89th Congress, Ist Session - - - - - House Report No. 963 HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 REPORT OF THE COMMITTEE ON INTERSTATE AND. FOREIGN COMMERCE ON H.R. 3140 SEPTEMBER 8, 1965.—Committed to the Committee of the Whole House on the State of the Union and ordered to be printed U.S. GOVERNMENT PRINTING OFFICE 83-111 0 WASHINGTON : 1965 CONTENTS Purpose of the bill...-----------------07007 7777 Nature of the proposed program... .-------------77777 777777777 Background....-.----------------- 900 Committee amendments_.------------------7-7777 077777777 Regional medica! programs- - ---—-~-7- 4-522 oo TTT Heart disease, cancer, stroke, and related diseases. ---------------- Cooperative activities. -----------------0 00777777777 Three-year program. ..---------2------770 77 - Pilot projects and feasibility studies..---------------"--7-0 707 Vraining------------------c--7 sca Financing of patient care; referral of patients... ----------------"- Composition of advisory committees. ----------------207 000077 Approval by advisor committees. ..---------------0 00 National Advisory Council...----------------7 7777777777777 Clinical research centers-.------------------777 7777777777077 Diagnostic and treatment stations. _.-----------------077 77777777 Information relating to facilities. _----------------7777 77777777 Relationship to existing Federal health programs- ----------------77777 Emphasis upon planning -- -------------77 "537 Go yanizations-._------ Participation of community physicians and health organizations-.------- Continuing education—Existing programs..-------------7 5577777777777 Continuing education—Future need... ----------n Effect on supply of physicians -..---------22----77 77777777 Effect on nonparticipating schools and hospitals Section-by-section description of committee substitute... --------------- ‘Agency reports...-------------------0 7 Changes in existing law------.-------;-G~--"7 7350 on Heart Disease, Appendix A. Membership of President’s Commission on Heart Disease, ancer, and Stroke------------------77 7 89ru Concress }) HOUSE OF REPRESENTATIVES Rerort Ist Session No. 963 HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 Sepremper 8, 1965.—Committed to the Committee of the Whole House on the State of the Union and ordered to be printed ce Mr. Harris, from the Committee on Interstate and Foreign Commerce, submitted the following REPORT {To accompany H.R. 3140] - The Committee on Interstate and Foreign Commerce, to whom was referred the bill (H.R. 3140) to amend the Public Health Service Act to assist in combating heart disease, cancer, stroke, and other major diseases, havin considered the same, report favorably thereon with amendments and recommend that the bill as amended do pass. The amendments are as follows: a Strike out all after the enacting clause and insert the following: That this Act may be cited as the “Heart Disease, Cancer, and Stroke Amend- ments of 1965”. Sec. 2. The Public Health Service Act (42 U.S.C., ch. 6A) is amended by adding at the end thereof the following new title: “T]TLE IX—EDUCATION, RESEARCH, TRAINING, AND DEMON- STRATIONS IN THE FIELDS OF HEART DISEASE, CANCER, STROKE, AND RELATED DISEASES “pURPOSES “Sec. 900. The purposes of this title are— “(a) Through grants, to encourage and assist in the establishment of regional cooperative arrangements among medical schools, research institutions, and hospitals for research and training (including continuing education) and for related demonstrations of patient care in the ficlds of heart disease, cancer, stroke, and related diseases; “(b) To afford to the medical profession and the medical institutions of the Nation, through such cooperative arrangements, the opportunity of making available to their patients the latest advances in the diagnosis and treatment of these diseases; and “(c) By these means, to improve generally the health manpowcr and facilities available to the Nation, and to accomplish these ends without interfering with the patterns or the methods of financing, of patient care or professional practice, or with the administration of hospitals, and in cooperation with practicing physicians, 1 2 HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1 965 medical center officials, hospital administrators, and representatives from appro- priate voluntary health agencies. “AUTHORIZATION OF APPROPRIATIONS “Sec, 901. (a) There are authorized to be appropriated $50,000,000 for the fiseal year ending June 30, 1966, $90,000,000 for the fiscal yeac ending June 30, 1967, and $200,000,000 for the fiscal year ending June 30, 1968, for grants to assist public or nonprofit private universities, medical schools, research institutions, and other public or nonprofit private institutions and agencies in planning, in conduct- ing feasibility studies, and in operating pilot projects for the establishment, of regional medical programs of research, training, and demonstration activities for carrying out the purposes of this title. Sums appro riated under this section for any fiscal year shall remain available for making suc grants until the end of the fiscal year following the fiscal year for which the appropriation is mace. “(p) A grant under this title shall be for part or all of the cost of the planning or other activities with respect to which the application is made, except that any such grant with respect to construction of, or provision of built-in (as determined in accordance with regulations) equipment for, any facility may not exceed 90 per centum of the cost of such construction or equipment. “(c) Funds appropriated pursuant to this title shall not be available to pay the cost of hospital, medical, or other care of patients except to the extent it is, as determined in accordance with regulations, incident to those research, training, or demonstration activities which are encompassed by the purposes of this title. No patient shall be furnished hospital, medical, or other care at any facility incident to research, training, or demonstration activities carried out with funds appropriated pursuant to this title, unless he has been referred to such facility by a practicing physician. . . “DEFINITIONS “Sec, 902. For the purposes of this title— “(a) The term ‘regional medical program’ means a cooperative arrangement among a group of public or nonprofit private institutions or agencies engaged in research, training, diagnosis, and treatment relating to heart disease, cancer, Or stroke, and, at the option of the applicant, related disease or diseases; but only if such group— “(1) is situated within a geographic area, composed of any part or parts of any one or more States, which the Surgeon General determines, in accord- a with regulations, to be appropriate for carrying out the purposes of this title; (2) consists of one or more medical centers, one or more clinical research centers, and one or more hospitals; and “(3) has in effect cooperative arrangements among its component units which the Surgeon General finds will be adequate for effectively carrying out the purposes of this title. “(p) The term ‘medical center’ means a medical school and one or more hospitals affiliated therewith for teaching, research, and demonstration purposes. “"(e) The term ‘clinical research center’ means an institution (or part of an institution) the primary function of which is research, training of specialists, and demonstrations and which, in connection therewith, provides specialized, high- quality diagnostic and treatment services for inpatients and outpatients. “(dy The term ‘hospital’ means a hospital as defined in section 625(c) or other health facility in which local capability for diagnosis and treatment is supported and augmented by the program established under this title. . “(c) The term ‘nonprofit’ as applied to any institution or agency means an institution or agency which is owned and operated by one or more nonprofit corporations or associations no part of the net earnings of which inures, or may lawfully inure, to the benefit of any private shareholder or individual. . “() The term ‘construction’ includes alteration, major repair (to the extent permitted by regulations), remodeling and renovation of existing buildings (in- eluding initial equipment thereof), and replacement of obsolete, built-in (as determined in accordance with regulations) equipment of existing buildings. “GRANTS FOR PLANNING “Sec, 903. (a) The Surgeon General, upon the recommendation of the National Advisory Council on Regional Medical Programs established by section 905 (hereafter in this title referred to as the ‘Council’), is authorized to make grants HEART DISEASE, CANCER, AND STROKE AMENDMENTSOF 1965 93 to public or nonprofit private universities, medical schools, research institutions, and other public or nonprofit private agencies and institutions to assist them in planning the development of regional medical programs. “(b) Grants under this section may be made only upon application therefor a pov by the Surgeon General. Any such application may be approved only if it contains or is supported by— “(4) reasonable assurances that Federal funds paid pursuant to any such grant will be used only for the purposes for which paid and in accordance with the applicable provisions of this title and the regulations thereunder; (2) reasonable assurances that the applicant will provide for such fiscal control and fund accounting procedures as are required by the Surgeon er phan to assure proper disbursement of and accounting for such Federal ‘unds; “(3) reasonable assurances that the applicant will make such reports, in such form and containing such information as the Surgeon General may from time to time reasonably require, and will keep such records and afford such - gecess thereto as the Surgeon General may find necessary to assure the correctness and verification of such reports; and “(4) a satisfactory showing that the applicant has designated an advisory group, to advise the applicant (and the institutions and agen cies participating in the resulting regional medical program) in formulating and carrying out the plan for the establishment and operation of such regional medical pro- gram, which advisory group includes practicing physicians, medical center officials, hospital administrators, representatives from appropriate medical societies, voluntary health agencies, and representatives of other organiza- tions, institutions, and agencies concerned with activities of the kind to be carried on under the program and members of the public familiar with the need for the services provided under the program. “GRANTS FOR ESTABLISHMENT AND OPERATION OF REGIONAL MEDICAL PROGRAMS “Sec, 904. (a) The Surgeon General, upon the recommendation of the Council, is authorized to make grants to pubtic or nonprofit private universities, medical schools, research institutions, and other public or nonprofit private a: encies and institutions to assist in establishment an operation of regional medical programs, ineluding construction and equipment of facilities in connection therewith. “(b) Grants under this section may be made only upon ap lication therefor approved by the Surgeon General. Any such application may be approved only if if is recommended b the advisory group described in section 903(b) (4) and contains or is support by reasonable assurances that— “(1) Federal funds paid pursuant to any such grant (A) will be used only for the purposes for which paid and in accordance with the a plicable pro- visions of this title and the regulations thereunder, and (B) will not supp ant funds that are otherwise available for establishment or operation of the regional medical program with respect to which the grant is made; “(2) the applicant will provide for such fiscal control and fund accounting rocedures as are required by the Surgeon General to assure proper dis- ursement of and accounting for such Federal funds; “(3) the applicant will make such reports, in such form and containing such information as the Surgeon General may from time to time reasonably require, and will keep such records and afford such access thereto as the Surgeon General may find necessary to assure the correctness and verifica- tion of such reports; and (4) any laborer or mechanic employed by any contractor or subcontractor in the performance of work on any construction aided by payments pursuant to any grant unde~ this section will be paid wages at rates not less than those prevailing on simik.r construction in the locality as determined by the Secre- tary of Labor in acuordance with the Davis-Bacon Act, as amended (40 U.S.C. 276a—276a-5) ; ana the Secretary of Labor shall have, with respect to the labor standards specified in this aragraph, the authority and func- tions set forth in Reorganization Plan Numbered 14 of 1950 (15 F.R. 3176; 5 U.S.C. 1332-15) and section 2 of the Act of June 13, 1934, as amended (40 U.S.C. 276c). 4 HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 “NATIONAL ADVISORY COUNCIL ON REGIONAL MEDICAL PROGRAMS “Szc. 905. (a) The Surgeon General, with the approval of the Secretary, may appoint, without regard to the civil service laws, a National Advisory Council on - egional Medical Programs. The Council shall consist of the Surgeon General, who shall be the chairman, and twelve members, not otherwise in the regular full-time employ of the United States, who are leaders in the fields of the funda- mental sciences, the medical sciences, or public affairs. At least two of the appointed members shall be practicing physicians, one shall be outstanding in the study, diagnosis, or treatment of heart disease, one shall be outstanding in the study, diagnosis, or treatment of cancer, and one shall be outstanding in the study. diagnosis, or treatment of stroke.” “ 5 Each appointed member of the Council shall hold office for a term of four at any member appointed to fill a vacancy prior to the expiration of the term for which his predecessor was appointed shall be appointed for the remainder of such term, and except that the terms of office of the members first taking office shall expire, as designated by the Surgeon General at the time of appointment, four at the end of the first year, four at the end of the second year, and four at the end of the third year after the date of appointment. An appointed member shall not be eligible to serve continuously for more than two terms. “(c) Appointed members of the Council, while attending meetings or confer- ences théreof or otherwise serving on business of the Council, shall be entitled to receive compensation at rates fixed by the Secretary, but not exceeding $100 per day, including traveltime, and while so serving away from their homes or regular places of business they may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5 of the Administrative Expenses Act of ari (6 U.S.C, 736-2) for persons in the Government service employed inter- mittently. *(d) The Council shall advise and assist the Surgeon General in the preparation of regulations for, and as to policy matters arising with respect to, the administra- tion of this title. The Council shall consider all applications for grants under this title and shall make recommendations to the Surgeon General with respect to approval of applications for and the amounts of grants under this title. years, except t ~ “REGULATIONS “Sec. 906. The Surgeon General, after consultation with the Council, shall prescribe general regulations covering the terms and conditions for approving applications for grants under this title and the coordination of programs assisted under this title with programs for training, research, and demonstrations relating to the same diseases assisted or authorized under other titles of this Act or other Acts of Congress. ‘INFORMATION ON SPECIAL TREATMENT AND TRAINING CENTERS “Sec. 907. The Surgeon General shall establish, and maintain on a current basis, a list or lists of facilities in the United States equipped and staffed to pro- vide the most advanced methods and techniques in the diagnosis and treatment of heart disease, cancer, or stroke, together with such related information, in- cluding the availability of advanced specialty training in such facilities, as he deems useful, and shall make such list or lists and related information readily available to licensed practitioners and other persons requiring such information. To the end of making such list or lists and other information most useful, the Surgeon General shall from time to time consult with interested national profes- sional organizations. “REPORT “Sec, 908. On or before June 30, 1967, the Surgeon General, after consultation with the Council, shali submit to the Secretary for transmission to the President and then.to the Congress, a report of the activities under this title together with (1) a statement of the relationship between Federal financing and financing from other sources of the activities undertaken pursuant to this title, (2) an appraisal of the activities assisted under this title in the light of their effectiveness in carry- ing out the purposes of this title, and (3) recommendations with respect to extension or modification of this title in the light thereof.” Sec. 3. (a) Seetion 1 of the Public Health Service Act is amended to read as follows: . “Section 1, Titles I to IX, inclusive, of this Act may be cited as the ‘Public’ Health Service Act’.” HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 5 (b) The Act of July 1, 1944 (58 Stat. 682), as amended, is further amended by renumbering title IX (as in effect prior to the enactment of this Act) as title , and by renumbering sections 901 through 914 (as in effect prior to the enact- ment .of this Act), and references thereto, as sections 1001 through 1014, respectively. Amend the title so as to read: A bill to amend the Public Health Service Act to assist in combating heart disease, cancer, stroke, and related diseases. PURPOSE OF THE BILL The principal purpose of the bill is to provide for the establish- ment of programs of cooperation between medical schools, clinical research institutions and hospitals by means of which the latest advances in the care of patients suffering from heart disease, stroke, cancer, and related diseases may be afforded through locally adminis- tered Programs of research, training, and continuing ‘education and related demonstrations of patient care. The reported bill authorizes appropriations of $50 million for the current fiscal year, $90 million for fiscal year 1967, and $200 million for fiscal year 1968. NATURE OF THE PROPOSED PROGRAM The program authorized under this legislation would provide support for cooperative arrangenients which would link medical schools and affiliated teaching hospitals, with their highly developed capa- bilities in diagnosis, training, and treatment, with clinical research centers, local community hospitals and practicing physicians. These cooperative arrangements would be planned and established locally with the participation of existing institutions and medical practitioners. These cooperative arrangements would permit the interchange of personnel and patients and would provide for the more effective flow of information concerning the latest advances in diag- nosis and treatment. There are several programs currently being conducted in the United States similar in nature to the programs proposed under the bil. For example, the Bingham Associates program, which was begun in 1931, links Tufts College Medical School and the New Eng- land Medical Center in Boston with a substantial number of commu- nity hospitals in Maine and other New England States. This program provides continuing education for physicians, training for medical specialists, and sup orting services for doctors in the New England area in paramedical fields. Through programs of patient referral, patients whose illnesses or disabilities are beyond the capabilities of local hospitals obtain care under this program at facilities where more advanced equipment and techniques are available, A similar program is carried out by the Department of Post Grad- uate Medicine at Albany Medical College of Union University. This program links the medical school to six community hospitals located as far as 90 miles from Albany and involves weekly yisits of medical school faculty to the participating hospitals, the conduct of teaching rounds and conferences in hospitals, special meetings on particular problems of medical education, the provision of guidance and advice to hospital administrators and staffs and directors of medical educa- nae btt O- 6 . HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 tion, and provision for guest speakers. In addition, the Albany Medical College conducts a widespread network of continuing medical education utilizing two-way radio hookups currently involving 72 hospitals throughout sever States. | uring the hearings the dean of the University of Wisconsin Medical School, Madison, Wis., and the vice president of Marquette University Medical School, Milwaukee, Wis., in testifying in favor of the legislation, described the programs conducted by their two medical schools involving continuing education, referral of patients from throughout the State to the teaching hospitals of the medical school, and intensive training of personnel. The representatives of these two schools testified that this legislation would greatly aid them in carrying out and expanding the programs which they are currently conducting. The statement of Dr. Robert C. Hardin, dean of the College of Medicine, University of Iowa (p. 478 of the hearings), points out: “The plan embodied in the bill reflects the steps in the evolution of a flexible pattern of medical research, education, and service which was begun in Iowa back in 1915.” In 1915 the Iowa Legislature created a central institution for the care of crippled children, which was so successful that in 1919 the program was extended to include all diseases and all age groups. medical school was built around this nucleus, serving as a regional medical center, which has become a center of 1,400 beds with an annual impatient admission rate of 33,000, a full-time staff of 300 physicians, a body of 500 medical students, postdoctoral training programs in all medical specialties, and en educational program producitg bioscientists. The Iowa program involves thorough an complete communication and co- operation with the physicians in the region served by the medical center. . Dr. Hardin’s statement points out further that in addition to training associated with the care of referred patients, seminars and clinical demonstrations are conducted at the center. The staff carries out teaching demonstrations throughout the State. Closed circuit television programs are conducted daily for hospitals in Des Moines and Cedar Rapids. Postgraduate programs are conducted in these hospitals. Through cooperation with the Iowa Medical Society, a receptorship program operates where medical students between the junior and senior years work with practitioners throughout the State. The success of the program in lowa demonstrates the potentials inherent in the legislation reported herewith. The approach of the bill, as amended by the committee, is consistent with the summary contained in Dr. Hardin’s statement based upon the 50 years’ experience with this program in Iowa. That summary is as follows: Our experience shows in summa that: (1) The develop- ment of categorical, highly specialized areas in a medical center enhances the practice of medicine in the region served and will affect the quality of medical care as well as the quantity. Such development need not interfere with the practice of medicine in the area but should attract physicians to it. (2) A medical center in a semirural area like Iowa can be developed only with the cooperation among all. mem- bers of the medical profession practicing in the area. This is extremely important and must be emphasized for such HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 196 5 67. productive cooperation is the key to success of the plan. (3) The flexibility embodied in the bill will allow for the development of complexes with a diversity necessary to the various parts of our country. (4) Trained manpower is the key to the success of any of these complexes and must be developed concomitantly with the building of research and treatment centers. Planning must preserve in the medical schools a suitable environment for both fundamental educa- tion and the later specialized training. Both are absolutely necessary for the modern medical center. (5) There will be need for continued planning after actual implementation of the program. BACKGROUND In March 1964 the President appointed a Commission on Heart Disease, Cancer, and Stroke to “recommend steps to reduce the in- cidence of these diseases through new knowledge and more complete utilization of the medical knowledge we already have.” A complete list of the members of this Commission is set out in appendix A to this report. Under the chairmanship of Dr. Michael DeBakey, the Commission received testimony from 166 expert witnesses and con- sulted 60 health organizations and associations. There were 45 -Commission hearings, over 7,500 pages of testimony prepared, and great amounts of data collected and analyzed. After 9 months of study, the Commission submitted its final report in December 1964 and made a number of specific as well as general recommendations. The report of the Commission points out that over 70 percent of all deaths occurring in the United States each year result from these three dread diseases. It was pointed out that these three diseases’ effects upon our economy cause close to $30 billion each year in losses due to premature disability and death. In order to carry out certain of the Commission’s recommendations which require legislation, the administration prepared legislation, H.R. 3140, which was introduced January 14, 1964. Hearings were held on this bill on July 20, 21, 22, 23, 27, 28, 29, and 30, 1965. Testimony favorable to the legislation was submitted on behalf of the American Heart Association, the American Cancer Society, the American Hospital Association, the American Public Health Associa- tion, the Association of American Medical Colleges, several deans and officers of medical schools, and others. Testimony in opposition to the legislation was submitted by the American Academy of General Practice, the American Medical Asso- ciation, several State medical societies, and others. The bill as reported by the committee differs substantially from the bill as originally introduced, although it will still carry out the basic objectives of the introduced legislation. Numerous changes have been made in the bill, and on September 2, 1965, the American Medical Association issued the following press release: (News release, American Medical Association, Sept. 2, 1965] Cutcaco.—Dr. James Z. Appel, president of the American Medical Association, disclosed today that an AMA advisory committee met this week with President Johnson and Secretary of Health, Education, and Welfare Gardner to 8 HEART DISEASE, CANCER, AN D STROKE AMENDMENTS OF 1965 discuss the medical profession’s concern about a bill that would have established regional medical complexes for the treatment of heart disease, cancer, and stroke. The AMA president said he was gratified that as a result of these meetings some 20 amendments to the bill recom- mended by the AMA committee were accepted by the administration. “Many of the changes are substantial and will allay many of the fears the medical profession had about the original bill,” he said. Dr. Appel said he had appeated to President Johnson to defer action on H.R. 3140 because the likelihood of its possage was jeopardizing AMA’s attempts to work with the ecretary of HEW to the extent of providing consultation in the preparation of regulations and in other actions relating to the medicare law. “President Johnson told us he could not support defer- ment of the bill, that he favored it and wanted it passed in this session of Congress,” Dr. Appel said. ‘President Johnson did, however, direct Secretary Gardner to work with the AMA committee to make the bill less objectionable.” ‘We feel we were successful in getting a number of major changes in the bill which will help to preserve the high quality of medical care and the freedom of hospitals and physicians.” Dr. Appel said he told administration officials that passage of the original bill would have been followed by a severe adverse reaction from the medical profession. “Most medical leaders felt that the establishment of the series of medical complexes initially conceived would have had a more serious long-term effect on medical practice than the recently enacted medicare law,” Dr. Appel said. “The already existing misgivings among some members of the medical profession about the AMA’s liaison relationships with the Department of HEW would have been markedly aggravated by the enactment of another law so strongly opposed by physicians,” Dr. Appel told the Secretary of “While we still cannot support H.R. 3140, as amended, because we believe it still introduces un undesirable concept, the amendments agreed to by the administration—and now adopted by the House Committee on Interstate and Foreign Commerce-—certainly make the bill much less objectionable.” The committee feels that the bill herewith reported has been modi- fied in such a fashion to meet the principal objections to the introduced bill, and the reservations about it expressed during the hearings. COMMITTEE AMENDMENTS The amendment as reported by the committee is a complete sub- stitute for the text of the bill. Numerous changes were made in the introduced bill by the committee designed generally to better define the scope of the program and to clarify the intent so as to guarantee that the legislation will accomplish its purposes without interfering HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 9 with the patterns, or the methods of financing, of patient care or professional practice or with the administration of hospitals. Regional medical programs.—Several of the changes made by the committee are primarily semantic changes, designed to allay mis- understandings which have occurred with respect to the provisions of the introduced bill. The introduced bill referred to “regional medical complexes.” Although Secretary Celebrezze explained that it is not intended by this program to construct a number of buildings, but that the intent rather is to utilize existing facilities and provide through the legislation for arrangements among existing facilities, many persons have expressed to the committee the fear that this program may involve ultimately construction of large Federal facilities scattered throughout the United States, staffed with Federal em- ployees, thereby downgrading local hospitals and local medical facilities, The committee has therefore substituted for the phrase “regional medical complexes” the phrase “regional medical programs,” so as to emphasize the local nature of this program, its limited scope, and the fact that the primary thrust of the program will be to facilitate arrangements among existing institutions. Complementary to this change is a change in the definition of “construction.” Under the change in the definition of this term in section 902(f), the only construc- tion which will be permitted under the reported bill will be alteration, major repair, remodeling, and renovation of existing buildings, and replacement of obsolete built-in equipment of existing buildings. No new construction will be permitted under this definition. It is intended by the committee that where new construction will be re in connection with any local program established under the bill, Federal participation in the costs of such new construction must come from sources other than this legislation. Witnesses on behalf of the administration specifically requested that authorization for new construction be retained in the bill. The justification for this position was that new construction will be required in some areas in order to meet the requirements of the legislation for establishment of a program. The lack of this authority for new construction should create no serious problems during the 3 years authorized in this legislation, and when a request is made for extension of this legislation in the future, the committee will review this question again, along with other questions. Heart disease, cancer, stroke, and related diseases.—The introduced bill would have established a program for heart disease, cancer, stroke, and other major diseases. The committee has deleted the phrase “other major diseases” and substituted “related diseases.” If at sometime in the future it is in the public interest to establish a program for major diseases not related to heart disease, cancer, or stroke, the Congress will give consideration to the establishment of such a program at that time; however, at present the committee feels that this program should be limited to the three named diseases and other diseases which are related to them. For example, it is known that there is an apparent relationship between diabetes and heart disease. A program of research, training, and demon- strations relating to heart disease which did not include work on diabetes would, of necessity, be incomplete; therefore, the com- mittee feels that research should be conducted into diabetes under 10 HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 the program dealing with heart disease insofar as diabetes is related to heart disease. Similar! , certain kidney diseases are associated with high blood pressure which, in turn, is associated with stroke and heart disease. ‘The committee feels that insofar as they relate to stroke or heart disease, these kidney diseases would be appropriate for coverage under the programs established under the bill. Cooperative activities —In several places, the introduced bill provided for “coordination” of programs, arrangements, or activities. Fears were expressed to the committee that these words implied some pos- sibility of Federal control of medical practice. The committee feels that there is no basis for these fears; however, in those places where “coordination” is referred to, the committee has substituted “cooperation” instead. In the opinion of the committee this does not constitute a substantive change in the legislation. Three-year program.—The committee has amended the bill to reduce the scope of the program from 5 years to 3 years; has retained the proposed $50 million authorization for current fiscal year and has changed the open end authorization for the remainder of the program to an authorization of $90 million for fiscal 1967 and $200 million for fiscal 1968. Pilot projects und feasibility studies—Under the introduced bill, these funds were authorized for grants for “planning, establishing, and operating regional medical complexes for research, training, and demonstration activities.’ The committee has changed this language so as to further delineate the scope of the program. As reported, the bill authorizes appropriations for grants for “plan- ning, for conducting feasibility studies, and for operating pilot projects for the establishment of regional medical programs of research, training and demonstration activities.” It is intended that there will be careful planning before the program is approved in any area. The committee has been informed that there are eight programs in the United States already in the planning stage which are well enough worked out so that it will be feasible to start these programs within the fairly near future. The committee anticipates that if these programs are authorized they will proceed, step-by-step, and provide in this fashion experience on the basis of which similar pro- ams may be established in other areas of the country if on the asis of the pilot projects authorized under the bill the establishment of further programs appears feasible and desirable. ; Training.—A further amendment adopted by the committee pro- vides increased emphasis’on training, by including this concept in the heading in the proposed new title IX. , Financing of patient care; referral of patients.—As introduced, the bill prohibited the use of appropriated funds to pay for the care of patients except to the extent that such care was incident to research, training, or demonstration activities. A clarifying amendment has been adopted which requires that the research, training, and demonstration activities referred to be those encom- passed by the reported bill. The committee has adopted a further amendment to this provision, which provides that no patient shall be furnished care incident to research, training, or demonstrations at any facility unless he has been referred to that facility by a practicing hysician. This is a customary arrangement at research institutions. Foe example, at the Clinical Center at the National Institutes of HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 19 65 «(11 Health, in Bethesda, Md., all patients who are treated are referred to the Clinical Center by practicing physicians. Except in the case of those patients who, after referral to a facility by a practicing physician, receive care incident to research, training, or demonstrations, the legislation will have no effect one way or the other upon the patterns, or methods of financing, of patient care. Composition of advisory committees. ~The committee has been very careful to establish machinery in the bill which will insure: local control of the programs conducted under the bill. The committee wishes to empahsize that this legislation is intended to be admin- istered in such a way as to make no change whatsoever in the tradi- tional methods of furnishing medical care to patients in the United States, or to methods of financing such care. As one means of insurin this result, the committee has changed the provisions of the bil relating to the designation of advisory groups on the local level to provide that before an application may be received and acted on under the bill, the applicant must have designated an advisory grou which will include practicing physicians, medical center officials, ospital administrators, representatives from appropriate medical societies, voluntary health agencies, re resentatives of other organizations con- cerned with the program, such as public health officials, and members of the public. ; Approval by advisory committees. —The committee has amended the bill to provide that before any application submitted for establishment and operition of a program in any area may be approved by the Surgeon General, the local advisory grou must have considered the application and recommended its a troval. National Advisory Council.—A further, similar, change has been made by the committee with respect to the National Advisory Council. Under the bill as introduced, an Advisory Council was required to be - established to advise the Surgeon General, to consist of 12 members of whom 1 was required to be outstanding in the study, diagnosis, and treatment of heart disease; 1 in cancer, and 1 in stroke. The com- mittee has added to this requirement a requirement that at least 2 of the members, in addition to the 3 previously referred to, shall be practicing physicians. In addition, the Surgeon General may not . make a grant for any program under the bill, except upon the recom- mendation of this Council. Clinical research centers.—The introduced bill provided that one of the component agencies required to be included in any area program was required to be a “categorical research center.” The committee has changed this concept to provide that the research center must be a “clinical research center.” This change in terms is intended to change the emphasis of the research programs conducted under the legislation to the end that such programs will involve atient care. Diagnostic and treatment stations. The introduced bill also provided that one of the components of local programs was to be one or, more “diagnostic and treatment stations,” defined as a “unit of a hospital or other health facility providing specialized, high- uality, diagnostic and treatment services.” The committee has deleted this concept from the bill, and has provided that as a substitute for the diagnostic and treatment station, the local program must include participation by hospitals. 12 HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 Information relating to facilities.—One further amendment was added by the committee, providing that the Surgeon General shall establish, and maintain, on a current basis, a list or lists of facilities in the United States providing the most advanced methods and tech- niques in_the diagnosis and treatment of heart disease, cancer, or stroke. The purpose of establishing these lists, and maintaining them on a current basis, is to provide in one place information for doctors in the United States concerning the places where patients presenting unusual problems can best be cared for. The lists would also indicate the availability of advanced specialty training. In order to make sure that these lists are most useful to doctors, the Surgeon General is required to consult from time to time with national professional organizations such as the American Medical Association and others. RELATIONSHIP TO EXISTING FEDERAL HEALTH PROGRAMS This program is not intended to supersede or absorb existing Federal health programs but rather to build on the capabilities created and strengthened through those programs. The many developments in the health field stimulated by previous legislation have established the opportunities for the further advances which would be possible under this legislation. Other programs have helped expand the supply of health manpower and facilities and have helped to support the extensive medical research activities in our great medical schools, universities, and research institutions. The regional medical pro- grams proposed in this bill will draw upon the accomplishments of these existing programs. EMPHASIS UPON PLANNING The committee has heard persuasive testimony that hastily planned programs, which would inevitably lead to poor performance, might result if this program were implemented quickly upon too large a scale. Moreover, it is apparent that sound programs will require extensive discussion among the local participating institutions and in medical and other professional organizations. The committee intends that, for these reasons, planning assisted by grants under section 903 will receive the most serious attention of the National Advisory Council on Regional Medical Programs and of the Surgeon General. Since in some areas of the country extensive planning and organization have already been carried out, this attention to intensive planning should not prevent the funding during the first year of pilot or demon- stration projects for which the Council is satisfied that a high standard of planning has already taken place. ; ; The projects to be undertaken under this program will be quite varied, depending upon the region of the country and the nature o the existing facilities. The problems to be overcome In a sparsely settled region in which most of the hospitals are relatively small anc are separated by considerable distances are clearly different from thos: to be met in congested urban areas. Because of the great variation and also because great differences exist in disease incidence in differen locations, the committee is of the opinion that several pilot project should be undertaken. Information available to the committee sug HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 13 gests that perhaps 8 communities have plans sufficiently advanced to begin their programs initially and that 25 might be activated during the 3-year period authorized. Planning will not, of course, be a one-shot operation in this program. Where a regional medical program has been funded under this legisla- tion and therefore moves from the stage of planning to establishment and operation, it is obvious that planning must continue. As the program continues in the area which it serves, experience will indicate changes that might be desirable, requiring further planning. Illustrative of the foregoing is the experience of the Bingham Associates program, which started in a very limited fashion, and, step by step, changed as experience indicated desirable modifications. This program began in 1931 with the support of the operating costs of a 20-bed diagnostic unit within the Boston Dispensary to be related to the 50-bed Oxford County (Maine) Community Hospital, 200 miles away. The plan was to bring Boston to the Rumford Hospital through a series of 10 one-month clinies conducted by the staff of the Dispensary. Paramedical supporting services were established. As the program grew, an intermediate level was created in the relationship between Rumford and the Dispensary, which was: the 190-bed Central Maine General Hospital in Lewiston. This hospital became the immediate referral center for problems beyond the scope of the Rumford Hospital and seven other area hospitals. Especially difficult cases were then referred to Boston. Later, the Eastern Maine General Hospital in Bangor was designated as the referral center for eastern Maine. By 1945, 28 Maine hospitals were linked around the 2 regional centers. Tufts Medical School became affiliated with this program, which now extends to community hospitals in other northeastern States. PARTICIPATION OF COMMUNITY PHYSICIANS AND HEALTH ORGANIZATIONS The committee notes the agreement among all concerned that full participation of practicing physicians is required for the successful “operation of this program. The President’s Commission on Heart Disease, Cancer, and Stroke stressed that its recommendations were designed to strengthen the Nation’s health resources, to make the best use of the resources we now have, and to assist the doctor in practice in the care of his patient. Noteworthy advances, made voluntarily and individually by members of the medical profession, have greatly improved the care of patients suffering from heart disease, cancer, and stroke, as well as many other diseases. Efforts to improve and to modernize the information of physicians and the facilities they require have been outstanding. Yet, there are limits to what, unaided, local communities can do and what individual physicians can accomplish. The committee believes that many improvements will be possible under this program. Among these are improvements in diagnostic laboratories, assistance in acquiring and operating new, complicated, and expensive equipment, and participation in the developing communication linkages reporting adverse drug reactions and transmitting biomedical information rapidly from the research laboratory, through the library to the doctor. 53-111 O--85----5 14 HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 Despite these advantages, the committee has noted several ways in which additional assurances against undue interference should be pro- vided. To assure that local physicians and institutions are ade- quately represented, the committee has stipulated that ‘practicing physicians, medical center officials, hospital administrators, representa- tives from appropriate medical societies, voluntary health agencies, representatives of other organizations * * * should be included as members of the local advisory group and that at least two members of the National Advisory Council should be practicing hysicians. The committee has also specified that patients provided care under this program shall have been referred by a practicing physician. And to assure that the locally initiated programs, whether supported by Fed- eral grants or not, are ade uately known to the medical profession, the committee has required that the Surgeon General publish a list of facilities equipped and staffed to provide the most advanced methods and techniques in heart disease, cancer, and stroke so that such lists may be available to licensed practitioners requiring such information. CONTINUING EDUCATION—EXISTING PROGRAMS The committee was impressed with the great advances that have been made in recent years in the continuing education of physicians. For example, in the last 5 years the number of formal courses reported for annual listing in the American Medical Association publication, “Continuing Education Courses for Physicians” has increased almost 50-percent from 1,105 for 1961-62 to 1,641 for 1965-66. In addition, the number of physicians attending these courses has also increased markedly. For the year 1954-55 the number of registrants in courses offered by medical schools was approximately 19,000. It is conserva- tively estimatéd that over 100,000 physicians will take some formal course offered during the coming academic year. In addition to formal courses, all medical organizations hold scien- tific meetings; medical education programs are conducted on radio or television networks; medical journals, books, abstracts, summaries, and monographs are available; in addition to hospital staff meetings, journal clubs, therapeutic conferences, and scientific lectureships. In May 1961, the board of trustees of the American Medical Association appointed a joint study committee to “spell out the dimensions of a program of continuing medical education.” The sponsors of the study included in addition to the AMA, the Association of American Medical Colleges, the American Hospital Association, the American College of Physicians, the American Academy of Pediatrics, the American Psychiatric Association, the American Col- lege of Obstetricians and Gynecologists, and the American Academy of General Practice. When this committee submitted its report, » program was initiated to create a nationwide “university without walls” responsible for developing educational programs of the highest caliber for all practicing physicians. Work on the recommendations of this com- mittee is progressing. HEART DISEASE. CANCER, AND STROKE AMENDMENTS OF 1965 15 CONTINUING EDUCATION—FUTURE NEEDS Notwithstanding the progress that has been made in the fields of continuing education, it seems to be generally recognized that the flood of new information developed through medical research presents extremely difficult problems for physicians seeking to remain abreast of the latest advances. In addition, it is frequently difficult for a busy physician who is working 60 to 80 hours a week to take the time to travel sometimes great distances to attend continuing education courses. Frequently the physician is faced with the choice between providing for the immediate day-to-day needs of his patients and the necessity of taking time away from his practice and the patients who need his services to pursue continuing education programs. It is intended by the committee that the programs established pur- suant to this legislation will include provisions to assist busy physicians in pursuing programs of continuing education. The rapid advances of medical knowledge in recent years and the prospect of further advances through our extensive research programs place a premium on the effective and convenient transmission of that knowledge to the medical practitioner and the development of the advanced skills necessary for utilization of the new knowledge. This is especially true in complicated disease fields such as heart disease, cancer and stroke where the difficulties of diagnosis and treatment present tremendous challenges to the skills and capabilities of our highly trained physicians. It is well recognized by all physicians that medical education is a lifetime process. Our American physicians have done an outstanding job of bringing to the benefit of their patients the many breakthroughs in medical science during the last several decades. But the magnitude of this need for continued learning is highlighted by a widely held estimate that the best medical education and training can become obsolete in 5 years unless the physician makes a very determined effort to continue his education. The hard-working physician needs every help and assistance in meeting his need for a continuing education. The reported bill will help to provide for significant improvements in the effectiveness of continuing education programs and will provide assistance for .the expansion of these programs and the development of new, creative approaches to the problems of postgraduate medical education for physicians. . The operation of programs under the bill will provide the continuity which is essential for any effective education program. A well- planned program with continuity between the separate elements will enable the practicing physician to make the most effective use of his valuable time by it. uring that each time he participates in the pro- ram he will be reintc~cing his earlier educational experiences. The bill will help to provide u.> staff, facilities, communication systems, and curriculum planning whicn are necessary for the development of a continuing education program with the essential element of con- tinuity. Increased accessibility is another desirable attribute of more effec- tive continuing education programs. In achieving the objective of providing assistance to the busy practicing physician, the bill will help to provide additional opportunities for participation in well- 16 HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 planned and substantial programs which do not require the practicing hysician to leave his practice and go off to a distant medical center or an extended period of time. By establishing continuing relation- ships between the medical center and the community hospital, the proposed program under the bill can provide continuing education programs that are integrated with the activities of the community ospital and readily accessible to the practicing physician. Within the community hospital setting, the education programs can be de- signed to have real and immediate relevance to the problems faced by the practicing physician in his daily activities. All of these continuing education activities will be enriched by the constant interaction between the medical center, with its advanced capabilities for research and specialized service, and the community hospital setting, with the day-to-day involvement of the practicing physicians in the problems oF delivering good medical service to the patient. This interaction will help to maximize the contribution of each element of the medical service team in bringing the latest ad- vances to the benefit of the patient. EFFECT ON SUPPLY OF PHYSICIANS One of the objections to the legislation expressed to the committee was that it would have an adverse effect upon the supply of scarce medical manpower, and would discourage physicians from locating in suburban or rural areas, These objections appear to have been based in part upon the theory that the programs established by the bill would involve massive construction of new facilities which would be required to be staffed with doctors and other medical personnel admittedly in scarce supply. Since, as has been pointed out, the bill does not provide for such a program, it will not have the effect feared in this area. In fact, the program established under the bill should serve to a degree to alleviate somewhat manpower shortages existing in the medical field and should encourage more physicians to settle and practice in suburban and rural areas than is now the case. The bill as reported will provide a more effective means for contin- uing education of present medical manpower and for the training of highly skilled medical specialists. The programs provided in the bill should lead to the development of new and creative methods to carry the benefits of scientific progress to the local practicing physician. By making the latest advances more widely available, existing ‘medical manpower can be more effectively utilized; better specialty training can be made more widely available so that the medical manpower already engaged in the treatment of the difficult problems presented by heart disease, cancer, and stroke can be afforded better opportunities to be trained in the latest techniques. he programs established under the bill make medical practice in rural or semirural areas more attractive through providing a variety of links on a continuing basis between medical centers and com- munity hospitals. The planning already done in States with large rural or. semirural populations such as Virginia, North Carolina Vermont, Wisconsin, Maryland, and Alabama shows that the pro- gram can have great benefits for such areas. Rather than central- izing medical capabilities in the great medical centers, the program HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 17 will provide the incentive and the means to break down the gap which too often exists between the medical centers and the practicing phy- sicians in the communities who remain the first line of defense in the fight against diseases. The experience in the State of Iowa reinforces the above statements to the effect that the establishment of regional medical programs under the bill will lead to (1) improved utilization of scarce medical man- power and (2) to encouraging physicians to locate in rural and semi- rural areas. The statement of Dean Hardiman of the College of Medicine, University of Iowa, concerning the experience in Iowa is as follows: In addition, in our experience, more formalized techniques for continuing education should be developed and intensively utilized. For example, the urologists of the State come to my department monthly for seminar and clinical demonstra- tions. Likewise, the. anesthesiologists frequently attend weekly meetings and seminars in the department of anes- thesiology. Similar programs are carried out in all the various clinical areas. Our staff moreover is ready at all times to carry out teaching demonstrations in appropriate areas throughout the State. We have developed closed circuit television programs daily for a series of hospitals in Des Moines and Gedar Rapids for the continuing e ucation of interns and practitioners. We have extended the dean’s committee concept of the Veterans’ Administration to com- munity hospitals in Des Moines and Cedar Rapids to help in developing postgraduate programs in these hospitals. We have appointed members of the staffs of these hospitals who participate in these educational programs to our faculty. We have set up » preceptorship program in which the medical students between their junior and senior year work' closely and intimately with general practitioners throughout the State. This has been done through the close cooperation and help of the Iowa Medical Society and has been of tremendous aid in educating the medical students with regard to com- munity medical problems and has also been a tremendously stimulating thing for the general practitioners of the State. ‘As we review the development of highly specialized areas in the college of medicine, such as the Crippled Children’s Center in 1915 and, subsequently, the various specialized services of ophthalmology, otolaryngology, urology, neu- rology, anesthesiology, surgery, and medicine, we note that the stronger they have become, the stronger and better has been the practice of medicine in the State. Both specialists and general practitioners have been attracted to the area as a result. For example, in urology alone there has been an increase from 5 urologists practicing in the State in 1936 to almost 50 at the present time. All of these are intimately associated with our department. The same is true in other specialties. It is important to note that there has been no significant increase in population during this 30-year period. The experience in Maine as a result of the Bingham Associates program has been similar to that in Towa. . 18 HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 EFFECT ON NONPARTICIPATING SCHOOLS AND HOSPITALS Fears were expressed during the hearings that the enactment of this legislation would adversely affect medical schools and hospitals which do not participate in the programs set forth in the legislation. It is true that those medical schools which participate in the pro- grams conducted under this legislation will derive added strength or their programs of research, training, and continuing education, and to that extent will be in a somewhat more favorable position than medical schools which do not participate in the program. The fact that one medical school may benefit from a program whereas another school which does not participate is not benefited is not, in the com- mittee’s opinion, a valid reason for saying that neither institution should be permitted to participate. The committee recognizes that there are medical schools in the United States which are in much stronger positions insofar as con- cerns their facilities, endowments, and sources of income than are others. The committee has recently reported, and the House has passed, H.R. 3141, a bill designed to dea with this precise problem, through providing basic improvement grants for all medical schools and a program of special improvement grants directed in large measure at the institutions which are financially the weakest. ; It would be desirable as an ultimate goal for all medical schools to be involved in programs of the sort contemplated by the reported bill, but some may choose not to participate, and otheis may become in- volved in the program at a later stage. With respect to the effect of the program on hospitals, the committee points out that the intent of this program is not to centralize medical capabilities in a single, or a few, medical centers within a region, but rather is to extend the capabilities now present in the medical centers more widely througliout the region. Participation in the program will, of course, be on & voluntary basis. In the initial phase of a pro- gram, not all institutions may wish to participate. In fact, since it is contemplated that the program will proceed on a step-by-step basis, it is unlikely that all institutions in an area will participate in the program initially, although they may join in as the program develops more fully in an area. It is expected by the committee that the plan submitted for programs in any given area will be established in such 2 manner as to add to the medical capabilities of the area, and will not adversely affect existing hospitals and other medical resources. The bill is not intended to support programs in competition with existing activities and one of the strengths of the bill is that it provides the. flexibility necessary to accommodate the many different patterns of medical institutions, population characteristics, and organizations of medical services found in this Nation. SEctIOoN-BY-SECTION DESCRIPTION OF THE ComMItTTEE SUBSTITUTE AMENDMENT This legislation has been reported by the committee with an amend- ment in the nature of a substitute. The following is @ section-by- section description of the committee substitute amendment. Section 1 provides that this legislation may be cited as the “Heart Disease, Cancer, and Stroke Amendments of 1965”. HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 19 _ Section 2 amends the Public Health Service Act by adding a new title [X at the end thereof. The following is a section-by-section description of this proposed new title: TITLE 1X— EDUCATION, RESEARCH, TRAINING, AND DEMONSTRATIONS IX THE FIELDS OF HEART DISEASE, CANCER, STROKE, AND RELATED DISEASES Section 900. Purposes This section sets forth the purposes of this proposed new title. They are (a) to encourage and assist in the estab ishment of regional cooperative arrangements among medical schools, research institu- tions, and hospitals for research and training (including continuing education) and for related demonstrations of patient care in the fields of heart disease, cancer, stroke, and related diseases; (b) thus to afford to the medical profession and the medical institutions of the Nation the opportunity of making available to their patients the. latest advances in the diagnosis and treatment of such diseases; and (c) by these means, to improve generally the health manpower and facilities available to the Nation, and to accomplish these ends without interfering with the patterns, or the methods of financing, of patient care or professional practice, or with the administration of hospitals, and in cooperation with practicing physicians, medical center officials, hospital administrators, and representatives from appropriate volun- tary health agencies. . Section 901. Authorization of appropriations Subsection (a) authorizes” the appropriation of $50 million for fiscal year 1966, $90 million for fiscal year 1967, and $200 million for fiscal year 1968. Amounts appropriated would be used for grants to assist in planning, in conducting feasibility studies, and in operating pilot projects for the establishment of regional medical programs of research, training, and demonstration activities for carrying out the purposes described above. The recipient of any grant under this proposed new title would have to be a public or nonprofit agency or institution. Sums appropriated would be available for making grants until the end of the fiscal year following the fiscal year for which they are appropriated. Under subsection (b), any such grant could be used for part or all of the cost of the planning or other activities with respect to which the application is made, except that any such grant with respect to construction of, or provision of built-in (as determined in accordance with regulations) equipment for, any facility could not exceed 90 percent of the cost of such construction or equipment. Under subsection (c), funds appropriated pursuant to this proposed new title would not be available to pay any cost of patient care except to the extent such care, as determined in accordance with regulations, is incident to those research, training, or demonstration activities which are encompassed by the purposes of the title (de- scribed above); nor could any patient be furnished any ‘care at any facility incident to research, training, or demonstrations carried out with such funds, unless he were referred to such facility by a practicing physician. 20 HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 Section 902. Definitions This section defines a number of terms which are used in the | proposed new title. These terms are used, as defined in section 902, throughout this section-by-section description. | “Regional medical program” is defined to mean & cooperative | arrangement among @ group of public or nonprofit private institutions or agencies engaged in research, training, diagnosis, and treatment relating to heart disease, cancer, or stroke and, at the option of the applicant, a related disease or diseases; but only if such group (1) is situated within a geographic area, composed of any part or parts of any one or more States, which the Surgeon General determines, in accordance with regulations, to be appropriate for carrying out the purposes of the title; (2) consists of one or more medical centers, one or more Clinical research centers, and one or more hospitals; and (3) has in effect cooperative arrangements among its component units which the Surgeon General finds will be adequate for effectively | carrying oat purposes of the title. “Medical center’ is defined to mean a medical school and one or more hospitals affiliated with it for teaching, research, and demonstra- tion ses. “Clinical research center’’ is defined to mean an institution (or part of an institution) the primary function of which is research, training of specialists, and demonstrations and which, in connection therewith, provides specialized, high-quality diagnostic and treatment services or inpatients and outpatients. “Hospital” would include general, tuberculosis, and other types of hospitals, and other health facilities, in which local capability for diagnosis and treatment is supported and augmented by the program onder this proposed new title. However, the term “hospital,” as defined, would not include any hospital furnishing primarily domi- ciliary care. “Nonprofit” as applied to any institution or agency, would mean an institution or agency which ig owned and operated by one or more nonprofit corporations or associations no part of the net earnings of which inures, or may lawfully inure, to the benefit. of any private shareholder or individual. “Construction” is defined to include alteration, major repair (to the extent permitted by regulations), remodeling and renovation of existing buildings (including initial equipment thereof), and replace- ment of obsolete, built-in (as determined in accordance with regula- tions) equipment of existing buildings Section 903. Grants for planning Subsection (a) authorizes the Surgeon General to make grants to assist in planning the development of regional medical programs. Any such grant would have to be recommended by the National Advisory Council on Regional Medical Programs (see description of sec. 905 below). Under subsection (b), each recipient of a grant would have to make an application therefor to the Surgeon General which would, in turn, have to be approved by the Surgeon General. He could approve any such application only if it contained or was supported by (1) reasonable assurances with respect to the use of, fiscal control of, and accounting for, funds received by the recipient under section 903, and with respec’ HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 21 to certain reporting and recordkeeping, and (2) a satisfactory showing that the applicant has designated an advisory group, to advise the applicant (and the institutions and agencies participating in the resulting regional medical program) in formulating and carrying out the plan for the establishment and operation of such regional medical program, which advisory group would have to include practicing physicians, medical center officials, hsspital administrators, repre- sentatives from appropriate medical societies, voluntary health agencies, and representatives of other’ organizations, institutions, and agencies concerned with activities of the kind to be carried on under the program and members of the public familiar with the need for the services provided under the program. Section 904. Grants for establishment and operation of regional medical programs Subsection (a) would authorize the Surgeon General to make grants to assist in the establishment and operation of regional medical programs, including construction and equipment of facilities in con- nection therewith. As in the case of planning grants, any grant for the establishment and operation of a regional medical program would have to be recommended by the National Advisory Council on Regional Medical Programs. Under subsection (b), a grant under section 904 could only be made on the basis of an application which was approved by the Surgeon General and recommended by the advisory group described in con- nection with section 903(b). Each such application would have to contain or be supported by reasonable assurances with respect to use of funds, prevention of supplanting of funds for the establishment or operation of regional medical programs, fiscal control and fund ac- counting for funds received under section 904, certain reporting and recordkeeping, and protection of laborers and mechanics employed in connection with construction assisted with a grant under section 904 (Davis-Bacon provisions). Section 905. National Advisory Council on Regional Medical Programs This section provides for a National Advisory Council on Regional Medical Programs. The Council would consist of the Surgeon General, who would be chairman, and 12 members, not otherwise in the recular full-time employ of the United States, who are leaders in the fields of the fundamental sciences, the medical sciences, or public affairs, The 12 mambers (other than the Surgeon Genern!) would be appointed by the Surgeon General, with the approval of the Secretary of Health, Education, and Welfare, without regard to the civil service laws. At least two of the appointed members would be practicing physicians, one would be outstanding in the study, diagnosis, or treat- ment of heart disease, one would be outstanding in the study, diag- nosis, or treatment of cancer, and one would be outstanding in the study, diagnosis, or treatment of stroke. The term of appointed menibers of the Council would be 4 years except for some initial appointees who would be appointed for a shorter period to achieve staggering of terms. No appointed member could serve continuously for more than two terms. Provision is made for compensating members of the Council while engaged in its business (including travel time) and for allowing travel expenses, including per diem in lieu of subsistence, while so engaged. 53-111 O--85-— - 4 22 HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 The Council would advise and assist the Surgeon General in the preparation of re ulations for, and as to policy matters arising with respect to, the a ministration of this new title. The Council would consider all applications for grants and make recommendations to the Surgeon General with respect to approval of applications for and the amounts of such grants. Section 906. Regulations Under this section, the Surgeon General, after consultation with the Council, would prescribe general regulations covering the terms and conditions for approving @ plications for grants and the coordination of programs assisted under title IX with programs for training, research, and demonstrations relating to the same diseases assis ted or authorized under other provisions of Federal law. Section 907. Information on special treatment and training centers This section requires the Surgeon General to establish, and maintain on a current basis, a list or ists of facilities in the United States equipped and staffed to provide the most advanced methods and techniques in the diagnosis and treatment of heart disease, cancer, or stroke, together with such related information, including the avail- ability of advanced specialty training in such facilities, as he deems useful. He would further be required to make such list or lists and related information readily available to licensed practitioners and other persons requiring such information. For the purpose of making such list or lists and other information most useful, the Surgeon General is directed to consult from time to time with interested national professional organizations. Section 908. Report Under this section, on or before June 30, 1967, the Surgeon General, after consultation with the National Advisory Council on Regional Medical Programs, would be re uired to submit to the Secretary of Health, Education, and Welfare for transmission to the President and then to the Congress, a report of the activities under title IX of the Public Health Service Act together with (1) a. statement of the rela- tionship between Federal financing and financing from other sources of the activities undertaken pursuant to such title, (2) an appraisal of the activities assisted under such title in the light of their effectiveness in carrying out its purposes, and (3) recommendations with respect to extension or modification of such title in the light thereof. Section 3 of the bill makes certain technical amendments required by the inclusion of a new title in the Public Health Service Act. Acency REPORTS DEPARTMENT OF HEALTH, EpucaTion, AND WELFARE, July 19, 1965. Hon. Oren Harris, Chairman, Committee on Interstate and Foreign Commerce, House of Representatives, Washington, D.C. Dear Mr. CHAIRMAN: This letter is in response to your request of February 15, 1965, for a report on ELR. 3140, a bill to amend the Public Health Service Act to assist in combating heart disease, cancer, stroke, and other major diseases. HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 23 We urge enactment of this bill. In his health message of January 7, 1965, the President recom- mended “legislation to authorize a 5-year program of project grants to develop multipurpose regional medical complexes for an all-out attack on heart Visease, cancer, stroke, and other major diseases.”’ H.R. 3140 embodies the administration’s legislative proposal to carry out the President’s recommendation. Since we are scheduled to testify on Tuesday, July 20, on this legis- lation, we shall not burden this report with a detai ed justification of its provisions. We are, however, enclosing for your convenience a section-by-section analysis of the bill. Sincerely, Wisur J. Couen, Under Secretary. SecTION-BY-SECTION ANALYSIS OF THE Bin To encourage greater activity in the medical sciences and to insure that the most recent advances in the medical sciences are made avail- able to the public, this bill authorizes the Surgeon General to make grants to public or nonprofit private institutions and agencies to assist them in planning and development, and in establishment and operation, of regional medical complexes. Each such complex would constitute, for the area for which it is established, an administrative framework for coordinating existing and (where necessary) newly constructed medical facilities devoted to research, training, diagnosis, and treatment relating to heart disease, cancer, or stroke, and other major diseases. The component units of each such complex would provide—without interfering with existing patterns or financing of patient care, professional practice, or hospital administration— demonstrations to the community of the most advanced specialized equipment and services available for patient care. SECTION 1 This section provides that the bill may be cited as the “Heart Disease, Cancer, and Stroke Amendments of 1965. SECTION 2 This section adds a new title IX, “Regional Medical Complexes for Research and Treatment in Heart Disease, Cancer, Stroke, and Other Major Diseases,” consisting of sections 900 to 907, to the Public Health Service Act. . Section 900. Purpose This section provides that the purposes of title IX are (1) to assist in the establishment of regionally coordinated arrangements for re- search, training, and demonstration of patient care related to heart disease, cancer, stroke, and other major diseases, (2) to enable the medical profession and medical institutions to make available to their patients the latest advances in diagnosis and treatment of such dis- eases, and (3) to accomplish these ends without interfering with patterns or financing of patient care, professional practice, or hospital administration. 24 HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 Section 901. Authorization of appropriations This section authorizes the appropriation of $50 million for fiscal 1966 and sucb sums as may be necessary for fiscal 1967, 1968, 1969, and 1970, for grants to assist in meeting all or part of the costs of plan- ning, establishing, and operating of regional medical complexes for research, training, and demonstration activities for carrying out the oses of this title. Grants for construction of facilities or Pro- vision of bui t-in equipment are limited to 90 percent of the cost thereof. Funds appropriated under this title may not be used to pay the cost of patient care not incident to research, training, OF demon- stration activities. $ This section would define the terms “regional medical complex,” “medical center,” “categorical research center,” ‘dia nostic an treatment station,” “nonprofit,” and “onstruction.” he regional medical complex ‘vould consist of local institutions oF agencies (in- cluding at least one or more medical centers, categorical research cen- ters, and diagnostic and treatment stations) engaged in research, training, diagnosis and treatment yelating to heart disease, cancer, other major diseases, and would serve as the administra- tive framework for the coordination of such units. The medical cen- ters would ain the administrative services for the complex an would, in & dition, serve a5 source of high-quality specialist person- nel for the centers and stations. The categorical research centers would serve primarily asresearch and training institutions, put woul also provide highly sophisticated and costly iagnostic and treatment services that cannot be made available at the stations. The stations would serve 8s the primary specialized diagnostic and treatment fa- cility of the community, but Federal funds rovided pursuant to this pill for their operation would be available only for research on training activities undertaken by them or in connection with their function as the medium for conveying to: the community, particularly to the local medical practitioners, the latest information on, and techniques for, diagnosis and treatment. The term “regional medical complex” is defined to mean a group of ublic or nonprofit private institutions Or agencies engaged in research, training, diagnosis, and treatment relating to heart disease, cancer, or stroke, and any other disease found by the Surgeon General to be of major significance and chosen by the applicant, which group (1) is situated in an appropriate geographic area, (2) consists of one or more. medical centers, categorical research centers, and diagnostic an treatment stations, and (3) has in effect arrangements for the coordina- tion of the activities of its component units. The term ‘medical center’’ 1s defined to mean # medical school and one or more hospitals affiliated with the school for teaching, research, and demonstration purposes. The term “categorical research center” is defined to mean an insti- tution, the primary function © which 1s research, training, an demonstrations and which provides specialized high-quality diagnostic and treatment services. The term “diagnostic ‘and treatment station” is defined to mean! unit of @ health acility, the primary function of which is to suppor and augment local capability for diagnosis and treatment by providin; specialized high-quality diagnostic and treatment services. HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 25 Section 903. Grants for planniny and development This section authorizes the Surgeon General, after consultation with the National Advisory Council on Medical Complexes, to make grants to public or nonprofit private universities, medical schools, research institutions, and other public or nonprofit private agencies an institutions to assist them in planning regional medical complexes. The Surgeon General may approve an application for such a grant only upon reasonable assurances that (1) grant funds will be used only for the purposes for which paid, (2) the applicant will provide adequate procedures for fiscal control and accounting of funds, (3) the applicant will make such reports, and will keep and afferd access to such records, as the Surgeon General requires, and (4) the applicant will provide for the designation of an advisory group to advise the applicant and the resulting regional medical complex in formulating and carrying out the plan for the establishment and operation of the complex. Section 904. Grants for establishment and operation of regional medical complezes This section authorizes the Surgeon General, after consultation with the National Advisory Council on Medical Complexes, to make grants to public or nonprofit private universities, medical schools, research institutions, and other public or nonprofit agencies and institutions to assist them in establishment and operation of regional medical complexes. The Surgeon General may approve an application for such a grant only upon reasonable assurances that (1) grant funds will be used only for the purposes for which paid and will not be used to supplant funds otherwise available to the complex, (2) the applicant will provide adequate procedures for fiscal control and ac- counting of funds, (3) the applicant will make such reports, and will keep and afford access to such records, as the Surgeon General re- quires, (4) the applicant has designated or will designate an advisory group to advise in carrying out the plan for the complex, and (5) Davis-Bacon Act labor standards will be applied to construction projects assisted under this section. Section 905. National Advisory Council on Medical Compleres This section provides for appointment of a National Advisory Coun- cil on Medical Complexes to advise and assist the Surgeon General in the preparation 0 regulations for, and as to policy matters arising with respect to, the administration of this title. The Council is also to consider all applications for grants and to make recommendations to the Surgeon General with respect to approval thereof. Section 906. Regulations This section requires the Surgeon General, after consultation with the National Advisory Council on Medical Complexes, to prescribe regulations for the approval of applications for grants an for the coordination of programs assisted under this title with similar pro- grams authorized under other acts. Section 907. Report his section requires the Surgeon General, on or before June 30, 1969, to submit to the Secretary for transmission to the President and to Congress, 2 report of the activities under this title together 26 HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 with (1) a statement of the relationship between Federal financing and financing from other sources of the activities assisted under this title, (2) an appraisal of the activities assisted under this title, and (3) recommendations with respect to the extension of modification of this title. SECTION 3 This section makes technical or conforming changes in the Public Health Services Act and the act of July 1, 1944 (58 Stat. 682), to take account of the amendments made by the bill. U.S. Department or Lazor, OrricE oF THE SECRETARY, Washington, August 24, 1965. Hon. Oren Harris, Chairman, Committee on Interstate and Foreign Commerce, House of Representatives, Washington, D.C. Dear Mr. Cuarrman: This is in response to your request for the views of the Department of Labor on H.R. 3140, a bill to amend the Public Health Service Act to assist in combating heart disease, cancer, and stroke, and for other purposes. It is our understanding that your committee is also considering S. 596, a similar bill passed by the Senate. This legislation is designed to implement recommendations of President Johnson in his January 7, 1965, health message to the Con- gress. We note with approval that section 904(b)(5) of both bills contains labor standards protection for workers on federally assisted construction. Although the language in section 902(f) which defines construction differs somewhat from the definition of construction in the Davis-Bacon Act, it is our understanding that the proposed legislation is intended to provide labor standards protection for employees engaged in construction, alteration, or repair, including painting and decorating of the type covered by the Davis-Bacon Act. With regard to other features of these bills, we defer to the Depart- ment of Health, Education, and Welfare, which has primary adminis- trative responsibility under the proposed legislation. The Bureau of the Budget advises that there is no obj ection to the submission of this report from the standpoint of the administration’s program. Sincerely, W. Wiirarp Wirtz, Secretary of Labor. US. Civ Service Commission, Washington, D.C., July 19, 1965. Hon. Oren Harris, Chairman, Committee on Interstate and Foreign Commerce, House of Representatives. Dear Mr. Cuarrman: This is in further reply to your request of February 15, 1965, for the views of the Civil Service Commission on TLR. 3140, a bill to amend the Public Health Service Act to assist in combating heart disease, cancer, stroke, and other major diseases. a7 HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 27 This legislation provides for the establishment of regional complexes for research, training, and demonstrations of patient care in the fields of heart disease, cancer, stroke, and other major diseases. The purpose is to coordinate efforts to combat these diseases. The Civil Service Commission strongly endorses this objective. There is only one section in H.R. 3140 having a direct bearing on the work of the Commission. Under section 905, a National Ad- visory Council on Medical Complexes would be established to assist in planning and developing regional arrangements. It would be com- osed of the Surgeon General and 12 members chosen from among eaders in the fundamental. sciences, medicine, or public affairs. Members would be appointed to 4-year terms without re ard to the civil service and classification laws. Rates of pay would be fixed administratively by the Secretary of the Department of Health, Education, and Welfare, but would not be in excess of $100 per day. Travel expenses would be allowed to the same extent as authorized under 5 U.S.C. 73b-2 for persons employed intermittently. The Civil Service Commission has no objection to any of the provisions of this section. The Bureau of the Budget advises that from the standpoint of the administration’s program there is no objection to the submission of this report. By direction of the Commission: Sincerely yours, Joun W. Macy, Jr., Chairman. CompTroLtLeR GENERAL oF THE Unitep StarTss, Washington, D.C., March 30, 1965. Hon. Oren Harris, Chairman, Committee on Interstate and Foreign Commerce, House of Representatives. Dear Mr. Cuarrman: By letter dated February 15, 1965, you re- quested our comments on H.R. 3140. The stated purpose of this measure is to amend the Public Health Service Act to assist in com- bating heart disease, cancer, stroke, and other major diseases. The following comments are offered to the committee for use in its consideration of this measure. This measure is, in many respects, similar to.the Health Research Facilities Act of 1956 which is codified at 42 U.S.C. 292. While that act at 42 U.S.C. 292e(a), provides for maximum Federal grants of up to 50 percent and the proposed measure would, in subsection 901(e), provide grants for part or all of planning costs and up to 90 percent of the cost of construction or built-in equipment, the mechanics of operation of the two grant programs have similarities. Subsection 8(c) of the cited act, 42 U.S.C. 292(c), provides that in determining the amount of the grant, there should be excluded from the cost of construction other Federal grants with respect to con- struction of the same facility and non-Federal matching funds required to be expended as a condition of the other Federal grants. While the percentage of non-Federal funds anticipated for use in construction under ELR. 3140 is small, the committee may want to include similar provision in the measure considered. By so doing funds granted 98 HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 under other Federal programs may not be used to meet the non- Federal portion of construction costs. The language codified at 42 U.S.C. 292(f) provides for the recapture of a certain portion of the Federal payments, if within 10 years, (1) the applicant of the facility ceases to be a public or nonprofit installation, or (2) the facility shall cease to be used for the research purposes for which it was constructed. We believe that a similar provision should be included in H.R. 3140. Subsection 903(b)(3) of H.R. 3140 affords the Surgeon General access to records of recipients of grants for planning and development and subsection 904(b) (3) similarly affords the Surgeon General access to records of recipients of grants for establishment and operation of regional medical complexes. However, no provisions are “included for access to such records by the Secretary of Health, Education, and Welfare and the Comptroller General. We suggest that language be included in the bill which would authorize access to pertinent records by these officials for purposes of audit and examination. The proposed bill is silent regarding the extent to which Federal funds will be available to aid projects which are under construction at the time the proposed bill may become law. We suggest that this matter be specifically covered in H.R. 3140. This measure, in certain respects, would authorize programs that are similar to existing programs currently being conducted by the Public Health Service. For example: (a) The Surgeon General through the National Cancer Institute, 42 U.S.C. 282a, conducts, assists, and fosters research, investigations, experiments, and studies relating to the cause, prevention, and methods of diagnosis and treatment of cancer. (b) The National Institutes of Health has programs for the estab- lishment of general and categorical clinical research centers. Grants for these centers are awarded to individual institutions by National Institutes of Health, whereas H.R. 3140 would provide for grants to a group of institutions on a coordinated basis. (c) Under title VII of the Public Health Service Act (Health Research Facilities) provision is made for the construction of facilities for the conduct of research in the sciences related to health. (d) Construction of hospitals and related facilities is provided for in title VI of the Public Health Service Act. (e) Under title III of the Public Health Service Act formula grants are made to the States for heart disease and cancer control programs. Generally, the existing programs require a greater financial partici- pation by the recipient than would be required by the subject bill. Because of the overlapping of these programs, and the greater Federal participation under H.R. 3140, we would like to point out that enact- ment of this bill with more favorable grant allotments could serve as a precedent for increasing the Federal portion of other grant programs. This is particularly true where the proposed program will overlap existing programs with less favorable Federal grant allotments. . . We have no further comments to make concerning this measure. Sincerely yours, JosEPpH CAMPBELL, Comptroller General of the United States. 30 HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 until the end of the fiscal year following the fiscal year for which the appropriation 18 made. (b) A grant under this title shall be for part or all of the cost of the planning or other activities with respect to which the application is made, + except any such grant uth respect to construction of, or provision of built-in (as determined in accordance with regulations) equipment for, any facility may not exceed 90 per centum of the cost of such construction or equipment. (c) Funds appropriated pursuant to this title shall not be available to pay the cost of hospital, medical, or other care of patients except to the extent it is, as determined in accordance with regulations, incident to those research, training, or demonstration activities which are encom- passed by the purposes of this title. No patient shall be furnished hos- pital, medical, or other care at an: facilitiy incident to research, training, or demonstration activities carried out with funds appropriated pursuant to this title, unless he has been referred to such facility by a practicing physician. “ DEFINITIONS Sc. 902. For the purposes of this title— (a) The term “regional medical program” means a cooperative arrange- ment among a group of public or nonpr fit private institutions or agencies engaged in research, training, diagnosis, and treatment relating to heart disease, cancer, or stroke, and, at the option of the applicant, related disease or diseases; but only x such group— (1) is situated within a geographic area, composed of any part or parts of any one or more States, which the Surgeon General deter- mines, in accordance with regulations, to be appropriate for carrying out the purposes of this title; (2) consists of one or more medical centers, one or more clinical research centers, and one or more hospitals; and (3) has. in effect cooperative arrangements among its component units which the Surgeon General finds will be adequate for effectively carrying out the purposes of this title. (b) The term ‘me neal center” means a medical school and one or more hospitals affiliated therewith for teaching, ‘research, and demonstration purposes. . (c) The term “clinical research center’? means an institution (or part of an institution) the primary function of which is research, training of specialists, and demonstrations and which, in connection therewith, provides specialized, high-quality diagnostic and treatment services for inpatients and outpatients. The term “hospital” means a hospital as defined in section 625 (ce) or other health facility in which local capability for diagnosis and treat- ment is supported and augmented by the program established under this title. ; oy (e) The term “nonprofit” as applied to any institution or agency means an institution or agency uhich is owned and operated by one or more nonprofit corporations or associations no part of the net earnings of which inures, or may lawfully inure, to the benefit of any private shareholder or individual. . ; Coe, . The term “construction” includes alteration, major repair (to the extent permitted by regulations), remodeling and renovation of existing buildings (including initial. equipment thereof), and replacement of HEART DISEASE, CANCER, AND STROKE AMENDMENTS OF 1965 31 obsolete, built-in (as determined in accordance with regulations) equipment of existing buildings. GRANTS FOR PLANNING Szc. 903. (a) The Surgeon General, upon the recommendation of the National Advisory Council on Regional Medical Programs established by section 905 (hereafter in this title referred to as the “Council’’), 8 authorized to make grants to public or nonprofit private universities, medical schools, research institutions, and other public or nonprofit private agencies and institutions to assist them in planning the develop- ment of regional medical programs. (6) Grants under this section may be made only upon application therefor approved by the Surgeon General. Any such application may be approved only if it contains or is supported by— (1) reasonable assurances that Federal funds paid pursuant to any such grant will be used only for the purposes jor which paid and in accordance with the applicable provisions of this title and the regulations thereunder; / (2) reasonable assurances that the applicant will provide for such fiscal control and fund accounting procedures as are required by the Surgeon General to assure proper disbursement of and accounting for such Federal funds; (8) reasonable assurances that the applicant will make such reports, in such form and containing such information as the Surgeon General may from time to time reasonably require, and will keep such records and, afford euch access thereto as the Surgeon General may find necessary to assure the correctness and verification of such reports; and (4) a satisfactory