Where this LCD applies
Each contract number is a jurisdiction on the remittance; the policy binds claims processed under these contracts and no others.
| Contract | Contractor | Type | States |
|---|---|---|---|
| 15102 | CGS Administrators, LLC | MAC - Part B | KY |
| 15202 | CGS Administrators, LLC | MAC - Part B | OH |
| 15101 | CGS Administrators, LLC | MAC - Part A | KY |
| 15201 | CGS Administrators, LLC | MAC - Part A | OH |
Billing and coding: diagnoses and procedure codes
Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A59423 (Billing and Coding: Urinary Biomarkers for Chronic Pain Management) carries the diagnosis and procedure lists the contractor loads as the claims edit. CPT codes are shown as bare numbers because the descriptors are licensed by the AMA; HCPCS Level II descriptors are public and shown.
A59423: Billing and Coding: Urinary Biomarkers for Chronic Pain Management (Billing and Coding, effective 2026-01-22)
- Covered ICD-10-CM codes
- 0
- 0 groups
- Non-covered ICD-10-CM codes
- 0
- Procedure codes listed
- 1
- Full article
- cms.gov record
Procedure codes: 0117U.
Coverage indications, limitations and medical necessity
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]
Summary of evidence (opening)
Literature search from PubMed, Google Scholar, Google, ClinicalTrials.gov, EBSCO Host with search words “chronic pain, pain biomarker OR oxidative stress” included 196 articles. An additional search was conducted on each biomarker included in the FPI panel. Three systematic reviews, 9 RCTs and 186 other papers and 11 citations added manually due to abstraction from bibliography were reviewed. The majority consisted of case reports, series, review papers and small cohorts. The LCD review was limited to cohort studies with >25 subjects and randomized controlled studies (RCT). If a paper was investigating a biomarker for pain management that was not one of the 11 analytes included in the FPI lab it was reviewed, but not added to evidence review.
Biomarkers for Chronic Pain
Randomized controlled trials identified in literature search as described above were reviewed for evidence to support the role of specific biomarkers for pain. Multiple small RCTs investigated a wide variety of biomarkers, but these reports all had inadequate sample sizes ( A 2021 narrative review was conducted to assess the literature regarding the use of laboratory biomarkers in chronic pain. A total of 304 manuscripts were produced from PubMed, Science Direct, and Google Scholar databases. Ultimately 75 manuscripts were included. Authors concluded that biomarkers, including urinary, serum, cerebrospinal fluid, and salivary, may be helpful in identifying patients at risk of developing disease and may help predict disease progression and assist with plan of treatment. They go further to state “additional research is necessary before specific recommendations can be made, and current clinical decision-making is modified”. [3] Two out of three authors of this paper have conflicts of interest due to relationship with Ethos Laboratories.
A 2020 systematic review on the metabolomics of chronic pain conditions reviewed published studies that used various metabolomic approaches to investigate chronic pain conditions among subjects of all ages. A total of 586 articles were identified and 18 included in the review that included fibromyalgia (n= 5), osteoarthritis (n=4), migraine (n=3), musculoskeletal pain (n=2), and other chronic pain conditions (n=1). The authors looked at several metabolites including amino acids (e.g., glutamine, serine, and phenylalanine) and intermediate products (e.g., succinate, citrate, acetylcarnitine, and Nacetylornithine) of pathways that metabolize various macromolecules. The authors conclude that despite the increase in research few metabolites have been validated as biomarkers for pain management. Preliminary evidence supports that there may be a role for these markers, and they call for a need for further investigation as this could be a potentially useful pathway to help in management of these conditions. They conclude “Alterations in the intermediate metabolites of carbohydrates, proteins, and other macromolecules are associated with chronic pain conditions such as fibromyalgia, osteoarthritis, and migraine. Unfortunately, many studies in the present review did not quantify the amount of pain experienced by participants. Further investigations are warranted to identify complete metabolomic profiles of various chronic pain conditions. Also, studies are needed to examine whether multiple metabolomic profiles correlate with pain outcomes such as pain severity and quality of life. These studies may lead to the identification of biomarkers and individualized strategies for the prevention, diagnosis, and management of chronic pain. Nurse scientists and other investigators should consider using standardized measurements to phenotype pain to facilitate comparisons across pain conditions and patient populations.” [4]
The contractor cites 65 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2023-10-08
- Current revision effective
- 2026-01-22
- Last reviewed by the contractor
- 2026-01-16
- MCD version
- 5
Other related documents: A59503 (Response to Comments).
Using this policy on a claim
Match the documented indication to the covered indications above before the service is scheduled, carry a diagnosis from the article's covered list on the claim line, and keep the elements the documentation section asks for in the record, because the contractor can request it later through medical review. A denial under this policy arrives as CARC 50 with remark N115; the LCD lookup guide walks through the appeal path and the Advance Beneficiary Notice rules, and the CGS Administrators, LLC hub lists every other active policy from the same contractor.
Frequently asked questions
What does LCD L39616 cover?
For this policy: Urinary biomarker laboratory tests for chronic pain are non-covered by this contractor. The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database export of September 24, 2026.
Which states does LCD L39616 apply to?
CGS Administrators, LLC applies it to Medicare claims in KY, OH. A Local Coverage Determination binds only the contractor that wrote it; the same service in another jurisdiction is judged under that contractor's own policy or, where none exists, claim by claim.
Which diagnosis codes support medical necessity under LCD L39616?
The current export links no billing and coding article with a diagnosis list to this LCD, so coverage is decided on the indications in the policy text and the documentation in the record rather than by an automated diagnosis edit.
How do I appeal a denial under LCD L39616?
The remittance carries claim adjustment reason code 50 with remark code N115, naming the LCD. Compare the documented indication with the policy's covered indications and the article's diagnosis list, then file a redetermination within 120 days with the record attached; if the service genuinely falls outside the policy, the patient can be billed only when a valid Advance Beneficiary Notice was obtained before the service.
Sources
Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.
- Medicare Coverage Database, current LCD exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file lcd.csvSHA-256 2fcc4251b6ddd1eb…
- Medicare Coverage Database, current Billing and Coding Articles exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file article.csvSHA-256 f31932f1df3b4035…
- ICD-10-CM FY2027 code descriptionsVersion FY2027 · effective 2026-10-01 · file icd10cm_codes_2027.txtSHA-256 3c0583a38ee0e848…
Disclaimer
The policy text and code lists are reproduced from the CMS Medicare Coverage Database export as an operational reference. Verify against the current LCD and article on cms.gov before billing; coverage depends on the full record and the contractor. Not legal, clinical or billing advice.