1. An Overview of the EEOCs GINA Regulations

2. 2 The GINA Act and Regulations The Genetic Information Nondiscrimination Act (GINA) was signed into law by President Bush on May 21, 2008 The EEOC issued Regulations on November 9, 2010 The Regulations went into effect on January 10, 2011

3. 3 GINA basics (Part 1) Title I of GINA primarily addresses the use of genetic information in group health insurance Title II of GINA also prohibits the acquisition, use, or discussion of genetic information in EMPLOYMENT Examples of genetic information include: results of genetic tests for breast/ovarian/colon cancer genes, amniocentesis, genetic abnormalities in a fetus, family medical history Purpose = anti-discrimination and privacy

4. 4 GINA applies to: Employees and former employees Applicants A wide variety of policies and practices Private, state, and local government employers with 15 or more employees GINA follows the Title VII model of exhaustion of administrative remedies by filing an EEOC charge GINA basics (Part 2)

5. 5 GINA EEOC Charges: As of January 2011, the EEOC had approximately 260 GINA Charges Mostly flowing from ADA violations Arising in the context of discharge or failure to hire GINA basics (Part 3)

6. 6 GINA prohibits employers from using genetic information for employment decisions ***There are NO DEFENSES AT ALL GINA basics (Part 4)

7. 7 The EEOCs Regulations: Are codified at 29 CFR § 1635 Restrict an employers ability to collect an employees genetic information Request is defined broadly Specifically address what might happen if the employer inadvertently learns of an employees genetic information pursuant to an otherwise lawful request for documentation related to an employees current medical condition e.g. to support an employees FMLA leave request or request for reasonable accommodation under the ADA

8. 8 The Six Exceptions (1) Inadvertent acquisition (2) Part of voluntary services provided (3) FMLA (4) Sources publicly available (5) Genetic monitoring in accordance with Federal law (6) Forensic labs

9. 9 Exception: (1) Inadvertent acquisition Water cooler exception Examples: Overhear that an employees parent was diagnosed with cancer In the context of an ADA request for an accommodation, which included the notice contained in the Regs OR the request was narrowly tailored (e.g. Dr.s note for absence), the Dr. sends family medical information to the employer Employers can be polite but not too nosy…

10. 10 Exception: (2) Part of voluntary services provided Wellness program As long as any individually identifiable genetic information that discloses the identity of the employee is accessible only to the employee and the health care provider involved in providing the services The employee must provide prior knowing, voluntary, and written authorization It is NEVER ok to induce participation with money for the purpose of obtaining genetic information An employer could offer incentives to employees that complete a health risk assessment that includes questions about family medical history or other genetic information as long as the employer specifically identifies those questions and clarifies that the participant need not respond to those questions to receive the incentive

11. 11 FMLA leave exception Only applies to certification for leave to take care of a sick family member Because…providing health-related information regarding a family member (or family medical history) is necessary to comply with the certification provisions of the FMLA to take leave to care for a sick family member Exception: (3) FMLA

12. 12 Exception: (4) Sources publicly available Internet sources: must be commercially and publicly available The determining factor is whether access requires permission of an individual or is limited to individuals in a particular group, not whether the source is categorized as a social networking site, personal website, or blog. Rule looks to intent: for example, an employer intentionally performs an internet search to see if an employee or applicant has a genetic condition, the employer would violate GINA even if the information is available on a publicly available site This exception does not apply to court or medical databases

13. 13 Exception: (5) Genetic Monitoring in accordance with Federal Law GINA permits employers to engage in genetic monitoring of the biological effects of toxic substances in the workplace, provided they notify employees they will do so, and where not required by law to conduct such monitoring, obtain the employees consent The Regs include a provision stating that an employee who refuses to participate in a voluntary genetic monitoring program cannot be discriminated against on that basis

14. 14 Exception: (6) Forensic labs Employers that engage in DNA testing for law enforcement or human remains identification purposes may require the genetic information of their employees

15. 15 NO exception for: Discovery in litigation Must be pursuant to a court order for genetic information to be produced

16. 16 Safe Harbor (Part 1) The Regulations create a safe harbor for employers who request medical information from employees under certain circumstances Employers will NOT be in violation of GINA if they receive genetic information in response to such a request if they provide the following warning to the employees health care provider (or third party provider):

17. 17 Safe Harbor Disclaimer The Genetic Information Nondisclosure Act of 2008 (GINA) prohibits employers and other entities covered by GINA Title II from requesting or requiring genetic information of 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 individuals family medical history, the results of an individuals or family members genetic tests, the fact that an individuals family member sought or received genetic services, and genetic information of a fetus carried by an individual or an individuals family member or an embryo lawfully held by an individual or family member receiving assistive reproductive services.

18. 18 Safe Harbor (Part 2) The warning may be accomplished in writing or orally, but must be documented The warning is not mandatory, but employers who fail to provide it and receive genetic information in response to a request for medical information could potentially have their request reviewed by the EEOC in its investigation of a Charge of Discrimination If the EEOC determines that the employers request was made in such a way that it was likely to result in the employer obtaining genetic information, the request will violate GINA

19. 19 Safe Harbor (Part 3) Employers should also take additional reasonable measures within [their] control if they learn that health care providers are requesting genetic information Such reasonable measures may include no longer using the services of a health care professional who continues to request genetic information in connection with medical examinations after being told not to do so

20. 20 Also… Always look to state law GINA provides a floor NOT a ceiling

21. 21 For discussion GINA implications for: Forms and medical exams HIPAA release forms FMLA certification forms Fitness for duty exams: return to work Request for an ADA accommodation Medical certifications to support an employees absence Training on GINA compliance Revision of EEO policies & handbooks to include genetic information Personnel records: storing genetic information in a confidential medical file Litigation discovery procedures: no disclosure of genetic information unless specifically required by court order

22. 22 For more information… Marcus & Shapira, LLP One Oxford Centre, 35 th Floor Pittsburgh, PA 15219 Stephanie Weinstein, weinstein@marcus-shapira.com Beth Henke, henke@marcus-shapira.comhenke@marcus-shapira.com