*EOOOI97* REVIEW PROCESS REQUIRE 0 0 0 REVIEW PROCESS REQUIREMENTS AND STANDARDS Revised January 1974 This document sets forth the requirements governing the decentral- ization of project review and funding authority to Regional Medical Programs. That is, it defines 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 pro- posed activities are to be funded within the total amount available to it. The document also outlines the general manner and schedule for implementation to be followed. A. Requirements The minimum requirements or standards that a Region's review process must meet if project review and funding authority is to be decentralized to it are grouped as follows: Review Criteria and Program Priorities Application Staff Assistance, Review, and Surveillance CHP Review and Comment Technical Review Project Ranking and Funding Determinations Feedback Appeal Procedures 1. Review Criteria and Program Priorities: There must be explicit (1) technical review criteria and (2) program priorities which are applied to all operational proposals. These criteria and program pri- orities must be made available to all prospective applicants and appropriate areawide CHP agencies within the Region as well as RMPS. The review criteria must as a minimum reflect those factors considered in assessing the technical and intrinsic adequacy of operational proposals (e.g., the feasibility of the project, quality of the personnel and facilities, resources to be involved, and adequacy of the proposed evaluation). These criteria must in fact be used in the technical review process. For example, they must be applied by those committees and other groups with substantive responsibilities for reviewing and making recommendations to the Regional Advisory Group as to the technical adequacy of operational proposals. Program priorities should reflect regional needs and problems and appropriately complement RMPS and other national priorities. Put another way, those things which the Regional Medical Program and its Regional Advisory Group have identified, and perhaps are actively promoting, that warrant particular and more immediate attention and January 1974 thus have a special claim on their limited dollar and other resources. As such, the program priorities constitute a major factor taken into account in determining which regionally approved 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., instructions and outline to be followed) that is employed by community hospitals, local medical societies, medical centers, and other applicants in requesting grant funds of it. It would be desirable if the review criteria and program priorities of the Region were an integral part of the application package sent to all prospective applicants. 3. Staff Assistante, Review and Surveillance: Program Staffs must 9 respond to preliminary applications and stand prepared to advise and assist all prospective applicants in a similar or equitable fashion. It is suggested that Program Staffs prepare summaries of proposed projects for the technical review committees and Regional Advisory Group. Furthermore, where proposals have been substantively reviewed by. Program Staff, these critiques should be provided to the technical review committees. Similarly, any suggested substantive changes in the proposal should be transmitted to applicants. Periodic surveillance or monitoring of funded operational. projects by core staff is required so as to insure that the original intent and purpose of such projects are being fulfilled and progress is stttisfac- tory. One way in which this requirement might be satisfied would be to assign a Program Staff member this responsibility at the outset of a project and have him follow that project through to its completion. It also would be desirable if periodic progress reports on projects were made to the Regional Advisory Group. 4. CHP Review and Comment: P.L. 91-515 provides that an RMP application may be approved iLt the Federal level only if recommended by the Regional Advisory Group and only "if opportunity have been provided, prior to such recommendation, for consideration o t e application by each public or nonprofit private agency or organi- zation 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 appli- cation is made will be located." 2 January 1974 As noted in the advice letter from the Director of RMPS to all coordinators, dated January 18, 1971, the agencies from which comments must be solicited include: (1) Areawide Comprehensive Health Planning agencies 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 areawide 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 any "B" agency comments received by the Region or in lieu of such comments, by a letter signed by the Chairman of the Regional Advisory Group certifying that the application or materials adequately describing the activities proposed in the application have been furnished to the appropriate "B" agency or agencies and that, after a period of thirty (30) days, no comments have been received. A shorter period or other modified procedures may be specified by RMPS in special instructions where necessary to accommodate special application deadlines with a short lead time. 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 intoiconsideration by that Group, it would be highly desirable if the application submitted to RNPS explicitly took cognizance of and spoke to any especially critical and/or negative "B" agency comments. Material sent to "B" agencies for comment should describe RMP activities in sufficient detail to enable the "B" agency to make appropriate comments, It is suggested that such material: (1) List or call attention to all health care facilities or institutions involved in the RMP activities described in the application. (2) Indicate the amount of RMPS 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. 3 January 1974 Materials sent to "B" agnecies for review and comment should encompass and include proposed Program Staff as well as operational activities. Information relating to all Program Staff activities must be sent for comment to all "B" agencies serving the Region, in whole or in part. While most operational activities should, like- wise, be sent to all "B" agencies. Information relating to those operational activities whose impact is confined to a specific area within the region, need to be sent for comment only to those "B" agencies directly concerned. 5. Technical Review: Each Region must have, in addition to the legislatively required Regional Advisory Group, technical review committees or groups. These may be either standing committees or ad hoc groups; they may be subcommittees of the Regional Advisory Group itself, linked to it, or quite separate from it4, and they may be single or multi-purpose groups (e.g., ad hoc review group, cate- gorical planning and review committee). In short, Regions have considerable latitude as to how their technical review is structured. 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, possibly from outside the Region, to provide adequate technical review of specific proposals from time to time. It would be desirable if the selection process for technical review committees includesnominations or suggestions from a variety of sources, including the Regional Advisory Group. It also is desirable that the composition of these committees feflect a broad spectrum of health interests and institutions, including private practitioners, community hospitals, and allied health personnel. The manner in which members 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 currently applicable RMPS requirements. Summaries of technical review committee findings and recommendations must be available to the Regional Advisory Group prior to their meeting at which the projects in question will be considered. With respect to technical review committees, the Regional Advisory Group and any other groups taking actions on applications, situations involving a potential conflict of interest must be avoided in the - 4 - January 1974 regional review process as well as in the Federal review system. Thus, it is required that persons affiliated with an institution or activity being considered, not be a part of the review process considering that application. 6. Project Ranking and Funding Determinations: Regions must establish a priority ordering or ranking system (in general) for all project applications for which support is requested. Since such ordering or ranking would by definition reflect the relative position- of projects in relation to stated goals and priorities, the system itself should incorporate regional needs and program objectives, priorities and policies. The specifics of such a project ordering or ranking system, however, are left to each Region to determine. Thus, it might provide for either an interval (e.g., 1-2-3-4-5) or ordinal (e.g., high-medium- low priority) ranking of projects, or some other suitable means for reflecting priorities. The application of the system must be the responsibility of the Regional Advisory Group. Final determination must be made by it as to the relative or comparative priority ordering or ranking of approved activities and their eventual funding. It is anticipated that regional funding decisions (e.g., whether to fund, level of funding) generally would be guided by each Region's own project priorities. 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 been dis- allowed in terms of technical adequacy and/or regional priorities. Applicants generally should not have to wait more than four months between the time the application is entered into the RMP review process and RAG notification of its action. If a project is approved with conditions, or has been modified as a result of the regional review, there should be evidence of acceptance of such conditions and/or modifications by the applicant organization add/or project director. 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) without reference to the RAG in order to provide applicants with the option of appealing such adverse actions to the Advisory Group itself. 5 - January 1974 The levels of review, prior to RAG action, should be clearly out- lined, including the method of appointing the membership of these groups and be made available at the time of site-vi.sit or manage- ment assessment-visits. Copies of this procedure should also be made known to all applicants. B. Scope In addition to meeting the minimum requirements and standards set forth above for operational proposals, the regional review process must also provide for general Regional Advisory Group review and approval of overall Program Staff funding and staffing. Where it is proposed that Program staff conduct project-like activities (disease registries, library services, pilot or experimental training programs, etc.), these should be reviewed for priority and technical adequacy in the same manner as clearly identified operational proposals. Special requirements may apply to kidney and renal disease proposals such as those for integrated dialysis-transplantation centers or pro- grams, or to major constituent elements thereof such as tissue typing or organ procurement. All kidney projects where Federal reimburse- ment for services is contemplated are subject to the provisions of the "HEW Interim Regulations on Payment for Treatment of Chronic Renal Disease." (See Federal Register, June 29, 1973.) The Regulations pertain to payment for services to entitled beneficiaries in connection with kidney transplants and renal dialysis. Where applicable, RMPs must advise the institution that is to conduct the kidney activity to obtain required interim approval from the Social Security Admin- istration in accordance with the above Regulations. Further, RMIPS funds may not be used to fund any kidney activity requiring interim approval until such approval is obtained. C. Documentation The following documentation reflective of a Region's review process and structure must either be routinely submitted to RMPS as specified elsewhere (e.g., application) and/or be available for its review and examination: The review criteria and program priorities currently employed in determining the technical adequacy of proposals and their priority rankings respectively The standard application form or format, and instruc- tions being used The comments submitted by areawide CHP (or "Btl) agencies The procedures or practices governing appointment to and the operations of these committees The current membership of technical review committees - 6 - 0 January 1974 The minutes, reports, or summaries of technical review committee and RAG meetings covering their deliberations and actions on proposals, including eventual funding determinations Where appropriate, the established appeal procedure; and RAG minutes reflecting any appeal actions Any other written materials, including general application review procedures, pertaining to the review of proposals, either generally or specifically, at the regional or local level. D. Implementation RMPS staff visit will be conducted to assess the regional review process subsequent to submission and examination of the documenta- tion enumerated above in Part C. In some instances, review process verification will be undertaken in conjunction with regular management assessment visits. Where discrepancies are found, RMPS staff is prepared to provide consultation and assistance to help Regional Medical Programs to meet the prescribed minimum standards. Any Regional Medical Program which within a reasonable period after notification of deficiencies is not in substantial compliance with minimum standards will forfeit its project review and funding authority. Failure to comply will also be brought to the attention of the Natianal Advisory Council. 7