HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
S-214-013
Topic:
Hematopoietic Cell Transplantation for Acute Myeloid Leukemia
Section:
Surgery
Effective Date:
May 24, 2021
Issued Date:
May 24, 2021
Last Revision Date:
May 2021
Annual Review:
May 2021
 
 

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.

Policy Position

Allogeneic HCT using a myeloablative conditioning regimen may be considered medically necessary to treat ANY of the following conditions: 

  • Poor- to intermediate-risk AML in first complete remission CR1 (see table below); or
  • AML that is refractory to standard induction chemotherapy but can be brought into CR with intensified induction therapy; or
  • AML that relapses following chemotherapy-induced CR1 but can be brought into CR1 or beyond with intensified induction chemotherapy; or
  • AML in individuals who have relapsed following a prior autologous HCT but can be brought into CR with intensified induction chemotherapy and are medically able to tolerate the procedure.  

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 allogenic HCT, autologous HCT may be considered medically necessary to treat AML in CR1 or beyond, or relapsed AML, if responsive to intensified induction chemotherapy.

The use of allogeneic or autologous HCT in individuals not meeting the criteria as indicated in this policy is considered not medically necessary.

38205

38206

38230

38232

38240

38241

38242

S2140

S2142

S2150

 

 

 

 


Risk status of AML based on Genetic 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 patient prognosis to guide management, as shown in the below table.

 Risk Status

Genetic Abnormalities

Favorable

t(8;21)(q22;q22.1); RUNX1-RUNX1T1
inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11
Biallelic mutated CEBPA
Mutated NPM1 without FLT3-ITD or with FLT3-ITDlow

Intermediate

Mutated NPM1 and FLT3-ITDhigh
Wild-type NPM1 without FLT3-ITD or with FLT3-ITDlow (without adverse-risk genetic lesions)
t(9;11)(p21.3;q23.3); MLLT3-KMT2A
Cytogenetic abnormalities not classified as favorable or adverse

 

Poor/Adverse

t(6;9)(p23;q34.1); DEK-NUP214
t(v;11q23.3); KMT2A rearranged
t(9;22)(q34.1;q11.2); BCR-ABL1
inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2); GATA2,MECOM(EVI1)
-5 or del(5q); -7; -17/abn(17p)
Complex karyotype, monosomal karyotype
Wild-type NPM1 and FLT3-ITDhigh
Mutated RUNX1 (if not co-occurring with favorable-risk AML subtypes)
Mutated ASXL1 (if not co-occurring with favorable-risk AML subtypes)
Mutated TP53

 

AML: acute myeloid leukemia; ITD: internal tandem duplication.

Related Policies

Refer to Medical Policy S-143, Donor leukocyte Infusion for Hematologic Malignancies that Relapse after Allogeneic Cell Transplant, for additional information.

Refer to Medical Policy S-226, Placenta/Umbilical Cord Blood as a Source of Stem Cells, for additional information.

Refer to Medical Policy Z-46, Blood and Bone Marrow Storage, for additional information. 

 


Professional Statements and Societal Positions Guidelines

National Comprehensive Cancer Network – 2021

The National Comprehensive Cancer Network clinical guidelines (v.3.2021), for acute myeloid leukemia state that allogeneic HCT is recommended for [individuals] aged less than 60 years after standard-dose cytarabine induction with induction failure or significant residual disease without a hypocellular marrow. It is also recommended after high-dose cytarabine induction with induction failure, or as post-remission therapy in those with intermediate-risk or poor-risk cytogenetics.

Allogeneic HCT is identified as a "reasonable option" for patients aged greater than or equal to 60 years after standard-dose cytarabine induction with residual disease or induction failure or following complete response (preferably in a clinical trial). In addition, allogeneic HCT is recommended for relapsed or refractory disease.

According to the guidelines, the role of autologous HCT is diminishing due to improvements in allogeneic HCT that have expanded the pool of potential donors outside the family setting. Autologous HCT should not be a recommended consolidation therapy outside the setting of a clinical trial.


Covered Diagnosis Codes

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

 

 

 

 


Place of Service: Inpatient/Outpatient

Hematopoietic cell transplantation for acute myeloid leukemia 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



Links





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 or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

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, and subject to the applicable laws of your state.


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.

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. 




Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect 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.