Coding Analysis for Labs (CAL) Tracking Sheet

Serum Iron Studies NCD 190.18 (Addition of ICD-9-CM diagnosis code 285.22 Anemia of Malignancy and 285.29 Anemia of Other Chronic Condition)

CAG-00406N

Issue

CMS received an external request to add ICD-9-CM diagnosis codes 285.22—Anemia of Malignancy and 285.29—Anemia of Other Chronic Condition as ICD-9-CM diagnosis codes covered under the National Coverage Determination (NCD) on Serum Iron Studies at section 190.18 of the Medicare National Coverage Determination Manual (NCDM).

Section 190.18 of the NCD Manual states that serum iron studies are useful in the evaluation of disorders of iron metabolism, particularly iron deficiency and iron excess. Iron studies are best performed when the patient is fasting in the morning and has abstained from medications that may influence iron balance.

Iron deficiency is the most common cause of anemia. In young children on a milk diet, iron deficiency is often secondary to dietary deficiency. In adults, iron deficiency is usually the result of blood loss and is only occasionally secondary to dietary deficiency or malabsorption.

Following major surgery the patient may have iron deficient erythropoiesis for months or years if adequate iron replacement has not been given. High doses of supplemental iron may cause the serum iron to be elevated. Serum iron may also be altered in acute and chronic inflammatory and neoplastic conditions.

Total iron binding capacity (TIBC) is an indirect measure of transferrin, a protein that binds and transports iron. TIBC quantifies transferrin by the amount of iron that it can bind. TIBC and transferrin are elevated in iron deficiency, and with oral contraceptive use, and during pregnancy. TIBC and transferrin may be decreased in malabsorption syndromes or in those affected with chronic diseases. The percent saturation represents the ratio of iron to the TIBC.

Assays for ferritin are also useful in assessing iron balance. Low concentrations are associated with iron deficiency and are highly specific. High concentrations are found in hemosiderosis (iron overload without associated tissue injury) and hemochromatosis (iron overload with associated tissue injury). In these conditions the iron is elevated, the TIBC and transferrin are within the reference range or low, and the percent saturation is elevated. Serum ferritin can be useful for both initiating and monitoring treatment for iron overload.

Transferrin and ferritin belong to a group of serum proteins known as acute phase reactants, and are increased in response to stressful or inflammatory conditions and also can occur with infection and tissue injury due to surgery, trauma or necrosis. Ferritin and iron/TIBC (or transferrin) are affected by acute and chronic inflammatory conditions, and in patients with these disorders, tests of iron status may be difficult to interpret.

We believe that the ICD-9-CM diagnosis codes 285.22—Anemia of Malignancy and 285.29—Anemia of Other Chronic Condition may flow from this narrative description of the tests for which the policy contained in section 190.18 of the NCDM applies.

National Coverage Determinations

Benefit Category

Diagnostic Laboratory Tests

Requestor Information

Requestor Name Requestor Letter
John D. Settlemyer, MBA/MHA N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
11/05/2008

Public Comment Period
11/05/2008 - 12/06/2008
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
12/18/2008
Comments for this CAL
View Public Comments

Contacts

Lead Analysts
Lisa Eggleston
Kimberly Long
kimberly.long@cms.hhs.gov
410-786-5702
Lead Medical Officers
Jeffrey Roche, MD

Medicare Benefit Category Determination Date

Actions Taken

November 5, 2008

CMS accepts a request to add ICD-9-CM diagnosis codes 285.22 -Anemia of Malignancy and 285.29-Anemia of Other Chronic Condition as ICD-9-CM diagnosis codes covered under the National Coverage Determination (NCD) on Serum Iron Studies at section 190.18 of the Medicare National Coverage Determination Manual (NCDM).

The 30-day public comment period begins with this date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the test under consideration.

December 18, 2008