Compliance with the provisions in this LCD may be monitored and addressed
through post payment data analysis and subsequent medical review audits.  
  
 **History/Background and/or General Information**

Hepatic (liver) function can be measured in terms of serum enzyme activity
such as alkaline phosphatase, transaminases, lactic dehydrogenase and serum
concentrations of proteins, bilirubin, ammonia, clotting factors and lipids.
Several of these tests may be helpful for the assessment and management of
individuals with hepatic (liver) disease or injury and for monitoring the
effects of medications and toxic material on liver function.

The hepatic (liver) function panel consists of Albumin, serum; Bilirubin,
total; Bilirubin, direct; alkaline phosphatase; transferase, alanine amino
(ALT) (SGPT), transferase, aspartate amino (ALT) (SGOT); and protein, total.  
  
 **Covered Indications**

A hepatic function panel will be considered medically necessary when performed
for the following clinically indicated conditions:

  * Signs and symptoms of liver disease (e.g., jaundice, nausea accompanied with vomiting and/or weight loss, bright yellow urine, grey or pale colored stools, change of sleep patterns, vomiting of blood or the passing of blood in the stools, tiredness or loss of stamina, abdominal swelling caused by: an enlarged liver or an enlarged spleen or excess fluid in the abdomen [ascities], pain associated with the abdomen, increased water consumption and urination, progressive depression or lethargy);
  * Hematologic disturbances which are commonly associated with liver disease (e.g., coagulation disorders, anemia, thrombocytopenia);
  * History of exposure to environmental toxins which may result in hepatotoxicity;
  * Patients under treatment with medications suspected or known to produce hepatotoxic effects. Commonly, instructions for use of such medications include manufacturer recommendations that frequent monitoring of liver function be performed while under treatment; 
  * An abnormal value of any of the components of the panel; and/or
  * A history of exposure to hepatitis.

**Limitations  
  
** The following are considered not medically reasonable and necesary:

  * Tests performed during annual physical examinations or other routine screening situations without signs, symptoms or illnesses which indicate medical necessity will result in denial as a non-covered benefit.
  * Payment is made only for those tests in an automated profile that meet coverage rules. Where only some of the tests in a profile of tests are covered, payment cannot exceed the amount that would have paid if only the covered tests had been ordered.

As published in the CMS IOM Publication 100-08, _Medicare Program Integrity
Manual_ , Chapter 13, Section 13.5.4, an item or service may be covered by a
contractor LCD if it is reasonable and necessary under the Social Security Act
Section 1862 (a)(1)(A). Contractors shall determine and describe the
circumstances under which the item or service is considered reasonable and
necessary.  
  
 **Notice** : Services performed for any given diagnosis must meet all of the
indications and limitations stated in this LCD, the general requirements for
medical necessity as stated in CMS payment policy manuals, any and all
existing CMS national coverage determinations, and all Medicare payment rules.