PURPOSE: This rule provides the information requirements and the application format of how to complete a Certificate of Need (CON) application for a CON review.

PUBLISHER’S NOTE: The secretary of state has determined that the publication of the entire text of the material which is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive. This material as incorporated by reference in this rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproduction. This note applies only to the reference material. The entire text of the rule is printed here.

1. (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. (2) A written application package consisting of an original and eleven (11) bound copies (comb or three (3)-ring binder) or an electronic file in PDF format shall be prepared and organized as follows:

   1. (A) The CON Applicant’s Completeness Checklists and Table of Contents should be used as follows:

      1. 1. Include at the front of the application;
      2. 2. Check the appropriate “done” boxes

to assure completeness of the application; SENIOR SERVICES

1. 3. Number all pages of the application

sequentially and indicate the page numbers in the appropriate blanks;

1. 4. Check the appropriate “n/a” box if an

item in the Review Criteria is “not applicable” to the proposal; and

1. 5. Restate (preferably in bold type) and

answer all items in the Review Criteria.

1. (B) The application package should use one (1) of the following CON Applicant’s Completeness Checklists and Table of Contents appropriate to the proposed project, as follows:

   1. 1. New Hospital Application (Form MO

580-2501, incorporated by reference);

1. 2. New or Additional Long-Term Care

1. (LTC) Bed Application (Form MO 580-2502, incorporated by reference). Use this for Residential Care, Assisted Living, Intermediate Care, and Skilled Nursing Facilities and Long-Term Care Hospitals;

   1. 3. New or Additional Long-Term Care

Hospital (LTCH) Bed Application (also use Form MO 580-2502);

1. 4. New or Additional Equipment Appli-

cation (Form MO 580-2503, incorporated by reference);

1. 5. Expedited LTC Renovation/Modern-

ization Application (Form MO 580-2505, incorporated by reference); or

1. 6. Expedited Equipment Replacement

Application (Form MO 580-2506, incorporated by reference).

1. (C) The application should be formatted into dividers using the following outline:

   1. 1. Divider I. Application Summary;
   2. 2. Divider II. Proposal Description;
   3. 3. Divider III. Service-Specific Criteria

and Standards; and

1. 4. Divider IV. Financial Feasibility

(only if required for full applications).

1. (D) Support Information should be included at the end of each divider section to which it pertains, and should be referenced in the divider 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.
2. (E) The application package should document the need or meet the additional information requirements in 19 CSR 60- 50.450(4)–(6) 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.

1. (3) An Application Summary shall be composed of the completed forms in the following order:

   1. (A) Applicant Identification and Certification (Form MO 580-1861, incorporated by reference). Additional specific information about board membership may be requested, if needed;
   2. (B) A completed Representative Registration (Form MO 580-1869, incorporated by reference) for the contact person and any others as required by section 197.326(1), RSMo; and
   3. (C) A detailed Proposed Project Budget (Form MO 580-1863, incorporated by reference), with an attachment which details how each line item was determined, including all methods and assumptions used.

2. (4) The Proposal Description shall include documents which:

   1. (A) Provide a complete detailed description and scope of the project, and identify all the institutional services or programs which will be directly affected by this proposal;

   2. (B) Describe the developmental details including:

      1. 1. A legible city or county 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;

1. 2. Preliminary schematics for the pro-

ject that specify the functional assignment of all space which will fit on an eight and onehalf inch by eleven inch (8 1/2" × 11") format (not required for replacement equipment projects). The Certificate of Need Program (CONP) staff may request submission of an electronic version of the schematics, when appropriate. The function for each space, before and after construction or renovation, shall be clearly identified and all space shall be assigned;

1. 3. Evidence of submission of architec-

tural 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 replacement equipment projects);

1. 4. 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;

1. 5. Documentation of ownership of the

project site, or that the site is available through a signed option to purchase or lease; and

1. 6. Proposals which include major and

other medical equipment should include an equipment list with prices and documentation in the form of bid quotes, purchase orders, catalog prices, or other sources to substantiate the proposed equipment costs;

1. (C) Proposals for new hospitals, new or additional long-term care (LTC) beds, or new major medical equipment must define the community to be served:

   1. 1. Describe the service area(s) popula-

tion using year 2015 populations and projections which are consistent with those provided by the Bureau of Health Informatics which can be obtained by contacting:

Chief, Bureau of Health Informatics Section of Public Health Practice and Administrative Support (SPHPAS)

Division of Community and Public Health Department of Health and Senior Services PO Box 570, Jefferson City, MO 65102 Telephone: (573) 751-6299

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 SPHPAS. Information requests should be made to SPHPAS such that the response is received at least two (2) weeks before it is needed for incorporation into the CON application.

1. 2. Use the maps and population data

received from SPHPAS with the CON Applicant’s Population Determination Method to determine the estimated population for LTC projects, as follows:

1. 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;

1. B. Reference a state highway map (or

a map of greater detail) to verify population centers (see Bureau of Health Informatics) within each zip code overlapped by the fifteen (15)-mile radius or geographic service area;

1. 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”;

1. D. Estimate, to the nearest ten per-

cent (10%), 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);

1. E. Multiply the remaining zip code

population (total population less the population centers) by the percentage determined in subparagraph (4)(C)2.D. (Due to numerous complexities, population centers will not be utilized to adjust overlapped zip code populations in Jackson, 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)(C)2.D.);

1. F. Add back the population center(s)

“inside” the radius or region for zip codes overlapped; and

1. 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.

1. 3. Provide other statistics, such as stud-

ies, 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”;

1. (D) Identify specific community problems or unmet needs which the proposed or expanded service is designed to remedy or meet;
2. (E) Provide historical utilization for each existing service affected by the proposal for each of the past three (3) years;
3. (F) Provide utilization projections through at least three (3) years beyond the completion of the project for all proposed and existing services directly affected by the project;
4. (G) 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
5. (H) 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.

1. (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 petitions, letters of acknowledgement, support or opposition received.
2. (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 by the applicant.
3. (7) 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 number of patients requiring treatment, the changing complexity of treatment, unique obstacles to access, competitive financial considerations, or the specialized nature of the service.

4. (8) The following forms cited in this rule are incorporated by reference and published by the Certificate of Need Program (CONP), October 1, 2009, and may be downloaded from http://www.dhss.mo.gov/CON/Forms.html, obtained by mailing a written request with a self-addressed stamped envelope to CONP, PO Box 570, Jefferson City, MO 65102- 0570, or acquired in person at the CONP Office, 3418 Knipp Drive, Jefferson City, Missouri, (573) 751-6403. This rule does not include any later amendments or additions.

   1. (A) New Hospital Application (Form MO 580-2501).
   2. (B) New or Additional Long-Term Care

5. (LTC) Bed Application (Form MO 580- 2502).

   1. (C) New or Additional Equipment Application (Form MO 580-2503).
   2. (D) Expedited LTC Renovation/Modernization Application (Form MO 580-2505).
   3. (E) Expedited Equipment Replacement Application (Form MO 580-2506).
   4. (F) Applicant Identification and Certification (Form MO 580-1861).
   5. (G) Representative Registration (Form MO 580-1869).
   6. (H) Proposed Project Budget (Form MO 580-1863).

AUTHORITY: section 197.320, RSMo 2000.* Emergency rule filed Aug. 29, 1997, effective Sept. 8, 1997, expired March 6, 1998. Original rule filed Aug. 29, 1997, effective March 30, 1998. Emergency rescission and rule filed June 29, 1999, effective July 9, 1999, expired Jan. 5, 2000. Rescinded and readopted: Filed June 29, 1999, effective Jan. 30, 2000. Emergency rescission and rule filed Dec. 14, 2001, effective Jan. 1, 2002, expired June 29, 2002. Rescinded and readopted: Filed Dec. 14, 2001, effective June 30, 2002. Emergency rescission and rule filed Dec. 16, 2002, effective Jan. 1, 2003, expired June 29, 2003. Amended: Filed June 9, 2003, effective Nov. 30, 2003. Emergency amendment filed June 8, 2005, effective July 1, 2005, expired Dec. 30, 2005. Amended: Filed June 8, 2005, effective Dec. 30, 2005. Emergency amendment filed Aug. 14, 2006, effective Aug. 28, 2006, expired Feb. 23, 2007. Amended: Filed Aug. 14, 2006, effective March 30, 2007. Amended: Filed Oct. 1, 2010, effective May 30, 2011.

*Original authority: 197.320, RSMo 1979, amended 1993, 1995, 1999. 19 CSR 60-50