Stem cell transplantation is a process in which stem cells are harvested from either a patient’s or donor’s bone marrow or peripheral blood for intravenous infusion. Autologous stem cell transplantation (AuSCT) must be used to effect hematopoietic reconstitution following severely myelotoxic doses of chemotherapy (HDCT) and/or radiotherapy used to treat various malignancies. Allogeneic stem cell transplant may also be used to restore function in recipients having an inherited or acquired deficiency or defect.

• Allogeneic Stem Cell Transplantation - Allogeneic stem cell transplantation is a procedure in which a portion of a healthy donor’s stem cell or bone marrow is obtained and prepared for intravenous infusion.  
• Autologous Stem Cell Transplantation - Autologous stem cell transplantation is a technique for restoring stem cells using the patient’s own previously stored cells.

Bone marrow and peripheral blood stem cell transplantation is a process which includes mobilization, harvesting, and transplant of bone marrow or peripheral blood stem cells and the administration of high dose chemotherapy or radiotherapy prior to the actual transplant. When bone marrow or peripheral blood stem cell transplantation is covered, all necessary steps are included in coverage. When bone marrow or peripheral blood stem cell transplantation is non-covered, none of the steps are covered.

Coverage is provided for allogeneic stem cell or bone marrow transplantation in the treatment of the following conditions:

• Leukemia, Leukemia in remission
• Aplastic anemia
• Severe combined immunodeficiency disease (SCID) 
• Wiskott - Aldrich syndrome

Coverage is provided for autologous stem cell transplantation in the treatment of the following conditions:

• Acute leukemia in remission who have a high probability of relapse and who have no human leukocyte antigens (HLA) - matched 
• Resistant non-Hodgkin’s lymphomas or those presenting with poor prognostic features following an initial response 
• Recurrent or refractory neuroblastoma 
• Advanced Hodgkin’s diseases who have failed conventional therapy and have no HLA - matched donor 
• Durie-Salmon Stage II or III patients that fit the following requirements:

• When recognized clinical risk factors are employed to select patients for transplantation, high-dose melphalan (HDM) together with autologous stem cell transplantation (HDM / AuSCT) is reasonable and necessary for members of any age group for the treatment of primary amyloid light chain (AL) amyloidosis who meet the following criteria:

See the “Diagnosis Codes” section for appropriate diagnosis codes.

Coverage is not considered medically necessary for stem cell or bone marrow transplants for the following conditions:

Allogeneic (Donor)

• Multiple myeloma
• Myelodysplastic Syndrome (MDS)*

Autologous (Self)

• Acute leukemia not in remission
• Chronic granulocytic leukemia
• Solid tumors (other than neuroblastoma)
• Non-primary (AL) amyloidosis
• Tandem transplantation (multiple rounds of AuSCT) for patients with multiple myeloma

* Effective for services performed on or after August 4, 2010, for the treatment of Myelodysplastic Syndromes (MDS), the use of allogeneic hematopoietic stem cell transplantation is covered under the Plan pursuant to Coverage with Evidence Development (CED) in the context of a Medicare-approved, prospective clinical study.

Claims for Medicare Advantage members who are participating in an approved clinical trial should be submitted to the appropriate fee-for-service Medicare carrier or intermediary. See www.cms.hhs.gov/clinicaltrialpolicies for the appropriate billing guidelines.

Refer to Medicare Advantage Medical Policy Bulletin N-27 for additional information regarding clinical trials.

Claims for members who do not meet all of the indications listed in the "Indications and Limitations of Coverage" section of this policy will be denied as not medically necessary. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Documentation in the medical record must contain a history pertinent to the indications of this policy.

Use procedure code 38230 to report the harvesting of allogeneic bone marrow.

Use procedure code 38240 to report the transplantation of allogeneic bone marrow. 

Use procedure code 38205 to report the harvesting of allogeneic peripheral stem cells.

Use procedure code 38206 to report the harvesting of autologous peripheral stem cells.

Use procedure code 38240 to report the transplantation of allogeneic peripheral stem cells.

Use procedure code 38241 to report the transplantation of autologous peripheral stem cells.

Use procedure code 38230 to report the harvesting of autologous bone marrow.

Use procedure code 38241 to report the reinfusion of ABMT.

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no payment shall be made for items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

On-Line Manual 100-03, Chapter 1, Section 110.8.1

On-Line Manual 100-04, Chapter 32, Section 90-90.3

Transmittal 1674, CR 1002

Transmittal AB-00-104, CR 1375

Transmittal 526, CR 3797

Transmittal 45, CR 4173

Transmittal 127, CR 7137

MLN Matters MM7137

Covered Diagnosis Codes

Allogeneic (Donor)(38205, 38230 and 38240)

Autologous (Self)(38206, 38230 and 38241)

When this procedure is being performed for a diagnosis of neuroblastoma, the appropriate "malignant neoplasm" diagnosis code should be used indicating that the neoplasm is a neuroblastoma.

Non-covered Diagnosis Codes

Allogeneic (Donor)(38240)

Autologous (Self)(38241)