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Coverage Policy

The information displayed below pertains specifically to the Hospital Outpatient setting of care. For information tailored to the Physician Office setting, please select the appropriate tab to the left. 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®.  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

Services paid under the Medicare Hospital Outpatient Prospective Payment System (OPPS) are assigned to an Ambulatory Payment Classification (APC) code.  Each APC is linked to a payment amount that represents the total payment to the hospital. In addition, separate payments are made for some drugs, biologicals, and devices. DACOGEN® is separately reimbursed by Medicare under the APC system at Average Sales Price (ASP) plus 4%, adjusted quarterly2.

Administration Services

Drug administration Current Procedural Terminology (CPT) codes are assigned to APCs according to their clinical and resource requirements. Several drug administration codes may map to a single APC. APCs for drug administration services are updated yearly by CMS. 

For more information on Medicare reimbursement for DACOGEN®, contact the Eisai Assistance Program at 1-866-61-EISAI  or  1-866-61-34724.

Related Forms & Coding

1. See the Medicare Benefits Policy Manual, Chapter 15, section 50 for further information.

2. Federal Register Vol. 76, No. 230. November 30, 2011. Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment; Ambulatory Surgical Center Payment; Hospital Value-Based Purchasing Program; Physician Self- Referral; and Patient Notification Requirements in Provider Agreements. http://www.cms.gov/HospitalOutpatientPPS/HORD/list.asp#TopOfPage. Accessed November 30, 2011.

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.

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