mye Draft: K, JULY 12, q i ig J / C. . DRAFT REGULATIONS paca, FOR dys GNATION OF HEALTH SERVICE AREAS FOR DISCUSSION. ONLY BASED ON HOUSE R FT BILL "fCcLintre M\\ BAUM 1974 een A. ¢ serenity, 5. The notice to each Governor required by 3 Such bqurtda DRAFT: 7/12/74 ANNOUNCEMENT OF AREA DESIGNATION PROCDURES 1. No later than 180 days following approval of the Act, the yréetary shall establish Health Service Areas throughout the i n¥@ted States, and, thereafter al] areas of every State shall all times be included in a Health Service Area so established for the purposes of the Act. ! 2. Th &niiBG OSS ary shall establish Health Service Areas, or 1 revise Buc } as, through publication of the boundaries (or revised n@aries) of such areas in the Federal Register. (or revised boundaries) shall. be effective : | upon the’ date of publication in the Federal Register. | a 3. Not later than 30 days following approval of the Act, o | the Secretary shall provige Udivicual written notice to the to the Governor of each fa Aelgnnouncing proceedings to desig- nate the initial Healt AETV Areas. All such notices to ioemmasesi? o each Governor shall be transmitted by registered mail and, in accordance with the requirements of the Act shall be deposited Tp h, Simultaneously with the mailing of threswptices required in the mail simultaneously. by A,2 , or immediately thereafter, th ecretary shall publish a Statement in the Pegeral Register that the required notices have been provided. The statement shall include the general criteria and procedures applicable to all States uy in such notices. , shall canforn “to. the requirements of Section Vail Cb) (1) of the Act: and; ~ in addition, shall include or be accompained by the following: A copy of the Act. A specific citation of all requirements of the Act relating to the definition and designation of Health Service Areas. A list of those agencies or organizations in, or ying, the State or any portian thereof which must He c nulted concerning the designation of Health i €e Agencies pursuant to Section G,5 ed ve toal date by which the Governors! proposals must be received by the Secretary. The information that must be submitted to the Secretary, and, a he option of the Secretary, the format theres if Special requiref 3 Or the designation of interstate eee fy Health servicé reas cougsuant to Section H. Where applicable, a list of interstate Standard Metropolitan Statistical Areas, Lats hsd,, as determined fucoe’, concerning which the Governors of the affdc tates are required @ by the Office of Management an to consult pursuant to SectionjHu The criteria to be considered by the Secretary in determining the suitability of Health Service Areas proposed by the Governor, which shall includes criteria set forth in Sections C,]l and 2. A copy of these Regulations The name, address and telephone nunber of the Fs, f 5 rceenes ee aa neartt . Sennett " , * \ ~ 3 ~ official who may be called upon for advice and technical assistance with respect to the design nation of Health Service Areas, i | Specific notification that the Secretary jis re- oe Se ag quired to and shall designate Health Service Areas for the entire territory of each State in any case where the Governor falls to act with | { to designation of areas for all or a portion | INFORM TON MATERIALS TO BE SUBMITTED ty \ | | I. Wig6hi ays of the date on which the notice described in A,3 is postmarked, the Governor of each state receiving such notice shal] submit the following materials and inform- t * ation to the Secretary In s ugh Format as the Secretary may A\\ te s\of maps showing the boundaries Eom ont of each Health Service Rrea Proposed by the Governor Prescribe, a. A legible map to be included in whole or in part within the State Such map or maps shall in additiag ow the Counties Si ganako or equivalent political subdiv ifs ong: included in each area and, where applicable, any taWdard Metropolitan Statistical Area included in or in part b. A distinctive numerical designation and name for each Proposed Health Service Area comprising a Portion of | any State including an agreed upon designatih Proposed interstate Health Service Areas. Such] nations and names shall be indicated on the map submitted pursuant to B,l,a eer Se c. The population of the Proposed Area. d. ao A list of major Health Care Facilities in: the Area. An interstate compact or agreement with respect to the designation and boundaries of any proposed interstate area. Such agreement may take the form of a joint declaration by the Governors of the States involved, or separate concurrence with respect to the agreed upon boundaries of the interstate Pealth MW Service Area(s) in question. proposed Health Service Area includes a portion got all) of a Standard Metropolitan Statistical ppropriate justification for dividing the SMSA among different Health Service Areas. ¢ A summary descriptjon of the procedures followed by the Governor in propofi areas and obtaining consultation thereon pursuany Action G. A list of all RNS, agencies, organizations and ‘government officials formally requested to comment on the designation of Health Service Areas. A summary of substantive comme from any source concerning the Service Areas or the final areas|to be proposed to the Secretary, and also including ° Emmary of any action taken with respect to such comments. Maps or narrative descriptions showing the which proposed health Service Areas submitted b Governor are coterminous. with or differ from (1 designated for Professional Standards Review Or hz- ations under Section 1152 of the Social Security Act, ~ § - (2) existing planning areas, including those served by Comprehensive Health Planning Agencies established Pursuant to P.L. 89-749, as amended and Regional Medical Programs established pursuant to PLL. 89-239, as amended. (3) other appropriate State Planning or administrative areas. APPROVAL OF HEALTH SERVICE AREAS BY THE SECRETARY a UE I. Prib ; Proving any Health Service Area Proposed by a ecretary shall take into consideration the Follow- determine to his satisfaction that all applic- able requirements of the Act and Regulations ‘have been met: a. That the the Population for such areas is within the minimum and maxim Specified by the Act, and that adequate justificf has been provided For any pro- posed Health Se AXea with a population of less than 500,000. b. That required consultation between the Governor and G,5 State and Loca] officials PurSuant to has taken Place, and that any comments an tions received have been taken into consideratfo, oe c. That there has been adequate co siltation and agree- ment among the Governors concerned with respect to any proposed interstate Health Service Area. d. That adequate Justification has been provided istical Area into two or more Health Service Are§ e. That all areas of the State re included withing, oo ~@ Health Service Area Ff. That all Proposed Health Service Areas are mutually j . exclusive. | 9. That each Proposed Health Service Area includes one Or more major health care Facilities or institutions i Providing general and Specialized health care services | | available to the general public residing in such Area, 1 each proposed Health Service Area constitutes i al region, in accordance with the criteria in er the planning and development of health services | "and resources serving the residents of such Area, : I In determining whether a Proposed Health Service Area | constitutes a rationa egion for planning pursuant to C,1,h » the Secretary take into consideration the Following factors: . a. ‘The extent of ithin the State and the Area among affected and concerned public and profess- ional groups and institutions and agencies, with respect to the Suitability of i for Planning. b. The extent to which the Area in the maximum feasible Population consistent th the Act and these Regulations. c. Availability for the Area of the data needed for Planning. plans and Health Maintenance Organizations. e. Congruence with areas established for Professiaqh os, - N -The capabilities of the area for supporting thef Standards Review Organizations and for existing or planned Emergency Medical Service Systems. For the initial designation of Health Service . Areas under the Act, congruence with the areas served by predecessor Regional Medical Programs, local Areawide Comprehensive Health Planning Agencies, Service Area, or areas containing a central : | city close to the minimum population for a Standard ‘ical Area). Metropolitan Statj| The extent to whif nterstate Health Service Areas have been develgp in\connection with Standard Metropolitan Boundaries. The extent to which area boundaries will promote appropriate planning for the di ged or other special population groups. (e. inartly, it would be considered desirable keep an indian reservation within a single Health Service Area.) The extent to which high quality services can be primary and specialized care, and appropriate p fentive and educational programs within’ the area. fullest possible range of general inpatient, ambulatory, long term care and home health services, and specialized services such as those relating to mental health, drug abuse, alcoholism, developmental disabilities, and physical and vocational rehabilitation. 1. Conflict with any Health Service Areas to be designated _by the Secretary pursuant to C,4 ; “nm. Division of any Standard Metropolitan Statistical Area into two or more proposed Health Service Areas. edd pursuant to A,3 was deposited tin the mails, the Secretary shall publish in the Federal Register the Health Service Area Boundary desi submitted by the Governors which upon their publicatio constitute the boundaries for such Health Service Are oe 4, If the Secretary determines that aJb him for a Health Service Area does not meet the requirements of Section 1411 (a) of the Act, of Sections C,1! and C,2 of these Regulations, he shall make such revision in the for such area ( and as necessary, in the boundaries forfaBjoin- ing Health Service Areas) as may be necessary to meet s§ quirements; and the revised boundary (or boundaries) sf | ] upon publication in the Federal Register, constitute the bound- ry (or boundaries) for such Health Service Area (or Areas). The Secretary shall notify the Governor of each State of the boundaries established for the Health Service Areas | for such State (including interstate areas lying partly within i a State). Such notice may take the form of a copy or citation of the s) published in the Federal Register pursuant to Sectio | gd C,4. In the case of any Health Service Area the Secretary,pursuant to Section C,4, the noti- ad by this Section shall include a full explana- . | tion of the reasons for the Secretary's action, citing the specific provisions of the Act and/or these Regulations. 6. In designating any H@aNth Service Area pursuant to Sec- tion C,4 , the Secretary Kely on information from any appropriate source incl information and materials submitted by the Governor pursuant ot Section B,!? , (b) inform- ation in the records of the Department of Health, Education and the staff of a fe sources. Welfare, (c) The Department's staff, i the HEW Regional Offices, and (d) othe BASIS FOR DETERMINING POPULATION 1. For the purpose of defining Health Service Areas and allocat- ing funds pursuant to the Act, the population of (a) each State, (b) each Standard Metropolitan Statistical Area, and County or equivalent political subdivision within a Sta shall be the most recent Current Population Estimate prepared the Bureau of the Census which is available for all States. . a { -10- ° . i Nae\essary for the purposes of the Act, the population of any anea within a State smaller than a County shall be determined he State in accordance with accepted statistical practice, and shall be consistent with the Census Bureau's Current Population Estimates for the State and related Counties and Standar gutiiiemQpolitan Statistical Areas therein. The approp- POPULAT® REQWEAMEMENTS FOR HEALTH SERVICE AREAS Tl. At the time of its initial establishment, no Health Service Af more than three million, unless such Area contains a Stangaf\ Netropolitan Statistical Area with a population of morg thg Mhree million. To the extent practical, areas of thé Ypopulation, or close to that figure, that are likely to substantially exceed three miltion population due to short term growth ord§ hould not be established. 2. After initial establishment, if the population of a Healt- Service Area increases substantially bet three million pop- ulation, the Secretary shall notify the Governor(s) of the State(s) involved of the need to consider revision of 3. No Health Service Are& may have a population of less five hundred thousand unless (a) such Area comprises the F population of a State which has a population of tess tha TVEe hundred thousand, or (b) has a population of at least two -~ TT] - hundred thousand and is deemed by the Governor(s) of the te(s) in which such Area is located (with the approval of ecretary) to comply with all other requirements of Section (a) of the Act. Publication of the boundaries of such ea by the Secretary in the Federal Register constitutes the Secretary's approval for the lower population limit for the Area. 4, In ofd promote economies of scale in Planning for health sé€r and resources, Governors are encouraged to propose vice Areas with the largest practical pop- ulation subject to the requirements of the Act and Regulations. 4 Where the population of a State exceeds Five hundréd thousand, the designation of smaller Mekith service Areas ordinarily will not be approved by t etary. Accordingly, Health Service Areas of less th undred thousand population will be approved only on request by the governor(s) involved and only on the basis of -(a) rapid potential population growth to five hundred thousand or more, or (b) tpeeeeqbstantial need fully documented and justified in such f i) the Secretary may prescribe. 5. Once established, Health Service Areas may be subdivided into areas of smaller population for the administrative con- venience of the Health Systems Agency serving such Ar All such subdivisions of a Health Service Area establishe any purpose shall be reflected in the Health Systems plan quired pursuant to Section 1413 (b) of the Act. Approval by th “T retary is not required for such sub-areas. F. SPEMIAL REQUIREMENTS FOR STANDARD METROPOLITAN STATISTICAL AREAS JAND INTERSTATE AREAS _/. nm accordance with Section 1411 (a)(4) of the Act, no Health Service Area boundaric: shall cross the boundaries of a Standard Metropolitan Statistic | Area which Standard Metropolitan Stat- istical A cated entirely within a single State, unless the Govern r sch State submits a request for an exception and the rebsbn herefor including patient origin data and other factual 5 orting the division of the Standard Metro- politan Statistical Area among two or more Health Service Areas. The Secretary shall approve sych request only if, in his opinion, a the division of the Standard leQropolitan Statistical Area is justified on the basis of a ptterns of care as reflected in the supporting data or ilable information. 2. A Health Service Area encompassing all, or part of a Stand- ard Metropolitan Statistical Area may als e contiguous territory not defined as Part of the Standhrp Metropolitan Stat- istical Area by the Office of Management ahd get. Contig- uous areas which appear likely to be incl as part of a Standard Metropolitan Statistical Area (in accordance with the Office of Management and Budget's definition of such areas) in the forseeable future should receive consideration for Cc ° in the Same Health Service Area as ‘the Standard Metropolita _~. Statistical Area in question. 3. Governors of adjoining States may agree (as specified in 1] Ty G > ~ > + Section B,].c_ ) on the designation of interstate Health Serv- ice Area. [In the case of interstate Standard Metropolitan tical Areas, the Governors of the States concerned are i d to consult in order to gain agreement on inclusion of terstate Standard Metropolitan Statistical Area in a nnn de single Health Service Area [fn accordance with Section 1411 (a) (4) of the Act and Section F,1 of these Regulations. Such agreement, | with respect to including any interstate Stand- ytatistical Area in a single Health Service Area shall be rEpp to the Secretary in accordance with Sections of the Governors concerned to agree on a single Health Service Area for any interstate Standard Metropol- ea itan Statistical Area shall be considered by the Secretary who, in accordance with Section C,4 ,] gall establish appropriate Health Service Area boundaries. CONSULTATIGN BY GOVERNORS ION WITH THE DESIGNATION OF HEALTH SERVICE AREAS T. tn considering Health Service Area boundaries to be proposed to the Secretary, either for initial establisf for subsequent revision, the Governor of each State is reh to consult with government and private agencies and organik ions, elected officials and consumers for the purpose of either (a soliciting initial suggestions concerning such Health Service Area boundaries, and (b) affording an opportunity to comment on such Areas atively selected by the Governor. 2. The method ot consultation required by G,1 may be speci by the Governor and may include, among other things, (a) public ! Mizations, (c) expressions of the views of concerned indavitduals or appropriate experts, (d) formal resolutions by legfsfative bodies or actions by elected officials, or (e) combination of these. 3. Consultation required by. Section G,5 must be requested from the propriate individuals and/or organizations in writing. received pursuent and records of hearings or other for@a geroceedings concerning the designation of Health Service Areas pursuant to the Act and these Regulations shall be filed in a single place and shall be available for tneral public or HEW officials. inspection and copying by thg Copies of such materials shf A furnished to the Secretary on request and summaries sXall be provided to the Secretary pursuant to Section B,1,9 5. In carrying out the requirements of § i » the Governor shall consult with the following, where th exPSt. a. State Agencies including, (1) The State Health Planning cy established pursuant to Section 314 (a) of the Public Health Service Aet. (2) State Health Facilities Construction Age (citation) . (3) State Mental Health Agencies (citation) (4) State Mental Retardation Agencies (citation (5) (6) (7) Voluntary Agencies including, (1) (3) (4) Elected Officials of Bodies, inc]u (1) (2) (3) Service Act. Security ActhZ State Vocational Rehabilitation Agencies . State Alcoholism Agencies | i State Drug Abuse Agencies | | Agency that carries out areawide comprehensive regtonal, metropolitan, or other local area planning pursuant to Section 314 (b) of the lic Health Service Act. ional Medical Programs established in | | Experimental Health Service Delivery Systems Professional designated ung Appropriatg€ i. Pegs iynal and consumer groups deemed by the Governor to have a significant interest a or to be tikely_to be affected by decisions concerning the de n of Health Service Areas Mayors of incorporated cities ot fifty thousand or more population Chief Executive Officers of Counties (orfe alent political subdivisions) of fifty thous or more populations Elected otficials of representative (as det | | by the Governor) of incorporated places and Counties i : of less than five hundred thousand population within i the State 1 Other appropriate groups or individuals, at the dis- i cretion of the Governor | | 6. Organizations enumerated in Section G,5, (1) through (4) rtion of a State must be consulted by the Acca: | ection ftrrespective of whether the principal office of ganization is, or is not, located in the State in + 7. With respect to the designation of interstate Healt | H | i Service Areas, the consultatipmrequired with the organizations ras of the political subdivisions of such State. Governors are urged agencies and officials enum in G,5 shall be required of each governor concerned, o WK respect to those organizations and agencies serving tha particular State and ofticials to exchange comments received for their r portions of proposed interstate Health Service Areas p o reaching a decision on whether to recommend such Area he Secretary. CONSULTATION BY GOVERNORS ON DESIGNATION NTERSTATE HEALTH SERVICE AREAS Consultation among Governors regarding designation ot Hf Service Areas for Interstate Standard Metropolitan Statistifa Areas, or any other proposed interstate Health Service Area may take place in any manner agreeable to the respective G TT within a State or States i | i oncerned. such consultation may be carried out through negotia- yetween representatives as authorized by Section J ; and ie rough written or oral communication. The latter may: be fr in person or by phone. Al] consultation among Governors their delegates, representatives, or staff concerning the desig- nation of interstate Health Service Areas, shall be evidenced by a writ d maintained by each State and showing al] communicat een the respective States concerning such matters. REVISICN OF HEALTH SERVICE AREA BOUNDARIES ¢ 1. The Governor of a State ma at any time after consultation with the entities specified in\Section G,5, and in the case of interstate Health Service A he Governor(s) of the adjoin- Secretary revised boundaries for one or more Health Service Areas ing State(s) concerned purg o\Section H, submit to the (previously established in accordance with the Act and Regulations) 2. The Governor of a State shall seek thelc Itation required by Section &, and in the case ot an inters ate Health Service Area, Section H, and shall Propose necessary revisions in the Boundaries of established Health Service Areas in the following cases: a. Establishment of « new Standard Metropolitan Stat ical Area by the Otfice ot Management and Budget b. Addition of a County or Counties to an establish Standard Metropolitan Statistical Area. Population growth of a Health Service Area substan- tially above three million (untess the Area contains a Standard Metropolitan Statistical Area of more than three million pooulation). Population loss below five hundred thousand for any Health Service Area not previously approved by the ary for such lesser population pursuant to t ion loss of any Health Service Aréa to less Msiundred thousand. 3. If any of the circumstances described in 1,2, a through d occur, the Secretary shall nq@@\fy the Governor(s) of the State(s) involved as soon thereafter Wssible by registered mail, and the Governor (s) in questip submit proposed revisions 4, tf the Governor(s) fail to submit proposed Health Service Area revisions in accordance with 1,3, thé tary shall make appropriate revisions in such boundar] mthin 150 days of the notice described in Section 1,3 and| publish such Boundaries in the Federal Register as the daries for such Health Service Area(s). DELEGATION OF THE GOVERNOR'S RESPONSIBILITIES 1. The term Governor shall mean the Governor or Chief Exec utive Officer of any State as defined in the Act. - 2. The duties and responsibilities of the Governor under the nd Regulations may be performed by any State employee talily designated to carry out such responsibilities through ogeration of State Law, or formal delegation or other i } { ten executive action by the Governor. wh oh ale oh ob ot. WN A | i | | | | | | | |