Mapping Public Policy for Genetic Technologies

Chapter 6. Federal Activity

NCSL staff contacts are Joy Johnson Wilson, senior committee director, Health Committee, and Steve Lewis, research analyst, Health Policy Tracking Service.

Information Contained in this Chapter

What is the Current Federal Legal Environment?

HIPPAA and Medical Records Confidentiality

President's Quality of Care Commission/Federal Standards for Managed Care

Genetic Nondiscrimination Legislation

Administration Report

What Is the Current Federal Legal Environment?

Activity and interest in genomics issues in the U.S. Congress exploded in 1997, spurred by the announcement of the cloning of an adult sheep in Scotland. A number of bills have been introduced in the 105^th Congress. These fall into three main areas:

Privacy and confidentiality of medical information and "genetic information;"
Nondiscrimination based on "genetic information;" and
Prohibitions against cloning of human beings.

In 1998, the primary area of focus for the U.S. Congress likely will be genetic nondiscrimination and medical records confidentiality legislation.

HIPPAA and Medical Records Confidentiality

Due to a self-imposed mandate to produce legislation by August 1999, congressional committees will consider medical records confidentiality legislation next year. The mandate forcing Congress's hand was imposed under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), which set out a number of important reforms in the private health insurance marketplace.

HIPPAA included provisions to streamline or simplify administrative record keeping by health insurers. This area of law, however, created concern among medical records privacy advocates that it would be too easy for third parties to gain access to sensitive individual medical records. To assure these groups that it would address these concerns, Congress passed the requirement that it must seek to pass medical records confidentiality legislation within three years of enactment of HIPAA (August 1999) or the Department of Health and Human Services would be free to promulgate regulations in this area.

HIPAA also required Department of Health and Human Services to recommend legislation to this area by August 1997. HHS Secretary Donna Shalala has recommended legislation that seeks to strike a balance between health care research (which requires long-term access to research data), quality assurance and treatment and payment activities, and the confidentiality of medical information. The secretary recommended that federal requirements set a floor for-and not preempt-state requirements.

Presently, it is expected that the Senate will take the lead in developing medical records privacy legislation. The Senate Labor and Human Resources Committee currently is meeting with administration staff to develop a bipartisan bill.

President's Quality of Care Commission/Federal Standards for Managed Care

Additionally, the need for medical records confidentiality and nondiscrimination standards has been included in discussions concerning the quality of health care in managed care organizations. The president's commission on this subject recently released a report setting out recommendations for a Consumer Bill of Rights, that encompasses confidentiality, as well as the right to appeal treatment and coverage decisions, and other proposed solutions to problems facing consumers of managed health care. If Congress takes up quality of care legislation, it could well encompass medical records confidentiality.

Genetic Nondiscrimination Legislation

Another major area of focus for Capitol Hill will be genetic nondiscrimination legislation. This past year, Rep. Louise Slaughter introduced a bill on this subject, H.R. 306, which has attracted more than 181 members of the House as cosponsors and 18 Senators on companion legislation in the Senate (S. 89). More than 70 patient and research organizations have formally endorsed the bill, or the concept of legislation prohibiting genetic discrimination by insurers and employers. As mentioned above, President Clinton announced his support for this type of legislation this summer at a White House ceremony.

"We cannot afford to let our progress either in science or in extending healthcare to the American people be undermined by the misuse of what is a miracle of genetic testing. Americans should never have to choose between saving their health insurance and taking tests that would save their lives."

Of the bills introduced in Congress, the majority address the issue of insurance and employment nondiscrimination based on genetic testing results. The Clinton administration also is developing legislation to address the employment nondiscrimination issue.

Genetic nondiscrimination legislation has become one of the most critical issues for the insurance industry, because many of the bills question their ability to conduct any type of risk-based health underwriting. Most of the bills, including the Slaughter and Clinton Administration measures, would define "genetic information" to encompass an individual's medical history, thus potentially the entire medical record.

Cloning

Lastly, a major area of interest during 1997 for the U.S. Congress was legislation banning cloning. Several bills were introduced, most notably by Rep. Vern Ehlers (R-Mich.), and Senator Kit Bond (R-Mo), that would ban the use of federal funds to support cloning of human embryos. Ehlers introduced another bill to prohibit such cloning in both the public and private sectors, despite obvious constitutional questions regarding such bans on privately funded research.

The House Science Committee passed H.R. 922, amending the bill to clarify that the bill would not restrict other areas of scientific research, including the use of somatic cells to clone DNA, cells, tissues, or non-human animals. This bill was jointly referred to the House Judiciary and House Commerce committees, and further action must be taken by these committees before the bill can be taken up by the full House.

Hearings were held on cloning in a number of committees in the House and Senate following the Dolly announcement earlier in 1997.

In addition, the annual appropriations measure for the National Institute of Health, included language that prohibits the use of federal funds for embryo research, including certain research on "human diploid cells." House Republican leadership has expressed an interest in bringing a cloning bill to the House floor next year. Members are feeling pressure from national right-to-life groups, and are considering making cloning legislation a political issue during the 1998 congressional elections.

However, House leadership has indicated that passage of the Ehlers measure will be a priority in 1998, due to pressure in an election year from national right-to-life organizations.

Administration Report

In January 1998, Vice President Al Gore released an administration report, Genetic Information and the Workplace. As a result of the findings of the report, the vice president called for legislation that would prohibit employers from requesting or requiring genetic information for hiring, prevent on-the-job discrimination, and ensure that genetic information is not disclosed without the explicit permission of the employee.

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