Coding & reimbursement support
MARGENZA Access Support is here to help assist healthcare professionals (HCPs) in obtaining insurance reimbursement for MARGENZA.
Billing and Coding Guide
Includes potential billing codes for MARGENZA (see below for list), as well as sample claim forms for physician’s office setting and institutional or hospital setting. Download to have as a reference.
Potential Billing Codes for MARGENZA
MacroGenics has identified the potential billing codes below to assist HCPs with obtaining insurance reimbursement for MARGENZA and its administration. Please note that coverage, coding, and payment may vary significantly by patient, payer, plan, treatment setting, and site of care. MacroGenics makes no representation, warranty, or guarantee that the information provided herein is up to date and/or accurate, will satisfy the requirements of the patient’s insurer or payer, or result in payment. All codes included in this guide are for informational purposes only and do not guarantee payment of any claim. It is the sole responsibility of HCPs to select the appropriate codes and ensure the accuracy of all claims submitted for reimbursement.
| Codes | Category of Treatment or Description |
|---|---|
| C50.011-C50.019, C50.111-C50.119, C50.211-C50.219, C50.311-C50.319, C50.411-C50.419, C50.511-C50.519, C50.611-C50.619, C50.811-C50.819, C50.911-C50.919 | Malignant neoplasm of female breast |
| C50.021-C50.029, C50.121-C50.129, C50.221-C50.229, C50.321-C50.329, C50.421-C50.429, C50.521-C50.529, C50.621-C50.629, C50.821-C50.829, C50.921-C50.929 | Malignant neoplasm of male breast |
| Codes | Category of Treatment or Description |
|---|---|
| J9353 | Injection, margetuximab-cmkb, 5 mg |
aEffective for dates of service on or after July 1, 2021.
| Codes | Category of Treatment or Description | |
|---|---|---|
| 10-digit NDC3 | 11-digit NDC3,4 | |
| 74527-022-02 | 74527-0022-02 | One (25 mg/mL) single-dose vial |
| 74527-022-03 | 74527-0022-03 | Four (25 mg/mL) single-dose vials |
| Codes | Category of Treatment or Description |
|---|---|
| 96413 | Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug |
| 96415 | Chemotherapy administration, intravenous infusion technique; each additional hour (list separately in addition to code for primary procedure) |
| 96417 | Chemotherapy administration, intravenous infusion technique; each additional sequential infusion (different substance/drug), up to 1 hour (list separately in addition to code for primary procedure) |
| Codes | Category of Treatment or Description |
|---|---|
| 0335 | Chemotherapy administration, intravenous |
| 0636 | Drugs requiring detailed coding |
| 0250 | Pharmacy, general |
| 0260 | Intravenous therapy, general |
CPT® is a registered trademark of the American Medical Association. AHA=American Hospital Association; CPT®=Current Procedural Terminology®; HCPCS=Healthcare Common Procedural Coding System; ICD-10-CM=International Classification of Diseases, 10th Revision, Clinical Modification; NDC=National Drug Code.
Benefit verification
Insurance verification is completed as part of the MARGENZA Copay Assistance Program. To help patients understand their cost share/responsibility under their insurance, they need to enroll in MARGENZA Access Support by following the instructions here.
Prior authorization support
In the event that prior authorization is necessary, prior authorization support may be provided by MARGENZA Access Support. Make sure that patients have a benefit verification completed as part of enrolling in MARGENZA Access Support via the Copay Assistance Enrollment Form.
Appeals support
If a claim is denied, MARGENZA Access Support can help by providing customized support for each case. Because each claim is different, we can help you create an appeal letter based on the reason for denial. Please contact MARGENZA Access Support for assistance at 1-844-MED-MGNX, Monday-Friday 9AM to 7PM ET. Use of the letter is not intended to substitute for the medical judgment of the healthcare provider; nor does it guarantee insurance company will approve coverage of MARGENZA.
References:
1. Centers for Medicare and Medicare Services. ICD-10 Code Lookup. Accessed May 20, 2021. https://www.cms.gov/
2. Centers for Medicare & Medicaid Services. Healthcare Common Procedure Coding System (HCPCS) Application Summaries and Coding Decisions First Quarter 2021 Coding Cycle for Drug and Biological Products. Accessed May 21, 2021. https://www.cms.gov/
3. MARGENZA Prescribing Information. MacroGenics, Inc; 2020.
4. Federal Register. Future Format of the National Drug Code; Public Hearing; Request for Comments. Vol 83, No. 152. Published August 7, 2018. Accessed May 20, 2021. https://
5. Synovec MS, Brin KP, Jagmin CL, et al, eds. CPT 2020 Professional Edition. Chicago, IL: American Medical Association; 2019.
6. Centers for Medicare & Medicaid Services. Medicare Intermediary Manual. Transmittal 1875. Published February 7, 2003. Accessed May 20, 2021. https://
Questions?
1-844-MED-MGNX
(1-844-633-6469)
MARGENZA Access Support is available
Monday-Friday 9AM to 7PM ET
IMPORTANT SAFETY INFORMATION
WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY
- Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function.
- Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception.
WARNINGS & PRECAUTIONS:
Left Ventricular Dysfunction
- Left ventricular cardiac dysfunction can occur with MARGENZA.
- In SOPHIA, left ventricular dysfunction occurred in 1.9% of patients treated with MARGENZA.
- MARGENZA has not been studied in patients with a pretreatment LVEF value of <50%, a prior history of myocardial infarction or unstable angina within 6 months, or congestive heart failure NYHA class II-IV.
- Withhold MARGENZA for ≥16% absolute decrease in LVEF from pretreatment values or LVEF below institutional limits of normal (or 50% if no limits available) and ≥10% absolute decrease in LVEF from pretreatment values.
- Permanently discontinue MARGENZA if LVEF decline persists greater than 8 weeks, or dosing is interrupted more than 3 times due to LVEF decline.
- Evaluate cardiac function within 4 weeks prior to and every 3 months during and upon completion of treatment. Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan.
- Monitor cardiac function every 4 weeks if MARGENZA is withheld for significant left ventricular cardiac dysfunction.
Embryo-Fetal Toxicity
- Based on findings in animals and mechanism of action, MARGENZA can cause fetal harm when administered to a pregnant woman. Post-marketing studies of other HER2 directed antibodies during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
- Verify pregnancy status of women of reproductive potential prior to initiation of MARGENZA.
- Advise pregnant women and women of reproductive potential that exposure to MARGENZA during pregnancy or within 4 months prior to conception can result in fetal harm.
- Advise women of reproductive potential to use effective contraception during treatment and for 4 months following the last dose of MARGENZA.
Infusion-Related Reactions (IRRs)
- MARGENZA can cause IRRs. Symptoms may include fever, chills, arthralgia, cough, dizziness, fatigue, nausea, vomiting, headache, diaphoresis, tachycardia, hypotension, pruritus, rash, urticaria, and dyspnea.
- In SOPHIA, IRRs were reported by 13% of patients on MARGENZA plus chemotherapy. Most of the IRRs occur during Cycle 1. Grade 3 IRRs were reported in 1.5% of MARGENZA-treated patients.
- Monitor patients during and after MARGENZA infusion. Have medications and emergency equipment to treat IRRs available for immediate use.
- In patients experiencing mild or moderate IRRs, decrease rate of infusion and consider premedications, including antihistamines, corticosteroids, and antipyretics. Monitor patients until symptoms completely resolve.
- Interrupt MARGENZA infusion in patients experiencing dyspnea or clinically significant hypotension and intervene with supportive medical therapy as needed. Permanently discontinue MARGENZA in all patients with severe or life-threatening IRRs.
MOST COMMON ADVERSE REACTIONS:
The most common adverse drug reactions (>10%) with MARGENZA in combination with chemotherapy are fatigue/asthenia (57%), nausea (33%), diarrhea (25%), vomiting (21%), constipation (19%), headache (19%), pyrexia (19%), alopecia (18%), abdominal pain (17%), peripheral neuropathy (16%), arthralgia/myalgia (14%), cough (14%), decreased appetite (14%), dyspnea (13%), infusion-related reactions (13%), palmar-plantar erythrodysesthesia (13%), and extremity pain (11%).
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to MacroGenics at (844)-MED-MGNX (844-633-6469).
INDICATION
MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.
Please see full Prescribing Information, including Boxed Warning.
IMPORTANT SAFETY INFORMATION
WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY
- Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function.
- Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception.
WARNINGS & PRECAUTIONS:
Left Ventricular Dysfunction
- Left ventricular cardiac dysfunction can occur with MARGENZA.
- In SOPHIA, left ventricular dysfunction occurred in 1.9% of patients treated with MARGENZA.
- MARGENZA has not been studied in patients with a pretreatment LVEF value of <50%, a prior history of myocardial infarction or unstable angina within 6 months, or congestive heart failure NYHA class II-IV.
- Withhold MARGENZA for ≥16% absolute decrease in LVEF from pretreatment values or LVEF below institutional limits of normal (or 50% if no limits available) and ≥10% absolute decrease in LVEF from pretreatment values.
- Permanently discontinue MARGENZA if LVEF decline persists greater than 8 weeks, or dosing is interrupted more than 3 times due to LVEF decline.
- Evaluate cardiac function within 4 weeks prior to and every 3 months during and upon completion of treatment. Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan.
- Monitor cardiac function every 4 weeks if MARGENZA is withheld for significant left ventricular cardiac dysfunction.
Embryo-Fetal Toxicity
- Based on findings in animals and mechanism of action, MARGENZA can cause fetal harm when administered to a pregnant woman. Post-marketing studies of other HER2 directed antibodies during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
- Verify pregnancy status of women of reproductive potential prior to initiation of MARGENZA.
- Advise pregnant women and women of reproductive potential that exposure to MARGENZA during pregnancy or within 4 months prior to conception can result in fetal harm.
- Advise women of reproductive potential to use effective contraception during treatment and for 4 months following the last dose of MARGENZA.
Infusion-Related Reactions (IRRs)
- MARGENZA can cause IRRs. Symptoms may include fever, chills, arthralgia, cough, dizziness, fatigue, nausea, vomiting, headache, diaphoresis, tachycardia, hypotension, pruritus, rash, urticaria, and dyspnea.
- In SOPHIA, IRRs were reported by 13% of patients on MARGENZA plus chemotherapy. Most of the IRRs occur during Cycle 1. Grade 3 IRRs were reported in 1.5% of MARGENZA-treated patients.
- Monitor patients during and after MARGENZA infusion. Have medications and emergency equipment to treat IRRs available for immediate use.
- In patients experiencing mild or moderate IRRs, decrease rate of infusion and consider premedications, including antihistamines, corticosteroids, and antipyretics. Monitor patients until symptoms completely resolve.
- Interrupt MARGENZA infusion in patients experiencing dyspnea or clinically significant hypotension and intervene with supportive medical therapy as needed. Permanently discontinue MARGENZA in all patients with severe or life-threatening IRRs.
MOST COMMON ADVERSE REACTIONS:
The most common adverse drug reactions (>10%) with MARGENZA in combination with chemotherapy are fatigue/asthenia (57%), nausea (33%), diarrhea (25%), vomiting (21%), constipation (19%), headache (19%), pyrexia (19%), alopecia (18%), abdominal pain (17%), peripheral neuropathy (16%), arthralgia/myalgia (14%), cough (14%), decreased appetite (14%), dyspnea (13%), infusion-related reactions (13%), palmar-plantar erythrodysesthesia (13%), and extremity pain (11%).
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to MacroGenics at (844)-MED-MGNX (844-633-6469).
INDICATION
MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.
Please see full Prescribing Information, including Boxed Warning.