should not consider itself compelled to come up with the single best approach to a patient problem or condition, if consensus cannot be reached on a single approach but there is agreement that care can be improved through the use of a set of guidelines. In such circumstances, the Forum can provide for alternative approaches, with appropriate commentary on which ones appear to be preferable under various circumstances. The Forum is to assist in the dissemination of guidelines, standards, measures, and criteria. Dissemination would primarily be the responsibility of organizations representing providers or consumers of health care, peer review organizations, and other entities. The Forum will evaluate the effect of its products on clinical practice and provide feedback to the Agency on research needed to carry out its purpose. The committee notes that the term "physician" used in this subtitle is intended to encompass a range of health care practitioners, including, in many cases, all those practitioners who are qualified to participate in the Medicare program. It is especially important that the process of developing guidelines under the Forum include the practitioners for whom the particular guidelines will be pertinent. PART B-OUTCOMES OF HEALTH CARE SERVICES AND PROCEDURES Sec. 4111-Establishment of Program of Research This section amends the Social Security Act to establish a program of Research on Outcomes of Health Care Services and Procedures. Under current law, section 1875 of the Social Security Act provides for the transfer of $10 million from the Medicare trust funds to the National Center for Health Services Research for outcomes studies. The committee bill establishes a similar, but greatly expanded, program. Because the National Center for Health Services Research is eliminated and replaced by the new Agency for Health Care Research and Policy, the bill requires the Secretary to conduct and support such research through that new Agency. Although the research program is to be conducted through the Agency, these provisions in the Social Security Act are the ones that establish the processes for setting priorities for outcomes research and for improving such research. The program allows the Administrator to conduct preliminary assessments to select the services and procedures that are to be given highest priority in outcomes research. In particular, it would be appropriate for the outcomes research to focus on services and procedures that vary in utilization rates, have uncertain effects, or are inappropriately used. For that reason, the Administrator could conduct preliminary assessments to identify the services and procedures that demonstrate those characteristics. The bill identifies four factors to be considered when the Administrator is establishing priorities for outcomes research. While these factors are always to be considered, it is not the committee's intent that all four factors necessarily be fully satisfied before an area is identified as appropriate for research. For example, research on the outcomes of primary care might well be considered a high priority, even though the data necessary for such evaluations are not readily available or readily developed, if the other three factors weigh heavily. To carry out the program of outcomes research, the bill authorizes appropriations of $8.3 million in fiscal year 1990, $12.5 million in fiscal year 1991, and $16.7 million in fiscal year 1992, and in addition authorizes transfers of $16.7 million in fiscal year 1990, $25 million in fiscal year 1991, and $33.3 million in fiscal year 1992 from the Federal Supplementary Medical Insurance (Medicare Part B) Trust Fund. PART C-ADDITIONAL AUTHORITIES AND DUTIES WITH RESPECT TO Sec. 4121-Advisory Council, Peer Review, Administrative Authorities, and other General Provisions This section adds further provisions to the new Title IX of the Public Health Service Act created by section 4101. The bill establishes a public-private council known as the National Advisory Council for Health Care Research, Evaluation, and Policy to advise the Agency. The Council is to advise the Secretary and the Administrator with respect to the carrying out the broad mandate of the Agency. Among its activities, the Council is to make recommendations regarding priorities for a national agenda for research, for the program of clinical practice guidelines, and for the development of technology assessments. The Council is to consist of both Federal and private individuals. The majority are to be distinguished researchers in related fields of health policy and practice. These researchers can and should include physicians, particularly physicians involved in primary care and clinical practice research. Other members of the Council would include distinguished medical practitioners, other distinguished professionals, and consumer representatives. Among the distinguished professionals are to be persons from the fields of business, law, ethics, economics, and public policy. Business representatives would appropriately include individuals from, for example, the health insurance industry, and the manufacturers of medical care products. As under current law, the bill requires scientific peer review of all grants and contracts. The committee notes that it has received numerous examples of areas in which the current peer review system could be improved. In particular, a number of researchers have commented that the peer review process does not assure that reviewers of particular proposals will actually be researchers with appropriate training and interests-i.e., peers. The committee expects the Agency to establish study sections with a composition and organization that will assure appropriate review by persons with experience and training directly relevant to the proposed research or other activities. In addition, for proposals of less than $50,000, an exception is made to the general requirement of peer review. The Administrator is permitted to establish a separate, and less burdensome, review process for such proposals. One purpose of doing so is to remove barriers for new researchers entering the field. This process should encourage new and future researchers, including those from institutions with future promise but limited track record, as well as those from clinical-practice situations rather than researchbased institutions. To carry out the activities other than research on the outcomes of heath care, the committee bill authorizes appropriations of $35 million for fiscal year 1990, $50 million for fiscal year 1991 and $70 million for fiscal year 1992, and sets aside 40 percent of departmental evaluation funds for use by the Agency (estimated at approximately $30 million for fiscal year 1990). PART D-GENERAL PROVISIONS Secs. 4131 through 4135 The committee bill also contains a variety of other provisions to implement the new agency authority and transfer functions and resources from existing agencies. It repeals the National Center for Health Services Research and Health Care Technology Assessment and the Council on Health Care Technology, but provides for a 1 year contract with the Institute of Medicine to complete current projects being undertaken by the Council and to facilitate a transition to the new Agency. It also makes other technical and conforming changes, including continuation of the National Center for Health Statistics. SUBTITLE C-MEDICAID PART A-INFANT MORTALITY PROVISIONS The United States ranks 19th among industrialized nations in infant mortality, behind Japan, Canada, Hong Kong, Singapore, and 14 other countries. About 40,000 American infants die each year before their first birthdays. A black infant in this country is twice as likely as a white child to die before the age of 1 year. In August, 1988, the bipartisan National Commission to Prevent Infant Mortality issued a report, Death Before Life: The Tragedy of Infant Mortality. The Commission called for universal access to early maternity and pediatric care for all mothers and infants. One element of the Commission's action plan for assuring universal access was upgrading coverage under Medicaid, the Federal-State entitlement for the poor. Another element was improving the Title V Maternal and Child Health Block Grant program. As contemplated by the fiscal year 1990 Budget Resolution, the committee bill revises both the Medicaid and MCH programs to target Federal resources more effectively on low-income pregnant women and infants in order to improve birth outcomes. Sec. 4201-Phased-in Mandatory Coverage of Pregnant Women and Infants up to 185 Percent of Poverty Level (a) Phased-in Mandatory Coverage. Under current law, States are required to offer Medicaid coverage to pregnant women and infants up to age 1 with incomes below 75 percent of the Federal poverty level. Effective July 1, 1990, States must extend coverage to all pregnant_women and infants with incomes below 100 percent of poverty. States have the option of extending Medicaid coverage to all pregnant women and infants with incomes up to 185 percent of the poverty level. In each case, the coverage determination is based on income, not on whether the woman or infant is receiving cash assistance, or whether the family unit has one parent or two, or whether the principal earner is unemployed. States also have the option of applying a resource test in determining eligibility for these individuals. Coverage for pregnant women is limited to services related to pregnancy (including prenatal, delivery, postpartum, and family planning services) and to other conditions which may complicate the pregnancy. Coverage for infants includes all the services the State offers to an individual receiving cash assistance under the Aid to Families with Dependent Children (AFDC) program. Over the past few years, a number of States have made substantial progress in improving Medicaid coverage for pregnant women and infants. The National Governors' Association reports that, as of July, 1989, 44 States (including D.C.) extended coverage to all pregnant women and infants with incomes at or below 100 percent of the Federal poverty level; 14 States offered coverage to those with incomes at or below 185 percent of poverty; and an additional 6 States offered coverage to those with incomes above 100 and below 185 percent of poverty. (See Table 1). While these expansions are important, they are not, in the view of the committee, sufficient to assure financial access to prenatal care for all poor and near-poor women and infants in this country. Table 1.-MEDICAID COVERAGE OF PREGNANT WOMEN, INFANTS AND CHILDREN, JULY 1989 Table 1.-MEDICAID COVERAGE OF PREGNANT WOMEN, INFANTS AND CHILDREN, JULY 1989— 1 Effective January 1, 1990, in New York; October 1, 1989, in South Carolina; September 1, 1989 in Texas. Source: National Governors' Association. In its August, 1988, report, the National Commission to Prevent Infant Mortality concluded that universal access to early maternity and infant care was an essential element of a national effort to reduce infant mortality. "The first step toward guaranteeing pregnant women and infants the care they need," the Commission found, "is assuring access to maternity and infant care. The primary responsibility for achieving this goal rests with the private sector and employers who help provide the vast majority of health care in this country. But the government must assure more responsibility for those who lack private insurance or are unable to pay. With respect to the government's responsibility, the Commission recommended that Medicaid be expanded to cover all pregnant women and infants with family incomes at or below 200 percent of the Federal poverty level. Death Before Life: The Tragedy of Infant Mortality at pp. 17-18. The committee concurs. We as a Nation must invest in prenatal and maternity care services for poor and near-poor women and infants. It is obvious from data presented by the Commission and by other witnesses before the Subcommittee on Health and the Environment, that private insurance coverage of low-income women and children is limited and cannot realistically be expected to fill the coverage gap. A sensible response at this point is to require of the States what is now optional: extend Medicaid coverage of pregnant women and infants up to age 1 with incomes at or below 185 percent of the Federal poverty level ($18,611 for a family of 3 in 1989). |