a)
Introduction
1)
A birth center shall
obtain a certificate of need from the Health Facilities and Services Review
Board under the Health Facilities Planning Act before receiving a license by
the Department. [210 ILCS
170/17(a) ]
2)
All birth centers in existence as
of September 1, 2023,
shall obtain a valid license to operate
by September 1, 2025. ([
210 ILCS 170/10 ] and 77 Ill.
Adm. Code
264.1250(a)).
3)
If, after obtaining an initial
certificate of need under subsection (a)(1), a birth center
seeks to increase the bed capacity of the birth center, the birth center must
obtain a certificate of need from the Health Facilities and Services Review
Board before increasing bed capacity. [210 ILCS
170/17(b) ]
4)
A birth center that is located in
a medically underserved area, as determined by the U.S. Department of Health
and Human Services, shall receive priority in obtaining a certificate of
need. [210 ILCS
170/17(c) ]
b) Review Criteria
1) These criteria are applicable only to
those projects or components of projects involving the birth center 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,
1120 and
1130.
Applicants proposing to establish, expand or modernize a birth center category
of service shall comply with the applicable subsections of this Section, as
follows:
|
PROJECT TYPE
|
REQUIRED REVIEW CRITERIA
|
|
Establishment of Service
|
(c)(1)
|
-
|
Formula Calculation
|
|
(c)(2)
|
-
|
Service to Area Residents
|
|
(c)(3)
|
-
|
Service Accessibility
|
|
(d)(1)
|
-
|
Unnecessary Duplication
|
|
(d)(2)
|
-
|
Maldistribution of Service
|
|
|
|
|
(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 a birth center on the same
site as the existing birth center, 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 birth center 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
1100.820(c).
5) All projects for a birth center shall
comply with the licensing requirements of the Illinois Department of Public
Health, which are set forth in the Birth Center Licensing Act [210 ILCS 170]
and the Birth Center Licensing Code (77 Ill. Adm. Code
264).
6) The applicant shall certify that it has
reviewed and understands the requirements to become certified under Titles
XVIII and IX of the federal Social Security Act and plans to seek certification
under this 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
birth center category of service.
2) Service to Area Residents
Applicants proposing to establish or expand a birth center
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) as
set forth under 77 Ill. Adm. Code
1100.510(d).
A) For projects to establish a birth center
category of service, the applicant shall document that at least 50% of the
projected patient volume will be residents of the GSA.
B) For projects to expand a birth center
category of service, the applicant shall provide patient origin information for
all admissions for the last 12-month period, verifying that at least 50% of
admissions were residents of the GSA. For all other projects, applicants shall
document that at least 50% of the projected patient volume will be from
residents of the GSA.
3)
Service Accessibility
The proposed project to establish or expand a birth center
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 a birth center within the
GSA;
ii) The area population and
existing care system exhibit indicators of medical care problems, such as high
infant mortality;
iii) All or part
of the GSA is located in the Center for Disease Control and Prevention's Social
Vulnerability Index for Social and Economic Status (accessible at
https://data.cdc.gov/Vaccinations/Social-Vulnerability-Index/ypqf-r5qs).
Factors contained within the Social and Economic Status include: number of
persons living below the federal poverty level, a higher civilian unemployment
rate (compared to the State rate), per capita income, and persons (age 25 and
older) without a high school diploma;
v) All existing birth centers 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
1100.820(c).
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; and
iv) Scheduling or admission restrictions that
exist with birth centers located within the GSA.
d) Unnecessary
Duplication/Maldistribution - Review Criterion
1) The applicant shall document that the
project will not result in an unnecessary duplication of birth centers. 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 estimates available for the State of Illinois); and
C) The names and locations of all existing or
approved birth centers situated within the established radii outlined in 77
Ill. Adm. Code
1100.510(d).
2) The applicant shall document
that the project will not result in maldistribution of services.
Maldistribution exists when the birth centers identified in subsection
(d)(1)(C), as established by 77 Ill. Adm. Code
1100.510(d),
have not met the target utilization. The applicant shall document the
following:
A) Historical utilization (for the
latest 12-month period prior to submission of the application) for existing
birth centers within the established radii, as 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
1100.820(c);
or
B) Insufficient population to
provide the volume or caseload necessary to utilize the birth center 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 will not:
A) lower the utilization of other birth
centers within the GSA below the utilization standard specified in 77 Ill. Adm.
Code
1100.820(c);
and
B) lower, to a further extent,
the utilization of other birth centers within the GSA that are currently
(during the latest 12-month period) operating below the utilization
standard.
4) The
applicant shall document that a written request was received by all existing
facilities that provide birth center services located within the established
radii outlined in 77 Ill. Adm. Code
1100.510(d) of
the project site asking the anticipated impact of the proposed project upon the
facility's utilization. The request shall include a statement that a written
response is to 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 the applicant's request and 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 birth center, the applicant shall
document that the existing treatment areas to be modernized have deteriorated
or are functionally obsolete and need to be replaced or modernized, due to
factors such 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) Commission for the
Accreditation of Birth Centers 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
1) An applicant proposing to establish a
birth center category of service shall document that a sufficient supply of
obstetric 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, existing birth centers that are located
in the GSA (in total or in part), if any, have not experienced a staffing
shortage.
2) A staffing shortage at
a licensed birth center is indicated by an average annual vacancy rate of more
than 10% for budgeted full-time equivalent obstetric personnel (staff who
deliver or assist in the delivery of a newborn). This staffing includes, but is
not limited to, advanced practice registered nurses, certified nurse midwives,
licensed certified professional midwives, obstetricians, and patient care
technicians.
3) The applicant shall
document that a written request for staffing information was received by all
existing licensed birth centers within the GSA, 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 licensed birth center to respond to
the applicant's request for information within the prescribed 15-day response
period shall constitute an assumption that the existing licensed birth center
has not experienced staffing vacancy rates in excess of 10%. Copies of the
applicant's request and any correspondence received from the facilities shall
be included in the application.
4)
If more than 25% of the licensed birth centers contacted indicate an
experienced obstetric 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.
g) Charity
Care
A birth center shall provide charitable care
consistent with that provided by comparable health care providers in
the GSA. [210 ILCS
170/40(c) ] Documentation shall
include a copy of the charity care policy that will be in effect at the birth
center and copies of charity care policies from other birth centers located
within the GSA. The applicant's charity care policy shall be compared to the
other birth center providers in the GSA. If the applicant's charity care policy
is inconsistent with the charity care policy of birth centers in the GSA, the
applicant shall provide an explanation.
h) Admission Policies
1) For projects to establish a birth center,
an applicant shall document that the birth center may not discriminate
against any patient requiring treatment because of the source of payment for
services, including Medicare and Medicaid recipients. [210 ILCS
170/40(d) ] Documentation shall
consist of a signed statement that no restrictions on admissions due to these
factors will occur.
2) For projects
to establish a birth center, an applicant shall document that all admission
protocols, as referenced at 77 Ill. Adm. Code
264.1550, will be implemented,
and followed once the birth center is licensed. Documentation shall consist of
a signed statement that the birth center will adhere to the established
requirements.
i) Transfer
Agreement and Hospital Proximity
For projects to establish a birth center, an applicant shall
document that it will have the mandatory linkage and integration requirements
and that it will have a transfer agreement with a nearby birthing hospital. An
applicant shall document the following:
1)
A birth center shall link and
integrate its services with at least one birthing hospital with a minimum Level
1 perinatal designation. [210 ILCS
170/20(a) ] The applicant shall
provide an attestation that it will establish the necessary services.
2) The
birth center shall have an
established agreement with a nearby receiving birthing hospital with policies
and procedures for timely transfer of maternal and neonatal patients.
[
210 ILCS
170/20(b) ] The transfer agreement
shall be in place prior to initiating the planning and construction of the
facility. (77 Ill. Adm. Code
264.2770(a)(2)(A)) Patient transfers shall be
within 30 minutes travel time for both rural and nonrural hospitals. (77 Ill.
Adm. Code
264.2250(b) and
264.2700(a)(3))
The applicant shall provide a copy of the transfer agreement in the application
for permit (77 Ill. Adm. Code
264.2700(a)(2)(A)).
j) Prenatal Care and Community
Education
For projects to establish a birth center, the applicant shall
document that it offers prenatal care and community education services
and coordinates these services with other health care services available in the
community. [210 ILCS
170/5(4) ] The applicant shall
provide a written narrative on how these services will be offered and
coordinated with other health care services in the community.
k)
Quality Assurance and
Improvement
For projects to establish a birth center, the applicant shall
document that it shall implement a quality improvement program
consistent with the requirements of the accrediting body and is encouraged to
participate in quality improvement projects implemented by the Department's
Administrative Perinatal Centers and other Department-supported perinatal
quality improvement projects. [210 ILCS
170/35 ] The applicant shall provide a written
narrative on how this requirement will be implemented at the birth
center.
l) Mandatory
Reporting of Data
Per Sections 13 and 14.1 of the Health Facilities Planning
Act and 77 Ill. Adm. Code
1100.60, licensed birth centers
shall provide HFSRB with data needed for planning. Data provided from these
facilities shall include, but not be limited to, facility capacity,
utilization, and socio-economic information. Data obtained from these
facilities shall be included in the State Board's Inventory of Health Care
Facilities and Services and Need Determinations.