Venofer J Code Procedure Description

Ferrlecit® and Venofer CPT CODE – J2916

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

The use of Ferrlecit® is covered as a first line treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.

The use of Venofer® is covered as a first line treatment of iron deficiency anemia in patients undergoing chronic hemodialysis. The use of Venofer® for iron deficiency anemia will be covered in non-dialysis dependent chronic kidney disease patients.

The primary cause of anemia in patients with chronic renal failure is insufficient production of erythropoietin (EPO) by the diseased kidney. Iron deficiency is also a contributing factor or cause of anemia. 

In hemodialysis patients, anemia can be attributed to several factors including substantial loss of blood from frequent blood tests, blood remaining in the dialysis tubing and dialyzer, gastrointestinal blood losses and an increase in the rate of erythropoiesis on epotein therapy.

Ferrlecit (sodium ferric gluconate complex in sucrose) is a stable macromolecular complex consisting of mono and di-nuclear iron (III) oxide hydrates which are directly and covalently bonded to saccharates. Venofer (iron sucrose) is a complex of polynuclear iron (III)-hydroxide cores surrounded by non-covalently-bound sucrose molecules.

According to Drug Facts and Comparisons® 2005 e-facts, Ferrlecit, most patients will require a minimum cumulative dose of 1.0 gram of elemental iron, administered over eight sessions at sequential dialysis treatments, to achieve a favorable hemoglobin or hematocrit response. The recommended dose for repletion therapy is 10 mL (125mg of elemental iron). 

Ferrlecit can be administered by slow IV injection undiluted solution at a rate of no greater than 1mL/min (12.5 mg elemental iron/min) max dose should not exceed 10mL (2 vials) or by IV infusion, dilute contents of 2 vial in 100mL 0.9% sodium chloride injection immediately prior to infusion and infuse over 1 hour. 

Patients may continue to require therapy with Ferrlecit or other iron preparations at the lowest dose necessary to maintain target levels of hemoglobin, hematocrit and laboratory parameters of iron storage within acceptable limits.

According to Drug Facts and Comparisons® 2005 e-facts, Venofer, most CKD patients will require a minimum cumulative dose of 1,000 mg of elemental iron, administered over 10 sequential sessions to achieve a favorable hemoglobin or hematocrit response. 

Iron Sucrose may be administered either by slow IV injection or by IV infusion directly into the dialysis line. If by slow IV injection, Venofer must be given at a rate of 1mL (iron 20mg) undiluted solution per minute (ie, 5minutes/vial) not exceeding 1 vial of iron sucrose (elemental iron 100mg) per injection. 

If giving Venofer by infusion, the content of each vial should be diluted exclusively in a maximum of 100mL if 0.9% sodium chloride, immediately prior to infusion. Infuse the solution at a rate of 100mg of iron over 15 minutes.

For non-dialysis dependent chronic kidney disease patients, Venofer® is administered as a slow IV injection over 2-5 minutes on five (5) different occasions within a fourteen (14) day period. The total cumulative dose should be 1000 mg of Venofer®.

Patients may continue to require therapy with Venofer® or other intravenous iron preparations at the lowest dose necessary to maintain target levels of hemoglobin and laboratory parameters of iron storage within acceptable limits.

Dosages in excess of iron needs may lead to accumulation of iron storage sites and hemosidrosis. Periodic monitoring of laboratory parameters of iron storage levels may assist in recognition of iron accumulation. Ferrlecit and Venofer should not be administered to patients with iron overload.

ICD-10 Codes that DO NOT Support Medical Necessity

Documentation Requirements

Medical record documentation maintained by the performing provider must substantiate the medical necessity for the use of Ferrlecit® and Venofer® by clearly indicating the condition for which this drug is being used. 

The documentation must support the criteria as set forth in the "Indications and Limitation of Coverage and/or Medical Necessity" section of this Local Coverage Determination (LCD). The managing physician’s target values for hemoglobin, hematocrit, transferrin saturation and/or serum ferritin levels must be recorded. 

Laboratory results must be maintained. In addition, documentation that the service was performed must be included in the patient’s medical record. 

This documentation is normally found in the history and physical or in the office/facility progress notes. 

The medical record documentation should support that dialysis dependent chronic kidney disease patients receiving Ferrlecit® are also receiving supplemental Epo therapy.

Ferrlecit® and Venofer – J2916 Coding Information and covered DX

Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

13 Hospital Outpatient

72 Clinic - Hospital Based or Independent Renal Dialysis Center

85 Critical Access Hospital

Revenue Codes Code Description

0636 Pharmacy - Drugs Requiring Detailed Coding

CPT/HCPCS Codes

Group 1 Paragraph

Group 1 Codes

J1756 Iron sucrose injection

J2916 Na ferric gluconate complex

ICD-9 Codes that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity

ICD-10 Codes that Support Medical Necessity

Group 1 Paragraph

Part A: For procedure code J2916 (Injection, sodium ferric gluconate complex in sucrose injection, 12.5 mg)

Group 1 Codes

D50.0 Iron deficiency anemia secondary to blood loss (chronic)

D50.1 Sideropenic dysphagia

D50.8 Other iron deficiency anemias

D50.9 Iron deficiency anemia, unspecified

N18.4* Chronic kidney disease, stage 4 (severe)

N18.5* Chronic kidney disease, stage 5

N18.6* End stage renal disease

Group 2 Paragraph

For procedure code J1756 (Injection, iron sucrose, 1mg)

Group 2 Codes

D50.0 Iron deficiency anemia secondary to blood loss (chronic)

D50.1 Sideropenic dysphagia

D50.8 Other iron deficiency anemias

D50.9 Iron deficiency anemia, unspecified

N18.3 Chronic kidney disease, stage 3 (moderate)

N18.4 Chronic kidney disease, stage 4 (severe)

N18.5 Chronic kidney disease, stage 5

N18.6 End stage renal disease

N18.9* Chronic kidney disease, unspecified

Group 3 Paragraph

Part B: For procedure code J2916 (Injection, sodium ferric gluconate complex in sucrose injection, 12.5 mg) and J1756 (Injection, iron sucrose, 1 mg)

Group 3 Codes

D50.0* Iron deficiency anemia secondary to blood loss (chronic)

D50.1* Sideropenic dysphagia

D50.8* Other iron deficiency anemias

D50.9* Iron deficiency anemia, unspecified

N18.1* Chronic kidney disease, stage 1

N18.2 Chronic kidney disease, stage 2 (mild)

N18.3 Chronic kidney disease, stage 3 (moderate)

N18.4 Chronic kidney disease, stage 4 (severe)

N18.5 Chronic kidney disease, stage 5

N18.6 End stage renal disease

N18.9* Chronic kidney disease, unspecified

*The billing of Ferrlecit® and Venofer® requires a dual diagnosis. ICD-10-CM codes N18.1-N18.9 and one of the secondary codes for iron deficiency anemia (ICD-10 codes D50.0, D50.1, D50.8, or D50.9) must be billed on the claim.