Mississippi Administrative Code
Title 15 - Mississippi Department of Health
Part 8 - Office of Health Policy and Planning
Subpart 90 - Planning and Resource Development
Chapter 07 - Other Health Services
Section 15-8-90-07-704 - Certificate of Need Criteria and Standards for End Stage Renal Disease Facilities
Section 15-8-90-07-704.01 - Policy Statement Regarding Certificate of Need Application for the Establishment of End Stage Renal Disease (ESRD) Facilities

Current through September 24, 2024

1. Establishment of an ESRD Facility: The provision or proposed provision of maintenance dialysis services constitutes the establishment of an ESRD facility if the proposed provider has not provided those services on a regular basis within the period of twelve (12) months prior to the time such services would be offered.

2. Type of Review: CON applications for ESRD services shall be considered substantive as defined under the appropriate Mississippi State Health Plan

3. ESRD Facility Service Area: An ESRD Facility Service Area is defined as the area within a thirty (30) mile radius of an existing or proposed ESRD facility. ESRD Facility Service Areas, including the Service Areas of existing facilities which overlap with the proposed Service Area, shall be used for planning purposes.

4. Utilization Definitions: These utilization definitions are based upon three (3) shifts per day six (6) days per week, or eighteen (18) shifts per week. Only equipment (peritoneal or hemodialysis) that requires staff assistance for dialysis and is in operation shall be counted in determining the utilization rate. Utilization of equipment in operation less than twelve (12) months shall be prorated for the period of time in actual use.

a. Full Utilization: For planning and CON purposes, full (100 percent) utilization is defined as an average of 936 dialyses per station per year.

b. Optimum Utilization: For planning and CON purposes, optimum (65 percent) utilization is defined as an average of 608 dialyses per station per year.

c. Need Utilization: For planning and CON purposes, need (80 percent) utilization is defined as an average of 749 dialyses per station per year.

5. Outstanding CONs: ESRD facilities that have received CON approval but are not operational shall be considered to be operating at 50 percent, which is the minimum utilization rate for a facility the first year of operation.

6. Utilization Data: The Department may use any source of data, subject to verification by the Department, it deems appropriate to determine current utilization or projected utilization of services in existing or proposed ESRD facilities. The source of data may include, but is not limited to, Medicare Certification records maintained by the Division of Health Facilities Licensure and Certification, ESRD Network #8 data, and Centers for Medicare and Medicaid Services (CMS) data.

7. Minimum Expected Utilization: It is anticipated that a new ESRD facility may not be able to reach optimum utilization (65 percent) of ten ESRD stations during the initial phase of operation. Therefore, for the purposes of CON approval, an application must demonstrate how the applicant can reasonably expect to have 50 percent utilization of a minimum of ten ESRD stations by the end of the first full year of operation and 65 percent utilization by the end of the third full year of operation.

8. Minimum Size Facility: No CON application for the establishment of a new ESRD facility shall be approved for less than ten (10) stations.

9. Expansion of Existing ESRD Facilities: Existing ESRD facilities may add ESRD stations as follows:

a. An existing ESRD facility with a CMS star rating of 1 or 2, may add ESRD stations without certificate of need review as long as the facility does not add, over the period of one (1) year, more than four (4) stations.

b. An existing ESRD facility with a CMS star rating of 3, may add ESRD stations without certificate of need review as long as the facility does not add, over the period of one (1) year, more than six (6) stations.

c. An existing ESRD facility with a CMS star rating of 4 or 5, may add ESRD stations without certificate of need review, as long as the facility does not add, over the period of one (1) year, more than eight (8) stations.

Note: An ESRD facility that has not yet been given a CMS star rating may add ESRD stations without certificate of need review as long as the facility does not add, over the period of one (1) year, more than four (4) stations.

10. Home Dialysis Programs: Each existing ESRD facility may establish or relocate a home dialysis program to any location within a 10-mile radius of the existing facility without certificate of need review; provided, however, that the facility shall submit an application for determination of non-reviewability prior to the establishment of the dialysis program. If such established or relocated home dialysis program is a freestanding program, the freestanding home dialysis program shall document that it has a back-up agreement for the provision of any necessary dialysis services with the existing ESRD facility. If an existing ESRD facility wants to create, either through establishment or relocation, more than two home dialysis program, the project shall be subject to CON review as the establishment of a new ESRD facility. Existing freestanding home dialysis programs may add home training stations as follows:

a. An existing freestanding home dialysis facility with a CMS star rating of 1 or 2, may add home training stations without certificate of need review as long as the facility does not add, over the period of one (1) year, more than four (4) stations.

b. An existing freestanding home dialysis facility with a CMS star rating of 3, may add home training stations without certificate of need review as long as the facility does not add, over the period of one (1) year, more than six (6) stations.

c. An existing ESRD facility with a CMS star rating of 4 or 5, may add home training stations without certificate of need review, as long as the facility does not add, over the period of one (1) year, more than eight (8) stations.

Note: An existing freestanding home dialysis facility that has not yet been given a CMS star rating may add home training stations without certificate of need review as long as the facility does not add, over the period of one (1) year, more than eight (8) stations.

11. Establishment of Satellite ESRD Facilities: Any existing ESRD facility which reaches a total of 30 ESRD stations, may establish a ten (10) station satellite facility. If a proposed satellite ESRD facility is to be located more than one (1) mile from the existing facility, a certificate of need must be obtained by the facility prior to the establishment of the satellite facility.

12. Non-Discrimination: An applicant shall affirm that within the scope of its available services, neither the facility nor its staff shall have policies or procedures which would exclude patients because of race, color, age, sex, or ethnicity.

13. Indigent/Charity Care: An applicant shall be required to provide a "reasonable amount" of indigent/charity care as described in Chapter 1 of this Plan.

14. Staffing: The facility must meet, at a minimum, the requirements and qualifications for staffing as contained in 42 CFR § 494.140. In addition, the facility must meet all staffing requirements and qualifications contained in the service specific criteria and standards.

15. Federal Definitions: The definitions contained in 42 CFR § 494.10 shall be used as necessary in conducting health planning and CON activities.

16. Affiliation with a Renal Transplant Center: ESRD facilities shall be required to enter into a written affiliation agreement with a renal transplant center.

Disclaimer: These regulations may not be the most recent version. Mississippi may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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