Summary & Overview
CPT 0608U: ALICE Endometrial PCR Test for Chronic Endometritis
CPT code 0608U designates a Proprietary Laboratory Analyses (PLA) test — ALICE (Analysis of Infectious Chronic Endometritis) from Igenomix® — that uses real‑time PCR to detect and quantify 10 bacterial DNA targets from an endometrial biopsy and provides treatment recommendations. As a PLA code, 0608U applies to a single manufacturer-specific assay and is relevant for fertility and gynecologic care where chronic endometritis is evaluated. Nationally, molecular diagnostic PLA codes influence laboratory billing policy, prior authorization practices, and coverage determinations because they represent unique tests with limited code interchangeability.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The publication outlines how payers approach coverage of proprietary molecular assays, common documentation and reporting expectations, and the clinical context in which 0608U is ordered.
Readers will learn: the clinical purpose of the test, typical sites of service and the laboratory service model, payer landscape coverage considerations, and where to find relevant billing descriptors and clinical context for use. Data not available in the input are noted where applicable, and the content focuses on national implications for coding and clinical use rather than state-level policy.
Billing Code Overview
CPT code 0608U is a Proprietary Laboratory Analyses (PLA) code for ALICE (Analysis of Infectious Chronic Endometritis) from Igenomix®. The test uses real–time polymerase chain reaction (PCR) to analyze an endometrial biopsy for 10 bacterial DNA targets associated with chronic endometritis. Results include quantified bacterial levels and treatment recommendations.
Service type: Laboratory diagnostic molecular test using real-time PCR to detect and quantify bacterial DNA in an endometrial biopsy.
Typical site of service: Clinical laboratory or reference laboratory performing specialized molecular diagnostic testing.
Clinical & Coding Specifications
Clinical Context
A 34-year-old woman with a history of two failed in vitro fertilization (IVF) cycles and persistent abnormal uterine bleeding is evaluated for possible chronic endometritis as a contributor to implantation failure. After hysteroscopic inspection and endometrial biopsy is performed in the outpatient gynecology clinic or ambulatory surgical center, a sterile endometrial tissue sample is sent to Igenomix® for the ALICE test. The laboratory performs real-time PCR targeting 10 bacterial DNA targets associated with chronic endometritis, quantifies bacterial load, and returns a report with bacterial levels and suggested antimicrobial treatment options. Typical workflow: patient seen by reproductive endocrinologist or gynecologist → informed consent and endometrial biopsy obtained during mid-luteal or clinically appropriate window → specimen labeled and shipped per manufacturer instructions → laboratory performs PLA test billed with 0608U → results reviewed by ordering clinician to guide targeted therapy and timing of subsequent fertility procedures.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | Use when billing separately for the physician interpretation of the laboratory result if applicable (facility bills technical component). |
TC | Technical component | Use when billing for the laboratory processing only, if split billing applies. |
59 | Distinct procedural service | Use when the biopsy collection is billed separately and is distinct from other services on the same day. |
76 | Repeat procedure by same physician | Use if the ALICE test is repeated during the same encounter by the same provider. |
77 | Repeat procedure by another physician | Use if a second provider repeats the test during the same day/encounter. |
90 | Reference (outside) laboratory | Use when the test is performed by an outside/reference lab (third-party lab) such as Igenomix®. |
91 | Repeat clinical diagnostic laboratory test | Use when repeating the same lab test on the same day to confirm prior results. |
QW | CLIA waived test | Not typically applicable; use only if the specific assay meets CLIA waived criteria and payer requires modifier. |
GQ | Remote patient monitoring (diagnostic) | Not typically applicable; listed for completeness in lab contexts where remote testing tech applies. |
XE | Separate encounter (Modifier XE) | Use to indicate services that are distinct because they occurred during a separate encounter (if payer requires granular modifier reporting). |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
2084P0800X | Reproductive Endocrinology & Infertility | Specialists ordering endometrial testing in infertility workups. |
207V00000X | Obstetrics & Gynecology | Gynecologists performing endometrial biopsies and managing chronic endometritis. |
207L00000X | Pathology & Clinical Laboratory | Laboratory directors and pathologists overseeing molecular diagnostic testing. |
334S00000X | Clinical Molecular Biology | Laboratory specialty involved in performing PCR-based assays. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
N75.0 | Abscess of Bartholin's gland | May be considered in differential if pelvic infection suspected when evaluating endometritis. |
N73.9 | Female pelvic inflammatory disease, unspecified | Chronic endometritis can be part of chronic PID spectrum impacting fertility. |
N85.0 | Endometritis, unspecified | Directly relevant as a general diagnosis for inflammation of the endometrium tested by 0608U. |
N96.9 | Habitual aborter, unspecified | Recurrent pregnancy loss may prompt investigation for chronic endometritis as a contributing factor. |
N97.9 | Female infertility, unspecified | Infertility evaluations commonly include endometrial testing for chronic endometritis contributing to implantation failure. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
58300 | Endometrial sampling (biopsy) with or without cervical dilation, any method | Typically performed to obtain the endometrial tissue specimen that is sent for the 0608U ALICE test. |
69090 | Collection of specimen from female genital tract (if applicable: office hysteroscopy codes vary) | May be used for specimens collected during hysteroscopic procedures before sending sample for PLA testing. |
87635 | Infectious agent detection by nucleic acid (DNA or RNA); Chlamydia trachomatis and Neisseria gonorrhoeae, amplified probe technique (two targets) | Represents molecular pathogen testing commonly performed in parallel or as part of infectious workup; not the same as 0608U but conceptually related. |
87070 | Culture, bacterial, any source, aerobic, with isolation and presumptive identification of isolates | May be performed in addition to PCR-based assays to attempt culture-based identification of bacteria associated with chronic endometritis. |
G0452 | Routine diagnostic laboratory tests, per-visit laboratory panel (Medicare lab code example) | Used by some payers to bundle or reimburse diagnostic lab services performed in the outpatient setting alongside specialized PLA testing. |