Hematopoietic Cell Transplantation for Acute Lymphoblastic Leukemia

Policy ID: S-220-011

Section: Surgery

Effective Date: July 01, 2018

Revised Date: September 21, 2020

Revision Effective Date: November 02, 2020

Last Reviewed: September 21, 2020

Description

Acute Lymphoblastic Leukemia (ALL) is a heterogeneous disease with different genetic variations resulting in distinct biologic subtypes. Individuals are stratified to risk-adapted therapy according to certain clinical and genetic risk factors that predict outcome. Therapy may include hematopoietic cell transplantation (HCT).

HCT involves the intravenous (IV) infusion of allogeneic (donor) or autologous stem cells to reestablish hematopoietic function in individuals whose bone marrow or immune system is damaged or defective. They can be harvested from bone marrow, peripheral blood, or umbilical cord blood and placenta shortly after delivery of neonates.

Criteria

Childhood ALL

Autologous or allogeneic (HCT) may be considered medically necessary to treat childhood ALL when at least ONE of the following criteria has been met:

In first complete remission and at high risk of relapse; or
In second or greater remission or refractory ALL.

Allogeneic HCT may be considered medically necessary to treat relapsing ALL after a prior autologous HCT in children.

Autologous or allogeneic HCT for any other indication than listed above will be considered not medically necessary.

Procedure Codes

38204	38205	38206	38208	38209	38210	38211
38212	38213	38214	38215	38230	38232	38240
38241	86812	86813	86816	86817	86821	S2140
S2142

Adult ALL

Autologous HCT may be considered medically necessary to treat adult ALL in first complete remission but at high risk of relapse.

Allogeneic (HCT) may be considered medically necessary to treat adult ALL when at leastONE of the following clinical criteria has been met:

In first complete remission for any risk level; or
In second or greater remission or with relapsed or refractory ALL;or
In relapse after a prior autologous HCT.

Autologous HCT to treat adult ALL in second or greater remission or with refractory disease is considered experimental and investigational (E/I) and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available peer-reviewed literature.

Autologous or allogeneic HCT for any other indication than listed above will be considered not medically necessary.

Procedure Codes

38204	38205	38206	38208	38209	38210	38211
38212	38213	38214	38215	38230	38232	38240
38241	86812	86813	86816	86817	86821	S2140
S2142

Reduced-Intensity Conditioning (RIC)

RIC-allogeneic HCT may be considered medically necessary as a treatment for ALL in patients who are in complete marrow and extramedullary first or second remission, and who, for medical reasons, would be unable to tolerate a standard myeloablative conditioning regimen.

RIC allogeneic HCT for any indication other than listed above is considered not medically necessary.

Procedure Codes

38230	38240	86812	86813	86816	86817	86821
S2140	S2142

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes: 38204, 38205, 38206, 38208, 38209, 38210, 38211, 38212, 38213, 38214, 38215, 38230, 38232, 38240, 38241, 86812, 86813, 86816, 86817, 86821, S2140, S2142

C91.00

C91.01

C91.02

Professional Statements and Societal Positions Guidelines

National Comprehensive Cancer Network – 2019

Current National Comprehensive Cancer Network guidelines (v.2.2019) for ALL indicate allo-HCT is appropriate for consolidation treatment of most poor risk (e.g., the Philadelphia chromosome-positive, relapsed, or refractory) patients with ALL. The guidelines state that for appropriately fit older adults with ALL who are achieving remission, “consideration of autologous or reduced-intensity allogeneic stem cell transplantation may be appropriate.” In addition, the guidelines note that chronologic age is not a good surrogate for fitness for therapy and that patient should be evaluated on an individual basis.

Current National Comprehensive Cancer Network guidelines (v.2.2020) for pediatric ALL say that "Allogeneic HSCT has demonstrated improved clinical outcomes in pediatric ALL patients with evidence of certain high-risk features and/or persistent disease. In addition, survival rates appear to be comparable regardless of the stem cell source (matched related, matched unrelated, cord blood, or haploidentical donor)."

American Society for Blood and Marrow Transplantation – 2015

The guidelines from the American Society for Blood and Marrow Transplantation (2015)were publishedon indications for autologous and allogeneic HCT. Recommendations were intended to describe the current consensus on theuseof HCT in and out of the clinical trial setting.Recommendations on ALLare listedin the below table.

Guidelines for Autologous and Allogeneic HCT in ALL

Indication	Children (Age <18 Years)		Adults (Age ≥18 Years)
	Allogeneic HCT	Autologous HCT	Allogeneic HCT	Autologous HCT
First complete response, standard-risk	N	N	S	C
First complete response, high-risk	S	N	S	N
Second complete response	S	N	S	C
At least third complete response	C	N	C	N
Not in remission	C	N	C	N

ALL: acute lymphoblastic leukemia; C: clinical evidence available; HCT: hematopoietic cell transplantation; N: notgenerallyrecommended; S: standard of care.

ND Committee Review

Internal Medical Policy Committee 9-26-2019 New policy
Internal Medical Policy Committee 9-21-2020 Coding update: removed procedures 38220, 38221 and 3822

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.

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