Serum Iron Studies (Addition of Restless Leg Syndrome as a Covered Indication)

Restless Leg Syndrome (RLS) is a sensation related disorder characterized by an urge to move a limb, frequently the legs. Usually, there is discomfort in the affected limb.  Some literature suggests a relationship between iron status and RLS.

CMS has a National Coverage Determination (NCD) on Serum Iron Studies at Section 190.18 of the NCD Manual.  The listed indications are summarized below:

• Differential diagnosis of iron deficiency, anemia, and for iron overload conditions.
• Monitoring response to therapy, e.g., oral or parenteral iron, ascorbic acid, and erythropoietin.
• After treatment for other nutritional deficiency anemias, such as folate and vitamin B12, because iron deficiency may not be revealed until such a nutritional deficiency is treated.
• Monitoring iron status in patients with chronic renal disease with or without dialysis.
• Evaluation of toxic effects of iron and other metals (e.g., nickel, cadmium, aluminum, lead) whether due to accidental, intentional exposure or metabolic causes.

In our initial review of the literature when this NCD was developed, we found no compelling scientific evidence to support the inclusion of RLS as a covered indication for the "ICD-9-CM Codes Covered by Medicare" list for this NCD. Consequently, RLS is currently included on the list "ICD-9-CM Codes That Do Not Support Medical Necessity" for this NCD.  Codes on this list do not have a presumption of medical necessity and therefore, are not automatically paid. However, Medicare contractors have discretion to support a determination of medical necessity in certain circumstances for codes on the list of "ICD-9-CM Codes That Do Not Support Medical Necessity."  This entails submission of additional documentation by the provider.

The requestor submitted a formal written request to CMS to reconsider the NCD and add RLS to the "ICD-9-CM Codes Covered by Medicare" list for Serum Iron Studies. The requestor included scientific literature that was not considered in the original determination.

We are seeking public comment on this reconsideration.

February 28, 2006

August 9, 2006

November 6, 2006