LCD/NCD MedicationsL29174-LCD

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Local Coverage Determination (LCD) for Ferrlecit® and Venofer® (L29174)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29174

LCD Title Ferrlecit® and Venofer®

Contractor's Determination Number J2916

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/02/2009

Original Determination Ending Date

Revision Effective Date

Revision Ending Date

CMS National Coverage Policy

CMS Manual System, Pub 100-03, Medicare National Coverage, Chapter 1, Section 110.10 CMS Manual System, Pub 100-04, Medicare Claims Processing, Chapter 8, Section 60.2.4.2

Indications and Limitations of Coverage and/or Medical Necessity

Medicare covers the use of Ferrlecit® its FDA approved indication as a first line treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.

Medicare covers the use of Venofer® for its FDA approved indication as a first line treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy. For dates of service on or after June 17, 2005, Medicare will cover the use of Venofer® for its additional FDA approved indication for iron deficiency anemia in non-dialysis dependent chronic kidney disease patients receiving a supplemental erythropoietin and for iron deficiency anemia in non-dialysis dependent chronic kidney disease patients not receiving a supplemental erythropoietin.

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® for 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® for Venofer®, most chronic kidney disease (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 CKD 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.

Coding Information

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.

999x Not Applicable

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

99999 Not Applicable

CPT/HCPCS Codes

J1756 INJECTION, IRON SUCROSE, 1 MG

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

ICD-9 Codes that Support Medical Necessity

For procedure code J2916 (Injection, sodium ferric gluconate complex in sucrose injection, 12.5 mg) and J1756

(Injection, iron sucrose, 1 mg)

280.1 IRON DEFICIENCY ANEMIA SECONDARY TO BLOOD LOSS (CHRONIC)

280.2 IRON DEFICIENCY ANEMIA SECONDARY TO INADEQUATE DIETARY IRON INTAKE

280.8 OTHER SPECIFIED IRON DEFICIENCY ANEMIAS

280.9 IRON DEFICIENCY ANEMIA UNSPECIFIED

585.1 * CHRONIC KIDNEY DISEASE, STAGE I

585.2 * CHRONIC KIDNEY DISEASE, STAGE II (MILD)

585.3 * CHRONIC KIDNEY DISEASE, STAGE III (MODERATE)

585.4 * CHRONIC KIDNEY DISEASE, STAGE IV (SEVERE)

585.5 * CHRONIC KIDNEY DISEASE, STAGE V

585.6 * END STAGE RENAL DISEASE

585.9* CHRONIC KIDNEY DISEASE, UNSPECIFIED

*The billing of Ferrlecit® and Venofer® requires a dual diagnosis. ICD-9-CM codes 585.1-585.9 and one of the secondary codes for iron deficiency anemia (ICD-9 codes 280.0, 280.1, 280.8 or 280.9 must be billed on the claim).

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations 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 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 either

Ferrlicet® or Venofer® are also receiving supplemental Epo therapy.

Appendices

Utilization Guidelines N/A

Sources of Information and Basis for Decision

Facts and Comparisons (2008). Sodium ferric gluconate complex. Available at www.factsandcomparisons.com

Facts and Comparisons (2008)). Iron sucrose. www.factsandcomparisons.com

Ferrlecit prescribing information, Watson Pharmaceuticals, 2007 available at www.ferrlecit.com

Food and Drug Administration (1999). New drug application (NDA) 20-955 Ferrlecit. [On-line]. Available: http://www.fda.gov/cder/approval/main2.htm

Health Care Financing Administration (2000, December). Sodium ferric gluconate complex in sucrose injection (CAG-00046). [On-line]. Available: http://www.hcfa.gov/coverage/8b3-p2.htm

Matzke, G.R. & Nolin, T.D. (1999). Concise review: Intravenous iron in end-stage renal disease. In Harrison’s. [On-line]. Available: http://www.harrisonsonline.com/server-java/Arknoid/harrisons/1096- 7133/U…/ed12265.htm

National Kidney Foundation Disease Outcome Quality Initiative Guidelines for Anemia of Chronic Kidney Disease, Guidelines 2000 and 2007 updates of hemoglobin targets available at www.kidney.org/professionals/kdoqi/guidelines_updates/

Venofer product information, American Regent, Inc. Shirley, NY

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 12/04/2008

Revision History Number Original

Revision History Explanation Revision Number:Original Start Date of Comment Period:N/A

Start Date of Notice Period:12/04/2008

Revised Effective Date:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29174) replaces LCD L28094 as the policy in notice. This document (L29174) is effective on 02/02/2009.

Reason for Change