Criteria and Standards for Equipment and New Hospitals

PURPOSE: This rule lists the service-specific criteria and standards used in the Certificate of Need (CON) review process. (1) For new units or services in the service area, use the following: (A) Provide the minimum annual utilization for each of the other providers in the service area for the most recent three (3) full years, if applicable. The provider(s) should achieve at least the following community need rates as follows by the final year: 1. Magnetic resonance imaging procedures: 2,000 2. Positron emission tomography/computed tomography procedures: 1,000 3. Lithotripsy treatments: 1,000 4. Linear accelerator treatments: 3,500 5. Cardiac catheterization procedures (include coronary angioplasties): 500 6. Gamma knife treatments: 200 7. Computed tomography: 3,500 8. Robotic surgery system: 240 (B) For long-term care hospitals (such as a hospital-withina-hospital or long-term acute care hospital), the applicant should comply with the standards as described in 42 CFR, section 412.23(e), and the bed need should meet the applicable population-based bed need methodology in 19 CSR 60-50.450; (C) Alternate methodologies may also be provided. (2) For additional units or services, provide the applicant’s annual utilization for the most recent three (3) full years, if applicable. The applicant should achieve at least the following community need rates as follows, by the final year: (A) Magnetic resonance imaging procedures: 3,000 (B) Positron emission tomography/computed tomography procedures: 1,000 (C) Lithotripsy treatments: 1,000 (D) Linear accelerator treatments: 6,000 (E) Cardiac catheterization procedures: 750 (F) Gamma knife treatments: 200 (G) Computed tomography: 4,000 (H) Robotic surgery system: 240 (3) For replacement equipment, utilization standards are not used, but rather the following questions shall be answered: (A) What is the financial rationale for the replacement? (B) How has the existing unit exceeded its useful life in accordance with American Hospital Association guidelines? (C) How does the replacement unit affect quality of care, utilization, and operational efficiencies compared to the existing unit? (D) Is the existing unit in constant need of repair? (E) Has the current lease on the existing unit expired? (F) What technological advances and capabilities will the new unit include? (G) How will patient satisfaction be improved? (H) How will the new unit improve outcomes and/or clinical improvements? (I) By what percentage will this replacement increase patient charges? (4) For the construction of a new hospital, the following questions shall be answered: (A) What methodology was utilized to determine the need for the proposed hospital? (B) 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%). (C) What impact would the proposed hospital have on utilization of other hospitals in the service area? (D) What is the unmet need according to the following population-based bed need formula using (Unmet Need = (R × P) – U), where— P = Projected year population in the service area; U = Number of licensed and approved beds in the service area; and R = Community need rate of one (1) bed per population in the service area as follows: 1. Medical/surgical bed: 570 2. Pediatric bed: 8,330 3. Psychiatric bed: 2,080 4. Substance abuse/chemical dependency bed: 20,000 5. Inpatient rehabilitation bed: 9,090 6. Obstetric bed: 5,880 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 Dec. 14, 2001, effective Jan. 1, 2002, expired June 29, 2002. Rescinded and readopted: Filed Dec. 14, 2001, effective June 30, 2002. 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. *Original authority: 197.320, RSMo 1979, amended 1993, 1995, 1999.