I m I i m I I B&B ImFoRmikreom & imAmE mAkmAko&wEmT 300 @ltd=c D=nucon aoulxvmm Upofocet MARLSO$to, MLw *40 ZO-7-72 0 USA a t:gol) 24wol 1 0 F. J, L BLASIIWrAUt. M.D. American Medical Association executive tnce president EitwasT D. HOWA]TD. M.D. sj'"Stdftt 535 NORTH DEARBORN STREET CHICAGO 10, ILLINOIS executive vice P?Md"mo AREA CODE 3t2 527-1500 I)ecomber 10, 1065 int= n. Stewart, M. D* Surgeon Cloneral Public Health Service 330 Indc,,pendcnct Ave.& S. W. V,,*BhLngton, Ds C* Dear Doctor StewgLrtt The following comments concerning the proposed regulations li-riplezncnting Public Law 89-239,, the @art Disease, Canccr and Strolte Anicndmonts of 1905, are submitted to you in response to the lnvitatioa extended to the @icipants at your meeting held on December 0, 1065. As you know, the American IvIL-diW Association has a very deep interest In this new program. . 'We are therefore very pleased to have the opportunity to continent upon the proposed re@ations. At the outset, we should like to moLlce the general observation that the proposed regdationa are apparently not intended as @ing com- plete regulations at thix tbne. coii appreciaLte that from time to time, regulations niust be amended azid amplified. Ilowever, it would appear that theme regulations,, insofar an it is possibl'@-, should provide a complete implementation of the Act, so that potential participants 9M others may moo this program In its full expectations W,eshouldalsoliketodirectyouratteationtoar.iatterwe drem to be of significant importance. Iv@o note that part of tlit', Act con- tained in Section 901(c) which provides that the funds oLppropriatcd shaU not bc* available to pay the cost of tiot!pital. medical, or otlier care of patients, exccpt to the @viit it la,, as determined in accordance with regulations, incident to those research, training, or demonstration activities which are encompassed by, the purposes of this title (the par- poses herein referred to being theme recited In Section 900). Under Section 900 the de-imonstratior.8 of patient care must be related to resoarch and tr (including Winning education). wtuis= B. stewam M.D. December 16, 1965 In our review of the propor-ed regulationx, we do not find regxtlLttions as contemplated @er @of ction 901(c). Vale btlieve that It in important that the intentions unrler this section tchould be fipelled out. As the Ilepart of the Comtrittee on Intcrstate and Foreign Comm, orce "An introduced, the bill probibitL@d the us,6 of appropri- states (p. 10): ated funds to pay for tire cart of patients except to the e@nt tha-t such C;Lre was incident to rescarch, troinin-, or demonstration activities. A clarifying muondment has be-c-n adoptt-d,%,Iilch requires that the research, training, iind dei@@-trat@n actWffics referred to be those encompemsed by the reported bill. " ThLt Report con@a the @her statement (P. II)i "'The comznlttee vrlvhejt to emphtkatze thvLt this legia- lation in intended to be admi@tered in such a way Qu to m@ no Omnge whatsoever in the traditional methods of furnishing medical care to imUerds in the United States, or to methods of financing such care. We belleve that @ ittent of C*ngreas is clear that poltient care Is limited as being "Incident" to reseslreh sad training act iyitiea. We &la* believe that @ intent should be *Iearly pronounced In re@a- tions. Our comments to @ sections of the proposed reguliLtions" in the order in wh@ they appear, toUow. Additlow which we believo should be made are indicated by underscored matter. (1) Section $6. 3 - Dc*ft,-iitions. Subsettlon (d), defirAng related dixessec, " should @ a=ended by lns@ing the words and estaLbIltilied after the word "direct,, so that tive phrase -,vill re@ '%car a @ct and establinbc,,d rolattonxhip, " etc. NVe @. ieve TioLt@ additional term etirrion the requirement that the related diseane I,.ave a madicaUy, reco@ed rclation to the primnry disease, and that this was @ int@- of Congress. (2) @ction 60. 3 - ]Dnfinitionsi. In subsection (,C). "prac- ticing physician" is dotined. Undc-.,r the term "prac- ticino pbypician, "' as defined in the reiftilations, eX that is r@itrcd Is licensure by the applicable state. We believe that Odis ool* criterion given no effect to the word "Practicing" iLnd in therefore not in keep@ with the Congression4 Intent. Accordingly,, we r* nd @ Om period after the word be WMtam B. Stewart, M.D. Decernber 10, l9G5 changed to a cor-ams. and that tile following phrase be addcd: , -.and who Is -,2ritnnril,Z,vn ;O, In tht, diafinonlfi stnd trr-ttr,,.c-tit It In our opinion that Conc-.-reas Lntead @ active prac,461tionors to be moribers of the advis- ory @p and ttie National Advisory Council. (3) Section 66. 3 - D-cfinitions. We believe thttt @ word "demonstreltions" r;li@d be defined to evapbasize the lntendmerd of this logislaLtion conetrnin,,T such demon- @atiorm. An otdditional definition under Motion 66. 3 should be added tz fouows.- (il "ren@ tgn awing opening e*p 1:111th the thf,, r-Tatio-inl@ A dvit -orZ Council send, i%IM t7olLice t--3 t.130 notice r@)l@ Retail flic- L,).r tharovoc.,it-ton or terr.,-Inn,ti 29i gr" aivard raw be revokt4 ete. Section 00.10 - EVetWItures by gr@ce. We would relwn=end the falling chstnge in su@stectioa (d)-. @ert In the secon