PURPOSE: This rule establishes, via regulation, the Department of Social Services’/MO HealthNet Division’s guidelines regarding MO HealthNet coverage and reimbursement for human organ or bone marrow/stem cell transplants and related medical services. These policies will be administered by the MO HealthNet Division with the assistance and guidance of its medical consultant and/or transplant consultants.

1. (1) Administration. Through its MO Health- Net program, the Department of Social Services (DSS)/MO HealthNet Division (MHD) will provide limited coverage and reimbursement for the transplantation of human organs or bone marrow/stem cell and the related medical services, including, but not necessarily limited to, treatment and necessary pretransplant and post-operative care for the specific procedures defined here and as further defined by the DSS/MHD and included in the provider program manuals.

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

2. (2) Conditions and Limitations.

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

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

      1. 1. Bone marrow/stem cell;
      2. 2. Heart;
      3. 3. Kidney;
      4. 4. Liver;
      5. 5. Lung;
      6. 6. Small bowel; and
      7. 7. Pancreas (in combination with or fol-

lowing a kidney transplant).

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 medical consultant and/or transplant consultants.
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 participant 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/MHD. These procedures and protocols will be developed with input by the MHD’s medical consultant and/or transplant consultants.

4. (F) Approved organ transplants can only be performed in a facility which submits documentation approved by MHD 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 MHD transplant facility approval;

1. 2. When the period for initial certifica-

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

1. 3. Each type of MO HealthNet-covered

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

1. 4. The transplant facility must notify

MHD of each new transplant surgeon who becomes a member of the transplant team. The transplant surgeons must be current MO HealthNet enrolled 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 Centers for Medicare and Medicaid Services (CMS) which designates the facility’s OPO as an acceptable organ procurement source;

1. 6. The transplant facility must provide

MHD 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 MHD in the provider program manual;

1. 7. Those facilities seeking certification

as a MO HealthNet-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/stem cell transplants can only be performed in a facility which submits documentation approved by MHD as complying with the following bone marrow/stem cell transplant facility criteria. An autologous only transplant facility must meet criteria items one through ten (1–10) of the following:

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

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

1. 2. Identified nursing unit with protective

isolation unit for bone marrow/stem cell 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/stem cell transplants a year or demonstrated an ability to care for prolonged marrow failure by treating twenty (20) adult or ten (10) pediatric 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/stem cell 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/stem cell transplantation program is in place and directed by a physician trained in an institution with a well established bone marrow/stem cell transplantation program;

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

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

1. 11. Physicians with expertise in infectious

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

1. 12. Tissue typing laboratory with capa-

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

1. 13. Cytogenetic laboratory; and
2. 14. Adequate laboratory facility to assay

drug levels including Cyclosporine A.

1. (H) All providers of transplantation and related services must sign a MO HealthNet 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 MO HealthNet program. In cases involving procedures that are to be performed outside of Missouri, however, the MO HealthNet Division, 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/MHD will reimburse qualified providers for a presurgery assessment at established MO HealthNet reimbursement rates.

1. (3) Procedure.

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

      1. 1. Patient’s full name;
      2. 2. Date of birth;
      3. 3. MO HealthNet ID or Social Security

Number;

1. 4. Synopsis of alternative treatments per-

formed and results;

1. 5. Diagnosis and prognosis;
2. 6. Specific transplant type being request-

ed;

1. 7. Name of the selected transplant center.

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 MO Health- Net Division);

1. 8. Medical records must be submitted

which substantiate the patient’s diagnosis, as well as results of the facility’s completed transplant evaluation indicating that the patient meets the facility’s “Patient Selection Protocols;” and

1. 9. Participant permanent residence; per-

tinent medical history; availability of other medical or Medicare coverage (including ID number); correspondence from referring physician; consultation reports/letters; transplant evaluation forms; medical records and laboratory reports showing HIV status (within six (6) months of the request date); donor compatibility for bone marrow/stem cell transplants; and full psychiatric/social service evaluations with impression of participant’s ability to be an adequate transplant candidate (within six (6) months of request date).

1. (B) The request for transplantation will be reviewed by MHD and the transplant facility advised in writing of the decision. An agreement will be issued on a case-by-case basis for approved transplants. 13 CSR 70-2

1. (4) Reimbursement.

   1. (A) Facility.

      1. 1. Reasonable charges will be paid by the

MO HealthNet Division up to a maximum cap amount for the type of transplant authorized as listed in the Transplant Provider Manual at http://manuals.momed.com/manuals/. 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. 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. 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.

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 MO HealthNet Division reimbursable rates, excluding the period and reimbursement set out in 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 made at established MO HealthNet Division reimburseable rates.

AUTHORITY: sections 208.153 and 208.201, RSMo Supp. 2013.* 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. Amended: Filed March 12, 2014, effective Sept. 30, 2014.

*Original authority: 208.153, RSMo 1967, amended 1967, 1973, 1989, 1990, 1991, 2007, 2012 and 208.201, RSMo 1987, 2007.