had experience with elements of the regional medical concept, and these applicants could expand their existing operating activities with minimal delay and without the need for extensive prior planning activities financed through these funds. Such applicants could also receive planning grants to finance the planning of additional expansion of operating activities or of feasibility studies.

For 1967, the request is for an increase of $19 million over the grant funds available in fiscal year 1966. The increase requested is based on the following factors:

1. The award of planning grants (including, in some cases, feasibility studies) to other regional groups that were not prepared to submit applications in 1966; 2. The amendment of planning grants awarded in 1966 to include feasibility studies or additional planning activities the need for which has been developed out of the original planning activity;

3. The submission of applications for pilot projects based on plans developed through planning grants awarded in 1966;

4. Increased costs, an especially important factor in this program since a basic objective is the rapid utilization of new methods and new technology, usually involving increased sophistication of equipment.

The major cost increase factor will be the support of new pilot projects or additional phases of pilot projects. Because of the many program elements that can be included in even the initial phase of a regional medical program, adequate support of a pilot project will involve a substantial grant. One cost estimate used in justification of the legislation amounted to an annual cost of over $4 million for a regional medical program. A less comprehensive beginning phase would still involve considerable sums. The increase requested for grants, there fore, is essential if orderly development of this new program is to include sufficient experience from a limited number of pilot projects. This experience will be necessary as the basis for evaluation of the program and the development of future program recommendations as required in the authorizing statute. The requested expansion is essential if the early years of this program are to serve the exploratory purpose which was the clear intent of the Congress in this initial authorization period.

These funds will be used for an expansion of the program development and technical assistance activities which will provide help to the regional groups who are involved in planning and implementing regional medical programs. This function will require extensive activities in the field in order to provide the necessary close contact with these regional groups and will provide a wide variety of consultative expertise which will help to assure the development of sound plans and programs at the regional level. The staff involved in this function will also be able to provide information to a regional group concerning similar efforts by other regional groups being undertaken in the initial phases of the program. This interchange of information will enable each regional group to benefit from the experiences and innovative solutions to problems being developed in many areas of the country.

The workload of this activity will undergo a considerable increase because of the increase in grants for operational pilot projects. To cope with this increased workload, an increase of 15 positions and $298,000 is requested, of which $170,000 is for annualization of positions new in 1966 and $11,000 is for the annualization of the general schedule pay increase.

The requested increase of $358,000 consists of $206,000 for annualization of positions new in 1966, $12,000 for annualization of the general schedule pay increase, and 18 positions and $140,000 to support increased activities in the program review and grants management branches. An increased activity level in the program review functions will be required to evaluate and process the larger number of grant applications and to prepare these grant applications for advisory council review. It is expected that in 1967 a higher proportion of the grant applications will be concerned with the establishment of pilot projects. The program review functions will then become considerably more complex and will require increased staff to deal with the larger workload. The grants management function will also need to be expanded to deal with the many difficult financial, legal, and management aspects of the regional medical programs.

The overall program leadership and administrative capability provided by the Office of the Chief will have to be expanded in 1967 to cope with the overall program expansion and the increased challenges to effective program direction and administration arising from the increased operational activities under regional medical programs. Many policy and administrative complexities requiring the attention of the top program leadership will be developed out of the plans being formulated throughout the Nation under planning grants awarded in 1966. Solution of these policy issues will place heavy demands on program leadership and will require expansion of supporting staff. Overall program expansion will also require increases in the administrative and coordinating functions located in the Office of the Chief.

The activities of the Planning and Evaluation Branch will have to be augmented to deal with the provision of the act that requires the submission of a report to the President and the Congress evaluating progress under the program and making recommendations for modifications and extension of the program. It is expected that some of the studies relating to the evaluation of the program and development of future plans will be conducted through contracts to competent professional organizations and academic institutions.

To provide the necessary expansion in the Office of the Chief and the Planning and Evaluation Branch, an increase of 17 positions and $368,000 is requested. Included in the net increase requested are $200,000 for annualization of positions new in 1966, $12,000 for annualization of the general schedule pay increase and $25,000 for centrally furnished services from the NIH management fund.

BACKGROUND AND OBJECTIVE OF PROGRAMS

Senator HILL. The subcommittee will kindly come to order. Now, Dr. Marston, we will be glad to have you proceed, any way you see fit, with reference to the regional medical programs.

Dr. MARSTON. Mr. Chairman, before going into my discussion of the regional medical programs, I would like to emphasize that this program is directly and intimately related to the testimony that you heard Jast week from the other institutes and divisions of NIH. The regional medical program has grown out of and is dependent upon. and will build upon, the scientific advances made possible through the existing programs at NIH.

This is my first opportunity to appear before you on behalf of the regional medical programs for heart disease, cancer, and stroke, which were authorized by Public Law 89-239 in the last session of Congress. Because this is the first full-scale presentation before this subcommittee on the regional medical programs, I will discuss briefly in this statement the background and objectives of the program. I will then bring you up to date concerning the status of administrative imple

mentation.

PROGRAM OBJECTIVES

The principal purpose of this important new program is to provide the medical profession and the medical institutions of the Nation greater opportunity to make available to their patients the latest ad

vances in the diagnosis and treatment of heart disease, cancer, stroke, and related diseases.

This overall objective is to be accomplished through the planning and establishment of regional cooperative arrangements among medical institutions, which can serve as the framework for linking programs of research, training, continuing education, and demonstration activities in patient care conducted by medical schools, clinical research institutions, and hospitals.

The regional cooperative arrangements are intended to assure close contact between the development of a new medical knowledge and technique in the environment of research and teaching, and the delivery of high-quality patient care in the hospital environment.

BACKGROUND

This program encompasses the major thrust of the first three recommendations of the President's Commission on Heart Disease, Cancer, and Stroke. This Commission was established by the President in 1964 "to recommend steps to reduce the incidence of these diseases through new knowledge and more complete utilization of the medical knowledge we already have.'

With this mandate from the President, the Commission heard testimony from scores of leaders in medicine and public affairs and reached the conclusion that something could, and must, be done to reduce the deaths and disability caused by heart disease, cancer, and stroke.

The testimony of these experts indicated that the toll of these diseases could be reduced significantly if the latest medical advances already developed or developed in the future through extended research opportunities could be made more widely available to our cit

izens.

They believed that there was danger of an increasing gap between the diagnostic and therapeutic capabilities found in the major medical centers where an effective interplay between research teaching and patient care can bring rapid and effective application of new medical knowledge and the medical capabilities available more widely in the hospitals of the Nation.

The Commission recognized that the complexities of modern techniques in the fields of heart disease, cancer, and stroke make more difficult the task of making these techniques available to more disease victims. Believing that medical resources of this Nation were equal to this challenge if given the necessary assistance and encouragement, the Commission presented a series of recommendations aimed at reducing the toll of these diseases through the development of more effective means of bringing the latest medical advances to the benefit of more people and through the provision of additional opportunities for research and training.

I would like to point out that the needs which were stressed by the President's Commission are, in fact, a statement of the great opportunities that exist for the improvement of the health of the American people. This committee deserves a full measure of the credit for the development of these opportunities.

The opportunity for further progress has been created by the great medical research effort, the provision of modern medical faci!!!

nd

the development of increased training opportunities for medical personnel. This new program is in the continuum of existing trends-the dynamic impact of scientific research, the high degree of complexity and specialization in the resulting new diagnosis and treatment techniques, and of the challenges of effective communication among all elements of our medical endeavor.

MAJOR PROVISIONS OF THE LEGISLATION

The legislation, which was passed by the Congress to carry out the objectives I have discussed, provides an excellent mechanism for moving ahead in a realistic way with implementation of the program. The legislation emphasizes the importance of local initiative and determination within a broad legislative framework that provides flexibility for innovation and adaptation which are particularly pertinent to regional needs, resources, and existing medical patterns.

The law provides that as a first step in setting up the relationships among medical schools, clinical research institutions, and hospitals, a local advisory group must be designated by the applicant to advise the applicant and the participating institutions in the planning and operation of a regional medical program. The law provides that this advisory group will be broadly representative of the interested health organizations, institutions, and agencies in the region, as well as of the general public interested in the purposes of the program.

Grants can be awarded for (1) planning of a regional medical program, and (2) the operation of pilot projects for the establishment of a regional medical program. The provision for planning grants assures that initiative and creative ideas within the region can be translated into an effective plan of action for the development of a regional medical program, supported by adequate data and the cooperative involvement of the relevant institutions and agencies. The pilot projects for the establishment and operation of a regional medical program will provide the basis for evaluation of the program concept and suggested modifications beyond the initial period of authorization.

The law provides for the appointment of a National Advisory Council on Regional Medical Programs which will provide the benefit of the advice and consultation of outstanding leaders in medicine and public affairs on the operation and development of the overall program. The Council will also review specific grant applications and make recommendations for approval or disapproval to the Surgeon General.

The law specifically provides that regional medical programs will not interfere with the patterns or the methods of financing of patient care or professional practice, or with the administration of hospitals. It is quite evident that the intent of the law is to build upon and improve the already great medical capability of our institutions and medical personnel.

CURRENT STATUS OF ADMINISTRATIVE IMPLEMENTATION

Many steps have already been taken to assure the early and effective implementation of the program set forth in the legislation. A Division of Regional Medical Programs has been established within the