M1396 HCPCS Reimbursement & Policy Benchmarks | OpenPayer

Summary & Overview

HCPCS M1396: Patients on a Therapeutic Clinical Trial

HCPCS Level II code M1396 designates services for patients enrolled in therapeutic clinical trials. Nationally, identifying trial-related care with a specific HCPCS Level II code supports appropriate billing, tracking of research-related services, and differentiation of clinical trial activity from standard care. Use of this code can affect reporting, payer adjudication, and institutional accounting for trial participants. 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 code’s clinical context, typical sites of service, and the payer landscape. The publication outlines common modifiers associated with trial-related billing, notes where data was not available in the input, and highlights operational considerations such as documentation needs and avenues for billing review. The summary addresses how the code is used for labeling trial participants in claims and what topics stakeholders review when validating trial-related claims, including eligibility criteria alignment, service attribution, and coordination between clinical trial sponsors and payers. Data not available in the input is clearly identified for items such as associated taxonomies, specific ICD-10 diagnoses, and related codes.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicareM1396HCPCS Level IIclinical trialtherapeutic trialoutpatient servicesresearch billingtrial patient managementbilling code overview

Billing Code Overview

HCPCS Level II code M1396 indicates services related to patients on a therapeutic clinical trial. This code is used to identify encounters or services provided to patients who are actively enrolled in a therapeutic clinical trial protocol.

Service type: Clinical trial patient management and associated trial-related services
Typical site of service: Hospital outpatient departments, physician offices, clinical research facilities, and other settings where therapeutic clinical trials are conducted

Clinical & Coding Specifications

Clinical Context

A patient enrolled in an oncology therapeutic clinical trial presents for scheduled study-related visits involving administration of investigational therapy and protocol-driven assessments. Typical workflow: pre-visit chart verification and insurance check; informed consent confirmation and research coordinator documentation; baseline and interval vitals and symptom assessment; protocol-specified medication administration (oral, IV, or investigational device) under direct physician or research nurse supervision; collection of research labs and specimen processing; adverse event assessment and attribution; documentation of study procedures in both research source and the medical record; billing stewardship to ensure services covered by study sponsor are billed appropriately and that clinically indicated services billable to payors are separated from sponsor-covered trial costs.

Typical site of service: outpatient infusion center, outpatient clinic research unit, academic medical center research clinic, or ambulatory surgical center when procedures are study-required.

Typical patient scenario: A 58-year-old patient with metastatic breast cancer enrolled in a phase II therapeutic trial receives IV investigational agent every 21 days in the outpatient infusion center. Pre-infusion labs and ECG are performed per protocol, study drug is administered by trained nursing staff, and the investigator documents response assessment and adverse events. Some supportive medications and imaging are billed to the insurer; the investigational drug and mandated research-only procedures are covered by the sponsor and tracked separately.

Coding Specifications

Modifier	Description	When to Use

HCPCS M1299: Influenza Immunization Administered or Previously Received

HCPCS-M1214-SPIROMETRY-CONFIRMED-AIRFLOW-OBSTRUCTION

HCPCS M1214: Spirometry with Confirmed Airflow Obstruction, Documented and Reviewed

HCPCS-M1353-SUICIDE-SAFETY-PLAN-NOT-COMPLETED

HCPCS Level II M1353: Suicide Safety Plan Not Completed

HCPCS-M1471-MEDICARE-PART-B-HEP-B-VACCINE-COVERAGE-STATUS

HCPCS M1471: Medicare Part B Hepatitis B Vaccine Coverage Status

HCPCS-M1239-PATIENT-DID-NOT-RESPOND-TO-HEARD-AND-UNDERSTOOD-QUESTION

HCPCS Level II M1239: Patient Did Not Respond to 'Heard and Understood' Question

HCPCS-M1162-VACCINE-ASSOCIATED-ENCEPHALITIS-PEDIATRIC

HCPCS M1162: Encephalitis Due to Tetanus/Diphtheria/Pertussis Vaccine

HCPCS-M1208-NO-SOCIAL-NEEDS-SCREENING

HCPCS Level II M1208: No Screening for Key Social Needs

HCPCS-M1184-DOCUMENTATION-MEDICAL-REASON-NO-CORTICOSTEROID-OR-IMMUNOSUPPRESSANT

HCPCS M1184: Documentation of Medical Reason for Not Prescribing Corticosteroid/Immunosuppressant

HCPCS-M1215-DOCUMENTATION-MEDICAL-REASON-NO-SPIROMETRY-REVIEW

HCPCS M1215: Documentation of Medical Reason for Not Reviewing Spirometry Results

HCPCS-M1242-PATIENT-DID-NOT-RESPOND-PATIENT-CENTEREDNESS-QUESTION

HCPCS M1242: Patient Nonresponse to Patient-Centeredness Question

Showing 1–10 of 356

Taxonomy Code	Specialty	Notes
207Q00000X	Medical Oncology	Principal investigators and treating oncologists managing therapeutic drug administration and adverse events.
363A00000X	Hematology	Specialists for hematologic malignancy trials or blood product management required by protocol.
207L00000X	Surgical Oncology	Surgeons performing trial-related biopsies, resections, or device implantations specified by protocol.
163W00000X	Nurse Practitioner	Advanced practice providers managing patient visits, symptom assessment, and coordination of trial procedures.
367500000X	Clinical Research Coordinator (Research Nurse)	Personnel performing protocol implementation, data collection, and sponsor communication (listed as nursing/research specialty).

ICD-10 Code	Description	Clinical Relevance
Data not available in the input.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`96413`	Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug	Commonly used for billing standard IV chemotherapeutic or biologic administration sessions performed alongside investigational agent infusion when clinically indicated and billable to insurer.
`96365`	Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up to 1 hour	Used for infusion of supportive medications (e.g., antiemetics, hydration) that accompany investigational therapy during a study visit.
`81002`	Urinalysis, non-automated, without microscopy	Protocol-specified point-of-care tests such as urinalysis performed at visits; often billed when payer responsibility applies.
`36415`	Collection of venous blood by venipuncture	Standard code for blood draws required by protocol for labs and pharmacokinetic sampling; often billed when clinical lab testing is billable.
`93000`	Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report	Baseline and interval ECGs required by many therapeutic trials; billed when insurer covers clinically indicated ECGs.

OpenPayer