@ i I 0 0 0 @0-136 OPTIONA@ FORM NO, 10 IAY 'V,2 EDITION GEN. LG. NO. 21 L:-\ITED S'RATES GO%'F-R-N.ViE\'Y NIH-OD-OPP DATE: December 31, i964 T 7)r, James M. F-Lndley Assistant Sargeon General for Ope@uiOrls, P.HS Office of Program Planning, OD., NIH FRo.m Chief, a- Specifications for a National Heart Disease) SUBJECT: ',NTTH Comments on Dr Lt Cancer, and Stroke Program ."te- ing, during vhich I transr@LU a In our telephone conversation this morn e-pared by Dr. Dempsey) in rought fashion the NIH comments on the draft P2? - uggested revision of this draft. The promised to send Iyou Our sthrough the use of underlining and b--ackets" attached revision indicates, Since the time br reviev has the changes made in the original draft. L these revisions still represent a limited effort to come been so Short, exities of this Proposed program- to gr-;-- os vith the many COMPI vvala also like to reiterate some Of Our general concerns vhich I We feel that there needs to be some additional expressed this morn-ng- ogram in terms of the limits Of clarification of the Derimeters of the Pr ided in the authority bei,@-,@ sought- The relationship of the services PrOv the normal medical services in diagnostic and @ieatment Stations to ti.Le f future community is uncertain in the draft and provides a source 0 ,,s are not sl, cont@-overs -5-'L the del@initio Larpened- The draft does mention y nancing of patient care vould -'Ln several places the intention that the fl'- lated to clinical ,rough present mechanisms ey@ce-@ot -,,qhere clearly re be done t@ @l Ought to be made more research. The general language of tqe proposa u of the @ion of the limits Of the functions consistent vith this 4"ndica, diagnostic and treatment s@uatio ns to be financed by Federal funds- he re"@a'-Uioiishi-p of this program to the present We are also unclear about t. '7s vhich reviev categorical Programs SUPI)o@ued by -NIH and to the counc-- lished those programs. Should the categorical research centers to be estab u t -0 rev;e@17 by the appropriate categorical as part of the net@7ork be slfc)jec u s Commission seems to . I I? advisory counci-. The report of the -president' ia the reviev categorical counc4L- Ls Around be involved i indicate tqat 'he shmen@ of such centers. :n-volving the establ-'- u of applications -L ,, involves the financing of a network -which includes a Since the proposa- -essio-,q in this pro- medical schools there needs to be some specific exP- -nly those medical school expenses posal 0-@F the intention of financing 0 vork. ary for the establishment and maintenance of the net which are necess that general Support of the medical school This statement should make clear centers of high quality -would be and development of additional medical provided through other mechanisms. 2 The specifications -or a-or,@ @ c@u@ 0-@@, s --ed on pages 4 and 5 of the proposal, are @,@ue de'-up--_--ec-L a--(id @-eeia -@o 'oe concerned Primarily -with the actual es@UECol@-; s-f@Le--t and ol' a network. A iTaZoer of the -'tems listed for inclusion -'@-ri an a@ID-1 cc----, 0--i -wo7a' d see-r!a to us to be the u -his reason we logical -orod@t o@- the -Liii-'-U 'a! pl Era-,it. For 4L, believe that it would be advi-s 'i@e to provide a different set of s-oeci-'icai',@Lc,---, for a-,a application. A major purpose of th@ grant -re -,-c, -o@--@ovide financing to the grantee for and e-.@tenstv6 plannin8 active '-U-'-, es -v'i-.@-ch be development of the coin!-ex SU7,-Oo@u Of @@-"Lc- @,,Te hope that -7e '.,iave the o-.rD-,,Do- -c @-'-y @-C) coimen-u on subsequent rafts of @-peci@L .@-c h-' s . C, I d 'C as vel-l- as the draft bill --cd7ak u i ,D -ed by 'he Office of General Co-@se'-. Since the deadlines are so tight, we 'gi!7 be gi@-d to co@e o the Office of the Surgeon General to look over the p--@oz ne does not - als if t i., oe@t you to send us a copy. -arta-a@, kttac'.-,me-@L, REVISED NIH-OD-OPP D@,T IP/31/6L@ M-@i D-IS SE@ C,"2@'CER@ AND STI@OIIE PROG@li' D -- s c ose The program sh,--17 have as its pu@rose 'he development Of net@-70ri@S 0- research service and training I)ro ra@,s in 'he fields c- heart disease, u cancer and stro'@e so as to increase the access 'o high @iu@'i@-y health u services for the d@-ar@,,.-Iosis and c- these diseases, @C) enhance the potential for r-ed-'@c--7 research aria uo e-n-,Large the nation's capaci'uy for education and in the health 2--c-.L'ess--ons. This -uaimose 'be garsued a E--anT, -2rograin to University medical centers or other or -,ori-va-uc- agencies to assist them in planri.,i7, es. L-Ls /jperatir@z7 netvorks oi co r c, dzna,-ed ara7f coo-rierazinz institutions for the cbr@duct of nical r s an cl:L - e earc- ra@@r@ - d for i@3rov@Lng and e@uer-d@-n,7 facilities and P-va-Ll-a-,@,l@- @'o.- the d4-a,-nosis and Treatment of persons Vi'-Uh heart disease, cancer, and s-U--oke. ]De [@ini-@i-ons k l@etvo---'K (medical coraDi ex) sha71 a medical center, categorical research ce-.-iter(s), and diagnostic and Treatment C, u stations for cancer, heart disease, and s@uroke, related -uhrouE;h specified arrangements for interaction be+@veen each -g, ana t -series -with respect to resea LI OL he ele: rch 'he provision ol seiTices for -a-Laziics-'@-s and treatment @@i-t'n@in a c geographical and conforming v-'@th a-oproDriate area, State, or regiona'L health -2!arini-ng. 2 2 A '.M-ed4@cal Center shall ecnsisk-, of acal school and one or more teaching hospitals a- iliated for t eachir-g, research, and demonstration .Lf pu-@oses. fir. an administrative and fLuac'u-"-onal rele@ionshia?.7 3. A Categorical Fesearch Center shall refer to an institution or part thereof enco assing a /@r7 -Drouram, -I)ecifically designed for research, /a-r.d7 traLn-Li-ig, and de-@-,-Lstr--Ticii referable to heart disease, cancer, or strokes 4. A and Treatment Station sL-,.all refer to a unified irgregation ca'- point 'L u of 1-fo or7 highly technical c-qu-'@ment- and personnel located in nonprofit or r,@olic hospitals or health facilities that are components of the complex specified in I above) and having the capability of providing /-Ekill highly sophisticated facilities and services for the diagnosis and of heart disease, cancer, @e c@Lliv-',-ties of these st--'ions shall be limited to thos or s'uroke. a e s-o@-cia!4-zed technical services and consultation which suID-oort and ai-,gment --local ca-)aoili'-Uy. A Regio-.i shall refer to a State, T)arus of a State, more than one State, or parts of more than one State (su@ch as a metropolitan area comprising a cohesive geographical area for the Maintenance of a ne'-O@qor'@. Legislative Sneci-.-L"ications Authorize a 5-year program of projects @-Ira@us to University medical- centers or other @olic or private agencies to assist ther, in planning, esta:ol-'@shi-rg, and Ma4@La4ning /.@fle:-ating7 regional r-eti,7orks of coordinated and cooperating institutions -'or enlarging and @Lr-proving activities 3 is@ and tr6atment in heart concerned with research '-U-.,ain@-ng., diaZ.!-.os disease., cancer., or stroke. 2. Author@@ze funds to cover all -necessary additional costs for il ecuiD,-j@,nL-,, s-La-Lfing, and a@--,Inister4-r@g plannir@ , constracti@'19, renovair-,-.1,- the network. It will not cover patient care costs other than those incurred -Llion v@t' -- research trairi:-nL@ and deraons-l-Ir@@io,-- activities - in associa n Cl@,l These grants s,,iall 'save -vo cc"@cn,-r-ts, as follows: 3. u a. initial grant (up to 2 years duration) to support tae devel-o-o@ment of the Dlan for the network. b. A subsequent grant for '(,he es4u-@olishment and maiiit,-=rarce /-@@eratio-,i7of a ne.vo--k r-@y include funds for (1) construction and renovation of facilities professional and '-@echr@-cal @ersorz.--'-, of supplies and eTaipmer--., E-nc, -.@ose /@xce-ot@@or-a:,-7 e:@oend@-@.ures for patient care related research and derions'ui-at4@.o-.@ ac'-.i-vi -ties and -@,dministrativc- cos-.s, and (2) general support for clinical research in the ca'ue- gorical@ areas oi ,-t cancer and stroke. 4. A--rLy application for a grant for estecolish-ynent ar.@. rL:a,.ir@Len--nce of a network ixast prov4-ae @or C-Loc=e-ntat@-c-n c@-' the: a. Geogra-phical areas and population of the region to be served 'he network (medical center coml? e b y i-I - 1 x); b. -.,,,-.ames and locations of 'he cooperating institutions or Organizations in 'vih-Lch /@ac-,@/ categorical research centers or diagnostic and treaL-,Mer,-,-. stations will be located; 4 Relationship of the proposed network and its constituents to regional, State, or local - planning for health services; d. Description of existing and planned relationships between the medical complex and its constituent units with other com-'a,r@4-ty health resources, including private practitioners; e. Description of -.orogray-s ol' research, /Tnd7 training, and demonstration to be undertaken within and by the various ur-,L-us ol' the medical com-3'Lex; -0 -ad-Lng continue ng -,7ed) f. S-@a@llemen@ of methods to be fol- incl education, uo maintain and @mprove the cii-,ality of patient care within the network -and the area or region in which it is situated; g. Description of a-.a operational plan for the time-phased implementation of the medical center complex and assurances .Lo.r its continued function sifDject to the availability of continued Federal funds; h. @scr4-.Dtion of criteria for admission to and discharge of @uients from each of the constituent units in the network; i. Description of the mechanisms to be undertaken to insure that grant fuqds will not be substituted for third party, vendor., or ind-7-cidual patient payments for services not associated with research, teaching, and demonstration activities 5 /7i-ealth7 cil to cuide the 5- Provide -'O@Lr a /@,qat the7 National ",dvi-s-Ory/Coun formation of Pol!CY) review applications and recommend action to the Surgeon General. 6. Provide 'or an evaluation O-' the program at the end of five .L L zt-@lrel7 @i-s vith recommendation to Congress for extension or modification of the legislation 7. Author-Tze P-p7 L propria'u'o.,is as 'ol'ovs: lst year $75 -,allion 2nd year 100 million 3rd year 200 Million 4th year 400 million 5th year 400 million