Freestanding Emergency Center Medical Services

Section 1110.280  Freestanding Emergency Center Medical Services a)         Introduction No person shall construct, modify or establish a freestanding emergency center in Illinois, or acquire major medical equipment or make capital expenditures in relation to such a facility in excess of the capital expenditure minimum, as defined by the Act, without first obtaining a permit from the State Board in accordance with this Section . [20 ILCS 3960/5.1a] b)         Review Criteria 1)         These criteria are applicable only to those projects or components of projects involving the freestanding emergency center (FEC) medical services (FECMS) category of service.  In addition, the applicant shall address other applicable requirements in this Part, as well as those in 77 Ill. Adm. Code 1100 and 1130.  Applicants proposing to establish, expand or modernize an FECMS category of service shall comply with the applicable subsections of this Section, as follows: PROJECT TYPE REQUIRED REVIEW CRITERIA Establishment of Service (c)(1) − Planning Area Need – 77 Ill. Adm. Code 1100 Formula Calculation (c)(2) − Service to Area Residents (c)(3) − Service Demand for Establishment (c)(4) − Service Accessibility (d)(1) − Unnecessary Duplication of  Services (d)(2) − Maldistribution (d)(3) − Impact on Other Providers (d)(4) − Request for Data from Other Providers (f) − Staffing Availability Expansion of Existing Service (c)(2) − Service to Area Residents (f) − Staffing Availability Category of Service Modernization (e)(1) − Deteriorated Facilities (e)(2) − Documentation (e)(3) − Additional Documentation 2)         If the proposed project involves the replacement of an FEC facility on site, the applicant shall comply with the requirements listed in subsection (b)(1) for Category of Service Modernization. 3)         If the proposed project involves the replacement of the FEC facility on a new site, the applicant shall comply with the requirements listed in subsection (b)(1) for Establishment of Service. 4)         All projects shall meet or exceed the utilization standards for the service, as specified in 77 Ill. Adm. Code 1100. 5)         All projects for an FEC shall comply with the licensing requirements established in Section 32.5 of the Emergency Medical Services (EMS) Systems Act, including the requirements that the proposed FEC is located: A) in a municipality with a population of 50,000 or fewer inhabitants; B) within 50 miles of the hospital that owns or controls the FEC; and C) within 50 miles of the Resource Hospital affiliated with the FEC as part of the EMS system . [210 ILCS 50/32.5(a)] 6)         The applicant shall certify that it has reviewed, understands and plans to comply with all of the following requirements: A)        The requirements of becoming a Medicare provider of freestanding emergency services; and B)        The requirements of becoming licensed under the Emergency Medical Services (EMS) Systems Act. c)         Area Need – Establishment or Expansion of Service 1)         77 Ill. Adm. Code 1100  Formula Calculation No formula need calculation has been established for the FECMS category of service. 2)         Service to Area Residents Applicants proposing to establish or expand an FECMS category of service shall document that the primary purpose of the project will be to provide necessary health care to the residents of the geographic service area (GSA) (see 77 Ill. Adm. Code 1100.510(d). A)        For projects to establish an FECMS category of service, the applicant shall document that at least 50% of the projected patient volume will be residents of the GSA.  Documentation shall consist of patient origin data, as follows: i)         Letters from authorized representatives of hospitals or other FEC facilities that are part of the Emergency Medical Services (EMS) System for the defined GSA, including patient origin data by zip code.  If letters are submitted as documentation, a certification in each letter, by the authorized representative, that the representations contained in the letter are true and correct.  A complete set of the letters with original notarized signatures shall accompany the application for permit; or ii)         Patient origin data by zip code from independent data sources (e.g., Illinois Health and Hospital Association CompData or IDPH hospital discharge data), based upon the patient's legal residence, for patients receiving services at the existing GSA facilities' emergency departments (ED), verifying that at least 50% of the ED patients served during the last 12-month period were residents of the GSA. B)        An applicant proposing to expand an FECMS category of service shall provide patient origin information for all patients served at the existing FEC facility for the last 12-month period, verifying that at least 50% of patients served were residents of the GSA.  The applicant shall submit patient origin information by zip code, based upon the patient's legal residence. 3)         Service Demand − Establishment of FECMS Category of Service The applicant shall document that establishment of an FECMS category of service is necessary to accommodate the service demand experienced annually by the existing GSA hospitals over the latest 2-year period. A)        Historical Utilization The applicant shall document the annual number of ED patients that have received care at facilities that are located in the applicant's defined GSA for the latest 2-year period prior to submission of the application. B)         Projected Utilization The applicant shall document: i)          the estimated number of patients anticipated to receive services at the proposed FEC.  The anticipated number cannot exceed the documented historical caseload of all hospitals that are located in the applicant's defined GSA. ii)         if applicable, the estimated number of patients anticipated to receive services at the proposed FEC, based upon rapid population growth in the applicant facility's existing market area. C)        Projected Service Demand – Documentation Parameters i)          Population projections shall be produced, using, as a base, the population census or estimate for the most recent year for zip code, county, incorporated place, township, or community area by the U.S. Census Bureau or IDPH; ii)         Projections shall be for a maximum period of 10 years from the date the application is submitted; iii)        The number of years projected shall not exceed the number of historical years documented; iv)        Projections shall contain documentation of population changes in terms of births, deaths, and net migration for a period of time equal to or in excess of the projection horizon; v)         Projections shall be for total population and specified age groups for the applicant's market area, as defined by HFSRB for each category of service in the application; and vi)        Documentation shall be submitted to HFSRB on projections methodology, data sources, assumptions and special adjustments. 4)         Service Accessibility The proposed project to establish or expand an FECMS category of service is necessary to improve access for GSA residents.  The applicant shall document the following: A)        Service Restrictions The applicant shall document that at least one of the following factors exists in the GSA: i)          The absence of ED services within the GSA; ii)         The area population and existing care system exhibit indicators of medical care problems, such as high infant mortality, or designation by the Secretary of Health and Human Services as a Health Professional Shortage Area, a Medically Underserved Area, or a Medically Underserved Population; iii)        All existing emergency services within the established radii outlined in 77 Ill. Adm. Code 1100.510(d) meet or exceed the utilization standard specified in 77 Ill. Adm. Code 1100. B)        Supporting Documentation The applicant shall provide the following documentation, as applicable, concerning existing restrictions to service access: i)          The location and utilization of other GSA service providers; ii)         Patient location information by zip code; iii)        Travel-time studies; iv)        A certification of waiting times; v)         Scheduling or admission restrictions that exist in GSA providers; vi)        An assessment of GSA population characteristics that documents that access problems exist; and vii)       The most recently published IDPH Hospital Questionnaire. d)         Unnecessary Duplication/Maldistribution − Review Criterion 1)         The applicant shall document that the project will not result in an unnecessary duplication.  The applicant shall provide the following information: A)        A list of all zip code areas (in total or in part) that are located within the established radii outlined in 77 Ill. Adm. Code 1100.510(d) of the project's site; B)        The total population of the identified zip code areas (based upon the most recent population numbers available for the State of Illinois population); and C)        The names and locations of all existing or approved health care facilities located within the established radii outlined in 77 Ill. Adm. Code 1100.510(d) from the project site that provide emergency medical services. 2)         The applicant shall document that the project will not result in maldistribution of services.  Maldistribution exists when the identified facilities within the relevant travel radius, as established by 77 Ill. Adm. Code 1100.510(d), have an excess supply of ED treatment stations characterized by such factors as, but not limited to: A)        Historical utilization (for the latest 12-month period prior to submission of the application) for existing ED within the established radii outlined in 77 Ill. Adm. Code 1100.510(d) of the applicant's site that is below the utilization standard established pursuant to 77 Ill. Adm. Code 1100; or B)        Insufficient population to provide the volume or caseload necessary to utilize the ED services proposed by the project at or above utilization standards. 3)         The applicant shall document that, within 24 months after project completion, the proposed project: A)        Will not lower the utilization of other GSA providers below the utilization standards specified in 77 Ill. Adm. Code 1100; and B)        Will not lower, to a further extent, the utilization of other GSA hospitals or FECs that are currently (during the latest 12-month period) operating below the utilization standards. 4)         The applicant shall document that a written request was received by all existing facilities that provide ED service located within the established radii outlined in 77 Ill. Adm. Code 1100.510(d) of the project site asking the number of treatment stations at each facility, historical ED utilization, and the anticipated impact of the proposed project upon the facility's ED utilization.  The request shall include a statement that a written response be provided to the applicant no later than 15 days after receipt.  Failure by an existing facility to respond to the applicant's request for information within the prescribed 15-day response period shall constitute an assumption that the existing facility will not experience an adverse impact on utilization from the project.  Copies of any correspondence received from the facilities shall be included in the application. e)         Category of Service Modernization 1)         If the project involves modernization of an existing FECMS category of service, the applicant shall document that the existing treatment areas to be modernized are deteriorated or functionally obsolete and need to be replaced or modernized, due to such factors as, but not limited to: A)        High cost of maintenance; B)        Non-compliance with licensing or life safety codes; C)        Changes in standards of care; or D)        Need for additional space for diagnostic or therapeutic purposes. 2)         Documentation shall include the most recent: A)        IDPH Inspection reports; and B)        The Joint Commission reports. 3)         Other documentation shall include the following, as applicable to the factors cited in the application: A)        Copies of maintenance reports; B)        Copies of citations for life safety code violations; and C)        Other pertinent reports and data. f)         Staffing Availability − Review Criterion 1)         An applicant proposing to establish an FECMS category of service shall document that a sufficient supply of personnel will be available to staff the service.  Sufficient staff availability shall be based upon evidence that for the latest 12-month period prior to submission of the application, those hospitals or FECs located in zip code areas that are (in total or in part) within one hour normal travel time of the applicant facility's site have not experienced a staffing shortage with respect to the categories of services proposed by the project. 2)         A staffing shortage is indicated by an average annual vacancy rate of more than 10% for budgeted full-time equivalent staff positions for health care workers who are subject to licensing by the Department of Financial and Professional Regulation. 3)         An applicant shall document that a written request for such information was received by all existing facilities within the zip code areas, and that the request included a statement that a written response be provided to the applicant no later than 15 days after receipt.  Failure by an existing facility to respond to the applicant's request for information within the prescribed 15-day response period shall constitute an assumption that the existing facility has not experienced staffing vacancy rates in excess of 10%.  Copies of any correspondence received from the facilities shall be included in the application. 4)         If more than 25% of the facilities contacted indicated an experienced staffing vacancy rate of more than 10% percent, the applicant shall provide documentation as to how sufficient staff shall be obtained to operate the proposed project, in accordance with licensing requirements.