D R A F T

FOR DISCUSSION ONLY

UNIFORM PROTECTION OF GENETIC INFORMATION IN EMPLOYMENT AND INSURANCE ACT

NATIONAL CONFERENCE OF COMMISSIONERS

ON UNIFORM STATE LAWS

MEETING IN ITS ONE-HUNDRED-AND-SEVENTEENTH YEAR

BIG SKY, MONTANA

JULY 18 - JULY 25, 2008

UNIFORM PROTECTION OF GENETIC INFORMATION IN EMPLOYMENT AND INSURANCE ACT

WITH PREFATORY AND REPORTER=S NOTES

NATIONAL CONFERENCE OF COMMISSIONERS

ON UNIFORM STATE LAWS

The ideas and conclusions set forth in this draft, including the proposed statutory language and any comments or reporter=s notes, have not been passed upon by the National Conference of Commissioners on Uniform State Laws or the Drafting Committee. They do not necessarily reflect the views of the Conference and its Commissioners and the Drafting Committee and its Members and Reporter. Proposed statutory language may not be used to ascertain the intent or meaning of any promulgated final statutory proposal.

DRAFTING COMMITTEE ON UNIFORM PROTECTION OF GENETIC INFORMATION IN EMPLOYMENT AND INSURANCE ACT

The Committee appointed by and representing the National Conference of Commissioners on Uniform State Laws in preparing this Act consists of the following individuals:

D. JOE WILLIS, 549 SW Mill View Way, Suite 100, Bend, OR 97702, Chair

PAMELA WINSTON BERTANI, 331 J St., Suite 200, Sacramento, CA 95814

MICHAEL B. GETTY, 430 Cove Towers Dr., #503, Naples, FL 34110

JOANNE B. HUELSMAN, 235 W. Broadway, Suite 210, Waukesha, WI 53186

SHELDON F. KURTZ, The University of Iowa College of Law, 446 BLB, Iowa City, IA 52242

PETER F. LANGROCK, P.O. Drawer 351, Middlebury, VT 05753

JAMES C. NELSON, Montana Supreme Court, 215 N. Sanders St., Room 425, P.O. Box 20031, Helena, MT 59620

LINDA K. NEUMAN, 28218 218th St., LeClaire, IA 52753

ARTHUR H. PETERSON, P.O. Box 20444, Juneau, AK 99802

KEN H. TAKAYAMA, Legislative Reference Bureau, State Capitol, Room 446, Honolulu, HI 96813

JAMES A. WYNN, JR., NC Court of Appeals, One W. Morgan St., P.O. Box 888, Raleigh, NC 27602

JOAN ZELDON, District of Columbia Superior Court, 500 Indiana Ave. NW, Room 1640, Washington, DC 20001

ELLEN E. DEASON, The Ohio State University, Moritz College of Law, 55 W. 12th Ave., Columbus, OH 43210, Reporter

EX OFFICIO

MARTHA LEE WALTERS, Oregon Supreme Court, 1163 State St., Salem, OR 97301‑2563, President

JAMES A. WYNN, JR., NC Court of Appeals, One West Morgan St., P.O. Box 888, Raleigh, NC 27602, Division Chair

AMERICAN BAR ASSOCIATION ADVISOR

ROGER L. JANSSON, 1201 Third Ave., Suite 2200, Seattle, WA 98101, ABA Advisor

ROBYN S. SHAPIRO, 777 E. Wisconsin Ave., Suite 2000, Milwaukee, WI 53202, ABA Advisor

EXECUTIVE DIRECTOR

JOHN A. SEBERT, 111 N. Wabash Ave., Suite 1010, Chicago, IL 60602, Executive Director

Copies of this Act may be obtained from:

NATIONAL CONFERENCE OF COMMISSIONERS

ON UNIFORM STATE LAWS

111 N. Wabash Ave., Suite 1010

Chicago, Illinois 60602

312/450-6600

www.nccusl.org

UNIFORM PROTECTION OF GENETIC INFORMATION IN EMPLOYMENT AND

INSURANCE ACT

TABLE OF CONTENTS

Prefatory Note................................................................................................................................ 1

[ARTICLE] 1GENERAL PROVISIONS

SECTION 101. SHORT TITLE.................................................................................................. 21

SECTION 102. DEFINITIONS................................................................................................... 21

[ARTICLE] 2EMPLOYMENT

SECTION 201. APPLICANT FOR EMPLOYMENT............................................................... 33

SECTION 202. GENETIC TESTING........................................................................................ 33

SECTION 203. EMPLOYEE AUTHORIZATION FOR A GENETIC TEST........................... 38

SECTION 204. ACCESS TO GENETIC INFORMATION...................................................... 43

SECTION 205. PROHIBITION ON USE OF GENETIC INFORMATION. A........................ 47

SECTION 206. AUTHORIZED USE OF GENETIC INFORMATION. ................................. 49

SECTION 207. ACCESS TO GENETIC INFORMATION BY EMPLOYEE......................... 50

SECTION 208. CONFIDENTIALITY; RETENTION AND DISCLOSURE OF

GENETIC INFORMATION.............................................................................................. 51

SECTION 209. AUTHORIZATION FOR ACCESS, USE, RETENTION, OR DISCLOSURE OF GENETIC INFORMATION OR FAMILY MEDICAL HISTORY...................................................... 52

SECTION 210. REVOCATION OF AUTHORIZATION........................................................... 58

SECTION 211. RETENTION OF AUTHORIZATION.............................................................. 59

SECTION 212. REMEDIES; LIMITATION OF ACTIONS...................................................... 59

[ARTICLE] 3HEALTH INSURANCE

SECTION 301. APPLICANT FOR INSURANCE................................................................... 62

SECTION 302. GENETIC TESTING; ACCESS TO GENETIC INFORMATION................. 63

SECTION 303. PROHIBITED USE OF GENETIC INFORMATION. ................................... 64

SECTION 304. AUTHORIZED USE OF GENETIC INFORMATION. ................................. 66

SECTION 305. RETENTION OF GENETIC INFORMATION. ............................................. 67

SECTION 306. DISCLOSURE OF GENETIC INFORMATION BY HEALTH

INSURERS....................................................................................................................... 67

SECTION 307. AUTHORIZATION FOR DISCLOSURE OF GENETIC

INFORMATION. ............................................................................................................. 69

SECTION 308. REMEDIES; ENFORCEMENT; LIMITATION OF ACTIONS...................... 72

[ARTICLE] 4LIFE INSURANCE, DISABILITY-INCOME INSURANCE, AND LONG-TERM-CARE INSURANCE

SECTION 401. APPLICANT FOR INSURANCE................................................................... 75

SECTION 402. GENETIC TESTING. ..................................................................................... 75

SECTION 403. AUTHORIZATION FOR GENETIC TEST..................................................... 78

SECTION 404. ACCESS TO GENETIC INFORMATION. .................................................... 82

SECTION 405. PROHIBITION ON USE OF GENETIC INFORMATION. ........................... 83

SECTION 406. REQUIRED DETERMINATION AND FILING FOR GENETIC

TESTING AND ACCESS AND USE OF GENETIC INFORMATION. ..................... 84

SECTION 407. CORRECTION OPTION FOR GENETIC INFORMATION. ....................... 89

SECTION 408. CONFIDENTIALITY; RETENTION OF GENETIC INFORMATION. .......... 90

SECTION 409. DISCLOSURE OF GENETIC INFORMATION. .......................................... 90

SECTION 410. AUTHORIZATION FOR ACCESS, USE, RETENTION, OR

DISCLOSURE OF GENETIC INFORMATION. .......................................................... 91

SECTION 411. REVOCATION OF AUTHORIZATION........................................................... 97

SECTION 412. RETENTION OF AUTHORIZATION.............................................................. 97

SECTION 413. REMEDIES; ENFORCEMENT; LIMITATION OF ACTIONS...................... 98

[ARTICLE] 5MISCELLANEOUS PROVISIONS

SECTION 501. UNIFORMITY OF APPLICATION AND CONSTRUCTION....................... 100

SECTION 502. RELATION TO ELECTRONIC SIGNATURES IN GLOBAL AND NATIONAL COMMERCE ACT................................................................................................................................ 100

SECTION 503. EFFECTIVE DATE....................................................................................... 100

UNIFORM PROTECTION OF GENETIC INFORMATION IN EMPLOYMENT

AND INSURANCE ACT

Prefatory Note

The scientific developments in the field of genetics are often characterized as a Arevolution.@ This revolution is ushering in a new era of greater understanding of human biological processes and the promise of new approaches to medicine that can tailor medical treatments to individuals= genetic traits. Genetic tests also offer the possibility of identifying individuals who are at risk of developing certain diseases in the future. Unfortunately, while risk information has the potential to improve preventative medicine, it is also subject to misunderstanding and misuse. This Act strikes a balance between making genetic information available for beneficial uses and preventing access to information that creates a risk of misuse.

There are important policy issues concerning the appropriate form and scope of regulation of genetic information. Appropriate goals for regulation include that (1) individuals should not be coerced into having genetic tests; (2) individuals who want to be tested should not be discouraged through fear of how the results will be used; (3) genetic information should not be used for irrational discrimination, that is, where there is no scientific basis for discrimination; and (4) even Arational@ discrimination should be prohibited when it violates public policy, including the policy of preventing discrimination on the basis of disability. Cynthia Nance, Paul Miller, & Mark Rothstein, Discrimination in Employment on the Basis of Genetics, 6 Employee Rights & Employment Policy Journal 57, 79 (2002). See also Henry T. Greely, Genotype Discrimination: The Complex Case for Some Legislative Protection, 149 U. Pa. L. Rev. 1483, 1500 (2001).

The Drafting Committee has articulated four concepts that support the goals of protecting privacy and encouraging testing: control, confidentiality, consent, and counseling. The principle of knowing and voluntary consent can allow an individual to control genetic testing by vesting the decision in the individual to be tested. A baseline rule of confidentiality, coupled with the individual=s capability to consent to exceptions, can allow an individual to control how others access, use, retain, or disclose the individual=s genetic information. Finally, given the complexities and uncertainties of genetic science, genetic counseling is necessary if these decisions about consent are to be knowing and informed.

The Drafting Committee has identified reasons why it is important to regulate genetic testing and access, use, retention, and disclosure of genetic information by employers and insurers. These include the need to prevent fears of adverse consequences associated with genetic testing; the tendency to overstate the predictive power of genetic information, which can lead to actions that are not justified by that information; and the growing availability of genetic information.

Fear as a deterrent to genetic testing. To encourage individuals to undergo testing that can lead to advances in genetics and improved medical care, it is important to prevent fears that their privacy may be invaded or that testing may lead to detrimental treatment by employers or insurers. Currently, the public is afraid of taking advantage of genetic testing. See, e.g., Amy Harmon, Fear of Insurance Trouble Leads Many to Shun or Hide DNA Tests, N.Y. Times, Feb. 24, 2008, at A1. There is more than anecdotal evidence that these fears are widespread. In a 1997 national survey, 63% of the respondents reported that they would not take genetic tests if employers or insurers could obtain access to the results. Department of Labor, Department of Health & Human Services, Equal Employment Opportunity Commission, & Department of Justice, Genetic Information and the Workplace (Jan. 20, 1998) (available at http://www.genome.gov/10001732). In an actual genetic study of individuals at risk for hereditary colon cancer, only 43% of those eligible participated. Of those who declined, 39% said the primary reason was fear that the test results would affect their medical insurance coverage. D. Hadley, et al, Genetic Counseling and testing in families with hereditary nonpolyposis colorectal cancer, Archives of Internal Medicine 163: 573-582 (2003). These examples illustrate that individuals must have control not only over whether or not to undergo a test, but also over the information that results from genetic testing.

Exaggerated predictive power of genetic information. Because the human genome has been portrayed with images such as Ablueprint,@ Acode,@ and Afuture diary,@ public misunderstandings of the role of genetics are common. Employers and insurers cannot be expected to be exempt from such misunderstandings, which may cause them to exaggerate the predictive potential of genetic information.

There are some rare genetic diseases, such as Huntington=s disease, that are caused by a single gene and that can be predicted with certainty from an individual=s genetic sequence. These diseases may arguably justify Arational@ discrimination. But such monogenetic diseases are the exception. They have received much attention as the first diseases for which researchers established a genetic link, but they afflict relatively few individuals. And even with such diseases, there is usually variation in the age that symptoms appear and in their severity that lessens predictability.

The genetic causation of most diseases, and hence their predictability is far more complex. It is more common for medical conditions to result from interactions among multiple genes and with the environment. Most of the diseases that are linked to a genetic variation do not appear in all of the individuals with that genotype. This is termed Aincomplete penetrance.@ For example, certain forms of the BRCA 1 gene are strongly associated with susceptibility to breast cancer. But only 50 to 85 percent of women who have this form of the gene will ever develop the disease. Moreover, the frequency of particular gene variants and their degree of penetrance often differ among ethnic groups, which also complicates the clinical sensitivity of genetic tests and their predictive capabilities.

Another complicating factor for accurate prediction is that often a large number of genetic variations can cause the same disease. More than 180 different sequences of beta-globin genes are associated with the blood disease beta-thalassemia. And the severity of the symptoms of patients with this disease vary dramatically. Similarly, there are more than 300 forms of the gene responsible for cystic fibrosis. Unfortunately, identifying the variant of the gene does not explain the variation in symptoms.

Low penetrance, multiple genetic variations that may cause a single disease, and other sources of complications diminish the predictive value of genetic testing. In addition to the over-inclusiveness of many medical predictions based on genetic tests (in that a person with a predisposing genotype may never have symptoms of the disease), genetic predictions are also often extremely under-inclusive. For example, the predisposing variants of the BRCA 1 and BRCA 2 genes are present in only 5 to 10 percent of breast cancer patients. Thus, genetic data often do not provide an accurate individualized prediction. This is a major justification for the regulation of genetic information.

Increased Availability of Genetic Information. Scientific advances in genetics mean that a very large amount of information can be obtained from one small sample that is easily obtained and analyzed, yielding data that is easily stored and disseminated. This is not unique, but the concentration of information makes genetic information, which combines the power of many other types of medical information, seem particularly threatening.

Recent developments are making genetic information far more available and increasing the risk that it can be misused. One development is in genetic testing offered directly to consumers. Companies such as 23andMe and Navigenics offer a genome scan of a saliva sample for as little as $1,000. There are companies that purport to help clients find DNA-compatible mates based on differences in immune systems or use DNA samples to identify nutritional needs that can be met by purchases of dietary supplements. See generally Rick Weiss, Genetic Testing Gets Personal: Firms Sell Answers on Health, Even Love, Wash. Post, Mar. 25, 2008.

A second development that will vastly increase the amount of readily available genetic information is the ongoing transition within the practice of medicine to electronic medical records. In 2005, the Secretary of Health and Human Services, Michael Leavitt, established the American Health Information Community, a federal advisory committee, to make recommendations on how to accelerate a shift to electronic records with the goal of reducing costs and improving medical care. Genetic information is typically contained in a standard medical record. Such records could be linked to each other and available electronically.

Scope of Regulation. Proposals to regulate genetic information, however, have provoked a major policy debate over the wisdom of Agenetic exceptionalism,@ that is, the regulation of genetic testing and information as a special category rather than as part of more comprehensive regulation of medical testing and information. See generally T.H. Murray, Genetic Exceptionalism and Future Diaries: Is Genetic Information Different from other Information, in Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era (Mark A. Rothstein ed. 1977); Sonia M. Sutter, The Allure and Peril of Genetics Exceptionalism: Do We Need Special Genetics Legislation?, 79 Wash U. L.Q. 669 (2001).

In the course of this debate, many arguments for singling out genetics for special attention have been raised and rejected. In the early 1990s, the Task Force on Genetic Information and Insurance, a joint working group of the National Institutes of Health and the United States Department of Energy, considered and rejected three justifications for such a policy: (1) They decided that genetic information is not sufficiently distinct from other health information on the basis of its prophetic potential. Genetic predispositions can be affected by many factors and information on non-genetic characteristics, such as lifestyle, may be better health predictors; (2) Genetic information is also not unique in its implications for family members; and (3) Genetic information is not the only type of health information with the ability to sigmatize.

Other arguments for exceptionalism include that genetic information is particularly sensitive in that it identifies normal variations that fuel discrimination despite their lack of clinical significance. Genetic codes are also viewed as immutable, so that one test can follow a person forever, and genetic information is more probabilistic than other types of medical information. These arguments can also be refuted as a basis for exceptionalism on the ground that they apply as well to other types of health information. Laine Friedman Ross, Genetic Exceptionalism vs. Paradigm Shift: Lessons from HIV, 29 J. L. Med. & Ethics 141 (2001).

There are also objections to treating genetic information separately on practical grounds. The distinction between genetic and non-genetic disorders is increasingly difficult to draw; most conditions have both a genetic and non-genetic component. Opponents of exceptionalism also contend that it is unrealistic to separate genetic information in medical records, so that it would be impossible to comply with restrictions on disclosing genetic information to employers or insurers. L.O. Gostin & J.G. Hodge, Genetic Privacy and the Law: An End to Genetics Exceptionalism, 40 Jurimetirics 21 (1999). Also, there is a social argument that it is unwise to enact laws that treat genetic conditions as if there is a stigma attached to them because that reinforces such attitudes and becomes a self-fulfilling prophecy. Moreover, treating genetics as unique only encourages the public view that genetics exert a special control over our lives, a view termed Agenetic essentialism.@ See, e.g., Rochelle Cooper Dreyfus & Dorothy Nelkin, The Jurisprudence of Genetics, 45 Vand. L. Rev. 313 (1992).

Most of the opponents of genetic exceptionalism do not oppose privacy protections, rather they advocate more holistic approaches to health information and its use in employment and insurance. The larger debate is about how to protect medical data from harmful uses while providing access for uses that individuals, clinicians, and society regard as beneficial. Genetic information is one part of the problem posed by the ease of collecting, storing, and disseminating personal information. Thus it is possible to argue that the exceptionalism debate is a distraction from more important questions about how regulations should be adapted to new scientific developments. Zita Lazzarini, What Lessons Can We Learn from the Exceptionalism Debate (Finally)?, 29 J. L. Med. & Policy 149 (2001). In the context of health insurance, one commentator maintains that A[g]enetic equity should be regarded not as an exceptional goal, but as an aim consistent with a broader movement toward equitable access to health care in a time of scarcity.@ John V. Jacobi, Genetic Discrimination in a Time of False Hopes, 30 Fla. St. U. L. Rev. 363, 364 (2003).

The drafting committee=s charge, which covers the misuse of genetic information in employment and insurance, responds to the large number of states that have enacted legislation. That legislation is highly inconsistent and often deals only partially with the issues associated with genetic information. The charge does contemplate genetic exceptionalism by focusing on use of genetic information rather than on health information or privacy more generally. Broader measures for all medical information may not be practical at this time. Nonetheless, it is still important to respond to problems with the use of genetic information. Perhaps regulation of the use of genetic information can serve as an example for policies that need to be developed for the treatment of medical information more generally.

Privacy Protections in General

General Policy Issues

The genetic revolution has raised challenges for several different aspects of privacy: informational privacy, physical privacy, decisional privacy, and proprietary privacy. See Anita L. Allen, Genetic Privacy: Emerging Concepts and Values, in Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era 31 (Mark A. Rothstein, ed. 1997).

Informational privacy can be thought of as an individual=s ability to determine what information about that individual should be available to others. ABy controlling personal information, individuals can control the extent to which other people can participate in their lives.@ David Orentlicher, Genetic Privacy in the Patient-Physician Relationship, in Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era 77 (Mark A. Rothstein, ed. 1997). Informational privacy of any type is challenging given advances in information technology that greatly increase the potential for others to access or disclose one=s personal information.

In the genetic context, an individual=s primary informational concern is the confidentiality or anonymity of the results of genetic testing. This privacy interest extends beyond the results of one=s personal genetic testing to genetic testing of blood relatives, which can also provide information about the individual. The desire to maintain the privacy of this genetic information often has a consequential motivation: people are concerned about others using their genetic information to their detriment. It also springs from a sense of the intrinsic value of keeping such personal information private whether or not the release of genetic information could lead to adverse consequences. The understanding that one=s characteristics, and even one=s personality, are strongly linked to one=s genetic composition heightens the sense that this information is a reflection of personal identity, and thus has inherent personal value.

The other forms of privacy are also important in the context of genetics. Physical privacy, the protection of bodily and personal space, is implicated by genetic testing or treatment. The importance of this form of privacy is recognized in concern for informed, voluntary consent for genetic testing. Decisional privacy, the freedom to make choices without interference by others, is implicated by the need to make decisions about using genetic services. Decisional privacy is an important tenet of genetic counseling, which supports autonomous decisionmaking about having genetic testing and learning the results of the testing. Proprietary privacy, control over possessions and economic interests, is implicated by the value of some individuals= samples or genetic information and by a sense of ownership of one=s own identity. See Anita L. Allen, Genetic Privacy: Emerging Concepts and Values, in Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era 31 (Mark A. Rothstein, ed. 1997).

Privacy is valued in society and law, but not absolutely. The important interest in genetic privacy and confidentiality must be balanced against competing values, including facilitating medical research, improving medical care, protecting public health, enforcing the law, and controlling costs.

The Federal Regulatory Context

State legislation on privacy of medical information is set against the background of the 1996 Health Insurance Portability and Accountability Act (HIPAA), which covers health insurers and other health practitioners, and the recently enacted Genetic Information Nondiscrimination Act of 2008 (GINA), Pub. L. 110-233, which covers health insurers and employers.

Title II of HIPAA required the Department of Health and Human Services to promulgate rules that created standards for the use and dissemination of health care information, including what is now called AThe Privacy Rule.@ The Privacy Rule, which took effect in 2003, regulates those who create and disclose health information B individual practitioners, multi-national health plans, pharmacies, and information clearinghouses B but not many of the key recipients of this information. ACovered entities,@ which include most health insurers, may disclose Aprotected health information,@ i.e., Aindividually identifiable health information@ to facilitate treatment, payment, or health care operations. For other disclosures, with some exceptions, they must first obtain Aconsent,@ Aauthorization,@ or Aagreement@ from the individual, depending on the circumstances of the disclosure. The Privacy Rule also allows individuals access to their own health information and gives them the right to request a correction of any inaccurate data. Covered entities must notify individuals of uses of their protected health information and keep records of disclosures.

Health insurers who are covered entities must follow these rules when they disclose health information to employers or life, disability-income, or long-term-care insurers, but employers and these insurers are not directly subject to the HIPAA regulations and so do not need to follow these rules in their own treatment of the information.

Although HIPAA does include general preemption provisions, they do not apply to state laws that relate to the privacy of individually identifiable health information that are contrary to and more stringent than the federal requirements. Thus HIPPA provides a floor, not a ceiling, for privacy protections and would not preempt the privacy provisions of the Act.

Recent federal legislation has established specific privacy requirements for genetic information. GINA supplements privacy regulations for group, individual and medigap health insurers already covered by the HIPAA privacy regulations. It prohibits these health insurers from requesting, requiring or purchasing genetic information before an individual=s enrollment and from using genetic information in underwriting or determining eligibility.

The legislation also limits access, use, and disclosure of genetic information by employers, labor organizations, employment agencies, and joint labor-management committees. Its provisions do not apply to life, disability-income, and long-term-care insurers. Like HIPAA, the GINA employment provisions do not preempt state legislation that provides equal or greater privacy protection to individuals.

Current State Statutes

Approximately 15 states have statutes that protect the privacy of genetic information in general, without regard to employment or insurance or any other specific context. Most of these statutes are tailored to cover information derived from genetic testing, although some establish a principle of confidentiality for medical information more generally. (Cal, Maine, ND) Many of these statutes declare that genetic testing and test results are confidential. See, e.g., Ariz. (confidential and privileged), Cal, Maine, New York, Oregon. A few states have established a property right in genetic test results. Alaska Stat. ' 18.13.010 (exclusive property right in DNA sample and results of analysis performed on sample); Fla. Stat. ' 760.40 (results of DNA analysis are the exclusive property of the person tested); OR (repealed)).

Most of these generally-applicable statutes prohibit obtaining, analyzing, retaining, or disclosing genetic test results without the informed consent or specific authorization of the tested individual. All these statutes also define exceptions where genetic information may be obtained or disclosures may be made without authorization. Typical exceptions include law enforcement purposes and paternity determinations. Some states also exempt certain forms of insurance. See, e.g., Mass. (disability-income and long-term-care insurance); NH (life, disability-income, and long-term-care insurance); NMex (life, disability-income, and long-term-care insurance if underwriting based on sound actuarial principles); OK (life, disability-income, and long-term-care insurance). Others make special provisions for research. See, e.g., NY; OR (repealed).

The NCCUSL Draft

This draft protects privacy through limitations on the ability of employers and insurers to require genetic tests and to access, use, retain, and disclose genetic information. These limitations are coupled with requirements that employees and insureds authorize testing and access, use, retention, and disclosure of their genetic information. The Drafting Committee considered adopting a property right as a means to protect privacy of genetic information, but decided against this approach. While it might make sense to recognize a property right in genetic information in general, it is difficult to do only in the context of employment and insurance. Moreover, a majority of the committee felt that a system of limitations on testing, access, use, retention, and disclosure would be as effective as a property right in providing control over genetic information.

Employment

General Policy Issues

Many contend that employers= ability to obtain genetic information should be limited because it has few appropriate uses in the workplace. The concern is that if employers are permitted to consider genetic information in making personnel decisions, individuals may be unfairly barred or dismissed from employment for reasons that are not related to their ability to do the job. This is an especially high risk with predictive genetic information because so many persons tend to exaggerate the role of genes in disease and mistakenly regard an increased risk of an illness as a certainty that it will occur.

Employers arguably have an economic incentive to use genetic information to avoid hiring employees with higher medical insurance claims, higher absenteeism, or lower productivity. They may also wish to avoid the effect of high health care costs incurred by employees= dependents. Somewhat perversely, because the federal Health Insurance Portability and Accountability Act (HIPAA) protects employees against discrimination in health insurance based on medical conditions, including genetic characteristics, the most effective way for employers to avoid high insurance costs is to screen applicants and avoid hiring high-risk individuals. Nonetheless, there are few well-documented cases of genetic discrimination in employment.

In 1996, the NIH-DOE Joint Working Group on Ethical, Legal, and Social Implications of Human Genome Research (ELSI Working Group) and the National Action Plan of Breast Cancer developed and issued the following recommendations for state and federal policy makers to protect against genetic discrimination in employment. To a large extent, these recommendations mirror the approach of the Americans With Disabilities Act, described below.

$ Employment organizations should be prohibited from using genetic information to affect the hiring of an individual or to affect the terms, conditions, privileges, benefits or termination of employment unless the employment organization can prove this information is job related and consistent with business activity.

$ Employment organizations should be prohibited from requesting or requiring collection or disclosure of genetic information prior to a conditional offer of employment, and under all circumstances, employment organizations should be prohibited from requesting or requiring collection or disclosure of genetic information unless the employment organization can prove this information is job related and consistent with business necessity, or otherwise mandated by law. Written and informed consent should be required for each request, collection or disclosure.

$ Employment organizations should be restricted from access to genetic information contained in medical records released by individuals as a condition of employment, in claims filed for reimbursement of health care costs and other sources.

$ Employment organizations should be prohibited from releasing genetic information without prior written authorization of the individual. Written authorization should be required for each disclosure and include to whom the disclosure will be made.

$ Violators of these provisions should be subject to strong enforcement mechanisms, including private right of action.

Karen Rothenberg et al., Genetic Information and the Workplace: Legislative Approaches and Policy Challenges, 275 Science 1755 (1996).

The Federal Regulatory Context

The states are legislating in a regulatory environment in which recent federal legislation, the Genetic Information Nondiscrimination Act of 2008 (GINA), has increased the role of the federal government in regulating genetic testing and genetic information in employment. The employment provisions of this act do not, however, preempt state legislation that provides equal or greater protection to individuals. 42 U.S.C. ' 2000ff-8(a)(1). In addition, two federal statutes provide modest legal protections against discrimination in employment on a genetic basis: Title VII of the Civil Rights Act of 1964 (Title VII) and the Americans with Disabilities Act (ADA). These statutes are also important because many states have their own version of these statutes which they have modified to incorporate genetic protections.

Recent federal legislation now specifically regulates access to genetic information and its use by employers. 42 U.S.C. '' 2000ff to 2000ff-11. GINA applies to employers, employment agencies, labor organizations, and training programs. These entities are prohibited from discriminating on the basis of genetic information. They are also prohibited from acquiring genetic information, with exceptions that include offering genetic services as part of an employer wellness program and genetic monitoring that is required by federal or state law. Employees may bring claims for disparate treatment based on genetic information, but not for disparate impact. In six years, a study group will make recommendations regarding whether or not to add a cause of action for disparate treatment. Remedies and enforcement are generally limited to those available under Title VII of the Civil Rights Act of 1964, which requires filing a claim with the Equal Employment Opportunity Commission.

GINA is supplemented by Title VII, which prohibits employer discrimination on the basis of race, sex, color, national origin, and religion. It is applicable to genetic discrimination if an employer tests a group of employees in one of the protected classes. For example, the court in Norman-Bloodsaw v. Lawrence Berkeley Laboratory, 135 F.3d 1260 (9th Cir. 1998), held that testing only black employees for the sickle cell trait violated Title VII by imposing a condition of employment on the basis of race. It is also possible that testing all employees could violate the Act if the test were for a trait closely associated with a protected group, such as sickle cell trait (which is more prevalent among African-Americans) or Tay-Sachs disease (associated with Ashkenazi Jewish ancestry). However, in these circumstances the statute would require the difficult showing that the testing was a pretext for intentional discrimination against the group or that it had a statistically significant disparate impact on employment opportunities of members of the group. Most importantly, the narrow focus on employers= actions with respect to certain groups means that Title VII would certainly not apply if an employer instituted a screening program for traits that are not strongly associated with a protected group. See Pauline T. Kim, Genetic Discrimination, Genetic Privacy: Rethinking Employee Protections for a Brave New Workplace, 96 NW U. L. Rev. 1497 (2002).

The ADA could provide some protections against genetic discrimination through its regulation of disability discrimination, although this potential is limited by the United States Supreme Court=s narrow interpretation of the statute. See, e.g., Sutton v. United Air Lines, Inc., 527 U.S. 471, 484-85 (1999) (stating ADA is intended to have limited coverage). ADisability@ is defined under the ADA as (1) a physical or mental impairment that substantially limits one or more of the major life activities of an individual; (2) a record of such impairment; or (3) being regarded as having such an impairment. 42 U.S.C. ' 12112(d)(2). If a genetically-caused disease results in a disability under the first prong of the definition, the ADA=s protections will apply. The genetic connection is irrelevant; the statute protects the person because of the person=s disability, not its cause. Similarly, under the second prong the ADA covers individuals with a prior history of a genetically-related disability, such as a person recovering from a cancer. Of course, if these genetic conditions do not qualify under the definition of Adisability@ by substantially limiting a major life activity, the individual is not covered by the ADA.

The application of the ADA to discrimination based on a genetic trait that is not manifested in symptomatic disease is a more difficult question. In 1995 the Equal Employment Opportunity Commission (EEOC) issued a policy statement that an individual should be Aregarded as@ having a disability under the statute=s third prong if the employer discriminates on the basis of Agenetic information relating to illness, disease, or other disorders.@ EEOC Order No. 915.002 ' 902 (1995). This interpretation of the statute has not been considered by the courts, although several United States Supreme Court justices have expressed their disapproval in dicta. See, e.g., Bragdon v. Abbott, 524 U.S. 624, 661 (1998) (Rehnquist, J., joined by Scalia, J. & Thomas, J., concurring in part & dissenting in part). Moreover, the EEOC=s position has been criticized in both conceptual and practical terms. See, e.g., Pauline T. Kim, Genetic Discrimination, Genetic Privacy: Rethinking Employee Protections for a Brave New Workplace, 96 NW U. L. Rev. 1497 (2002).

The ADA protects a disabled job applicant or employee from discrimination in the workplace. This includes a duty to provide reasonable accommodations to a qualified individual with a disability unless the accommodation would impose an undue hardship on the operation of the business. The ADA also regulates testing and access to information by prohibiting medical examinations or testing before a job offer. However, after making a Aconditional offer,@ an employer may require an applicant to take a medical exam. After making a conditional offer employers also have the right to require that individuals sign a blanket release disclosing all their medical records to the employer. Furthermore, once an individual is hired, an employer may test the employee if it can justify the testing as job-related.

Current State Statutes

Concern about economic incentives for employers has led 34 states, as of January 2006, to enact statutes that regulate the use of genetic information or genetic testing by employers. One group of states has used an existing state statute as a platform, amending it to apply to genetic testing or information. A second, larger, group has enacted statutes that are specifically tailored for genetic issues. This diversity of approaches has led to much inconsistency in state law.

In the first group, some states have extended their disability statutes to prohibit discrimination by employers based on genetic information under the rubric of disability. See, e.g., Hawaii RS '' 378-1 to 378-6; Illinois, 410 ILCS 513/5 to 513/30 (tied to federal Americans with Disability Act); Mich Comp Laws Ann '' 37.1201-37.1202; NY Exec Law '' 292, 296 (adds genetic conditions to the definition of protected disability).

Other states in the group that has adapted existing statutes have built on their statutes that prohibit discrimination in employment, expanding them from race, sex, national origin, and other protected classes, to include discrimination based on genetic information. See, e.g., Ariz Rev Stat Ann ' 41-1463; Cal Govt Code '' 12926, 12940; Conn Gen Stat Ann ' 46a-60; Mass Gen L ch 151B; Nev Stat ' 613.345; NJ Stat Ann '' 10:5-5, 10.5-12.

Wisconsin has used its Fair Employment Act as its vehicle, amending it to restrict the ability of employers to conduct genetic testing and use genetic information. Wis Stat ' 111.372.

States in the second group have enacted special statutes that regulate genetic testing or the use of genetic information. This is the largest group of states, but the extent to which they concentrate on the context of employment varies to some extent. Most commonly, the provisions are tailored specifically for employment. See, e.g., Ark Code Ann '' 11-5-401 to 11-5-405; Del Code Ann ' 710; Kan Stat Ann '' 44-1002(m), 44-1009(a)(9); La Rev Stat Ann '' 23.302, 23.368-369; Iowa Code ' 729.6; Me Rev Stat Ann tit 5, ' 19301; Md Code Ann art. 49B '' 15,16; Minn Stat ' 181.974; Neb Rev Stat ' 48-236; NH Rev Stat Ann '' 141-H:1 to 141-H:5; NC Gen Stat ' 95-28.1A; Okla Stat tit 36, ' 3614.2; Or Rev Stat ' 659A.300; RI Gen Laws '' 28-6.7-1 to 28-6.7-4; S.D. codified laws '' 60-2-20 to 60-2-21; Tex Lab Code Ann ' 21.401; Utah Code Ann '' 26-45-101 to 26-45-106; Vt Stat Ann tit 18, '' 9331-9335; Va Code Ann ' 40.1-28.7:1(A); Wash Rev Code Ann ' 49.44.180. Some statutes cover genetic information more broadly, regulating its use in employment along with insurance and other activities. See, e.g., N Mex Stat Ann ' 24-21-2. For other statutes, the focus is on broad regulation of genetic testing and information, with coverage that applies to employers along with others who might use the information. See, e.g., Fla Stat ' 760.4; NJ Stat Ann ' 10:5-44, Or Rev Stat ' 192.537.

The states that have special statutes limiting genetic testing or the use of genetic information in the employment setting have obviously embraced exceptionalism. But so, for the most part, have the states that have added discrimination based on genetic information to their employment discrimination statutes. This is the case because genetic characteristics are singled out and treated differently from other medical conditions under these statutes. An exception is California, whose statute prohibits employment discrimination on the basis of medical conditions in addition to the more traditional categories of race, sex, and national origin. Under this statutory scheme, a genetic characteristic is treated as a medical condition and receives the same protection as other health problems. Finally, disability statutes by definition single out certain types of medical conditions for special protection: those that are disabling because they limit a major life activity. When genetic predispositions or conditions are defined as disabilities, they are treated similarly to this class of medical conditions. However, to the extent that a genetic condition does not fit within the rubric of Alimiting a major life activity,@ it is being treated differently from other non-disabling medical conditions under these statutes.

The NCCUSL Draft

The draft imposes strict limitations on genetic testing and access to genetic information by employers, employment agencies, labor organizations, and credentialing authorities. Exceptions include genetic screening for susceptibility to harm from a workplace condition and genetic monitoring of the effects of exposure, which are permitted with the employee=s authorization. These employment entities= use of genetic information is also limited and an they may not take an adverse employment action against an employee based on an employee=s genetic information. An employment entity must treat an employee=s genetic information as confidential and may not keep it or disclose it to others without employee authorization. Remedies are broadly availably to individuals, who need not elect to exhaust administrative procedures.

Health Insurance

General Policy Issues

As in the employment arena, the treatment of genetic information by health insurers raises concerns for individuals= privacy and for how genetic information may be used by the industry. Privacy is a great concern because the health care system is where much genetic information is generated and stored.

Discrimination in health insurance is a uniquely American problem because the United States does not guarantee coverage of health care expenses for its citizens as other wealthy nations do. Legislation in this area responds to public perceptions that health insurers will deny coverage or increase premiums based on predictive genetic information. This may be irrational discrimination. In addition, individuals who fear reduced or more expensive health care coverage may avoid genetic tests that could provide useful information for improving their health. The legislative restrictions are designed to avoid these outcomes.

The main argument against regulation in this market is that genetic information would allow insurers to decrease adverse selection. Adverse selection is the disproportionate purchase of insurance by individuals who have medical reasons to believe they will need to make claims. It leads to insurer losses when applicants fail to disclose the relevant health information and it is a particular concern with individual health insurance policies. The industry and a number of scholars contend that avoiding losses due to adverse selection based on genetic information will lead to more affordable insurance.

In 1995, the NIH-DOE Joint Working Group on Ethical, Legal, and Social Implications of Human Genome Research (ELSI Working Group) and the National Action Plan of Breast Cancer developed and issued the following recommendations for state and federal policy makers to protect against genetic discrimination in health insurance. The recommendations apply to both group and individual health plans.

$ Insurance providers should be prohibited from using genetic information, or an individual's request for genetic services, to deny or limit any coverage or establish eligibility, continuation, enrollment or contribution requirements.

$ Insurance providers should be prohibited from establishing differential rates or premium payments based on genetic information or an individual's request for genetic services.

$ Insurance providers should be prohibited from requesting or requiring collection or disclosure of genetic information.

$ Insurance providers and other holders of genetic information should be prohibited from releasing genetic information without prior written authorization of the individual. Written authorization should be required for each disclosure and include to whom the disclosure would be made.

Kathy Hudson et al., Genetic Discrimination and Health Insurance: An Urgent Need for Reform, 270 Science 392 (1995).

One study of state restrictions on the use of genetic information in health insurance concluded that there are almost no well-documented cases of insurers asking for genetic test results for pre-symptomatic conditions in either states with regulation or states without such regulation. The author argued that use of genetic information is not cost effective and is not seen by insurers as increasing the accuracy of their underwriting. Nonetheless, he believes that state laws will have an effect by making it less likely that insurers will use genetic information in the future, because the laws have helped convince insurers that use of this information is not socially acceptable. Mark A. Hall, Legal Rules and Industry Norms: The Impact of Laws Restricting Health Insurers= Use of Genetic Information, 40 Jurimetrics J. 93 (1999).

The Federal Regulatory Context

As with employment, the states legislate against the background of federal statutes governing health insurance. The 1996 Health Insurance Portability and Accountability Act (HIPAA) partially addresses the treatment and use of genetic information in health insurance. Title I amends the Employee Retirement Income Security Act (ERISA) and the Public Health Service Act with regard to availability of health insurance.

Under HIPAA=s Title I provisions on availability of health insurance, an employer-sponsored group health insurance plan may not deny an applicant coverage as a result of a health-status related factor, including genetic information. Plans are specifically prohibited from using Agenetic information@ in establishing eligibility or benefit levels. The law also prohibits exclusions for pre-existing conditions on the basis of a genetic predisposition to a particular condition. Moreover, a plan may not restrict coverage, restrict benefits, or charge higher premiums based on the health status of an enrolled employee. Title I covers employer-sponsored group health insurance plans for 50 or more individuals, including self-insured plans. As a result, this part of HIPAA regulates only a portion of the health insurance market. It does not apply to employees in small group health insurance plans or to individual health insurance coverage.

Title II of HIPAA mandated security and privacy provisions for health care information. The Department of Health and Human Sevices issued regulations called the Privacy Rule, which took effect in 2003. The regulations cover Ahealth plans,@ a category that includes both individual and group health insurers. It allows health insurers to disclose Aprotected health information,@ i.e., Aindividually identifiable health information@ to facilitate treatment, payment, or health care operations. Otherwise, health insurers must first obtain authorization from the individual. The privacy rule also allows individuals access to their own health information and gives them the right to request a correction of any inaccurate data. Insurers must notify individuals of uses of their protected health information and keep records of disclosures of that information. The Privacy Rule applies more widely than Title I because it includes individual health insurance, but there are some exceptions to its coverage that would be closed by this Act.

Recent federal legislation more specifically regulates genetic tests and the use of genetic information in the health insurance industry. GINA extends the HIPAA protections against use of genetic information to determine eligibility or establish exclusions for pre-existing conditions to the individual and small group health insurance market. It also adds new protections. In terms of access, it prohibits a health insurer from requesting or requiring an individual to take a genetic test, with an exception for requests for research purposes, and from collecting genetic information by requesting, requiring, or purchasing it. In terms of use of genetic information, health insurers may not use genetic information adjust premium rates and may not use or disclose genetic information for use in underwriting health insurance.

Current State Statutes

The law in 47 states restricts the use of genetic information by health insurers in some way. Some states impose restrictions only on group health insurance (Ak, Iowa, SD, Wy), and some only on individual policies (Hawaii, Nebraska, WVa), but most cover both group and individual health insurance and hence have a broader reach than HIPAA=s coverage provisions.

There are five main types of state regulation of genetics in health insurance. First, many states prohibit insurers from requiring individuals to have genetic tests or to disclose genetic information to the insurer. (Ark, Cal, Col, Fla, Ga, Haw, Ill, Ind, Kan, Md, Mich, Minn, Mo, Montana, Neb, NH, NMex, NY, OH, OK, Or, RI, SD, Tenn, UT, Wis). In a few states (Mich, Neb) this restriction on access to information stands alone, but most states have additional measures.

Second, a number of states prohibit health insurers from disclosing genetic information without informed consent or authorization. (Ariz, Cal, Col, Del, Ga, Haw, Ill, Ky, La, Me, Md, Mass, Mich, Mo, Nev, NH, NJ, NMex, NY, Or, RI, SC, Tenn, Tex, Vt, Va, Wash).

In addition to these privacy-based protections, there are also restrictions on health insurers= use of genetic information. In a third category, a large number of statutes provide that insurers may not establish rules for eligibility, that is, deny coverage, based on genetic information. (Alaska, Ariz, Ark, Cal, Col, Conn, Del, Fla, Ga, Haw, Ill, Ind, Iowa, Kan, Ky, La, Me, Mass, Minn, Mo, Mont, Nev, NH, NJ, NMex, NY, NC, OH, OK, Or, RI, SC, SD, Tenn, Tex, UT, Ve, Va, WVa, Wis, Wy).

Fourth, most of these same states impose some type of limit on the use of genetic information for risk selection or classification in health insurance, such as higher premiums, reduced coverage or reduced benefits. Many states simply prohibit insurers from considering genetic information for these purposes.

Fifth, some states do not permit health insurers to impose pre-existing condition exclusions based on predictive genetic information in the absence of a diagnosis based on symptoms of the disease or condition. (Alaska, Conn, Idaho, Iowa, Ky, others ).

The NCCUSL Draft

The draft prohibits genetic information from being considered in determining eligibility for health insurance coverage or in setting rates, terms, and conditions for health insurance policies. Health insurers are permitted to consult genetic information for their billing functions. And the draft does not restrict testing and access to genetic information for therapeutic purposes by insurers who provide health care services.

The draft does not consider the emerging health issue of access to genetic services and insurance coverage for their costs. Currently the states with laws in this area cover newborn screening and genetic childhood diseases. According to the National Conference of State Legislatures, no state currently requires coverage of testing for adult onset genetic disorders such as breast cancer, but bills are being introduced frequently.

Life Insurance, Disability-income Insurance, and Long-term-care Insurance

General Policy Issues

Life, disability-income, and long-term-care insurance can be distinguished from health insurance in that individual underwriting of policies is more common. This is because a larger proportion of the market for these insurance products consists of individual coverage than group coverage. According to the National Conference of State Legislatures, approximately 60 percent of life insurance, 40 percent of disability-income insurance, and almost all of long-term-care insurance is underwritten individually, compared to only about 10 percent of health insurance. Individual underwriting decisions take individual characteristics into account in determining risk and use this risk calculation in determining an individual=s premium rates and the terms and conditions for coverage and benefits. Individual underwriting could be done more accurately with access to genetic information if that genetic information provides an accurate prediction of the likelihood of claims.

The argument for restricting access to genetic information by the insurance industry is that its predictive power is easily exaggerated and insurers may force applicants to take genetic tests and then deny insurance or charge more based on genetic characteristics. This raises the possibility that a large class of people will lack coverage even though they are not sick and never will become sick. There are also privacy concerns with commercial access to sensitive genetic information and predictions that individuals will avoid genetic testing for fear of adverse effects on their insurability. From the industry perspective, as with health insurance, insurers worry about adverse selection. If applicants seek coverage because a genetic characteristic exposes them to risk, but the insurer does not have this information, this puts the insurer at a financial disadvantage. See generally Mark A. Rothstein, ed., Genetics and Life Insurance: Medical Underwriting and Social Policy (2004).

The Federal Regulatory Context

Life, disability-income, and long-term-care insurance are not covered by the recent federal Genetic Information Nondiscrimination Act of 2008.

Obtaining, retaining, and disclosing information. The insurance industry is primarily regulated by the states, but there are federal laws that affect privacy procedures for some aspects of obtaining, retaining, or disclosing medical information. First, HIPAA is the primary source of privacy rules in the medical context. Long-term-care insurers, like health-care insurers, are directly subject to the privacy rules in HIPAA.

Life and disability-income insurers are not directly subject to HIPAA, but their methods of obtaining medical information are affected indirectly because HIPAA controls the way in which health care providers can furnish them with medical information. Under HIPAA, the consumer must first provide an authorization for disclosure by the health care provider. Therefore, in order to obtain medical information from a health care provider to underwrite new coverage or evaluate a claim, an insurer=s forms must meet HIPAA requirements for consumer authorization. HIPAA does not apply, however, to other forms of access, (such as genetic testing by a life or disability-income insurance company) or to the use, retention, or disclosure of genetic information by life or disability-income insurers.

Second, the Fair Credit Reporting Act affects insurers= ability to disclose as well as obtain medical information (including genetic information). It imposes requirements on obtaining, using, and disclosing Aconsumer reports.@ The term consumer report may include medical information, including genetic information, that is used as a factor in establishing eligibility for insurance. It does not, however, include medical information disclosed to an affiliate in connection with the business of insurance or annuities and hence such disclosures are not regulated by the act.

The Fair Credit Reporting Act was amended in 2003 by the Fair and Accurate Credit Transactions Act (FACT Act) in response to concerns about the use of medical information in determinations of eligibility for credit. Under the FACT Act, consumer reporting agencies may furnish a consumer report containing medical information in connection with an insurance transaction only with consumer consent. In addition, an insurer or other third party who receives medical information from an insurer in connection with the business of insurance may not re-disclose that information except as necessary to carry out the purpose for which the information was initially disclosed or as otherwise permitted by law.

Third, the Gramm-Leach-Bliley Act (GLBA) protects consumers from certain disclosures of their Anonpublic personal information.@ In general, this information may not be shared by a financial institution (including insurers) with an unaffiliated third party unless the consumer has been given notice and an opportunity to opt-out of such sharing. However, sharing without an opt-out opportunity is permitted if it is in connection with the performance of business activities or a joint marketing agreement between financial institutions. The GLBA requires state insurance regulators to adopt rules to implement and enforce its provisions. In doing so, many states have gone further in protecting medical information by requiring an authorization from the consumer (opt-in) before medical information may be shared, as described below.

The State Regulatory Context

Obtaining, retaining, and disclosing information. Disclosure of genetic information by insurers is covered under state provisions on general information practices in the insurance industry. First, about 18 states have adopted provisions based on the National Association of Insurance Commissioners= Insurance Information and Privacy Protection Model Act. These provisions require written authorization from a consumer before an insurer may share personal consumer information, except as needed to perform basic insurance functions. See, e.g., Ariz. Rev. Stat. '' 20-2101 to 20-2102; Cal. Ins. Code '' 791.01 to 791.23; Conn. Gen. Stat. '' 38a-975 to 38a-999a; Ga. Code Ann. '' 33-39-1 to 33-39-23; 215 Ill. Comp. Stat. Ann. 5/1001 to 5/1024; Me. Rev. Stat. Ann. tit. 24-A '' 2201 to 2220; Mass. Gen. Laws ch 175I '' 1 to 22; Minn. Stat. Ann. '' 72A.49 to 72A.505; Mont. Code Ann. '' 33-19-101 to 33-19-409; Nev. Admin Code '' 679B.560 to 679B.750; N.J. Stat. Ann. '' 17:23A-1 to 17:23A-22; N.C. Gen. Stat. '' 58-39-1 to 58-39-125; Ohio Rev. Code Ann. '' 3904.1 to 3904.22; Or. Rev. Stat. '' 746.600 to 740.690; Va. Code Ann. '' 38.2-600 to 38.2-620.

Second, in implementing the GLBA, 27 states have adopted provisions specifically protecting medical information from disclosure by insurance companies. These provisions are based on the National Association of Insurance Commissioners= Privacy of Consumer Financial and Health Information Model Regulation. It provides that an insurer may not disclose nonpublic personal health information unless the consumer has provided authorization or unless the disclosure is made in connection with insurance business functions. See Alaska Admin. Code tit. 3 '' 26.605 to 26.749; Ark. Ins. Rule & Reg. 74; Cal. Fin. Code '' 4050 to 4060; Colo. Admin. Ins. Reg 6-4-1; Conn. Admin. Code tit. 38a '' 8-105 to 8-123; Fla. Admin. Code '' 69O-128.001 to 69O-128.025; Iowa Admin. Code '' 191-90.1 to 191-90.26; Kan. Admin. Regs. ' 40-1-46; 806 Ky Admin. Regs. 3:210-3:220; Md. Admin. Code '' 31.16.08.01 to 31.16.08.24; Neb. Rev. Stat.' 44-901 to 44-925; N.H. Admin. Code Ins. '' 3001.01 to 3006.05; N.Y. Comp. Code R. & Regs. tit 11, '' 420.0 to 420.24 (Reg. 169); N.D. Admin. Code '' 45-14-01-01 to 45-14-01-25; Okla. Admin. Code '' 365:35-1-1 to 365:35-1-54; Or. Admin. R. 836-080-0501 to 836-080-0551 & 836-080-0600 to 836-080-0700; 31 Pa.Code '' 146a.1 to 146a.44 & 146b.1 to 146b.24; R.I. Code Regulation 100; S.C. Code Ann. Regs. 69-58; S.D. Admin R. 20:06:45:01 to 20:064531; Tex. Admin Code '' 22.1 to 22.67; Utah Admin Code 590-206; Vt. Code R. IH-2001-1; Wash. Admin Code '' 284-04-120 to 284-04-260; W. Va. Code St. R. '' 114-57-1 to 114-57-22; Wis. Admin. Code ' ' 25.01 to 25.95; Wyo Ins. Regs. ch. 54 '' 1 to 26.

Use of Information. General limitations on the use of information in insurance underwriting are included in the Unfair Trade Practices Acts in effect in almost every state. These limitations apply to genetic information as well as to other information. Typically, these provisions prohibit Amaking or permitting any unfair discrimination between individuals of the same class and equal expectation of life in the rates charged for any life insurance policy or annuity . . . or in any other terms and conditions of such policy.@ National Association of Insurance Commissioners Model Unfair Trade Practices Act ' 4(G)(1). In many states, disability-income and long-term-care insurance are regulated as health insurance. For health insurance, a typical provision prohibits Aunfair discrimination between individuals of the same class and of essentially the same hazard in the amount of premium, policy fees or rates charged for any accident or health insurance policy or in the benefits payable thereunder, or in any of the terms and conditions of such policy, or in any other manner.@ ' 4(G)(2).

In both life and health insurance, practices that constitute Aunfair discrimination@ between individuals of the same class are identified as Arefusing to insure, refusing to continue to insure, or limiting the amount, extent, or kind of coverage available to an individual or charging a different rate for the same coverage solely because of a physical or mental impairment, except where the refusal, limitation or rate differential is based on sound actuarial principles or is related to actual or reasonably anticipated experience.@ National Association of Insurance Commissioners Model Regulation on Unfair Discrimination in Life and Health Insurance on the Basis of Physical or Mental Impairment ' 3.

Some states also specifically regulate the use of genetic information in life, disability-income, or long-term-care insurance. Many of them reiterate their Unfair Trade Practices Act by requiring an actuarial justification for the use of genetic information in determining eligibility and in underwriting. This does not address, however, the important question of whether there is a sufficient scientific basis for assessing risk and how the sufficiency of that scientific basis should be determined. Moreover, an additional question in the genetic context is whether or not there are conditions that should be excluded from consideration even if there is an actuarial justification for different treatment.

A 1997 study by the Human Genetics Advisory Commission in the United Kingdom concluded that it is unlikely that actuarially-sound genetic predictions of adult death will be validated and available anytime in the near future. Genetic tests need to be connected to medical and epidemiological research to establish what consequences for health and life-span can be inferred from a given genetic test. The Commission concluded that a requirement to disclose genetic tests as a condition of obtaining insurance would be acceptable only after research has established an association between a given pattern of test results and life events that are relevant for the insurance product. They recommended continuing a moratorium on requiring test results. They also predicted that the life insurance industry could withstand the limited adverse selection that might result from non-disclosure. Human Genetics Advisory Commission, The Implications of Genetic Testing for Insurance (1997).

Current State Genetic Statutes

At least twenty-three states have legislation that regulates genetic testing or the use of genetic information in life, disability, or long-term-care insurance. Twenty-two states have statutes that pertain to life insurance, nineteen apply to disability insurance, and fifteen cover long-term-care insurance.

Obtaining and disclosing genetic information. The most common privacy protection in state law is a requirement for informed consent or authorization for genetic testing by the individual to be tested. Several states have general provisions requiring informed consent to obtain genetic information that are applicable to insurers. See, e.g., Alaska Stat. '' 18.13.010 (informed and written consent needed for DNA collection, analysis, retention, & disclosure); Del. Code Ann. ' 1221(a) (same); Fla. Stat. Ann. ' 760.40(2)(a) (informed consent necessary to perform DNA analysis). A larger number of states specifically require an individual=s informed consent or authorization for genetic testing for life, disability-income, or long-term-care insurance. See Ariz. Rev. Stat. Ann. ' 20-448.02(A) (life, disability-income, long-term-care); Cal. Ins. Code ' 10148 (life, disability-income); Colo. Rev. State ' 10-3-1104.7(10)(a) (life, individual disability-income); Minn. Stat. Ann. ' 72A.139 (life); Nev. Rev. Stat. Ann. ' 629.151 (life); N.J. Stat. Ann. ' 17B:30-12(f) (life, disability-income); N.Y. Ins. Law ' 2615(a) (life, disability-income, long-term-care); Or. Rev. Stat. ' 192.535 (life, disability-income, long-term-care); Vt. Stat. Ann. tit. 18, ' 9332(d) (life, disability-income, long-term-care). In a couple of states, insurers that require genetic tests must pay the cost of the test. Cal. Ins. Code ' 10148 (life and disability-income); Minn. Stat. Ann. ' 72A.139 (life).

Other states prohibit insurance companies from requiring genetic testing as a condition of obtaining insurance. For all three types of insurance, insurers may not require applicants in Massachusetts or Vermont to undergo a genetic test as a condition of issuing or renewing a policy. Mass. Gen. Laws Ann. Ch. 175, ' 120E (life); Mass. Gen. Laws Ann. Ch. 175, ' 108I (disability-income, long-term-care); Vt. Stat. Ann. tit. 18, ' 9334(a). In California, there is a special provision for long-term-care insurance that prohibits insurers from requiring genetic testing to determine insurability or for underwriting. Cal. Ins. Code ' 10233.1.

A couple of states impose restrictions on asking applicants for genetic information. In Kentucky, disability-income insurers may not request or require an applicant to disclose a genetic test. Ky. Rev. Stat. Ann. ' 304.12-085(3). In contrast, in Massachusetts, all three types of insurers may ask if an applicant has taken a genetic test. The application form must indicate, however, that the applicant is not required to answer questions about genetic testing or genetic information, but that failure to answer may result in denial of coverage or an increased rate. Mass. Gen. Laws Ann. Ch. 175, ' 120E (life insurance); Mass. Gen. Laws Ann. Ch. 175, ' 108I (disability-income and long-term-care insurance).

Finally, some states also regulate disclosure of genetic information, requiring either informed consent or authorization of the individual tested. See, e.g., Alaska Stat. '' 18.13.010; Cal. Ins. Code ' 10149.1. Another approach classifies genetic information with mental health information and HIV status as Asensitive health information@ that requires protections against disclosure beyond that required for medical information. See, e.g., Conn. Gen. Stat. ' 38a-999. In terms of access to test results by the individual tested, some states require insurers to provide test results to the individual or the individual=s designated physician. See, e.g., Fla. Stat. ' 760.40(3) (general); Minn. Stat. Ann. ' 72A.139 (life insurance); N.J. Stat. Ann. ' 17B:30-12(f) (life & disability-income insurance, with option for genetic counseling); N.Y. Ins. Law ' 2615(e) (if adverse decision for life, disability-income, or long-term-care insurance).

Use of genetic information. The broadest restrictions on use of genetic information prohibit insurers from using genetic testing results or genetic information to determine eligibility or for underwriting. See Colo. Rev. Stat. ' 10-3-1104.7(3)(b) (group disability-income & long-term-care insurance); Kan. Stat. Ann. ' 40-2259(d) (disability-income & long-term-care insurance). Arizona prevents disability-income and long-term-care insurers from using information about a genetic predisposition in underwriting by permitting those insurers to use genetic test results only if there is an actual diagnosis of a genetic condition. Ariz. Rev. Stat. Ann. ' 20-448(F). Both Oregon and Vermont prevent all three types of insurers from using any genetic information about a blood relative for either eligibility or underwriting. Or. Rev. Stat. ' 746.135; Vt. Stat. Ann. tit. 18, ' 9334(a).

Other states restrict use of genetic information by prohibiting insurers from denying coverage or underwriting based on the applicant=s status as a carrier of a genetic disease. California specifies that life and disability-income insurers may not rely on information about an applicant=s genetic characteristic that causes no adverse effects on the carrier, even though it might be associated with disability in the applicant=s offspring. Cal. Ins. Code ' 10143. These traits include, but are not limited to, Tay Sachs trait, sickle cell trait, thalassemia trait, and X-linked hemophilia A. Other states similarly prohibit insurance decisions based on specific genetic traits. See Fla. Stat. Ann. ' 626.9706 (sickle-cell trait) (life); La. Rev. Stat. Ann. ' 22:652.1(A), (D) (sickle-cell trait & severe disability) (life and disability-income); N.C. Gen. Stat. ' 58-58-25 (sickle-cell trait & hemoglobin C trait) (life); Tenn. Code Ann. ' 56-7-207 (sickle-cell trait & hemoglobin C trait) (life).

Finally, a number of state genetic statutes reiterate standards for underwriting that duplicate provisions of most state Unfair Practices Act, stating that the use of genetic information in underwriting must be based on an actuarial justification, may not be used for unfair discrimination, or must be reasonably related to risk. See Ariz. Rev. Stat. Ann. ' 20-448(E) (life, disability-income, & long-term-care insurance); Kan. Stat. Ann. ' 40-2259(d) (life insurance); 24A Me. Rev. Stat. Ann. ' 2159-C(3) (life, disability-income, & long-term-care); Md. Code Ann., Ins. ' 27-208(a)(3) (life, disability-income, & long-term-care insurance); Mass. Gen. Laws Ann. Ch. 175, ' 120E (life, disability-income, & long-term-care insurance); Mont. Code Ann. ' 33-18-206 (life, disability-income, & long-term-care insurance); N.J. Stat. Ann. ' 17B:30-12(f) (life & disability-income insurance); N.M. Stat. Ann. ' 24-21-4 (C) (life, disability-income, & long-term-care insurance); Vt. Stat. Ann. tit. 18, ' 4724(3) (life, disability-income, & long-term-care insurance); Wis. Stat. Ann. ' 631.89 (life & disability-income insurance).

The NCCUSL Draft

The draft allows life insurers, disability-income insurers, and long-term-care insurers to require genetic tests and use genetic information for coverage and underwriting decisions only as scientific developments justify that use. The draft places a burden on insurers to show that a positive genetic test is reliably associated with increased medical risk of mortality or morbidity. If an insurer can demonstrate that to a reasonable degree of scientific certainty, it can use the information. If the available scientific evidence does not meet this standard, use of the genetic information would be a violation of state unfair practices insurance law.

UNIFORM PROTECTION OF GENETIC INFORMATION IN EMPLOYMENT

AND INSURANCE ACT

[ARTICLE] 1

GENERAL PROVISIONS

SECTION 101. SHORT TITLE. This [act] may be cited as the Uniform Protection of Genetic Information in Employment and Insurance Act.

Reporter=s Notes

The Drafting Committee has asked the Chair to request that the Executive Committee authorize changing the name of the act to AProtection of Genetic Information in Employment and Insurance.@ They believe that AMisuse@ is a misnomer in the context of the act because many of the provisions of the act permit certain uses. In addition, the proposed title better reflects the scope of the act, which goes beyond use to include access, retention, and disclosure of genetic information, setting a balance that provides appropriate protection for genetic information in all these contexts. (NOTE: this name change was approved by the Executive Committee via Conference Call on June 19, 2008.)

SECTION 102. DEFINITIONS. In this [act]:

(1) AAdverse insurance determination@ means a denial of coverage or the offering of less favorable rates, terms, or conditions for insurance than would be available if the insurer did not use genetic information in making the determination.

(2) AApplicant for employment@ means an individual who is applying to become an employee.

(3) AApplicant for insurance@ means an individual who is applying for health, life, disability-income, or long-term-care insurance.

(4) AChild@ means a son or daughter of an individual, whether related by whole or half blood, affinity, adoption, or born as the result of assisted reproduction technology, who is deemed to be a child of the individual under law other than this [act].

(5) ACredentialing authority@ means a governmental or private entity that provides a license, registration, or credential or certifies competence that is necessary for an individual to qualify for employment or to participate in an occupation or profession.

(6) ADisability-income insurance@ means insurance intended to protect against loss of occupational or professional earning capacity arising from injury, sickness, or disablement. The term includes insurance that provides benefits for overhead expenses of a business, occupation, or profession when the insured becomes disabled.

(7) AEmployee@ means an individual who works for compensation. The term includes an individual employed in a supervisory, managerial, or confidential position. The term does not include an independent contractor.

(8) AEmployer@ means a person that has an employee.

(9) AEmployment entity@ means an employer, employment agency, labor organization, or credentialing authority.

(10) AFamily medical history@ means information about a current or past medical condition of a family member of an individual.

(11) AFamily member@ means an individual=s spouse or [domestic partner], child, and all individuals related by whole or half blood within the fourth degree of consanguinity measured using the civil law method to the individual, the individual=s spouse or [domestic partner], or the individual=s child.

(12) AGenetic counseling@ includes:

(A) assessing an individual=s genetic risk for an inherited condition by interpreting family medical histories;

(17) AGenetic test@ means an analysis of human genetic material, including deoxyribonucleic acid, ribonucleic acid, chromosomes, proteins, and metabolites, that is intended to detect:

(A) a genotype or genetic marker; or

(B) a mutation or chromosomal change.

(18) AHealth insurance@ means a health-care arrangement assuming financial risk to pay for, purchase, or furnish health-care services to patients, insureds, or beneficiaries.

(19) AInsured@ means an individual who is covered by health, life, disability-income, or long-term-care insurance.

(20) AInsurer@ means a person engaged in the business of health, life, disability-income, or long-term-care insurance in this state, regardless of where a contract of insurance is entered into or issued or a plan is administered. The term includes an insurance agent, broker, underwriter, and third-party administrator.

(21) ALife insurance@ means insurance against the financial risk of death.

(22) ALong-term-care insurance@ means insurance that provides coverage for not less than 12 consecutive months for one or more necessary diagnostic, preventive, therapeutic, rehabilitative, maintenance, or personal-care services provided in a setting other than an acute care unit of a hospital. The term includes a policy or rider that provides for payment of benefits based upon cognitive impairment or inability to perform the activities of daily living.

(23) APerson@ means an individual, corporation, business trust, estate, trust, partnership, limited liability company, association, joint venture, public corporation, government or governmental subdivision, agency or instrumentality, or any other legal or commercial entity.

(24) APredisposing genetic characteristic@ means a gene variant or genetic marker that is determined from genetic information and is associated with an individual=s increased risk of developing a disease or medical condition for which the individual is presently asymptomatic.

(25) ARecord@ means information that is inscribed on a tangible medium or that is stored in an electronic or other medium and is retrievable in perceivable form.

(26) ASign@ means, with present intent to authenticate or adopt a record:

(A) to execute or adopt a tangible symbol; or

(B) to attach to or logically associate with the record an electronic symbol, sound, or process.

(27) ATribunal@ means a court, arbitral tribunal, or administrative agency.

Legislative Note: In the definition of Afamily member@ states should insert for [domestic partner] the appropriate term for an unmarried partner who is eligible for benefit coverage such as health insurance in the workplace, such as Apartner,@ Asignificant other,@ Adomestic partner@ or other term.

Reporter=s Notes

Paragraph (1). (Adverse insurance determination) The use of genetic information makes an insurance determination adverse if it leads to denial of coverage or coverage on less favorable terms than would have been available absent the insurer=s consideration of the information. This definition is relevant to an individual=s ability to correct a faulty genetic test that has consequences for insurance eligibility or terms and conditions for issuance of insurance.

Paragraph (2). (Applicant for employment) This definition is added at the request of members of the style committee to differentiate applicants from employees. Article 2 provides that applicants for employment and employees are to be treated identically in terms of an employer=s genetic testing and access, use, retention, and disclosure of genetic information.

Paragraph (3). (Applicant for insurance) This definition is added to create a parallel structure for the insurance and employment articles by separating out applicants in both contexts.

Paragraph (4). (Child) This definition acknowledges the many ways in which the relationship of parent-child is created, including by adoption and assisted reproductive techniques. This relationship is governed by other law, such as the Uniform Parentage Act.

Paragraph (5). (Credentialing authority) Credentialing authorities serve as gatekeepers to certain types of employment by providing credentials that are required either under state law or by an employer. Examples include state bar and medical examination boards, which control entry to the practice of law and medicine, and state departments of motor vehicles, which issue commercial drivers licenses necessary for some employment. Access or use of genetic information by a credentialing authority could have the same effects on employees and applicants for employment as access or use by an employer.

Paragraph (6). (Disability-income insurance) This definition of disability-income insurance is used in several state statutes on genetic testing. See, e.g., Cal. Ins. Code ' 10147; N.H. Rev. Stat. Ann. ' 141-H:1. The committee discussed substituting the term Aincome@ for Aearning capacity,@ but decided not to make this substitution.

Paragraph (7). (Employee) The definition of employee is adapted from the National Conference of Commissioners on Uniform State Law=s Model Employment Termination Act. The definition=s requirement for compensation is intended to exclude volunteers from the definition of employee.

The drafting committee considered including independent contractors in the definition of employees, but decided to exclude this category of workers. This approach is not intended, however, to provide employers with an avenue to evade their obligations by classifying employees as independent contractors.

Paragraph (8). (Employer) The definition of employer is linked to the definition of Aperson@in paragraph 16 and therefore encompasses all types of entities, including governmental and non-profit employers. AEmployer@ takes its meaning from the broad definition of Aemployee@ in paragraph 7.

As the definition of employer is currently drafted, the act would cover all employers regardless of size. One consideration is whether the requirements of the act would prove too burdensome for small employers. Many statutes specify a minimum size using the number of employees as a proxy for size. For example, Title VII of the Civil Rights Act of 1964 covers employers who had 15 or more employees for each working day in 20 or more weeks over the course of a year. The definition in the Uniform Law Commissioner=s Model Employment Termination Act requires five employees and extends the measurement period to two years.

Another way to limit the types of employers that are covered would be to exclude immediate family members from the count of employees, as is done in the Fair Labor Standards Act and the National Conference of Commissioners on Uniform State Law=s Model Employment Termination Act. In addition, some state statutes exclude particular employee groups, such as household workers or farm workers, in determining employer status.

Paragraph (9). (Employment entity) Employment entity is the term used in the act to collectively indicate an employer, an employment agency, a labor organization, or a credentialing authority.

Paragraph (10). (Family medical history) Family medical history is often a source of genetic information in that it is used to evaluate the likelihood that an individual carries an inherited trait. The act=s definition of Agenetic information@ does not encompass medical history, so a separate definition is needed when the act=s provisions apply to this category of information.

Paragraph (11). (Family member) A family member is defined broadly to encompass all individuals whose own genotype could influence an employment or insurance decision. The term includes (1) biological relations whose genetic information might provide information about the genetic make-up of an individual employee or insured, (2) dependants whose risk of future genetically-linked medical conditions could affect employer health care costs or family insurance coverage and hence affect employment or insurance decisions, and (3) dependants= biological relations whose genetic information might provide information about the genetic make-up of a dependant. The separately-defined term Achild@ includes both adopted and biologically-related children because either can affect health-care costs or family insurance coverage.

Many employers provide health insurance for employees= unmarried partners. Therefore, an unmarried partner can be a dependent whose risk of a genetically-linked medical condition could affect employment or insurance decisions. As a result, Adomestic partner@ is included in the definition of family member for purposes of obtaining, retaining, using, and disclosing genetic information. The brackets around this term are not meant to indicate that a state may drop the concept, but only that a state should substitute the term it uses for a person in this relationship. This definition is not meant to affect other state law definitions of marriage or family.

Genetic counselors typically collect information on genetic diseases of family members related to the third degree of consanguinity and often to the fourth degree. The drafting committee considered a provision that replaced the designation Afourth degree of consanguinity@ with a list of family members, but decided instead to include information in the notes that designates which family members are included within the fourth degree of consanguinity.

Lineal consanguinity is the relationship between persons when one is directly descended from the other. Each generation in this direct line constitutes a degree. Collateral consanguinity refers to the relationship between persons who descend from the same common ancestor, but not from each other. The civil law method of calculating degree of collateral consanguinity, used in most states, is to count the number of generations from one person up to the common ancestor and then down to the other person. The following table identifies the relatives within four degrees of consanguinity from an individual, with each row representing a generation.

Great-great- grandparents (4)

Great-grandparents (3)

Grandparents (2)

Grand Aunts and Grand Uncles (4)

Parents (1)

Aunts and Uncles (3)

Individual

Sisters and Brothers (2)

First Cousins (4)

Children (1)

Nieces and Nephews (3)

Grandchildren (2)

Grandnieces and Grandnephews (4)

Great- grandchildren (3)

Great-great- grandchildren (4)

Paragraph (12). (Genetic counseling) Genetic counseling is a key to an individual=s informed decision making about getting a genetic test, understanding the result, and authorizing its use, retention, or disclosure. Most states that license genetic counselors have a definition of genetic counseling, but the majority of states do not license genetic counselors or regulate genetic counseling. Note that the definition does not require that genetic counseling be performed by a genetic counselor. Physicians and geneticists are also qualified to provide genetic counseling.

The definition uses the term genetic Acondition,@ which is intended to have a broad interpretation. Genetic condition includes the concepts of genetic disease and disorder, but in some circumstances it may also refer to a positive or benign trait or characteristic that is linked to a particular genotype.

Genetic counseling is usually a two-step process consisting of 1) counseling before a test about the decision whether or not to have the test and 2) counseling after the test if the test indicates the individual is at risk. In addition, for some conditions counseling may also be appropriate if the test indicates the individual is not at risk. The functions listed in (A)-(C) of the definition of genetic counseling take place before an individual decides whether or not to have the test. The functions in (D) and (E) take place after the test, if necessary.

Paragraph (13). (Genetic education) Genetic education is one element of genetic services. It is typically less tailored to individual circumstances then a one-on-one genetic counseling session. The definition is meant to be broad enough to include information provided by support groups for genetic conditions to those who may have the condition. It is not meant to encompass general genetic education such as that received in biology class or medical school.

Paragraph (14). (Genetic information) This definition of Agenetic information@ is modeled on state provisions that do not include family history in the definition. (Ark, Del, LA, Minn, Neb, NH, NY, OK, OR, UT, VT) This narrow definition of genetic information is important for Article 4 on life, disability-income, and long-term-care insurance, in which the draft allows these insurers to continue to collect information on family history, even though family history is a major source of information to evaluate an individual=s genetic risks.

Many states use a more comprehensive definition of Agenetic information@ that includes information on genetic characteristics broadly, whether obtained from genetic tests or family medical history. (Cal, Conn, Hawaii, LA, Maine, MD, Mass, Mich, NJ, NMex, NC, RI, SD, TX, WA). In addition, the federal Genetic Information Nondiscrimination Act of 2008 also uses a broad definition that includes family history. The federal definition provides that the term means Ainformation about (i) an individual=s genetic tests; (ii) the genetic tests of family members of the individual; or (iii) the occurrence of a disease of disorder in family members of the individual.@ Information about the sex or age of an individual is excluded from this definition.

The drafting committee has decided to use the broader concept of information, including family history, for Articles 2 and 3 on employment and health insurance. This meaning is conveyed in these articles by using the narrowly-defined term Agenetic information@ in combination with the term Afamily medical history.@

Information about an individual=s request for or receipt of genetic services is included in the category of genetic information for ease of drafting.

Paragraph (15). (Genetic monitoring) The definition of Agenetic monitoring@ is drawn from the description in Office of Technology Assessment, Genetic Monitoring and Screening in the Workplace 4 (1990). The focus in monitoring is not on inherited characteristics, but on genetic alterations in a group of exposed individuals over time. Genetic monitoring is typically undertaken by employers to identify risks for groups of employees who have been exposed to hazardous substances or to target work sites for safety and health measures. Testing for this purpose is permitted in Section 202.

Paragraph (16). (Genetic service) AGenetic service@ is a broader category than genetic testing. The term includes activities associated with obtaining genetic information that could create assumptions about an individual=s genetic status even in the absence of information about genetic test results or medical history. ACounseling@ implies a one-on-one consultation, so the definition also includes Agenetic education@ in order to capture group information sessions on genetic conditions. While the definition of a Agenetic service@ does not separately define the term Agenetic,@ the term should be interpreted to be consistent with the definitions of Agenetic test@ and Agenetic information.@

Paragraph (17). (Genetic test) AGenetic test@ is defined in terms of (1) the material that the test analyzes and (2) the purpose of the test. This structure and the lists in the definition are consistent with the definition of Agenetic test@ in the medical insurance provisions of the federal Genetic Information Nondiscrimination Act of 2008, which prohibits discrimination on the basis of genetic information with respect to health insurance and employment.

The first clause makes specific reference to the types of biological material that are currently analyzed in genetic tests. Note that genetic tests can be conducted not only on gene sequences, but also on biological products such as proteins or metabolites that can indicate genetic make-up. The second clause specifies that the test must be for the purpose of determining an individual=s genetic make-up, either through the identification of a genotype or genetic marker or by looking for a mutation or chromosomal change.

Both clauses are equally important to the definition. First, some of the materials listed in the first clause, especially proteins and metabolites, are tested for many medical purposes. A test of a protein or metabolite does not constitute a genetic test unless it is administered for the purpose of determining individual=s genetic make-up as specified in the second clause.

Second, some genetic diagnoses are made without laboratory tests of the type listed in the first clause. For example, a doctor may identify a genetic condition based on specific physical features occurring in combination, or Adismorphology.@ This physical diagnosis of an individual=s genetic-make-up does not constitute a genetic test under the draft because it is not a test of Agenetic material.@

Insurance industry representatives have expressed the fear that this definition is so broad that it will sweep in routine medical tests such as blood tests of lipoproteins to measure cholesterol levels. It is true that a cholesterol test analyzes proteins. A cholesterol test is not, however, given specifically to detect a genotype, genetic marker, mutation, or chromosomal change, so it would not be considered a genetic test under the draft. Instead, a high cholesterol reading may indicate a number of causal factors, including inappropriate diet, lack of exercise, and/or a condition called inherited familial high cholesterol. If the measurement of cholesterol leads a doctor or insurance company to do further testing to see if an individual has a specific genotype, then that would be a genetic test under the draft=s definition. Other common medical tests of proteins or metabolites that would not fall under the definition of Agenetic test@ include urine tests for kidney disease, blood protein and creatinin tests for diabetes, blood tests of liver enzyme proteins for liver function, urine tests measuring glucose to diagnose diabetes, blood tests measuring serum blood glucose for diabetes, and triglycerides for heart disease.

The draft follows the example of states with definitions of genetic testing that are not limited to identifying genotypes associated with diseases or impairments. (Fla, Haw, Mass, NH, Ore, UT). In contrast, many other states statutes limit their definition of Agenetic test@ to testing for disease-related genes. (Ariz, Ark, Del, Ill, Iowa, Kan, LA, Maine, MD, Mich, Minn, Nev, MO, Neb, NJ, NM, NY, NC, OK, OR, RI, TX, VT, VA, WI). While most of the reasons that an employer or insurer might currently seek or use genetic information probably involve a disease, disorder, or impairment, this may not always be the case. One can imagine, for example, that the presence or absence of behavioral traits might also be a criterion for selecting an employee. While the current evidence linking behavior to genes is tenuous, this area continues to be the subject of investigation. Moreover, a broad definition of Agenetic test@ will facilitate extension to topics outside employment and insurance, if that is a direction the National Conference of Commissioners on Uniform State Laws takes in future uniform acts. For example, provisions governing the retention of samples used for research or identification would cover testing that is not necessarily linked to disease.

Paragraph (18). (Health insurance) The definition of Ahealth insurance@ is meant to be broad. Definitions and terms of art vary greatly among the states. For example, a number of states use the term Adisability insurance@ for what is commonly thought of as Ahealth insurance.@ The definition is written in terms of functions and is intended to capture the full range of organizational structures for health insurance without regard to specific state designations. These organizational structures include insurance that covers hospital, medical, or health expenses; employee welfare-benefit plans; health maintenance organizations; preferred-provider organizations; medical service organizations; physician-hospital organizations; self-insured health plans; and prepaid health-care service plans.

Paragraph (19). (Insured) The definition of Ainsured@ encompasses individuals with the types of insurance policies covered by the act.

Paragraph (20). (Insurer) The definition of Ainsurer@ is intended to cover broadly insurance companies and other persons and individuals that issue health, life, disability-income, or long-term-care insurance and all persons who might obtain, use, or disclose genetic information associated with that process. Nothing in this definition is intended to subject insurance agents, brokers, underwriters, or third-party administrators to insurance regulations to which they are not already subject.

Paragraph (21). (Life insurance) ALife insurance@ is intended to be defined broadly. This definition is drawn from N.H. Rev. Stat. ' 401:1(III).

Paragraph (22). (Long-term-care insurance) The starting point for the definition of Along-term-care insurance@ is N.H. Rev. Stat. ' 415-D:3(V). The definition is intended to include all coverage of this nature whether it is provided on an expense-incurred, indemnity, prepaid, or other basis.

Paragraph (23). (Person) This draft uses the broad version of the standard National Conference of Commissioners on Uniform State Laws definition of Aperson.@

Paragraph (24). (Predisposing genetic characteristic) A Apredisposing genetic characteristic@ refers to a genotype that signals an increased risk of a certain disease or condition. The term does not include symptomatic diseases or conditions or genetic characteristics that are manifest in a disease, medical condition, or disability. The broader terms Agenetic test@ and Agenetic information@ may include both predisposing and manifest genetic characteristics as well as genetic information that does not necessarily pertain to health.

While the terms Apropensity@ or Asusceptibility@ are often used, the actual manifestation of a disease or condition may depend on a complex chain of events and the degree to which risk is elevated may be quite small. The use of the term Apredisposing@ is meant to signal the tenuous connection between a genotype or marker and a physical manifestation.

Paragraph (25). (Record) The definition of Arecord@ is the standard National Conference of Commissioners on Uniform State Laws definition.

Paragraph (26). (Sign) The definition of Asign@ is the standard National Conference of Commissioners on Uniform State Laws definition.

[ARTICLE] 2

EMPLOYMENT

SECTION 201. APPLICANT FOR EMPLOYMENT. For purposes of this [article] an applicant for employment shall be treated the same as an employee.

Reporter=s Notes

Applicability of Article 2. This article is intended to apply broadly in the employment setting to any employment entity. Employment agencies, labor organizations, and credentialing authorities are included within the scope of the article in addition to employers because they control access to employment through referrals or licensing.

Applicants. For simplicity, the article refers only to employees. The provisions apply equally to applicants for employment.

SECTION 202. GENETIC TESTING.

(a) Except as otherwise provided in this section or by law other than this [act], an employment entity may not require, offer, or provide a genetic test to an employee.

(b) An employment entity may offer a genetic test and, with prior authorization for the test by an employee that meets the requirements of Section 203, may provide the genetic test:

(1) to determine the employee=s predisposing genetic characteristics that may create susceptibility to harm to the employee from a workplace condition;

(2) to monitor the effects of the employee=s exposure to a workplace condition as part of a genetic monitoring program; or

(3) as part of a confidential, preventative health program for employees.

(c) An employment entity that offers a genetic test to an employee shall provide and pay for genetic counseling for the employee about the risks and benefits of the genetic test before the employee considers authorizing the test unless the employee knowingly and voluntarily waives counseling in a signed record that informs the employee of the benefits of genetic counseling;

Genetic testing. Many states broadly prohibit employers from subjecting employees to genetic testing. See, e.g., Iowa Code Ann. ' 729.6 (employer may not Asolicit, require, or administer@ a genetic test as a condition of employment); Kan. Stat. Ann. ' 44-1009(a)(9) (employer may not subject, directly or indirectly, any employee to any genetic screening or test); Md. Code Art. 49B ' 16(a) (employer may not Arequest or require@ genetic tests as a condition for hiring or determining benefits); Mass. Gen. L. Art. 151B ' 4(19) (unlawful to Asolicit submission to, require, or administer a genetic test@ as a condition of employment); Mich. Comp. Laws ' 37.1202 (no employer may require a genetic test as a condition of employment); Minn. Stat. Ann. ' 181.974(subd. 2) (employer may not Aadminister a genetic test@ as a condition of employment); Neb. Rev. Stat. ' 48-236 (employer may not require a genetic test as a condition or employment or promotion); Nev. Rev. Stat. ' 613.345 (unlawful employment practice to Arequire or administer@ a genetic test as a condition of employment); N.H. Rev. Stat. ' 141-H (may not Asolicit, require, or administer@ genetic testing as a condition of employment); RI Stat. ' 28-6.7-1 (employer may not Arequest, require, or administer@ a genetic test); Utah Code Ann. ' 26-45-103 (employer may not Arequest or require@ an individual or blood relative to submit to a genetic test in connection with an employment decision); Vt. Stat. Ann. ' 9333 (may not require genetic testing as a condition of employment); Va. Code Ann. ' 40.1-28.7-1 (employer may not Arequest, require, solicit, or administer@ a genetic test as a condition of employment); Wash. Rev. Code Ann. ' 49.44.180 (unlawful to require employee to submit to genetic screening as condition of employment); Wis. Stat. Ann. ' 111.372 (employer may not Asolicit, require, or administer@ a genetic test as a condition of employment unless employee requests test).

In contrast, this section does not prohibit testing entirely, but instead strictly limits the purposes for which an employment entity may provide a genetic test.

Subsection (a) General prohibition on genetic testing. The general rule is that an employment entity may not offer or provide genetic tests to employees. The other subsections establish limited exceptions and set requirements for counseling and reporting that must be met if an employer provides a genetic test.

Subsection (b) Acceptable purposes for an employment entity to supply genetic tests. The draft permits employers to offer genetic testing for three purposes: to determine predisposing characteristics that may create susceptibility for harm to the employee due to workplace conditions, to monitor exposure to workplace conditions as part of an ongoing program, and as part of a confidential preventative health program for employees.

The drafting committee considered, but did not adopt, a provision that would permit employers to supply genetic testing in order to protect the safety of other employees in the workplace. It would be very rare for a genetic marker to indicate a safety threat to other employees with sufficient certainty to justify a genetic test. The draft does not limit an employer=s ability to take an employee=s manifested medical condition into account for safety purposes, subject to the provisions of the Americans With Disabilities Act.

Subsection (b)(1) Employee susceptibility. Determining employee susceptibility to harm from exposure to workplace substances, called Agenetic screening,@ is one situation in which some states have permitted employers to test with the consent of the employee. Iowa, Louisiana, New Hampshire, New York, and Wisconsin all have nearly identical provisions that permit genetic testing of an employee to determine an employee=s susceptibility to toxic substances if the employee requests testing, provides informed consent or authorization, and the employer does not terminate the employee or take other adverse action as a result of testing. Iowa Code Ann. ' 729.6(7); N.H. Rev. Stat. ' 141-H:3; N.Y. Exec. Law ' 296; Wis. Stat. Ann. ' 111.372.

The utility of testing for susceptibility to workplace exposures is illustrated by chronic beryllium disease. Beryllium is a lightweight metal used in many industries that poses the threat of this disease when dust or fumes are inhaled. Industry protections have greatly reduced exposure, but a small portion of the population can contract the disease even after a very brief exposure. A genetic marker has reportedly been identified for this extreme sensitivity that purports to show with certainty which individuals will contract beryllium disease and die from short exposure. Cynthia Nance, Paul Miller, & Mark Rothstein, Discrimination in Employment on the Basis of Genetics, 6 Employee Rights & Employment Policy Journal 57, 63-64 (2002). If so, testing could provide information that could define an individual=s risk from workplace exposure to beryllium.

The draft allows an employment entity to supply testing for such susceptibilities, but unless the employee volunteers the test results under Section 204(b), the employment entity is not authorized to obtain them.

Subsection (b)(2) Genetic monitoring program. Monitoring for damage to employees= genes from workplace exposure to harmful substances is another possible justification for testing. The states that permit an employer to screen for genetic susceptibility to harmful workplace substances also permit monitoring for exposure provided that the employee requests testing, provides informed consent or authorization, and the employer does not terminate the employee or take other adverse action as a result of testing. Iowa Code Ann. ' 729.6(7); N.H. Rev. Stat. ' 141-H:3; N.Y. Exec. Law ' 296; Wis. Stat. Ann. ' 111.372. In addition, Louisiana authorizes monitoring of biological effects of toxic substances in the workplace if the employee has provided authorization and is notified of the results. La. Rev. Stat. ' 23:368. More generally, the definitions and prohibitions in many state=s statutes do not appear to restrict monitoring for genetic damage, or are ambiguous on this issue.

Genetic damage is caused by mutagens, that is, substances that are capable of triggering change in the genetic material of a cell. Genetic damage appears in the form of recessive and dominant mutations, large rearrangements of DNA, point mutations, or loss of genetic material. Office of Technology Assessment, Genetic Monitoring and Screening in the Workplace 71 (1990).

There are multiple genetic tests for exposure to mutagens at both the chromosomal and molecular level. The most common indicators of chromosomal (cytogenic) damage are chromosomal aberrations (CAs) and sister chromatid exchanges (SCEs). CAs are chromosomes with breakage or rearrangements. Id. at 62. CAs are more likely to be induced by ionizing radiation than chemical agents, but there are notable exceptions. For example, vinyl chloride exposure results in increased CAs and places workers at risk of developing a form of liver cancer. Workers exposed to benzene show elevated CAs and are at increased risk of leukemia. Id. at 65. Sister chromatics are the two daughter strands of a duplicated chromosome. An exchange results when apparently equivalent sections of the sister chromatics of the same chromosome are switched during cell division. SCE is a sensitive marker for DNA damage and repair that results only from chemical mutagens, not from radiation. Id. at 63.

As of 1990, no occupational studies had directly connected chromosomal abnormalities to increased individual risk for disease. Thus, while CA and SCE monitoring may have predictive value for a group, it is not a reliable way to predict health risks for an individual. Id. at 66. Monitoring can, however, be used by employers to reduce exposures to known mutagens to a level that does not affect individuals= chromosome morphology or DNA. Data on CAs are routinely used by regulatory agencies in the process of setting exposure standards for industry. Id.

There are also new techniques that measure exposure to mutagens at the molecular level. They include measuring the frequency of lymphocytes (T-cells) in which the HPRT gene has been inactivated by mutation; detecting DNA Aadducts@ (an alteration in which exogenous material is bound to DNA); determining DNA repair (which indicates excision damage); measuring the DNA content of cells as a means to detect tumors (which contain cells with elevated levels of chromosomes); and detecting oncogenes (cancer-causing genes), which can be activated by damage such as translocations, breaks, and deletions of DNA. Id. at 66-69. There is a potential that detecting activated oncogenes and DNA adducts may eventually provide a method for predicting disease in asymptomatic individuals. Id. at 71.

This draft recognizes the utility of monitoring in the workplace using such tests, and permits employment entities to supply genetic testing as part of a genetic monitoring program. Employment entities may not, however, have access to test results except in the aggregate, non-individually identifiable form prescribed in Section 204(c).

Subsection (b)(3) Employee health plan. An employer that provides preventative health services to encourage a healthy workplace may include genetic testing as part of those services.

The test results would not be available to the employer unless the employee volunteers them under section 204(b).

Subsection (c) Genetic counseling when an employment entity offers a test. The draft requires employers to provide genetic counseling about the risks and benefits of the test before signing the authorization for testing, so that the employee can make an informed decision about whether or not to have the test. The committee decided that an employee may, however, decline the counseling.

Employer-provided genetic counseling should normally be conducted by professionals B typically genetic counselors, geneticists, or physicians B from outside the employer organization.

Subsection (d) Requirements when an employment entity provides a genetic test.

Subsection (d)(1) Payment. This subsection imposes a payment obligation on the employment entity that provides a genetic test.

Subsection (d)(2) Reporting test results. This subsection provides for reporting genetic test results to the employee when an employment entity supplies testing. The reporting obligation is incurred whether or not the employer may obtain the test results under Section 204. An employer must be sensitive, however, to the fact that not all individuals wish to know their genetic information. The draft recognizes an employee=s right to decline to know the results of a genetic test. An employee may not wish to be informed of the result because of the psychological burdens that may accompany such knowledge.

Subsection (d)(3) Genetic counseling. Along with reporting test results to a health care professional, the draft mandates the availability of genetic counseling so that the results can be interpreted for the employee if the result is positive.

Subsection (d)(4) Destruction of the sample obtained for testing. The provision for prompt destruction of a sample obtained for genetic testing supplied by an employer protects the employee=s privacy by preventing subsequent testing of the sample. It also recognizes, however, that a testing laboratory is required to retain samples for certain time periods for certification testing and other purposes. The provision follows statutes adopted in New Jersey and Oregon.

Possible alternative approaches (1) put the burden on the employee by requiring that the sample be destroyed promptly on the request of the individual tested or (2) specify that a sample may be retained for a period of time. Some provisions combine elements of more than one approach. In New York, for example, a sample may be retained for ten years if authorized by the individual from whom the sample was obtained.

Subsection (e) Legal proceedings. This subsection requires an employer to supply the genetic testing when a tribunal has ordered that an employer may obtain genetic information relevant to a claim or defense in a legal proceeding under subsection 204(d).

SECTION 203. EMPLOYEE AUTHORIZATION FOR A GENETIC TEST.

(a) Except as otherwise provided by law other than this [act], an employee=s authorization for a genetic test must be knowing and voluntary and indicated in a record signed by the employee that complies with subsection (b) of this section. An employment entity that receives a valid authorization for genetic testing may provide a test only in accordance with the authorization. An authorization may not expand the genetic testing permitted by this [article] and may not include exculpatory language waiving any of the employee=s legal rights.

(b) An authorization for a genetic test for employment must:

(1) describe the genetic test to be performed, its purpose, and its permitted uses;

(2) inform the employee that only the authorized genetic test will be performed on the employee=s biological sample;

(3) inform the employee that the employment entity is obligated to provide and pay for genetic counseling about the risks and benefits of the test before the employee decides to authorize the test;

(4) inform the employee that the employment entity is obligated to provide and pay for genetic counseling about the test result unless the employee waives genetic counseling;

(5) inform the employee that the test result will be reported to the employee and a health-care professional designated by the employee unless the employee directs otherwise;

(6) include an opportunity for the employee to provide directions about reporting test results and genetic counseling;

(7) inform the employee that the employee=s biological sample will be destroyed as soon as permitted by law after the test is completed unless the employee authorizes retention of the sample or unless otherwise ordered by a tribunal; and

(8) state that the employee is entitled to a copy of the authorization.

AUTHORIZATION FOR GENETIC TESTING

Limited Authorization. Only the genetic tests that you authorize on this form will be

performed on your biological sample. These tests are voluntary.

Availability of Genetic Counseling. Before you complete this authorization, it is highly

recommended that you meet with a genetic counselor who will help you understand and evaluate

the risks, benefits, and consequences for you and your family of having the tests listed below.

_________________________ will provide and pay for this genetic counseling.

[Name of employment entity]

Proposed Genetic Tests. ________________________ proposes to provide the following

[Name of employment entity]

genetic tests:

9 __________________

[Name of test]

The purpose of this test is to determine if you have a genetic characteristic that

predisposes you to harm from __________________. _________________________

[workplace condition] [Name of employment entity]

may not request or require you to disclose this test result and it will not have access to the

test result unless you authorize it. If you authorize _____________ to have access to the

[employment entity]

test result, it will be used only for the following purposes:_________________________.

9 _________________

[Name of test]

This test is provided as part of a genetic monitoring program. The purpose of this test is

to monitor the effect of your exposure to ______________. The result of the test will be

[workplace condition]

used only for the following purposes: _________________. _______________________

[Name of employment entity]

will have access to the test results of all employees who authorize this test only in an

aggregate form that does not include individually identifiable information.

9 _________________

[Name of test]

This test is provided as part of a confidential preventative health plan. The purpose of the

test is ______________________. __________________________ may not request or

[Name of employment entity]

require you to disclose this test result and it will not have access to the test result unless

you authorize it. If you authorize access to the test result, it will be used only for the

following purposes: __________________________.

Reporting Test Results and Genetic Counseling. The test results will be reported to you and

to a health-care professional whom you designate unless you direct otherwise. It is

recommended that you receive genetic counseling about the test results. ___________________

[Name of employment entity]

will provide and pay for genetic counseling about the test results unless you decline genetic

counseling. Genetic counseling is important for understanding the test results in the context of

your medical and family history. It can also provide you with support, informational resources,

and referrals, as appropriate, that can help you adapt to the implications of being at risk of a

genetic condition.

Destruction of your Biological Sample. After the genetic test, your biological sample will be

destroyed as soon as permitted by law unless you agree to authorize otherwise in writing or a

court, arbitral tribunal, or administrative agency requires retention of the sample.

By signing this authorization, you do not lose any legal rights to which you are entitled. You are

entitled to a copy of this authorization.

I, ____________________, authorize the genetic test(s) I have checked above.

[print name]

9 I wish to receive test results.

9 I do not wish to receive test results.

9 Report test results to the following health care professional:

Name: _________________________

Address: _______________________

9 Do not report test results to a health care professional.

______________________________ ______________________

Signature Date

Reporter=s Notes

The Drafting Committee has chosen to maintain privacy for genetic testing and genetic information by establishing an authorization requirement that is coupled with statutory limits and duties imposed on employers, employment agencies, labor organizations, and credentialing authorities. Under this approach, before any genetic testing can be performed, an employee must affirmatively authorize any genetic testing or access, use, retention, or disclosure of genetic information. The authorization requirement is not simply a procedural step because Article 2 establishes limitations on the situations in which employment entities may request authorization from employees.

The drafting committee considered, but did not adopt alternatives that would (1) establish a general property right in a biological sample an individual provides for genetic testing and in the resulting genetic information or (2) establish a limited property right applicable only to the context of employment.

This section deals with genetic testing. It sets forth an authorization requirement and the elements that must be contained in an authorization form. The term Aauthorization@ is used instead of Ainformed consent@ to avoid confusion with the use of that term in medical practice.

Subsection (a) Requirement for authorization for genetic testing. Under Section 202, an employment entity may supply genetic tests under certain circumstances but only with prior authorization from the employee.

In order to meet the requirement of this subsection that an authorization be knowing and voluntary, an employee or insured should have genetic counseling before signing the authorization. Genetic counseling provides employees or insureds with adequate information to make an informed decision about genetic testing. It also makes them aware of their options regarding reporting of test results and help in interpreting them through genetic counseling. An employment entity that offers a genetic test has an obligation to provide genetic counseling at the entity=s cost under Section 202(c). Genetic counseling may be provided by a genetic counselor, but may also be provided by a qualified physician or geneticist. An employee may waive genetic counseling, but must first be made aware of the benefits of genetic counseling.

The Drafting Committee anticipated that there might be circumstances in which an individual is incapacitated or incapable of authorizing a genetic test. This situation is left to existing law of the state that provides for power of attorney, guardianship, or other substitute decision makers.

Subsection (b) Content of authorization for testing. The section draws on N.Y. Civ. Rights Law ' 79-l (McKinney), which establishes requirements for consent for a genetic test.

The limitation in (b)(2) to the authorized test is consistent with the requirements for prior authorization in Section 202.

The requirements in subsection (b)(3)-(6) reflect the obligation of the employment entity to provide genetic counseling under Section 202(c).

The notification provision for retention of the sample in (b)(7) is consistent with the employment entity=s obligation to ensure that the sample is destroyed under Section 202(c)(3), which recognize that the testing laboratory may be required to retain the sample for certification purposes.

Subsection (c) Authorization form. The use of a form following the pattern in this subsection would comply with the requirements of the section.

SECTION 204. ACCESS TO GENETIC INFORMATION.

(a) Except as otherwise provided in this section, an employment entity may not knowingly obtain or directly or indirectly inquire about, request, or require an employee to provide an employee=s genetic information or family medical history.

(b) An employment entity may access an employee=s genetic information or family medical history if the employee voluntarily submits the employee=s genetic information or family medical history to the employment entity. If an employee voluntarily submits genetic information or family medical history retained by a source other than the employee, the employee must authorize the employment entity=s access in accordance with Section 209.

(c) If an employment entity offers a genetic test as part of a genetic monitoring program under Section 202, the employment entity must receive the genetic test results in an aggregate form that does not disclose individually identifiable information.

(d) An employment entity may obtain genetic information or family medical history about an employee without the employee=s authorization if:

(1) the employee has placed the employee=s health at issue in a proceeding before a tribunal in which the employment entity is a party;

(2) the genetic information or family medical history is relevant to a claim or defense in the proceeding; and

(3) on a motion by the employment entity a tribunal orders the employee to take a genetic test or provide genetic information or family medical history after finding that the employment entity has demonstrated a compelling need and that the information is otherwise unavailable.

Reporter=s Notes

Existing state law. An employment entity gets health information in a variety of ways including applications, interviews, references, post-offer medical exams, post-offer releases of medical records, Family and Medical Leave Act requests, workers= compensation claims, health insurance claims to self-insured employers, and voluntary disclosures by employees. Many states have tried to limit employer access to genetic information. There are statutes that prohibit an employer from requiring, requesting, or administering genetic testing, obtaining genetic information, making inquiries about genetic information, or some combination of these methods of accessing genetic information. (Conn, Del, Iowa, Kan, MD, Mass, Mich, Minn, Neb, Nev, NH, NY, OR, RI, Tex, UT, VT, VA, WA, WI).

Privacy rationale. One rationale for limiting employer access to genetic information is the view that an employee should be able to keep genetic information private. At least one state has a constitutional right of privacy that appears to be relevant to genetic information. (Alaska) Another rationale is to make genetic discrimination less likely. Unlike discrimination based on sex or race, an employer cannot discriminate on the basis of genetic characteristics unless it has access to genetic information.

Scholars have argued that a privacy rationale makes more sense for protecting genetic information in the employment context than an anti-discrimination rationale. Statutory protections based on anti-discrimination rationales are designed for socially-recognized groups that have been historically disadvantaged. Genetic variations do not fit especially well within this paradigm. See, e.g., Pauline T. Kim, Genetic Discrimination, Genetic Privacy: Rethinking Employee Protections for a Brave New Workplace, 96 NW U. L. Rev. 1497 (2002).

Subsection (a) Access to genetic information. The draft permits an employment entity to access genetic information about an employee at the employee=s instigation only. This follows the approach of a number of states that restrict an employer=s ability to require or obtain genetic information. See, e.g., Conn. Stat. Ann. ' 46a-60(11) (employer may not Arequest or require@ genetic information from employee); Kan. Stat. Ann. ' 44-1009(a)(9) (employer may not seek to obtain, obtain, or use testing information to distinguish employees or restrict a right or benefit); La. Rev. Stat. ' 23:368 (employer may not Arequire, collect, or purchase@ protected genetic information with respect to an employee); Md. Code Art. 49B ' 16(a) (employer may not Arequest or require@ genetic information as a condition for hiring or determining benefits); Mass. Gen. L. Art. 151B ' 4(19) (unlawful to Acollect, solicit or require disclosure of genetic information@ as a condition of employment); Mich. Comp. Laws ' 37.1202 (no employer may Adirectly or indirectly acquire or have access to@ an employee=s or family member=s genetic information unless an individual provides it voluntarily); Minn. Stat. Ann. ' 181.974(subd. 2) (employer may not Arequest, require, or collect@ protected genetic information as a condition of employment); Neb. Rev. Stat. ' 48-236 (employer may not require genetic information as a condition or employment or promotion); Utah Code Ann. ' 26-45-103 (employer may not Aaccess or otherwise take into consideration@ private genetic information in connection with an employment decision); Wash. Rev. Code Ann. ' 49.44.180 (unlawful to require employee to submit genetic information as condition of employment).

The draft also allows employees to keep private information that could lead to discrimination based on assumptions about genetics, even in the absence of genetic information. It does this by including information about requests for or receipt of genetic services in the definition of genetic information. If an individual is unable to keep private his use of genetic services such as counseling, the individual may be deterred from obtaining this service for fear that an employer will assume the employee has reason to think he has a genetic disorder.

The draft follows a number of state statutes that prohibit employers from accessing or using information about an employee=s request for or use of genetic services. See, e.g., La. Rev. Stat. ' 23:368 (employer may not Arequire, collect, or purchase@ information about an employee=s request for or use of genetic services); Maine Rev. Stat. Ann. ' 19302 (employer may not discriminate on basis that an individual received a genetic test or genetic counseling except when based on a bona fide occupational qualification); N.C. Gen. Stat. Ann. ' 95-28.1A (unlawful to deny employment of account of request for genetic testing or counseling services); Utah Code Ann. ' 26-45-103 (employer may not inquire into whether an individual or blood relative has taken or refused to take a genetic test); Vt. Stat. Ann. ' 9333 (employer may not use the fact that genetic counseling or tested services have been requested or performed).

The draft=s approach to employer access is in contrast to that of anti-discrimination statutes, which typically allow employers to compel testing or to require employees to provide genetic information under certain circumstances. Most of the states that rely on disability statutes to regulate genetic information follow the Americans with Disabilities Act (ADA), which permits an employer to test an applicant and access an applicant=s medical records after a conditional offer of employment. 29 C.F.R. ' 1630.14(b). This approach opens the door broadly to genetic information once an employer has made a conditional offer of employment. In addition, under the ADA and most state statutes modeled on it, after an employee is hired, an employer can obtain medical information if it has a reasonable belief that the employee is unable to perform the essential functions of his or her job due to a medical condition. 29 C.F.R. ' 1630.14(c). States that have amended their employment discrimination statutes to include genetics usually follow the rubric of these statutes and permit genetic testing or collection of genetic information when it is relevant to Ajob-related qualifications@ or justified by Abusiness necessity.@ However, members of the drafting committee were concerned that tying the Act=s protections to the concept of Ajob-related@ medical information would not provide adequate protection for genetic information. In interpreting the ADA, some courts have interpreted that category broadly to permit employers to access medical information, thus narrowing the scope of protection.

The draft=s approach also contrasts with California=s and Minnesota=s more comprehensive limitations on employer access, which prohibit employers from accessing non-job-related medical information at any time. An advantage of California=s and Minnesota=s approach is that it does not depend on how Agenetic information@ is defined. In addition, it does not rely on custodians of medical files to make a distinction between genetic information and medical information more generally, which are usually mixed in medical files. Practically speaking, when an employee signs a release permitting employer access to medical records, everything in the records is included. There are those who maintain that legislation is needed to limit an employer=s ability to obtain any non-job-related health information during the hiring process or employment. See Mark A. Rothstein, Genetic Exceptionalism and Legislative Pragmatism, 35 Hastings Center Report No. 4 (2005), at 35. The drafting committee discussed this approach, but declined to adopt it because it extends beyond the scope granted to the committee.

The prohibition on seeking or inquiring about genetic information is not intended to prevent an employer from informing an employee about the availability of a genetic test that is relevant to conditions in the workplace or from informing an employee about a genetic monitoring program.

If an employee authorizes employer access to genetic information, the conditions under which an employee grants that authorization are important. Some states permit employers to request genetic information under the apparent assumption that an employee=s consent to an employer=s request is voluntary. It is possible, however, to argue that in the context of at-will employment, the need to retain one=s job may turn an employer=s request for genetic information into a demand that an employee dare not refuse. Thus some statutes prohibit even requests or inquiries. See, e.g., Mass. Gen. L. Art. 151B ' 4(19) (unlawful to Aquestion a person about their genetic information or genetic information concerning their family members@); Nev. Rev. Stat. ' 613.345 (unlawful employment practice to Aask or encourage@ an employee to submit to a genetic test). This draft follows that approach.

A more stringent level of protection could protect workers from ever providing genetic information or authorizing access, even on their own initiative. But a blanket prohibition on any disclosure arguably goes too far. It would prevent an employee from sharing information that could be used to protect the person from situations in which the employee is genetically susceptible to harm. In addition, it would make it easy to violate the act inadvertently by disclosing information an employee does not realize is genetic information. Instead, this draft follows a middle approach that permits employees to volunteer genetic information, but does not generally permit employers to require it.

Subsection (b) Voluntary provision. Employees who provide genetic information voluntarily may do so directly, through oral statements or by turning over reports of test results. They may also do so by permitting an employment entity to see medical records held by a third party. In the case of disclosures made by a third party to an employer, the draft requires prior authorization by the employee. The prohibition on employer inquiries is intended to apply to inquires directed to other entities as well as to inquiries directed to the employee.

A complication is that employers who have access to medical records (which is permitted under the ADA after a conditional offer of employment or during employment for job-related purposes) will in practical terms also have access to genetic information because it is interspersed throughout medical records. An employer that requests any medical information is likely to receive the entire file, including genetic information. The committee considered the fact that mental health records are kept separate from medical records and HIPAA requires a separate authorization before they can be disclosed. However, mental health records are not determined by the content of the record, but as those kept by a psychologist or psychiatrist. The committee considered, but rejected, requiring genetic tests to be kept in a separate record. An alternative solution would be to develop technologies that can limit the scope of information disclosed by health care providers. Mark A. Rothstein & Meghan Talbott, Compelled Disclosure of Health Information: Protecting Against the Greatest Potential Threat to Privacy, 295 JAMA 2882 (2006).

Subsection (c) Genetic monitoring programs. Genetic monitoring programs are typically undertaken by employers to identify risks for groups of employees who have been exposed to hazardous substances or to target work sites for safety and health measures. Monitoring is testing designed to detect whether the genetic material of a group of individuals has changed over time. The premise is that such changes could indicate increased risk of future illness. Aggregated data from tests for genetic damage is sufficient to allow an employer to reduce exposures to levels that do not affect individuals= chromosome morphology or DNA. Office of Technology Assessment, Genetic Monitoring and Screening in the Workplace 66 (1990). However, while monitoring may have predictive value for a group, the techniques that are used do not currently measure increased individual health risks.

This subsection permits employers to access genetic information as part of a genetic monitoring program. Section 202 permits an employer to offer employees genetic tests as part of a monitoring program and section 206 permits employers to use genetic information for monitoring purposes. The rationale for genetic monitoring programs is discussed in more depth in the Reporter=s notes to section 202.

Subsection (d) Legal proceedings. This draft provides for an employer to obtain an employee=s genetic information if the employee places the employee=s health at issue in a legal proceeding. This right is limited in that it applies only if the employer has satisfied the burden of proof to show compelling need and that the information is otherwise unavailable. Only that portion of an employee=s genetic information that is relevant to a claim or defense may be provided. This subsection is meant to operate in conjunction with subsection 206(a)(2), which permits an employer to use genetic information in a legal proceeding. Subsection 202(a) requires the employer to pay for this test. These procedures provide more protection than Rule 35 of the Federal Rules of Civil Procedure or state equivalents, which provide that a court may order a physical examination on motion for good cause shown. The drafting committee considered a requirement that the genetic test results be sealed or placed under a protective order, but decided to leave this to existing law.

The substance of the subsection follows Utah=s statute, which authorizes genetic testing when an employee has placed his or her health at issue in a proceeding, but only by order of a court or administrative agency after finding compelling need and that the information is otherwise unavailable. Utah Code Ann. ' 26-45-103(2). Other states have more narrowly authorized employer testing to investigate a workers= compensation claim. (NH, NY).

SECTION 205. PROHIBITION ON USE OF GENETIC INFORMATION. An employment entity may not take an adverse employment action against an employee based on the employee=s genetic information or family medical history.

Reporter=s Notes

Many state statutes limit use of genetic information by prohibiting discrimination among employees or applicants for employment on the basis of genetic information. (Ark, Ill, Kan, LA, Maine, MD, Mass, Mich, MO, Neb, Nev, NJ, NY, NC, OK, OR, RI, SD, Tex). Others more generally ban any use of genetic information in employment. For example, New Mexico=s 2005 statute provides simply that A[i]t is unlawful for a person to use genetic information in employment, . . . .@ In Utah, employers may not take into account genetic information about an individual in connection with an employment decision. Similarly, in Iowa, an employer may not use genetic information to Aaffect the terms, conditions, or privileges of employment@ of a person who gets a genetic test. Iowa Code Ann. ' 729.6(2).

This draft follows the example of Minnesota and Wisconsin, which prohibit adverse employment actions based on genetic information. Minn. Stat. ' 181.974 subd. 2(a)(2) (may not Aaffect the terms or conditions of employment or terminate the employment of any person based on protected genetic information@); Wis. Stat. ' 111.375 (may not Aaffect terms, conditions or privileges of employment, labor organization membership or licensure or terminate the employment labor organization membership or licensure@).

The term used in the draft, Aadverse employment decision@ is a term of art in employment law that does not need to be defined in this act. The drafting committee decided not to list adverse employment actions in the black letter law because of the risk that something would be left off the list and the list would be treated as limiting. The committee intends, however, for the term to be interpreted broadly. One example of a broad statement of adverse employment actions can be found in the District of Columbia Human Rights Act, which makes it a discriminatory practice for an employer A[t]o fail or refuse to hire, or to discharge, any individual; or otherwise to discriminate against any individual, with respect to his compensation, terms, conditions, or privileges of employment, including promotion; or to limit, segregate, or classify his employees in any way which would deprive or tend to deprive any individual of employment opportunities or otherwise adversely affect his status as an employee.@ D.C. Code ' 2-1402.11. The term Aadverse employment action@ is consistent with and intended to include the actions listed in the federal Genetic Information Nondiscrimination Act of 2008, which makes it an unfair employment practice for an employer A(1) to fail to hire, or to discharge, any employee, or otherwise to discriminate against any employee with respect to the compensation, terms, conditions, or privileges of employment of the employee, because of genetic information with respect to the employee; or (2) to limit, segregate, or classify the employees of the employer in any way that would deprive or tend to deprive any employee of employment opportunities or otherwise adversely affect the status of the employee as an employee, because of genetic information with respect to the employee.@ 42 U.S.C. ' 2000ff-1(a).

The restriction on employment actions in this Act is particularly important because of uncertainty about how courts will apply federal statutes to decisions based on genetic information that predicts employee susceptibility to harm from workplace exposures. On one hand, in 1991 the United States Supreme Court held that a chemical company=s policy barring women of child-bearing age from employment opportunities that involved exposure to lead violated Title VII prohibitions on gender discrimination. International Union v. Johnson Controls, 499 U.S. 187 (1991). On the other hand, the ADA allows employers to act on health information, even in the case of disability, when there is a direct threat to the health or safety of others in the workplace. The Equal Employment Opportunity Commission (EEOC) has interpreted this ADA provision to apply when there is no risk to others but when an employer can show that an individual=s disability poses a significant risk of harm to the individual. The United States Supreme Court upheld this interpretation. Chevron v. Echazabal, 122 S. Ct. 2045 (2002). Although the Echazabal case did not involve a genetic characteristic, but rather a worker=s liver damage due to exposure to workplace solvents, the implication of the case is that in the absence of a prohibition in a state statute, an employer may make adverse employment decisions based on genetic screening or monitoring requested by an employee even if there is no threat to others. Section 205 does not permit an employer to take an adverse employment action under these circumstances. Harm to the employee or to others is not a justification. As a result, employers would not be able to use an employee=s genetic information in the way the employee=s health information was used in the Echazabal case.

Note that the section does not necessarily prevent an employer from making decisions based on the effects of an employee=s manifest genetic condition or disease in the workplace. This is because the section uses the term Agenetic information,@ which is defined with reference to a Agenetic test.@ Some employees with manifest genetic conditions would be covered under the ADA if the condition limits a major life activity, but there is no comprehensive protection for individuals with medical conditions that result from genetic traits. While some maintain that attempts to prevent genetic discrimination are mostly meaningless without protection for people who have genetic diseases, see Mark A. Rothstein, Genetic Privacy and Confidentiality: Why They are so Hard to Protect, 26 J. L. Med. & Ethics 181 (1998), others emphasize the difficulties with either policy choice, see Henry T. Greely, Genotype Discrimination: The Complex Case for Some Legislative Protection, 149 U. Pa. L. Rev. 1483, 1503 (2001).

SECTION 206. AUTHORIZED USE OF GENETIC INFORMATION.

(a) An employment entity that obtains genetic information or family medical history in compliance with Section 204 may use the genetic information or family medical history to:

(1) monitor the effects of an employee=s exposure to a workplace condition as part of a genetic monitoring program; or

(2) defend a claim in a proceeding before a tribunal in which an employee has placed the employee=s health at issue.

(b) An employment entity that obtains genetic information or family medical history in compliance with Section 204 about an employee=s predisposing genetic characteristic that may create susceptibility to harm to the employee from a workplace condition may use the genetic information or family medical history only to reduce the employee=s exposure to the workplace condition but not to take adverse employment action against an employee.

Reporter=s Notes

The draft selectively authorizes ways that an employment entity may use genetic information in employment decisions about individual employees.

The drafting committee considered a provision that would have allowed adverse employment actions in the case of an employee with a predisposing genetic characteristic that poses a direct threat of harm to others. It decided not to include this provision because the drafting committee was unable to identify any known genetic trait that would qualify and if testing is permitted for this purpose it could be abused.

Subsections (a)(1) and (a)(2). Monitoring programs or legal proceedings. This subsection permits an employment entity to use genetic information for a monitoring program or defending a legal proceeding, which is consistent with the purposes for which an employment entity may access an employee=s genetic information under Section 204.

Subsection (b). Employee susceptibility to harm in the workplace. This subsection, in combination with section 205, follows the lead of the states that permit genetic testing to determine susceptibility to harm from a workplace substance only when an employer does not use the information to terminate or take other adverse action against the employee. See Iowa Code Ann. ' 729.6(7); N.H. Rev. Stat. ' 141-H:3; N.Y. Exec. Law ' 296; Wis. Stat. Ann. ' 111.372. An employer may offer genetic testing to screen for susceptibility to harm under section 202, but may not access the results of the testing without authorization from the employee. If an employee volunteers genetic information about susceptibility to harm from workplace exposures under section 204, the draft permits the employer to reduce the potentially harmful exposure, but not to make an employment decision that would adversely affect the employee.

The Brush-Wellman company in Cleveland, Ohio, developed a program (since discontinued) that provides a model for permissible use of screening or monitoring information. Brush-Wellman conducted genetic tests for its employees who work with beryllium, but the testing was voluntary and confidential. Moreover, the test results were provided to the employee, who made the decision on what action to take. The company took no action against the employee as a result of the genetic testing. Cynthia Nance, Paul Miller, & Mark Rothstein, Discrimination in Employment on the Basis of Genetics, 6 Employee Rights & Employment Policy Journal 57, 64-65 (2002).

SECTION 207. ACCESS TO GENETIC INFORMATION BY EMPLOYEE. An employee may inspect, request correction of, or obtain a copy of the employee=s genetic information or family medical history in any record of an employment entity which contains the information. If an employee requests correction of genetic information or family medical history, the employment entity shall include the request for correction and supporting data in the employee=s record.

Reporter=s Notes

This section is based on the conclusion that an employee ought to be able to find out what genetic information an employer knows about an employee and to have the same information. It is based on 16 Del. Code ' 1223. It also provides a mechanism for an employee to correct genetic information contained in employer records.

If the employer supplied the genetic testing, information may also be kept in files at the laboratory that performed the testing. The employer=s responsibility to correct errors does not extend to the testing laboratory, which is regulated under the Clinical Laboratory Improvement Amendments, (CLIA), 42 U.S.C.' 263a.

The drafting committee considered but rejected an exception that would have prohibited employee access to information compiled for litigation. This situation will be governed by normal discovery rules, which are unaffected by this section.

SECTION 208. CONFIDENTIALITY; RETENTION AND DISCLOSURE OF GENETIC INFORMATION.

(a) An employment entity shall treat an employee=s genetic information and family medical history as a confidential record.

(b) If an employee authorizes an employment entity to keep a record of an employee=s genetic information or family medical history, the employment entity shall keep the record or require the record to be kept separately from the employee=s personnel file.

(c) Except as necessary to defend a claim in a proceeding before a tribunal, an employment entity may not disclose an employee=s individually identifiable genetic information to a person other than the employee unless the employee authorizes the disclosure or unless otherwise ordered by a tribunal.

(d) Notwithstanding this section, an employment entity may keep and disclose genetic information obtained in aggregate form pursuant to Section 204(c) for use in a genetic monitoring program.

Reporter=s Notes

Subsection (a) Confidentiality. This subsection declares that genetic information, family medical history, and authorizations concerning genetic tests or information is confidential in the employment context. AGenetic information@ is a category that includes information about use of or request for genetic services.

Subsection (b) Retention of genetic information or family medical history. If an employment entity obtains any genetic information or family medical history under Section 204, it needs the employee=s authorization under Section 209 to retain the information. The separate storage requirement serves to protect the employee=s privacy and is modeled on La. Rev. Stat. ' 23:368(B). Under Section 210, an employee may revoke this authorization.

Subsection (c) Disclosure of genetic information or family medical history. The draft is consistent with disclosure provisions in a number of states that have enacted (1) general privacy protections for genetic information that prohibit disclosure without informed consent or authorization (Alaska, Cal, Del, Fla, Maine, Mass, Nev, NH, NJ, NMex, NY, OR) or (2) specific protections against the disclosure of genetic information by employers (Ariz, Fla, LA, Mass, NH, NJ, Or, RI).

Subsection (d) Genetic monitoring program. An employer may retain and disclose genetic information without an employee=s specific authorization for a genetic monitoring program. An employer is allowed access to this information only in an aggregate form that does not identify individual employees, which should minimize the effects of retaining monitoring information for an employee=s privacy. An employer may need to disclose aggregate monitoring information in order to analyze trends or take action to reduce risk in the workplace.

SECTION 209. AUTHORIZATION FOR ACCESS, USE, RETENTION, OR DISCLOSURE OF GENETIC INFORMATION OR FAMILY MEDICAL HISTORY.

(a) Except as otherwise provided by this [act] or by law other than this [act], an employment entity may not access, use, keep or disclose an employee=s genetic information or family medical history without the employee=s knowing and voluntary authorization indicated in a record signed by the employee that complies with subsection (c). An employment entity that receives a valid authorization may access, use, keep or disclose genetic information or family medical history only in accordance with the authorization. An authorization may not expand the access, use, retention, or disclosure of genetic information or family medical history permitted by this [article] and may not include exculpatory language waiving any of the employee=s legal rights.

(b) Except as otherwise provided by this [act] or law other than this [act], a person who receives genetic information disclosed by an employment entity must maintain the confidentiality of the employee=s genetic information and may not disclose the information without the employee=s knowing and voluntary authorization indicated by a record signed by the employee that complies with subsection (c). A recipient that receives the employee=s valid authorization to disclose genetic information may disclose the information only in accordance with the authorization. An authorization may not expand the disclosure of genetic information permitted by this [article] and may not include exculpatory language waiving any of the employee=s legal rights. When an employment entity discloses an employee=s genetic information, it must notify the recipient of the information about these obligations.

(1) describe the genetic information or family medical history to be accessed, used, retained, or disclosed in a specific and meaningful fashion;

(2) identify or describe the person that is authorized to access, use, keep, or disclose the genetic information or family medical history;

(3) if the authorization is for access to genetic information or family medical history through disclosure by another person to an employment entity, identify or describe the person authorized to make the disclosure;

(4) if the authorization is for use of genetic information or family medical history, describe the permitted uses;

(5) if the authorization is for retention of genetic information or family medical history, describe where the information will be retained and identify or describe the custodian of the information;

(6) if the authorization is for disclosure to a third person, identify or describe the third person to which the authorized person may disclose the genetic information or family medical history;

(7) indicate the duration of the authorization with an expiration date if any or expiration event that relates to the employee or to the purpose of the access, use, retention, or disclosure;

(8) state that the employee may revoke the authorization at any time in a signed record, subject to the right of a person that acted in reliance on the authorization before receiving notice of revocation, and provide instructions on how to revoke an authorization; and

(9) state that the employee is entitled to a copy of the authorization.

(d) The use of the following forms comply with this section:

Authorization for Access and Use

__________________________ seeks your authorization to access the following genetic test

[Name of employment entity]

results or family medical history and use it for the purposes identified:

9 __________________________________. The purpose of this test is to determine if you have

[Name of test and condition tested for]

a genetic characteristic that predisposes you to harm from ____________________.

[workplace condition]

_____________________________ will use this information only for the following purposes: __

[Name of employment entity]

_________________________.

9 Family medical history information about _________________________. _______________ [name of medical condition] [Name of

__________________will use this information only for the following purposes: _____________.

employment entity]

9 Disclosure by _________________________ of genetic information about _______________

[name of person to disclose] [name of test and

__________. __________________________ will use this information only for the following

condition] [Name of employment entity]

purposes: _________________________.

You may revoke this authorization for access and use at any time by sending a letter to

________________ unless ____________________________ has ________________________

[name and address] [name of employment entity] [description of action that

___________________________________.

would be taken based on the information]

You are entitled to a copy of this authorization. By signing this authorization, you do not lose any legal rights to which you are entitled.

This authorization is valid until _______________.

[date or event]

I, _______________, authorize _________________________ to access the genetic information

[print name] [name of employment entity]

and family medical history checked above for use for the purposes indicated.

______________________________ ______________________

Signature Date

Authorization for Retention of Genetic Information

___________________________ seeks your authorization to keep the following genetic

[Name of employment entity]

information or family medical history to which you have granted _________________________

[name of employment entity]

access. This information will be treated as a confidential record and kept separately from the rest

of your personnel records.

9 _____________________________________

[Name of test and condition tested for]

9 Family medical history information about __________________________

[name of medical condition]

The purpose for keeping this information is _______________________________________.

You may revoke this authorization for retention at any time by sending a letter to ________________ unless ____________________________ has ______________________

[name and address] [name of employment entity] [description of action that

___________________________________.

would be taken based on the information]

You are entitled to a copy of this authorization. By signing this authorization, you do not lose any legal rights to which you are entitled.

This authorization is valid until _____________________.

[date or event]

I, _______________, authorize __________________________ to keep the information checked

[print name] [name of employment entity]

above.

______________________________ ______________________

Signature Date

Authorization for Disclosure of Genetic Information

___________________________ seeks your authorization to disclose the following genetic

[Name of employment entity]

information or family medical history to ___________________________________________.

[name of recipient of the information]

__________________________ will notify ___________________________________ that

[Name of employment entity] [name of recipient of the information]

__________________________________ is legally obligated to maintain the confidentiality

[name of recipient of the information]

of this information and that if may not make further disclosures without your authorization.

9 __________________________________

[Name of test and condition tested for]

9 Family medical history information about __________________________

[name of medical condition]

You may revoke this authorization for disclosure at any time by sending a letter to ___________

[name and

________ unless ____________________________ has already disclosed the information.

address] [name of employment entity]

You are entitled to a copy of this authorization. By signing this authorization, you do not lose

any legal rights to which you are entitled.

This authorization is valid until ___________________.

[date or event]

I, ________________, authorize ___________________________________________

[print name] [name of person authorized to make disclosure]

to make the disclosures checked above.

______________________________ ______________________

Signature Date

Reporter=s Notes

This section requires an employee to provide an authorization before an employment entity may access, use, keep or disclose genetic information or family medical history.

The draft does not disturb existing law that allows a minor to seek repudiation of consent and expunge records when the minor reaches the age of majority.

Subsection (a) General requirement for authorization. This subsection would establish a requirement that an employment entity must be authorized by the employee before it may access, keep, or disclose genetic information, except as provided elsewhere in the act. In order to give a valid authorization, the employee must be informed as provided in the following subsections and must act voluntarily. This subsection also includes a requirement that an authorization must be indicated by a signed record. This authorization requirement is coupled with limitations on access, use, retention, and disclosure in Sections 204, 205, 206, and 208.

Subsection (b) Obligation of recipient of authorized disclosure. One of the difficulties in authorizing disclosure is control over the information once it has been disclosed. The Drafting Committee decided that regulation of the initial disclosure is ineffective without a continuing obligation of confidentiality that is binding on the recipient. Hence under this subsection a recipient may not redisclose the genetic information without the insured=s authorization. This provision extends beyond the privacy protections provided by HIPAA. States are permitted to depart from HIPAA privacy provisions if they impose more stringent protections. 45 C.F.R. ' 160.203(b).

The Committee considered and rejected several approaches to the issue of redisclosures, including 1) a notice to the insured that the genetic information disclosed by the authorized person may be subject to redisclosure by the recipient and not longer protected, and 2) a provision that an insured could enter into a confidentiality agreement with recipients of their genetic information.

Subsection (c) Content of authorization. The provision on authorization for access, use, retention, or disclosure of genetic information or family medical history is adapted from the HIPAA Privacy Rule regulations for Auses and disclosures for which an authorization is required.@ 45 C.F.R. '' 164.508 (a) and (c), 164.512(a). The subsection adapts these regulations to apply to genetic information and family medical history, and expands them to include authorization for access and retention as well as for use and disclosure.

An advantage of using the HIPAA regulations as the foundation for the authorization requirements is that the requirements to authorize a disclosure by a health care provider to an employer, employment agency, labor organization, or credentialing authority would be similar to the requirements that health care provider must follow as a covered entity under HIPAA. The context of the HIPAA regulations is different enough, however, that they cannot be transported directly into the Act without modification. Moreover, under HIPAA, states are permitted to impose their own, more stringent, privacy requirements. 45 C.F.R. ' 160.203(b). Some have enacted statutes with different requirements for disclosing health care information, which reduces the uniformity that would theoretically be achieved by using the HIPAA format. Therefore, while the structure of this subsection is modeled on the HIPAA regulations, it includes some additional provisions from various state statutes. See, e.g., Me. Rev. Stat. Ann. tit. 22 ' 1711-C.

Subsection (d) Authorization forms. The subsection includes forms that could be used for an employee to authorize an employment entity to access and use genetic information, to keep genetic information, or to disclose genetic information. The use of a form following this pattern would comply with the requirements of the section.

SECTION 210. REVOCATION OF AUTHORIZATION.

(a) Except as otherwise provided in subsection (b) or by law other than this [act], an employee may revoke an authorization provided under this [article] at any time in a signed record.

(b) An employee=s revocation of an authorization under subsection (a) has no effect to the extent that an employment entity has taken action in reliance on the authorization.

Reporter=s Notes

The Drafting Committee considered expanding this section to give employees the ability to amend their authorizations short of revoking them, but decided that it would be preferable for employees to revoke one authorization and execute a new one.

Other law of the state may provide for a substitute decisionmaker or signer if the employee is incapacitated or incompetent. Revocation by a substitute is left to existing law of the state that governs power of attorney, guardianship, or other substitute decision makers.

SECTION 211. RETENTION OF AUTHORIZATION. An employment entity that receives an employee=s authorization under this [article] shall treat the authorization as a confidential record and keep the authorization or require the authorization to be kept separately from the employee=s personnel records. The employment entity shall keep a record of the authorization for six years from the expiration date of the authorization or, if the authorization does not have an expiration date, for six years from the date the authorization was created.

Reporter=s Notes

An employee=s authorization for genetic testing or employer access, retention, or disclosure of genetic information under Sections 203 or 209 is a confidential record that must be kept separate from the employee=s personnel files. The provision that the authorization must be retained for six years is adapted from the HIPAA regulations that govern documentation and retention of a signed authorization. 45 C.F.R. ' 164.508 (b) (6), ' 164.530(j).

SECTION 212. REMEDIES; LIMITATION OF ACTIONS.

(a) An individual aggrieved by a violation of this [article] may file a civil action without exhausting arbitral procedures or administrative remedies provided by an agreement of the parties or by law other than this [act]. This section does not prohibit an employee from pursuing administrative remedies or other remedies available under law other than this [act].

(b) All remedies at law and in equity are available to enforce this [article], including compensatory damages, back pay, front pay, reassignment, reinstatement, injunctive relief, punitive damages, expungement of records, and the right to a jury trial.

(d) An individual may file the civil action authorized in subsection (a) not later than two years after the individual discovers the violation of this [article] or an individual exercising reasonable care should have discovered the violation.

Reporter=s Notes

The draft is intended to provide remedies for privacy violations, employment determinations based on misuse of genetic information, and other harms. Privacy violations involve access, retention, or disclosure of genetic information that does not comply with the Act. Employment determinations could include failure to license, hire, refer for employment, promote, or decisions to terminate, demote, reduce pay, reassign, or to take any other adverse action. Other harms could include torts such as intentional infliction of emotional distress. The appropriate remedy will vary with the type of violation.

The draft provides for a civil cause of action that will supercede limitations in union contracts, arbitration agreements, and administrative processes that otherwise apply in the employment context. At the same time, the draft preserves existing remedies. The cause of action created by the statute is cumulative and available in addition to existing remedies.

The section does not increase the enforcement burden on state agencies. The primary remedy for a violation of the article is a private civil action. Fee and cost shifting are included to compensate prevailing employees for their costs to enforce the statute.

The drafting committee considered a tolling provision, but rejected this approach because they did not want to impose a long period of potential liability on employment entities.

States with genetic statutes tend to provide relief for violations using a mixture of administrative and civil processes, and a few have even enacted criminal penalties. Many state statutes that emphasize discrimination require employees to submit claims of unlawful employment discrimination based on use of genetic information to a state agency or the federal Equal Opportunity Employment Commission. Using a state employment discrimination agency makes sense for enforcement of provisions related to employment decisions because such agencies already have the apparatus in place to enforce state civil rights and disability statutes. The draft does not prevent that avenue of enforcement. For privacy violations, however, other avenues are desirable. Discrimination agencies do not have expertise in privacy violations and the typical remedies for employment discrimination are not necessarily appropriate for a privacy violation. Enforcement could be turned over to an agency with that expertise, but the drafting committee wish to avoid the cost of creating and funding a new agency. Moreover, the drafting committee did not want to impose the delay associated with administrative processes on an aggrieved employee.

A privacy rights perspective assumes an intrinsic harm from the invasion of privacy, whether or not consequential damages are incurred. Because of difficulties in measuring damage to privacy interests, several states that provide a private right of action for privacy violations involving genetic information also specify statutory damages, with higher amounts when the violation is willful or leads to monetary gain for the violator. Alaska Stat. ' 18.13.020 (actual damages plus $5,000, or plus $1,000 if there is monetary gain); N.H. Rev. Stat. ' 141-H:6 (not less than $1,000 per violation); NM Stat. Ann. ' 24-21-6 (economic loss plus damages of up to $5,000 if the violation results from willful or grossly negligent conduct). The drafting committee did not take this approach because statutory damages often become a limit on the recovery available.

[ARTICLE] 3

HEALTH INSURANCE

SECTION 301. APPLICANT FOR INSURANCE. For purposes of this [article] an applicant for health insurance shall be treated the same as an insured.

Reporter=s Notes

Applicability of Article 3. The article is meant to apply broadly to health insurance, whether issued on an individual, group, or other basis. It does not apply to disability-income insurance or long-term-care insurance.

This article closes the gaps left by Title I of HIPAA, which prohibits discrimination in enrollment and premiums based on health status related factors, including genetic information. Title I, however, does not apply to small group and individual coverage, which is covered by this article. In addition to individual and group health insurance policies, some state statutes reference health insurance issued on a franchise or blanket basis. These forms of health insurance are also subject to this article.

The drafting committee intends that this article also applies to employee welfare plans unless there is a controlling judicial decision that the article is preempted by the Employee Retirement Income Security Act of 1974 (ERISA), 29 U.S.C. ' 1001 et seq. Federal preemption is relevant because the United States Supreme Court has held that ERISA applies to employee benefit plans such as health insurance as well as to employee pension plans. Inter‑Modal Rail Employees Ass'n v. Atchison, Topeka and Santa Fe Ry. Co., 520 U.S. 510 (1997). The United States Supreme Court has recognized three types of preemption under ERISA that are relevant to this draft act: express, complete, and conflict preemption. Complete preemption and conflict preemption are relevant to enforcement and civil remedies and are discussed in the notes to Section 307.

In order to simplify the administration of plans by ensuring that they are subject to only one set of regulations, ERISA expressly preempts state regulation of the administration of employee benefit plans to the extent those regulations Arelate to@ employee benefit plans. 29 U.S.C. ' 1144(a). The statute contains a savings clause, however, that saves laws that regulate insurance from ERISA preemption. 29 U.S.C. ' 1144(b)(2)(A). The issue of whether state regulations are preempted by ERISA has led to extensive litigation.

Recently, the United States Supreme Court clarified the application of the savings clause. In order to fall under ERISA=s savings clause, a state law must first be Aspecifically directed toward@ the insurance industry. Kentucky Ass'n of Health Plans, Inc. v. Miller, 123 S. Ct. 1471, 1475 (2003). Laws of general application that merely have Asome bearing on insurers@ do not fall under the clause. Id. Second, the ERISA provision saves state laws that regulate Ainsurance,@ not Ainsurers,@ so a law must regulate insurers Awith respect to their insurance practices.@ Id. A state law regulates an insurer with respect to insurance practices if it controls the terms of insurance policies, id. at 1476, or if it Asubstantially affect[s] the risk pooling arrangement between the insurer and the insured,@ id. at 1477. This act regulates insurance practices and thus falls under ERISA=s savings clause.

The preemption question is further complicated by that fact that ERISA also contains what is referred to as the Adeemer clause,@ which creates an exception to the savings clause. It provides that Aneither an employee benefit plan . . . nor any trust established under such plan, shall be deemed to be an insurance company or other insurer . . . for purposes of any law of any State purporting to regulate insurance companies . . . .@ 29 U.S.C. ' 1144(b)(2)(B). The United States Supreme Court has interpreted the deemer clause to exempt self‑funded (i.e. uninsured) health plans from the savings clause. Thus the Court concluded that Aself‑funded ERISA plans are exempt from state regulation insofar as that regulation >relate[s] to= the plans.@ FMC Corp. v. Holliday, 498 U.S. 52, 61 (1990). Under this decision, this act is preempted as applied to self-funded employee benefit plans.

The distinction in FCM Corp. between insured and self-insured health plans has not been overruled and continues to be applied by lower courts. See, e.g., Daly v. Marriott International, Inc., 415 F.3d 889 (8th Cir. 2005) (Adeemer clause@ of ERISA preemption provision exempted employer funded health plan from application of state mental-health parity law); Blue Cross Blue Shield of Alabama v. Sanders, 138 F.3d 1347 (11th Cir. 1998).

Applicants. For simplicity, the article refers only to insureds. The provisions apply equally to applicants for insurance.

SECTION 302. GENETIC TESTING; ACCESS TO GENETIC INFORMATION.

(a) In determining eligibility for health-insurance coverage and in setting rates, terms, and conditions, a health insurer may not:

(1) require or request an insured or an insured=s family member to take a genetic test;

(2) require or request an insured=s genetic information [or family medical history]; or

(3) inquire whether an insured or an insured=s family member has taken or refused to take a genetic test or accessed genetic services.

(b) Except as otherwise prohibited by law other than this [act], a health insurer that receives a claim for payment for health-care services may access, without specific authorization by the insured, genetic information and family medical history contained in the insured=s medical records that the insurer may use under Section 304 to determine a payment obligation.

(c) This [article] permits an insurer that directly provides health-care services to provide a genetic test to an insured or to access an insured=s genetic information or family medical history in the insured=s medical records for the purpose of providing health-care services for the insured.

Reporter=s Notes

Access to Genetic Information. This section limits the ability of health insurers to access genetic information and family medical history consistent with the uses prohibited in Section 303 and permitted in Section 304.

Subsection (a) Coverage decisions. This subsection prohibits a health insurer from requiring genetic tests or obtaining genetic information for uses associated with the issuance of insurance. The draft prohibits those uses in Section 303.

Recent state legislation that prohibits the use of genetic test results to set terms for medical insurance also prohibits the use of family medical history for this purpose. This is also the approach taken in the federal bill on genetic discrimination. The reference to family medical history is bracketed in this draft, however, because the drafting committee would like further reaction and input from the industry on this provision.

Subsection (b) Claims processing. This subsection allows health insurers to access genetic information for use in determining an insured=s payment obligations, as permitted in Section 304. The exception for other legal requirements is included to avoid conflict with HIPAA regulations on using and disclosing medical information for payment operations.

Subsection (c) Medical treatment. For health insurers such as HMOs, which also provide health care services, access to genetic information for functions that involve determining eligibility and terms of insurance need to be separated from access for health care provider functions. These insurers may provide genetic tests to patients or access genetic information or family medical history for therapeutic purposes as part of the practice of medicine, but not as part of determining eligibility for insurance or for underwriting. Specific conditions for access to genetic information for diagnosis or treatment are not covered by this draft because those uses constitute the practice of medicine. Likewise, the draft does not cover authorization for genetic testing because that is treated as a matter of informed consent, with standards set as a matter of the practice of medicine.

SECTION 303. PROHIBITED USE OF GENETIC INFORMATION. A health insurer may not consider an insured=s genetic information [or family medical history] in determining eligibility for health-insurance coverage or in setting rates, terms, and conditions for health-insurance.

Reporter=s Notes

This section reflects and combines the approaches of many states that prohibit the use of genetic information for setting eligibility requirements and for underwriting in health insurance. It partially closes the gaps left by HIPAA and is consistent with the federal Genetic Information Nondiscrimination Act (GINA) in that it extends beyond merely prohibiting complete denial of coverage; the section also prohibits use of genetic information in determining rates, terms, and conditions.

Recent state legislation that prohibits the use of genetic test results to set terms for medical insurance also prohibits the use of family medical history for this purpose. This is also the approach taken in GINA. The reference to family medical history is bracketed in this draft, however, because the drafting committee would like further reaction and input from the industry on this provision.

A determination of eligibility for coverage is meant to include decisions made in connection with the offer, sale, continuation, or renewal of a health insurance policy. A determination of rates, terms, and conditions includes establishing premiums, limiting coverage, limiting or conditioning benefits, or making any other underwriting decisions. The prohibition on using genetic information for these purposes also precludes an insurer from treating a predisposing genetic characteristic as a preexisting condition for purposes of limiting or excluding benefits or coverage. This is consistent with statutes in several states that do not permit health insurers to impose preexisting condition exclusions based on predictive genetic information in the absence of a diagnosis based on symptoms of the disease or condition. (Alaska, Conn, Idaho, Iowa, Ky, OR).

There are many alternative approaches to regulating the use of genetic information in health insurance. Some other states take an approach like that of HIPAA and use a non-discrimination provision that prohibits higher premiums than those charged to similarly situated individuals. (Alaska, Ark, Ill, Iowa). Yet other states prohibit the use of genetic information for underwriting health insurance without actuarial justification. (Ariz, WVa). In some states, use of genetic information for risk selection is permitted if an individual submits the information voluntarily or if the information is favorable to the individual. (Ill, Ind, Mass, Mo, NY). Yet other states regulate this use by prohibiting insurers from increasing policy rates based on genetic information. (Md, Mont, Or, Tex). The Drafting Committee decided that a more comprehensive limitation on use to determine eligibility or for any form of underwriting is the appropriate course to take for health insurance.

It is often permissible for insurers to consider existing medical conditions in determining coverage and premiums under other law so long as they treat like situations alike. This section would impose a different standard by prohibiting consideration of genetic information, which includes conditions revealed by a genetic test. The language chosen by the Drafting Committee creates a different standard for genetic illnesses than for other medical conditions, thus raising the practical question of which conditions are Agenetic.@ The prohibition on considering genetic information is broader than if it were limited to an insured=s predisposing genetic characteristics. Some analysts endorse this approach by maintaining that attempts to prevent genetic discrimination are mostly meaningless without protection for people who have genetic diseases. See Mark A. Rothstein, Genetic Privacy and Confidentiality: Why They are so Hard to Protect, 26 J. L. Med. & Ethics 181 (1998). Others think that this would place too great a burden on insurers. See, e.g., Henry T. Greely, Genotype Discrimination: The Complex Case for Some Legislative Protection, 149 U. Pa. L. Rev. 1483, 1503 (2001).

SECTION 304. AUTHORIZED USE OF GENETIC INFORMATION.

(a) A health insurer that receives a claim for payment for a genetic test or genetic counseling may use genetic information and family medical history contained in the insured=s medical records regarding the need for a genetic test to determine the insurer=s payment obligation. The insurer is not entitled to use the results of the test.

(b) A health insurer that receives a claim for payment for health-care services rendered because of a genetic condition or predisposing genetic characteristic may use the genetic information or family medical history that is necessary to determine the insurer=s payment obligation.

(c) This [article] permits an insurer that directly provides health-care services to use an insured=s genetic information or family medical history for the purpose of providing health-care services for the insured.

Reporter=s Notes

Subsections (a) and (b) Payment obligations. This subsection highlights the potential role for genetic information in providing payment for genetic tests and health care services. First, genetic information such as family history may be necessary for preauthorization for a genetic test or service or for approval of payment for a genetic test or service. Second, health care services may be medically justified by a predisposing genetic characteristic or a genetic condition. In this context, genetic Acondition@ should be interpreted broadly to include the full range of health effects influenced by a genotype, including a disease or disorder.

These subsections are modeled on a Utah provision.

Subsection (c) Health-care services. Health insurers such as HMOs, which also provide health care services, need to be able to use genetic information in order to function as health care providers. These insurers may use genetic information or family medical history for therapeutic purposes as part of the practice of medicine, but not as part of determining eligibility for insurance or for underwriting. Specific conditions for use of genetic information for diagnosis or treatment are not covered by this draft because those uses constitute the practice of medicine.

SECTION 305. RETENTION OF GENETIC INFORMATION. A health insurer that keeps genetic information or family medical history in the insured=s medical records shall comply with the terms of the regulations that govern Security Standards for the Protection of Electronic Protected Health Information, 45 C.F.R. Part 164 Subpart C, and Privacy of Individually Identifiable Health Information, 45 C.F.R. Part 164, Subpart E, adopted by the Secretary of Health and Human Services under Part C of Title XI of the Social Security Act, 42 U.S.C. '' 1320d-1320d-8, and Section 264 of the Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. ' 1320d-2 note, as of the effective date of this [act] as if the insurer were covered by those regulations.

Reporter=s Notes

This section extends the protections of HIPAA regulations to all genetic information retained by health insurers, whether covered by HIPAA or not. The health insurers that are not covered by HIPAA=s Privacy Rule but would be brought under it by this provision are primarily small employer-sponsored group health plans (less than 50 participants) or employer-sponsored group health plans that are administered solely by the employer that established and maintains the plan. See 45 C.F.R. ' 160.202. The drafting committee noted that it would consider deleting this section.

SECTION 306. DISCLOSURE OF GENETIC INFORMATION BY HEALTH INSURERS.

(a) A health insurer may disclose an insured=s genetic information to a person other than the insured if the health insurer has obtained the insured=s authorization under Section 307.

(b) A person who receives an insured=s genetic information from a health insurer may disclose the insured=s genetic information to a person other than the insured if the recipient has obtained the insured=s authorization under Section 307.

(c) This [article] permits an insurer that directly provides health-care services to disclose an insured=s genetic information or family medical history in the insured=s medical record to the extent appropriate for the purpose of providing health-care services for the insured.

Reporter=s Notes

This section conditions the disclosure of an insured=s genetic information on the authorization of the insured. In some jurisdictions, however, health care providers may have a common-law duty to inform others of a genetic disorder. This case law creates malpractice liability that may require disclosure by a health insurer without the insured=s consent.

New Jersey=s court has recognized a physician=s duty to warn those Aknown to be at risk of avoidable harm from a genetically transmissible condition.@ Safer v. Pack, 677 A.2d 1188 (N.J. Super. Ct. App. Div. 1996). The defendant in the case was the physician who had treated the plaintiff=s father for colorectal cancer that led to the father=s death when the plaintiff was a child. The plaintiff inherited multiple polyposis, an inherited condition that if undiscovered and untreated, leads to metastatic colorectal cancer. The court found a duty to Atake reasonable steps@ to warn that Aextends beyond the patient to members of the immediate family of the patient who may be adversely affected by a breach of that duty.@ It noted, but did not determine, the issue that would arise if the father had instructed the doctor not to disclose details of the illness or the genetic risk. In that event, it would be necessary to resolve the conflict between physician-patient confidentiality and the duty to warn.

Minnesota has also recognized a duty regarding genetic testing and diagnosis that reaches beyond the patient. The plaintiff alleged that her daughter=s physicians were negligent in failing to diagnose a genetic disorder in the daughter that led the mother to conceive another child with the same genetic disorder. Molloy v. Meier, 679 N.W.2d 711 (Minn. 2004). The court noted that genetic testing and diagnosis affect not only the patient, but can benefit or harm both the patient and her family. The Fragile X disorder is one that physicians ordinarily report to parents and it was foreseeable that a negligent diagnosis of the disorder would cause harm to the family as well as the patient. The court held that the duty to warn extends to Abiological parents who foreseeably may be harmed by a breach of that duty.@ It did not consider whether it should extend to additional family members.

The Florida Supreme Court has similarly held there is a duty to warn of the likelihood that a condition was inherited by a patient=s children but, in contrast to the Minnesota and New Jersey courts, it found that the duty is satisfied by warning the patient. Pate v. Threlkel, 661 So.2d 278 (Fla. 1995). The court observed that a patient can normally be relied upon to pass on the warning and emphasized the heavy burden that would be entailed in seeking out and warning family members.

SECTION 307. AUTHORIZATION FOR DISCLOSURE OF GENETIC INFORMATION.

(a) Except as otherwise provided by this [act] or law other than this [act], a health insurer may not disclose an insured=s genetic information without the insured=s knowing and voluntary authorization indicated by a record signed by the insured that complies with subsection (c) of this section. A health insurer that receives a valid authorization to disclose genetic information may disclose the information only in accordance with the authorization. An authorization may not expand the disclosure of genetic information permitted by this [article] and may not include exculpatory language waiving any of the insured=s legal rights.

(b) Except as otherwise provided by this [act] or law other than this [act], a person who receives genetic information disclosed by a health insurer must maintain the confidentiality of the insured=s genetic information and may not disclose the information without the insured=s knowing and voluntary authorization indicated by a record signed by the insured that complies with subsection (c) of this section. A recipient that receives the insured=s valid authorization to disclose genetic information may disclose the information only in accordance with the authorization. An authorization may not expand the disclosure of genetic information permitted by this [article] and may not include exculpatory language waiving any of the insured=s legal rights. When a health insurer discloses an insured=s genetic information, it must notify the recipient of the information about these obligations.

(1) describe the genetic information or family medical history to be disclosed in a specific and meaningful fashion;

(2) identify or describe the person that may disclose the genetic information;

(3) identify or describe the third person to which the authorized person may disclose the genetic information;

(4) indicate the duration of the authorization with an expiration date if any or expiration event that relates to the insured or to the purpose of the access, use, retention, or disclosure;

(5) state that the insured may revoke the authorization at any time in a signed record, subject to the right of a person that acted in reliance on the authorization before receiving notice of revocation and provide instructions on how to revoke an authorization; and

(6) state that the insured is entitled to a copy of the authorization.

(d) The use of the following form complies with this section.

Authorization for Disclosure of Genetic Information

_________________________________ requests your authorization to disclose the following

[Name of person seeking to make disclosure]

genetic information to ________________________________. _________________________

[name of recipient of the information] [Name of person seeking

_________________ will notify _________________________________ that _____________

to make disclosure] [name of recipient of the information] [name of

___________________________ is legally obligated to maintain the confidentiality of this

recipient of the information]

information and that it may not make further disclosures without your authorization.

9 _______________________________________

[Name of test and condition tested for]

You may revoke this authorization for disclosure at any time by sending a letter to

__________________ unless _______________ has already disclosed the information.

[name and address] [name of insurer]

You are entitled to a copy of this authorization. By signing this authorization, you do not lose

any legal rights to which you are entitled.

This authorization is valid until _______________.

[date or event]

I, ________________, authorize __________________________________________ to disclose

[print name] [name of person authorized to make disclosure]

the genetic information I have checked above to ____________________________________.

[name of recipient of the information]

______________________________ ______________________

Signature Date

Reporter=s Notes

This section requires an insured to provide an authorization before a health insurer may disclose genetic information.

The draft does not disturb existing law that allows a minor to seek repudiation of consent and expunge records when the minor reaches the age of majority.

Subsection (a) General requirement for authorization. This subsection would establish a requirement that an insurer must be authorized by the insured before it may disclose genetic information, except as provided elsewhere in the act. In order to give a valid authorization, the insured must be informed as provided in the following subsections and must act voluntarily. Subsection (a) also includes a requirement that an authorization must be indicated by a signed record. The authorization requirement is coupled with limitations on disclosure in Section 306. It establishes a statutory confidential relationship. In some states this might support a cause of action for breach of confidence. See, e.g., Munzer v. Blaisdell, 183 Misc. 773, 49 N.Y.S.2d 915 (NY Sup. Ct. 1944), aff=d mem., 269 A.D. 970, 58 N.Y.S.2d 359 (1945) (common law remedy implicit in statutory prohibition of disclosure of treatment information by mental hospital).

Other law of the state may provide for a substitute decisionmaker or signer if the employee is incapacitated or incompetent. This situation is left to existing law of the state that governs power of attorney, guardianship, or other substitute decision makers. Again, the Drafting Committee has indicated that it wishes to consider whether or not to include a provision for incapacitation or incompetence into the text of the draft.

Subsection (b) Obligation of recipient of authorized disclosure. One of the difficulties in authorizing disclosure is control over the information once it has been disclosed. The Drafting Committee decided that regulation over the initial disclosure is ineffective without a continuing obligation of confidentiality that is binding on the recipient. Hence under this subsection a recipient may not redisclose the genetic information without the insured=s authorization. This provision extends beyond the privacy protections provided by HIPAA. States are permitted to depart from HIPAA privacy provisions if they impose more stringent protections. 45 C.F.R. ' 160.203(b).

The Committee considered and rejected several approaches to the issue, including 1) a notice to the insured that the genetic information disclosed by the authorized person may be subject to redisclosure by the recipient and not longer protected, and 2) a provision that an insured could enter into a confidentiality agreement with recipients of their genetic information.

Subsection (c) Content of authorization. The provision on authorization for disclosure of genetic information is adapted from the HIPAA Privacy Rule regulations for Auses and disclosures for which an authorization is required.@ 45 C.F.R. '' 164.508 (a) and (c), 164.512(a).

An advantage of using the HIPAA regulations as the foundation for the authorization requirements is that the requirements to authorize a disclosure by a health care provider to an insurer would be similar to the requirements that health care provider must follow as a covered entity under HIPAA. The context of the HIPAA regulations is different enough, however, that they cannot be transported directly into the Act without modification. Moreover, states are permitted to impose their own, more stringent, privacy requirements. 45 C.F.R. ' 160.203(b). Some have enacted statutes with different requirements for disclosing health care information, which reduces the uniformity that would theoretically be achieved by using the HIPAA format. Therefore, while the structure of this subsection is modeled on the HIPAA regulations, it includes some additional provisions from various state statutes. See, e.g., Me. Rev. Stat. Ann. tit. 22 ' 1711-C.

Subsection (d). Authorization form. This subsection provides a form that a health insurer may use for an insured to authorize disclosure of genetic information. The use of a form following this pattern would comply with the requirements of the section.

SECTION 308. REMEDIES; ENFORCEMENT; LIMITATION OF ACTIONS.

(a) An individual aggrieved by a violation of this [article] may initiate an appropriate proceeding with the [state commissioner of insurance] for whatever action the [commissioner] may be authorized to take under the [state unfair practice insurance law] or may file a civil action without exhausting administrative remedies.

(b) All remedies at law and in equity are available to enforce this [act], including punitive damages and a right to a jury trial. In addition, a court may order expungement of records.

(d) An individual may initiate the administrative action or file the civil action authorized in subsection (a) not later than two years after the individual discovers the violation of this [article] or an individual exercising reasonable care should have discovered the violation.

Legislative Note: States should insert for [state commissioner of insurance] the appropriate title of this department. [The state unfair practices insurance law] should be replaced with the title of the relevant statute.

Reporter=s Notes

The draft=s remedy section is written to respond to privacy violations as well as discrimination or misuse of genetic information in insurance. It provides a private right of action for an aggrieved individual. Alternatively, an aggrieved individual may seek enforcement through the State Commissioner of Insurance. An administrative remedy such as this is typical in state statutes that prohibit discrimination in health insurance based on genetic testing or information. These statutes declare that a violation is an unfair and deceptive insurance act or practice under the state insurance code. They often provide that the State Commissioner of Insurance shall enforce the prohibitions.

The committee considered and rejected statutory damages as a remedy for a privacy violation for the reason that statutory damages often serve primarily to limit recovery. The absence of statutory damages, however, makes the availability of punitive damages particularly important.

This section is identical to the enforcement provision for life insurance, income-disability insurance and long-term-care insurance in Article 4.

Certain enforcement and remedies may be preempted by ERISA. AComplete preemption@ occurs when Congress has Aso completely [preempted] a particular area that any civil complaint raising this select group of claims is necessarily federal in character.@ Metropolitan Life Ins. Corp. v. Taylor, 481 U.S. 58, 63-64 (1987). In Taylor, the United States Supreme Court held that the civil enforcement provision of ERISA, 29 U.S.C. ' 1132(a), completely preempts common law breach of contract and tort claims for wrongful termination of disability benefits. See also Prudential Ins. Co. of Amer. v. Nat=l Park Med. Center, Inc., 413 F.3d 897 (8th Cir. 2005) (with respect to suits that could be brought under ERISA, civil enforcement provision preempts Arkansas Patient Protection Act civil penalties).

[ARTICLE] 4

LIFE INSURANCE, DISABILITY-INCOME INSURANCE,

AND LONG-TERM-CARE INSURANCE

SECTION 401. APPLICANT FOR INSURANCE. For purposes of this [article], an applicant for life insurance, disability-income insurance, or long-term-care insurance shall be treated the same as an insured.

Reporter=s Notes

Applicability of Article 4. This article applies to life insurance, disability-income insurance, and long-term-care insurance issued on an individual, group, or other basis. Including individual policies is significant because individual insurance policies are subject to underwriting and many life, disability-income, or long-term-care insurance policies are issued on an individual basis. The draft does not distinguish between individual and group insurance, however, because most of the states that regulate genetic testing or the use of genetic information for issuing life, disability-income, or long-term-care insurance treat both individual and group insurance identically.

The justification for including life, disability-income, and long-term-care insurance in a separate article from health insurance is that these insurance policies tend to be viewed as financial products that are less necessary than health insurance. That, however, is a contested view. Life insurance plays a central role in the financial lives of many individuals and families. Disability-income and long-term-care insurance are increasingly viewed as a necessary adjunct to health insurance and many states regulate disability-income and long-term-care insurance as health insurance.

There are differences in underwriting principles among the three types of insurance. Life insurance underwriting is concerned with mortality and uses life expectancy tables. In contrast, disability-income underwriting is concerned with morbidity and long-term-care underwriting is a hybrid process. These differences do not seem to require different treatment in terms of genetic information.

Applicants. For simplicity, the article refers only to insureds. The provisions apply equally to applicants for insurance.

SECTION 402. GENETIC TESTING.

(a) If an insurer files information on a genetic test that meets the standards of Section 406, an insurer may request or require an insured to take the genetic test in connection with the provision of life insurance, disability-income insurance, or long-term-care insurance and, with prior authorization of the insured that meets the requirements of Section 403, may provide the test to the insured.

(b) An insurer that requests or requires a genetic test in connection with the provision of life insurance, disability-income insurance, or long-term-care insurance shall provide and pay for genetic counseling for the insured about the risks and benefits of the genetic test before the insured decides to authorize the test. The insured may knowingly and voluntarily waive counseling in a signed record that informs the insured of the benefits of genetic counseling.

(c) An insurer that provides a genetic test to an insured in connection with the provision of life insurance, disability-income insurance, or long-term-care insurance shall:

(1) pay for the genetic test;

(2) require the testing organization to make a report of the test result to the insured and a health-care professional designated by the insured unless the insured directs otherwise;

(3) provide and pay for genetic counseling for the insured about a test result unless the insured knowingly and voluntarily waives counseling in a signed record that informs the insured of the benefits of genetic counseling; and

(4) require the destruction of the insured=s biological sample obtained for a genetic test as soon as permitted by law after the test is completed unless retention of the sample is authorized by the insured, permitted by law other than this [act], or ordered by a tribunal.

Reporter=s Notes

Genetic testing and genetic information. This section and the section 404 limit access to genetic information by insurers that provide life, disability-income, or long-term-care insurance. This section limits genetic testing and section 404 limits access to genetic information in general. The limitations are based on the philosophy that insurers may continue current information gathering practices, but may not expand their collection of genetic information unless and until there is a strong scientific basis for its use to predict mortality and morbidity. It is the drafting committee=s understanding that life, disability-income and long-term-care insurers do not at present require applicants to take genetic tests, but do collect family history information for use in determining eligibility and in underwriting.

The drafting committee considered, but did not adopt, an approach to regulating genetic information for life, disability-income or long-term-care insurance based on the amount of the insurance policy. The suggestion was to prohibit genetic testing and consideration of genetic information for policies worth less than a specified monetary threshold. Above that value, insurers would be permitted to consider genetic information freely.

The arguments for restricting access to genetic information by the insurance industry are that this information is particularly private and its predictive power is easily exaggerated. There are privacy concerns with commercial access to sensitive genetic information and predictions that individuals will avoid genetic testing for fear of adverse effects on their insurability. There is also a possibility that insurers may require applicants to take genetic tests and then deny insurance or charge more based on genetic characteristics, unfairly making coverage unavailable to people who are not sick from the genetic condition and never will become sick from that condition. From the industry perspective, as with health insurance, insurers worry about adverse selection. If applicants seek coverage because a genetic characteristic exposes them to risk, but the insurer does not have this information, this puts the insurer at a financial disadvantage. See generally Mark A. Rothstein, ed., Genetics and Life Insurance: Medical Underwriting and Social Policy (2004).

A 1997 study by the Human Genetics Advisory Commission in the United Kingdom concluded that it is unlikely that actuarially-sound genetic predictions of adult death will be validated and available anytime in the near future. Genetic tests need to be connected to medical and epidemiological research to establish what consequences for health and life-span can be inferred from a given genetic test. The Commission concluded that a requirement to disclose genetic tests as a condition of obtaining insurance would be acceptable only after research has established an association between a given pattern of test results and life events that are relevant for the insurance product. It recommended continuing a moratorium on requiring test results. Human Genetics Advisory Commission, The Implications of Genetic Testing for Insurance (1997).

Genetic testing. This section prohibits insurers from requiring applicants to have genetic testing as a condition of obtaining life, disability-income or long-term-care insurance unless scientific developments support a conclusion that a test provides a relevant prediction. The section is consistent with genetic testing prohibitions in force in California, Massachusetts, and Vermont, except that it allows the prohibition to be modified as justified by scientific developments. Vermont and Massachusetts prohibit insurers from requiring applicants to take a genetic test as a condition of obtaining or renewing a policy. California prohibits long-term-care insurers from requiring genetic testing for use in determining insurability or in underwriting. See Cal. Ins. Code ' 10233.1 (long-term-care insurance); Mass. Gen. L. Ann. 175 ' 120E (life insurance); Mass. Gen. L. Ann. 175 ' 108I (disability and long-term-care insurance); Vt. Stat. Ann. ' 9334 (any insurance).

The section also sets forth requirements similar to those imposed on employers who provide genetic tests.

Genetic Counseling. This section requires insurers who have applicants take genetic tests to provide genetic counseling. The counseling occurs in two stages: before the test to assist in the decision to take the genetic test and after the test to interpret results if the test indicates the individual is at risk. Counseling is an important component of the testing process in the field of genetics for several reasons. Tests may indicate a risk of a condition for which there is no treatment and the information may have implications for family members who are not tested directly. The outcomes require interpretation of complex probabilities which can be easily misunderstood. The genetic counseling that is required before the test is covered in subsection (b) and the counseling that is appropriate after a test is covered in subsection (c).

The committee received differing opinions from industry participants on this issue which ranged from opposition to any obligation to provide counseling to a view that if insurance companies request the tests they should provide and pay for counseling in conjunction with the test.

SECTION 403. AUTHORIZATION FOR GENETIC TEST.

(a) An insured=s authorization for the genetic test requested or required under Section 402 must be knowing and voluntary and indicated in a record signed by the insured that complies with subsection (b) of this section. An insurer that receives a valid authorization for genetic testing may provide a test only in accordance with the authorization. An authorization may not expand the genetic testing permitted by this [act] and may not include exculpatory language waiving any of the insured=s legal rights.

(b) An authorization for a genetic test for life insurance, disability-income insurance, or long-term-care insurance must:

(1) describe the genetic test to be performed, its purpose, and its permitted uses;

(2) state that only the authorized genetic test will be performed on the insured=s biological sample;

(3) inform the insured that the insurer is obligated to provide and pay for genetic counseling about the risks and benefits of the test before the insured decides to authorize the test;

(4) inform the insured that the insurer is obligated to provide and pay for genetic counseling about the test result unless the insured waives genetic counseling;

(5) state that the test result will be reported to the insured and a health-care professional designated by the insured, unless the insured directs otherwise;

(6) include an opportunity for the insured to provide directions about reporting test results;

(7) inform the insured that the insured=s biological sample will be destroyed as soon as permitted by law after the test is completed unless the insured authorizes retention of the sample or unless otherwise ordered by a tribunal; and

(8) state that the insured is entitled to a copy of the authorization.

Authorization for Genetic Testing

Limited Authorization. Only the genetic tests that you authorize on this form will be performed

on your biological sample. These tests are voluntary, but refusing a test requested by

________________ may mean that your application for insurance will be denied.

[name of insurer]

Availability of Genetic Counseling. Before you complete this authorization, it is highly

recommended that you meet with a genetic counselor who will help you understand and evaluate

the risks, benefits, and consequences for you and your family of having the tests listed below.

__________________ will provide and pay for this genetic counseling.

[Name of insurer]

Proposed Genetic Tests. Based on a review of your family medical history, ________________

[name of insurer]

requests the following genetic test:

9 __________________

[Name of test]

The purpose of this test is to determine if you have a predisposition for _________________ .

[genetic condition]

If you authorize__________ to have access to the test result, it will be used only for the

[insurer]

following purposes: ___________________________________.

Reporting Test Results and Genetic Counseling. The test results will be reported to you and to a

health-care professional whom you designate unless you direct otherwise. It is recommended that

you receive genetic counseling about the test results. Genetic counseling is important for

understanding the test results in the context of your medical and family history. It can also

provide you with support, informational resources, and referrals, as appropriate, that can help you

adapt to the implications of being at risk of a genetic condition. ______________________ [Name of insurer]

will provide and pay for genetic counseling about the test results unless you decline genetic

counseling.

Destruction of your Biological Sample. After the genetic test, your biological sample will be

destroyed as soon as permitted by law unless or a court, arbitral tribunal, or administrative

agency requires retention of the sample or you sign a written authorization for _______________

[name of insurer]

to keep the sample.

Retention of Legal Rights. By signing this authorization, you do not lose any legal rights to

which you are entitled.

Copy of this form. You are entitled to a copy of this authorization.

I, ____________________, authorize the genetic test(s) I have checked above.

[print name]

9 I wish to receive test results.

9 I do not with to receive test results.

9 Report test results to the following health care professional:

Name: _________________________

Address: _______________________

9 Do not report test results to a health care professional.

______________________________ ______________________

Signature Date

Reporter=s Notes

The Drafting Committee selected a method for protection privacy for genetic testing and genetic information by establishing an authorization requirement that is coupled with statutory limits and duties imposed on insurers. Under this approach, an insured must affirmatively authorize any genetic testing or access, use, retention, or disclosure of genetic information. The authorization requirement is not simply a procedural step because Article 4 establishes limitations on the situations in which insurers may request authorization from insureds.

Subsection (a) Requirement for authorization for genetic testing. Under Section 402, an insurer may require a genetic test as a condition of obtaining life, disability-income, or long-term-care insurance if the test has been filed and meets the standards of Section 406. This subsection adds an additional requirement that genetic testing is permitted only with the prior authorization of the insured.

In order to meet the requirement that an authorization be knowing and voluntary, an employee or insured should have genetic counseling before signing the authorization. Genetic counseling provides insureds with adequate information to make an informed decision about genetic testing. It also makes them aware of their options regarding reporting of test results and help in interpreting them through genetic counseling. Genetic counseling may be provided by a genetic counselor, but may also be provided by a qualified physician or geneticist.

Subsection (b) Content of authorization for testing. The section draws on N.Y. Civ. Rights Law ' 79-l (McKinney), which establishes requirements for consent for a genetic test.

The limitation in (b)(2) to the authorized test is consistent with the requirements for prior authorization in Section 402.

The notification provision regarding destruction of the sample in (b)(7) is consistent with the insurer=s obligation to ensure the sample is destroyed under Section 402(c)(4), which recognizes that the testing laboratory may be required to retain the sample for certification purposes.

Subsection (c). Authorization form. The subsection provides a form that may be used to authorize an insurance company to provide a genetic test. The use of a form following this pattern would comply with the requirements of the section.

SECTION 404. ACCESS TO GENETIC INFORMATION.

(a) Unless an insurer has filed information on a genetic test that meets the standards of Section 405, an insurer may not knowingly obtain or directly or indirectly inquire about, request, or require an insured to provide the insured=s genetic information based on a genetic test in connection with the provision of life insurance, disability-income insurance, or long-term-care insurance.

(b) Nothing in this [article] prohibits an insurer from obtaining medical records of an applicant for insurance that contain genetic information in connection with the provision of life insurance, disability-income insurance, or long-term-care insurance.

(c) An insurer may request or require an insured to provide family medical history in connection with the provision of life insurance, disability-income insurance, or long-term-care insurance.

Reporter=s Notes

This section limits the extent to which an insurance company may access genetic information or the results of genetic testing based on the rationale discussed in the reporter=s notes to Section 402. Subsection (a) permits access to genetic information if it is based on a genetic test that meets the standards set forth in Section 406.

Subsection (b) is included to reassure the industry that its traditional access to medical records is preserved, despite the fact that medical records may contain genetic information.

The prohibition on access to genetic information does not apply to family medical history, which is not included in the definition of Agenetic information.@ Subsection (c), moreover, explicitly permits insurers to seek information about family medical history, which they have traditionally used for underwriting.

SECTION 405. PROHIBITION ON USE OF GENETIC INFORMATION. Unless genetic information is based on a genetic test that has been filed and meets the standards provided in Section 406, an insurer may not use the genetic information about an insured=s predisposing genetic characteristics to determine eligibility for or rates, terms, and conditions of life insurance, disability-income insurance, or long-term-care insurance.

Reporter=s Notes

The determination of eligibility for coverage includes decisions made in connection with the offer, sale, continuation, or renewal of an insurance policy. The determination of rates, terms, and conditions includes establishing premiums, limiting coverage, limiting or conditioning benefits, or making any other underwriting decisions.

This section prohibits the use of genetic information for determining eligibility or underwriting of life, disability-income, and long-term-care insurance unless the genetic test has been filed and meets that standards provided in Section 406. Traditional insurance underwriting has been based on medical histories and tests that indicate existing medical conditions. The draft permits those practices to continue. Using predictions based on predisposing genetic characteristics that have not been expressed as a disease or condition would be a new step, however, and there is a great risk that such predictions would not be reliable in the context of insurance.

Unlike the draft=s treatment of genetic information in employment or health insurance, the restriction on use of genetic information in life, disability-income & long-term-care insurance is narrower in that it applies only to predisposing genetic characteristics. Therefore, insurers are not restricted from using genetic information with regard to a medical condition that has been diagnosed.

The section ties use of genetic information about predisposing characteristics to the process in Section 406 for ensuring that the genetic test provides a reliable prediction of individual mortality or morbidity. Otherwise, life, disability-income and long-term-care insurers may not use genetic information about predisposing characteristics for determining eligibility or in underwriting.

This prohibition is consistent with regulation in a number of states. Because genetic tests are not yet routine in medical care and few individuals have previously taken genetic tests when they apply for insurance, the prohibitions on requiring tests in California, Massachusetts, and Vermont have the effect of preventing the use of genetic information in insurance determinations. In addition, a number of states directly prohibit insurers from using genetic information to determine eligibility or in underwriting. See Colo. Rev. Stat. ' 10-3-1104.7(3)(b) (group disability-income & long-term-care); Kan. Stat. Ann. ' 40-2259(d) (disability-income & long-term-care); Or. Rev. Stat. ' 746.135 (genetic information from a blood relative for life, disability-income & long-term-care insurance); Vt. Stat. Ann. tit. 18, ' 9334(a) (same). See also Ariz. Rev. Stat. Ann. ' 20-448(F) (permitting disability-income and long-term-care insurers to use genetic information only if there is an actual diagnosis of a genetic condition).

The insurance industry maintains that any restrictions on their ability to use genetic information will undermine the availability and pricing structure of life, disability-income & long-term-care insurance. However, there is broad international consensus that the use of genetic information in life insurance should be restricted. Numerous countries have enacted restrictions, as have the states noted above. There is no evidence, moreover, that these restrictions have been associated with adverse selection, increased pricing, reduced availability of policies, or decreased profitability of the insurance industry. Without some supporting evidence, these industry concerns do not outweigh the importance of protecting against new uses of information that would diminish privacy and that carry a high risk of irrational discrimination.

With the draft=s narrow definition of Agenetic information,@ an insurer would be able to use genetic data revealed by an individual=s family medical history to determine eligibility or to underwrite without restriction. One member of the subcommittee raised the question of whether there should be any limits on insurers= use of family medical history. The question was motivated by a concern that even if disclosures to insurers do not change, insurers may be able to do more with those disclosures using ever more sophisticated computer technology. The drafting committee may want to consider whether it is desirable to prevent new uses of family history information that may become possible and if so, what limits would be appropriate.

SECTION 406. REQUIRED DETERMINATION AND FILING FOR GENETIC TESTING AND ACCESS AND USE OF GENETIC INFORMATION. A life insurer, disability-income insurer, or long-term-care insurer may request or require a genetic test or access and use genetic information based on the results of a genetic test if the insurer files with the [state commissioner of insurance] the test and documentation supporting to a reasonable degree of scientific certainty the test=s analytical validity, clinical validity, and a scientific association between the test and an increased risk of morbidity or mortality. The insurer=s use of genetic information about an insured=s predisposing genetic characteristic to determine eligibility or rates, terms, or conditions for life insurance, disability-income insurance, or long-term-care insurance without a filing by the insurer that meets this standard is a violation of the [state unfair practices insurance law].

Legislative Note: [State unfair practices insurance law] should be replaced with the title of the relevant statute and [state commissioner of insurance] should be replaced with the appropriate title.

Reporter=s Notes

The risk of misuse of genetic information is increasing because of the explosion of genetic tests available, the general lack of governmental oversight for these tests, and common misperceptions about the extent to which a genetic test can predict a future medical disease or condition. In addition, the pathways for gene expression remain uncertain. Links between most genetic characteristics and the incidence of disease are extremely complex and depend on the interrelation of many factors, both genetic and environmental.

Even with draft=s restrictions on genetic testing by insurance companies, access to genetic information in medical records will increase. More than 1,000 genetic tests are available clinically as of early 2007; hundreds more are available to researchers. Some are marketed directly to consumers with claims that they can be used to individually customize vitamins and diet as well as test for future disease. There is no government oversight of the validity of the tests used for research or available through medical professionals. Through the mechanisms of this section that protect against the premature or improper use of predictions based on genetic information, the draft provides assurance that insurance companies are permitted to use genetic information, but not misuse it.

The insurance industry has expressed a view that it must be able to develop its use of genetic information along with the rapid development of knowledge in the genetic field. The section provides a mechanism that will allow use of genetic information to evolve, in response to new scientific information that may justify the use of genetic information for eligibility and underwriting determinations as determined by an evidence-based review process.

The drafting committee considered and rejected an approach that would have established regulatory oversight of the use of genetic information by insurers by requiring a prior finding of an association with mortality or morbidity by state insurance regulators in consultation with state public health authorities. The committee also considered and rejected an approach that would have required that the appropriate finding be made by a geneticist or genetic counselor. Instead, the drafting committee decided that the insurance industry should be responsible for determining the accuracy and completeness of the data on a genetic test and the reliability of the prediction possible with the genetic information.

The approach selected by the committee requires an insurance company to identify genetic tests that it plans to use and to file documentation supporting the validity of the test with the state insurance commissioner. This documentation would then be open to public scrutiny, creating transparency that can provide a check on a company=s determination. This process will allow an insurer=s use of genetic information to change as research develops reliable connections between genetic characteristics and risk of mortality or morbidity.

The process required here contemplates the type of evidence-based review of genetic tests conducted by the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group formed under the auspices of the Centers for Disease Control National Office of Public Health Genomics. See http://www.cdc.gov/genomics/gtesting/EGAPP/about.htm.

As explained in the following excerpt from the Final Report of the Task Force on Genetic Testing, Promoting Safe and Effective Genetic Testing in the United States (1997) (available at http://www.genome.gov/10001733), before relying on a genetic test, there must be scientific evidence to (1) establish a reliable relationship between a disease, genes, and inherited mutations; (2) establish the analytical validity of the test; and (3) establish the clinical validity of the test.

Establishing Associations Between a Disease, Genes, and Inherited Mutations

In developing genetic tests, scientists must first be confident that the DNA segments under investigation play a role in the disease in question. These segments might be apparently functionless markers that appear to be spatially linked on a chromosome to a disease-related gene. Linkage is demonstrated when, within families, one form of the marker is found in those with the disease more often than in blood relatives in whom the disease is absent. Because such associations might be due to chance, as was the case for the linkage claimed between bipolar affective disorder and markers on chromosome 11, and between schizophrenia and markers on chromosome 5, stringent statistical standards must be satisfied before accepting linkage, and the findings much be confirmed in additional families with the disease. . . .

Further research leads scientists from the linked, functionless marker to a nearby gene suspected of being casually related to the diseases in question. The proof depends on finding mutations in the gene that are only present (in gene dosage sufficient to cause disease) in family members with disease. Further proof that a gene is causally related to disease comes from demonstrating that the protein encoded by the gene is absent, not synthesized in adequate amounts, or manifests a structural or functional aberration that plausibly accounts for symptoms and signs of the disease.

Another approach to identifying a disease-related gene does not depend on linkage but on suspecting that a gene that has been previously identified (Acandidate gene@) plays a role in a specific disease. Here too, mutations must be found only in those with the disease.

The DNA segments associated with a disease might be functional, common, polymorphic gene variants. Recently, attention has been given to the association between the apolipoprotein E polymorphism and Alzheimer disease (AD). A higher proportion of people with apoE4 will develop AD than those with other forms of the polymorphism. Some people with AD, however, will not inherit apoE4 and other with apoE4 will never develop AD; the polymorphism is neither a necessary nor sufficient cause for the disease. It is not clear whether polymorphic variants themselves predispose to the disease, whether the association is spurious (unlikely in the case of apoe4 and AD), or whether a marker liked to both the polymorphic gene and the disease-related gene is responsible. The following criterion must be satisfied before either linked markers or putative disease-related mutations are used as the basis of a genetic test. The genotypes to be detected by a genetic test must be shown by scientifically valid methods to be associated with the occurrence of a disease. The observations must be independently replicated and subject to peer review.

Analytical Validity

For DNA-based tests, analytical validity requires establishing the probability that a test will be positive when a particular sequence (analyte) is present (analytical sensitivity) and the probability that the test will be negative when the sequence is absent (analytical specificity). In contrast to DNA-based tests, enzyme and metabolite assays measure continuous variables (enzyme activity or metabolic concentration). One key measure of their analytical validity is accuracy, or the probability that the measured value will be within a predefined range of the true activity or concentration. Another measure of analytical validity is reliability, or the probability of repeatedly getting the same result.

[V]alidation includes performing replicate determinations to ensure that a single observation is not spurious, and Ablind@ testing of coded positive samples (from patients with the disease in whom the alteration is known to be present) and negative samples (from controls). Organizations engaged in new test development should have access to a sufficient number of patient samples to have statistical confidence in the validation. In validating a new test analytically, the laboratory techniques should be as similar as possible to those used when the test will be performed clinically once it is validated.

Analytical sensitivity and specificity of a genetic test must be determined before it is made available in clinical practice.

Clinical Validity

Clinical validity involves establishing several measures of clinical performance including (1) the probability that the test will be positive in people with the disease (clinical sensitivity), (2) the probability that the test with be negative in people without the disease (clinical specificity), and (3) the probability that people with positive test results will get the disease (positive predictive value (PPV)) and that people with negative results will not get the disease (negative predictive value.) Predictive value depends on the prevalence of the disease in the group or populations being studied, as well as on the clinical sensitivity and specificity of the test.

Two intrinsic features of genetic diseases, heterogeneity and penetrance, affect clinical validity.

Heterogeneity. The same genetic disease might result from the presence (in the necessary gene dosage) of any of several different variants (alleles) of the same gene (allelic diversity) or of different genes (locus heterogeneity). With current technology, all disease-related alleles cannot always be identified, particularly when there are many of them, which is often the case. This failure to detect all disease-related mutations reduces a test=s clinical sensitivity.

Penetrance. The probability that disease will appear when a disease-related genotype is present is the penetrance of the genotype. When penetrance is incomplete, PPV is reduced. Penetrance is incomplete when other genetic or environmental factors must be present. In high-risk breast cancer families, 10 to 15 percent of women with inherited susceptibility mutations of the BRCA1 gene will never develop breast cancer. Environmental factors and possibly other inherited factors are required as well. In women without a family history of breast cancer, the penetrance of a BRCA1 or BRCA2 is even lower. Allelles at other gene loci and similar environments are more likely to be shared by relatives than by people in the general population.

* * *

Parameters of clinical validity will depend in part on the group r population in which the test will be used. For instance, the frequency of disease-related alleles might differ between ethnic groups, making it difficult if not impossible to extrapolate the test sensitivity from one group to another. This is the case for cystic fibrosis and breast cancer in which certain alleles can predominate in one ethnic group or geographical area but not in others. Penetrance can also differ among ethnic groups. The prevalence of allele frequencies will have a marked effect on PPV; the greater the prevalence, the higher the PPV. Age will also affect allele prevalence; in a population older than the age at which the disease usually causes death, the allele frequency will be lower than in a younger population. For all these reasons, validation studies should be conducted in a group representative of the one in which the test is intended for clinical use.

When tests are developed for one purpose are used for another, there is no assurance that the sensitivity or PPV will be the same. . . .

The three following criteria help ensure that appropriate data on the clinical validity of genetic tests will be collected during the developmental stages.

$ Data to establish the clinical validity of genetic tests (clinical sensitivity, specificity, and predictive value) must be collected under investigative protocols.

$ In clinical validation, the study sample must be drawn from a group of subjects representative of the population for whom the test is intended.

$ Formal validation for each intended use of a genetic test is needed.

(emphasis in original, citations omitted)

SECTION 407. CORRECTION OPTION FOR GENETIC INFORMATION. If an insurer uses an insured=s genetic information to make an adverse determination regarding eligibility or rates, terms, or conditions for life insurance, disability-income insurance, or long-term-care insurance, the insurer shall provide notice of that use to the insured. The insured may choose to repeat a genetic test to verify the analysis used in the adverse determination. If the initial test was performed at the request of the insurer, the insurer shall pay for a repeat test requested by the insured. If the first analysis is found to be inaccurate, the insurer shall reconsider the adverse determination.

Reporter=s Notes

Under this section, an insured is provided an opportunity to correct mistakes in genetic information. The section is modeled on Florida procedures which require the DNA analysis to be repeated in the event of an adverse determination. Fla. Stat. ' 760.40(3). Delaware also has a special provision that allows an individual to access his genetic records and to correct those records. 16 Del. Code Ann. ' 1223.

SECTION 408. CONFIDENTIALITY; RETENTION OF GENETIC INFORMATION. An insured=s genetic information is a confidential medical record. Except as otherwise provided by law other than this [act], a life insurer, disability-income insurer, or long-term-care insurer may keep an insured=s genetic information only with authorization of the insured in accordance with Section 410.

Reporter=s Notes

This section permits insurers to retain genetic information under certain circumstances. It follows the practice of the states with statutes that require authorization or informed consent for the retention of genetic information and do not treat life, disability-income, or long-term-care insurers differently than others who might retain such information. It departs from the approach of some other states, however, that exempt these insurers from their requirements for authorization or informed consent. (E.g., Mass., Nev., NH, NMex, Ok)

There are arguments that insurers should not be limited in retaining genetic information. They typically have two years to rescind a policy for misrepresentation, and may need the information submitted with the application in order to show misrepresentation. In addition, reinsurers may audit underwriting practices several years after a policy issues. Insurance industry representatives state that under current practice, information is retained indefinitely because of the risk of class action suits.

SECTION 409. DISCLOSURE OF GENETIC INFORMATION.

(a) Except as otherwise provided in Section 410, a life insurer, disability-income insurer, or long-term-care insurer may disclose an insured=s genetic information to a person other than the insured only if the insurer has obtained the insured=s prior authorization for the disclosure in accordance with Section 410.

(b) An insured, upon request, may inspect and obtain a copy of genetic information from the insurer=s files on the insured.

Reporter=s Notes

Subsection (a). This subsection restricts the ability of life, disability-income, and long-term-care insurers to disclose genetic information without authorization of the insured.

(b) Except as otherwise provided by this [act] or law other than this [act], a person who receives genetic information disclosed by an insurer must maintain the confidentiality of the insured=s genetic information and may not disclose the information without the insured=s knowing and voluntary authorization indicated by a record signed by the insured that complies with subsection (c) of this section. A recipient that receives the insured=s valid authorization to disclose genetic information may disclose the information only in accordance with the authorization. An authorization may not expand the disclosure of genetic information permitted by this [article] and may not include exculpatory language waiving any of the insured=s legal rights. When an insurer discloses an insured=s genetic information, it must notify the recipient of the information about these obligations.

(1) describe the genetic information to be accessed, used, kept, or disclosed in a specific and meaningful fashion;

(2) identify or describe the person that is authorized to access, use, keep, or disclose the genetic information;

(3) if the authorization is for access to genetic information through disclosure by another person to an insurer, identify or describe the person authorized to make the disclosure;

(4) if the authorization is for use of genetic information, describe the permitted uses;

(5) if the authorization is for retention of genetic information, describe where the information will be kept and identify or describe the custodian of the information;

(6) if the authorization is for disclosure to a third person, identify or describe the third person to which the authorized person may disclose the genetic information;

(7) indicate the duration of the authorization with an expiration date if any or expiration event that relates to the insured or to the purpose of the access, use, retention, or disclosure;

(8) state that the insured may revoke the authorization at any time in a signed record, subject to the right of an insurer or other person that acted in reliance on the authorization before receiving notice of revocation, and provide instructions on how to revoke an authorization; and

(9) state that the insured is entitled to a copy of the authorization.

(d) The use of the following forms complies with this section.

Authorization for Access and Use of Genetic Information

__________________ requests your authorization to access the following genetic test results and

[Name of insurer]

use them for the purposes identified:

9 Access to the results of the test for __________________________________. The purpose

[name of test and condition tested for]

of this test is to determine if you have a genetic characteristic that predisposes you towards the

following medical condition: ______________. _________________ will use this information

[Name of insurer]

only for the following purposes: _______________________.

9 Disclosure by _________________________ of genetic information about _______________

[name of person to disclose] [name of test

_____________to ___________________. _________________ will use this information

and condition] [name of insurer] [Name of insurer]

only for the following purposes: ________________________________.

You may revoke this authorization for access and use at any time by sending a letter to

__________________ unless _________________ has ________________________________

[name and address] [name of insurer] [description of action that would

_______________________________.

be taken based on the information]

You are entitled to a copy of this authorization. By signing this authorization, you do not lose

any legal rights to which you are entitled. This authorization is valid until _________________.

[date or event]

I, _________________, authorize ___________________ to access and use my genetic

[print name] [name of insurer]

information as checked above.

______________________________ ______________________

Signature Date

Authorization for Retention of Genetic Information

_________________ requests your authorization to keep the following genetic information:

[Name of insurer]

9 ______________________________________

[Name of test and condition tested for]

You may revoke this authorization for ________________ to keep your genetic information at

[name of insurer]

any time by sending a letter to __________________ unless ________________________

[name and address] [name of insurer]

has ___________________________________________________________.

[description of action that would be taken based on the information]

You are entitled to a copy of this authorization. By signing this authorization, you do not lose

any legal rights to which you are entitled. This authorization is valid until _________________.

[date or event]

I, __________________, authorize ____________________ to keep the genetic information

[print name] [name of insurer]

checked above.

______________________________ ______________________

Signature Date

Authorization for Disclosure of Genetic Information

_________________ seeks your authorization to disclose the following genetic information to

[Name of insurer]

_________________________________. _________________ will notify _______________

[name of recipient of the information] [Name of insurer] [name of recipient

____________________ that __________________________________ is legally obligated

of the information] [name of recipient of the information]

to maintain the confidentiality of this information and that if may not make further disclosures

without your authorization.

9 ________________________________________

[Name of test and condition tested for]

You may revoke this authorization for disclosure at any time by sending a letter to

__________________ unless __________________ has already disclosed the information.

[name and address] [name of insurer]

You are entitled to a copy of this authorization. By signing this authorization, you do not lose

any legal rights to which you are entitled. This authorization is valid until _______________. [date or event]

I, _________________, authorize __________________________________________ to

[print name] [name of person authorized to make disclosure]

disclose my genetic information checked above to __________________________________.

[name of recipient of the information]

______________________________ ______________________

Signature Date

Reporter=s Notes

This section requires an insured to provide an authorization before an insurer may access, use, keep, or disclose genetic information. The provisions differ from those in the employment context in that insurers are permitted to continue their traditional use of family medical history without special authorization requirements.

The draft does not disturb existing law that allows a minor to seek repudiation of consent and expunge records when the minor reaches the age of majority.

Subsection (a) General requirement for authorization. This subsection would establish a requirement that an insurer must be authorized by the insured before it may access, keep, or disclose genetic information, except as provided elsewhere in the act. In order to give a valid authorization, the insured must be informed as provided in the subsection (b) and must act voluntarily. Subsection (a) also includes a requirement that an authorization must be indicated by a signed record. The authorization requirement is coupled with limitations on access, use, retention, and disclosure in Sections 404, 405, 406, 408, and 409.

Subsection (b) Obligation of recipient of authorized disclosure. One of the difficulties in authorizing disclosure is control over the information once it has been disclosed. The Drafting Committee decided that regulation over the initial disclosure is ineffective without a continuing obligation of confidentiality that is binding on the recipient. Hence under this subsection a recipient may not redisclose the genetic information without the insured=s authorization. This provision extends beyond the privacy protections provided by HIPAA. States are permitted to depart from HIPAA privacy provisions if they impose more stringent protections. 45 C.F.R. ' 160.203(b).

Subsection (c) Content of authorization. The provision on authorization for access, use, retention, or disclosure of genetic information is adapted from the HIPAA Privacy Rule regulations for Auses and disclosures for which an authorization is required.@ 45 C.F.R. '' 164.508 (a) and (c), 164.512(a). The subsection adapts these regulations to apply to genetic information and expands them to include authorization for access and retention as well as for use and disclosure.

An advantage of using the HIPAA regulations as the foundation for the authorization requirements is that the requirements to authorize a disclosure by a health care provider to an insurer would be similar to the requirements that health care provider must follow as a covered entity under HIPAA. The context of the HIPAA regulations is different enough, however, that they cannot be transported directly into the Act without modification. Moreover, states are permitted to impose their own, more stringent, privacy requirements. 45 C.F.R. ' 160.203(b). Some have enacted statutes with different requirements for disclosing health care information, which reduces the uniformity that would theoretically be achieved by using the HIPAA format. Therefore, while the structure of this subsection is modeled on the HIPAA regulations, it includes some additional provisions from various state statutes. See, e.g., Me. Rev. Stat. Ann. tit. 22 ' 1711-C.

Subsection (d). Authorization form. This subsection provides forms that may be used for an insured to provide authorization for use, retention or disclosure of genetic information. Forms following these examples would comply with this section.

SECTION 411. REVOCATION OF AUTHORIZATION.

(a) Except as otherwise provided in subsection (b) or by law other than this [act], an insured may revoke an authorization provided under this [article] at any time in a signed record.

(b) An insured may not revoke an authorization provided under this [article]:

(1) to the extent that an insurer or other person has taken action in reliance on the authorization; or

(2) if the authorization was granted as a condition of obtaining insurance and other law provides the insurer with a right to contest a claim under, or the validity of, the policy.

Reporter=s Notes

This section is adapted from the HIPAA regulation that governs revocation of an authorization. 45 C.F.R. ' 164.508 (b) (5). It is similar to provisions governing health care information that have been adopted by some of the states. Long-term-care insurers are subject to HIPAA, but life insurers and disability-income insurers are not, so this section extends the law in order to give an insured greater control over his genetic information.

Subsection (b)(2) is included because Section 402 permits an insurer to condition the availability of life, disability-income, or long-term-care insurance on an applicant=s authorization for a genetic test or access to genetic information about the test, if the test meets the standards of Section 406 for providing a reliable prediction of mortality or morbidity. An insurer needs to continue to access this information in order to protect against fraud or misrepresentation in an insurance application; it has two years in which to contest the validity of the insurance contract. Records are also kept for reinsurance purposes and for reapplications by the insured.

SECTION 412. RETENTION OF AUTHORIZATION. An insurer that receives an authorization under this [article] shall keep a record of the authorization for six years after the expiration date of the authorization or, if the authorization has no expiration date, for six years from the date the authorization was created.

Reporter=s Notes

This section on the length of the obligation to keep an authorization is adapted from the HIPAA regulations that govern documentation and retention of a signed authorization. 45 C.F.R. '' 164.508 (b) (6), ' 164.530(j).

SECTION 413. REMEDIES; ENFORCEMENT; LIMITATION OF ACTIONS.

(b) All remedies at law and in equity are available to enforce this [article], including punitive damages and a right to a jury trial. In addition, a court may order expungement of records.

Reporter=s Notes