ti I i Discussion Draft 1/21./71 @IENTS AND STANDARDS MIP REVIEW PROCESS REQIJIRL@ This document outlines the requirements governing the dece ntral- izatiori of project review to Regional Medical Programs. That is, those minimum standards which must be met by a Region for it to make the final decisions regarding (1) the technical adequacy of proposed operational projects and (2) which proposed activities are to be funded within the total amount made available to it. (These require- ments and standards will be incorporated within the revised RMP Guidelines now being developed and reflected by the RMP Regulations which also are in the process of being revised.) Decentralization of project review authority is of course inherent ,in the developmental component concept of Anniversary Review4 Moreover, it was recommended by the FAST Task Force in its Report on Re-. ional 9 Medical Programs.. Requirements The minimum requirements or standards that a Region's review process must meet before project review authority will be decentral- ized to it, fall into the following categories: Review Criteria and Program Priorities (2) Application (3) Staff Assistance, Review, and Surveillance (4) CHP Review and Comment (5) Technical Review Structure (6) RAG Ranking and Funding Determinations (7) Feedback (8) Appeal Procedures (9) Documentation (1) Review Criteria and Program Priorities. There must be explicit (1) technical review criteria and (2) program priorities which are applied to all operational and other project-type proposals. These criteria and priorities must be made available to all prospective applicants and appropriate area-wide CHP agencies within the Region as well as @S. The review criteria must as a minimum reflect those factors (e.g., the feasibility of the project, quality of the personnel and facilities, resources to be involved, and adequacy of the proposed evaluation) considered in assessing the technical or scientific adequacy of operational proposals. These criteria must in fact be applied by technical review committees and any other groups with sub- stantive responsibilities for reviewing and making recommendations to the Regional Advisory Group as,to the technical adquacy of operational proposals. Program priorities are those factors, which reflect regional needs and problems and appropriately complement RMPS and other national priorities (e.g., prevention and early detection, younger age groups, Model Cities related) taken into account (and/or processes followed in which) regionally approved in determining which (or the order proposals (i.e., technically adequate) are to be funded. The final responsibility for funding determinations, and thus the application of these program priorities, must reside with the Regional Advisory Group. (2) Application. The Region must have.a standardized application form or format (e.g., outline to be followed and instructions) that is employed by community hospitals, local medical societies, medical centers, and other applicants in requesting grant funds of it. It would be desir- able if the review criteria and program priorities of the Region were an integral part of the appli cation package sent to all prospective applicants. (3) Staff Assistance, Review and Surveillance The core staff must be prepared to assist all prospective ap- plicants in a similar fashion in preparing their applications or proposals. Moreover, once an application has been received, if it is reviewed and critiqued by the core staff, they should transmit any suggested changes in the proposal with the applicant. Proposals of a multi-faceted nature (e.g., cardiovascular nurse training, continuing cancer education for physicians, screening for hypertension as part of a health mainenance program) should be as- signed to the appropriate technical review committee (or committees) either (1) in accordance with a prescribed procedure or (2) upon the 'determination of the coordinator or his immediate deputy. It would be desirable if core staff prepared summaries of pro- posed projects for use by the technical review coDr;iittees. Further- more that where proposals have been substantively reviewed by core staff, their critiques be provided to the technical review committee. Periodic surveillance or monitoring of funded operational projects by core staff is required in order to insure that the original intent and purpose of such projects are being fulfilled and progress is satisfactory. One way in which this requirement might be satisfied would be by assigning a core staff member this responsibility at the outset of a project and having him following it through to its comple- tion. It also would be desirable if periodic or project progress were made'to the Regional Advisory Group routinely. (4) CHP Review and Comment POIL. 1-515 provides that an RMP application may be approved at the Federal level only if recommended by the Regional Advisory Group and only "if opportunity has been provided, prior to such recommendation, for consideration of the application by each public or nonprofit private agency or organization which has developed a comprehensive regional, metropolitan area or other local area plan referred to in Section 314(b) covering any area in which,the regional medical program for which the application is made will be located." As'noted in the advice letter: from the Director of RMPS to all coordinators, dated January 18, 1971, the agencies from i,7hich comments must be solicited include: (1) Areawide Comprehensive Ilealth Planning ac,encies receiving Federal assistance under Section 314(b) of the Public Health Service Act as amended ("B" agencies). (2) Other organizations meeting the requirements of Section 314(b) and designated as areaiqide comprehensive health planning agencies by the appropriate State Comprehensive Health Planning Agency ("A!' agency).. Furthermore each application to RMPS requesting grant Federal. support must be accompanied by copies of @"B" agency comments received by the Region or in lieu of such comments, by a letter signed by the Chairman of the Regional Advisor y Group certifying that the application or materials adequately describing the activities proposed in the application have been furnished to the appropriate "IV' agency or agencies and that, after a period of thirty (30) days, no comments have been received. While the signature of the Chairman of the Regional Advisory Group on the application, among other things signifies that any comments received have been taken into consideration by that Group, it would be highly desirable if the application submitted to RMPS explicitly took cognizance of and spoke to any -6- .especially critical and/or negative "B" agency comments. Material sent to "B" agencies for coirlment should describe RIP activities in sufficient detail to er,,.ible the "B" -agency to make appropriate corzients. It is suggested that such material, (1) list or call attention to all health care facilities or institutions involved in the PKIP activities described in the application. (2) Indicate the amount of RI@IPS funds to be requested for each. (3) Summarize any proposed steps to strengthen primary care through cooperative arrangements and regional linkages among health care institutions and providers. (4) Identify any major therapeutic equipment to be acquired or constructed or major alteration or renovation of health care facilities to be undertaken in connection with proposed RMP activities. Materials sent to "B" agencies for review and comment should encompass and include proposed core and developmental component activ- ities as well as operational proposals. Information relating to core activities or a developmental component must be sent for comment to all agencies serving the Region, in whole or in part. Information relating to projects whose impact is confined to a specific area within the region,.need to be sent for comment only to those "B" agen cies directly concerned. -7- It is strongly recommended that material be sent to the "B" agency sufficiently early in the revic@q cycle to permit any comments to be considered by the @IP's technical and area review groups, as well as the RAG, althouah only projects which have met the Region's criteria and priorities should be sent at this early stage. (5) Technical Review Structure Each Region must have in addition to the legislatively required Regional. Advisory Group technical review com-Laittes or groups. These may be either standing committees or ad hoc groups; they may be sub- committees of the Regional Advisory Group itself, linked to it, or quite separate from it; and they may be single or multi-purpose groups (e.g., ad hoc review group, categorical planning and review committee). In short,Regions have considerable latitude as to the how their review structure is organized. The composition of these technical review committees, individually and collectively, must be such that the technical, scientific, and professional expertise represented adequately embraces the scope of its review function (e.g., cancer, manpower, research and evaluation). This may necessitate bringing in additional expertise, including possibly from outside the Region, to provide adequate technical review of specific proposals from time to time. It is desirable if the selection process for technica rev-.ew committees include nominations or suggestions from a variety of sources (e.g., RAG, Regional Health Director, State and/or areawide CHP agencies). It also is desirable that the composition of these committees reflect a broad spectrum of health interests and insti- tutions, including private practitioners, community hospitals, and allied health personnel. The manner in which raembers are chosen or appointed, procedures or practices governing the frequency,and conduct of meetings, and the like must be in writing and have the concurrence of the Regional Advisory Group. In addition to employing explicit review criteria,, these committees should always have available to them and be guided by any RMPS requirements currently applicable. Summaries of technical review committee findings and recommenda- tions must be made available to the Regional Advisory Group before- hand. It is required that with respect to technical review committees, the Regional Advisory Group and any other groups taking actions on applications, that situations involving a conflict of interest be -avoided in the review process as it is in the Federal review system. That is,, by the requirement that persons affiliated with an institu- tion.or project being considered, not be a part of the review process considering that application. (6) RAG Ranking and Funding Determinations Inherent in Anniversary Review is the need for (or requirement) Regions to es tPILY l@ish prior-.+--y ranl-,i.ng system for all project applications for which support is requ,-,@tcei. This means that all project requests must.be given a priority ranking when submitted with the AR application. This i.-anRi-'n@ by definition would mean the deter- minat'&on of the relative position of projects in relation to stated goals end priorities of th.(-- program. Projects, as defined in the Guidel.i.nes, are particular activi- ties which are proposed for undertaking by a @IP as an integral part of its overall operational program. Thi..,13 Would include such discrete activates supported from core funds or conducted by core staff as specific feasibility studies and central regional resources or services. It is expected that high priority core activities will complement the Region's other activities. Thus, a mechanism also should be established which allows the RAG to oversee core projects which they have approved. The ranking system itself should reflect and/or incorporate regional needs and program objectives, priorities, and policies. The specifics of ranking system, however, are left to each Region to design. Application must be the responsibility of the Regional Advisory Group. Final determination must be made by it as to the relative or comparative ranking (or priority) of approved projects and their eventual funding. It is anticipated that fundinQ decisions generally would be guided by project rankings. (7) Feedback Each Region must have a formal feedback mechanism. Applicants and prospective project directors, whose proposals have been disapproved, should be given specific reasons why they have beer,, disallowed in terms of technical adequacy and/or regional priorities. Applicants should not have to wait more than approximately four months between the time the application is entered into the @IP review process and RAG notification of its action. If a project is approved with conditions, a formalized a-reement between the r-,MP and the C> project director should make those conditions clear. (8) Appeal Procedure A formal appeal mechanism must exist-in any Region where a proposal may be disapproved by a body other than the Regional Advisory Group (e.g., an executive or steering committee, the board of trustees of a new corporation) so the applicant has the option of appealing to the RAG as the final arbiter. The levels of review, prior to RAG action, should be clearly outline , inc uding the method of appointing the membership of these groups and be made available at the time of site-visit or management assessment-visit. Copies of this procedure should also be,made known to all applicants. (9) Documentation The following documentation reflective of a Region's review structure and function must either be routinely submitted to PINIPS and/or be available for its review and examination: (a) The review criteria and priorities currently employed in determining the technical adequacy of proposals and their priority rankings respectively. (b) The standard application form or format, and instructions being used. (c) The comments submitted by "B" agencies. (d) The current membership of technical review committees. (e) The procedures or practices governing appointment to and the operations of these committees. (f) The minutes, reports, or summaries of 'technical review committee and RAG meetings covering their deliberations and actions on proposals, including eventual funding determinations. (g) Where appropriate, the established appeal procedure; and RAG minutes reflecting any appeal actions. (h) t@y other written materials, including general application review procedures, pertaining to the review of proposals, either generally or specifically, at the regional or local level. ementation It is anticipated that most Regions will be able to fulfill the above requirements and thus have project review authority by December 31, 1971, and that all Regions must meet these minimum standards by no later than December 31, 1972. Any Region requesting a developmental component must meet them before such will be awarded to it. Regions that will be site visited or have a management assessment visit during this year MaNlll upon request, and as an adjunct to such a visit, have their review structure and process examined as to whether or not it meets the minimum Standards which have been established. Those Regions not scheduled fo r a site or management assessment team visit this year may request that their review process and structure be examined specifically so they may qualify to have project review authority decentralized to them. The latter will (1) necessitate that they submit the kinds of documentation set forth above and (2) probably require a special staff visit also. The objective is to have as many Regions qualify as soon as possible. Thus, RMPS staff is prepared not only to assess-regional review processes as to whether or not they meet these requirements, but to provide such consultation and assistance as will permit or assist Regions to meet the'minimum standards prescribed.