Ala. Admin. Code r. 410-2-3-.05

Current through Register Vol. 42, No. 8, May 31, 2024

Section 410-2-3-.05 - End Stage Renal Disease Services

(1)Discussion

(a) Those who suffer with End Stage Renal Disease have inadequate renal function to support life. Individuals with end-stage disease must rely on kidney dialysis or peritoneal dialysis to survive. End Stage Renal Disease may be caused by a number of problems including diabetes, sickle cell disease, hypertension and congenital renal disease (polycystic kidney disease).

(b) In 1991 the Legislature declared that it was in the best interest of the state and its residents for kidney disease treatment centers to be established and operated throughout the state so that any patient needing such treatment would be able to utilize a hemodialysis unit located within a reasonable distance of their home. § 22-21-278Code of Alabama, 1975, allows kidney disease treatment centers with ten (10) stations or less located in a Class 3, 4, 5, 6, 7 or 8 municipality to be established without a Certificate of Need. Kidney disease treatment centers located in a Class 4, 5, 6, 7, or 8 municipality located in a county in which a Class 1, 2 or 3 municipality, or any part of such municipality, are located are required to receive Certificate of Need approval for any dialysis stations.

(c) In order to further expand access to End Stage Renal Disease treatment in rural areas, any existing kidney disease treatment center located in a county that does not contain all or any part of a Class 1, 2, or 3 municipality (as such classes are defined in sections 11-40-12 and 11-40-13, Code of Alabama, 1975) shall qualify for this exception to the need methodology set forth in 410-2-3-.05(2) to add up to six (6) stations if the existing kidney disease treatment center can demonstrate an average weekly utilization at or above the Optimal Utilization of eighty percent (80%) of Present Capacity (as such terms are defined in 410-2-3-.05(2)) for a period of ten (10) consecutive weeks within the six (6) months immediately preceding the filing of a Letter of Intent for the additional stations. Such additional stations shall be considered an exception to the need methodology set forth within 410-2-3-.05(2) and shall be considered regardless of the utilization of any other kidney disease treatment centers in the county. However, any present in-center stations developed pursuant to a CON granted under this provision will thereafter be included in future need methodology calculations in accordance with 410-2-3-.05(2).

In addition to such additional information that may be required by SHPDA, a kidney disease treatment center seeking a CON under this provision must provide the following information:

Demonstration of compliance with the utilization rate in paragraph (1) (c);

The existing kidney disease treatment center has not been granted a CON for an increase of stations under this section within the preceding twelve (12) month period, which twelve (12) month time period begins to run upon the issuance of a license by the Alabama Department of Public Health for the additional stations in accordance with paragraph (1)(c); and

The kidney disease treatment center must have been licensed for at least one (1) year as an End Stage Renal Disease treatment center.

(2)Planning Policies

(a) The determination of need for additional hemodialysis stations will be based on the utilization of present in-center hemodialysis stations (capacity at the time of application as utilized by census at the time of application) and any anticipated increases in census.

1. In calculating the present capacity, "Isolation Stations" (stations reserved for Hepatitis-B positive patients) and stations used for home hemodialysis training will be removed from the total number of stations at the facility. No further reduction of station count will be made for down-time, transients, or back-up of home patients, since provision is made for these in the Optimal Utilization Criterion.

2. Present Capacity is defined as two shifts per day, six days per week, based on the fact that most patients require three dialysis treatments per week. Third shift ("evening dialysis") will not be considered in calculating capacity since patient demand for this shift is erratic and unpredictable.

3. Optimal Utilization is defined as 80% of present capacity, thus making provision for cost-effective use of services and orderly growth, as well as reserving some capacity for downtime, transients, and back up of home patients. Optimal capacity is 9.6 dialysis treatments per station per week (.80 x 12 dialysis treatments/station/week = 9.6 dialysis treatments/station/week).

4. Maximum Optimal Capacity is defined as the number of patients who can receive treatment under optimal capacity on a three-dialysis treatment per week schedule.

EXAMPLE (Numbers not reflective of a specific reporting timeframe):

Total Stations	20
Dialysis Treatments/Station/Week	x	12
Present Capacity	240 Available Dialysis Treatments/Week
Optimal Utilization	x	.80
Maximum Optimal Capacity	192 Available Dialysis Treatments/Week
Patient Usage	÷	f- 3 Dialysis Treatments/Week
Maximum Optimal Census	64 Patients

(b) Projection of census will be submitted in a yearly fashion for the three years subsequent to the date of application. Note that much of the first year will be consumed by the application process (both state and federal), construction or renovation and licensure process. Calculations of anticipated census are to be based on:

1. Present In-Center Hepatitis-Negative Hemodialysis Patients.

(i) Other patients treated by the facility in the home settings [(Home Hemodialysis, Continuous Ambulatory Peritoneal Dialysis (CAPD), Continuous Cyclic Peritoneal Dialysis (CCPD)], will be excluded; Hepatitis-B positive patients will be excluded;

(ii) Note that if more than one End Stage Renal Disease facility exists within the defined service area, all present dialysis stations and present patients in all End Stage Renal Disease facilities must be considered in developing a demonstration of need.

2. New End Stage Renal Disease patient projections shall be based on:

(i) The total population of the county in which the stations are to be located plus any contiguous county that does not have a dialysis center.

(ii) Incidence Rate: The definition of incidence rate is the rate at which new events occur in a population. The formula to determine incidence rate is as follows: The numerator is the number of new events occurring in a defined period; the denominator is the population at risk of experiencing the event during this period. Applicant will use the statewide total incidence rate, or the sum of the statewide non-white incidence rate plus the statewide white incidence rate, from the most recently published statistical update produced by the Agency.

(iii) Note that if more than one End Stage Renal Disease facility exists within the service area, the historical distribution of patients between the facilities will be used in determining the number of new patients who will seek services at the applying facility.

(I) Loss Rate:

EXAMPLE (Numbers not reflective of a specific reporting timeframe):

In-Center Census Start of Year:	100 Patients
New Patients During Year: 150	50
Less: 16% Death	24
Less: 5% Transplant	8
Less: 11% Home Training	6
In-Center Census, Year End	112

Note: As of October 2018, Network 8, Inc. does not publish the data tables on its website. SHPDA is authorized to continue utilization of the most recent data provided to the Agency by Network 8, Inc. upon request. Requests for information contained in data tables must be obtained by interested parties directly from Network 8, Inc.

(iv) SHPDA continues to attempt to obtain data necessary for calculating need for dialysis stations pursuant to the above need methodology from Network 8, Inc. If SHPDA has not obtained the necessary data from Network 8, Inc. or from another publicly available source by December 31, 2020, SHPDA shall require each licensed ESRD facility to submit an annual report on a form developed and issued by SHPDA, with the advice and consent of the Health Care Information and Data Advisory Council, to report the minimum necessary data required to update the ESRD need methodology.

3. A kidney transplant is a surgical procedure by which a healthy kidney is removed from one person and implanted in the ESRD patient. Transplantation is, ideally, a one-time procedure; if the donated kidney functions properly, the patient can live a relatively normal life.

4. A free-standing licensed pediatric facility shall have the ability to make application directly to the Certificate of Need Review Board for the purpose of adding dialysis stations serving pediatric patients, provided it can clearly demonstrate that the need cannot be met by existing ESRD facilities.

Ala. Admin. Code r. 410-2-3-.05

Effective May 18, 1993. Amended: Filed June 19, 1996; effective July 25, 1996. Amended: Filed March 19, 1997; effective April 12, 1997. Repealed and New Rule: Filed October 18, 2004; effective November 22, 2004. Amended: Filed June 30, 2006; effective August 4, 2006. Amended: Filed January 24, 2012; effective February 28, 2012. NOTE: Statistically Updated: August 3, 1994. These updates reflect changes in inventories, utilization, population, and need projections, effective August 3, 1994. Statistically Updated: effective August 21, 1995.

Amended by Alabama Administrative Monthly Volume XXXIII, Issue No. 03, December 31, 2014, eff. 1/6/2015.

Amended by Alabama Administrative Monthly Volume XXXVIII, Issue No. 06, March 31, 2020, eff. 5/15/2020.

Author: Statewide Health Coordinating Council (SHCC)

Statutory Authority:Code of Ala. 1975, § 22-21-260(4).

NOTE: Statistically Updated: August 3, 1994. These updates reflect changes in inventories, utilization, population, and need projections, effective August 3, 1994. Statistically Updated: effective August 21, 1995.