Coding Analysis for Labs (CAL) Tracking Sheet

Hepatitis Panel/Acute Hepatitis Panel (Addition of ICD-9-CM 790.4, Elevation of Levels of Transaminase or Lactic Acid Dehydrogenase)

CAG-00304N

Issue

CMS received an external request to add Elevation of Levels of Transaminase or Lactic Acid Dehydrogenase, ICD-9-CM 790.4, to the covered indication code list for the Hepatitis Panel/Acute Hepatitis Panel 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 http://www.cms.hhs.gov/coverage/labindexlist.asp.

The narrative covered indications for the Hepatitis Panel/Acute Hepatitis Panel NCD states that the panel of tests is used for differential diagnosis in a patient with symptoms of liver disease or injury. We believe elevated levels of transaminase and lactic acid dehydrogenase are indicators of damage to the liver.  Consequently, we believe code 790.4, Elevation of Levels of Transaminase or Lactic Acid Dehydrogenase, flows from the narrative.  We are seeking public comment on the addition of code 790.4 to the code list of covered indications for the Hepatitis Panel/Acute Hepatitis Panel NCD.

Benefit Category

Diagnostic Laboratory Tests

Requestor Information

Requestor Name Requestor Letter
Judy A. Lien, President Clinical Laboratory Management Association(CLMA) View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
10/24/2005
Expected CAL Completion Date
02/24/2006
Public Comment Period
10/24/2005 - 11/24/2005
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
12/14/2005

Contacts

Lead Analysts
Maria Ciccanti
Lead Medical Officers
Jim Rollins, MD, MSHA, PhD

Medicare Benefit Category Determination Date

Actions Taken

October 24, 2005

CMS accepts a request to add ICD-9-CM code 790.4 as a covered indication in the Hepatitis Panel/Acute Hepatitis Panel national coverage determination list of covered indications.

The initial 30-day public comment period begins with this acceptance 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.

November 1, 2005

CMS corrects name of requestor on the tracking sheet.

December 14, 2005

CMS posts a decision memorandum  to the Internet.