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Coding Analysis for Labs (CAL) Tracking Sheet for Human Chorionic Gonadotropin (Addition of ICD-9-CM Code 158.9, Malignant Neoplasm of Peritoneum, Unspecified) (CAG-00372N)

CMS received an external request to add ICD-9-CM code 158.9—Malignant neoplasm of peritoneum, unspecified—as a covered indication for the national coverage determination (NCD) on Human Chorionic Gonadotropin (hCG) at section 190.27 of the Medicare National Coverage Determination Manual (NCDM).

Section 190.27 of the NCDM states that hCG is “useful for monitoring and diagnosis of germ cell neoplasms of the ovary, testis, mediastinum, retroperitoneum, and central nervous system.”

We believe that the ICD-9-CM code 158.9—Malignant neoplasm of peritoneum, unspecified—may flow from this narrative.

We seek public comments on the request to add code 158.9 to the list ICD-9-CM Codes Covered By Medicare for the hCG NCD.

CAL Process

CMS, in conjunction with committees of stakeholders, used a negotiated rulemaking process to develop NCDs that cover 23 distinct diagnostic laboratory services under a negotiated rulemaking process.  These final NCDs were published in 2001.  For each of these 23 laboratory services, CMS listed the ICD-9-CM diagnosis codes and the CPT/HCPCS procedure codes for which Medicare provides coverage.

Since 2001, CMS has received requests to revisit these diagnosis and/or procedure code lists.  To accommodate these requests, CMS established an abbreviated administrative process for considering these coding change requests.  This process is known as the “Coding Analysis for Labs (CALs)” process.  CMS describes this CAL process in a Federal Register notice, which was published on February 25, 2005, and is available online at

Because the hCG NCD is one of these 23 NCDs, and because we believe that the code referenced above may flow from the NCD narrative, we are conducting this analysis under the abbreviated CAL process.

Diagnostic Laboratory Tests
Requestor Name(s)Sandra Oprsal, RHIA, CCS; Compliance Audit Coordinator; Ingham Regional Medical Center; Lansing, Michigan
Requestor Letter(s)View Letter
Formal Request Accepted and Review Initiated01/12/2007
Expected NCA Completion Date04/12/2007
Public Comment Period01/12/2007 - 02/11/2007
Decision Memo Released02/16/2007
Lead Analyst(s)
  • Kelly Anderson
Lead Medical Officer(s)
  • Jim Rollins, MD, MSHA, PhD

January 12, 2007

CMS accepts a request to add ICD-9-CM code 158.9 as a covered indication in the hCG 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.

February 16, 2007

Decision memo  posted.