Coverage Policies

Use the index below to search for coverage information on specific medical conditions.

High-Tech Imaging: High-Tech Imaging services are administered by National Imaging Associates, Inc. (NIA). For coverage information and authorizations, click here.

Medical Providers: Payment for care or services is based on eligibility, medical necessity and available benefits at time of service and is subject to all contractual exclusions and limitations, including pre-existing conditions if applicable.

Future eligibility cannot be guaranteed and should be rechecked at time of service. Verify benefits by signing into My Account or calling Customer Service at 800.235.7111 or 501.228.7111.

If not specified in a QualChoice coverage policy (Benefit Interpretation), QualChoice follows care guidelines published by MCG Health.

QualChoice reserves the right to alter, amend, change or supplement medical policies as needed. QualChoice reviews and authorizes services and substances. CPT and HCPCS codes are listed as a convenience and any absent, new or changed codes do not alter the intent of the policy.


Effective Date: 02/08/2007 Title: Leustatin (Cladribine)
Revision Date: 10/01/2015 Document: BI179:00
CPT Code(s): J9065
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above Revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Leustatin (cladribine) is an injectible medication for the treatment of a rare form of leukemia called Hairy Cell Leukemia. Hairy Cell Leukemia is a chronic, low-grade form of leukemia that is usually easily controlled.

2)    Leustatin requires pre-authorization.

Medical Statement

1)    Decision To Treat:

a)    About 10% of Hairy Cell Leukemia patients remain asymptomatic with normal blood cell counts and never require treatment.

b)    Treatment of Hairy Cell Leukemia becomes warranted given the onset of:

i)     Significant cytopenias: neutropenia, anemia or thrombocytopenia

ii)    Symptomatic splenomegaly

iii)   Significant constitutive symptoms: fever, fatigue, night sweats.

2)    Treatment Status:

a)    Treatment naïve: cladrabine and pentostatin are the treatments of choice.

b)    Treated successfully and relapsed: If the patient responded initially and subsequently relapsed, a second course of the same medication as that initially used will be successful in about 70% of cases.

c)    Treatment failure: treatment is indicated with a different purine analog from the one that failed. Thus, if cladrabine was the first choice, treatment should be switched to pentostatin – or vice versa.

3)    Leustatin is considered indicated for the treatment of Hairy Cell Leukemia:

a)    For the initial treatment of symptomatic Hairy Cell Leukemia (C91.40); OR

b)   For treatment of relapse (C91.42) after successful initial treatment with Leustatin; OR

c)    For treatment of patients who had no benefit from an initial course of pentostatin or interferon (C91.40).

4)    Leustatin is considered experimental and investigational for all other uses.

5)    Source:  This drug can be ordered through a contracted specialty pharmacy company.  This option will provide the medication to the physician’s office on the day specified and in the dose required, at no expense to the physician.  Billing for the medication, in this circumstance, will be handled by the specialty pharmacy; the physician will bill appropriate administration charges.


Codes Used In This BI:

J9065             Inj cladribine per 1 MG


More than one course of therapy will not be covered except when indicated for a relapse after a previously successful course of treatment. A course of therapy is daily infusion for 7 consecutive days.


1)    Cladribine; indications and dosage RxList at :

2)     Leustatin; Prescribing information Ortho Biotech at:

3)    Belani R, Saven A; Cladribine in hairy cell leukemia.
Hematol Oncol Clin North Am. 2006 Oct;20(5):1109-23. Review.

4)    Ulrich M et al:  Advances in the treatment of hairy-cell leukaemia; Lancet Oncol. 2003 Feb;4(2):86-94.

5)   National Cancer Institute: treatment/hairy-cell-leukemia/HealthProfessional/page3

6)    Treatment of hairy cell leukemia Martin S Tallman, MD; Up-To-Date 7/31/06.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
This policy has recently been updated. Please use the index above or enter policy title in search bar for the latest version.