fetus carried by a pregnant woman and the genetic information of any embryo legally held by an individual or family member using assisted reproductive technology. Genetic information does not include information about the gender or age of an individual.

Regulation Of Insurers

GINA regulates insurers, including those covered by the Employee Retirement Income Security Act (ERISA), state regulated plans, and the individual market. Group health plans, including small group health plans, health insurance issuers offering health insurance coverage in the individual market, non-federal governmental plans and issuers of Medicare supplemental policies are all subject to nondiscrimination provisions in GINA.

Group health plans and health insurance issuers offering health insurance coverage in the individual market are prohibited from using genetic information to adjust premiums or contribution amounts for a group or individual. Additionally, they are proscribed from requesting or requiring an individual or family member of an individual to undergo a genetic test. Health insurance issuers offering health insurance coverage in the individual market are also prohibited from establishing eligibility rules for enrollment based on genetic information and from imposing a preexisting condition exclusion on the basis of genetic information.

Similarly, issuers of Medicare supplemental policies are prohibited from denying or conditioning the issuance or effectiveness of a policy based on genetic information, nor may they impose an exclusion of benefits based on a preexisting condition due to genetic information. Issuers of Medicare supplemental policies are also barred from discriminating in the pricing of a policy, including the adjustment of premiums, based on genetic information.

Insurers are prohibited from requesting, requiring or purchasing genetic information for underwriting purposes. However, insurers may obtain and use the results of genetic tests to make determinations regarding payment, consistent with other provisions of the Act, as long as they only request the minimum amount of information necessary to accomplish the intended purpose. Moreover, GINA specifically provides exceptions to general rules for genetic tests for research purposes. Insurers may request, but may not require, an individual to undergo a genetic test for research purposes if (a) the research complies with the Common Rule (part 46 of title 45, Code of Federal Regulations); (b) it is clearly specified that compliance with the request to submit to genetic testing is voluntary and that refusal to undergo the test will not impact enrollment status or premium or contribution amounts; (c) they notify the Secretary of the Department of Health and Human Services that such activities are being conducted; (d) they provide the Secretary with a description of the activities; and (e) they comply with other requirements set forth by the Secretary.

GINA amends the privacy regulations promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) by prohibiting the use or disclosure by a group health plan, health insurance issuer, or issuer of a Medicare supplemental policy of genetic information about an individual for underwriting purposes. GINA also specifies that genetic information should be treated as health information for the purposes of HIPAA.

Regulation Of Employers

Employers, employment agencies, labor organizations and joint labor-management committees also are prohibited from discriminating against an employee, individual or member based on genetic information. Employers may not refuse to hire or discharge an employee, or otherwise discriminate against an employee with respect to compensation, terms, conditions, or privileges of employment on the basis of genetic information. Likewise, employment agencies are prohibited from failing or refusing to refer an individual for employment based on genetic information, and labor organizations may not exclude or expel a member due to genetic information.

Employment agencies, labor organizations, and joint labor-management committees are prohibited from causing or attempting to cause an employer to discriminate against a member in violation of GINA. Employers, labor organizations, and joint labor-management committees also are prohibited from discriminating against an individual regarding admission to, or employment in apprenticeship or training programs.

Additionally, employers, employment agencies, labor organizations and joint labor-management committees are prohibited from limiting, segregating, or classifying employees, individuals or members based on genetic information in a manner that would deprive or have a propensity to deprive the individuals of employment opportunities or have an otherwise negative impact on their status as employees. They are prohibited from requesting, requiring or purchasing an employee's genetic information except in specified circumstances, including when the entity:

  • Inadvertently requests or requires family history of the employee or family member of the employee;

  • Offers health or genetic services and certain conditions are met, such as obtaining an individual's voluntary, written authorization, and disclosure to the entity is limited to aggregate terms that do not disclose the identity of an individual;

  • Requests or requires family medical history to comply with certifications required by the Family and Medical Leave Act;

  • Purchases commercial and publicly available documents that include medical history;

  • Uses the information for genetic monitoring of the biological impact of toxic substances in the workplace, and certain conditions are met; or

  • In certain circumstances, conducts DNA analysis for law enforcement purposes as a forensic laboratory and requires such analysis for quality control purposes.

In cases where employers, employment agencies, labor organizations or joint labor-management committees obtain an individual's genetic information, they may not use the information for discriminatory purposes. The genetic information must be maintained in separate medical files and be treated as a confidential medical record of the employee. These entities may only disclose such information in specified instances, such as: (a) at the written request of an individual; (b) to an occupational or other health researcher if the research is conducted in accordance with the Common Rule (part 46 of title 45, Code of Federal Regulations); (c) in response to an order of a court; (d) to government officials investigating compliance with GINA; (e) if the disclosure is needed in connection with the employee's compliance with the certification provisions of the Family and Medical Leave Act; or (f ) to a Federal, State or local public health agency with respect to information related to a contagious disease that presents an imminent hazard of death or life-threatening illness. These provisions of the statute create one of the greatest potential traps for employers as they do not authorize disclosure in response to discovery requests or even a subpoena. Thus, employers responding to such requests will need to take special care to ensure that information which falls within the definition of "genetic information" is withheld and maintained in confidence.

As with other non-discrimination statutes, employees who believe that they have been discriminated against in violation of the law must file a charge of discrimination with the Equal Employment Opportunity Commission. If litigation is filed in federal court, a prevailing plaintiff may recover any damages authorized by the Civil Rights Act of 1991, including compensatory damages, back pay, front pay, and equitable relief.

In a provision unrelated to the genetic information purposes of the Act, the law also amends the Fair Labor Standards Act to increase the penalties for child labor violations which result in death or serious injury.

Conclusion

The new Federal law follows many state laws already enacted which relate to genetic discrimination in employment and health insurance. However, GINA is even more far-reaching because it imposes nondiscrimination provisions on ERISA plans, something that states are not permitted to do.

Although GINA provides individuals with some important protections, GINA is not a panacea. Some critics have indicated that GINA does not go far enough. For example, GINA does not prohibit discrimination against individuals once they have manifested a condition. GINA is also limited to health insurance; it does not cover other types of insurance, such as life insurance. On the other hand, GINA also has been criticized for being unnecessary, burdening employers when there is little evidence of abusive practices by employers, or potentially interfering with an insurer's ability to request certain genetic tests to ensure proper treatment for an enrollee.

GINA attempts to balance potential medical advances, such as using genetic information to permit the early detection of illnesses, enable individuals to take preventive steps to decrease their likelihood of contracting a disorder, or develop effective therapies, against the potential for misuse of the information. The ultimate impact of GINA on an individual's interest in obtaining genetic information and on preventing discriminatory practices remains unknown.

Practical Tips For Employers:

  • The statute will not go into effect for 18 months, but employers should look for the Equal Employment Opportunity Commission to publish regulations interpreting the new law within the next year.

  • Employers should review their discrimination policies now to ensure that they cover genetic information.

  • Employers should carefully review and revise documents soliciting medical information (e.g. post-offer medical examination records, fitness for duty records, or other authorizations for the release of medical records) to ensure that they specifically exclude questions requesting genetic information, unless there is a direct and compelling need for the information.

  • Employers should roll-out training on this new law for managers. This would be a good time to refresh training on all types of discrimination, harassment and retaliation and to tie in the new provisions of your Company's policies.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Cynthia E. Berry
 
In association with
Related Video
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert
Email Address
Company Name
Password
Confirm Password
Mondaq Topics -- Select your Interests
Accounting and Audit
Anti-trust/Competition Law
Consumer Protection
Corporate/Commercial Law
Criminal Law
Employment and HR
Energy and Natural Resources
Environment
Family and Matrimonial
Finance and Banking
Food, Drugs, Healthcare, Life Sciences
Government, Public Sector
Immigration
Insolvency/Bankruptcy, Re-structuring
Insurance
Intellectual Property
International Law
Litigation, Mediation & Arbitration
Media, Telecoms, IT, Entertainment
Privacy
Real Estate and Construction
Strategy
Tax
Transport
Wealth Management
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

Disclaimer

Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

Registration

Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

Cookies

A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

Links

This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

Mail-A-Friend

If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

Security

This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.