PURPOSE: This rule establishes, via regulation, the Department of Social Services’/Division of Medical Services’ guidelines regarding Medicaid coverage and reimbursement for human organ or bone marrow transplants and related medical services. These policies will be administered by the Division of Medical Services with the assistance and guidance of its Transplant Advisory Committee. (1) Administration. Through its Medicaid program, the Department of Social Services (DSS)/Division of Medical Services (DMS) will provide limited coverage and reimbursement for the transplantation of human organs or bone marrow and the related medical services, including, but not necessarily limited to, treatment and necessary pre-transplant and post-operative care for the specific procedures defined here and as further defined by the DSS/DMS and included in the provider program manuals.

1. (A) The recipient must be Medicaid-eligible on each date on which services are rendered.
2. (B) Medicaid shall be the payor of last resort and all other appropriate funding sources must be exhausted prior to obtaining Medicaid reimbursement.

3. (2) Conditions and Limitations.

   1. (A) The procedures of transplantation and the related medical services must be prior authorized by DSS/DMS.

   2. (B) Medicaid benefits may be provided for transplantation of the following:

      1. 1. Bone marrow;
      2. 2. Heart;
      3. 3. Kidney;
      4. 4. Liver; and
      5. 5. Lung (effective for dates of service

October 1, 1991 and after that date.)

1. (C) Transplants which include multiple organs, at least one (1) of which is covered under subsection (2)(B), may be covered at the recommendation of the Transplant Advisory Committee.
2. (D) Each request for coverage will be handled on a case-by-case basis. A separate Prior Authorization Request must be submitted for each individual recipient and transplant.
3. (E) In order to be considered for approval, each proposed transplant case must meet all of the requirements of procedures and protocols specific to the service as defined by DSS/DMS. These procedures and protocols will be developed with input by the DMS’ Transplant Advisory Committee.

4. (F) Approved organ transplants can only be performed in a facility which submits documentation approved by DMS as complying with the following criteria:

   1. 1. The transplant facility must qualify

for membership in the national transplantation network and must provide a copy of a current effective certification from the United Network for Organ Sharing (UNOS) granting approval to perform a specific transplant(s). The certification from UNOS will be considered appropriate verification and documentation for DMS transplant facility approval;

1. 2. When the period for initial certifica-

tion expires, the transplant facility must provide DMS evidence that continued approval from UNOS allowing participation to perform the transplant(s) has been granted;

1. 3. Each type of Missouri Medicaid-cov-

ered organ transplant will be subject to separate UNOS certification for each type of organ transplant;

1. 4. The transplant facility must notify

DMS of each new transplant surgeon who becomes a member of the transplant team. The transplant surgeons must be current Missouri Medicaid participating providers;

1. 5. The transplant facility must name the

organ procurement organization (OPO) presently utilized by the facility. The transplant facility must furnish a copy of the notification from Health Care Financing Administration (HCFA) which designates the facility’s OPO as an acceptable organ procurement source;

1. 6. The transplant facility must provide

DMS with a yearly report of the number of patients receiving transplants at the facility and the average charge for the inpatient transplant stay (by type of the transplant(s) performed) as defined by DMS in the provider program manual;

1. 7. Those facilities seeking certification

as a Medicaid-approved Kidney Transplant Center must furnish a copy of their current Medicare certification indicating active participation in the Medicare Renal Transplant Program; and

1. 8. The facility must submit a copy of its

Protocol for Transplantation Cases and Patient Selection Criteria for the type(s) of transplant(s) for which it is requesting transplant facility approval.

1. (G) Approved bone marrow transplants can only be performed in a facility which submits documentation approved by DMS as complying with the following bone marrow transplant facility criteria. An autologous only transplant facility must meet criteria items one through twelve (1–12) of the following:

   1. 1. A physician(s) with expertise in pedi-

atric and/or adult bone marrow transplantation, hematology and oncology;

1. 2. Identified nursing unit with protective

isolation unit for bone marrow transplantation;

1. 3. Blood bank with Pheresis capability

and the capability to supply required blood products or association with a qualified blood bank;

1. 4. Physicians with expertise in infec-

tious disease, immunology, pathology and pulmonary medicine;

1. 5. Capability of providing cardiac/respi-

ratory intensive care and renal dialysis;

1. 6. Performance of at least thirteen (13)

bone marrow transplants a year or demonstrated an ability to care for prolonged marrow failure by treating twenty-two (22) marrow failure patients per year;

1. 7. Capability for marrow cryopreserva-

tion and purging techniques or affiliation with a facility which has these capabilities;

1. 8. Capability to provide psychosocial

support to patients and their families;

1. 9. Close affiliation with academically

based institutions to insure that all components of comprehensive care for patients undergoing bone marrow transplantation are present in the facility. The mere presence or availability of the components one through eight (1–8) is not adequate. The facility must demonstrate that a coordinated bone marrow transplantation program is in place and directed by a physician trained in an institution with a well established bone marrow transplantation program;

1. 10. The capacity and commitment to

conduct a systematic evaluation of outcome and cost (refer to paragraph (2)(F)6.);

1. 11. Once approved, continuing approval

of the facility requires evidence of a record of success and safety with bone marrow transplantation, and that the program continues to meet the previously mentioned criteria;

1. 12. The facility must submit a copy of

its Protocol for Transplantation Cases and Patient Selection Criteria for the type of bone marrow transplants to be performed at the facility. Once approved as a facility each new type of bone marrow transplant or diagnosis added for treatment by the facility must be documented by submitting the new protocol and patient selection criteria;

1. 13. Physicians with expertise in infec-

tious disease, immunology, pathology (of Graft vs. Host Disease) and pulmonary medicine;

1. 14. Tissue typing laboratory with capa-

bility to perform typing for HLA-A, B, C, D/DR, and MLC;

1. 15. Cytogenetic laboratory; and
2. 16. Adequate laboratory facility to assay

drug levels including Cyclosporine A.

1. (H) All providers of transplantation and related services must sign a Missouri Medicaid Provider Participation Agreement in order to receive reimbursement.
2. (I) In the case of a medical emergency, submittal of the required facility documentation may be waived for a period of ninety (90) days. During that period, the facility must submit the appropriate documentation as described in subsections (2)(F) or (2)(G) and (2)(J) and (3)(A)—and they shall be financially at risk regarding state approval for any transplant related services rendered prior to the approval of its application.
3. (J) The transplant facility or surgeon must submit medical documentation that verifies that the transplant candidate has met the facility’s Patient Selection Criteria documented by the facility’s Protocol for Transplantation Cases.
4. (K) All transportation and housing costs incurred in connection with transplant procedures will be treated as noncovered services.
5. (L) The transplant procedures and related services outlined previously will be reimbursable when they are performed/provided by a qualified provider who participates in the Missouri Medicaid program. In cases involving procedures that are to be performed outside of Missouri, however, the Transplant Advisory Committee, at its discretion, may require an eligible client’s physician to file a statement indicating why the transplant procedure must be performed at an out-of-state facility.
6. (M) DSS/DMS will reimburse qualified providers for a presurgery assessment at established Medicaid reimbursement rates.

1. (3) Procedure.

   1. (A) The physician or transplant facility must make a written request to DSS/DMS for coverage of the transplant. This request must include, at a minimum, the following information:

      1. 1. Diagnosis;
      2. 2. Pertinent medical history;
      3. 3. Alternative treatments performed and

results.

1. 4. Recommended transplant procedure;
2. 5. Prognosis;
3. 6. Results of a presurgery assessment

and copies of medical documentation verifying that the patient has completed the selected facility’s Protocol for Transplantation. Cases and meets the Patient Selection Criteria; and

1. 7. Name of the selected transplant cen-

ter. In cases involving out-of-state facilities, a statement from the patient’s physician explaining why the transplant procedure must be performed there. (Note: Those statements may be requested at the discretion of the DMS Transplant Advisory Committee).

1. (B) The request for transplantation will be reviewed by DMS and the transplant facility advised in writing of the decision. An agreement will be issued on a case-by-case basis for approved transplants.

1. (4) Reimbursement.

   1. (A) Facility.

      1. 1. Reasonable charges will be paid by

the Medicaid program up to a maximum cap 13 CSR 70-2

amount for the type of transplant authorized as listed in subparagraph (4)(A)1.A. The cap will cover the costs associated with the transplant for the patient’s hospitalization from the date of the transplant procedure until the date of discharge except as further defined in paragraph (4)(A)2. These charges will include organ procurement, donor costs or both, inpatient surgery costs and all postsurgical hospital costs as defined in the provider program manual.

1. A. Type Maximum of Transplant Cap Amount Kidney $ 39,000 Heart $100,000 Bone Marrow $100,000 Liver $100,000 Lung $100,000
2. B. Reimbursement for multiple organ

transplants involving a transplant covered in subsection (2)(B), may not exceed the maximum of highest coverage for highest single transplant, that is, heart/kidney = $100,000 cap.

1. 2. Payment for all other transplant-relat-

ed medical services provided prior to the date of the transplant surgery or subsequent to the date of discharge will be made at established Medicaid reimbursable rates, excluding the period and reimbursement set out in subparagraph (4)(A)1.A. and otherwise subject to the limitations as defined in the appropriate provider program manuals.

1. (B) Physician. Payment for the physician’s services for the actual transplant surgery will be determined through a medical review by the DMS physician consultant.

AUTHORITY: sections 208.153 and 208.201, RSMo Supp. 1990.* This rule was previously filed as 13 CSR 40-81.035. Emergency rule filed April 2, 1986, effective April 12, 1986, expired Oct. 10, 1986. Original rule filed April 2, 1986 effective June 28, 1986. Rescinded and readopted: FIled Jan. 17, 1990, effective April 26, 1990. Emergency amendment filed July 25, 1991, effective Aug. 5, 1991, expired Dec. 2, 1991. Emergency amendment filed Sept. 27, 1991, effective Oct. 7, 1991, expired Feb. 3, 1992, Amended: Filed Oct. 9, 1991, effective April 9, 1992. Emergency amendment filed Jan. 17, 1992, effective Feb. 4, 1992, expired June 2, 1992. *Original authority: 208.153, RSMo 1967, amended 1967, 1973, 1989, 1990, 1991 and 208.201, RSMo 1987.