Practical matters

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 the treatment of iron deficiency anemia in adult and pediatric patients 2 years and older with chronic kidney disease. Please refer to the Important Safety Information below and Venofer® Full Prescribing Information.

As of January 1, 2011, Average Sales Price (ASP) plus 6 percent remains the payment methodology for all separately payable drugs administered in physician offices under Medicare.

Insurers of 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 (2.5 mL) or 50 mg equals 50 service units
  • 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-use vial containing either 50 mg, 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)



 






IMPORTANT SAFETY INFORMATION

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Venofer® (iron sucrose injection, USP).  Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse.  If hypersensitivity reactions or signs of intolerance occur during administration, stop Venofer® immediately.  Monitor patients for signs and symptoms of hypersensitivity during and after Venofer® administration for at least 30 minutes and until clinically stable following completion of the infusion.  Only administer Venofer® when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.

Venofer® may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Venofer®. Hypotension following administration of Venofer® may be related to rate of administration and total dose delivered.

Venofer® is contraindicated in patients with known hypersensitivity to Venofer®. Do not administer to patients with evidence of iron overload.

In efficacy studies in non-dialysis dependent-CKD patients (N=139), the most frequent adverse events (≥5%) whether or not related to Venofer® administration, were nausea (8.6%), taste disturbance (7.9%), peripheral edema (7.2%), diarrhea (7.2%), dizziness (6.5%), hypertension (6.5%), infusion site pain or burning (5.8%), dyspnea (5.8%), and vomiting (5.0%).

In multi-dose efficacy studies in hemodialysis dependent-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%), pain in extremity (5.6%) and diarrhea (5.2%). In the study of peritoneal dialysis dependent-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer® administration, reported by ≥5% of these patients were infections and infestations (nasopharyngitis, sinusitis, upper respiratory tract, pharyngitis) (16.0%), diarrhea (8.0%), vomiting (8.0%), hypertension (8.0%), peripheral edema (5.3%), and nausea (5.3%).

In a randomized open-label dose ranging trial of iron maintenance treatment in pediatric patients with CKD on stable erythropoietin therapy, 57% of the Venofer® treated patients (27/47) receiving 0.5 mg/kg Venofer® experienced a treatment-emergent adverse reaction, 11% of which were serious. The most common treatment-emergent adverse reactions (> 2% of patients) in all patients were headache (6%), respiratory tract viral infection (4%), peritonitis (4%), vomiting (4%), pyrexia (4%), dizziness (4%), cough (4%), renal transplant (4%), nausea (3%), arteriovenous fistula thrombosis (2%), hypotension (2%), and hypertension (2.1%).



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