f K JULY @12,1 DRAFT REGULATIONS GNATION OF HEALTH SERVICE AREAS FOR D!SCUSSION-.ONLY '\FT BILL "CLIt.@'T" BASED ON HOUSE JR DR [A F'T : 7/ 1 2 I'll A. A.@,ill'OLli,CEMENT OF AREA DESIGiNA-TIO,'-, PROCDURES No later than 180 days following approval of the Act, the retary shall establish Health Service Areas throughout the ted States, and, thereafter all areas of every State shall all times be included in a Health Service Area so e stablished for the purposes of the Act. 2, Th r-etary shall establish Health Service Areas, or revise s as, through publication of the boundaries (or revised ies) of such areas in the Federal Register. Such b u da (or revised boundaries) shall,be effective upon the'date of publication in the Federal Register. 3. Not later than 30 days.following approval of the Act, the Secretary shall provide dividual written notice to the to the Governor of ea ouncing proceedings to desig- nate the initial He6l r e a sAll such notices to each Governor shall be transmitted by registered mail and, in accordance with the requirements of the Act shall be deposited in the mail simultaneously. 4. Simultaneously with the mailing offt tices required by Ai@@ . or immediately thereafter, th2jecretary shall publish a statement in the Federal Register that the required notices have been provided. The statement shall include the general criteria and procedures applicable to all States COP n( in such notices. 5. The notice to each Governor required by I SFall force to he re-qu i regents of S-ect-ion 1 4 1 1 (-b (:I of the- Act' and 2 p a i i-ied by t [IC f C) Owl 11(i' in addition, shall include or be accorf) a. A copv of the Act. b. A specific citation of all requirei-,ieiits of the. Act relating to the definition and designation of Health Service Areas. C. A list of those agencies or organizations ii-@, or @ing,the State or any portion thereof which must ulted ccnc--rning the designation of I-'icalth Agencies pursuant to Section G,5 d. I date by which the Governorsi proposals must be received by th.e Secretary. e. The information that must be submitted to the Secretary, and, afNhe o.ption of the Secretary, the format th f. Special requi the designation of interstate Health Servic eas, uant to Section H. g. Where applicable, a list of interstate Standard Metropolitan Statistical Areas. as determined by the Office of Management anN( u@dge\j, concerning which the Governors of the af f tates are required to consult pursuant to Section h. The criteria to be considered by the Secretary in determining the suitability of Health Service Areas proposed by the Governor, which shall inclu e criteria set forth in Sections C.1 and 2. 1.@ A copy of these Regulations a a The name, d d re s.s -id .-t e@ I e"io ii e n;-, Jibe r o.f1 3 officiz,,] who may be calls--' upo:i ['or advicc- and tecl-,i)ical assistance with respect to the desig- natiori of Health Service Areas. k. Specific notification that the Secretary is re- quired to at-id shall designate Health Service Areas for the entire territory of each State i.@n any case where the Governor fails to act t-,,Ith, to designation of areas for all or a portion a t e . INFORtiAT MATERIPLS TO BE SUBMITTED ays Of the date on which the notice described in A,3 is postmarked, the Governor of each state receiving such notice shall submit the following materials and i,'nform- ation to the Secretz-,ry format as the Secretary may prescribe. a. A legible map f maps showing the boundaries of each Healt ea proposed by the Governor to be included in whole or in part within the State Such map or maps shall in addi@i oiq the Counties or equivalent political subdiv i@is included in each area and, where applicable, a ard Metropolitan Statistical Area included in or in part b. A distinctive numerical designation and name for each proposed Health Service Area comprising a po any State including an agreed upon designate' proposed interstate Health Service Areas. S isig- nations and names shall be indicated on the map @ submitted pursuant to D,l C. The Population of the Droposee Area. 4 d. A list o@,@ major Health Care Facilities in-the Area. e. 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 Sta tes involved, or separate concurrence with respect to the agreed upon boundaries of the interstate Pealth Service Area(s) in question. f. proposed Health Service Area includes a portion all) of a Standard Metropolitan Statistical e propriate justification for dividing the SMSA among different Health Service Areas. 9. A summary descrip@n of the procedures followed by the Governor in pr reas and obtaining consultation thereon pursua tion G. h. A list of all S, agencies, organizations and-government officials formally requested to comment on the designation of Health Service Areas. i. A summary of substantive commert! ived by the State from any source concerning the d4 lation of Health Service Areas or the final are o be proposed to the Secretary, and 'also including mmary of any action taken with respect to such comments. j. Maps or narrative descriptions showing the which proposed health Service Areas submitted b@, Governor are coterminous-with or differ from (I,' areas designated for Professional Standar'(Is Review Or;j--44z- ations under Section 115 .2 of the Social Security Act, 5 (2) existing Planning areas, including those served by Comprehensive Health Planning Agencies established Pursuant to P.L. 89-749, as amended and Regional tAed-ic:al Programs established pursuant to P.L. 89-239, as amended. (3) other appropriate State planning or administrative a r e a s . C. APPROVAL OF HEALTH SERVICE AREAS BY THE SECRETARY 1. Pr roving any Health Service Area proposed by,a Governi cretary shall take into consideration the ih§ fa etermine to his satisfaction that all applic- abl.e r of the Act and Regulations have been met: a. That the the population for such areas is within the minimum and max!mL6spec.ified by the Act, and that adequate justif as been provided for any pro- posed Health Se a with.a population of less than 500,000. b. That required consultation between the Governor and State and Local officials pursuant to G.-; has taken place, and that any comments ani ;Ugg tio.ns received have been taken into considerat 0 C. That there has been adequate c Itation and agree'- ment among the Governors concerned with respect to any proposed interstate Health'Service Area. d. That adequate justification has been provide IF proposed division of any Standard Metropolitan S:a:- istical Area into two or more Health Service Ar e. That all areas of the State re included within .a Health Service Area f. That all proposed Health Service Areas are mutually exclusive. That each proposed Health Service Area include!s one or more major health care facilities or institutions providing general and specialized health careiservices available to the general-public residing in su ch Area. h. ch proposed Health Serv.ice Area constitutes nal region, in accordance with the criteria in the planning and development of heal@h services urces serving the residents of such Ae ea. 2. In determining whether a proposed Health Service Area constitutes a rationa ion for planning pursuant to C,I,h, the Secretar 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 ilh for planning. b. The extent to which the Area irc he maximum feasible population consisten h the Act and these Regulations. C. Availability for the Area of the data needed for planning. d. Congruence with the coverage of major prepaymen plans and Health Maintenance Organizations. e. CongruenIce with areas established for Profess! a Standards Review Organizations and for existing or planned Emergency Medical Service Systems. f. 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, erimental Health Service Delivery Systems. 9- al population growth (particularly with respect are close to the maximum population for @ea Service Area, or areas containing acentral city close to the minimum population for a Standard Metropolitan St I Area). h. The extent to w erstate Health Service Areas have been devel connection with Standard Metropolitan Areas which cross State Boundaries. i. The extent to which area boundaries will promote appropriate planning for the diszdvan ;ged or other special population groups. (e. inarily, it would be considered desirable t an indian reservation within a single Hea rvice Area.) j. The extent to which high. quality services can be enhanced through the promotion of linkages bte er primary and specialized care, and appropriate preventive and educational programs within the area. k. The capabilities of the area for supporting t@i- 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 ',Iealth Service Areas to be designated Secretary pursuant to c,.4 M. nces among Governors of the States involved. ing the proposed boundaries of any interstate. ervice Area proposed. L n. Division of any Standa.rd Metropolitan,Statistical Area into two or more proposed Health Service Areas. 0. Other relevant d-eemed appropriate by the Secre- tary, either ge or in specific cases. 3. Except as provided ithin,]50 days of the date on which the the noti equ pursuant to A,3 was deposited in the mails, the Secretary shall publish in the Federal Register the Health Service Area Boundary desicn;;t-ir)n&- submitted by the Governors which upon their publication onstitute the boundaries for such Health Service Areis 4. If the Secretary determines that a ry submitted to IL him for a Health Service Area does not meet the requirements of Section 1411 (a) of the Act, of Sec'tions C,l and C,2 of these Regulations, he shall make such revision in tt @ u @r es for such area ( and as necessary, in the boundaries for aljoin- ing Health Service Areas) as may be necessary to meet re- quirements; and the revised boundary (or boundaries s upon publication in the Federal Register, constitute the bound- (or boundaries) for such Health Service Area (or Areas). The Secretary shall notify the Governor of each cate the boundaries established for the Health Service Areas for such State (including interstate areas lying partl.'y within a State). Such notice may take the form of a copy oricitation of the published in the Federal Register pursuant.to Sectior d C,4. In the case of any Health Servtce Area De-sig e Secretary,pursuant to Section C,4, the noti- ficat d by this Section shall include a fulli 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 Service Area pursuant to Sec- tion C,4 , the Secretar ly on information from any appropriate source in information and materials submitted by the Gove nor t ot Section B,l t (b) inform- ation in the records of the Department of Health, Education and Welfare, (c) The Department's staff, itiCi qlthe staff of the HEW Regional Offices, and (d) other re ble sources. D. BASIS FOR DETERMINING POPULATION For the purpose of defining Health Servi.ce Areas and allocat- ing funds pursuant to the Act, the population of (a) each State, (b) each Standard Metropolitan Statistical Area, and I County or equivalent political subdivision within a State, shall be the most recent Current Population Estimate prepared the Bureau of the Ce nsus which is available for all States. 10 ssary for the purposes of the Act, the population of any within a State smaller than a County shall be determined he State in accordance with accepted statistical practice, d shall be consistent with the Census Bureau's Current Population Estimates for the State and related Counties and Standar U-@_nDOlitan Statistical Areas therein. The approp- riate Cn!s ures shall be transmitted annually to each State by th Resources Administration. E. POPULAT4 MENTS FOR HEALTH SERVICE AREA@ @l. At the time of its initial establishment, no Health Service area,;shall have a populati, ore than three million, unless such Area contains a Stan tropolitan Statistical Area with a population of m ee million. To the extent practical, areas of th population, or close to that figure, that are likely to substantially exceed three million population due to short term growth ord., -,..,should not be established. 2. After initial establishment' if the )o tion of a Healt- Service Area increases substantially be 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 :han five hundred thousand unless (a) such Area Comprises the -,--re population of a State which has.a population of less tha4$.,Ve hundred thousand,'or (b) has a population of at least two undred 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 Sectlion (a) of the Act. Publication of the boundaries of such a by the Secretary in the Federal Register constitutes the Secretary's approval for the lower population limit for the Area. 4. In o romote economies of scale in planning for health s d resources, Governors are encouraged to vice Areas with the largest practical pop- propose&( ulation subject to the requirements of the Act and Regulations. Where the population of a State exceeds five hundred thousand, the designation of smalle h service Areas ordinarily will not be approved by t etary. Accordingly, Health Service Areas of less th dred thousand population will be approved only on.recuest the governors) involved and only on the basis of-(a) rapid potential population growth to f i ve hund red thou s and or more, or (b) % @t bstantial need fully documented and justified in such forl the Secretary may prescribe. 5. Once established, Health Service Areas may be subdivided into areas of smaller population for t he administrative con- venience of the Health Systems Agency serving such Ar-l-L- All such subdivisions of a Health Service Area establishe !or any purpose shall be reflected in the Health Systems plan r@quired pursuant to Section 1413 (b) of the Act. Approval by t@l 1 2 ary is not r6quired for such sub-areas. EQUIREMETITS FOR STANDARD MLTROPOLITAN STATISTICAL INTERSTT-L@ATE- S accordance with Section 1411 (a)(4) of the Act, no Health Service Area boundaric@,@ @.hall cross the boundaries of a Standard Metropolitan Statisti@, Area which Standard Metropolitan Stat- r e, unless istical A ate; entirely within a single Stat the Govern h State submits a request for an exception and,the r efor including patient origin data and other factual s orting the division of the Standard Metro- politan Statistical Area.among two or more Health Service Areas. The Secretary shall approv h request only if, in his opinion, the division of the Standa politan Statistical' Area is justified on the basis of terns of care as reflected in the supporting data 0 ]able 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 Standirl Metropolitan Stat- istical Area by the Office of Man@,-gem.ent aid get. Contig- uous areas which appear 1-ikely to be incl 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 @c lsio@ in the same Health Service Area as the Standard Metropolitai Statistical Area in question. 3. Governors of.adjoining States may agree (as specified in 13 Section B,Ir- interstate Health Serv- or, @.!,e designation of Area. In the c;.-)se of interstate Standard Metropolitan ical Areas, the Governors of the States concerned are re d to consult iri order to gain agreement on inclu!5!ion of terst,-@te Stat-id@.!-d Metropolitan Statistical Area in' a single Health Servic(, A,-ea in accordance with Section 1411 (a)(4) I i of the Act and Sectiofi F,l of these Regulations. Such !agreement, or.lack t@IT itli respect to including. any interst,ate.Stand- are Metrop)] atistical Area in a single Health Service Area shall be r@ the Secretary in accordance with Sections p B,I,c and of the G ove rnors concerned to agree' on a single Health Service Area for any interstate Standard Metropol- itan Statistical Area shall be considered by the Secretary who, in accordance with Section C,4 I establish appropriate Health Service Area boundaries. G. CONSULTATIOT" BY GOVER.@IOR! ION WITH THE DESIGNATION OF HEALTH SERVICE ARE;"".S ].In considering Health Service Area boundaries to be proposed to the Secretary, either for,i.nitial establishment for subsequent revision, the Governor of each State is rel to consult with government and private agencies and organ s, elected officials and consumers for the purpose of-either soliciting initial suggestions concerning such Health Service Area boundaries, and (b) affording an opportunity to co mment on such Areas t atiVely selected by the Governor. 2. The method ot cot-is@iltation required by G,l may be spec by the Governor and may include, among other things, (a) public 4 rings, (b) writ+,-en or or@] positions or statements by zations, (cj) expressior,,r, of the views of concerned ini duals or appropriate experts, (d) formal resolutions by le ative bodies or actions by elected officials, or (e) ination of these. 3. Consultation required, by.Section G,5 must be requested from the appropriate individuals and/or organizations in writ i ng. 4. All corrr ceivee pursuent and records of hearings or er forL oth @st roceedings concerning the designation of Health Service Areas pursuant to the Act and these Regulations shall be filed in a single and shall be available for inspection and copying by t era] public or HEW officials. Copies of such materials rnished to the Secretary on request and summaries 11 be provided to the Secretary-pursuant to Section B,I,g 5. In carrying out the requirements of Sipnt-inn r@ the Governor t shall consult with the following, where the t. a. State Agencies including, (1) The State Health Planning cy established pursuant to Section 314 (a) of the Public Health Service Act. (2) State Health Facilities Construction Age 5 (citat i o n (3) State Mental Health Agencies (citation) L Retardation Agencies (ci 4 S t -ntL tatTon4.s 5 (5) State Vocational Rehabil,tation Agencies (6) State Alcoholism Agencies (7) State Drug Abuse Agencies Voluntary Agencies including, (1) Agency that carries out areatilde comprehensive regional, metropolitan, or other local a ea planning pursuant to Section 314 (b) of the ic Health Service Act. (2 tonal Medical Programs established inl dance with Title IX of the,Public H alth ce Act. (3) Experimerrtal Health.Service Delivery Systems (4) Professional @ndards Review Organizations designated tion 1152 of the Social Security Ac (5) Appropria rof a] and consumer groups deemed by the Governor to have a significant interest in or to be likely to be affected by decisions concerning the de i n of Health Service Areas C. Elected Officials of Bodies, in ng, (1) Mayors of incorporated cities of fifty thousand or more population- (2) Chief Executive Officers of Counties (or v alent political subdivisions) of fifty thous ni or more populations (3) Elected officials of' representative (as det ed by the Gove rno r) o fn co rpo ra ted p I a ces a nd Cou n t i e s of less than five hundred thousand population,within the State d. Other appropriate groups or individuals, at the dis- cretion of the Governor 6. Organizations enumerated in Section G,5, (1) through (4) which.serv tion of a State must be' consulted by'the Governor t ction irrespective of whether the principal office of ization is, or is not, loca,ted in the 'State in 7. With respect to the designation of interstate HealtH Service Areas, the consult quired with the organizations agencies and officials enu in G,5 shall be required of each governor concerned, espect t o those organizations and agencies serving tha particular State and officials of the political subdivisions of such State. Governors are urged to exchange comments received for their r -p @ v4t portions of proposed interstate Health Service Areas p i r Ao reaching a decision on whether to recommend such Area he Secretary. H. CONSULTATION BY GOVERNORS ON DESIGNATION RSTATE HEALTH SERVICE AREAS Consultation among Governors regarding designation ot Hia= i- Service Areas for Interstate Standard Metropolitan Statisti:al Areas, or any other proposed interstate Health Service Area, may take place in any manner agreeable to the respective G ve Ol'S cerned. Such consultation may be carried out through negotia- etween representatives as authorized by Section i and rough written or oral communication. The latter may@be in person or by phone. Al] consultation among Governors their delegates, representatives, or staff concerning the dcsig- nation of interstate Health Service Areas, shall be evidenced by a writtE!n maintained by each State and showing all communicatio en the respective States concerning such matters. REVISICN OF HEALTH SERVICE AREA BOUNDARIES I.- The Governor of a State m@ at any. time after consultation with the entities specifie ction G,5, and in the case of interstate Health Service e Governor(s) of the adjoin- ing State(s) concerned p ection H, submit to the Secretary revi-sed boundaries for one or more Health Service. Areas (previously established in accordance with the Act and Regulations) within a State or States 1 2. The Governor of a State shall seek the c Ita-tion required by Section G, and in the case of an inter ealth Service Area, Section H, and shall propose necessary revisions in the Boundaries of established Health Service Areas in the following c a s e s a. Establishment of e new Standard Metropolitan Stat s:ical Area by the Office of Ma nagement and Budget b. Addition oi' a County or Counties to an establishment Standard Statist',cal Area. C. Population growth of' a Health liervice Area substan- tially above three million (L.iniess the Area contains a Standard Metropolitan Statistical Area of more than three .-r@l II i on po,.Du Iat i on d. Population loss belc)@@@ five hundred thousand for any Health Service Area not previously approved by the r such ',lesser population pursuant to e e. loss of any Health Service Area to less undred thousand. 3. If any of the circu@ tanc--s described in -1,2, a throu d occur, the Secretary shall n the Governor(s) of the State(s) involved as soon thereafter sible by registered mail, and the Governor (s) in que I subii-,it proposed revisions within 90 days of such n 4. If the Governor(--,) fail to submit proposed Health Service I - Area revisions in accordance with 1,3, th4 S ry shall make appropriate revisions in such boundar ei thin 15o days of the notice described in Secticiii 1,3 and s publish such Boundaries in the Federal Register as tileAo ries for such Health Service Area(s). J. DELEGATION OF THE GOVERNOR'S RESPONSIBILITIES 1. The term Governor shall mean the Governor or Chief Exec utive Officer of an), Stite as cl--fineci in the Act. 2. The duties and responsibilities of the Governor under the Regulations may be per-formed by any State employee y designated to carry out such responsibilities t@fir-ough th ration of State Law, or formal-delegation or othe't- executive action by the Governor.