Current through Register Vol. 49, No. 18, September 16, 2024
PURPOSE: The committee is amending this rule to add
equipment application requirements, require MO SOS business registration
documentation, require long-term care project affiliate and Medicare and/or
Medicaid certification information, update DHSS bureau name information,
decrease population estimate percentages, update form reference and add public
notice requirements.
(1) A
Certificate of Need (CON) application package shall be accompanied by an
application fee which shall be a nonrefundable minimum amount of one thousand
dollars ($1,000) or one-tenth of one percent (0.1%), which may be rounded up to
the nearest dollar, of the total project cost, whichever is greater, made
payable to the "Missouri Health Facilities Review Committee."
(2) A written application package consisting
of an electronic file in PDF format or a paper original shall be prepared and
organized as follows:
(A) The CON Applicant's
Completeness Checklists and Table of Contents shall be used as follows:
1. Include at the front of the
application;
2. Check the
appropriate "done" boxes to assure completeness of the application;
3. Number all pages of the application
sequentially and indicate the page numbers in the appropriate blanks;
4. Check the appropriate "N/A" box if an item
in the Review Criteria is "not applicable" to the proposal type; and
5. Restate the Review Criteria (preferably in
bold type) and answer all Review Criteria items.
(B) The application package shall be based on
one (1) of the following CON Applicant's Completeness Checklists and Table of
Contents appropriate to the proposed project type, as follows:
1. New Hospital Application (Form MO
580-2501), included herein. Use this for a new or replacement hospital
project;
2. New or Additional
Long-Term Care (LTC) Bed Application (Form MO 580-2502), included herein. Use
this form for a Residential Care Facility project, Assisted Living Facility
project, Intermediate Care Facility project, or Skilled Nursing Facility
project or Long-Term Care Hospital project;
3. New or Additional Long-Term Care Hospital
(LTCH) Bed Application (also use Form MO 580-2502), included herein;
4. New or Additional Equipment Application
(Form MO 5802503), included herein;
5. Expedited LTC Bed Replacement/ Expansion
Application (Form MO 580-2504), included herein;
6. Expedited LTC Renovation/Modernization
Application (Form MO 580-2505), included herein; or
7. Equipment Replacement Application (Form MO
580-2506), included herein.
(C) The application shall be divided into
these sections:
1. Divider I. Application
Summary;
2. Divider II. Proposal
Description;
3. Divider III.
Service-Specific Criteria and Standards; and
4. Divider IV. Financial Feasibility (only
required for full applications or expedited replacement equipment applications
which do not currently hold a valid CON).
(D) Support Information shall be included at
the end of each section to which it pertains, and shall be referenced in the
section narrative. For applicants anticipating having multiple applications in
a year, master file copies of such things as maps, population data (if
applicable), board memberships, IRS Form 990, or audited financial statements
may be submitted once, and then referred to in subsequent applications, as long
as the information remains current.
(E) The application package shall document
the need or meet the additional information requirements in
19 CSR
60-50.450(4)-(5) for the proposal by
addressing the applicable Community Need Criteria and Standards using the
standards in
19
CSR 60-50.440 through
19 CSR
60-50.460 plus providing additional documentation to
substantiate why any proposed alternative Criteria and Standards should be
used.
(3) An Application
Summary shall be composed of the completed forms in the following order:
(A) Applicant Identification and
Certification (Form MO 5801861), included herein. Additional specific
information about board membership may be requested, if needed.
1. Provide documentation from the Missouri
Secretary of State that the proposed owner(s) and proposed operator(s) are
registered to do business in Missouri.
2. For long-term care projects-
A. State if the license of the proposed
operator or any affiliate of the proposed operator has been revoked within the
previous five (5) years;
B. If the
license of the proposed operator or any affiliate of the proposed operator has
been revoked within the previous five (5) years, provide the name and address
of the facility whose license was revoked;
C. State if the Medicare and/or Medicaid
certification of any facility owned or operated by the proposed operator or any
affiliate of the proposed operator has been revoked within the previous five
(5) years; and
D. If the Medicare
and/or Medicaid certification of any facility owned or operated by the proposed
operator or any affiliate of the proposed operator has been revoked within the
previous five (5) years, provide the name and address of the facility whose
Medicare and/or Medicaid certification was revoked;
(B) A completed Representative
Registration (Form MO 5801869), included herein, for the contact person and any
others as required by section 197.326.1, RSMo;
(C) A detailed Proposed Project Budget (Form
MO 580-1863), included herein; and
(D) An attachment which details how each line
item was determined, including all methods and assumptions used. Documentation
of costs may be requested.
(4) The Proposal Description shall include
documents which-
(A) Provide a complete
detailed description and scope of the project, and identify all institutional
services or programs which will be directly affected by this
proposal;
(B) Describe the
developmental details including:
1. A timeline
of anticipated events for the proposal from the time of the CON application
review through project completion, including the commencement and completion of
new construction or renovation, or purchase and installation of equipment;
2. A legible street or road map
showing the exact location of the facility or health service, and a copy of the
site plan showing the relation of the project to existing structures and
boundaries;
3. Preliminary
schematics for the project on an eight and one-half inch by eleven inch (8 1/2"
x 11") format (not required for replacement equipment projects). The function
for each space, including the location of each existing and proposed bed before
and after construction or renovation, shall be clearly identified and all space
shall be assigned;
4. Evidence of
submission of architectural plans to the Division of Regulation and Licensure,
Department of Health and Senior Services, for long-term care projects and other
facilities (not required for equipment projects);
5. For long-term care proposals, existing and proposed
gross square footage for the entire facility and for each institutional service
or program directly affected by the project. If the project involves
relocation, identify what will go into vacated space;
6. Documentation that the proposed owner owns the
project site, or that the proposed owner has an executed option to purchase or
lease the site; and
7. Proposals
which include major medical equipment shall include an equipment list with
prices and also documentation in the form of bid quotes, purchase orders,
catalog prices, or other sources to substantiate the proposed equipment
costs;
(C) Proposals for
major medical equipment must define the geographic service area;
(D) Proposals for new hospitals or new or
additional longterm care (LTC) beds must define the community to be served-
1. Describe the service area(s) population
using year 2025 populations and projections provided by the Bureau of Health
Care Analysis and Data Dissemination (BHCADD), which can be obtained by
contacting:
Chief, Bureau of
Health Care Analysis and Data Dissemination (BHCADD)
Department of Health and Senior Services
PO Box 570, Jefferson City, MO 65102
Telephone: (573) 751-6272
There will be a charge for any of the information requested,
and seven to fourteen (7-14) days should be allowed for a response from BHCADD.
Information requests should be made to BHCADD such that the response is
received at least two (2) weeks before it is needed for incorporation into the
CON application;
2. Use the
maps and population data received from BHCADD with the CON Applicant's
Population Determination Method to determine the estimated population for LTC
projects, as follows:
A. Utilize all of the
population for zip codes entirely within the fifteen- (15-) mile radius for LTC
beds or geographic service area for hospitals and major medical
equipment;
B. Reference a state
highway map (or a map of greater detail) to verify population centers (see
BHCADD) within each zip code overlapped by the fifteen- (15-) mile radius or
geographic service area;
C.
Categorize population centers as either "in" or "out" of the fifteen- (15-)
mile radius or geographic service area and remove the population data from each
affected zip code categorized as "out;"
D. Estimate, to the nearest five percent
(5%), the portion of the zip code area that is within the fifteen- (15-) mile
radius or geographic service area by "eyeballing" the portion of the area in
the radius (if less than five percent (5%), exclude the entire zip
code);
E. Multiply the remaining
zip code population (total population less the population centers) by the
percentage determined in subparagraph (4)(D)2.D. (Due to numerous complexities,
population centers will not be utilized to adjust overlapped zip code
populations in Jackson, Clay, St. Louis, and St. Charles counties or St. Louis
City; instead, the total population within the zip code will be considered
uniform and multiplied by the percentage determined in subparagraph
(4)(D)2.D.);
F. Add back the
population center(s) "inside" the radius or region for zip codes overlapped;
and
G. The sum of the estimated zip
codes, plus those entirely within the radius, will equal the total population
within the fifteen-(15-) mile radius or geographic service area;
3. Provide other statistics, such
as studies, patient origin, or discharge data, Hospital Industry Data
Institute's information, or consultants' reports, to document the size and
validity of any proposed user-defined "geographic service area";
(E) Identify specific community
problems or unmet needs which the proposed or expanded service is designed to
remedy or meet;
(F) Provide
historical utilization for each existing service affected by the proposal for
each of the past three (3) full years;
(G) Provide utilization projections through at least
three (3) full years beyond the completion of the project for all proposed and
existing services directly affected by the project;
(H) If an alternative methodology is added, specify
the method used to make need forecasts and describe in detail whether projected
utilizations will vary from past trends; and
(I) Provide the current and proposed number of
licensed beds by type for projects which would result in a change in the
licensed bed complement of the LTC facility.
(5) Document that consumer needs and
preferences have been included in planning this project. Describe how consumers
have had an opportunity to provide input into this specific project, and
include in this section all peti- tions, letters of acknowledgement, support or
opposition received.
(6) Document
that providers of similar health services in the proposed service area have
been notified of the application by a public notice in the local newspaper of
general circulation before it was filed with the CON Program from the
applicant. The public notice shall include a contact person's name and phone
number and/or email for the project.
(7) For proposed full or expedited CON
applications, excluding equipment replacement applications, document that
administrators or directors of all affected facilities in the proposed
fifteen-(15-) mile radius or service area were addressed letters regarding the
application.
(8) In addition to
using the Community Need Criteria and Standards as guidelines, the committee
may also consider other factors to include, but not be limited to, the needs of
residents based upon religious considerations, residents with HIV/AIDS, or
mental health diagnoses, and special exceptions to the Community Need Criteria
and Standards.
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*Original authority: 197.320, RSMo 1979, amended 1993,
1995, 1999.
