ia regional medical - SPECIAL ISSUE. programs FOR LIMITED DISTRIBUTION 5 service e news ‘Information oc ‘data A communication device designed to speed the exchange of news, ; information and data on "FAST" REPORT Re Regional Medical Programs Regional Medical Programs and? related activities. October 22, 1970 - Vol, 4, No. 455 Keproduced in this issue is that section of the "FAST" Report of July 8, 1970 which is concerned with Regional Medical Programs Service. FAST, an acronym for Federal Assistance Streamlining Task Force, was a special Department of Health, Education, and Welfare group working under Frederic V. Malek, former Deputy Under Secretary. This group was assigned to study grant review procedures of various Depart-- mental agencies and to make recommendations to streamline them by eliminating "red tape." The recommendations of this report are currently being studied to see how they can best be implemented in accordance with the orders of the Department, the plans of Health Services and Mental Ilealth Administration and Regional Medical Programs Service, and in the best interests of the Regional Medical Programs themselves. Distribution: . Coordinators of Regional Medical Programs Members of National Advisory Council and Review Committee on Regional Medical Programs Staff of Regional Medical Programs Service Regional Health Directors of Department of llealth, Education, and Welfare Regional Offices U.S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Publie Health Service « Health Services and Mental Health Administration ¢ Rockville, Marvland 20852 July 8, 1970 Regional Medical Program The Regional Medical Program, administered by the Regional Medical Program Service (HSMHA-RMPS) , provides grant support for organizations or groups of organizations or agencies es- tablished on a regional basis for combatting heart disease, cancer, stroke and related diseases in a defined geographical area, (RMP). There are presently 55 RMP's covering the entire -nation.— (See map). An RMP generally includes a medical school, clinical research center and teaching hospital. Some RMP's are incorporated as separate legal entities. Others consist of confederations of cooperating groups with a medical society or a medical school serving aS a fiscal agent. Fach RMP is required to have a Regional Advisory Group (RAG) which usually functions like a : board of directors and sometimes as a technical review group. The 55 RMP's were set up between 1966 and 1969 under the au- thority of PL 89-239, enacted in 1965. The law provides grant support for (a) organizing and establishing regional medical programs (planning grants), and (b) supporting research, demonstrations and training projects relating to the various disease categories (operational grants). All but one region are now."operational". a Passage of. PL 89-239 was stimulated by the report of the Commission on Heart, Cancer and Stroke established earlier by Congress "to recommend steps to reduce the incidence of these diseases" which account for over 70% of all deaths in the U.S. The,Commission was made up of a panel of medical -experts and distinquished citizens. The basic purpose of the legislation is to diffuse and dis- seminate rapidly expanding medical knowledge from the labo- “ratories and educational institutions to practitioners for the benefits of their patients. Purpose - ~ gection 900, Title IX of the Public Health Service Act defines the goal of the Regional Medical Program (RMP) in detail: “TITLE IX--EDUCATION, RESEARCH, TRAINING, AND DEMON- | STRATIONS IN THE FIELDS OF HEART DISEASE, CANCER, STROKE, AND RELATED DISEASES" _ : : Purposes (a) Through grants, to encourage and assist in the establishment of regional cooperative arrangements among medical schools, research institutions, and hospitals for research and training (including con- -cinuing education) and for related demonstrations of patient care in the fields of heart disease, cancer, stroke, and related diseases; , (b) To afford to the medical profession and the medi- cal institutions of the Nation, through such cooper~ ative arrangements, the opportunity of making available to their patients the latest advances in the diagnosis and treatment of these diseases; and (c) By these means, to improve generally the health manpower and facilities available to the Nation, and to accomplish these ends without interferring with the patterns, or the methods of financing, or patient care or professional practice, or with the adminisr ~ tration of hospitals, and in cooperation with practicr ing physicians, medical center officials, hospital. ad~ ministrators, and representatives from appropriate _ voluntary health agencies." The Surgeon General has appointed a National Advisory Coungil on Regional Medical Programs to assist in the preparation of regulations and to advise on policy matters concerning the administration of this Title. The Council consists of the Administrator of the Health Services and Mental Health Aginp nis tration and 15 members who are leadérs in the fields of fh fundamental sciences, the medical sciences and publi¢ affairs, It should be noted that review and approval of the 55 Regional Medical Programs is not a matter of periodic competition among eligible applicants which results in the full funding 9f some Regional Medical Programs and no funding of others. It is © rather a continuing assessment of the progress with which each © TTT individual Regional Medical Program is carrying out.the purposes of the legislation. . The law authorized Regional Medical Programs for three years. In 1968, Congress extended the authorization for two more years. Fiscal year ending: Appropriation: 6/30/66 $24,000,000 6/30/67 43,000,000 6/30/68 53,900,000 6/30/69 56,200,000 6/30/70 93,600,000 There is no apparent national strategy for carrying out the program. The RMP's initiate projects and submit applications ‘to the Government for review. Reviews are carried out on a _ project-by-project basis. Statistics for approved projects by disease category and type of activity are as follows: Total Number Current Percent Disease’ Activities Funding of total (thousands) Heart . 168 $14,872.8 28.0. Cancer 86 6,978.2 13.0 Stroke 56 6,320.8 12.0 Other 56 5,647.0 11.0 ; Number Total Percent Activity Emphasis Activities Funding of total , (thousands) Education & Training 330 28,106.8 53.0 Demonstration of Care 161 18 ,990.6 . 36.0 Research & Development 59 6,091.2 11.0 (Core staff activities support = $40 million). Examples of. the types of projects funded under PL 89-239 in- clude: cancer registries, mobile coronary care, training in coronary care, and bioinstrumentation. . The number of projects per RMP varies from 3 to 27 averaging about 10. For obvious reasons the regions which were es- tablished first generally have more operational projects than ‘those: organized later. There is also considerable variation ' in project emphasis from region-to-region. One region for example is predominantly involved in projects relating to instrumentation and electronic hardware. Some are involved primarily in projects relating. to heart disease. PL 89-239 is administered by the Regional Medical Program Service, 4 unit of the Health Services and Mental Health Ad- ministration. (To avoid confusion, referred to in this report as HSMHA-RMPS as opposed to the abbreviation RMP used to. designate grantees) - Eligible Applicant Public or nonprofit private universities, medical schools, research institutions and other public or nonprofit private agencies and institutions are eligible to apply for a grant | to plan and/or operate a Regional Medical Program. Bach appli- cant must be authorized to represent the agencies and insti- tutions which propose to cooperate in planning for and de- veloping the Regional Medical Program. Additionally, each applicant must be able to exercise program coordination and fiscal responsibility- The Regional Advisory Group The Act specifies that each applicant must have designated a “~ Regional Advisory Group (RAG) to advise him in planning and far operating the Program. The Act also specifies that the Moy - Advisory Group must approve an application for any operational grant. The Advisory Group includes practicing physicians, medical center officials, hospital aaministrators, representa- tives of other organizations, institutions, and agencies, and members of the public familiar with the need for the services provided under the Program. The Regional Advisory Group provides overall advice and gui- dance to the Regional Medical Program jin the planning and operating phases of the program from the initial steps onward. It is actively involved in the development of the regional objectives, ag well as the review, guidance, and coordinated evaluation of the ongoing planning and operating functions. Present Program Since the signing of the Act, broadly representative groups have organized themselves to. conduct Regional Medical Programs in 55 regions which they themselves have defined. Together - these regions encompass the Nation's population. The 55 regions first received planning grants (Section 903). — Each award was based on a narrative escription of the proposed region including appropriate demographic and descriptive data supporting the preliminary delineation of the region, back~ ground and history of the proposed organizational structure and how it will function, the nature of the Regional Advisory Group and how it was selected and a description of how the planning activities will contribute to the goal of that Regional Medical Program. Of the 55 Regional Medical Programs, all but one have since achieved operational status (Section 904). Operational Grant Application A Regional Medical Program operational grant is made up of a number of components. The principal one is referred to as the Program core. It provides the funds for the Program staff activities, including program direction and coordination of planning, and professional services to the institutions, agencies, and ‘individuals that cooperate to make up a Regional Medical Program. The core component is identified by a separate budget line item. The other grant components are generally referred to as. rojects. The activities they support are individually des-~ Gribed in Regional Medical Program applications and each has a separate budget. These activities are conducted and ad- ministered in much the same way as any project grant. Their. . individual objectives are time limited (usually from one to three and occasionally five years) and they are undertaken as an adjunct activity of an institution or agency whose person nel and facilities they usually share. It is important to note, however, that the projects which make up a Regional Medical Program Grant have goals and objectives which are re- Tated to the goals and objectives of the total Program Grant. The planning activities initially funded under the provisions of section 903 may be continued and expanded as integral part of the operational activities. Regional Medical Program Review Applications for initial operational grants (Type I--New) undergo a rather thorough review at the Regional Medical Program Grant level. Most of the 55 regions have in addition to. their statutory Regional Advisory Group, a series of cate- gorical and other planning and review committees to assist with the review of operational project proposals. These com- mittees review and evaluate proposed projects and activities aN tn, 6 for their technical or substantive merit prior to final action by the Regional Advisory Group. Only those favorably recom- mended or approved by the RAG may be included in the Regional Medical Program grant application to the Public Health Service (RMPS). Federal Review Upon receipt of the application by the HSMHA Regional Medical Programs Service all project components contained in the grant application are subjected to a series of HSMHA Regional Medi- ‘cal Programs Service staff comments and then evaluated by a technical review panel and the Public Health Service Regional Medical Program Review Committee (an Advisory Committee com- posed of non-Federal specialists). Review Committee meetings are scheduled regularly to review and evaluate the professional aspects of all 55 Regional Medical Program applications. They consider reports of Public Health Service staff, outside re- viewers and site visit teams and recommend time and amount of support to the National Advisory Council for its consideration at a subsequent meeting. The Review Committee and Advisory Council members participate in site visits to RMP. The final review of applications is by the National Advisory Council on Regional Medical Programs. The Council considers fhe recommendations and findings of the Review Committee in- cluding the full array of material assembled during the entire review process. The Council's final recommendation, required by statute before a grant can be awarded, concerns the ap- plication as a whole and includes a recommendation of an overall grant amount. Awards After the Council's recommendations are made, the HSMHA Regional > Medical Programs Service staff informs the applicant and re- lates the Council's concerns and recommendations in detail. If the recommended amount has been reduced below the amount requested for those projects or activities not specifically disapproved, the applicant must return to its own decision- making group (Regional Advisory Group), which reassesses pri- orities, and submits a revised budget to HSMHA Regional Medi- cal Programs Service showing a redistribution of the recommended amount among the approved projects or component activities. -It is on the basis of this resubmitted budget with the projects it covers that an award is made for the program. 7 A single grant igs made for a "program period" of three years, which is made Up of "budget periods" of 12-months each. Having received such a grant, an "operational re jon" may ap7. ply at any time for additional funding (Type TiT-supplemental) to initiate new components oF to expand existing ones- These applications go through the same review process as described previously, beginning with the Regional Advisory Group and with final action recommended by the National Advisory council. on Applications: at the end of each "budget period" Continuati PP of each program award, HSMHA Regional Medical Programs Service - staff review precedes funding of a continuation award (Type V)- Renewal A plications: at the end of the "program period" of the initial operational grant, the entire program of the appli-. cant region (including all components added by supplemental grants, regardless of their budget periods) undergoes the com- . plete review by peers and staff, as for a new application. The award that is made as a4 result of this review provides for | the renewal of support of the RMP (Type II) and as such renews, ‘or more accurately, extends the program period--with the program goals and purposes remaining essentially the same but with the components changing from time to time. In summary, new and renewal operational project applications are generally reviewed as follows: Grantee Review 1) Application submitted to RMP. 2) Review by RMP staff and RMP technical panel. 3) Copy. of application to 314(b) agency for information. 4) Review by RMP review committee. 5) Review and approved by RAG. Federal Review 6) Submitted to HSMHA-RMPS.- 7) Grants review branch (GRB) solicits management and techni- | cal review from RMPS staff. 8) GRB submits package to Technical Review Branch. 8 9) Recommendations submitted to RMP Review Committee (site visit, if necessary) .- 10) Review Committee recommendations submitted to National Advisory Council on RMP. 11) NACRMP recommendations submitted to Director, RMPS. 12) Director, RMPS, office negotiates approvals to RMP. 13) Director, RMPS, office issues awards. The findings and recommendations address themselves to the following issues: A) Program review at the Federal level. B) Project review at the RMP level. C) Policy and procedures documents. D) Application forms. E) Core staff of the RMP. F) Periodic reporting procedures. G) Role of HEW Regional Office. Findings | The review process has been a source of concern to HSMHA-RMPS. A consultant was hired and served for a year as a member of the staff. During 1968-69, he conducted a study for HSMHA~RMPS titled."The Review Process for Regional Medical Programs". This report states that: "In the spring of 1968, only 13 of the 54 regional programs had progressed from the planning to the oper- ational stage. In the spring of 1969, when the total number of programs had risen to 55, 44 of them were operational. Starting with the April-May 1968 review cycle, the volume of applications for grants began to escalate sharply. Primarily, applications for initial oper- ational grants and for operational supplements, the volume grew to a level which inundated the Division. Regions have been allowed to request operational ‘supplements in every review cycle or as often as four times a year. Consequently, in the last two quarter- ly cycles of calendar 1968 and the first two cycles of 1969, the number of applications being presented to staff, Review Committee and National Advisory Council ranged between 45 to 75 applications from 35 to 45 regions in each cycle. In addition there were the usual number of Type V extensions for staff review. This process of coming of age strained the review process, at both the Federal and the regional levels, in such a vay as to make it a crucial subject for study. At the same time the rushing pace of events made it difficult to get the proper perspective. Fundamental conditions which were the basis of recommended change were themselves being altered with frequency. , The overwhelming volume of applications for review is probably most obvious when they are presented to the Review Committee. At the January 1969 committee there were 55 applications from 36 regions and at the April 1969 committee there were 47 ap lications from 33 regions. in each meeting the applications contained over 200 projects or proposals. In each session the Committee had to be divided into two panels, each of which re- viewed roughly one-half of the applications, represented by a stack of 'phone books! at each member's seat. Even augmented by some ad hoc members, each panel numbered only eight persons and a chairman, with the number dropping as low as five on the afternoon of the second day. With a few exceptions, even the most complicated - applications were not considered by the entire Committee, Inevitably there were differing interpretations of policy and other inconsistencies jn the two panels. At neither meeting did either panel learn precisely what action the other panel had taken prior to adjournment." The anniversary or annual review system proposed by the Regional Medical Programs Service and announced t9 the RMP coordinators May 8, 1970, is a major step twoard the reduction of frequency of project review of each Regional Medical Program. However, it does not reduce the annual workload of the Regional Medical Program or the HSMHA Regional Medical Program Service. There would still be more than 400 project proposals per year, plus a 6-month Federal review period for eagh project. In addition, the RMP could apply for up to-10% of the award as a "de- , yelopmental component" to be used tq fund projects during the period between annual Federal reviews. If the RMP does this, 10 however, it automatically would lose any discretionary use of carryover funds. Moreover, the Regional Medical Program would submit a relatively large package of project proposals only once each year and thereby lose the opportunity to fund projects when they are most timely. Project review by the Regional Medical Program is conducted in most instances very much like the Federal review. Peer experts and others participate in reviews-in-depth. Recommendations It is recommended that an anniversary or triennial review system be adopted in the following way: 1. Program Review at the Federal level be conducted trienni- ally by Regional Medical Program Review Committee and National Advisory Council for Regional Medical Program to include in depth site visit. 2. Annual Continuation Awards be made on the basis of the previously approved level of funding for the total program. 3. Applications that involve significant change in program direction or supplementary funds receive full pederal review by the HSMHA Regional Medical Programs Service for the pro- posed program changes. ll Findings The present HSMHA-RMPS review system for project applications .. submitted by the 55 Regional Medical Programs involves the’ full-time efforts of 20 headquarter staff plus the part-time efforts of at least 20 HSMHA~RMPS and other Federal staff. These may include the personnel of the Grants Review Branch, Grants Management Branch and, as needed, Program Assistance Branch, Continuing Education, Chronic Diseases, Systems Analy- Sis, etc. Recommendations are then forwarded to the Review Committee and Council. The process for an application re~ quires about six months. (At least 400 projects are reviewed each year.) Recommendations It is recommended that: 1. RMPS-HSMHA phase out project-by-project technical review. >. RMPS-HSMHA develop criteria by November 1, 1970 to permit each RMP to seek qualification as its own project review agency. 3. Application forms be revised to contain only elements necessary for review process. ; 12 oy Findings Regional Advisory Groups must review and act upon all opera- tional proposals. Only those favorably recommended or ap- proved may be included in the 55 Regions’ grant requests to the HSMHA Regional Medical Programs Service. The fact that as of January 1970, slightly less than two- thirds of the proposed operational projects or activities _ presented to Regional Advisory Groups have been approved by them--1021 out of a total of 1553--provides evidence that the technical and peer review procedure is being exercised in a critical, rather than mere rubber-stamp fashion. Most Regional Medical Programs have, in addition to their Regional Advisory Groups, a series of categorical and other planning and review committees to assist with the review of operational proposals. These committees generally review and evaluate proposed operational projects and activities for ‘their technical or substantive merit prior to final action by the Regional Advisory Groups. Recommendations It is recommended that: | ft » ue ‘te 1. Project review and funding responsibility be decentralized directly to each Regional Medical Program as soon as it meets established criteria. 13 Findings The current guidelines for HSMHA Regional Medical Programs Service policies and procedures used by the 55 Regional Medi- cal Program coordinators are inadequate. They are cumbersome, complex and repetitive. For example, on page 5 of the Guide- ‘lines dated May 1968, there is a functional statement for the > RAG. This statement is repeated on page 8 of the same docu-~ ment, with only minor modifications. The Addendum dated February 1970 is not presented in the same order as the origi- nal. . The coordinator gets no clear statement of Departmental, Health Services and Mental Health Administration, and Regional Medical Programs Service policies and procedures from which he can manage his program without frequent communication to elements of HSMHA Regional Medical Programs Service to seek advice in these areas. In addition several of the RMPS have established their own guidelines which appear to vary as to the felt needs of the region as stated in the RMP progress summaries dated April 27, 1970. It is not known what consti- tuted the source material of these local guidelines. At the © recently held Airlie House Conference for the 55 Regional Medical Programs'. Coordinators and Directors, several coordi- nators related experiences where the same question was answered differently by different elements of the HSMHA Regional Medical Programs Service. While it is necessary for the Regional Medical Program coordi~ nators to have fully detailed statements of instructions con- — cerning the types of support permitted under the authority of pitle IX, too much detail in the application form instructions - tends to solidify the nature of the program and reduce the opportunities for innovation. Recommendations It is recommended that: 1. HSMHA-RMPS prepare a clearly stated looseleaf policy and procedures manual for use by RMP staff and RO-HEW staff. 2, The manual contain detailed instructions for application procedures. — Findings The currently proposed application form requires that infor- mation be supplied repetitively but in different configur~- ations for detailed project review. The sample reviewed at the Airlie House meeting May 8, 1970 contained 112 pages of instructions ana forms. Form No. 7, for example is used at least five times. Continuation Reviews: Continuation applications like new. applications generally exceed the size of major city telephone -@irectories. One application examined by the Task Force was 5-1/2 inches thick weighing 14 pounds. These continuation applications are reviewed by an internal staff committee which has neither fixed membership, rules of procedure Or criteria for review. Membership varies depending on the staff available for attendance. Decisions are usually made on the basis of informal concensus. If. detailed project review at the Federal level ig eliminated, there is no need for a lengthy and complex application form with accompanying complex instructions. Recommendations It is recommended that: 1. An application form for new and renewals (Types I, Il, III) be developed consistent with proposed HSMHA master forms. 2. An application form for continuation (Type v) be developed. 15 Findings: Core staff of the 55 Regional Medical programs performs two primary functions: (1) Administrative management of the basic grant and its components, and (2) Operational activities related to the development, review, and maintenance of projects and programs. For example, the maintenance of a headquarters library facility falls under (1) above, while the development of an areawide library system falls under (2). Of the $93.6 million available funds, $40.4 million is used for core support. Generally RMP's estimate that 25-35% of total core staff time is currently spent preparing applications for project-by-_ project review and prior approval correspondence. Recommendations It is recommended that: 1. Applications for Regional Medical Program support indicate clearly the differentiation between core staff support for , administrative management and core staff support for other program functions. This will permit the National Advisory Committee to evaluate more critically the needs of different core functions. oo 16 a Findings The proposed triennial review of program will no longer en- able the 55 Regional Medical Programs to provide in a timely fashion the management information which is requested on the application form. Thus, there is a need for periodic report- ing procedures which will obtain from the 55 Regional Medical Programs, on a regular basis, information which the HSMHA Regional Medical Program Service can use for its own budget development program evaluation, etc. All updated expenditures and budget data for each region should be provided to the HSMHA Regional Medical Program Service on a continuing basis rather than "45 days prior to the Region's Anniversary Date or 120 days after the end of each grant period." The HSMHA Regional Medical Program Service procedure for the accountability, control, disbursement and reporting of RMP - grant funds should be included in the periodic reporting pro- cedure. Recommendations It is recommended that: “1. Periodic reporting procedures be developed independent aes of applications for support. a 17 Findings It is essential that staff of the Health, Education and Welfare Regional Offices be knowledgeable about all Federal programs which in one way or another interlock and be able to coordinate these efforts. The staff from the Health, Education and Welfare Regional Offices should work with Regional Medical Programs so that they may understand problems, be thoroughly familiar with the projects being considered and be able to provide opinions to the Regional Medical Programs and/or the HSMHA Regional Medical Programs Service on the merits or demerits of any particular project or program. Recommendations It is recommended that: 1. Copies of Program applications be sent to the HEW Regional Office from Regional Medical Programs for information and comment to be forwarded to HSMHA Regional Medical Program Service. This activity may facilitate more meaningful coordi- nation of RMP with other health programs. 2. Copies of award statements be sent to the HEW Regional Office by the HSMHA Regional Medical Programs Service. 3. Program Assistance activities be conducted from the HEW Regional Office by appropriate staff. These include attendance at RAG meetings, review meetings, etc., and the alerting of : headquarters to any significant changes in programs. 4... HEW Regional Office staff participate in all program re- view site visits. : i 5. Agreements be executed to assign responsibility to a single Regional Office for those Regional Medical Programs which cross HEW Regional boundaries. eo «€ @ © © @ @ e e@ a ee eb WD O49 8 ON Te ee nw i . 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. Regional Medical Program Map Key’ Maine | Tri State Northern New England Connecticut Metropolitan~-New York Nassau - Suffork Albany Central New York . Rochester Western New York New Jersey Greater Delaware Valley Susquehanna Valley » Western Pennsylvania Maryland D.C, Virginia West Virginia North Carolina South Carolina Northeast Ohio Northwest Ohio Ohio State Ohio Valley Tennessee Mid~South Memphis Georgia Alabama 52. - Colorado ~ Wyoming = é- Inter~Mountain » Hawaii - Florida Mississippi - Michigan - Indiana Wisconsin Tllinois - Bi+State Northland (Minnesota) © Towa - Missouri . Arkansas Louisiana - North Dakota - Nebraska ~- South Dakota’ Kansas - Oklahoma Texas Mountain States New Mexico Arizona Washington ~ Alaska Oregon California Puerto Rico. wt Be, REE a ee z GLOSSARY HSMHA-RMPS - Regional Medical Programs Service-HEW. NACRMP - National Advisory Council for Regional Medical Programs. RMPRC - Regional Medical Program Review Committee. - GRB - Grants Review Branch-HSMHA-RMPS. 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