98-874 STM Updated January 5, 1999 CRS Report for Congress Received through the CRS Web Women’s Health: Provisions of Selected Legislation, 1983-1998 Irene Stith-Coleman Joy Austin-Lane Science, Technology, and Medicine Division Summary For a number of years, Congress and several Administrations have been concerned about women’s health issues. More than 20 laws with provisions relating to women’s health were enacted between 1983 and 1998 and a number of federally supported women’s health programs have been created and/or expanded. This report, which may be updated, summarizes the major women’s health provisions of selected legislation enacted from 1983 through 1998 that relate to women’s health. The laws highlighted do not include appropriations acts. Introduction Improving women’s health was presented in 1997 as a top priority of the Department of Health and Human Services (HHS).1 HHS affirmed its commitment to a comprehensive, science-based approach to help address “longstanding inequities in women’s health.” Many of the actions identified by HHS to demonstrate the department’s commitment pertain to women’s health research. Examples include: increased funding of and major national projects for women’s health research; inclusion of women in clinical research trials; examination of gender differences in cause, treatment and prevention of disease; and helping to assure that women have access to senior positions in health and science careers. Congress has played a significant role in elevating the public’s awareness about women’s health issues and has passed laws to address many of these issues. In the last 15 years, more than 20 laws have been enacted that relate to women’s health. Table 1 provides a selected chronology of such legislation enacted from 1983 through 1998. Enacted provisions cover a wide group of activities that range from mandating that women and minorities be included in clinical research conducted or supported by the National Institutes of Health (NIH), to authorizing block grants for breast and cervical 1 [http://www.hhs.gov/news/press/1997pres/971025c.html], 31 October 1997. Congressional Research Service ˜ The Library of Congress CRS-2 cancer screening, to mandating an epidemiological study of adverse health effects on women Vietnam veterans resulting from exposure to chemicals or medications during service, to expanding research on the aging process in women. Responsibility for the administration of the women’s health provisions is shared by several federal departments and a number of federal agencies and institutes. Acronyms appearing in Table 1 include the following: ! ADAMHA - Alcohol, Drug Abuse and Mental Health Administration (now ! ! ! ! ! ! ! ! ! ! abolished) CDC - Centers for Disease Control and Prevention DOD - Department of Defense HHS - Department of Health and Human Services VA - Department of Veterans Affairs FDA - Food and Drug Administration HCFA - Health Care Financing Administration IHS - Indian Health Service IHS NIH - National Institutes of Health NCI - National Cancer Institute NICHD - National Institute of Child Health and Human Development NIMH - National Institute of Mental Health NIA - National Institute on Aging NIAAA - National Institute on Alcohol Abuse and Alcoholism NIDA - National Institute on Drug Abuse SAMHSA - Substance Abuse and Mental Health Services Administration USPS - United States Postal Service The table is organized to include the Public Law number, the date of enactment, the short title of the legislation, expiration date of authorization of appropriations (where present), the agency with principal responsibility for implemention of the provisions, and a brief description of the women’s health provisions, with an indication as to where in the law they are found. In cases where the original authorization of appropriations was extended, the extending Public Law number is included with the extended expiration date. In this report, “research” includes research and development.2 Examples of areas involving biomedical research and development (R&D) include: clinical trials; epidemiological or toxicological studies; prevention studies; trauma and shock R&D; R&D to assess how stress conditions affect human life processes; R&D on contraceptive devices; R&D on the biological, medical, and behavioral problems caused by environmental agents; and development of methods to predict effects of human exposure to environmental agents. 2 “Research encompasses both basic research (the gaining of fuller knowledge or understanding of the subject under study) as well as applied research (the practical application of such knowledge or understanding for the purpose of meeting a recognized need). Development is the systematic use of knowledge and understanding obtained from research and is aimed at the production of useful materials, devices, methods, or systems.” National Institutes of Health, Federal Health R&D Survey, FY1995-FY1997, Instructions for Reporting Obligations for Medical and Health-Related R&D. DATE ENACTED 11-21-83 10-19-84 10-30-84 4-7-86 12-19-89 8-10-90 7-10-92 10-13-92 PUBLIC LAW 98-160 98-509 98-558 99-272 101-239 101-354 102-321 102-409 DES Education and Research ADAMHA Reorganization Act Breast and Cervical Cancer Mortality Prevention Act of 1990 Omnibus Budget Reconciliation Act of 1989 Consolidated Omnibus Budget Reconciliation Act of 1986 Human Services Reauthorization Act Alcohol Abuse, Drug Abuse and Mental Health Amendments of 1984 Veterans’ Health Care Amendments of 1983 SHORT TITLE 9-30-96 9-30-94 9-30-93 Extended by PL 103-183 to 9-30-98 NAA NAA 9-30-87 9-30-87 Extended by PL 102-321 to 9-30-94 NAA (no appropriations authorized) EXPIRATION DATE* C C mandated block grants to states for breast and cervical cancer screening, referral and follow-up services, public information and education, training for health professionals, and assuring quality of screening (Sec. 2) required that grant services and activities be made available throughout states, including to Indian tribe members or tribal organization (Sec. 2) mandated an Associate Administrator for Women’s Services at SAMHSA and creation of an Advisory Committee for Women’s Services (Title I, Subtitle A) required a study on the extent to which women are represented among senior personnel at SAMHSA (Title I, Subtitle A) mandated an Associate Director for Special Populations at NIMH to manage policies and programs regarding women, minorities, and discrimination (Title I, Subtitle B) required HHS to contract a study on fetal alcohol syndrome (Title VII) C SAMHSA C NIH NIH CDC C C C C mandated programs for research, training and dissemination of expanded Medicare coverage to include pap smear screening for women who have not undergone one during the preceding three years or who are at higher risk of developing cervical cancer (Title VI, Subtitle B) C HCFA C mandated an epidemiologic study of any long-term adverse health effects on women veterans of Vietnam as a result of traumatic experiences or exposure to chemicals or medications during their service (Title XIX, Subtitle B) C VA NIH authorized appropriations for a research center at the University of Utah and a cancer screening and research clinic in St. George, Utah to study the effects of nuclear testing, especially its effects on reproduction (Title V) authorized alcohol and drug abuse block grants from ADAMHA (now SAMHSA), NIDA and NIAAA for programs to prevent and treat substance abuse among women (Title I, II) mandated a study of Post Traumatic Stress Disorder in Vietnam veterans, especially in women and those with service-related disabilities (Title I) established an advisory committee on women veterans (Title III) WOMEN’S HEALTH PROVISION(S) C SAMHSA C NIH VA AGENCY Table 1. Selected Legislation, 1983 through 1998 CRS-3 DATE ENACTED 10-24-92 10-27-92 10-27-92 10-29-92 11-4-92 6-10-93 PUBLIC LAW 102-515 102-531 102-539 102-573 102-585 103-43 NIH Revitalization Amendments of 1993 Women Veterans’ Health Programs of 1992, Title I of Veterans’ Health Care Act Indian Health Amendments of 1992 Mammography Quality Standards Act of 1992 Preventive Health Amendments of 1992 Cancer Registries Amendment Act (1992) Amendments of 1992 SHORT TITLE 9-30-96 9-30-95 9-30-00 9-30-97 9-30-97 9-30-97 EXPIRATION DATE* NIH VA IHS FDA CDC CDC AGENCY CRS-4 authorized block grants for screening, treatment, counseling, and referral programs that address sexually transmitted diseases that cause infertility in women and improvement in the delivery of these services to women (Title III) mandated that mammography facilities be certified, meet standards of safety and quality, and submit to inspections (Sec. 2) mandated evaluation of certification program (Sec. 3) authorized grants to tribes for alcohol and substance abuse prevention and treatment for Indian women (Title VII) mandated that mammography screening be offered to Indian women 35 years of age and older (Title II) established an Office of Indian Women’s Health Care (Title II) expanded funding for women veterans’ health care to include PAP smear screening, breast exams, mammography, reproductive health care and menopause-related care (Title I) provided counseling for women who are traumatized or discriminated against while on active duty (Title I) mandated that each regional office have a coordinator for women’s services to increase access to care and foster initiation and expansion of research on women’s health (Title I) mandated that women and minorities be included as subjects in clinical research conducted or supported by the agency (Titles I, XVIII, XIX) codified the establishment of the Office of Research on Women’s Health (Title I) mandated that the Secretary, acting through the Director of NIH and Directors of the agencies of NIH, provide for an increase in the number of women and individuals from disadvantaged backgrounds (including racial and ethnic minorities) in the fields of biomedical and behavioral research (Title II) directed the Secretary of HHS to provide National Research Service Awards in a manner that will result in recruitment of women and individuals from disadvantaged backgrounds (including racial and ethnic minorities) into fields of biomedical or behavioral research and in the provision of research training to women and such individuals (Title XVI) C C C C C C C C C C C C C mandated establishment and operation of state cancer registries and research on elevated breast cancer rates in certain states (Sec. 3) C C information on diethylstilbestrol (DES) and a longitudinal study of certain diseases and problems resulting from DES (Sec. 2) mandated education of health professionals and public (Sec. 2) WOMEN’S HEALTH PROVISION(S) DATE ENACTED 11-30-93 12-14-93 11-2-94 10-9-96 8-5-97 PUBLIC LAW 103-160 103-183 103-446 104-262 105-33 Balanced Budget Act of 1997 Veterans’ Health Care Eligibility Reform Act of 1996 Veterans’ Benefits Improvements Act of 1994 Preventive Health Amendments of 1993 National Defense Authorization Act for Fiscal Year 1994 SHORT TITLE NAA NAA NAA 9-30-98 9-30-94 EXPIRATION DATE* HCFA VA VA CDC DOD AGENCY CRS-5 established a Defense Women’s Health Research Center at an existing DOD medical center to serve as the coordinating agent for DOD research on women’s health issues related to service in the armed forces provided for the inclusion of women and minorities in DOD clinical research projects mandated an evaluation of the provision of primary and preventive health care services to women through military medical facilities and CHAMPUS expanded breast and cervical cancer preventive health and research grants (Title I) revised breast and cervical cancer screening quality assurance requirements (Title I) allowed breast and cervical cancer grants to be made to tribes and tribal organizations directly (Title I) established a committee to coordinate federal agency activities regarding established objectives for reductions in breast and cervical cancer in the United States by the year 2000 (Title I) extended the program regarding preventable cases of infertility arising as a result of sexually transmitted diseases (Title IV) mandated a system for comprehensive medical evaluation of Gulf War veterans with special attention to complaints involving the reproductive system (Title I) established a Center for Women Veterans (Title V) mandated compliance with the Public Health Service Act requirements for mammography facilities and quality assurance in the performance and interpretation of mammograms (Title III, B) directed that women veterans’ access to health care be evaluated (Title III, B) expanded Medicare coverage to include annual mammograms for women C C C C C C C C C C C C C C C C C directed NIA to study the aging processes of women, with particular emphasis on menopause, the loss of ovarian hormones and associated physiological and behavioral changes (Title VIII) directed NICHD to make grants or contracts for contraception and infertility research centers (Title X) directed NICHD to establish and maintain an intramural laboratory and clinical research program in obstetrics and gynecology (Title X) directed NCI to expand activities on breast and ovarian cancer and other cancers of the reproductive system (Title IV) mandated an expansion of activities on osteoporosis, Paget’s Disease and bone disorder research and the establishment of an information clearinghouse (Title III) C WOMEN’S HEALTH PROVISION(S) 8-13-97 11-21-97 11-21-97 4-21-98 10-9-98 10-31-98 105-41 105-114 105-115 105-168 105-248 105-340 Women’s Health Research and Prevention Amendments of 1998 Mammography Quality Standards Reauthorization Act of 1998 Birth Defects Prevention Act of 1998 Food and Drug Administration Modernization Act of 1997 Veterans’ Benefits Act of 1997 Stamp Out Breast Cancer Act SHORT TITLE 9-30-03 9-30-02 9-30-02 NAA NAA NAA EXPIRATION DATE* CDC NIH FDA CDC FDA VA USPS AGENCY directed that a national policy be developed for mammography standards and frequency of screening for women veterans over 39 years old or who have inherent breast cancer risk factors (Title II) directed that guidelines be developed for the inclusion of women and minorities in clinical trials (Title I, B) mandated that states carry out surveillance, research and prevention programs for birth defects (Sec. 2) authorized appropriations to carry out certification of mammography facilities requirements required that standards for accreditation bodies mandate review of clinical images by qualified review physicians and prohibit review by those who have relationship with facility under review that would constitute conflict of interest extended authorizations of appropriations for: research on osteoporosis, Paget’s disease, and related bone disorders; breast cancer programs, and programs on ovarian and other cancers of women reproductive systems mandated expansion, intensification and coordination of research and related activities of the NHLBI involving heart attack, stroke, and other cardiovascular diseases in women extended authorization of appropriations for the National Cancer Registries required that certain breast and cervical cancer programs be performed by public or private entities extended authorization of appropriations for various breast and cervical cancer preventive measures extended authorization of community projects to coordinate intervention and prevention of domestic violence C C C C C C C C C C C C allowed contributions during a 2 year period to breast cancer research at the NIH and DOD through postage stamp purchase (Sec. 2) C over age 39 and triennial (annual for those at high risk for cervical or vaginal cancer) pap smears and pelvic exams for any woman (Title IV, B) WOMEN’S HEALTH PROVISION(S) 105-392 11-13-98 Health Professions Education Partnership Act of 1998 9-30-03 HHS directed Secretary to establish a Fetal Alcohol Syndrome Prevention, Intervention and Services Delivery Program that shall include a program to develop prevention services and interventions for pregnant * Expiration date of authorization of appropriations. Where there is no date entry, NAA indicates that no appropriations are specifically authorized. DATE ENACTED PUBLIC LAW CRS-6