Section 580. Other medically necessary transplantation procedures that are determined to not be experimental or investigational (coverage for persons younger ...

A. Patient selection criteria for any other medically necessary transplantation procedures that are determined to not be experimental or investigational.

1. The following general conditions shall apply to these services:

a. Coverage shall not be provided for procedures that are provided on an investigational or experimental basis.

b. There must be no effective alternative medical or surgical therapies available with outcomes that are at least comparable.

c. The transplant procedure and application of the procedure in treatment of the specific condition for which it is proposed have been clearly demonstrated to be medically effective and not experimental or investigational.

d. Prior authorization by the Department of Medical Assistance Services is required. The prior authorization request must contain the information and documentation as required by DMAS.

2. The following patient selection criteria shall apply for the consideration of authorization and coverage and reimbursement:

a. The patient must be under 21 years of age at time of surgery.

b. The patient selection criteria of the transplant center where the surgery is to be performed shall be used in determining whether the patient is appropriate for selection for the procedure. Transplant procedures will be preauthorized only if the selection of the patient adheres to the transplant center's patient selection criteria, based upon review by DMAS of information submitted by the transplant team or center.

The recipient's medical condition shall be reviewed by the transplant team or program according to the transplant facility's patient selection criteria for that procedure and the recipient shall be determined by the team to be an appropriate transplant candidate. Patient selection criteria used by the transplant center shall include, but not necessarily be limited to, the following:

(1) Current medical therapy has failed and the patient has failed to respond to appropriate therapeutic management;

(2) The patient is not in an irreversible terminal state, and

(3) The transplant is likely to prolong life and restore a range of physical and social function suited to activities of daily living.

B. Facility selection criteria.

1. The following general conditions shall apply:

a. Procedures may be performed out of state only when the authorized transplant cannot be performed in the Commonwealth because the service is not available or, due to capacity limitations, the transplant cannot be performed in the necessary time period.

b. Criteria applicable to transplantation services and centers in the Commonwealth also apply to out-of-state transplant services and facilities.

2. To qualify for coverage, the facility must meet, but not necessarily be limited to, the following criteria:

a. The transplant program staff has demonstrated expertise and experience in the medical and surgical treatment of the specific transplant procedure;

b. The transplant surgeons have been trained in the specific transplant technique at an institution with a well established transplant program for the specific procedure;

c. The facility has expertise in immunology, infectious disease, pathology, pharmacology, and anesthesiology;

d. The facility has staff or access to staff with expertise in tissue typing, immunological and immunosuppressive techniques;

e. Adequate blood bank support services are available;

f. Adequate arrangements exist for donor procurement services;

g. Current full membership in the United Network for Organ Sharing, for the facilities where solid organ transplants are performed;

h. Membership in a recognized bone marrow accrediting or registry program for bone marrow transplantation programs;

i. The transplant facility or center can demonstrate satisfactory transplantation outcomes for the procedure being considered;

j. Transplant volume at the facility is consistent with maintaining quality services;

k. The transplant center will provide adequate psychosocial and social support services for the transplant recipient and family.

Historical Notes

Derived from Volume 16, Issue 18, eff. July 1, 2000.

Statutory Authority

§ 32.1-325 of the Code of Virginia.