2. GENETIC DISCRIMINATION IN A POST-GINA WORLD 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

3. 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.

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

5. As of 2009, all but 3 states (MS, PA, WA) prohibit genetic discrimination in health insurance. The laws generally prohibit the acquisition of genetic information (27 states); the use of genetic information in determining insurability (45 states); and the use of genetic information in risk classification or pricing (42 states). Genetic information is variously defined to include test results, the test results of family members, and family history.

6. B. Federal Law The Health Insurance Portability and Accountability Act of 1996 (HIPAA) provides: “[A] group health plan, and a health insurance issuer offering group health insurance coverage in connection with a group health plan, may not establish rules for eligibility (including continued eligibility) of any individual to enroll under the terms of the plan based on any of the following health status- related factors in relation to the individual or a dependent of the individual:

7. (A)Health status. (B)Medical condition (including both physical and mental illness). (C)Claims experience. (D)Receipt of health care. (E)Medical history. (F)Genetic information. (G)Evidence of insurability (including conditions arising out of domestic violence). (H)Disability. 42 U.S.C. § 300gg-1(a).

8. “A group health plan, and a health insurance issuer offering health insurance coverage in connection with a group health plan, may not require any individual (as a condition of enrollment or continued enrollment under the plan) to pay a premium or contribution which is greater than such premium or contribution for a similarly situated individual enrolled in the plan on the basis of any health status-related factor in relation to the individual or to an individual enrolled under the plan as a dependent of the individual.” 42 U.S.C. § 300gg-1(b)(1).

9. C. 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. Was there a need for GINA?

10. D. 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.By 2008, GINA was intended to improve upon the “confusing and inadequate” patchwork of state and federal laws.

11. 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.

12. GINA’S PROTECTIONS

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.

14. 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).

15. 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.”

16. “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).

17. 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.”

18. 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).

19. KEY PROVISIONS OF GINA (Title I) "A group health plan, and a health insurance issuer offering health insurance coverage in connection with a group health plan, shall not request or require an individual or a family member of such individual to undergo a genetic test."

20. "A group health plan, and a health insurance issuer offering health insurance coverage in connection with a group health plan, shall not request, require, or purchase genetic information for underwriting purposes." GINA § 101(c) and (d).

21. A health insurance issuer offering health insurance coverage in the individual market shall not: (a)(1) establish rules for eligibility (including continued eligibility) to enroll on the basis of genetic information.... (b)(1) adjust premium or contribution amounts for an individual on the basis of genetic information....

22. (c)(1) impose any preexisting condition exclusion on the basis of genetic information... (d)(1) request or require an individual or family member to undergo a genetic test... (e)(1) request, require, or purchase genetic information for underwriting purposes. GINA § 102(b).

23. Benefits of GINA Under GINA, the rates for group health insurance may not be raised based on predictive genetic information. Under GINA, an individual will be able to obtain an individual health insurance policy without being disqualified because of genetic risk factors.

24. The Main Problems with Title I of GINA 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”?

25. 2.GINA’s health insurance provisions do not apply to people who are symptomatic.

26. “Nothing in this paragraph shall be construed to preclude a health insurance issuer from establishing rules of eligibility [or adjusting premium amounts or imposing preexisting condition exclusions] for an individual to enroll in individual health insurance coverage based on the manifestation of a disease or disorder in that individual, or in a family member of such individual where such family member is covered under the policy that covers the individual.” GINA § 102.

27. State health insurance laws determine whether it is lawful for an insurer offering individual health insurance to increase rates and/or decline to renew the policy of an individual who has developed an illness (genetic or otherwise) during the preceding period of coverage. Virtually all states permit insurers to do so.

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

29. 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

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

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

32. 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;

33. 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.

34. The Main Problems with Title II of GINA 1.GINA’s employment provisions are unlikely to limit the disclosure of genetic information to employers.

35. 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”

36. 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.

37. 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.

38. 2.GINA’s employment provisions create a gap with the ADA’s protections.

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

40. THE POST-GINA WORLD 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. GOING FORWARD Does GINA represent a “foot in the door” to more comprehensive and effective legislation OR...

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

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