Wednesday, November 18, 2015

CPT code J1439, J1756, J2916 Guidelines

Procedure code and description

J1439 Injection, Ferric Carboxymaltose, 1 mg

J1756 - INJECTION, IRON SUCROSE, 1 MG

J2916 - INJECTION, SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 12.5 MG

Parenteral Iron Supplementation for Patients Receiving ESA Therapy for Anemia of Chronic Kidney Disease or Iron Deficiency Anemia – J1439



Coverage Guidance

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.

Ferrlecit® is covered for the FDA approved indication as a first line treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.

Venofer® (iron sucrose) is a complex of polynuclear iron (III)-hydroxide cores surrounded by non-covalently-bound sucrose molecules.

Venofer® is covered for the FDA approved indication as a first line treatment of iron deficiency anemia in patients undergoing chronic hemodialysis as well as for the treatment of iron deficiency anemia in non-dialysis dependent chronic kidney disease patients.

INJECTAFER® (ferric carboxymaltose injection), is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron.

INJECTAFER®is indicated for the treatment of iron deficiency anemia in adult patients:

who have intolerance to oral iron or have had unsatisfactory response to oral iron; or
who have non–dialysis-dependent chronic kidney disease

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 epoetin therapy.

According to Drug Facts and Comparisons® , most patients will require a minimum cumulative dose of 1.0 gram of elemental iron with Ferrlecit®, 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) per treatment . 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. Furthermore, for Venofer® administration, most chronic kidney disease (CKD) patients will require a minimum cumulative dose of 1,000 mg of elemental iron over 10 sequential sessions to achieve a favorable hemoglobin or hematocrit response

Dosages in excess of iron needs may lead to accumulation of iron storage sites and hemosiderosis. Periodic monitoring of laboratory parameters of iron storage levels may assist in recognition of iron accumulation. Ferrlecit®, Venofer®, and INJECTAFER® should not be administered to patients with iron overload. Serum iron, total iron binding capacity, transferrin saturation, and ferritin measurements may all contribute to estimating a patient’s level of iron repletion and requirement for ongoing therapy.





General Information

Associated Information Documentation Requirements

Medical record documentation maintained by the performing provider must substantiate the medical necessity for the use of Ferrlecit®, Venofer® or INJEXTAFER® 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 policy. 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 Ferrlicet® are also receiving supplemental EPO therapy.



CPT CODE J1756

Sodium Ferric Gluconate Complex in Sucrose Injection 

Sodium Ferric Gluconate Complex in sucrose injection may be payable for claims with dates of service on or after December 1, 2000 when furnished intravenously, for first line treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoeitin therapy. Physicians bill and carriers pay for HCPCS code J1756 when submitted with a primary diagnosis for chronic renal failure and a secondary diagnosis for iron deficiency anemia


These are: Chronic Renal Failure (Primary Diagnosis)

• ICD-9-CM – 585
• ICD-10-CM –N18.3, N18.4, N18.5, N18.6

Iron Deficiency Anemia (Secondary Diagnosis)
• ICD-9-CM – 280.0, 280.1, 280.8, or 280.9
• ICD-10-CM – D50.0, D50.1, D50.8, D50.9,D63.1

This benefit is subject to the Part B deductible and coinsurance and should be paid per current Medicare drug payment reimbursement rules. Carriers may cover other uses of this drug at their discretion.


B. Iron Sucrose Injection

Iron Sucrose injections are payable for claims with dates of service on or after October 1, 2001, when furnished intravenously, for first line treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoeitin therapy. Until a specific code for iron sucrose injection is developed, providers must submit HCPCS code J1756, with the appropriate explanation of drug name and dosage entered on the claim. The primary diagnosis code for chronic renal failure and one of the following secondary diagnosis codes for iron deficiency must be entered.

These are: Chronic Renal Failure (Primary Diagnosis)
• ICD-9-CM - 585
• ICD-10-CM - N18.3, N18.4, N18.5, N18.6,

Iron Deficiency Anemia (Secondary Diagnosis)
• ICD-9-CM – 280.0, 280.1, 280.8, or 280.9
• ICD-10-CM – D50.0, D50.1, D50.8, D50.9,D63.1

Iron sucrose injection is subject to the Part B deductible and coinsurance and should be paid per current  Medicare drug payment reimbursement rules. Carriers may cover other uses of this drug at their discretion



Indications and Limitations of Coverage and/or Medical Necessity

Intravenous iron preparations are indicated in the treatment of iron deficiency anemia in patient's undergoing chronic hemodialysis, who are receiving supplemental EPO therapy.

Intravenous iron preparations are contraindicated in the patients with:

- Evidence of iron overload,
- Known hypersensitivity to the specific iron preparation being considered, and
- Anemia not caused by iron deficiency.


Three IV iron preparations currently available for iron deficiency
anemia are:

1. iron dextran,
2. sodium ferric gluconate,
3. iron sucrose.

Iron dextran is indicated for use as a second line therapy only after patients fail oral iron therapy.

Sodium ferric gluconate and iron sucrose are indicated for "the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin (EPO) therapy." No limits were placed on usage as either a first or second line therapy option. Due to the FDA indications, both of these products are considered an alternative to oral iron therapy as a first line therapy option for chronic hemodialysis patients.

Iron Dextran

Intravenous or intramuscular injections of iron dextran are indicated in the treatment of patients with documented iron deficiency in which oral administration is unsatisfactory or impossible. There are two categories of iron replacement that may be candidates for iron dextran injections:

- Iron deficiency anemia patients in whom the cause of the deficiency has been corrected, the patient is symptomatic, and a trial of oral administration has been documented as unsuccessful or impossible; or
- Patients with intermittent or repetitive blood loss requiring higher doses of iron than tolerable by oral administration. Examples of these conditions include familial telangiectasis, hemophilia, gastrointestinal bleeding or renal hemodialysis.
Iron dextran injection is a complex of ferric hydroxide and dextran for intravenous or intramuscular injection. Each milliliter contains the equivalent of 50 mg of elemental iron useful in replenishing hemoglobin and depleted iron stores.

Generally, systemic iron therapy would not be indicated unless the serum ferritin and/or serum transferrin is below normal for standard lab values.

Sodium Ferric Gluconate

Sodium ferric gluconate complex in sucrose injection is an iron product indicated for " the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental EPO therapy". No other limitations were placed on its use as either first or second line therapy option. Sodium ferric gluconate contains no dextran polysaccharides and can thus serve as an alternative to patients who exhibit dextran sensitivity. Due to its FDA indications, this product is also considered an alternative to oral iron therapy.

- Sodium ferric gluconate is also indicated as an "off label" indication for iron replacement in patients unable to tolerate oral, IM, or other IV iron therapy. Oral iron is generally used as a first line therapy in treating iron deficiency.
- Therefore, if a claim is received for indications other than hemodialysis, documentation must justify the need to receive IV sodium ferric gluconate vs oral, IM or other IV therapy.

Iron Sucrose

Tufts Health Plan does not compensate for iron sucrose (J1756, Venofer®) for more than 200 units unless the diagnosis on the claim is chronic kidney disease.

Tufts Health Plan does not compensate for iron sucrose (J1756) when billed with a diagnosis of encounter for antineoplastic chemotherapy and immunotherapy, or convalescence and palliative care following chemotherapy if a diagnosis of anemia of
chronic disease is not also present on the claim.

5Tufts Health Plan does not compensate for iron sucrose (J1756) when billed with a diagnosis of non-myeloid malignancy if a diagnosis of antineoplastic chemotherapy induced anemia is not also present on the claim.

Tufts Health Plan does not compensate for iron sucrose (J1756) unless billed with a diagnosis of cancer-induced anemia, chemotherapy-induced anemia, chronic kidney disease, intolerance to oral iron supplementation, iron deficiency anemia, iron deficiency anemia of pregnancy, malabsorption disorders, or preterm infant with neonatal anemia.

Tufts Health Plan does compensate for iron sucrose (J1756) when billed with a diagnosis of chronic kidney disease only if a diagnosis of iron deficiency or anemia of chronic disease is also present on the claim.

Effective for dates of service on or after January 1, 2016, Tufts Health Plan will not compensate for iron sucrose (J1756) when a diagnosis of intestinal malabsorption intolerance to oral iron supplementation, iron deficiency anemia of pregnancy or

malabsorption disorders is billed and a diagnosis of iron deficiency anemia is not also present on the claim.

Iron Sucrose injection is a complex of polynuclear iron (III)-hydroxide in sucrose. It is approved for use in replenishing iron in patients receiving erythropoietin (a hormone that stimulates red blood cell production) and undergoing chronic hemodialysis, which involves filtering the blood in order to remove waste products. In these patients, an iron deficiency is caused by blood loss during the dialysis procedure, increased erythropoiesis (red blood cell production) and insufficient absorption of iron from the gastrointestinal tract. Iron is essential for the synthesis of hemoglobin, which is responsible for the transport of oxygen throughout the body.

The evidence reviewed on iron sucrose also supports the use of this IV iron product as an alternative to IV iron dextran and oral iron therapy.

The FDA approved indication is the same as the indication for sodium ferric gluconate and the evidence that suggests that IV iron supplementation plays an prominent role in the clinical management of iron deficiency anemia in ESRD patients.

Therefore, CMS has revised its current national policy on IV iron therapy to include coverage of iron sucrose in the first line treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental EPO therapy. This revision in Medicare's national coverage policy will result in identical coverage for sodium ferric gluconate and iron sucrose.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R2905CP.pdf

A. Sodium Ferric Gluconate Complex in Sucrose Injection

Sodium Ferric Gluconate Complex in sucrose injection may be payable for claims with dates of service on or after December 1, 2000 when furnished intravenously, for first line treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoeitin therapy.

Physicians bill and carriers pay for HCPCS code J1756 when submitted with a primary diagnosis for chronic renal failure and a secondary diagnosis for iron deficiency anemia.

These are:

Chronic Renal Failure (Primary Diagnosis)

• ICD-9-CM – 585

• ICD-10-CM –N18.3, N18.4, N18.5, N18.6,


Iron Deficiency Anemia (Secondary Diagnosis)

• ICD-9-CM – 280.0, 280.1, 280.8, or 280.9

• ICD-10-CM – D50.0, D50.1, D50.8, D50.9,D63.1



B. Iron Sucrose Injection

Iron Sucrose injections are payable for claims with dates of service on or after October 1, 2001, when furnished intravenously, for first line treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoeitin therapy. Until a specific code for iron sucrose injection is developed, providers must submit HCPCS code J1756, with the appropriate explanation of drug name and dosage entered on the claim. The primary diagnosis code for chronic renal failure and one of the following secondary diagnosis codes for iron deficiency must be entered.

These are:

Chronic Renal Failure (Primary Diagnosis)

• ICD-9-CM - 585

• ICD-10-CM - N18.3, N18.4, N18.5, N18.6,

Iron Deficiency Anemia (Secondary Diagnosis)


• ICD-9-CM – 280.0, 280.1, 280.8, or 280.9

• ICD-10-CM – D50.0, D50.1, D50.8, D50.9,D63.1

Iron sucrose injection is subject to the Part B deductible and coinsurance and should be paid per current Medicare drug payment reimbursement rules. Carriers may cover other uses of this drug at their discretion.


POLICY SUMMARY
Overview

Iron is a critical structural component of hemoglobin, a key protein found in normal red blood cells (RBCs) which transport oxygen. Without this important building block, anemic patients experience difficulty in restoring adequate, healthy RBCs that improve hematocrit levels. Iron deficiency is a common condition in end stage renal disease (ESRD) patients undergoing hemodialysis. Clinical management of iron deficiency involves treating patients with iron replacement products while they undergo hemodialysis. The available evidence suggests that the mode of intravenous administration is perhaps the most effective treatment for iron deficiency in hemodialysis patients. Unlike oral iron products, which must be absorbed through the GI tract, IV iron products are infused directly into the bloodstream in a form that is readily available to the bone marrow for RBC synthesis, resulting in an earlier correction of iron deficiency and anemia.


Guidelines

Medicare covers Sodium Ferric Gluconate Complex in Sucrose Injection as a first line treatment of Iron Deficiency Anemia when furnished intravenously to patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.


Medicare also covers Iron Sucrose Injection as a first line treatment of Iron Deficiency Anemia when furnished intravenously to patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.


APPLICABLE CODES

The following list(s) of codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this guideline does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply.


HCPCS Code Description

J1439 Injection, Ferric Carboxymaltose, 1 mg (Replaces Q9970, Effective 01/01/2015)

J1750 Injection, Iron Dextran, 50 mg

J1756 Injection, Iron Sucrose, 1 mg (Venofer®)

J2916 Injection, Sodium Ferric Gluconate Complex in Sucrose Injection, 12.5 mg (Ferrlecit®)

Q0138 Injection, Ferumoxytol, for treatment of Iron Deficiency Anemia, 1 mg (Non-ESRD use)

Q0139 Injection, Ferumoxytol, for treatment of Iron Deficiency Anemia, 1 mg (For ESRD on dialysis)




Coding Clarification: For ICD-10 diagnosis codes, dual diagnosis required (one from anemia codes and one fromkidney disease codes).

ICD-10 Diagnosis Code Description

D50.0 Iron deficiency anemia secondary to blood loss (chronic)
D50.8 Other iron deficiency anemias
D50.1 Sideropenic dysphagia
D50.9 Iron deficiency anemia, unspecified
D63.1 Anemia in chronic kidney disease
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


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