Mo. Code Regs. tit. 19 § 60-50.430

Current through Register Vol. 49, No. 21, November 1, 2024.

Section 19 CSR 60-50.430 - [Effective until 11/30/2024] Application Package

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.

(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.

Click to view image

19 CSR 60-50.430

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.

Amended by Missouri Register September 15, 2014/Volume 39, Number 18, effective 10/31/2014

Amended by Missouri Register February 3, 2020/Volume 45, Number 3, effective 3/31/2020

Amended by Missouri Register December 1, 2022/Volume 47, Number 23, effective 1/29/2023

*Original authority: 197.320, RSMo 1979, amended 1993, 1995, 1999.