Coverage
Medicare is likely to cover Venofer® (iron sucrose injection, USP) and its administration when used for its approved indications. In the physician office, Venofer® is approved for adult (>18 yrs) non-dialysis dependent CKD patients receiving or not receiving an erythropoietin, but only when administered incident to a provider's service (under his or her direct supervision). Please refer to the Important Safety Information below and Venofer® Full Prescribing Information.
As of January 1, 2010, Average Sales Price (ASP) plus 6 percent ramains the payment methodology for all separately payable drugs administered in physician offices under Medicare.
Insurers of adult CKD patients not on dialysis including Medicaid and leading private insurers, may also cover Venofer®. Medicaid coverage policies vary from state to state. Private payer coverage policies can vary considerably from one insurer to another and from patient to patient based on specific policy benefits. Some insurers may not have a formal coverage policy for Venofer®.
Coding
Proper coding of services provided is critical to ensuring appropriate reimbursement. The National Healthcare Common Procedure Coding System (HCPCS) Panel has granted a specific HCPCS code (also known as J code) for Venofer®.
J1756 Injection, Iron Sucrose, 1 mg
Each 1 mg of Venofer® equals one (1) service unit. When billing for quantities greater than 1 mg, indicate the total amount used as a multiple of service units on the claim form.
For example:
Since Venofer® is a single-dose vial containing either 100 mg or 200 mg, if less than the entire vial is administered, the remainder must be discarded. Current CMS policy permits billing for the entire vial even if the entire vial is not used, but only if the remainder is discarded and there is documentation that the remainder was discarded. The discarded amount is billed as a second line with the JW modifier. It is not permissible to bill Medicare twice for the same vial.
- Billing for drug administration
- Outpatient Departments
- Physician's Offices
- Dialysis Centers
- National Drug Code (NDC)
Hypotension has been reported frequently in non-dialysis dependent-CKD patients receiving IV iron. Hypotension following administration of Venofer® may be related to rate of administration and total dose delivered.
In a multi-dose efficacy study in non-dialysis dependent-CKD patients (N=91), the most frequent adverse events (≥5%) whether or not related to Venofer® administration, were taste disturbance (7.7%), peripheral edema (7.7%), diarrhea (5.5%), constipation (5.5%), nausea (5.5%), dizziness (5.5%), and hypertension (5.5%). In an additional study of Venofer® with varying erythropoietin doses in 96 treated NDD-CKD patients, adverse events, whether or not related to Venofer® reported by ≥5% of Venofer® exposed patients are as follows: diarrhea (16.5%), edema (16.5%), nausea (13.2%), vomiting (12.1%), arthralgia (7.7%), back pain (7.7%), headache (7.7%), hypertension (7.7%), taste disturbance (7.7%), dizziness (6.6%), extremity pain (5.5%), and injection site burning (5.5%).
In multi-dose efficacy studies in HDD-CKD patients (N=231), the most frequent adverse events (> 5%) whether or not related to Venofer® administration, were hypotension (39.4%), muscle cramps (29.4%), nausea (14.7%), headache (12.6%), graft complications (9.5%), vomiting (9.1%), dizziness (6.5%) hypertension (6.5%), chest pain (6.1%), and diarrhea (5.2%). In post-marketing safety studies in HDD-CKD patients (N=1051), the most frequent adverse events reported (>1%), whether or not related to Venofer® administration, were congestive heart failure, sepsis, and taste disturbance. In the study of PDD-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer®, reported by ≥5% of these patients were diarrhea (8.0%), peritoneal infection (8.0%) vomiting (8.0%), hypertension (8.0%), pharyngitis (6.7%), peripheral edema (5.3%), and nausea (5.3%).
Medicare is likely to cover Venofer® (iron sucrose injection, USP) and its administration when used for its approved indications. In the physician office, Venofer® is approved for adult (>18 yrs) non-dialysis dependent CKD patients receiving or not receiving an erythropoietin, but only when administered incident to a provider's service (under his or her direct supervision). Please refer to the Important Safety Information below and Venofer® Full Prescribing Information.
As of January 1, 2010, Average Sales Price (ASP) plus 6 percent ramains the payment methodology for all separately payable drugs administered in physician offices under Medicare.
Insurers of adult CKD patients not on dialysis including Medicaid and leading private insurers, may also cover Venofer®. Medicaid coverage policies vary from state to state. Private payer coverage policies can vary considerably from one insurer to another and from patient to patient based on specific policy benefits. Some insurers may not have a formal coverage policy for Venofer®.
Coding
Proper coding of services provided is critical to ensuring appropriate reimbursement. The National Healthcare Common Procedure Coding System (HCPCS) Panel has granted a specific HCPCS code (also known as J code) for Venofer®.
J1756 Injection, Iron Sucrose, 1 mg
Each 1 mg of Venofer® equals one (1) service unit. When billing for quantities greater than 1 mg, indicate the total amount used as a multiple of service units on the claim form.
For example:
- One (1) vial (5 mL) or 100 mg equals 100 service units
- Two (2) vials (10 mL) or 200 mg equals 200 service units
Since Venofer® is a single-dose vial containing either 100 mg or 200 mg, if less than the entire vial is administered, the remainder must be discarded. Current CMS policy permits billing for the entire vial even if the entire vial is not used, but only if the remainder is discarded and there is documentation that the remainder was discarded. The discarded amount is billed as a second line with the JW modifier. It is not permissible to bill Medicare twice for the same vial.
- Billing for drug administration
- Outpatient Departments
- Physician's Offices
- Dialysis Centers
- National Drug Code (NDC)
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Venofer iron sucrose injection, USP. Reinvigorating anemia management
American Regent. Enriching the lives of anemia patients. ™
IMPORTANT SAFETY INFORMATION: Venofer® (iron sucrose injection, USP) is contraindicated in patients with evidence of iron overload, in patients with known hypersensitivity to Venofer® or any of its inactive components, and in patients with anemia not caused by iron deficiency. Serious hypersensitivity reactions have been reported in patients receiving Venofer®. In clinical studies, several patients experienced hypersensitivity reactions presenting with wheezing, dyspnea, hypotension, rashes, or pruritus. The post-marketing spontaneous reporting system includes reports of patients who experienced serious or life-threatening reactions (anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea, or convulsion) associated with Venofer® administration.Hypotension has been reported frequently in non-dialysis dependent-CKD patients receiving IV iron. Hypotension following administration of Venofer® may be related to rate of administration and total dose delivered.
In a multi-dose efficacy study in non-dialysis dependent-CKD patients (N=91), the most frequent adverse events (≥5%) whether or not related to Venofer® administration, were taste disturbance (7.7%), peripheral edema (7.7%), diarrhea (5.5%), constipation (5.5%), nausea (5.5%), dizziness (5.5%), and hypertension (5.5%). In an additional study of Venofer® with varying erythropoietin doses in 96 treated NDD-CKD patients, adverse events, whether or not related to Venofer® reported by ≥5% of Venofer® exposed patients are as follows: diarrhea (16.5%), edema (16.5%), nausea (13.2%), vomiting (12.1%), arthralgia (7.7%), back pain (7.7%), headache (7.7%), hypertension (7.7%), taste disturbance (7.7%), dizziness (6.6%), extremity pain (5.5%), and injection site burning (5.5%).
In multi-dose efficacy studies in HDD-CKD patients (N=231), the most frequent adverse events (> 5%) whether or not related to Venofer® administration, were hypotension (39.4%), muscle cramps (29.4%), nausea (14.7%), headache (12.6%), graft complications (9.5%), vomiting (9.1%), dizziness (6.5%) hypertension (6.5%), chest pain (6.1%), and diarrhea (5.2%). In post-marketing safety studies in HDD-CKD patients (N=1051), the most frequent adverse events reported (>1%), whether or not related to Venofer® administration, were congestive heart failure, sepsis, and taste disturbance. In the study of PDD-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer®, reported by ≥5% of these patients were diarrhea (8.0%), peritoneal infection (8.0%) vomiting (8.0%), hypertension (8.0%), pharyngitis (6.7%), peripheral edema (5.3%), and nausea (5.3%).
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