This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Autologous HSCT may be considered medically necessary to treat AL amyloidosis (primary systemic amyloidosis) when ALL of the following patient selection criteria are met:

• Age greater than eighteen (18) years; and
• Tissue diagnosis of amyloidosis by abdominal fat aspirate or biopsy of involved organ; and
• Eastern Cooperative Oncology Group (ECOG) performance status score of zero-two (0- 2); and
• New York Heart Association class I/II and no more than two involved major organs (liver, heart, kidney, autonomic nerve); and
• Supine systolic blood pressure greater 90 mm/Hg; and
• Asymptomatic or compensated cardiac function (e.g. absence of congestive heart failure),echocardiographic left ejection fraction greater than 40%; and cardiac interventricular septal thickness is greater than 12 mm; and
• Renal function with a creatinine clearance of at least 30 ml/min.

 Note:  When available, a clinical trial should be utilized.  

Allogeneic HSCT is considered experimental/investigational and therefore non-covered to treat AL amyloidosis (primary systemic amyloidosis). Available scientific evidence does not permit conclusions concerning this intervention on health outcomes.

Refer to medical policy Z-46, Blood and Bone Marrow Storage, for additional information.

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Hematopoietic Stem Cell Transplantation for Primary Amyloidosis is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

• Link to Diagnosis Codes

• Link to References