LAB.00048 Pain Management Biomarker Analysis Form

Subject:

Description/Scope

This document addresses the Foundation Pain Index (FPI), a test panel of pain functional biomarkers in urine that is intended to identify sources of chronic pain. The FPI is based on liquid chromatography tandem mass spectrometry (LCM/MS) analysis of urine for 11 endogenous analytes (methylmalonic acid, xanthurenic acid, homocysteine, pyroglutamic acid, vanilmandelate, 5-hydroxyindoleacetic acid, hydroxymethylglutarate, ethylmalonate, 3-hydroxypropyl mercapturic acid [3-HPMA], quinolinic acid, kynurenic acid). The manufacturer claims the index indicates the likelihood that a patient’s pain is due to a biochemical abnormality, and thereby aids in clinical management.

Note: This document does not address drug testing for chronic pain. For more information see:

• CG-LAB-09 Drug Testing or Screening in the Context of Substance Use Disorder and Chronic Pain

Position Statement

Investigational and Not Medically Necessary:

The functional pain biomarker urine test panel is considered investigational and not medically necessary for chronic pain management and for all other indications.