Highmark Commercial Medical Policy - Pennsylvania

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Medical Policy: S-223-009
Topic: Hematopoietic Stem Cell Transplantation for Amyloid light-chain (AL) Amyloidosis (Primary Systemic Amyloidosis)
Section: Surgery
Effective Date: November 13, 2017
Issue Date: November 13, 2017
Last Reviewed: October 2017

Hematopoietic Stem-Cell Transplantation
Hematopoietic stem-cell transplantation (HSCT) refers to the infusion of hematopoietic stem cells to restore bone marrow function in cancer patients who receive bone-marrow-toxic doses of cytotoxic drugs with or without whole body radiation therapy. Hematopoietic stem cells may be obtained from the transplant recipient (autologous HSCT) or from a donor (allogeneic HSCT).

Primary Systemic or AL amyloidosis is the most common type of amyloidosis.  The clinical features are dependent on the organs involved, typically cardiac, renal, hepatic, peripheral, and autonomic neuropathy and soft tissue.

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.

Policy Position Coverage is subject to the specific terms of the member’s benefit plan.

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.  

Procedure Codes
38206, 38220, 38221, 38232, 38241, S2150

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.

Procedure Codes
38205, 38220, 38221, 38230, 38240, S2140, S2142, S2150

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

Professional Statements and Societal Positions

National Comprehensive Cancer Network (NCCN).  NCCN Guidelines Version 1. 2018, Systemic Light Chain Amyloidosis. 

The current NCCN Guidelines list the following as therapeutic considerations for management of patients with systemic light chain amyloidosis (all category 2A recommendation) along with best supportive care:  high-does melphalan followed by autologous SCT; oral melphalan and dexamethasone; dexamethasone in combination with alpha-interferon; thalidomide plus dexamethasone; lenalidomide and dexamethasone; Lenalidomide/cyclophosphamide/dexamethasone; pomalidomide and dexamethasone; bortezomib with or without dexamethasone; bortezomib with melphalan plus dexamethasone; cyclophosphamide, thalomide, and dexamethasone; bortezomib, and dexamethasone.

Place of Service: Inpatient/Outpatient

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.

The policy position applies to all commercial lines of business

Denial Statements

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.


Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages
If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

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