February 20., 1965 CGB Analysis of S. 596; A Bill to amend the Public Health Service Act to assist in combatting heart disease, cancer, stroke and other major diseases. Major points of the Bill include the following: Section 900 1. Funds for carrying out the purposes of this part of Title IX of (Page 2) the Act are only for grants (no provision was made in the Bill for utilizing some of the funds for operational costs; a subsection in Section 901 permitting this expenditure would be an improvement in the wording of the Bill). 2. The purposes of the Title are to encourage and assist in the establishment of Regional @dical Complexes and to afford to the medical profession and the medical institutions the opportunity of making avail- able to patients latest advances in diagnosis and treatment. It is of interest that the purpose is not stated to be actually to make avai - able these advances, but rather to afford an opportunity for this to be done. It should also be noted that causation and prevention are not mentioned - 3. The Title is "to accomplish these ends without interfering with the patterns, or the methods of financing, of patient care or pro- fessional practice, or with the administration of hospitals." It is not possible to accomplish these ends without some interference in these activities. -2- Section 901 4. The babid,legislative authority for the Title is for a five year period. 5. nfty million dollars is authorized in the first year with amounts for each of the next four years to be determined by the Appropriations Comittees ancL the Congress e 6. while it is implied that associations of institutions and a cies listed could be recipients of grants for operation of Regional Wdi@ea Complexes,, the wording might be improved if this were explicitly included in the language. 7. The funds appropriated for each fiscal year are available for a two year period. 8. A 10% matching requirement for construction and built-in (fixed) 6quipment 34-9 required. gi Patients or an appropriate third party would pay for medical care costs unless such costs are incident to research, training or demon- strations activities. 10. It should be noted that the Bill does not contain a subsection stating that the functions of the PHS and the authorities of the Surgeon General under other Titles of the Act axe not to be limited nor expenditure of funds therefor by this Title. Section 902 e 4) ii. each of which" is hot clear in the sentence at the top of page 4 as to whether each participating unit of a Regional Phdical -3- C lex must be engaged in research, training., qi #66is and tr6atment, or ther the group as a whole must be engaged in a of these activities. sumably it is e I-atter. Whi e Bill gives specific emphasis to art disease, cancer stroke, at the option of an applicant any othe d sease found by the eon Gen r to be of major significance to e health of the Nation be dealt with in Regional @dical Complexes f app cation for a t is acted up6 favorably (It is difficult to@ ee how the Surgeon General can rule that most diseases are not of major significance to e' ealth of the Nation; therefore., the effect of s Title is to provide me ani or p sm for supp ting medical activities adr ss the board.) 13- 'Ihe Subsection under definitions dealing a R&ographic area re 7 says no more than that the complexes axe to 6 situated V'Ithih ted'States. The meaning of geographic a ot clear other that it mav be composed Of any part or parts of aav one or more s @Sime definitions require that a medical center =st contain cal school @a Regional @dical Complex must contain a medical' ce r. the Regional @didal Complex must contain a medical school. it s be noted that some major cancer research ins tutes are already 'providing the ntegrated elements of research, traini and care., even -extending into the surrounding commmities., which arently this Title -4- is designed to encourage, but these institutes axe not eligible for grants under this Title unless they have it arrangements for the coordination of activities" with other units, including a medical school. 15. It is not very clear what is intended by "arrangements for the coordination of the activities of component units of the Regional Wdical Complex. 16. A categorical research center, a required e ement of a Regional Wdical Complex., is an institution or paxt of an institution the primary functions of which are research (including clinical research), (Page training of specialists., and demonstrations and which., in connection therewith., provides specialized high quality diagnostic and treatment services for in-patients and outpatients. 17. A Diagnostic and Treatment Station,, also a required element of a Regional Wdical Complex., is a unit of ahospital or other health facility which will be engaged in diagnostic and treatment activities with patients. 18. The definition of "construction" given in sub-section (f) includes renovations, remodeling and alterations. As the wording now stands in the Bill., it would require 10% ma@ching for these items; therefore an addition to this subsection allowing for costs for these items to be considered as operating costs would avoid the problem. Also the word 'Ibuilt-in" should be inserted between the words "initial" and "equipment" -5- n order to make it clear that the 10% matching is required only for fi d equipment and not for subsequently needed non-fixed equipment. 19. These definitions would presumably permit the establishment and operation of a new medical school. Also it would appear that VA Hospitals are eligible to receive funds or even possibly a grant,, pro- vi d they have coordinated arrangements with a medical center. Con- ceivab3,v PHS hospitals might also be eligible under such arrangements. Section 903 20. Grants are of two types: (a) planning and development and @),establishment and operation of Regional @dical Complexes. -urgeon General is required to the Nationa The S consult with Advisory Council on I&dical Conplexes., but no wording is included 'ch states that 'favorable action of a Council is required before a gr may be awarded., as is common in several of the grants programs 6P the Public Health Service. 6) 22. Grants can be made only upon application. 23. A local advisory group for the Regional Medical Complex is required and such group will include representatives of organizations 7) institutions. and agencies concerned with activities of the kind to be carried on by the complex and members of the public familiax with the ne d for the services provided by the complex.11 Section 904 24. Grants for establishment and operation of the Regional Medical Complexes must be administered such that applications may be approved -6- only if they contain, or are supported by reasonable assurances that., (Page 8) Federal funds paid pursuant to the grant will not supplant funds that are otherwise available for establishment or operation of the Regional @dical Complex. It shou3-d be noted this requirement is extremely difficult to administer and is probably unenforceable. Section 905 (Page 9) 25. The Title reqinres the establishment of a new Council with at least one of the appointed members outstanding in heart disease., one in cancer, and one in stroke. The relationship to existing programs and Councils., especially in the three disease areas., is not clear (and will likely create considerable operational difficulties). Provided the clause "not otherwise in the employ of the United States" does not pre- vent a person's serving on more than one Council, it may be important for the new Council to consist at least in part of a number of persons also serving on existing statutory Councils. Section go6 (Page 11) 26. The Surgeon General shall prescribe general regulations covering the terms and conditions for "the coordination of the 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 the Congress" (This Title will make this coordination quite difficult with much staff time and effort possibly being diverted from direct program development into complex and complicated coordination activities). -7- Section 907 27. A report on the program is required before the end of the fifth year and will include a statement on the relationship between Federal financing and financing from other sources of the activities undertaken pursuant to this Title. It is obvious that various interpretations are being given to the meaning of the parts of the Bill, as well as to the implications for the future. Some consider the Title in a rather narrow sense to provide for the mechanics of establishing the coordinated arrangements of the various components of a Regional Nhdical Complex. Others see the Bill as a broad omnibus bill which will eventually allow for funding of programs for research, training, and service under Title IX. If the Bill is read literally and attention is not given to the intent of those who wrote the Bill (and we cannot yet tell how interpretation will be modified on the basis of hearings and the Congressional Committee actions and reports since they have not yet been completed), there seems little doubt that the Title could permit funding of a wide variety of programs in research., training, and service and, indeed., some believe the Bureau of the Budget -might well believe it would be simpler to place the appro- priations and programs within this one Title rather than funding the various activities in the current program throughout the Service. These various interpretations of the Bill and the uncertainties resultant from actions not yet taken by the Congress make very difficult the task of visualizing the operation of the program and deciding on its preferred placement for responsibility of implementation in the Service.