Coverage Policy
The information displayed below pertains specifically to the Physician Office setting of care. For information tailored to the Hospital Outpatient setting, please select the appropriate tab to the right. Coding, coverage, and reimbursement may vary significantly by payor, plan, patient, and setting of care. See below
Physician-administered drugs are generally covered under Medicare Part B if 1) they are reasonable and necessary for the diagnosis or treatment of the illness or injury for which they are administered according to accepted standards of medical practice; (2) they are not usually self-administered; and (3) they meet the requirements for coverage of items as incident to a physician’s service. The general requirements for coverage under the “incident to” provision are that the drug be of a form that is not usually self-administered and that the drug be furnished and administered by a physician.1 Medicare has not issued a National Coverage Determination (NCD) for DACOGEN® (decitabine for injection). Local Medicare contractors (Fiscal Intermediary, Carrier or Part A/B Medicare Administrative Contractor (MAC)) may make coverage decisions for DACOGEN®. Some local contractors have published Local Coverage Determinations (LCDs) and other coverage instruction through articles and bulletins that relate to DACOGEN®. However, the absence of a published coverage policy does not mean that there is no coverage for DACOGEN®.
For more information on Medicare reimbursement of DACOGEN®, contact the Eisai Assistance Program at 1-866-61-EISAI or 1-866-61-34724.
Payor Reimbursement
Medicare Part B reimbursement for DACOGEN® administered in the physician office setting is based on Average Sales Price (ASP). Medicare sets an allowable payment amount, updated quarterly, at ASP plus 6%. Medicare reimbursement is based on the lesser of this allowable amount or actual charges, as follows: physician offices are reimbursed for 80% of the allowable amount and the patient or patient’s secondary insurer is responsible for the remaining 20% coinsurance.
Administration Services
Medicare reimbursement for DACOGEN® drug administration services provided in the physician office setting is based on the national fee schedule that is adjusted for geographic variations and updated annually. Medicare reimbursement is based on the lesser of the adjusted fee schedule amount or actual charges, as follows: physicians are reimbursed for 80% of the allowable amount and the patient or patient’s secondary insurer is responsible for the remaining 20% coinsurance.
1. See the Medicare Benefits Policy Manual, Chapter 15, section 50 for further information.
Indication
DACOGEN® is indicated for treatment of patients with myelodysplastic syndromes (MDS) including:
- Previously treated and untreated
- De novo and secondary
- All French-American-British (FAB) subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia)
- Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System groups.
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. After administration of the recommended dosage for the first cycle, treatment for subsequent cycles should be adjusted if indicated by dose adjustment guidelines. 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. Women of childbearing potential should be counseled to use effective contraception during this time. Men should be advised not to father a child while receiving treatment with DACOGEN® and for 2 months following completion of treatment. DACOGEN may cause fetal harm. Men with female partners of childbearing potential should use effective contraception during this time.
- In the phase 3 clinical trial, the highest incidence of Grade 3 or Grade 4 adverse events in the DACOGEN® arm was 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, the median duration of this delay was 7 days.. 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 >e;2 mg/dL; (2) SGPT, total bilirubin >e;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.
