Current through Register Vol. 48, No. 12, March 22, 2024
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.