Summary & Overview
CPT 0607U: Endometrial Microbiome Metagenomic Analysis (EMMA)
CPT code 0607U designates EMMA (Endometrial Microbiome Metagenomic Analysis), a proprietary molecular diagnostic test from Igenomix® that uses real‑time PCR to detect and quantify 31 bacterial species in DNA from an endometrial biopsy. As a PLA code, 0607U applies to a single manufacturer’s test, which directly links the billing code to a unique laboratory service. Nationally, such PLA codes matter because they standardize billing for novel, lab‑specific assays and influence coverage, coding clarity, and laboratory reporting practices.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the test purpose and clinical context, payer coverage considerations, where the service is typically furnished, and what benchmarks and policy topics commonly accompany PLA molecular diagnostics — including coding specificity, billing practices, and implications for laboratory workflows. The publication outlines available information on service configuration and sites of care and identifies areas where payer policy language and coverage criteria are typically relevant for adoption and reimbursement decisions.
Data not available in the input: common modifiers, associated taxonomies, ICD‑10 diagnoses, related codes, and detailed payer policy language.
Billing Code Overview
CPT code 0607U is a Proprietary Laboratory Analyses (PLA) code that applies only to a single, manufacturer‑specific laboratory test. Report 0607U only for EMMA (Endometrial Microbiome Metagenomic Analysis) from Igenomix®. The test analyzes DNA from an endometrial biopsy using real‑time polymerase chain reaction (PCR) to detect and quantify 31 bacterial species and provides targeted treatment recommendations based on the bacterial profile.
Service Type: Molecular diagnostic microbiome analysis of endometrial tissue
Typical Site of Service: Clinical laboratory or specialized molecular diagnostics laboratory; specimen collected in an outpatient clinic or ambulatory procedure setting (endometrial biopsy)
Clinical & Coding Specifications
Clinical Context
A 34-year-old woman with a history of recurrent implantation failure after in vitro fertilization (IVF) and recurrent early pregnancy loss presents to a fertility clinic for evaluation. After counseling, an endometrial biopsy is obtained during the mid-luteal phase in a sterile outpatient procedure. The specimen is submitted to Igenomix® for the EMMA (Endometrial Microbiome Metagenomic Analysis) test, reported under 0607U. EMMA uses targeted real-time PCR to detect and quantify 31 bacterial species from endometrial tissue, generating a microbiome profile and providing targeted treatment recommendations. Typical workflow steps include scheduling the biopsy with a reproductive endocrinology or maternal-fetal medicine provider, obtaining informed consent, performing the endometrial sampling in an outpatient procedure room, packaging and shipping the specimen per the laboratory’s instructions, receiving the molecular report into the electronic health record, and integrating the results into the infertility treatment plan.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | Use when only the physician interpretation is billed separately from the laboratory component (rare for PLA codes). |
TC | Technical component | Use when billing only the technical/lab processing component and not the physician interpretation. |
59 | Distinct procedural service | Use if another independent procedure or service not normally billed together was performed the same day and is distinct from the biopsy collection or lab testing. |
56 | Preoperative care | Use when designating the surgical package split, if a qualifying surgical procedure with global period is involved and preoperative care is billed separately. |
78 | Unplanned return to the operating/procedure room by the same physician following initial procedure for a related procedure during the postoperative period | Use if an unexpected complication requires return to the procedure room for management after the initial biopsy procedure. |
22 | Increased procedural services | Use when the collection procedure required substantially greater effort beyond the usual biopsy technique (documented evidence required). |
24 | Unrelated evaluation and management service by the same physician during a postoperative period | Use when an unrelated E/M service is provided the same day separate from the biopsy and testing. |
90 | Reference (outside) laboratory | Use when the performing laboratory is an outside reference lab; applicable for PLA testing sent to a specific manufacturer lab. |
91 | Repeat clinical laboratory test | Use when repeat testing on the same day is performed and reported as appropriate per payer rules. |
QW | CLIA-waived test | Generally not applicable for PLA molecular assays; include only if a payer-specific rule requires it. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207RC0000X | Reproductive Endocrinology and Infertility | Common ordering and performing specialty for endometrial sampling and fertility-focused microbiome testing. |
207RP2900X | Obstetrics & Gynecology | Gynecologists in fertility clinics often obtain endometrial biopsies and coordinate testing. |
208M00000X | Maternal-Fetal Medicine | May perform biopsy collection in complex infertility or recurrent pregnancy loss cases. |
363LF0000X | Clinical Laboratory | Laboratory specialty that processes molecular diagnostic PLA tests (may represent the performing reference lab). |
2084P0800X | Gynecologic Oncology | Occasionally involved when endometrial sampling is performed in patients with concurrent oncologic concerns; less common for routine EMMA testing. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
N97.0 | Female infertility associated with anovulation | Infertility codes commonly accompany endometrial microbiome testing when evaluating implantation failure. |
N97.1 | Female infertility of tubal origin | Used in fertility workups where endometrial environment assessment may inform management. |
N97.9 | Female infertility, unspecified | General infertility diagnosis associated with EMMA testing in IVF evaluation. |
N94.6 | Dysmenorrhea, unspecified | Pelvic symptoms prompting uterine evaluation and possible endometrial sampling. |
N83.2 | Polycystic ovarian syndrome (PCOS) | PCOS is frequently present in infertility patients undergoing comprehensive evaluation including endometrial assessment. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
83001 | Drug confirmation; qualitative, single drug class method (e.g., immunoassay) | May be performed concurrently in fertility evaluations when substance exposure screening is needed; not specific to EMMA. |
58100 | Endometrial sampling (biopsy) without dilation and curettage | Commonly performed prior to sending tissue for 0607U; the physical specimen collection procedure. |
88112 | Cytopathology, evaluation of fine needle aspirate or nongynecologic; classification | If cytologic evaluation of endometrial sampling is performed alongside molecular testing, this code may be used for cytology interpretation. |
87149 | Culture, bacterial, other source, require isolation and presumptive identification | In some infertility evaluations, parallel bacterial cultures may be obtained; cultures differ from molecular EMMA testing. |
0000U | Proprietary laboratory analyses example (placeholder) | Data not available in the input. |
If any listed related CPT codes were not provided in the input, "Data not available in the input."