Proposed LCD - Urinary Biomarkers for Chronic Pain Management (DL39616)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Title XVIII of the Social Security Act, 1862(a)(1)(D) Investigational or Experimental42 Code of Federal Regulations (CFR) 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: ConditionsCMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic TestsCMS Internet-Only Manuals, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, 80.1.2 A/B MAC (B) Contacts With Independent Clinical Laboratories.CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, 50.5 Jurisdiction of Laboratory Claims.Coverage Indications, Limitations, and/or Medical NecessityFor this policy:Urinary biomarker laboratory tests for chronic pain are non-covered by this contractor.BackgroundChronic 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).1Biomarkers 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.1Commercially 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 includesanalysis 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.2General InformationAssociated InformationN/ASources of InformationN/ABibliographyBorsook D, Becerra L, Hargreaves R. Biomarkers for chronic pain and analgesia. Part 1: the need, reality, challenges, and solutions.Discovery medicine.2011;11(58):197-207.Peabody J, Paculdo D, Tamondong-Lachica D, Cabaluna IT, Gunn J. Randomized Trial on the Clinical Utility of a Novel Biomarker Panel to Identify Treatable Determinants of Chronic Pain.Diagnostics (Basel).2020;10(8).Hagedorn JM, Gunn J, Budwany R, DSouza RS, Chakravarthy K, Deer TR. How Well Do Current Laboratory Biomarkers Inform Clinical Decision-Making in Chronic Pain Management?Journal of Pain Research.2021:3695-3710.Aroke EN, Powell-Roach KL. 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