Application Package

PURPOSE: This rule provides the information requirements and the application format for 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 nonre fundable 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 580-2503 included herein); 5. Expedited LTC Bed Replacement 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 6050.450(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 new or additional long-term care bed and new hospital 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. If a third-party vendor or contractor was used to determine costs, provide documentation of costs. (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" × 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 new, additional, and replacement major medical equipment must define the community to be served and geographic service area; (D) Proposals for new hospitals or new or additional long term care (LTC) beds must define the community to be served— 1. Describe the service area(s) population using projected year populations 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 petitions, 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 admin istrators 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. SENIOR SERVICES SENIOR SERVICES Certificate of Need Program NEW HOSPITAL APPLICATION Applicant’s Completeness Checklist and Table of Contents Project Name: Project No: Project Description: Done Page N/A Description Divider I. Application Summary: __ ________ __ 1. Applicant Identification and Certification (Form MO 580-1861) __ ________ __ 2. Representative Registration (From MO 580-1869) __ ________ __ 3. Proposed Project budget (Form MO 580-1863) and detail sheet with documentation of costs. __ ________ __ 4. Provide documentation from MO Secretary of State that the proposed owner(s) and operator(s) are registered to do business in MO. __ ________ __ 5. State if the license of the proposed operator or any affiliate of the proposed operator has been revoked within the previous five (5) years. __ ________ __ 6. If the license of the proposed operator or any affiliate of the proposed operator has been revoked within the previous 5 years, provide the name and address of the facility whose license was revoked. __ ________ __ 7. 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 5 years. __ ________ __ 8. 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 5 years, provide the name and address of the facility whose Medicare and/or Medicaid certification was revoked. Divider II. Proposal Description: __ ________ __ 1. Provide a complete detailed project description. __ ________ __ 2. Provide the proposed number of licensed beds by medical specialty. __ ________ __ 3. Provide a timeline of events for the project, from CON issuance through project competition. __ ________ __ 4. Provide a legible city or county map showing the exact location of the proposed facility. __ ________ __ 5. Provide a site plan for the proposed project. __ ________ __ 6. Provide preliminary schematic drawings for the proposed project. __ ________ __ 7. Provide evidence that architectural plans have been submitted to the Department of Health and Senior Services. __ ________ __ 8. Provide the proposed square footage. __ ________ __ 9. Document ownership of the project site or provide an option to purchase. __ ________ __ 10. Define the community to be served (service area: projected population, area, rationale). __ ________ __ 11. Provide utilization projections through the first three (3) FULL years of operation of the new beds __ ________ __ 12. Identify specific community problems or unmet needs the proposal would address. __ ________ __ 13. Provide the methods and assumptions used to project utilization. __ ________ __ 14. Document that consumer needs and preferences have been included in planning this project and describe how consumers had an opportunity to provide input. __ ________ __ 15. Provide copies of any petitions, letters of support or opposition received. __ ________ __ 16. 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. __ ________ __ 17. Document that providers of all affected facilities in the proposed 15-mile radius were addressed letters regarding the application. Divider III. Service Specific Criteria and Standards: __ ________ __ 1. Document the methodology utilized to determine the need for the proposed hospital. __ ________ __ 2. Provide the most recent three (3) FULL years of evidence that the average occupancy of the same type(s) of beds at each other hospital in the proposed service area exceeds eighty percent (80%). __ ________ __ 3. Discuss the impact the proposed hospital would have on utilization of other hospitals in the geographic service area. __ ________ __ 4. Document the unmet need in the geographic service area for each type of bed being proposed according to the population-based need formula Divider IV. Financial Feasibility Review Criteria and Standards: __ ________ __ 1. Document that the proposed costs per square foot are reasonable when compared to the latest “RS Means Construction Cost data” __ ________ __ 2. Document that sufficient financing is available by providing a letter from a financial institution or an auditor’s statement indicating that sufficient funds are available. __ ________ __ 3. Provide Service-Specific Revenues and Expenses (Form MO 580-1865) for the latest three (3) years, and projected through three (3) FULL years beyond project completion. __ ________ __ 4. Document how patient charges are derived. __ ________ __ 5. Document responsiveness to the needs of the medically indigent. MO 580-2501 (03/26) SENIOR SERVICES Certificate of Need Program NEW OR ADDITIONAL LONG TERM CARE BED APPLICATION (Use for RCF/ALF, ICF/SNF and LTCH beds) Applicant’s Completeness Checklist and Table of Contents Project Name:________________________________________________________ Project No:_____________________________ Project Description:_______________________________________________________________________________________________ Done Page N/A Description Divider I. Application Summary: __ _______ __ 1. Applicant Identification and Certification (Form MO 580-1861) __ ________ __ 2. Representative Registration (From MO 580-1869) __ ________ __ 3. Proposed Project budget (Form MO 580-1863) and detail sheet with documentation of costs. __ ________ __ 4. Provide documentation from MO Secretary of State that the proposed owner(s) and operator(s) are registered to do business in MO. __ ________ __ 5. State if the license of the proposed operator or any affiliate of the proposed operator has been revoked within the previous five (5) years. __ ________ __ 6. If the license of the proposed operator or any affiliate of the proposed operator has been revoked within the previous 5 years, provide the name and address of the facility whose license was revoked. __ ________ __ 7. 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 5 years. __ ________ __ 8. 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 5 years, provide the name and address of the facility whose Medicare and/or Medicaid certification was revoked. Divider II. Proposal Description: __ ________ __ 1. Provide a complete detailed project description. __ ________ __ 2. Provide a timeline of events for the project, from CON issuance through project competition. __ ________ __ 3. Provide a legible city or county map showing the exact location of the proposed facility. __ ________ __ 4. Provide a site plan for the proposed project. __ ________ __ 5. Provide preliminary schematic drawings for the proposed project. __ ________ __ 6. Provide evidence that architectural plans have been submitted to the Department of Health and Senior Services. __ ________ __ 7. Provide the proposed square footage. __ ________ __ 8. Document ownership of the project site, or provide an option to purchase. __ ________ __ 9. Define the community to be served. __ ________ __ 10. Provide projected population projections for the 15-mile radius service area. __ ________ __ 11. Identify specific community problems or unmet needs the proposal would address. __ ________ __ 12. Provide historical utilization for each of the past three (3) years and utilization projections through the first three (3) FULL years of operation of the new LTC beds. __ ________ __ 13. Provide the methods and assumptions used to project utilization. __ ________ __ 14. Document that consumer needs and preferences have been included in planning this project and describe how consumers had an opportunity to provide input. __ ________ __ 15. Provide copies of any petitions, letters of support or opposition received. __ ________ __ 16. 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. __ ________ __ 17. Document that providers of all affected facilities in the proposed 15-mile radius were addressed letters regarding the application. Divider III. Service Specific Criteria and Standards: __ ________ __ 1. For ICF/SNF beds, address the population-based bed need methodology of fifty-three (53) beds per one thousand (1,000) population age sixty-five (65) and older. __ ________ __ 2. For RCF/ALF beds, address the population-based bed need methodology of twenty-five (25) beds per one thousand (1,000) population age sixty-five (65) and older. __ ________ __ 3. For LTCH beds, address the population-based bed need methodology of one-tenth (0.1) bed per one thousand (1,000) population. __ ________ __ 4. Document any alternate need methodology used to determine the need for additional beds such as Alzheimer’s, mental health or other specialty beds. __ ________ __ 5. For any proposed facility which is designed and operated exclusively for persons with acquired human immunodeficiency syndrome (AIDS) provide information to justify the need for the type of beds being proposed. __ ________ __ 6. If the project is to add beds to an existing facility, has the facility received a Notice of Noncompliance within the last 18 months as a result of a survey, inspection or complaint investigation? If the answer is yes, explain. Divider IV. Financial Feasibility Review Criteria and Standards: __ ________ __ 1. Document that the proposed costs per square foot are reasonable when compared to the latest “RS Means Construction Cost data” __ ________ __ 2. Document that sufficient financing is available by providing a letter from a financial institution or an auditor’s statement indicating that sufficient funds are available. __ ________ __ 3. Provide Service-Specific Revenues and Expenses (Form MO 580-1865) for the latest three (3) years, and projected through three (3) FULL years beyond project completion. __ ________ __ 4. Document how patient charges are derived. __ ________ __ 5. Document responsiveness to the needs of the medically indigent. __ ________ __ 6. For a proposed new skilled nursing or intermediate care facility, what percentage of your admissions would be Medicaid eligible on the first day of admission or become Medicaid eligible within 90 days of admission? __ ________ __ 7. For an existing skilled nursing or intermediate care facility, what percentage of your admissions are Medicaid eligible on the first day of admission or becomes Medicaid eligible within 90 days of admission. MO 580-2502 (10/24) SENIOR SERVICES Project Name: Project No: Project Description: Done Page N/A Description Divider I. Application Summary: 1. Applicant Identification and Certification (Form MO 580-1861). 2. Representative Registration (Form MO 580-1869). 3. Proposed Project Budget (Form MO 580-1863) and detail sheet with documentation of costs. Divider II. Proposal Description: 1. Provide a complete detailed project description. 2. Provide a timeline of events for the project, from the issuance of the CON through project completion. 3. Provide preliminary schematic drawings for the proposed project. 4. Prove the existing and proposed gross square footage. 5. Document ownership of the project site. Divider III. Community Need Criteria and Standards: 1. If the proposal is to relocate RCF/ALF beds within 6-mile radius in accordance with §197.318.4(4) provide the following: - Documentation that all facilities involved are under the same licensure ownership or control; - Documentation that all facilities involved are within the 6-mile limit; and - Documentation that all owners and operators of the facility from which the beds are being transferred are aware of the proposal and consent to it. 2. If the proposal is to replace one-half of a qualifying licensed facility’s beds within a 30-mile radius in accordance with §197.318.5 provide the following: - Documentation that the facility has only been operating 50% of its licensed capacity with every resident residing in a private room and all vacant beds have been reported to the Division of Regulation and Licensure as unavailable for occupancy for at least the most recent four consecutive calendar quarters; - Documentation that the replacement beds shall be built to private room specifications and only used for single occupancy; and - Documentation that the existing and proposed facilities have the same owner or owners, and that the owner or owners stipulate that the beds to be replaced shall not be used later for long term care; if the existing facility is being operated under a lease, both the lessee and owner shall stipulate the same. 3. If the proposal is to replace a facility in its entirety at a single site within a 15-mile radius in accordance with §197.318.6 provide the following: - Documentation that all facilities involved are within the 15-mile limit; and - Documentation that the existing facility and the proposed facility have the same owner or owners with a written stipulation that the facility to be replaced will not be used later for a long term care. MO 580-2504 (03/26) Certificate of Need Program EXPEDITED LTC BED REPLACEMENT APPLICATION Applicant’s Completeness Checklist and Table of Contents SENIOR SERVICES Certificate of Need Program EQUIPMENT REPLACEMENT APPLICATION Applicant’s Completeness Checklist and Table of Contents Project Name: Project No: Project Description: _ Done Page N/A Description Divider I. Application Summary: 1. Applicant Identification and Certification (Form MO 580-1861) 2. Representative Registration (From MO 580-1869) 3. Proposed Project Budget (Form MO 580-1863) and detail sheet with documentation of costs. Divider II. Proposal Description: 1. Provide a complete detailed project description, CON project number of the existing equipment (if prev. CON approved), and include the type/brand of both the existing equipment and the replacement equipment. 2. Provide a listing with itemized costs of the medical equipment to be acquired and bid quotes. 3. Provide a timeline of events for the project, from CON issuance through project completion. Divider III. Service Specific Criteria and Standards: 1. Describe the financial rationale for the proposed replacement equipment. 2. Document if the existing equipment has exceeded its useful life. 3. Describe the effect the replacement unit would have on quality of care. 4. Document if the existing equipment is in constant need of repair. 5. Document if the lease on the current unit has expired. 6. Describe the technological advances provided by the new unit. 7. Describe how patient satisfaction would be improved. 8. Describe how patient outcomes would be improved. 9. Describe what impact the new unit would have on utilization. 10. Describe any new capabilities that the new unit would provide. 11. By what percent will this replacement increase patient charges. (If replacement equipment was not previously approved, also complete Divider IV below.) Divider IV. Financial Feasibility Review Criteria and Standards: 1. Document that sufficient financing is available by providing a letter from a financial institution or an auditor's statement indicating that sufficient funds are available. 2. Provide Service-Specific Revenues and Expenses (Form MO 580-1865) projected through three (3) FULL years beyond project completion. 3. Document how patient charges are derived. 4. Document responsiveness to the needs of the medically indigent. MO 580-2506 (11/22) AUTHORITY: section 197.320, RSMo 2016.* 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: Filed March 10, 2014, effective Oct. 30, 2014. Amended: Filed Aug. 9, 2019, effective March 30, 2020. Amended: Filed June 29, 2022, effective Jan. 30, 2023. Amended: Filed April 22, 2024, effective Nov. 30, 2024. Amended: Filed Aug. 19, 2025, effective April 30, 2026. *Original authority: 197.320, RSMo 1979, amended 1993, 1995, 1999.