Many states have enacted, or are in the process of enacting over the past several years, legislation to prohibit genetic discrimination, protect confidentiality and broaden health care coverage protections. In response to advances in genetics, the New York State (NYS) Legislature has enacted several laws pertaining to these and related issues in order to promote the public health, safety and welfare of the people of NYS. However, state laws do not provide protection for the approximately 125 million Americans who obtain their health insurance coverage through private sector, employer sponsored, self-funded plans because the Federal Employment Retirement Income Security Act (ERISA) exempts the administration of these plans from state oversight.

New York State Law

Among these laws are amendments to the state's Human Rights Law which make it an unlawful discriminatory practice for an employer, labor organization, or employment agency to require a genetic test or directly or indirectly require such test results except where such a test is shown to be directly related to the occupational environment such that the employee or applicant might be at increased risk of disease from working in such an environment. This provision also requires that the employee authorize any test information disclosure (NY Executive Law §292 and 296).

Other recently enacted New York State laws amend the civil rights law and insurance law to protect the confidentiality of genetic test results and prohibit the administration of a genetic test without valid informed consent by, or on behalf of, the subject of the test. Each disclosure or redisclosure of the test results requires the express informed consent of the test subject, and no general waivers are deemed informed consent. Nonconsensual genetic testing and nonconsensual disclosure of genetic test results are permitted in certain enumerated contexts, such as New York's Newborn Screening Program and New York's program to 'genetically fingerprint' specific classes of convicted criminals. Outside of these enumerated contexts, nonconsensual genetic testing and/or nonconsensual disclosure of genetic test results are permitted only if a court orders such testing and/or disclosure after considering the privacy interests of the subject and the subject's close relatives, the public interest, and, in the case of medical or anthropological research, the ethical appropriateness of such research [N.Y. Civ. Rights Law Section 79-1(4)(d)]. There also is a requirement in the civil rights law that the person signing the informed consent form be advised that he or she may wish to seek professional genetic counseling prior to signing the consent. While informed consent is required to allow research access to specimens, explicit reconsent is not required once linked identifiers are removed (Civil Rights Law §79-l; Insurance Law §2612).

New York State Public Health Law Article 5, Title V, requires the licensure of clinical laboratories and blood banks, by establishing minimum qualifications for directors, and by requiring that the performance of all procedures employed by clinical laboratories and blood banks meets minimum standards accepted and approved by the Department of Health. These licensing requirements have been established for laboratories located in or accepting laboratory specimens originating from New York State.

As yet there is no law in New York State that prohibits insurance companies from refusing to insure or raising premiums based on genetic information.

Other States

Currently at least 20 states have enacted genetic privacy laws with more being considered in at least 30 states.

Federal Law

HIPAA Legislation

In 1996, the Federal government passed the Health Insurance Portability and Accountability Act (HIPAA). In general, with HIPAA, the states will remain the primary regulator of health insurance. This allows the states to go beyond federal minimum standards. HIPAA prohibits group health insurers from establishing rules for the eligibility or continued eligibility of an individual on the basis of any "health status-related factors". These factors explicitly include genetic information. Therefore, HIPAA prohibits the use of genetic information to determine an individual's eligibility for a group health plan, regardless of whether the group is large or small. HIPAA also prohibits health insurers from charging an individual participating in a group health plan a greater premium, based on a health status-related factor, than any other "similarly situated" individual participating in that group health plan. In addition, HIPAA prohibits a health insurer from treating genetic information as a preexisting condition, unless the individual has been diagnosed with a condition related to the genetic information.

The regulations promulgated under HIPAA define "genetic information" very broadly. As used in HIPAA, the term means: "...information about genes, gene products, and inherited characteristics that may derive from the individual or a family member. This includes information regarding carrier status and information derived from laboratory tests that identify mutations in specific genes or chromosomes, physical medical examinations, family histories, and direct analysis of genes or chromosomes".

These provisions of HIPAA, combined with existing state reforms in the small group and individual market, significantly curtail the use of genetic information by health insurers in the group health insurance market. But HIPAA does not contain a similar prohibition of discrimination on the basis of health status-related factors in the individual health insurance market. Moreover, it is unclear whether HIPAA prevents group health insurers from charging the entire group a higher premium based on genetic information about members of that group or to enroll an entire group on that basis.

A number of bills have been introduced in the United States Congress to close gaps in HIPAA, barring rate hikes in the group market on the basis of genetic information, prohibiting discrimination by insurers in the individual market and assuring the privacy of genetic information. Among them are H.R.306, the Genetic Non Discrimination in Health Insurance Act (Slaughter) and the Genetic Confidentiality and Non Discrimination Act of 1997 (Domenici). Passage of legislation to remedy omissions in HIPAA may be imminent, so monitoring of legislative developments in this fast moving area is necessary.

A Guide to Resources about Genetics-Related Legislation

Resources for those interested in accessing information about recent legislative changes pertaining to genetics at both state and federal levels are listed below.

Web-sites

The federal government has launched "healthfinder," a new Web site on health care with links to other health related sites, online documents, databases and search engines located at: http://www.cancergenetics.org..

A more detailed explanation of the provisions and limitations of HIPAA can be found on the Internet at: http://www.os.dhhs.gov/news/press/1996pres/960821.html. The full text of the Act is available at: http://www.ggtech.com/hr3103.html..

NYS Legislature

For specifics about laws and the current status of bills in NYS, please contact the NYS Legislature. Inquiries can be mailed to: Public Information Office, Room 202, Legislative Office Bldg., Albany, NY 12248 or call 518-455-4218. The New York State and Local Government (Library of Congress) web site is at: http://lcweb.loc.gov/global/state/ny-gov.html.

NYS Department of Health

For further information about health rules, regulations and public health law in NYS, please consult the NYSDOH website. The Department has a web site at: http://www.health.state.ny.us/events/index.htm.

DNA-Based Tests: Policy Implications for New York State

NYS Legislative Commission on Science and Technology, LCST Report No. 94-1, September, 1994. This publication is available by contacting The Legislative Commission on Science & Technology, Assembly P.O. Box 167, Albany, NY 12248.

Other

For a summary of genetics-related legislation, contact the Genome Action Coalition, 317 Massachusetts Avenue, NE, Suite 100, Washington, DC 20002. Tel 202-546-4732.

For information about genetics related legislation in the 50 states, contact the National Conference of State Legislatures, 1560 Broadway, Suite 700, Denver, CO 80202; telephone (303) 830-2200; fax (303) 863-8003; Email: www.ncsl.org.