* DRAFT 12/17/74 Part 11--Area Designation Requirements A. PurRose of this Part The purpose of this Part is-to explain how.and what each State must submit in order to participate in the desia ation of health ,n service areas under the National Health Policy Planning and Resources Development Act, PL .B. Area Designation A rit The Congress has provided in the statute for the designation of health service'areas which cover the entire country. Section 1411(b) of the Act :f gives the authority for the designation of health service areas\to State Governors. The Secretary of HEW, however, may intervene and designate areas, but only if 1. the criteria in Section 1411(a) of the Act are not met; 2. A Governor requests a waiver of:one of the various criteria where exceptions are expressly permitted by the Act; 3. A Governor fails to include all or part o' his-State in any designated health service area. C. Deadlines for Submission Each Governor has been notified officially of the commencement of the area designation process. The notice includes a deadline date for the submission of area designations to HEW. In accordance with the Law, the deadline is 90 days from the date of notice. HEW is required by statute to complete the area designation process within six months of enactment, and it is imperative that the 90 day statutory deadline be adhered to strictly. Governors' designations should be Postmarked on or before the deadline date specified in the initial notice, 2 DRAFT 12/17/74 D. Submission of Area Designat ons 4# Area designations should be submitted to HEW at one time as a cmplete package for the State. The designations should include all Materials, information, and justifications required by the instructions in this Part. Submissions must include a covering letter signed by the Governor (not a delegate). The Governoris letter should specify that the material submitted constitutes his official designation of health service areas for the State pursuant to Section 1411 of PL Any other lixt pertinent information or.coments may be included., and no special format is necessary. In order to insure that the submitted materials is complete, each separate attachment or enclosure and the number of pages in each should be identified in or on the Governor's cover letter. Deliver or mail copies of the designation material -to.,the Regional Director in the appropriate HEW Regional Office. (See attachment for addresses of Regional Offices And States covered). Mailed submissions thould be sent first class Certified or Registered with a return receipt. 'In order to insure expeditious handling at the Regional Office, it is conspicuously suggested that submissions be/zEmxp:i@@sty marked on the envelope or wrapper as, "AREA DESIGNATION PER SECTION 1411.11 E. Review and Approval Health Service Areas are officially established through a publication in the Federal Register subsequent to HEW review of the Governor's designations, To insure consistency nationally in considering the State's submissions, 0,A 3 DRAFT 12/17/74 .all final atea designations by the Secretary will be published simultaneously. Designation of areas throughout the United States will be completed on or before 1975, as required by the Act. The appropriate Governor will be consulted in Any case where HEW proposes, under Section 1411(b) to modify.the Governor's health service area designations. F. What to Submit All materials which Governors are required to submit in connection with area designation is related to specific requirements of the Act. A table summarizing requirements for area designation and the related materials to be submitted is shown in Attachment 2. All materials which States Are requested to sabmit in connection with health service area designation are either specifically required by the Act or related to determining that proposed areas meet requirements. EadIh Governor is required to submit't@e following materials,. in order to designate health service areas: 1. Maps of Designated Areas-- A legible map or maps showing the boundaries of each Health Service Area proposed by the Governor to be iticludedi in whole or in part within the State. Such map or maps shall, in addition, show the counties or equivalent political subdivisions included in each area. A single map may be submitted for an entire State provided that all required p boundaries can be shown distinctly. Shading and coloring or overlays can be used provided that a legend or key DRA-FT 12/17/74 If necessary for clarity, separate maps may be provided for each H.S.A. if an interstate health service area is being designated jointly by the Governors of adjoining states, the map(s) submitted by each State should show the entire interstate area (not just the portion in the particular State.) If a State includes one or more Standard Metropolitan Statistical Areas, a up map must be xi submitted showing the SMAS(S) superimposed on the designated health service areas. This map should show the entire extent of any interstate SNSA which is located partly in an adjoining State or States. In any case, where the boundary of the health service area does not follow county lines or other political subdivisions, a description of the areas' boundary should be provi ded (e.g., "All of County'B' xk south of the XYZ River.") Each health service area should be give n a name and number which is to be shown on the map(s), (e.g., Michigan #2, Upper Peninsula). The maps submitted should clearly indicate the boundaries of the designated HSAs for the entire State and their relationship to County and State boundaries, and SMSAS. Maps of any reasonable size may be submitted pro-tided that the requir6d information is clearly shown. 2* Evidence of Consultation As part of the area designation material, each Governor must submit evidence of compliance with Section 1411(b)(2) DlZhl-'I' 1-2/17/74 5 of Act wli;-cl-i requires coiis U.! La t-j'on certain o c:-i officials and specified health agencies. Necessary materials are:.. ef descripti -ocess a d procedur a. A.bri on of the pi. n e @ll f o'l-loxqed in t'ne State in obtaining consultation on proposed health -service areas; -ier b. Samples of notices,.Ietters, or otl publicity requesting consultation or comment on health @service area des4-giiation-, C.. Name and addresses of all institutions,agencies, organizations, government officials, or other individuals formally requested to comment on the designation of Healtli Service Areas. (Consultation with State and ar6awide CHP agencies is required by Law:, and must -include each Federally-funded CHP and RMP serving a or a portion of the State. In addition to the mandatory consultation prescribed above, it would be highly desirable for Governors, or their representatives, to consult with other agencies, groups, and,organizations in their Sk States,, including (1) Various State health and related agencies (e.g., mental health departments, vocational, rehabilitation agencies); (2) Any EHSDS sits(s) within the State4, (3) Major health provider groups (e.g., State Medical Society,Hospital Association);(4) PSROS; (5) Voluntary health organizations (e.g;, State Ifeart Association,'@klental Retardation Chapter); and (6) Appropriate consumer groups' 6 1.2/17/71@ d. Names and addresses of all. or iii(jiv comaents on area designa tion x@@l.@iether @,.cl(-,ctecl or e. Actual ,7ritten corfnients and suin-,naries of oral coiTLiic-iits received from 314(a) and (b) (Stite and Areawide hensive Health Planning Agencies), !U@iPs, and county or other local officials required to be consulted under Section 1411(b)(3); fs Actual written comments and summari6s of oral comments received from any source with respect to,waivers; g. Summaries of other substantive comments; h. A resume of action taken with respect to any comments and the reason therefore; i. The location of files where all subcitations and comments are filed and available for inspection by Federal officials; j. tf hearings are held, their dates and a list of organizations individuals attending. Comments received by States and action thereon should be discussed in the same format and s tyle used in discussing comments on proposed rules in the Federal Register. Actual comments anxgxmpnr.E-Axxniux and summaries required to be submitted (See (a)-(g) above) can be submitted in an appendex. 3. Recuired Consultation The CHP and IUlPs serving the State which must be consulted have been specifically enumerated in the initial notification to each Governor. The Act for less specific, w-i-th resp@.2ct to the, local. off require(.i to 1)(@ coiistilted 'th Section 1.1ill (b) (3) As a' iiiiniT@liLini, consultation c6unty'officials and Mayors of the larger cities (particularly central cities and larger suburban jurisdictions in SMSAS) would seem to be required. The number and types of local. officials contacted for corm-neiit is left to the discretion of the Governor but should include officials in each SMSAs as we is representative rural areas, and areas for which waivers are requested. Consu'Ltation pursuant to Section 1411(b) can take .any one or combination of which is acceptable provided that files and written records are maintained. (1) Letters from individuals or organizations; (2) l'oy-mal resolutions or statcTnents adopted by organizations or agencies; Presentations to the Governor or other State officials;. (4) Public hearings; (5) Meetings with appropriate organizations. Where hearings or other meetings are held to obtain coiiunents, States are.requested to notify the I.IEI@14 Regional Director to 'pemi,t him to send staff to attend where feasible. Minutes or transcripts should made of -u(.,,!- 0 be to HER,,' unless rc(iue5; tc@d. States may Solicit COTM-fir@,nts on are-,i Ct(@si.gn.ati(,)ns at any I)oint in the 90 day period.allow(:,-d for submission, but the agencies and officials whose comments are required to be solicited under Section @411(b)(2) must be afforded an opportunity to comment on the final designations to be submitted to by the Governor. Comments required by Section 1411(b)(2) must be solicited even though the.ontire State is to be designated as an ILOA. This gives appropriate opportunity to propose appropriate waivers or participate in interstate health service areas. 3.' Required Materials on Interstate Areas A Governor may designate, in cooperation with the other Governor(s) involved, health service areas loc@tted 'Partly in his State and partly in an adjoining State as authorized pursuant to Section 1411(b)(1)(B) of the Act. Designation of interstate,health survey areas requires submissions the following: a) Evidence or.certification that the Governors involved or their designees have consulted and agreed on the interstate area (exchange of letters,. identical designations, formal interstate agreements, etc.); b) The comments received by each Gov6rnor concerning the intei-sta te area frcri respon,,]@ii.it,,, i-r@ ti-)f,' -,,-C'F;Pc@ctiVI2 States. (Corfmeiits @--hould be r, soli-ci't:c(l on tiic, ciitT.re ii-iters Late area, but should be requested separately by each State from a.@,,e--ncies, institutions, and individuals in its portion of the area. Cor@,ments received should be exchanged by the cooperating States included in the submissions of both; c) population, statistical,.and other required descriptive data and information for the entire interstate area as fme:x jointly developed and agreed upon by the cooperating States; d) jointly developed justification for the entire interstate .area (i.e., why an interstate area is needed); e) a map and other information re@luired for all area designations. In summary, the general rule for interstate areas is that all States involved agree upon.area boundaries and required information with respect to an interstate area. Identical material is then submitted in each'State's area designation padkage. See the next,Section of these instructions for procedures relating to interstate SMSAS. 4. SMSAs In addition t6 the maps previously mentioned, showing SMSAs superimposed on designated health service areas, special information on SIISAs is not required unless the SMSA is to be cli-vid(@(@l @10 0i: Case, a reIques nd j us t i ft -i. On f 0 @r @,;!i ivc--, ris (see n e@.t Sect'oi-i on '@Waiv(-L:s'@) Where an area includes an SMSA ovcr 3-Tii@Lllion population,. no waiver request is nce(-Ied since the 3--million upper population limit can be exceedec'-.-,,l uy-ldcl.- tile provision @of Section 1411(a)(3)(A). Where such an area also includes population in contiguous territory which is not part of the SI%ISA (as defined by Oi,,IB), full justification and explanation must be provided (i.e., the,additional territory is soon expected to cross the dc-fii-i.4-onal line, or to be amended, and become part of the S@ISA in question. Each standard metropolitan statistical area (ST@4SA) must be entirely contained within the boundaries of one health service area unless the Governor of each S tate in wh&ch a SMSA is located determines, with the approval of the Secretary,, that a health service area should contain only part of the SMSA in order to meet -t oth r requ remen s of the law. Any Governor proposing to divide an interstate SMSA along the State line must submit a request for a waiver. Congress has expressed clear intent that where a major metropolitan area straddles a State boundary its health service area will also cross the State boundary. While provision is made for waiving this requirement, Congress has indicated that waivers are expected to be granted rarely. I,,IAIVER In the event arty areas arc proposed for which @@aive-Y.-s a-re being 40 requested, additional information and justification must be supplied. Ally Irea (I.) with a current population of IcEs than 500,000 if it is one enco-,ipa,-sj-ng an entire Stite with a lesser population and/or (2) that splits or divides an S'@':--i%,requires a waiver. All waiver requests will be revj.ei,,cd, closely scrutinized in terms of certain specific factors or conditions. In the case of proposed less than 500,000 these include: areas with a population 1. Rate of population growth in recent years. 2. Low population density over a large geographis area. 3. Major geographical barriers or natural isolation. 4. Sufficic@.ncy of health facilities, manpower, resources, and services within the area to generally meet the needs of its residents. 5. Present hospital (or health services) utilization and re erra patterns. .6. Whether the area is essentially a self-contained economic trade area. 7. Special population characteristics that have a district areal dimension (6.g., reservation Indians). 8. Reasonable assurance or evidence to indicate that the liSA serving the area xqould be able to obtaiii'suffi.cic-nt iaatchiii- and/or other funds to support i itiiiiii-,it!iii required c 0, p staff of fivc,@(5). that the Fccl(!r.,il. r@ii-it-. of @.50 p(.!r/@ti,.d otlic-'r fui-,@is would c-qij@il or !de I%Tlierc, ti@e z3.rca propos,@e@ woul-@'t ol: cl:lv '.,',.A the spc@c.-;.,fi factors or conditions that wc;,,il(.1 bc.,. at particul.,,.ii-ly included: I.. In the case of @@riter-State S',ISA.s, to xqh:i.cli its population is olieri,7h--lmirigi-y (c.c,., 80/'. or r@iore) in one St@i.te; or coi-iversel y, ,where only a small fraction of its polLilation is in one State or another. 2. t.Iso in the case of inter-State S.',ISAs, extent of cooperation (or noncooperator) in other or efforts in recent years. 34 In the case of intr,-,-State Sl,!Sils, eyteii@ to which its is coterpiinous with existing PSRO areas. 4. Extent to which it is cote-i--minbLs witli.: (a) existing health pl.anr@ina areas CIIP, EIISI)S, l@IT) and/or (b) Departriient of ComTocrce defined economic trade areas. 5. Iligh degree. of acceptability to local. elect.e-,l officials, health providers, consumer groups,,and others in the area proposed. 'therefore, the basis for each waiver r(iquc,,,jt should be explicit in terms of the above or other special factors or conditions. Appropriate but rare and @ c@ifLc information and d.ctta (,i.s opposed to isrci--rtioiis or generalities) in the way of justification and explanation of each requested wa-Lver must be submitted as part your proposed Area DesJ.gnati.on Plan. Morc@ovc@r act@,ja' copies (@.-,s or, o-,e('l t:o --c') f -1 th coi;,-.tL iits iiid t i-i c@- little rece 'Ivc@d IL):or,,i I.c)cz@l c IC! c tl-,-@d bodies, CHPS, and otli,-r roupL-, vie%,;s were solicited, iiiu s t be incl.uded w@4th your Area Designat,i.oii P I.aii subrii.ss.,iori. u j.@ Ljp L,@ tII I 0 i,@ ),,7@ t ic) i@ i a r) (I c@ ra i cr. t i,". o i I The -icc)llowin,- -a each service I 1973 poptii..itioia for the S'tate@ area .and each SMSA.- 2. Total land area for the State, each health servi(,e a-rea, and each SMSA (in square miles); 3. Populatiob projections to 1980 and population change 1970-73 for aii,v health service area for which waivers are required. Population figures are to be based on the U.S. Bureau of thb Census is current population estimates for 1973. These are the most recent -ity. figures available nationally by cou-L 1. Coordinat-I.on of TISA Boundaries with Other Tvpos of Areas In accordance with Section 1411(a)(4), to the maximum extent feasible, the boundaries of the health service must be coordinated with the boundaries of Professi-onal Standards Review Organizations, existing regional planning areas, and State planning and administrative areas. Since it is reco nized that -he boundaries of areas defined 9 for different purposes cannot all be identical, the criteria for designation of health service areas do not requite that their boundaries be identical with those for PSRO areas, regional planning areas, or State planning and administrative areas. -in order to comply with the above requirement, however,'where a health service area contains more than a single PSRO, an effort should be made to include two or more whole PsItos . If a health ubstate service area is not to have identical boundaries with those of s I)IaT-.,-iin,, arcas3 it would be iLlclude the areas of t-vio or -,@tc@re whole 11-ezis. Finally, i-f any such areas are to be divicl(@cl aTiion, health service areas., the divis4@on shbtild generally follow existing geopolitical boundaries.- In order to demonstrate compliance N,7itli Sect,i.on the following materials are required- 1. 'k@fl-tIateinent or certification signed by an appropriate State official to the effect that the requirements of Section 1411(a)(4) have been d considered in the process of developing health service area designations; 2. Statements or map, or diagrams showing how the designated areas match the boundaries for: (A) Pto-Lessional Standard Review Organization; (b) Sub-State Planning and Development Districts; (c) Comprehensive 2: Health Program; (d) Regional Medical Programs; (e) Local political boundaries, i..e., counties and equivalents, major municipalities, and appropriate ,and special districts; (f) Councils of Governments; (g) Multiple Planning Districts. ..Keep the submissions on coordination as simple as possible. A statement such as "The State PSRO, and health service area are identical will suffice where appropriate. J Cen@@(",rs for requires -Lliat @,o v'L@f@ exUcti@ przictical)l(@, a health service area must include at I(.@,ist one for the provision of Iii,,Tily specialized services. The requirement for the inclusion of such @i center reflects Coi),Frc@s,,ion,-Al desire that the health service areas provide a self-contained, comprehensive and complete range of health services such that an individual residing in the area would rarely if ever have to leave it in order to obtain needed medical care. In order to comply with the above requirement, the names and locations of medical schools, academic health centers or 1-najor tiospita s in each designated health ax ser\7ice area should bc!.provided. $inte the legislation only requires a center for highly specialized services where feasible, failure of an area to have such a center does not require a request for a waiver. Where a center is absent in any area, however, the designation materials should include an explanation of how the people residing within this area will receive such specialized services, i.e., affiliated agreements with existing facilities or proposed approved construction plans. K. Descriptive Area Information and Statistics Section 1411(a)(1) of the Act requires that each health xE@E service area must be a rational'geographic region containing a comprehensive range of health services and of a character suitable for the.eff6ctive planning and development of health services. Suitable narrative and statistical information must be submitted for each designated health service area to insure compliance with this requirement. Any narrative xknxdi should be brief possible ari.cl la t@h l@lit- d @,cril)tions @@iill ,;iynply hinder must be completed within two months of the Statc,'s Relevant data which should be included is listed below: 1. Facilities Descri.i)ti,,)ii. For each proposed health service area a list of hospitals by name and number of beds. if possible, the number of long term care facilities and beds should be included for each proposed health service area. Also show riiental ka health and reh@-abi itatioli facilities, where these exist; 2. an 01-7er Resources e@c ti-on Description of manpower resources within the proposed health service area. a) Number of M.D.'8 by specialty; b) Number of nurses by RN's and LPN; c) Availabilitv of Allied Health Manpower; 3. Other Relevant I)ata and Information a) Cov6rage of major prepayment plans; b) @"A, PHS, and military facilities in the area, and population covered; c) Special characteristics of the area such as major vacation populations, flood, or earthquake hazards, etc. L-ist of 1. Addresses of IILIL Regionnl offices and States covered. 2. Table showing materials required for area clesigi@iziti.on in relation to requirements of the Act. 3. Illustrative maps. I[. Illu§trative format for submission. 5. Check list of items to be submitted. 6. Copy of Section 1411 of the Act.