ANI) ION The Assistant Secretary for licaltli I)ATE: NOV 1 1974 Througl-i: 1--,S/IL F@ROM Administrator, HRA SL)I'JECT- Implei,-ientation Plan for Title I, P I,.@ 93-,353 I@T!OIUIATTON As requested in your rieTorandura dated Septc.-ii,!ccr -L7, we have prepared. a scoping'documerlt concerning i-Pir@lc@nientatio-@). pi.o.iir, relates, to Title I of Public Laiq 93-353. the document You will note t. - contains a draft delegation of authority which, @i-f s.l.giicj, would authorize you to exercise essentially of tl,e. ati.!:Iiorities related to P.L.; 93-353. The dele-r-.tion would also f(-)-rpi.-.illy e-stz3,'I)Iish two .nex-7 national centers pursi-ini-it to the law. Fc),-:ii-..al documents will be submitted throLZh channels @;hortly. A formal. implementation plan will be submitted after we have reCC:LV cd your reaction to the scopin,- docu@tic@rj.t. .Dr. John Dalton in our Office of Yiana.gep)(-nt j,,4 coordina-tiii,, FTRA staff actions related to the implem6n.tation plan. Pleaje have your staff tall Dr. Dalton on extension 33580 for any information vote may need. Kenneth M. Endicott, M.D, Enclosures Tab A - Scopiilf,- Dociiif.-c-rit Tab B - 'Lc-l-@tat4@7e Tab C - Draft ',':ieiiiorailclu,-,, for Se-cre@Lary's Prepared by: IIRA:001-1., citLlj'014, 10/31/74, 3'@32/i@-@O SCOPING DOCUMENT To Implement Title I of the Health Services Research, Act of 1974 Health Statistics, and Medical Libraries TITLE: Health Services Research, Health Statistics, and Medical Libraries Act of 1974 (Public Law 93-353) DATE ENACTED: July 23, 1974 NARRATIVE SUMMARY: A. General Provisions The general authority and provisions contained in Title.I require the Secretary to undertake, through the National Centers for Health Services Research and for Health Statistics, research and statistical activities focusing on: individual health and envi- ronmental impact-- on it and on health care, health care access ibility, acceptability, organization, technology utilization, quality, financing and delivery, and public information concerning health care delivery systems. The Secretary is authorized to: utilize Departmental resources and grants and contracts for health services research and health statistical activities, admit and treat non-beneficiaries at PHS facilities, make' use of domestic and foreign consultants, an acquire, construct, and otherwise maintain a d operate research n facilities. The Secretary is required to report to Congress by September 1 each year on the administration, current state and progress of health services research and health statistics and, in addition, to make reports on the following to the President and Congress by September 1 each year: health care costs and financing, health resources, utilization of health resources, and the health of the Nation's people. Provisions relating to Confidentiality of Information concern both .NCHS and NCHSR and require that information may not be published or released without consent of the subject if the person or an establishment is identifiable in the case of health statistics or if a person is identifiable in the case of health services research. The Act also specifies that any NCHSR grant or contract application that is submitted for'possible funding under this authority and that exceeds $35,000 in direct costs must be reviewed for scien- tific merit by a panel of experts who are not employees of the United States. -2- 'contract is prohibited for a project The awarding of a grant or under the authority of Sections 304, 305, or 306 of the Act for Health Services Research and Health Statistics if authority for such a project exists elsewhere in the PHS Act. Applicants who submit applications under Sections 304, 305, or 306, for funds authorized elsewhere in the PHS Act must be notified of the other provision (or provisions) of the PHS Act under which such appli- cation may be submitted. B. Provisions of Title I Specifically Concerning the National Center for Health Services Research Establishes by statute -the National Center for Health Services Research.- Provides authority for the Department through the National Center to undertake and support research, evaluation, and demonstration projects which deal with the problem of organizing and delivering health services. Requires the National Center for Health Services Research to support and otherwise assist public and private nonprofit entities to plan and operate six multi-disciplinary research centers, and specifies that two of-the centers must be special emphasis centers, one to focus on-4,he application of technology to health care delivery, the other on the management of health delivery organi- The aggregate number of grants and contracts and aggregate amount of funds i-)i any fiscal year are restricted to 20 and $5 million respectively for any particular means or aspect of delivery of health set-,j.ces. C. Provisions of Title I Specifically Concerning the National Center for Health Statistics Statutorily establishes the National Center for Health Statistics' in DHEW. Provides authority to assist Federal, State, and local health agen.cies in designing and implementing a cooperative system for producing comparable and uniform health information and statistics at the Federal, State, and local levels. -3- Requires that the Secretary provide the Federal share of the data collection costs under such system and review statistical activ- ities of the Department of Health, Education, and Welfare to assure that they are consistent with the data system developed. Requires the collection, analysis, publication, and dissemination of statistics on a wide range of health and health related topics. Establishes in the Office of the Secretary a fifteen-member United States National Committee on Vital and Health Statistics. The principal functions of the Committee are to advise and assist the Secretary on various health statistical matters, to cooperate with national committees of other countries and the World Health Organization on health related issues, and to advise on the annual report on the state of the Nation's health, its health services, their cost and distribution, and to make proposals for improvement of the Nation's health statistics and health information systems. Provides for participation with other countries in cooperative endeavors with respect to health statistical activities. IV. MAJOR ACTIONS REQUIRED BY THE PHS: Delegation of authority (See Attachment A, draft memorandum). Determination of the resources that will be required to implement the Act. Establishment within the Office of the Secretary of a United States National Committee on Vital and Health Stat.;-stics, program advisory. and review committees, and national health (--,ouncils. Approval of implementation plans (See Attachment B, Tentative Implementation Plan). -V. ISSUES AND PROBLEMS: Implementation of training p rograms for health services researchers and health statisticians. Early implementation of the requirement that not less than 25 percent of the monies appropriated for the National Center for Health Services Research be used to fund an intramural research program. VI. LEGAL INTERPRETATIONS REQUIRED OR OBTAINED: The following legal issues have been identified and are being worked on with the Office of General Counsel: (1) Organizational location of United States National Committee on Vital and Health Statistics--Section 306(i). (2) Requirements oh furnishing Congress special statistical compilations and surveys--Section 306(c). (3) Legal requirements on all regulations and guidelines oh grants, contracts, cost sharing, written agreements--Sections 305(d) and 306(f). (4) Status of grant and contracting authority prior to the issuance of new regulations. (5) Interpretation of the section prohibiting.the use of National Center for Health Services Research funds for projects that could be funded under another authority. (6) The use of contracts as a means of conforming with the intra- 9 mural research requirement. VIIT, DHEW ORGANIZATIONS INVOLVED IN IMPLEMENTATION: The law requires that the health services research and health statistical activities of units of DHEW be coordinated and that all statistical activities of the Department b(@ reviewed to assure that they are consistent with the cooperative health statistics system. In this respect, all units of the Department involved in health services research, evaluation, or demonstration or in the collection of health data will be involved in the implementation of this law; This will include at least all H organizations, SSA, and SRS. VIII. DELEGATIONS OF AUTHORITY REQUIRED: (S6e Attachment A, already referred,to) IX. REGULATIONS REQUIRED: Both new and revised regulations will be required. We have consulted with OGC and have identified the regulations that will have to be developed, as follows: (1) Regulations for grants and contracts to implement Section 306(b). (2) Regulations for grants and contracts for the centers under Section 305 (d) (1) (3) Regulations for grants and contracts for activities under Section 305(b). (4) Regulations for both grants and contracts to implement Section 304 (b) (1) (c) . (5) Regulations for both grants and contracts to implement Section 306 (b) (2) . (6) Regulations for both grants and contracts to implement Section 306 (e) (3) . (7) Regulations to implement Section 308(d) which should deal with both the issues of consent and the circumstances under which the program would wish to authorize the material to be used for purposes other than the purposes for which collected. X,. REPORTS @UIRED: The Secretary is required (Section 308(a)) to sub mit detailed reports to Congress and the President by September 1 each year on the status -and progress of NCHSR and NCHS programs. XI. DOLLAR AUTHORIZATION PROVIDED: Title I, Section 308(i)(1) authorized apprc)oriations of $65,200,000 for the fiscal year ending June 30, 1975, @Lnd $80,000,000 for the fiscal year ending June 30i 1976, for health services research, evaluation, and demonstration activities under Sections 304 or 305. Of the funds authorized for any fiscal year, not less than 25 per centum shall be made available only for health services research, evaluation, and demonstration activities directly undertaken by the Secretary. The aggregate number of grants and contracts made or entered into under Sections 304 and 305 for any fiscal year may not exceed 20, and the aggregate amount of funds obligated under grants and contracts under Sections 304 and 305 for any fiscal year may not exceed $5,000,000. Title I, Section 308(i)(2), authorized appropriations of $30,000,000 for the fiscal year ending June 30, 1975, and $30,000,000 for the fiscal year ending June 30, 1976, for health statistical activities under Sections 304 or 306. -6- Xii. IMPACT ON H RESOURCES: The impact of the law on H resources will depend on the priorities of H and the Department and the extent to which the Secretary decides to implement the authorities granted him. For NCHS, the Department budget request for FY 1976 includes $39.3 million and 547 positions (an increase of $15.3 million and 23 positions). This budget is based on getting legislative approval for increases in the NCHS ceiling per the Congressional Conference Committee report on this law. The budget developed does not include implementation of the grant programs, the cost of developing the required reports, nor increased coordination and other respons'ibil- ities, which are estimated to require an additional $6 million and 30 positions in FY 1976. A further increase of $16 million is estimated for PY 1977. Specific position allocations will be dependent on the resolution of the implementation issues and plans for both Centers. For NCHSR, Section 308(i) of the Act requires for health services research, evaluation, and demonstration activities undertaken or supported under Sections 304 or 305, that not less than 25 percent of the monies appropriated for health services research must be used to support such activities directly undertaken by the Secretary (intra- mural activities). Congress intended that such a program shall be operated by the National Center for Health Services Research. Although NCHSR cannot fulfill this specific legislative requirement immediately, we estimate that a meaningful intramural research program can be implemented at annualized end-of-fiscal-year obligation rates of $3, $10.5, and $18 million for FY 1975, 1976i and 1977 respectively. Based on an examination of staffing patterns at NIH and among its own grantees, NCHSR estimates that such a program will require 20 additional positions in FY 1975 and 50 more in both FY 1976 and 1977. A research activity is much more labbr-intensive than the adminis- tration of giants and contracts. XIII. DATE OF FINAL PLAN SUBMISSION: The date of submission of the final plan to H is highly dependent upon H and/or OS reaction to the issues raised in this scoping document. 9'-353 official to be in charge of o,7ersee@r. F i-a'@erials to aoo'@i-sh the current enIA @uD,-ait r,,aL@C-rj4-als to establish the new -.,-d sub-'t necessary A-ele@at-Lons of authority to '-'@o--altb and from foz to t"-ie Au@M4 4s-rator, ".@-,COScary 1-clegat-@or-s of aL,@.hority 'L r c:-, ii c I) 4 ol ITC-1 to t@,a rc-s-@-,ccti-ve -L-.cectors s step will be accomplished tT,,o @,,-ceKs after e-at4onS. other de'-- Pra-.7r,-- c-,n;4- ;-zl@Llr-@ t a1t c issues requir4--i-, resolution y -MP P@-e regulations concerning t@-.e i lea-er-tation of I Ai @-,echan4---ms as specified in, Sec. -',04. @j c I - -.L -L 1 -Dec. f and Sec. @@07 s 4-'c, -Lire information regc-rci,,,.g the provisions of the T 4- a! Off4-ces as to the provisions of the ard T)rc,-ress in ir-lple:rer-tatio-@i of the provisions TE'@\'T@-,--'-rVE PLA-N, P.L,. 93-353 2 I C 131 7:7! n u T H S 1 C S RESEAY,,.!@'H rf,,@@llatiolis for research revise and s d,-Dends upon clearance in @Lc)-c c,rant procran,.s OIL7f-'@zc-- 04 the Secretary) --!-cants for crart --struct@o-s to ap, p,eV4 c or develop grant aDDl@l-ca@14.on for'cs if necessary O', clearance or, -I.nst-f--uctio-,is, and application n@--,2ssary Ar.r,ou-nce grant pro-ram to clientele incl,,id4n- dates for ilz-,--ss-'on o applications (to be done within three weel@s afte@ a,? -p r forms and instructions) c-@,7al o--F' -i-@h r)eer review groups or realign ct,-i-rcnt g-rou,)s Devello regulations and/or I-lu4@deli-nes for application p -v4ew as Necessary 4 "lOT)l icat4-ons Al I D&vel-cD plans for irLplerent-',-ng i-rtratu--al research Al 4 V- S C, T.': research act -ntramural ivities -n--val-bp re-,.ilati6-,is for contracts--Sec. -0- con@rrct ro,-,ram eevejoD work i5l ans a-rd RFPs IA R.@,v4 co-@ti - cts zl--,@ard coil-@-@act@- riev=-!oD -retaliations for the Cementation of Sec.3'jS(d)(2) -4- c 'FO" F@@AL-"H STA'-IIST-ICS at@ onal Cor:m' an! the U-,i4ted States N -ttee on Vital abo!4-s'a prc-ldecessor--co@-jnittp-e rct-ulations for 4,72,)lemc-ntaL- 4- o I-Al :@DC-VP-16r, zuide!4-,-.es for of @c. 3o6. (f) D rec@-L-liat-',-Ons for S--c '&' Sec 3'V'6 @'e) (3) -or con-.--acL@ Dto--r-am develop work plans and -RFPs Rev4-c;T- contracts t@T"" corrr@,cts ---L @n'd Drocedures --For dater-@4-,ra@-@Lo-.i OIL Feder-a! s r- s':,. u- c r S c- c 'o (e) 4) a,- d S e c 3 li 'o (h) a. s h@. e -n- of -roup of the CHSS Advisory C a e o-r plan reno.-t to Ad,,-.i-sory Cor@,pittee c .r--t@osal for interim cost sharip-c, arrangements Al '-er4a ar,-d Dro--ed.-,ires are --ost sha--r-Trc, c.--- to take another year.) TO The Assistant Secretary for Health Po Secretary SUBJECT: Designation of National Centers and Delegation of Authority Pursuant to the provisions of Public Law 93-353, the National Center for Health Services Research and the National Center for Health Statistics. are hereby established as bureau-level organizations within the Health Rpsources Administration of the Public Health Service. The new National Centers replace the previously established Bureau of Health Services Research and the National Center for Health Statistics, respectively. .The Directors of the predecessor organizations are hereby designated as -Directors of tl-ie new National Centers. All delegations or redelegations to any officers or employees of the National Center for Health S ervices Research or the National Center for Health.Statistics which were in effect prior to the eff&ctive date of this memorandum cont nue in effect in them or their successors, pending further redelegation. I hereby delegate to the Assistant Secretary for Health the authority vested in me by Public Law 93-353, except for the prescribing of regulations. These authorities may be redelegated and they supersede any delegations of authority under the sections of the Public Health Service Act amended by' Public Law 93-353. The designations and delegations outlined above are effective as of this date. Caspar,W. Weinberger