Louisiana Administrative Code
Title 48 - PUBLIC HEALTH-GENERAL
Part I - General Administration
Subpart 5 - Health Planning
Chapter 115 - Health Resource requirements
Subchapter B - Facility or Service-Specific Criteria and Standards
Section I-11519 - End Stage Renal Disease Services

Universal Citation: LA Admin Code I-11519

Current through Register Vol. 50, No. 9, September 20, 2024

A. Definition

1. End Stage Renal Disease services are diagnostic, therapeutic, maintenance, and rehabilitative services required for the care of patients with End State Renal Disease. End Stage Renal Disease (ESRD) is defined as renal impairment which is permanent and irreversible.

2. It is estimated that eight million persons in the United States have some form of kidney disease, and about 60,000 persons die each year from End State Renal Disease. The two major types of ESRD services are transplantation and dialysis.

B. Transplantation

1. Transplantation is a process by which a kidney is excised from a donor and implanted into an ESRD patient, and supportive care is furnished to the donor and to the recipient following implementation. Transplantation is, ideally, a one-time procedure; if the donated kidney functions properly, the patient can live a relatively normal life.

2. A Renal Transplantation Center is a hospital which is approved by the Social Security Administration to directly furnish transplantation and other medical and surgical services required for the care of ESRD transplant patients. The Transplantation Center also furnishes dialysis (a process which removes impurities from the blood), either directly or by arrangement. If transplantation is not successful, dialysis must be readily available to sustain life.

3. There were 73 transplantation procedures performed in the ESRD Network in Louisiana in 1980, and as of December, 1980, 139 dialysis patients were awaiting transplants. There are five ESRD facilities in Louisiana which perform transplants.

C. Dialysis

1. In general, dialysis is a procedure which removes impurities from the blood. One type of dialysis, Peritoneal Dialysis, is less common and is not subject to 1122 Review, since it does not require any special health care facility or equipment for its performance. Hemodialysis is the most common form of treatment for ESRD patients. Hemodialysis is a procedure which filters waste from the blood by circulating it through an artificial kidney machine by diffusion and returning the cleansed blood to the patient's body.

2. Hemodialysis requires from 4-6 hours per session, 2-3 times per week, throughout the patient's lifetime. it can be performed in the home, in a free-standing dialysis facility, or in a hospital dialysis center, and is classified by the level of patient participation. Home dialysis requires self-care with the assistance of a trained family member or other person. Dialysis in a free-standing facility or in a hospital center can require full staff assistance, or varying degrees of self-care and professional assistance and instruction. Dialysis which is regularly furnished on an outpatient basis to ESRD patients, whether in a free-standing facility, hospital or at home, is referred to as Chronic Maintenance Dialysis.

D. Home Dialysis vs. Outpatient Dialysis

1. Home dialysis offers a number of advantages to ESRD patients. It enables the patient to set his own schedule and it eliminates travel time, whereas in other settings the time required for the procedure and for travel can curtail normal activities and often preclude employment. Home dialysis is less expensive for the patient, and offers certain psychological advantages for the patient's confidence and sense of independence. From a medical standpoint, the more familiar and knowledgeable a patient is about his care and condition, the better and more likely he is to take care of himself and to follow instructions. Home dialysis also reduces the danger of hepatitis and other infections. While facility-based dialysis provides easy access to professional help, home-based dialysis does not have this advantage. Home dialysis has certain requirements (such as physical space, electrical facilities, and the presence of another persons trained in dialysis) which can render it impossible for some patients.

E. Availability/Accessibility of ESRD Services

1. Accessibility to ESRD services is often restricted by lack of transportation. Facilities should assess the problems and patterns and assist the patients in arranging for transportation. Both accessibility and cost savings are increased when hemodialysis stations are operated for longer hours.

2. Distance to care is not a significant factor for transplantation services, since the procedure involves a shorter course of treatment than dialysis, and requires costly, sophisticated medical resources.

3. Routine dialysis services should be available to ESRD patients within two hours round trip (except in sparsely population areas), and patients should not have travel more than 100 miles round trip for services.

4. There are over 1100 patients receiving care in the ESRD network in Louisiana; 1050 are on hemodialysis, 13 are on self-dialysis in facilities, and 50 are on home hemodialysis. There are 43 ESRD facilities within the network, 5 of which perform transplants.

Louisiana Approved ESRD Facilities

February 22, 1985

Facility Name

City

Approved ESRD Stations*

File

Date of Approval

New 1122 Approvals

Louisiana - Total

490

17

Planning District 1

212

Jefferson Parish

27

6

BMA of Marrero

Marrero

6

BMA of Metairie

Metairie

11

Dialysis Center of Kenner

Kenner

6

West Jefferson Dialysis

Marrero

4

Kenner Renal Center

Kenner

4086

06/06/84

6

6027

08/21/84

Orleans Parish

158

4

BMA of New Orleans

New Orleans

31

BMA of New Orleans East

New Orleans

10

Hotel Dieu Hospital

New Orleans

4

Kidney Care

New Orleans

8

Mid-City Dialysis

New Orleans

6

New Orleans Charity

New Orleans

11

Ochsner Clinic

New Orleans

11

St. Charles Hospital

New Orleans

6

St. Claude Dialysis Center

New Orleans

6

Southern Baptist Hospital

New Orleans

18

Touro Infirmary

New Orleans

14

Tri-Parish Renal Center

New Orleans

8

Tulane Medical Center

New Orleans

14

Westbank Chronic Renal Center

New Orleans

11

Ochsner Clinic

New Orleans

NSTR

12/14/84

4

St. Bernard Parish

Chalmette Dialysis

Chalmette

11

St. Tammany

16

St. Tammany Dialysis Center

Slidell

8

St. Tammany Renal Center

Slidell

8

Planning District 2

East Baton Rouge Parish

39

BMA of Baton Rouge

Baton Rouge

24

BMA of Baton Rouge Central

Baton Rouge

12

Earl K. Long Hospital

Baton Rouge

3

Caddo Parish

49

BMA of Shreveport

Shreveport

12

Louisiana State University Hospital

Shreveport

10

Shreveport Regional Dialysis

Shreveport

18

Willis Knighton Hospital

Shreveport

9

Nachitoches Parish

Nachitoches Dialysis

Nachitoches

6

Planning District 8

Ouachita Parish

Northern Louisiana Dialysis

Monroe

25

*Source: ESRD Network 12 Listing of approved stations, received 1/11/85, and verbal communication. (Mr. Armistead, 2/21/85)

F. Legislation/Funding/Cost

1.Section 2991 of Public Law 92-603, the 1972 Social Security Amendments, established a federal program to finance medical care for almost all ESRD patients. This was the first program in which the federal government assumed responsibility for treatment costs of cirtually an entire patient population. The legislation provided for ESRD patients to be defined as disabled, and therefore eligible for participation in the Medicare program. An individual can qualify if he suffers from permanent kidney failure, meets Social Security insured status or receives Social Security cash benefits, or is a spouse or dependent child of someone who has insured status or receives cash benefits. The only ESRD patients not eligible are teachers, government employees, college students over age 21, and others who have worked under the Social Security program.

2. Medicare reimburses 80 percent of all allowable costs for covered treatment services for eligible persons, in facilities and for the home training program. In Louisiana, approximately 93 percent of ESRD patients qualify for Medicare coverage. Prior to the legislation, costs for the average ESRD patient could range up to $30,000 a year for clinic services, or $10,000 a year for home dialysis.

3. In 1978, the Medicare ESRD Program Amendments were enacted, in order to encourage the use of lower-cost treatment modalities, specifically self-dialysis and transplatation, for the maximum number of patients who are medically, socially, and psychologically suitable for such treatments. In recognition of the fact that many patients are unable to dialyze at home, a provision was included to encourage the use of self-dialysis stations in dialysis facilities. Reimbursement for all forms of therapy was made approximately equal, thus allowing the patient and his physician the choice of the most acceptable form of therapy. Total costs are not equal, but cost to the patient is approximately the same regardless of the treatment modality.

4. The Medicaid (Title XIX) Program in Louisiana provides coverage for eligible persons for services received in free-standing ESRD facilities which are certified for medicare participation. Medicaid does not cover most pharmacy charges, or laboratory services not performed in the dialysis facility. Medicaid reimburses for dialysis treatment and routine lab services, medically necessary non-routine lab services, physician supervision of dialysis, dialysis training and counseling for home dialysis care, and medically necessary injections. In 1980, the Louisiana Medicaid program spent approximately $2,000,000 for ESRD services in free-standing centers, for 2375 ESRD patients.

5. Costs vary considerably among treatment types; for example, home dialysis is less expensive than facility-based dialysis. The initial cost of tranplantation is $15,000-$25,000, with annual follow-up costs ranging from $1,500 to $3,000. In the long run, transplantation is the least expensive form of treating ESRD. Home dialysis has an initial cost of approximately $2,000, with the cost per dialysis session $115-$130. Hemodialysis in a hospital-based facility is approximately $175 per session, and is slightly less expensive in a free-standing facility. A number of studies have estimated cost differences between home and facility dialysis to range from $7,900 to $13,400 after the first year.

6. The present cost of the federally funded ESRD program is over $20,000 per patient per year in Louisiana.

G. ESRD Network

1. The federal regulations for Medicare coverage of ESRD suppliers have the following objectives, which are carried out through a regional ESRD Network:
a. to assist SSI recipients with ESRD in receiving needed medical care;

b. to encourage the availability, accessibility, and appropriate use of ESRD treatment facilities while maintaining or improving the quality of care;

c. to provide the flexibility needed for physicians to efficiently deliver appropriate care.

2. Each network covers a specific geographical area designated by the Secretary of DHHR, and all facilities within the area must be part of the network. The network has a coordinating council, which represents each ESRD treatment facility in the area, and which serves as coordinator of ESRD activity within the network. Louisiana is served by ESRD Network Coordinating Council Number 12. The major functions of the council include:
a. establishing a medical review board to determine the appropriateness of ESRD care and services within the network;

b. establishing methods and procedures for the medical review board;

c. establishing working relationships with Professional Standards Review Organizations in the network;

d. reporting information to the secretary of DHHS on the ESRD activities within the network;

e. developing an annual plan which outlines the network's objectives;

f. conducting certification reviews and making recommendations to the State Health Planning and Development Agency (aSHPDA) and DHHS on each request for a new or expanded ESRD service.

3. The functions of the seven member medical review board are to develop ways of monitoring patient care, to review and coordinate facilities and physicians, to coordinate medical care evaluations, and to make written recommendations to facilities and physicians based on the evaluations.

H. Minimal Use Rates

1. Medicare-approved ESRD treatment facilities must meet certain federal regulations. Two of the requirements are that the facility must be a member of the network, and that it must meet minimum use rates for transplantation and dialysis.

2. The use rate status is defined in the regulations, and is summarized below. Institutions with high use will be given unconditional ratings and are thereby eligible for reimbursement. Institutions with lower ratings may be given conditional status, which means that they can be reimbursed until a specified time, after which payment terminates unless usage is within the unconditional range. Under special circumstances, institutions may be given exception status, which means that they do not have to meet usage requirements. (For example, if a facility serves a sparsely populated area where no other dialysis services are available, reimbursement would not be denied because of failure to meet use requirements.)
a. ESRD minimal utilization rates for dialysis facilities performing greater than 20 percent of their dialysis on outpatients in a Standard Metropolitan Statistical Area (SMSA) of 500,000 population or greater are:
i. Unconditional approval: six or more dialysis stations with an average of 4.5 or more dialyses per week.

ii. Conditional approval: six or more dialysis stations with an average of between 4.0 and 4.5 dialyses per station per week; or 4 or 5 dialysis stations with an average of 4.5 or more dialyses per station per week.

b. ESRD minimal utilization rates for dialysis facilities performing greater than 20 percent of the dialyses on outpatients in an SMSA of less than 500,000 or in an area not included in an SNSA are:
i. Unconditional approval: three or more dialysis stations with performance of an average of 4.0 or more dialyses per stations per week.

ii. Conditional approval: two dialysis stations with performance of an average of 4.0 ore more dialyses per station per week.

c. ESRD minimal utilization rates for renal dialysis centers performing 20 percent or less of their dialyses on outpatients are:
i. Unconditional approval: three or more dialysis stations with performance of an average of 4.0 or more dialyses per station per week.

ii. Conditional approval: two dialyses stations with performance of an average of 4.0 more dialyses per station per week.

d. Minimal utilization for a transplantation facility/center is 7 to 14 renal transplants performed annually during the first two years of operation, and 15 or more renal transplants performed annually during each succeeding year.

I. Resource Goals

1. For a system of ESRD services to best meet the needs of the ESRD patients in Louisiana, the following factors should be considered:
a. the projected number of people needing the service in an area;

b. the availability of enough services in the proper geographical distribution;

c. the ability of the people of travel to services;

d. the efficient utilization of facilities.

2. A facility should be considered fully utilized if there is a 75 percent utilization rate based on two patient shifts per day, 6 days per week.

3. Routine dialysis services should be available to ESRD patients within 2 hours round trip (except in sparsely populated areas), and patients should not have to travel more than 100 miles round trip for services.

4. Hemodialysis services should be available for two patient treatment shifts, 6 days per week.

J. Resource Goal Adjustment and Need Calculations

1. Methodology for determining need for chronic maintenance hemodialysis services within the service area
a. Factors to be included in the methodology for determining the need for hemodialysis services are:
i. The most recent available area-wide census of ESRD patients receiving in-facility maintenance hemodialysis for chronic renal failure.

ii. The projected annual incidence rate of chronic renal failure in the service area (new cases per million population per year).

iii. The number of renal transplant operations performed on residents of the service area for the most recent twelve month period available.

iv. The number of renal transplant operations performed on residents of the service area which did not result in a properly functioning kidney in the patient and did not result in the death of the patient.

v. The projected number of patients to receive home dialysis training in the forthcoming calendar year in the service area.

vi. The projected number of patients to begin peritoneal dialysis in the forthcoming calendar year.

vii. The mortality rate observed for the ESRD chronic maintenance hemodialysis patient population in the service area during the preceding year.

viii. Ten percent of the current area-wide census of patients receiving chronic maintenance hemodialysis at home in the service area.

ix. A factor of 80 percent of full utilization.

x. The service area's projected estimate of the population of the health service area in the year being considered.

2. Methodology Formula

(factor 1) + [(factor 10) (factor 2)]-(factor 3) + (factor 4)-(factor 5) - (factor 6)-[(factor 1) (factor 7)] + (factor 8)=The projected total number of ESRD patients needing in-facility chronic maintenance hemodialysis (factor 11)

(factor 11)-(factor 4)=

The projected total minimum number of in-facility chronic maintenance hemodialysis stations needed in the area assuming full utilization of all dialysis stations (factor 12)

[(factor 12)-(factor 9)]=The number of in-facility chronic hemodialysis stations needed in the area.

a. Additional factors which may influence the need for chronic hemodialysis stations may include transient patients and/or existing facilities operating on a three shift per day basis.

Methodology for Determining Need for In-facility Chronic Maintenance Hemodialysis Stations

Current areawide census of patients receiving chronic maintenance hemodialysis in facilities

Projected number of new ESRD cases for the next year

-

The projected number of ESRD patients who will receive kidney transplants

+

The projected number of ESRD patients who will undergo kidney transplants and survive despite failure of grafted kidney to function properly

-

The projected number of patients who will be trained for home dialysis in the next year

-

The projected number of patients who will begin peritoneal dialysis in the next year

-

The projected number of ESRD patients receiving chronic maintenance hemodialysis who will die for any cause next year

+

Ten percent of the current areawide census of patients receiving chronic maintenance hemodialysis at home

=

The projected total number of ESRD patients needing in-facility chronic maintenance hemodialysis

Full utilization is 12 treatments per week per station. Most hemodialysis patients require dialysis three times per week. Thus, full utilization is also about 4 patients per station. To determine the projected minimum number of in-facility chronic maintenance hemodialysis stations needed in the area assuming full utilization of all station, in the next year, the total from the equation above is divided by 4.

Because full utilization is an unreasonable expectation as a result of:

1. Isolation requirements for hepatitis-positive patients and patients with other infectious diseaee;

2. Transient or emergency outpatients requiring temporary dialysis; and

3. Normal variation in the number of patients requiring chronic. maintenance hemodialysis, the optimal number of in-facility chronic maintenance hemodialysis stations is defined as that which would result in a utilization race equal to eighty percent of the projected minimum number of stations needed. Therefore, the minimum number of stations needed would be divided by 0.80 to calculate the optimal number.

AUTHORITY NOTE: Promulgated in accordance with P.L. 93-641 as amended by P.L. 96-79, and R.S. 36:256(b).

Disclaimer: These regulations may not be the most recent version. Louisiana 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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