Summary & Overview
CPT 0117U: Foundation PI Urine Metabolic Pain Index
CPT code 0117U denotes a Proprietary Laboratory Analyses (PLA) test — the Foundation PI assay from Ethos Laboratories — that uses LC–MS/MS to analyze urine metabolites and applies an algorithmic model to generate a pain index score. The code captures a single-manufacturer, lab-specific diagnostic offering that links biochemical markers to chronic pain assessment. Nationally, PLA codes like 0117U matter because they represent proprietary diagnostics with unique coding, pricing, and coverage considerations distinct from broadly used laboratory tests.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield plans, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of clinical context for biochemical pain-marker testing, payer coverage landscape highlights, and the types of benchmarks and policy factors that influence adoption and reimbursement for PLA codes. The publication outlines what stakeholders need to know about the service line (specialized clinical laboratory testing), typical site of service (clinical or reference laboratory), and the role of algorithm-derived scores in clinical interpretation.
This summary prepares payers, laboratorians, and policy analysts to understand where 0117U fits within diagnostic coding, what to expect from coverage evaluation, and which operational and policy topics to consider when handling proprietary, algorithm-driven laboratory tests.
Billing Code Overview
CPT code 0117U is a Proprietary Laboratory Analyses (PLA) code for the Foundation PI test from Ethos Laboratories. The test uses liquid chromatography–tandem mass spectrometry (LC–MS/MS) to evaluate a patient’s urine for metabolic compounds and metabolism breakdown products related to chronic pain. Results are incorporated with patient data into an algorithm that produces a pain index score based on biochemical markers associated with pain.
Service Type: Proprietary laboratory diagnostic test using LC–MS/MS with algorithmic interpretation
Typical Site of Service: Clinical laboratory or reference laboratory performing specialized urine testing
Clinical & Coding Specifications
Clinical Context
A 48-year-old patient with chronic low back pain managed in a multidisciplinary pain clinic is referred for biochemical pain phenotyping using the Foundation PI urine test from Ethos Laboratories (0117U). The patient has persistent pain despite opioid-sparing therapy and the clinician orders the test to evaluate metabolic compounds and breakdown products related to chronic pain. A urine specimen is collected in the clinic, shipped to Ethos Laboratories, and analyzed by LC–MS/MS. Results are returned as quantitative biochemical markers and a composite pain index score that is reviewed by the treating clinician and incorporated into the overall pain assessment along with medication history, past imaging, physical exam findings, and patient-reported outcomes. Typical use cases include treatment planning for chronic nonmalignant pain, assessing biochemical contributors to pain symptoms, and aiding risk stratification when considering changes in analgesic regimens. Typical site of service is an outpatient pain management clinic, physician office, or ambulatory laboratory collection site. Specimen collection, shipment, analysis, and result reporting are handled by the laboratory per manufacturer-specific protocols.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default (no modifier) | Use when no special circumstances apply and both technical and any unique reporting elements are routine. |
11 | Professional component | Use if reporting a distinct professional interpretation separate from the laboratory’s proprietary test reporting (rare for PLA tests). |
22 | Increased procedural services | Use when substantial additional work is documented beyond the routine test (e.g., extensive consultation or report addenda). |
52 | Reduced services | Use if the test was partially performed or specimen was inadequate but partial testing completed. |
53 | Discontinued procedure | Use if specimen collection or analysis was initiated but discontinued for documented clinical reasons. |
62 | Two surgeons/clinical team | Use when two providers from different specialties are jointly responsible for unique procedural elements related to testing workflow. |
78 | Unplanned return to the operating/procedure room | Typically not applicable; use only if testing was part of a procedure requiring return to the OR and code linkage is appropriate. |
80 | Assistant surgeon | Use when an assistant surgeon is documented as providing services directly related to a procedure coupled with testing workflow. |
82 | Assistant (when a qualified resident not available) | Use when a qualified assistant is documented and needed for specimen collection in the absence of a resident. |
AD | Post-operative services by assistant surgeon | Use when the assistant surgeon provides post-procedure services tied to the testing episode. |
QK | Medical direction of two, three, or four assistants | Use in complex procedural settings where medical direction for assistants is documented in relation to the clinical encounter. |
QX | Qualified nonphysician health care professional | Use when a qualified nonphysician collector or professional performs elements of the service under applicable supervision rules. |
QY | Attending physician service for resident | Use when the attending documents primary supervision of specimen collection/processing by a resident. |
SH | Diagnostic laboratory specimen handling (ASCP) | Use when special handling requirements are documented by the performing laboratory per payer rules. |
TC | Technical component | Use only if a billing entity separates the technical component of the laboratory analysis from the professional/reporting component. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207RH0000X | Pain Medicine | Clinicians ordering and interpreting pain biomarker tests in chronic pain management. |
207RI0200X | Physiatry (Physical Medicine & Rehabilitation) | Specialists who manage chronic pain and use biochemical phenotyping to guide therapy. |
208D00000X | Anesthesiology | Anesthesiologists specializing in pain medicine who may order the test. |
363A00000X | Clinical Laboratory | Laboratory professionals responsible for performing LC–MS/MS and reporting PLA tests. |
261QM2100X | Nurse Practitioner | Advanced practice clinicians in pain clinics who may order and manage follow-up for testing. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
M54.5 | Low back pain | Common indication for biochemical pain phenotyping in patients with chronic low back pain to inform management. |
G89.29 | Other chronic pain | General code for chronic pain conditions where metabolic biomarker profiling may aid assessment. |
M79.2 | Neuralgia and neuritis, unspecified | Neuropathic pain presentations that may be evaluated with biochemical markers as part of phenotyping. |
F45.41 | Pain disorder with related psychological factors | Pain disorders with complex biopsychosocial components where objective biomarker data can contribute to overall evaluation. |
M25.50 | Pain in unspecified joint | Regional chronic pain syndromes where metabolic profiling may be used adjunctively. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0117U | Foundation PI test (Ethos Laboratories) — LC–MS/MS urine metabolic biomarker panel with proprietary algorithm reporting a pain index score | This is the primary test code; it covers the laboratory analysis and proprietary pain index reporting used for biochemical pain phenotyping. |
81002 | Urinalysis, by dipstick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; non-automated, without microscopic examination | May be performed at the point of care to assess urine integrity prior to specimen shipment for LC–MS/MS. |
81005 | Urinalysis, by dipstick or tablet reagent, with microscopy | May be performed when microscopic assessment is needed to document hematuria, pyuria, or contamination that could affect test interpretation. |
36415 | Collection of venous blood by venipuncture | May be billed if blood tests (e.g., toxicology, metabolic panels) are ordered concurrently to complement urine biomarker results. |
99000 | Handling and/or conveyance of a specimen for transfer from the office to a laboratory | Use for documented specimen handling/transport services associated with sending urine to the performing laboratory. |
99070 | Supplies and materials (e.g., bandages, gauze) provided by the physician over and above those usually included with the office visit | Use when specialized collection kits or shipping materials for the proprietary test are provided by the clinic. |