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Coding Analysis for Labs (CAL) Tracking Sheet for Prostate Specific Antigen (Addition of ICD-9-CM 600.00, Hypertrophy (benign) of Prostate Without Urinary Obstruction, as a covered indication) (CAG-00326N)

CMS received an external request to add Hypertrophy (benign) of prostate without urinary obstruction, ICD-9-CM code 600.00, as a covered indication for the Prostate Specific Antigen (PSA) NCD at 190.31 of the NCD Manual.

The narrative covered indications for the PSA NCD state, “PSA is of proven value in differentiating benign from malignant disease in men with lower urinary tract signs and symptoms as well as with patients with palpably abnormal prostate glands on physician exam and in patients with other laboratory or imaging studies that suggest the possibility of a malignant prostate disorder.”

We believe code 600.00, Hypertrophy (benign) of prostate without urinary obstruction, flows from the narrative. We are seeking public comment on the addition of code 600.00 to the ICD-9-CM Codes Covered By Medicare list for the PSA NCD.

The regulation for maintaining code lists in the negotiated NCDs for clinical diagnostic laboratory services states that codes on the covered list flow from the existing NCD narratives of covered indication. The regulation was published February 25, 2005 in the Federal Register, Vol.70, No. 37 and can be viewed at

Diagnostic Laboratory Tests
Requestor Name(s)Marie McCoy, Northwest Hospital
Requestor Letter(s)View Letter
Formal Request Accepted and Review Initiated04/18/2006
Expected NCA Completion Date07/18/2006
Public Comment Period04/18/2006 - 05/18/2006
Proposed Decision Memo Due Date07/18/2006
Decision Memo Released05/31/2006
Comments for this CAL:View Public Comments
Lead Analyst(s)
  • Maria Ciccanti, RN
Lead Medical Officer(s)
  • James Rollins, MD, MSHA, PhD

April 18, 2006

CMS accepts a request to add ICD-9-CM code 600.00 as a covered indication in the PSA national coverage determination list of covered indications.

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.

May 31, 2006

Posted decision memo.