Urinary Biomarkers for Chronic Pain Management

Jurisdiction: J15 MAC Part B. States: Kentucky, Ohio. Type: Active LCD

For this policy: Urinary biomarker laboratory tests for chronic pain are non-covered by this contractor. Background Chronic pain is a significant problem that is complex and challenging to treat. The mechanisms of chronic pain are not well understood, and the lack of objective diagnostic tests adds to this challenge. Research to develop biomarkers for chronic pain is of interest as this may provide guidance for drug development and clinical practice. A biomarker is defined as “a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathological processes or pharmacological responses to a therapeutic intervention” (Biomarker Definitions Working Group, 2001). [1] Biomarkers aim to help diagnose, aid in prognosis and evaluation of treatment responses and can inform rational drug development. There are no specific biomarkers for chronic pain. [1] Commercially available at the time of this LCD includes a novel, pain algorithmic based biomarker test panel called Foundation Pain Index (FPI) was developed by Ethos Laboratories, Newport, KY to evaluate biomarkers of systemic inflammation, oxidative stress, neurotransmitter turnover, and micronutrient status. The test includes analysis of 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), LC- MS/MS collected via urine sample. An algorithm is used to report a pain-index score with likelihood of atypical biochemical function associated with pain. The concept is based on emerging research that nutrition-based interventions could reduce the severity and intensity of pain and that nearly all neurogenerative diseases appear to have an underlying diet-induced, pro-inflammatory state that can be mitigated if diagnosed. [2] This test is a laboratory-developed test and therefore not regulated by FDA. [48]