PURPOSE: This rule lists the service-specific criteria and standards used in the Certificate of Need (CON) review process.

1. (1) For new units or services in the service area, use the following methodologies:

   1. (A) The population-based need formula should be (Unmet need=(R×P) – U) where: P=Year 2005 population in the service area(s); U=Number of service units in the service area(s); and R=Community need rate of one (1) unit per population listed as follows:

      1. 1. Magnetic resonance imaging unit 100,000
      2. 2. Positron emission tomography unit 500,000
      3. 3. Lithotripsy unit 1,000,000
      4. 4. Linear accelerator unit 100,000
      5. 5. Adult cardiac catheterization lab 50,000
      6. 6. Pediatric cardiac catheterization lab 50,000
      7. 7. Adult open heart surgery rooms 100,000
      8. 8. Pediatric open heart surgery rooms 100,000
      9. 9. All general surgery 10,000
      10. 10. Gamma knife 7,500,000
      11. 11. Excimer laser 500,000

   2. (B) The minimum annual utilization for all other providers in the service area should achieve at least the following community need rates as follows:

      1. 1. Magnetic resonance imaging procedures 2,000
      2. 2. Positron emission tomography procedures 1,000
      3. 3. Lithotripsy treatments 1,000
      4. 4. Linear accelerator treatments 3,500
      5. 5. Adult cardiac catheterization procedures (include coronary angioplasties) 500
      6. 6. Pediatric cardiac catheterization procedures 250
      7. 7. Adult open heart surgery operations 200
      8. 8. Pediatric open heart surgery operations 100
      9. 9. All general surgery 750
      10. 10. Gamma knife treatments 200
      11. 11. Hemodialysis treatments 200
      12. 12. Excimer laser procedures 1,800
   3. (C) Long-term care hospitals (such as a hospital-within-a-hospital or long-term acute care hospital) should comply with the standards as described in 42 CFR, section 412.23(e), and bed need requirements should meet the applicable population-based bed need and utilization standards in 19 CSR 60- 50.450;
   4. (D) Alternate methodologies may be provided.

2. (2) For additional units or services, the applicant’s optimal annual utilization should achieve at least the following community need rates as follows:

   1. (A) Magnetic resonance imaging procedures 3,000
   2. (B) Positron emission tomography procedures 1,000
   3. (C) Lithotripsy treatments 1,000
   4. (D) Linear accelerator treatments 6,000
   5. (E) Adult cardiac catheterization procedures 750
   6. (F) Pediatric cardiac catheterization procedures 375
   7. (G) Adult open heart surgery operations 300
   8. (H) Pediatric open heart surgery operations 150
   9. (I) All other general surgery 1,125
   10. (J) Gamma knife treatments 200
   11. (K) Hemodialysis treatments 200
   12. (L) Excimer laser procedures 3,600

3. (3) For replacement equipment, utilization standards are not used, but rather the following questions should be answered:

   1. (A) What is the financial rationale for the replacement?
   2. (B) How has the existing unit exceeded its useful life in accordance with American Hospital Association guidelines?
   3. (C) How does the replacement unit affect quality of care compared to the existing unit?
   4. (D) Is the existing unit in constant need of repair?
   5. (E) Has the current lease on the existing unit expired?
   6. (F) What technological advances will the new unit include?
   7. (G) How will patient satisfaction be improved?
   8. (H) How will the new unit improve outcomes and/or clinical improvements?
   9. (I) What impact will the new unit have on utilization and operational efficiencies?
   10. (J) How will the new unit add additional capabilities? 19 CSR 60-50
   11. (K) By what percentage will this replacement increase patient charges?

4. (4) For the construction of a new hospital, the following questions should be answered:

   1. (A) What methodology was utilized to determine the need for the proposed hospital?
   2. (B) Provide evidence that the current occupancy of other hospitals in the proposed service area exceeds eighty percent (80%).
   3. (C) What impact would the proposed hospital have on utilization of other hospitals in the service area?
   4. (D) What is the unmet need according to the following population-based bed need formula using (Unmet Need=(R×P) – U), where: P=Year 2005 population in the service area; U=Number of beds in the service area; and R=Community need rate of one (1) bed per population as follows:
   5. 1. Medical/surgical bed 570
   6. 2. Pediatric bed 8,330
   7. 3. Psychiatric bed 2,080
   8. 4. Substance abuse/chemical dependency bed 20,000
   9. 5. Inpatient rehabilitation bed 9,090
   10. 6. Obstetric bed 5,880

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 Dec. 14, 2001, effective Jan. 1, 2002, expired June 29, 2002. Rescinded and readopted: Filed Dec. 14, 2001, effective June 30, 2002. *Original authority: 197.320, RSMo 1979, amended 1993, 1995, 1999.