Summary and Background

During the week of April 21, 2008, the Senate is expected to begin consideration of H.R. 493, the Genetic Information Nondiscrimination Act (GINA). This bill passed the House on April 25, 2007 on a vote of 420 to 3 and was placed on the Senate Legislative Calendar. When the Senate takes up the legislation, one amendment will be offered, a substitute amendment by Senators Snowe, Kennedy, and Enzi (the Senate substitute), which is nearly identical to H.R. 493.

GINA would establish strong protections against discrimination on the basis of genetic information by health insurance companies and employers (private and public) by:

•        Prohibiting insurance enrollment restrictions and premium adjustment on the basis of genetic information or genetic services;

•        Preventing health plans and insurers from requesting or requiring that an individual take a genetic test;

•        Covering all health insurance programs, including ERISA, state-regulated plans, and the individual market;

•        Prohibiting employers from discriminating against workers in hiring, compensation and other personnel decisions; and

•        Prohibiting employers from collecting genetic information, save only to monitor the adverse effects of hazardous workplace exposures.

Scientists have completed the historic task of mapping the human genome, which has given physicians better tools to diagnose, prevent, and treat diseases. To fulfill the promise of this new knowledge, however, Americans need to be assured that their genetic information will not be used to discriminate against them.

Surveys reveal that the public's concern about the misuse of genetic information has led many to refrain from taking life-saving genetic tests and participating in critical genetic research. Moreover, the patchwork of existing state and federal laws are confusing to everyone -- insurers, employers, patients, and workers -- and inadequate to protect against genetic discrimination. GINA would ensure that genetic information is safeguarded and give Americans the confidence they need to take advantage of genetic services.

Major Provisions

The Senate Substitute

Title I: Genetic Nondiscrimination in Health Insurance

GINA would prohibit health insurance discrimination on the basis of genetic information. The bill would prohibit companies in both the group and individual insurance markets from using genetic information, including information about genetic services, to deny insurance coverage or to adjust premium rates paid by the individual or the group to which that individual belongs.

GINA also sets limits on requesting or requiring genetic tests. The bill would bar a health plan from requesting or requiring an individual, or a family member of that individual, to undergo a genetic test. The legislation also would prohibit a health care professional from requiring that an individual undertake a genetic test; however, health professionals are not prohibited from requesting that their patients have a genetic test, and a health care professional employed by or affiliated with a health plan is not prohibited from informing an individual about the availability of a genetic test if it is part of a bona fide wellness program. The bill seeks to strike a balance between protecting consumers from being compelled to take genetic tests as a requirement of treatment or coverage, while ensuring that medical professionals are not inhibited from giving their patients the full benefit of genetic tests.

GINA addresses concerns about maintaining the privacy of genetic information. The health care privacy regulations issued by the Department of Health and Human Services generally allow the use and disclosure of medical information for enrollment, premium rating, or the creation, renewal, or replacement of an insurance plan, but GINA would bar use or disclosure of genetic information for these purposes.

The time when health insurers are most likely to use genetic information for discriminatory purposes is during the period prior to a person's enrollment. This is the time when insurance companies decide whether to offer a person coverage and, if so, what premium to charge. To prevent insurance companies from factoring genetic information into these decisions, the bill would prohibit insurance companies from requesting, requiring, or purchasing genetic information about an individual prior to that individual's enrollment in coverage. The legislation would establish conditions for when the incidental collection of genetic information is not a violation of this prohibition, so as not to penalize companies who inadvertently receive genetic information. However, the bill would ban discriminatory uses of that information, even if the information has been acquired inadvertently.

Regulations. GINA would require that final regulations reflecting the provisions of this title are to be released within one year of enactment and would take effect 18 months after enactment.

Enforcement. By building these protections against genetic discrimination into existing statutes (e.g., the Employee Retirement Income Security Act of 1974, the Public Health Service Act, the Social Security Act, and the Internal Revenue Code of 1986, Title I of GINA would generally use the same enforcement mechanisms as the underlying statutes. Provisions related to the privacy of genetic information would be covered by the same enforcement structure that applies to improper disclosures of individually identifiable health information under the Health Insurance Portability and Accountability Act of 1996.

Title II: Prohibiting Employment Discrimination on the Basis of Genetic Information

GINA would bar public and private sector employers (including state, federal, and Congressional employers), employment agencies, labor organizations, and joint labor-management committees from making employment-related decisions based on genetic information. GINA would make it unlawful to refuse to hire or discharge an employee, or otherwise discriminate against an employee with respect to compensation, terms, conditions, or privileges of employment because of genetic information. Employers would not be able to limit, segregate or classify employees in a way that would deprive them of employment opportunities or otherwise adversely affect their status because of genetic information. Unions also would be barred from making membership decisions based on genetic information, and both unions and employment agencies could not discriminate in job referrals based on this information.

GINA would protect the privacy of employees' genetic information. GINA would bar employers and the other covered organizations from requesting, requiring, or purchasing genetic information except in limited circumstances. And even when a covered entity acquires genetic information under one of these exceptions, the bill would ensure that individuals remain protected regarding maintenance, disclosure, and use of the information. Moreover, individuals would be allowed to enforce these protections in accordance with the remedies and procedures allowed under current employment discrimination laws.

Title III: Miscellaneous Provisions

To offset the cost of the bill, which is estimated by the Congressional Budget Office at less than $500,000 per year, GINA would enhance civil penalties under the Fair Labor Standards Act for violations of child labor law.

Legislative History

Legislation addressing genetic nondiscrimination was first considered in the 103^rd Congress as part of the national health care reform debate. Genetic nondiscrimination protections, in stand-alone bills or in broader legislation, were introduced in the 104^th Congress and in subsequent Congresses. Since 1996, the HELP Committee has examined the issue of genetic discrimination in health insurance and employment, including conducting five hearings on genetic discrimination as well as hearings on the related issue of medical privacy.

In 2003, a bipartisan agreement was reached among the Senate sponsors of competing genetic nondiscrimination legislation. The legislation, S. 1053, was unanimously passed by the HELP Committee and was approved by the Senate on a unanimous vote of 95 to 0 in October 2003, but the House did not take-up the legislation and protections against genetic discrimination were never enacted into law.

In February 2005, Senator Snowe reintroduced the 2003 bipartisan bill, as S. 306, GINA, as amended. The HELP Committee unanimously approved the measure, and the legislation passed the Senate on a unanimous, 98 to 0 vote, but an identical bill in the House, H.R. 1227, was never brought-up for a vote, and again GINA never became law.

On January 16, 2007, at the beginning of the 110^th Congress, Representative Louise Slaughter reintroduced the 2005 bipartisan bill, as H.R. 493. The bill was reported as amended by the Committee on Education and Labor, the Committee on Ways and Means, and the Committee on Energy and Commerce. The legislation, which has 224 co-sponsors, was passed on April 25, 2007 on a 420 to 3 vote and placed on the Senate Legislative Calendar. On January 22, 2007 Senator Snowe introduced an identical measure (S. 358) in the Senate. The bill was referred to the HELP Committee and was favorably reported, as amended, on March 29, 2007. The committee filed a written report on the measure, which has 44 co-sponsors, on April 10, 2007.

During the week of April 21, 2008, the Senate is expected to begin consideration of the House-passed measure, H.R. 493.

Expected Amendments

When the Senate takes up the measure, it is anticipated that only one amendment, a nearly identical substitute amendment by Senators Snowe, Kennedy, and Enzi, will be offered.

Statement of Administration Policy

On April 25, 2007, the Administration issued a Statement of Administration Policy (SAP) in support of H.R. 493.