Medicare Advantage Medical Policy Bulletin
Section: CMS National Guidelines
Number: N-106
Topic: Intravenous Iron Therapy - NCD 110.10
Effective Date: June 29, 2009
Issued Date: June 29, 2009

General Policy

Iron deficiency is a common condition in end stage renal disease (ESRD) patients undergoing hemodialysis. Iron is a critical structural component of hemoglobin, a key protein found in normal red blood cells (RBCs) which transports oxygen. Without this important building block, anemic patients experience difficulty in restoring adequate, healthy RBCs that improve hematocrit levels. Clinical management of iron deficiency involves treating patients with iron replacement products while they undergo hemodialysis. Body iron stores can be supplemented with either oral or intravenous (IV) iron products. 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.

Indications and Limitations of Coverage

Sodium ferric gluconate complex in sucrose injection is covered as a first line treatment of iron deficiency anemia when furnished intravenously to patients undergoing chronic hemodialysis who are receiving supplemental erythropoeitin therapy.

Iron sucrose injection is covered as a first line treatment of iron deficiency anemia when furnished intravenously to patients undergoing chronic hemodialysis who are receiving supplemental erythropoeitin therapy.

Claims for members who do not meet all of the indications listed in the "Indications and Limitations of Coverage" section of this policy will be denied as not medically necessary. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Documentation Requirements

The medical record must reflect that the patient meets all the criteria outlined in the "Indications and Limitations of Coverage" section of this policy.

NOTE:
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Procedure Codes

J1750J1756J2916   

Coding Guidelines

Publications

References

CMS Pub. 100-3, Medicare National Coverage Determinations Manual, Chapter 1, Section 110.10

Medicare Coverage Issues Manual, Transmittal 139, CR 1682

Medicare Coverage Database, Decision Memo for Venofer: Intravenous Iron Therapy (CAG-00080N).

Medicare Coverage Database, Decision Memo for Ferrlecit: Intravenous Iron Therapy (CAG-00046N).

www.cms.gov
www.medicare.gov

Attachments

Procedure Code Attachments

Diagnosis Codes

Glossary




This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Medical policies are designed to supplement the terms of a member's contract. The member's contract defines the benefits available; therefore, medical policies should not be construed as overriding specific contract language. In the event of conflict, the contract shall govern.

Medical policies do not constitute medical advice, nor the practice of medicine. Rather, such policies are intended only to establish general guidelines for coverage and reimbursement under Medicare Advantage plans. Application of a medical policy to determine coverage in an individual instance is not intended and shall not be construed to supercede the professional judgment of a treating provider. In all situations, the treating provider must use his/her professional judgment to provide care he/she believes to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions.

Medicare Advantage retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Medicare Advantage. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.