L28848

 

GEMTUZUMAB OZOGAMICIN (MYLOTARG TM)

 

03/22/2012

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Gemtuzumab ozogamicin (Mylotarg TM)-J9300

• Gemtuzumab Ozogamicin (Mylotarg TM) is FDA approved for the treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy.

Coding Information

 

Bill Type Codes

• Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.

• Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type.

• Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

 

13x Hospital Outpatient

21x Skilled Nursing - Inpatient (Including Medicare Part A)

23x Skilled Nursing - Outpatient

85x Critical Access Hospital

 

Revenue Codes

• Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service.

• In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination.

• Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

 

 

0636 Pharmacy - Drugs Requiring Detailed Coding

 

 

CPT/HCPCS Codes

 

 

J9300 INJECTION, GEMTUZUMAB OZOGAMICIN, 5 MG

 

 

ICD-9 Codes that Support Medical Necessity

 

 

205.00 ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION

205.01 MYELOID LEUKEMIA ACUTE IN REMISSION

205.02 ACUTE MYELOID LEUKEMIA, IN RELAPSE

Diagnoses that Support Medical Necessity

See ICD-9 Codes that Support Medical Necessity

 

 

Documentation Requirements

• Medical record documentation maintained by the ordering/referring physician must substantiate the medical need for the use of these chemotherapy drugs by clearly indicating the condition for which these drugs are being used.

o This might include the type of cancer, staging, if applicable, prior therapy and the patient’s response to that therapy.

o This documentation is usually found in the history and physical or in the office/progress notes.

• If the provider of the service is other than the ordering/referring physician, that provider must maintain copies of the ordering/referring physician’s order for the chemotherapy drug.

o The physician must state the clinical indication/medical need for using the chemotherapy drug in the order.

 

Treatment Logic

• Gemtuzumab ozogamicin (Mylotarg TM) for injection is a chemotherapy agent composed of a recombinant humanized IgG4, Kappa antibody conjugated with a cytotoxic antitumor antibiotic isolated from fermentation of a bacterium.

• The antibody portion of Mylotarg binds specifically to the CD33 antigen, a sialic acid-dependent adhesion protein found on the surface of leukemic blasts and immature normal cells of myelomonocytic lineage, but not on normal hematopoietic stem cells.

 

Sources of Information and Basis for Decision

 

Compendia-Based Drug Bulletin. (February 2007). The Association of Community Cancer Centers. [On-Line]. Available: http://www.accc-cancer.org/.

 

FCSO LCD 29183, Gemtuzumab Ozogamicin (Mylotarg™), 03/22/2012. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Sievers, E., Larson, R., Stadtmauer, E., Estey, E., Lowenberg, B., Dombret, H., et al. (2001).Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse. Journal of Clinical Oncology, 19(13), 3244-3254.

 

Thomson Micromedex (2007). USP DI Drug Information for the Health Care Professional. [On-Line]. Available: http://www/thomsonhc.com/home/dispatch

 

U.S. Food and Drug Administration, Department of Health and Human Services, CDER web site updates, March 2007.

 

 

AMA CPT Copyright Statement

CPT codes, descriptions and other data only are copyright 2012 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply.

 

© Automated Clinical Guidelines, LLC 2012-2013

 

CMS LCD GEMTUZUMAB OZOGAMICIN (MYLOTARG TM)