Yann Joly, L.L.B, L.L.M.

Transcription

1 Predictivity, Genetic Testing and Insurance: North American Perspective Strasbourg, December 2007 Yann Joly, L.L.B, L.L.M. Projet génétique et société, Centre de recherche en droit public, Université de Montréal. Prepared by: Yann Joly & Ina Yazerskaya

2 Outline 1. Canada a) Healthcare system. b) Regulatory framework. c) Evidence of discrimination. d) Stakeholder s position. 2. United States. a) Healthcare system. b) Regulatory framework. c) Evidence of discrimination. d) Stakeholder s position.

3 1. CANADA: Legislative Inertia & Stakeholders Relative Indifference

4 Healthcare System Universal health care system. Largely government-funded (69-75% ), with most services provided by private enterprises. OECD- Health Data 2007, Frequently requested data. An interlocking set of ten provincial and three territorial health insurance plans. The federal government is committed to providing funding as long as the provinces abide by accessibility guarantees.

5 Regulatory Framework Under the Canadian Constitution, life insurance falls under provincial jurisdiction. Federal government cannot directly legislate on this topic. British North America Act of 1867.

6 Regulatory Framework No legislative text at the provincial level addressing the use of genetic information or tests by insurers. No moratorium or para-legal system of control of the use of genetic information by insurers. Federal and provincial privacy laws generally allow third-party access to personal information with the consent of the concerned individual. Charters could be interpreted by tribunals as protecting individuals in cases of unjustified discrimination on prohibited (or analogous) grounds.

7 Regulatory Framework Audet v. l Industrielle-Alliance [1990] RRA 500 (Sup Ct). Carrier of genetic mutation for myotonic dystrophy of Steinert (affected individual). Did not disclose this information in insurance application. The insured died in a car-accident. Policy was annulled upon request of the insurer.

8 Evidence of Discrimination No comprehensive studies have been done on the issue of use of genetic information by insurers in Canada. Family traits as well as genetic results could be taken into consideration for the determination of individual life and disability insurance premiums. In practice, few incidences of insurers asking to see test results and no report of insurance denials because of a genetic predisposition.

9 Evidence of Discrimination Ex. Quebec case study 2004 Clinical Setting : Clinique des cancers familiaux (CHUM). Starting date : 2002 Patients : 959 patients Insurers requests : 4 No complaints of discrimination, denial of insurance or premium raise. Joly, 2004 (unpublished).

10 Stakeholders Position There are limitations to the usefulness of genetic testing for the purposes of today s underwriting. Results of genetic testing are not definitive enough in most cases to be useful as the sole determinant of assessing insurance risk. Insurers do not require an applicant to undergo genetic testing, but if genetic testing has been done and the results are available to the insurance applicant, insurers expect to receive the information. Canadian Institute of Actuaries, Statement on Genetic Testing and Insurance (2000) CLHIA Position Statement on Genetic Testing (updated 2003) Canadian Life Insurance Medical Officers Association, CLIMOA Guidelines on genetic testing (2002)

11 Stakeholders Position Canadian Genetics and Life Insurance Task Force Task Force multidisciplinary, pan-canadian working group (insurers, researchers, doctors, legal scholars, patient group advocates) created in the summer of Solutions identified by the Task Force were the following: The adoption of a moratorium on the use of genetic tests by insurers, and The evaluation of the validity of genetic tests and the management of customer complaints by an independent consulting committee. CGLITF - Genetics and Life Insurance in Canada Points to Consider (2004).

12 Stakeholders` Position Survey of 1000 Canadians and eight focus groups nationwide showed that: 54% of Canadians would like the rules governing access to genetic information to be more strictly regulated than other health information, while 43% said that the same kind of regulations would be fine. The majority of Canadians don't want genetic information to be revealed to insurance companies. There is initial evidence of a chill effect on getting tested in the absence of firm rules about what information is protected and from whom. Public Opinion Research into Biotechnology Issues in Canada prepared by Pollara in December 2003 for the Biotechnology Assistant Deputy Minister Coordinating Committee (BACC).

13 2. United States: Navigating the Legislative Patchwork

14 U.S. Health Care System U.S. have a privately-oriented health care system. Around 84% of citizens have health insurance, either through their employer (60%), purchased individually (9%), or provided by government programs (Medicare and Medicaid);16% are uninsured. In 2004, private insurance paid for 36% of personal health expenditures, private out-of-pocket payments were 15%, while federal, state, and local governments paid 44%. Statistics is taken from Income, Poverty, and Health Insurance Coverage in the United States: 2006, U.S. Census Bureau and Facts about Healthcare - Health Insurance Coverage, The National Coalition on Health Care.

15 Regulatory Framework The United States is a federation of states that retain sovereignty over all matters that do not fall within the purview of the federal government. The Federal government has traditionally imposed few regulatory requirements on private health insurers. Most insurance sold by private companies is regulated by the state. Self-insured employer plans, however, do not fall under the jurisdiction of state insurance laws.

16 Regulatory Framework: Federal Level The Health Insurance Portability and Accountability Act (HIPAA) was enacted in Title I of HIPAA regulates the availability and breadth of group and individual health insurance plans. It prohibits any group health plan from creating eligibility rules or assessing premiums for individuals in the plan based on health status, medical history, genetic information, or disability. This does not apply to private individual insurance.

17 Regulatory Framework: Federal Level Genetic Information Non-Discrimination Act (GINA) Prohibit insurers from adjusting premium on the basis of genetic information or from using it to establish eligibility. Prohibit insurers from requesting or requiring an individual to undergo a genetic test, but it would still allow the use of the results of a genetic test by group insurance plans. Authorize the imposition of a monetary penalty or tax for any failure to meet requirements of the Act. Prohibit the use or disclosure of genetic information for underwriting purposes.

18 Regulatory Framework: Federal Level Genetic Information Non-Discrimination Act First introduced in Congress 12 years ago, approved twice in the Senate by unanimous votes (2003, 2005). Current version of the bill introduced in the House of Representatives on January 22, On April 25, 2007, GINA passed the House of Representatives, but was blocked in the Senate. The White House issued a statement supporting passage of the bill. The next step for the bill will be to pass the Senate and be signed by the President.

19 Regulatory Framework: Federal Level Bills that have not been enacted The Genetic Privacy and Non-discrimination Act of S.1416, H.R The Genetic Fairness Act of 1996, S The Genetic Information Non-discrimination in Health Insurance Act of 1995, H.R. 2748, S Genetic Confidentiality and Non-discrimination Act of 1996, S.1898.

20 Regulatory Framework : Provincial Level Health Insurance 44 American states have legislated to prohibit the use of genetic information for establishing eligibility rules; 42 of them also prohibited the use of genetic information for risk selection and risk classification. 26 states prohibited health insurance providers from requiring genetic testing or genetic information. 5 states adopted anti-discrimination laws only for group insurance policy, and 3 others only for individual one. One state (Indiana) permit the use of genetic information when favorable to the individual. National Conference of State Legislatures, NCSL Genetic Tables: Genetics and Health Insurance, 2007.

21 Regulatory Framework : Provincial Level Health Insurance Enforcement Provisions 21 states provided for the possibility of an insurer's license suspension or revocation in case of discrimination. 8 states grant individual victims of genetic discrimination the possibility of a civil action. 22 states authorize regulatory penalties. 28 states provide for criminal penalties and administrative fines. National Conference of State Legislatures, State Genetic Nondiscrimination in Health Insurance Laws Enforcement Provisions (undated).

22 Regulatory Framework : Provincial Level Life, Disability and Long-term Care Insurance 7 states prohibit the use of genetic information without actuarial justification. 5 states prohibit insurers from requiring applicants to undergo genetic testing, but 4 out of them still permit the use of test results. 9 states have an informed consent requirement for the use of genetic information. 16 states have no provisions relating to the use of genetic information for this type of insurance; 15 states mention life, disability or long-term care as exclusions to their genetic non-discrimination legislation. National Conference of State Legislatures, NCSL Genetic Laws and Legislative Activity: Genetics and Life, Disability and Long-Term Care

23 Evidence of Discrimination Empirical studies remain limited in scope and the results are sometime contradictory. In a survey of people in families with genetic disorders, 22% indicated they, or a member of their family, had been refused health insurance on the basis of their genetic information. July 14, 1997, Health Insurance in the Age of Genetics, Report from the Department of Health and Human Services (DHHS) to former President Clinton. A retrospective cohort study of 636 women who underwent BRCA1/2 testing for breast cancer between 1995 and 2000 revealed no evidence of actual insurance discrimination. Katrina Armstrong et al, Life Insurance and Brest Cancer Risk Assessment: Adverse Selection, Genetic Testing Decisions, and Discrimination, American Journal of Medical Genetics 2003.

24 Stakeholders Position National Association of Heath Underwriters NAHU supports the prohibition of the use of genetic information in the health insurance underwriting process, provided that the definition of genetic information is limited to DNA, RNA and related gene testing. National Association of Heath Underwriters, Position on Genetic Testing (2003)

25 Stakeholders Position American Academy of Actuaries While the academy does not know of any life insurer that currently requires DNA-based tests, it is possible that such tests maybe required in the future. Life insurers may require applicants to reveal results of genetic tests already performed. Private health insurers do not currently require applicants for insurance to undergo genetic testing or use genetic testing to limit coverage for preexisting conditions. Insurers in the voluntary, individual medical expense market do ask applicants about their health and some may inquire about the results of any prior tests. Currently insurers rarely encounter any such information.

26 Stakeholders Position American Academy of Actuaries Genetic Information and Voluntary Life Insurance (1998). Risk Classification in Individually Purchased Voluntary Medical Expense Insurance (1999). Genetic Information and Medical Expense Insurance (2000). Risk Classification in Voluntary Individual Disability Income and Long-Term Care Insurance (2001). The Use of Genetic Information in Disability Income and Long-Term Care Insurance (2002).

27 Stakeholders Position 92% of Americans are concerned that results of genetic test could be used in ways that are harmful to the person; Only 15% support the use of genetic testing by insurance companies for the purposes of insurability and premium determination; 93.1% believe that health insurers should not be able to deny or limit insurance coverage based on genetic test results; 76.3 % support a law forbidding genetic discrimination by health insurers. The Genetics and Public Policy Center Public Opinion Survey 2007

28 Conclusion Canada - Statu Quo position. - Insurers have adopted a defensive approach. - Research community has expressed concerns about possibility of a backlash against genetic research. United States - Legislative patchwork. - Nature of the American healthcare system has substantially influenced the debate. - Enactment of GINA could have a significant impact on the debate.

29 Acknowledgements Bartha M. Knoppers Mark A. Rothstein Jacques Simard Ina Yazerskaya The Genetics and Society Project