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Healthcare Common Procedure Coding System (HCPCS) Level II Code

HCPCS codes are 5-digit alphanumeric codes that are assigned to drugs by the Centers for Medicare and Medicaid Services (CMS).  DACOGEN® has been assigned the following unique HCPCS in the “J” series (known as J-codes):

DACOGEN® HCPCS Code Description
J0894 Injection, decitabine, 1 mg

When billing for a drug payors require physicians to indicate on the claim form the quantity of product administered to the patient, expressed in the number of units described by the HCPCS code. Because the HCPCS code for DACOGEN® is expressed as 1 mg, the amount of DACOGEN administered to a patient is expressed in multiples of 1 mg on the claim form.

Example Number of Units to Report for DACOGEN®
25 mg Report 25 units J0894
50 mg Report 50 units J0894

Payors may reimburse providers for the remainder of the contents of the DACOGEN® single dose vial if it is not administered and must be discarded.  However, payors’ wastage policies may require that physicians schedule patients in such a way that they can use drugs most efficiently, in a clinically appropriate manner.  Payors may require that drug wastage be documented in the patient’s medical record with the date, time, amount wasted, and reason for wastage.  In addition, some payors may require physicians to include the amount of product administered and the amount discarded when line item billing for DACOGEN®.  Finally some payors request that physicians identify any discarded product by appending the JW modifier to the claim.1

For more information on HCPCS Level II code reporting requirements contact the Eisai Assistance Program at: 1-866-61-EISAI  or  1-866-61-34724.

1. See the Medicare Claims Processing Manual, Chapter 17, section 40 for further information on Medicare's wastage policy.

Indication

Important Safety Information:

Treatment with DACOGEN® is associated with neutropenia and thrombocytopenia. Complete blood and platelet counts should be performed as needed to monitor response and toxicity but at a minimum prior to each dosing cycle. Clinicians should consider the need for early institution of growth factors and/or antimicrobial agents for the prevention or treatment of infections in patients with MDS.

DACOGEN® may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with DACOGEN® and for 1 month following completion of treatment. Men should be advised not to father a child while receiving treatment with DACOGEN® and for 2 months following completion of treatment.

In the phase 3 clinical trial, the highest incidences of Grade 3 or Grade 4 adverse events in the DACOGEN® arm were neutropenia (87%), thrombocytopenia (85%), febrile neutropenia (23%), and leukopenia (22%). Bone marrow suppression was the most frequent cause of dose reduction, delay, and discontinuation. Six patients had fatal events associated with their underlying disease and myelosuppression (anemia, neutropenia, and thrombocytopenia) that were considered at least possibly related to drug treatment. Of the 83 DACOGEN®-treated patients, 8 permanently discontinued therapy for adverse events compared to 1 of 81 patients in the supportive care arm.

In the single-arm study, the highest incidence of Grade 3 or Grade 4 adverse events was neutropenia (37%), thrombocytopenia (24%), and anemia (22%). Seventy-eight percent of patients had dose delays. Hematologic toxicities and infections were the most frequent causes of dose delays and discontinuation. Eight patients had fatal events due to infection and/or bleeding that were considered at least possibly related to drug treatment. Nineteen of 99 patients permanently discontinued therapy for adverse events.

Other commonly occurring reactions include fatigue, pyrexia, nausea, cough, petechiae, constipation, diarrhea, and hyperglycemia.

If hematologic recovery from a previous DACOGEN® treatment cycle requires more than 6 weeks when administering the 3-day dosing, then the next DACOGEN® cycle should be delayed and dosing temporarily reduced. When administering the 5-day dosing, the DACOGEN® cycle should be delayed until there is hematologic recovery. If the following nonhematologic toxicities are present, DACOGEN® treatment should not be restarted until the toxicity is resolved: (1) serum creatinine ≥2 mg/dL; (2) SGPT, total bilirubin ≥2 × ULN; and (3) active or uncontrolled infection.

Because there are no data on use of DACOGEN® in patients with renal or hepatic dysfunction, DACOGEN® should be used with caution in these patients.

For more information about DACOGEN® please see full Prescribing Information.



Eisai cannot guarantee payment of any claim. Coding, coverage, and reimbursement may vary significantly by payor, plan, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payors following the receipt of claims. For additional information, customers should consult with their payors for all relevant coding, reimbursement, and coverage requirements. It is the sole responsibility of the provider to select the proper code and ensure the accuracy of all claims used in seeking reimbursement. All services must be medically appropriate and properly supported in the patient medical record.

This information is intended for use by our healthcare professionals in the United States only. Eisai Inc. recognizes the Internet is a global communications medium; however, laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here is not appropriate for use outside the United States. This site contains information about products that may have different product labeling in different countries.

DACOGEN® is a registered trademark used by Eisai Inc. under license from Astex Pharmaceuticals, Inc., Dublin, CA, U.S.A.

Distributed and marketed by Eisai Inc. CORP74BR6 ©2012 Eisai Inc. All rights reserved.

This site was last modified on : December 19, 2011 at 5:45pm ET