THE NEW GINA REGULATIONS:WHAT YOU DON'T KNOW CAN HURT YOU

WESLEY C. REDMONDwredmond@bakerdonelson.com

RACHEL E. VANNORTWICKrvannortwick@bakerdonelson.com

November 17, 2011

The Genetic Information Nondiscrimination Act

• Enacted and signed into law by President Bush May 21, 2008

• Became effective November 21, 2009

• EEOC proposed regulations in March 2009

• Final regulations went into effect on January 10, 2011

Science Fiction Becomes Fact

Genetic Testing Issues Have Popped Up In More Recent Film Context

"Officially they are called"In-valids'… They are the'healthy ill'. They don't actually have anything yet – they may never have. But since few ofthe pre-conditions canbe cured or reversed, itis easier to treat themas if they were alreadysick."

Pre-G.I.N.A?

History Demonstrates Need for Genetic Information Protection

According to Congress, advances in genetic information require legal protection of that information for individuals because government, insurers and employers have misused this informationto discriminate in the past. For example:

• State laws have been enacted that discriminate based upon genetics in the past

• Forced sterilization• Sickle cell anemia

• Genetic information has been used improperly to discriminate against individuals in the past

Advancements in Genetics Provide Increasing Basis for Discrimination

• New knowledge of genetics allows for earlier detection of illnesses (even before any symptoms manifest);

• New knowledge allows detections of genetic disorders;

• Many genetic conditions and disorders are associated with particular racial and ethnic groups and gender;

• Congress found examples of genetic discrimination by employers, including the use of pre-employment genetic screening;

• Health insurance and employment are two areas where discrimination based upon genetic discrimination are likely in the future.

What GINA Regulates

Title I – Health Insurance

• Amends Employee Retirement Income Security Act of 1974 (ERISA)

• Prohibits adjustment of a premium for a group on the basis of genetic information

• Prohibits requiring an individual or family member to undergo a genetic test

• Prohibits collection of genetic information

• Applies to private, state and federal insurance

What GINA Regulates

Title II - Employment

• Prohibits discrimination in employment based upon genetic information

• Prohibits employers from acquiring genetic information

• Prohibits disclosing genetic information

• Applies to employers, employment agencies, labor unions, labor- management committee apprentice programs or other training programs

GINA Creates a New Cause of Action

• GINA creates a new cause of action for protected individuals for any employment-related violation of the Act

• Follows Title VII's procedures.

Damages Under Title II of GINA

GINA incorporates all of the Title VII Remedies:

• Back Pay (up to two years)

• Front Pay/Reinstatement

• Injunctive Relief

• Attorney's fees and costs

• Compensatory damages

• Punitive damages

• Liquidated damages

Unlawful Employment Practices Under GINA

GINA prohibits employers from discriminating against an employee or job applicant based upon genetic information or from acquiring genetic information.

Areas where discrimination may occur:• Hiring

• Promotions

• Discharge

• Compensation

• Terms, conditions or privileges of employment

Unlawful Employment Practices Under GINA

• GINA prohibits employers from limiting, segregating, and classifying employees based upon genetic information.

• An employer "may not limit, segregate or classify an individual . . . in any way that would deprive or tend to deprive the individual of employment opportunities or otherwise affect the status of the individual as an employee, because of genetic information with respect to the individual." (29 CFR § 1635.5).

Unlawful Employment Practices Under GINA

• GINA absolutely prohibits an employer from "acquisition" of genetic information concerning an employee or applicant (other than five specific exceptions).

• An employer may not request, require or purchase genetic information of an individual.

QUESTION

Your grandfather, father, and you have all worked for the same Company. Your father and grandfather both died at age 50 from heart attacks. Company refuses to promote you to CEO at age 49 because your father and grandfather died of heart attacks at 50.

Answer

Yes, since the decision was made based on family medical history.

Question

Female employee informs Company that she was having a genetic test to learn whether she was predisposed to breast cancer. She was soon fired with her boss saying the Company could not afford to keep her if the results were positive.

Answer

True story relayed to Congress in support of the legislation. Probably a violation since GINA prohibits discrimination based on genetic tests.

QUESTION

UNDER GINA, "GENETIC INFORMATION" INCLUDES WHICH OF THEFOLLOWING?

(A) Any and all health information about the person.

(B) Any demographic information which may have a bearing on the individual's health, including race, age and gender.

(C) Family medical history.

ANSWER

THE CORRECT ANSWER IS "C."

GENETIC INFORMATION UNDER GINA INCLUDES FAMILY MEDICAL HISTORY.

What Is "Genetic Information" ?

• An individual's genetic tests;

• Genetic tests of family members of an individual

• The manifestation of a disease or a disorder in the family members of an individual;

• Family medical history;

• Requests for, and receipt of, genetic services by an individual or a family member, or about an embryo legally held by the individual or family member using assisted reproductive technology. 29 C.F.R. § 1635.5.

"Genetic test" means an analysis of human DNA, RNA, chromosomes, proteins or metabolites that detects human genotypes, mutations, or chromosomal changes.

What Is Not "Genetic Information"?

• Information about the age, sex, race or ethnicity of an individual.

• Whether the subject individual currently has a disease or disorder (but this may be protected under ADA).

• Genetic information does not include tests for alcohol or drug use (where no other genetic information is collected).

• Information about a family member's age, sex, race or ethnicity that is not derived from a genetic test.

QUESTION

A "FAMILY MEMBER" UNDER GINA INCLUDES?

(A) A CHILD

(B) A GREAT-GRANDPARENT

(C) COUSIN

(D) ALL OF THE ABOVE

ANSWER

THE CORRECT ANSWER IS "D" – ALL OF THE ABOVE.

"Family Member of an Individual"

Examples of Family Members:

• Children of the individual.• Siblings of the individual, half-siblings of the individual.• Parents (first degree), grand-parents (second degree), great-

grandparents (third degree), and great-great grandparents (fourth- degree).

• Aunts and uncles (second degree), great aunts and uncles (third degree), nieces and nephews (third degree).

• First cousins (third degree), first cousins once removed (the children of a first cousin) (fourth degree).

Scope of Information Protected Under GINA is Broad

Putting together the definitions of "Genetic Information" and "Family Member" under GINA makes the scope of information protected under the Act extremely broad.

• Reaches information of virtually all relatives of an individual;

• GINA does not limit liability for the manner in which information is acquired, other than when acquired "inadvertently or through the "publically available" exception;

• This makes employers potentially liable for acquisition of information in many contexts.

Acquisition Exceptions

1. "Inadvertent acquisition." The accidental or inadvertent acquisition of genetic information of an individual is not a violation of GINA.

2. "Health or genetic services."The employer is allowed to acquire genetic information about an employee where the information is acquired pursuant to program for health or genetic services, but only if:a. The individual provides written consent;b. Only the individual and the licensed health care professional

receive individually identifiable information; andc. The individually identifiable information is only available for

the purpose of the program and is not available to the employer.

Acquisition Exceptions (continued)

3. "FMLA". The employer may acquire genetic information where the employer requires family history to comply with the certification requirements under the FMLA.

4. "Publically available." The employer may acquire genetic information from documents publically available (i.e., information in newspapers and magazines).

5. "Genetic monitoring." The employer may acquire genetic information where the information is to be acquired for genetic monitoring of the biological effects of toxic substances in the workplace (additional rules for this).

QUESTION – Inadvertent Acquisition

Joe Brown has been absent on FMLA leave to care for an ailing parent. You overhear co-workers discussing Joe's father's illness in the break room. You linger at the water cooler to hear more so you know where to send get-well flowers. Have you violated GINA?

ANSWER – Inadvertent Acquisition

THE FINAL REGULATIONS PROVIDE YOU MAY VIOLATE GINA BY "ACTIVELY LISTENTING TO THIRD PARTY CONVERSATIONS FOR THE PURPOSE OF OBTAINING GENETIC INFORMATION." 29 C.F.R. § 1635.8(B)(ii).

INADVERTENT ACQUISITION

• INADVERTENT ACQUISITION INCLUDES:

1. Accidentally overhearing a conversation.

2. Receiving unsolicited email about the health of an employee or an employee's family member.

3. Receiving genetic information directly from an employee or third party in response to an expression of ordinary concern.

• EXAMPLES:

- Permissible: A manager may ask an employee "How are you" or "Did theycatch it early?"

- Prohibited: A manager may not follow up with probing questions such as"Does cancer run in your family" or "Has your cousin been tested for thedisease?"

Question

You are the Company's Sales Manager, and you supervise 10 salespeople. One of your long-time salespeople informs you that he may be absent some because his father has cancer. You send the following e-mail out to the 9 other salespeople "Don's father has been diagnosed with cancer. Please keep him and his family in your thoughts and prayers." You obtained the information inadvertently, but have you violated GINA?

Answer

By disclosing the family medical history you have violated GINA.

QUESTION – Publicly Available Information

Jane Johnson has requested FMLA leave to care for her child, Lucy, who is in the hospital. One evening you look at Jane's Facebook profile to see if she has posted any updates about Lucy. You read the following post: "Dr. Smith told us today that Lucy is a Type I diabetic. I am not surprised because diabetes runs in my husband's family. Thanks to everyone for your thoughts and prayers."

Have you violated GINA?

ANSWER – Publicly Available Information

MAYBE. YOU MAY HAVE VIOLATED GINA IF YOU ARE NOT THE EMPLOYEE'S FACEBOOK "FRIEND" OR YOU DO NOT HAVE PERMISSION TO VIEW THE EMPLOYEE'S PROFILE.

Publicly Available Information

• AN EMPLOYER DOES NOT VIOLATE GINA WHEN IT ACQUIRES GENETIC INFORMATION FROM A PUBLICLY AVAILABLE SOURCE, SUCH AS A NEWSPAPER, TELEVISION, OR THE INTERNET.

• THIS INCLUDES INFORMATION AN EMPLOYER OBTAINS THROUGH SOCIAL NETWORKING SITES UNLESS THE MANAGER WHO OBTAINS THE INFORMATION DOES NOT HAVE ACCESS TO THE EMPLOYEE'S PERSONAL PAGE. 29 C.F.R. § 1635.8 (B)(ii)(D).

• EMPLOYERS CANNOT CONDUCT "AN INTERNET SEARCH ON AN INDIVIDUAL THAT IS LIKELY TO YIELD A RESULT CONTAINING GENETIC INFORMATION. FOR EXAMPLE, A MANAGER SHOULD NOT DO A GOOGLE SEARCH FOR "JANE JOHNSON AND DIABETES."

QUESTION – Requests for Medical Information

When Sally Sanders turns in FMLA paperwork to HR, the manager notes that Sally's doctor has stated Sally will need to be absent from work for a surgical procedure because a recent genetic test revealed Sally has a gene which predisposes her to cancer.

Has Sally's employer violated GINA?

ANSWER – Request for Medical Information

• A GINA violation may occur when an employer obtains genetic information from an otherwise lawful request for medical information if:- (1) the request is not narrowly tailored so that it is likely a covered entitywill acquire genetic information; or- (2) the medical request fails to instruct the medical provide not to provide genetic information. 29 C.F.R. § 1635.8(b)(1)(i)(C) .

• Types of personnel forms implicated.- Fitness for duty verification or - Sick leave requests or disability leave request- FMLA paperwork- Medical certifications related to requests for a reasonable accommodation under the Americans with Disabilities Act.

How Do I Prevent Medical Request GINA Violations?

• Use "safe harbor" language on all forms which request medical information.

• The final regulations provide an employer does NOT violate GINA when it acquires genetic information pursuant to a request for medical information if the employer uses the "safe harbor" language on the request form.

GINA Safe Harbor Language

The Genetic Information Non-Discrimination Act of 2008 (GINA) prohibits employers and other entities covered by GINA Title II from requesting or requiring genetic information on an individual or family member of the individual, except as specifically allowed by this law. To comply with this law, we are asking that you not provide any genetic information when responding to this request for medical information. "Genetic information" as defined by GINA, includes an individual's family medical history, the results of an individual's or family member's genetic tests, the fact that an individual or an individual's family member sought or received genetic services, and genetic information of a fetus carried by an individual or an individual's family member or an embryo lawfully held by an individual or family member receiving assistive reproductive services.

29 C.F.R. § 1635.8(b)(i)(B).

QUESTION – Wellness Programs

Company ABC has implemented a voluntary wellness program. To encourage participation, ABC is giving a $50.00 gift card to all of the employees who sign up for the program and complete a medical questionnaire. The medical questionnaire asks about the employee's family medical history to assess the employee's risk factors. Bob Brown met all of the program requirements, but did not fill out the part on the medical questionnaire concerning his family medical history. The HR Manager, Harry Horsely, informs Bob he is not eligible for the gift card because he failed to complete the questionnaire. Did Harry violate GINA?

ANSWER – Wellness Programs

Yes. Employee wellness programs may not discriminate against employees who choose not to disclose genetic information. 29 C.F.R.§ 1635.8(b)(1)(i)(B).

WELLNESS PROGRAMS

• Employees may provide genetic information in connection with voluntary wellness programs without causing the employer to violate GINA.

• To safeguard against GINA violations, employers should:- Obtain the employee's written consent on a form that states

the employee is voluntarily providing the information.- Limit access to the genetic information. Only licensed health

care professionals and genetic counselors should be able to access the genetic information. Managers and supervisors should not have access to this information.

- Not discriminate against employees who choose not to provide genetic information.

Confidentiality of Information

• All genetic information must be maintained on separate forms and kept in separate medical files.

• Compliance is presumed when genetic information is treated the same way medical information is treated under the ADA (42 U.S.C. § 12112(d)(3)(B)).

Disclosure of Information is Prohibited

An employer may not disclose any genetic information except:

1. To the employee;2. To certain occupational health researchers conducted in compliance

with federal law;3. In response to an order of a court (provided the employee is

notified);4. To government officials investigating compliance with GINA;5. Pursuant to certification requirements under FMLA; and6. To a health agency concerning a contagious disease that presents

an imminent hazard of death or a life-threatening illness.

GINA Prohibits Retaliation

• An employer may not retaliate against an individual because the individual has opposed any practice made unlawful in GINA.

• This exception applies to both the individuals who have been subject to the allegedly unlawful practice, and individuals otherthan the "victims" who oppose the unlawful practice.

• "Opposition" not defined: It will likely be defined broadly asunder Title VII.

• For example, providing adverse information in an internal investigation may be considered "opposition." (Crawford v. Metropolitan Gov't of Nashville).

Compliance Issues

What should employers do to comply with GINA?

1. Obtain and post a copy of the EEOC's revised "Equal Opportunity is the Law" Poster.

2. Review your employee policies and employee handbook – update them to include protection for genetic information.

3. Review and update any HR policies regarding handling of genetic information to make sure it is treated the same as medical information under the ADA.

4. Add safe harbor language to all forms that request medical information.

Compliance Issues

5. Communicate the nondiscrimination, acquisition limitations, and confidentiality requirements of GINA to supervisors and individuals who may have any genetic testing responsibilities at your company or facility (HR staff, nurses, medical officers, etc.).

6. Employers should make sure their policies communicate that family medical history is confidential and should be treated accordingly.

7. Managers and supervisors should be made aware not to unnecessarily inquire about employees' family medical histories.

8. Social Networking. Be wary when looking at employees' information on social media sites.

How Are Courts Interpreting GINA?

• Very few opinions. No published opinions at the appellate level.

• In most of the court opinions thus far, GINA claims have been immediately dismissed at the district court level for the plaintiff's failure to exhaust administrative remedies (i.e. file an EEOC Charge) or for failure to adequately plead sufficient allegations in the Complaint (i.e. failing to describe what genetic information the employer obtained or how the employer discriminated on the basis of the genetic information).

Conclusion

• GINA imposes new regulatory burdens on employers.• GINA prohibits discrimination based upon genetic information.• GINA restricts employers from acquiring and disclosing genetic

information.• "Genetic information" is broad.• GINA provides strong remedies for violations.

• This could be a "sleeper statute" –The extent to which it will increase litigation remains to be seen and will require some time to determine.

• Quick compliance is the most cost-effective way to avoid litigation under this statute.