Hematopoietic Cell Transplantation (HCT)
Acute myeloid leukemia (AML) refers to leukemias that arise from a myeloid precursor in the bone marrow. There is a high incidence of relapse, which has prompted research into various post-remission strategies using either allogeneic or autologous 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.
Allogeneic HCTusing a myeloablative conditioning regimen may be considered medically necessary to treat ANY of the following conditions:
Allogeneic HCT using a reduced-intensity conditioning regimen may be considered medically necessary as a treatment of AML in individuals who are in complete marrow and extramedullary remission (CR1 and beyond), and who for medical reasons would be unable to tolerate a myeloablative conditioning regimen.
In individuals who are not candidates for allogeneic HCT, autologous HCT may be considered medically necessary to treat AML inCR1 or beyond, or relapsed AMLif responsive to intensified induction chemotherapy.
The use of allogeneic or autologous HCT in individuals not meeting the above criteria is considered not medically necessary.
| 38205 | 38206 | 38230 | 38232 | 38240 | 38241 | 38242 |
| S2140 | S2142 | S2150 |
Risk status of AML based on Cytogenetic and Molecular Factors
The newer, currently preferred, World Health Organization classification of AML incorporates and interrelates morphology, cytogenetics, molecular genetics, and immunologic markers. It attempts to construct a classification that is universally applicable and prognostically valid. The World Health Organization system was adapted by National Comprehensive Cancer Network to estimate individual prognosis to guide management, as shown in the below table.
Risk Status |
Cytogenetic Factors |
Molecular Abnormalities |
Favorable |
Inv16, t(8;21), t(16;16) |
Normal cytogenetics with isolated NPM1 variant |
Intermediate |
Normal +8 only, t(9;11) only Other abnormalities not listed with better-risk and poor-risk cytogenetics
|
c-KIT variant in individuals with t(8;21) or inv16
|
Poor |
Complex (greater than or equal to 3 abnormalities) -5, -7, 5q-, 7q-, +8, inv3, t(3;3), t(6;9), t(9;22) Abnormalities of 11q23, excluding t(9;11)
|
Normal cytogenetics with isolated FLT3-ITD variant
|
AML: acute myeloid leukemia; ITD: internal tandem duplication.
| C92.00 | C92.01 | C92.02 | C92.40 | C92.41 | C92.42 | C92.50 |
| C92.51 | C92.52 | C92.60 | C92.61 | C92.62 | C92.A0 | C92.A1 |
| C92.A2 | C93.00 | C93.01 | C93.02 | C94.00 | C94.01 | C94.02 |
| C94.20 | C94.21 | C94.22 |
National Comprehensive Cancer Network – 2019
The National Comprehensive Cancer Network clinical guidelines (v.2. 2020) for acute myeloid leukemia state that allo-HCTis recommendedfor individualsaged<60 years after standard-dose cytarabine induction with induction failure or significant residual disease without a hypocellular marrow or as post-remission therapy in those with intermediate-risk or poor-risk cytogenetics. Allo-HCT is recommended for individuals aged ≥60 years after standard-dose cytarabine induction with residual disease or induction failure or following complete response (reduced-intensity HCT). In addition, allo-HCT is recommended for relapsed or refractory disease.
Under discussion are recommendations that also include autologous HCT for individuals who achieve second molecular remission and to reserve allogeneic transplant for those individuals who have persistent disease, despite therapy for therelapsed disease.
Internal Medical Policy Committee May 19, 2020 Policy language updated regarding complete remission, table added
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.