APPENDIX

I. Requests for exception to allow the provision of transplant services.

II. Requests for exception to allow the provision of chronic maintenance dialysis services.

III. Definitions.

GUIDELINES AND DEFINITIONS FOR THE ENDSTAGE RENAL DISEASE (ESRD)* PROGRAM

(Terms defined in section III are indicated by asterisk)

I. Facilities wishing to provide renal transplant services must be in substantial compliance with the following criteria and guidelines. A. The facility is participating in the Medicare program. The facility is a hospital which meets all the requirements of section 1861(e) of the Social Security Act, and has entered into an agreement to participate in the Medicare program.

B. The facility can reasonably be expected to perform a sufficient number of transplants per year and otherwise demonstrates a capacity to perform with high quality. (Performance of 25 or more transplants per year has been shown to be positively correlated with adequate economies of scale and favorable patient and graft outcome. While such performance is not required during the interim period, similar performance may be a requirement of the long-range program.)

1. The facility is expected to perform a sufficient number of transplants. Compliance with this criterion requires the following:

a. The hospital has a sufficient number of beds to meet the intensive and acute care equirements of its End-Stage Renal Distase (ESRD) patients.

b. The hospital has an adequate number of qualified personnel to meet the requirements of its ESRD patients.

c. The hospital provides inpatient acute (back-up) dialysis* services to support the transplant program.

d. The hospital offers both living related donor (LRD)* and cadaver donor (CD) transplant services.

e. The unsatisfied demand for services in the area and the availability of suitable donor organs is such that there is a likelihood that a reasonable scale of operations (at least 15 transplants) can be expected to be attained within one year.

2. The facility demonstrates a capacity to perform with high quality. Compliance with this criterion requires:

a. Minimal personnel requirements. (1) A licensed physician is responsible for directing, planning, organizing, and conducting transplant services, and devotes sufficient time to carry out these responsibilities. This physician is board certified in surgery (by

any American Medical Association or American Osteopathic Association surgical specialty board), in internal medicine (by the American Board of Internal Medicine or the American Osteopathic Board of Internal Medicine) or, if the facility is a children's hospital, in pediatrics (by the American Board of Pediatrics or the American College of Osteopathic Pediatricians). In addition this physician has:

(a) A minimum of one year's formal training in a teaching institution in ESRD patient care and transplant immunology, or

(b) A minimum of two year's experience in delivering ESRD care.

(2) The surgeons performing the transplants are board certified (by any American Medical Association or American Osteopathic Association surgical specialty board), and have:

(a) A minimum of one year's formal training in a teaching institution in renal transplantation, or

(b) Two years' experience performing renal transplant.

(3) If pediatric transplant services (for children under age 14) are offered as part of a general program, children's care shall be under a pediatrician with qualifications as outlined in (1) above.

(4) There is at least one registered nurse responsible for ESRD nursing care on a fulltime basis with:

(a) A minimum of six months' training in a teaching institution providing dialysis and transplant patient care, or

(b) A minimum of two years' experience in caring for dialysis and transplant patients. (5) The nursing service also meets the requirement of § 405.1024 of the Health Insurance Regulations.

(6) A qualified dietician (preferably meets the A.D.A.'s standards for qualification) provides diet management and counseling to meet ESRD patient needs.

(7) The facility provides a social worker, directly or under arrangement, to meet the social service and counseling needs of ESRD patients.

(8) The medical staff of the hospital has the following specialties:

(a) Cardiology, endocrinology, hematology, neurology, infectious disease, orthopedics, pathology, psychiatry, and urology.

b. Minimal service requirements. (1) The hospital provides on the premises,* either directly or under arrangement*: (a) Inhalation therapy; (b) Angiography;

(c) Nuclear medicine;

(d) Emergency (24 hours a day) laboratory services of C.B.C., platelet count, ABO blood cross matching, blood gases, blood pH, serum calcium, serum potassium, BUN, creatinine, serum glucose, prothrombin time, spinal fluid exam, urine sediment, and urine glucose.

(2) The hospital provides, either directly or under arrangement with another facility: (a) Immunofluorescence and electron microscopy;

(b) Unusual pathogen cultures: fungal cultures, tissue cultures, and TB cultures;

(c) Outpatient services for the evaluation, care, and follow-up of transplant and ESRD patients.

(3) The following services are provided under arrangement with another facility or, if they are not reasonably available elsewhere, are added to the applicant facility's capability:

(a) Tissue typing and immunology testing. (b) Cadaver kidney preservation using perfusion equipment.*

(4) If the hospital is not approved to provide Regular (Chronic) Maintenance Dialysis* under Medicare, it has an agreement* with a facility which has such approval, to provide:

(a) Regular (chronic) maintenance dialysis: and

(b) If a facility providing such services is reasonably available in the community:

(i) Self-dialysis training program* including a procedure for the evaluation of home conditions to assess and place the patient in home dialysis.

(ii) Self-dialysis* in an outpatient facility for patients who cannot perform self-dialysis at home, and

(iii) Limited care dialysis* in an outpatient facility for patients who cannot perform self-dialysis.

C. The facility makes a needed contribution to access of care in an area. Exception to facilities will only be granted when:

1. There is evidence to document that there are ESRD patients acceptable for transplantation,

2. These patients cannot reasonably be expected to receive appropriate therapy from another transplant facility, and

3. There are no other applicants better qualified to meet the needs of such patients.

D. The facility contributes to a coordinated system of care by its arrangements for cooperation with other facilities in the area offering the same or other modalities of care for ESRD patients so that patients should be placed in the appropriate site and receive the appropriate service. This criterion will require an analysis of other services available in the applicant's area. Determinants will include:

1. The hospital makes the ESRD services it is approved to provide available to the ESRD patients of other facilities in the area that do not provide those services.

2. If the services indicated in B.2.b.(2), and (3), and B.2.b.(4)(b), are reasonably available in other facilities in the area in a manner that can be reimbursed by the Medicare program, the hospital carries out arrangements and agreements, as indicated

in those sections, for these services for its ESRD patients.

3. The hospital cooperates and participates in a recipient registry.*

4. The hospital cooperates and participates in an organ procurement* and preservation program, if such exist, and the development of an organ procurement program, if none exists.

5. The hospital carries out agreements with cooperating institutions for timely transfer of medical data on the ESRD patients.

E. The costs of performance are not expected to exceed the reasonable costs of like or comparable services in the community.

F. The capital expenditures for the facility's transplant services have not been disapproved in accordance with section 1122 of Title XI of the Social Security Act.

II. Facilities wishing to provide chronic maintenance dialysis services must be in substantial compliance with the following criteria and guidelines. A. Hospital-operated facilities. 1. If the facility is hospital-operated, the hospital is participating in the Medicare program. The hospital meets all the requirements of section 1861(e) of the Social Security Act, and has entered into an agreement to participate in the Medicare program.

2. The facility is expected to meet an acceptable utilization rate and otherwise demonstrate a capacity to perform at high quality.

a. Expected to meet an acceptable utilization rate means the facility has a minimumof two maintenance dialysis stations, and operates each maintenance dialysis station a minimum of 5 dialysis sessions per week.

b. Demonstrates a capacity to perform at high quality means:

(1) Minimal personnel requirements. The hospital and its dialysis facility has an adequate number of personnel to meet the requirements of its ESRD patients; minimal requirements are:

(a) A licensed physician is responsible for planning, organizing, conducting, and directing ESRD services, and devotes sufficient time to carry out these responsibilities. This physician is board certified or board eligible in internal medicine (by the American Board of Internal Medicine or the American Osteopathic Board of Internal Medicine) and has:

(i) A minimum of one year's formal training in a teaching institution in ESRD patient care, or

(ii) A minimum of two years' experience delivering ESRD care.

(b) The surgeons performing the vascular access procedures (cannula/fistula placement and revisions) are board certified (by any American Medical Association or American Osteopathic Association surgical specialty board) and have:

(i) A minimum of one year's formal training at a teaching institution in vascular surgery, or

(ii) Two years' experience performing vascular access procedures.

(c) There is at least one R.N. responsible for ESRD nursing care on a full-time basis with a minimum of:

(i) Six months' training in a teaching institution providing dialysis and ESRD patient care, or

(ii) Two years' experience in caring for dialysis and ESRD patients.

(d) The nursing service also meets the requirements of § 405.1024(c) of this part.

(e) A qualified dietician (one who preferably meets the A.D.A.'s standards for qualifications) provides diet management and counseling to meet ESRD patient needs.

(f) The facility provides a social worker, directly or under arrangement,* to meet the social service and counseling needs of ESRD patients.

(g) The facility is capable of providing timely specialty evaluation and consultation for its ESRD patients in cardiology, endocrinology, hematology, neurology, orthopedics, pathology, pediatrics (if children with ESRD are cared for), psychiatry, and in urology.

(2) Minimal service requirements. (a) The hospital provides on its premises,* either directly or under arrangement*:

(i) Inpatient acute (back-up) dialysis to support the ESRD patient needs;

(ii) Inhalation therapy;

(iii) Emergency (24 hours a day) laboratory services of C.B.C., platelet count, ABO Flood cross matching, blood gases, blood pH, s.rum calcium, serum potassium, BUN, serum glucose, prothrombin time, spinal fluid exam, urine sediment, and urine glucose.

(b) The hospital provides directly* limited-care dialysis in an outpatient facility for patients who cannot perform self-dialysis.

(c) The hospital provides, either directly,* or under arrangement* with another facility, for the following:

(i) Angiography; (ii) Nuclear medicine;

(iii) Immunofluorescence and electron microscopy;

(iv) Unusual pathogen cultures, fungal cultures, tissue cultures, and TB cultures;

(v) Outpatient services for the evaluation, care, and follow-up of ESRD patients, including cannula and fistula care, and homedialysis support services*.

(d) The hospital provides either directly* or by an agreement* with another facility:

(i) Self-dialysis training program including a procedure for the evaluation of home conditions to assess and place the patient at home;

(ii) Self-dialysis in an outpatient facility for patients who cannot perform self-dialysis at home;

(e) The hospital provides by an agreement* with a facility already certified to provide the service under Medicare:

(i) Evaluation of its patients for transplantation. (The transplantation facility is responsible for tissue typing and immunology testing, and prospective patient registration for transplantation.);

(ii) Transplantation.

3. The facility makes a needed contribution to access of care. This means that an exception to dialysis facilities will only be granted when:

a. There is evidence to document that there are ESRD patients acceptable for therapy,

b. These patients cannot reasonably be expected to receive appropriate therapy from another facility, and

c. There are no other applicants better qualified to meet the needs of these patients.

4. The facility makes a positive contribution to the total system of care of ESRD by working in cooperation with other sites and modalities of care. The use of this criterion will require an analysis of other services available in the applicant's area. Determinants will include:

a. The hospital makes the ESRD services, it is approved to provide available and accepts ESRD patients referred from other facilities in the area that do not provide those services.

in

b. If the services indicated II.A.2.b.(2)(d) are reasonably available in other Medicare approved facilities in the area, the hospital carries out agreements with cooperating institutions for these services, and the services indicated in II.A.2.b.(2)(e) for its patients.

c. The hospital cooperates and participates in a recipient registry.

d. The hospital cooperates and participates in an organ procurement and preservation program, if such exist.

e. The hospital carries out agreements with cooperating institutions for timely transfer of medical data on the ESRD patients.

5. The facility has arrangements for a patient review mechanism to assure that all patients are screened for the appropriateness of their treatment modality—including suitability for transplant and home dialysis. Prior to the establishment of Medical Review Boards, the facility refers each of its patients to appropriate facilities for transplant and self-dialysis training evaluation. A formal recommendation shall be made to the referring facility as to the most appropriate mode of therapy. When the recommended mode of therapy differs from the current mode of therapy, and the patient

desires the recommended therapy, the referring facility shall provide such, directly or by agreements. Patients will be re-evaluated on an annual basis, except when the patient specifically requests a change in mode of therapy, in which case such re-evaluation should be carried out within six months from the time of such request (if the six month limit comes before the annual re-evaluation date).

6. The cost of the service offered by the faIcility is not expected to exceed the reasonable cost or charges for like or comparable services in the community.

7. Capital expenditures for this service have not been disapproved in accordance with section 1122 of Title XI of the Social Security Act.

B. Free-Standing Facilities. 1. Free-standing facilities must:

a. Meet State or local licensure requirements, if any.

b. Be a facility in which treatment is under the general supervision of a physician (who need not be a full-time supervisor). The supervisory physician is a licensed physician responsible for planning, organizing, conducting, and directing the facility's ESRD services, and devotes sufficient time to carry out these responsibilities. This physician is board certified or board eligible in internal medicine (by the American Board of Internal Medicine or the American Osteopathic Board of Internal Medicine) and has a minimum of one year's formal training in ESRD patient care, or a minimum of two years' experience in delivering ESRD

care.

c. Have an affiliation, e.g., has arrangements for back-up care, etc., with a participating hospital. The participating hospital with which the free-standing facility has its arrangements and agreements* is approved to deliver ESRD services under the Medicare program.

d. Agree that no charge will be made for covered dialysis service provided by the facility that is in excess of the charge determined to be the reasonable charge of that facility. The facility agrees to bill the program and not the patient for amounts reimbursable under the program.

2. Free-standing facilities are expected to meet an acceptable utilization rate and otherwise demonstrate a capacity to perform at high quality.

a. Free-standing facilities are expected to meet an acceptable utilization rate. The facility has a minimum of two maintenance dialysis stations, and operates each maintenance dialysis station a minimum of 5 dialysis sessions per week.

b. Free-standing facilities must demonstrate a capacity to perform at high quality. (1) The facility has an adequate number of qualified personnel to meet the require

ments of its ESRD patients; minimal requirements are:

(a) Treatment is under the general supervision of a physician as set out in II.B.1.b. (b) There is at least one full-time registered nurse with:

(i) A minimum of six months' training in a teaching institution providing dialysis and ESRD patient care, or

(ii) A minimum of two years' experience in dialysis and ESRD patient care.

(c) The facility provides through its affiliation with a participating hospital, in a timely fashion, any necessary vascular access procedures by a qualified surgeon (as defined in II.A.2.b.(1)(b)); diet management and counseling by a qualified dietician (as in II.A.2.b.(1)(e)); social services and counseling by a social worker (as in II.A.2.b.(1)(f)); and specialty evaluation and consultation for its ESRD patients in cardiology, endocrinology, hematology, neurology, orthopedics, pathology, pediatrics (if children with ESRD are cared for), psychiatry and in urology (as in II.A.2.b.(1)(g)).

(2) Service requirements the free-standing facility provides directly are limited care dialysis services.

(3) The facility provides, directly or by agreement through its affiliated hospital: (a) Self-care dialysis, and (b) self-dialysis training.

(4) The facility provides, under arrangement, or by agreement with its affiliated hospital, all those services indicated in II.A.2.b.(2).

3. The facility makes a needed contribution to access of care. Exception for freestanding dialysis facilities will only be granted when:

a. There is evidence to document that there are ESRD patients acceptable for therapy,

b. These patients cannot reasonably be expected to receive appropriate therapy from another facility, and

c. There are no other applicants better qualified to meet the needs of these patients.

4. The facility makes a positive contribution to the total system of care of ESRD by working in cooperation with other sites and modalities of care. a. The facility makes available the dialysis services it is approved to provide, and accents ESRD patient referred from other facilities in the area that do not provide such services.

b. The facility carries out the agreements with its affiliated hospital for those services for its patients which it does not provide.

c. It cooperates and participates in recipient registries.

d. It carries out agreements with cooperating institutions for timely transfer of medical data on the ESRD patients.

5. The facility has arrangements for a patient review mechanism to assure that all

patients are screened for the appropriateness of their treatment modality—including suitability for transplant and home dialysis. Prior to the establishment of Medical Review Boards, the facility shall refer each of its patients to appropriate facilities for transplant and self-dialysis training evaluation. A formal recommendation shall be made to the referring facility as to the most appropriate mode of therapy. When the recommended mode of therapy differs from the current mode of therapy, and the patient desires the recommended therapy, the referring facility shall provide such (directly or through its agreements) as outlined above. Patients will be re-evaluated on an annual basis, except when the patient specifically requests a change in mode of therapy, in which case such re-evaluation should be carried out within six months from the time of such request (if the six month limit comes before the annual re-evaluation date).

6. The charge for the service is related to the cost of the service and does not exceed the reasonable costs or charges for like or comparable services in the community.

7. Capital expenditures for this service have not been disapproved in accordance with section 1122 of Title XI of the Social Security Act.

NOTICE: Attention is invited, as applicable, to the requirements of Title VI of the Civil Rights Act of 1964 (Pub. L. 88-352; 78 Stat. 252; 42 U.S.C. 2000d-2000d-4) which provides that no person in the United States shall, on the ground of race, color, or national origin be excluded from participation in, be denied the benefits of, or be subject to discrimination under any program or activy receiving Federal financial assistance (sec. 42 U.S.C. 2000d), and to the implementing regulation issued by the Secretary of Health, Education, and Welfare with the approval of the President (Part 80 of 45 CFR Subtitle A).

III. Definitions. A. A number of terms used in the guidelines text have specific meanings which are different from their use in common language. Some definition is necessary to prevent confusion and permit maximum comprehension of the intent of these guidelines. Some of these terms have specific meaning in relation to the medical care of renal disease; other terms have a specific meaning in the terminology of the Health Care Financing Administration.

B. The following definitions are intended as an aid in understanding the terms involved and do not replace regulations pertaining to the same terms.

1. End stage renal disease (ESRD). Although much of what has been written about Section 2991 of Pub. L. 92-603 refers to coverage of care for chronic renal disease, the law in effect provides coverage only for patients with end stage renal disease

(ESRD). This scope of coverage is implicit because the law states that there is coverage for a patient who "is medically determined to have chronic renal disease and who requires hemodialysis or renal transplantation for such disease." End stage renal disease is that stage of renal impairment which cannot be favorably influenced by conservative management alone, and requires dialysis and/or kidney transplantation to maintain life or health. Therefore, the term end stage renal disease (ESRD) in reference to section 2991 of Pub. L. 92-603 is more appropriate than the term chronic renal disease (CRD).

2. Dialysis. A process by which waste products are removed from the body by diffusion from one fluid compartment to another across a semipermeable membrane. There are two types of dialysis in common clinical usage: Hemodialysis-where blood is passed through an artificial kidney machine and the waste products diffuse across a man-made membrane into a bath solution known as dialysate after which the cleansed blood is returned to the patient's body; and, peritoneal dialysis—where the waste products pass from the patient's body, through the peritoneal membrane into the peritoneal (abdominal) cavity where the bath solution (dialysate) is introduced and removed periodically. While there are processes, such as hemoperfusion and diafiltration which may become a substitute for, or replace, dialysis in the future, their limited usage in this country today does not merit their separate definition or consideration in these guidelines.

3. Regular (chronic) maintenance dialysis. The usual periodic dialysis treatments which are given to a patient who has end stage renal disease in order to sustain life and ameliorate uremic symptoms. Currently, such treatments are usually given two or three times a week.

4. Back-up hospital, back-up dialysis. A back-up hospital is a hospital which is approved to deliver ESRD services under the Medicare program and has an arrangement or agreement to make these services available to referred home dialysis patients and/ or patients from specific free-standing dialysis facilities for all the ordinary and specialized medical and surgical consultation services which are not available in the home or at the free-standing dialysis facility, and are required for the care of ESRD patients. The number of back-up dialysis stations must be appropriate for the number of patients for which the back-up hospital has accepted responsibility.

Back-up dialysis is dialysis given to a patient under special circumstances, in a situation other than the patient's usual dialysis environment. Although back-up dialysis required by home dialysis patients for nonmedical reasons (i.e., mechanical problems