National Coverage Analysis (NCA) Tracking Sheet

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

CAG-00263R

Issue

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.

National Coverage Determinations

Benefit Category

Diagnostic Laboratory Tests

Requestor Information

Requestor Name Requestor Letter
Karen H. Rice, M.D., Capital City Medical Associates, Jefferson City, Missouri View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
02/28/2006
Expected NCA Completion Date
11/07/2006
Public Comment Period
02/28/2006 - 03/30/2006
Proposed Decision Memo Due Date
Proposed Decision Memo Released
08/09/2006
Proposed Decision Memo Public Comment Period
08/09/2006 - 09/08/2006
Decision Memo Released
11/06/2006
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Maria Ciccanti, RN
Lead Medical Officers
James Rollins, M.D., Ph.D.

Medicare Benefit Category Determination Date

Actions Taken

February 28, 2006

CMS opens this reconsideration for review of addition of Restless Leg Syndrome to the covered indications for Serum Iron Studies. CMS is opening a 30 day public comment period on this reconsideration.

August 9, 2006

CMS posts the proposed decision memorandum  and invites public comments. The 30 day public comment period begins.

Instructions on submitting public comments can be found at: http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage

November 6, 2006