1. EMPLOYMENT LAW PROVISIONS OF THE GENETIC INFORMATION NONDISCRIMINATION ACT OF 2008 (GINA) Mark A. Rothstein, J.D. Herbert F. Boehl Chair of Law and Medicine Director, Institute for Bioethics, Health Policy and Law University of Louisville School of Medicine © 2009

2. LIFE BEFORE GINA A. State Laws First state laws prohibiting genetic discrimination in health insurance and employment were enacted by Florida, Louisiana, and North Carolina in the early 1970s. They applied only to discrimination based on sickle cell trait. The number of states and conditions expanded through the 1970s and 1980s.

3. The launch of the Human Genome Project in 1990 provided the impetus for most states to enact genetic privacy and nondiscrimination laws.

4. WHAT IS DISCRIMINATION? It is more than just drawing distinctions. In common usage and in legal terms it refers to drawing distinctions based on invidious, unfair, or socially unacceptable criteria.

5. CONCERNS ABOUT GENETIC DISCRIMINATION 1.Predictions are inaccurate 2.Predictions are accurate

6. Categories of discrimination LEGAL RATIONAL Choosing an employee based on relative skill or other job-related criteria Choosing an employee based on medical assessment of ability to perform the job IRRATIONAL Choosing an employee based on Zodiac sign Choosing an employee based on a coin toss ILLEGAL Excluding a person with cancer from consideration for employment based on concerns about health care costs Excluding a pregnant woman from consideration for employment because she may soon go on maternity leave Excluding a person from consideration for employment based on religion (in a secular enterprise) Excluding a person from consideration for employment based on national origin

7. STATE GENETIC NONDISCRIMINATION LAWS 34 states and the District of Columbia prohibit genetic discrimination in hiring, firing, and/or terms, conditions, or privileges of employment. 25 states prohibit employers from requiring genetic information or a genetic test. 18 states prohibit employers from requesting genetic information or a genetic test.

8. 16 states prohibit employers from performing a genetic test. 14 states provide specific penalties for genetic discrimination in employment. 11 states prohibit employers from obtaining information about a genetic test result.

9. Federal Law Executive Order 13145 (2000) Prohibits discrimination in federal government employment based on genetic information Prohibits federal employers from acquiring genetic information Prohibits federal employers from disclosing genetic information (with some exceptions) Federal employers must protect the confidentiality of the genetic information of employees

10. A. Need for GINA HIPAA prevents genetic discrimination in employer-sponsored group health plans (both commercial and self-insured). Laws in most states prohibit genetic discrimination in individual health insurance policies and employment. Was there a need for GINA?

11. B. Reasons for Enacting GINA 1.GINA was originally introduced in Congress (1995) before HIPAA was enacted (1996) and before most states had enacted laws prohibiting genetic discrimination in health insurance. 2.GINA was intended to improve upon the “confusing and inadequate” patchwork of state and federal laws.

12. 3.GINA was intended to add protection in states without genetic nondiscrimination laws. 4.GINA was intended to allay the concerns of individuals who (despite a lack of documented instances of discrimination and existing protections) were afraid to undergo genetic testing in research and clinical settings because of possible discrimination.

13. GENETIC INFORMATION NONDISCRIMINATION ACT OF 2008 Public Law 110-233, 122 Stat. 881 42 U.S.C. § 2000ff Title I. Genetic Nondiscrimination in Health Insurance Title II.Prohibiting Employment Discrimination on the Basis of Genetic Information Title III.Miscellaneous Provisions.

15. GINA is intended “to fully protect the public from discrimination and allay their concerns about the potential for discrimination, thereby allowing individuals to take advantage of genetic testing, technologies, research, and new therapies.” GINA § 2(5).

16. A. Definition of Genetic Information “The term ‘genetic information’ means, with respect to any individual, 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.”

17. “Such term 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.” GINA § 101(d).

18. B. Definition of Genetic Test “The term ‘genetic test’ means an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, that detects genotypes, mutations, or chromosomal changes.”

19. It does not include an analysis “that is directly related to a manifested disease, disorder, or pathological condition that could reasonably be detected by a health care professional with appropriate training and expertise in the field of medicine involved.” GINA § 101(d).

20. KEY PROVISIONS OF GINA (TITLE II) Coverage and Remedies Similar to Title VII Applies to employers with 15+ employees, employment agencies, labor organizations, and training programs EEOC to issue regulations by May 21, 2009 Proposed regulations issued March 2, 2009 (74 Fed. Reg. 9056)

21. Remedies the same as Title VII No disparate impact claims State laws not preempted

22. Prohibitions under Title II Employment Discrimination Based on Genetic Information Hiring, firing, job assignments/training, compensation, terms, conditions, and privileges of employment Limiting, segregating, classifying in ways that adversely affect employee status

23. Requesting, requiring, or purchasing genetic information about employees (including applicants) Retaliating against employees who exercise rights under GINA

24. Some Methods of Acquiring Genetic Information That Are Not Unlawful Inadvertent requests/ requirements/ voluntary disclosures Workplace health services (e.g., wellness programs) FMLA certification

25. Some Permissible Disclosures of Genetic Information To employee on written request In response to court order To public health agencies when it concerns a contagious disease that presents an imminent threat of death or serious illness

26. Permissible Genetic Monitoring To assess the effects of toxic substances in the workplace under the following conditions: 1.written notice is provided to the employee; 2.the employee provides voluntary, written authorization or the monitoring is required by law;

27. 3.the employee is informed of individual results; 4.the monitoring is in compliance with applicable regulations; and 5.the employer receives results only in aggregate form. Note: GINA makes no provision for similar preplacement genetic tests of applicants and employees.

28. GINA’S LIMITATIONS 1.GINA does not apply to life insurance, disability insurance, long-term care insurance, or other uses of genetic information. Are the limited protections (health insurance and employment) enough “to allay the concerns of the public”?

29. 2.GINA does not apply to “non-genetic” predictive testing and information (e.g., epigenetics).

30. Epigenetic changes are alterations in the chemical makeup of DNA that do not involve modifying the DNA sequence. Epigenetic changes influence whether genes are expressed. Q: Is GINA stuck in today’s (or yesterday’s) science?

31. 3.GINA adopts the approach known as “genetic exceptionalism.” Will enacting genetic-specific federal legislation increase the stigma associated with genetic conditions, genetic tests, and genetic services? If so, GINA will have made matters worse.

32. 4.GINA’s employment provisions are unlikely to limit the disclosure of genetic information to employees. GINA § 202(b) makes it an unlawful employment practice for an employer to “request, require, or purchase genetic information with respect to an employee or a family member of the employee….”

33. But, § 102(d)(3) of the ADA permits employers, after a conditional offer of employment, to require the individual to sign an authorization for the disclosure of all of the individual’s health records, regardless of the job in question or the individual’s health status.

34. Each year, there are at least 10.2 million blanket authorizations signed at the preplacement stage of the employment process. Even if the custodians of the health records wanted to release only “non-genetic” information, there is no practical way to do so with either paper or electronic health records, and most custodians are likely to continue the current practice of releasing everything.

35. GINA does not address the issue of using "contextual access criteria" (computer software) to limit the scope of disclosure of health information.

36. 5.GINA’s employment provisions create a gap with the ADA’s protections.

37. Asymptomatic Biomarkers, mild symptoms "Manifestation of disease" GINAYes?No ADANo Yes

38. Genetic Predisposition and the ADA In 1995, the EEOC issued a non-binding interpretation of the ADA that individuals who are subject to discrimination on the basis of “genetic information relating to illness, disease, or other disorders” are being regarded as having a disability.

39. Most observers believed that this interpretation did not survive Sutton in 1999, but the ADA Amendments Act of 2008 overturned Sutton in major respects, including the effect of “mitigating measures.” The issue is largely academic now because such discrimination violates GINA.

40. EVALUATING GINA 1.GINA has symbolic value, and that may be important (e.g., ADA)

41. 2.GINA avoids the underlying societal problem. Genetic discrimination in health insurance is not about genetics!

42. It is about health care finance and access to health care.

43. The key questions: Should individuals who are ill or more likely to become ill (for any reason) be able to obtain individual health insurance coverage without medical underwriting? Should there be a universal right of access to health care coverage?

44. 3.GINA does not resolve the broader issue of the relative rights of employers vs. employees to control access to health information, including predictive health information.

45. 4.GINA does not address the issue of genetic privacy. Electronic health records and networks create comprehensive, longitudinal, interoperable health files for all individuals.

46. To what extent, if any, should individuals be able to isolate or sequester sensitive information in their health records? When will additional restrictions be placed on access to and use of sensitive health information by third party requestors?

47. GOING FORWARD Does GINA represent a “foot in the door” to more comprehensive and effective legislation OR...

48. ... is GINA the one bite of the apple in enacting genetic nondiscrimination law?

49. Will any attempt to amend GINA be met with “legislative fatigue,” as policy makers think they have resolved genetic discrimination?