M1404 Therapeutic Clinical Trial — HCPCS Reimbursement

HCPCS Level II code M1404 identifies services provided to patients enrolled in therapeutic clinical trials. This designation matters nationally because it captures clinical trial–related care that may be billed separately from standard treatment, influences coverage determinations, and affects tracking of research-related service utilization across payers.

Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of the code’s purpose, common payer considerations, and typical settings where M1404 is used. The publication outlines what organizations commonly evaluate for coverage — such as whether trial-related routine care is billed to the sponsor or the payer — and describes how the code maps to service lines in research clinics and outpatient trial sites.

The report provides benchmarks and operational guidance on coding practice (when available), summary of common modifiers that may accompany this HCPCS Level II code, and clinical context for when M1404 applies. Where data elements were not included in the input, the report notes that information is not available and focuses on available descriptive and payer-related content to inform billing and administrative teams.

Billing Code Overview

HCPCS Level II code M1404 denotes services for patients on a therapeutic clinical trial. The service type is clinical trial participant support and management related to therapeutic investigational interventions. The typical site of service is research clinics or outpatient clinical trial sites where investigational treatments are administered and monitored.

Data not available in the input.

Clinical Context

A 58-year-old patient with metastatic colorectal cancer is enrolled in a Phase II therapeutic clinical trial testing a novel targeted agent. Study visits occur at an academic cancer center's outpatient infusion clinic. At enrollment, the research nurse confirms trial eligibility, documents informed consent, and verifies baseline labs and imaging. The patient returns for scheduled trial-related visits every 2–3 weeks for investigational drug administration, safety assessments, adverse event surveillance, physical exams, vital signs, and collection of blood samples for pharmacokinetic and biomarker analysis. The billing code M1404 is used to indicate the patient is participating in a therapeutic clinical trial when services are otherwise reportable. Typical workflow steps: pre-visit eligibility and consent confirmation, administration of investigational therapy, documentation of trial-mandated assessments in the medical record, coordination with clinical research staff for trial-specific procedures, and submission of claims with appropriate modifiers and diagnosis pointers to distinguish trial-related services from standard care.

Coding Specifications

Modifier	Description	When to Use
`22`	Increased procedural services	Use when trial-related service requires substantially greater work than typical and documentation supports increased complexity due to protocol requirements.

Taxonomy Code	Specialty	Notes
`208000000X`	Hematology & Medical Oncology	Primary specialty enrolling and managing patients on therapeutic oncology trials.
`208600000X`	Medical Oncology	Providers overseeing systemic investigational therapies and trial-related safety monitoring.
`207RC0000X`	Internal Medicine — Research	Clinicians conducting protocol visits and coordinating trial logistics.
`363L00000X`	Clinical Research Coordinator	Non-physician provider role (credentialed taxonomy) frequently listed for research visit coordination.
`207K00000X`	Surgery	Surgeons performing protocol-directed operative interventions within surgical trials.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`Z00.6`	Encounter for examination for normal comparison and control in clinical research program	Used to indicate a patient visit associated with participation in a clinical trial when there is no active disease management claim.
`Z51.89`	Encounter for other specified aftercare	May be applied for follow-up care related to trial treatment side effects and supportive care.
`C18.9`	Malignant neoplasm of colon, unspecified	Representative cancer diagnosis for patients enrolled in colorectal therapeutic trials.
`C78.7`	Secondary malignant neoplasm of liver and intrahepatic bile duct	Common metastatic site relevant to staging and eligibility for systemic investigational therapies.
`R53.1`	Weakness	Symptom often assessed and documented as an adverse event during therapeutic trial visits.
`T45.1X5A`	Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter	Used when a trial patient experiences an adverse reaction requiring clinical management.
`Z51.11`	Encounter for antineoplastic chemotherapy	Used when trial therapy is a chemotherapeutic agent and the visit is for administration and monitoring.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`96365`	Intravenous infusion, chemotherapy administration, initial, up to 1 hour	Commonly billed when investigational systemic therapy is administered during a therapeutic trial visit.
`96366`	Intravenous infusion, chemotherapy administration, each additional hour	Used for extended infusion times required by trial protocols beyond the initial hour.
`99024`	Postoperative follow-up visit, typically without E/M when related to care only	May be used for routine trial postoperative surveillance when payers accept and no E/M is separately reported.
`36415`	Collection of venous blood by venipuncture	Frequently performed for protocol-mandated labs, pharmacokinetic sampling, and biomarker collection.
`99214`	Office or other outpatient visit for the evaluation and management of an established patient, moderate complexity	Often used for trial-related medical management visits that meet E/M documentation requirements.

OpenPayer

Summary & Overview

HCPCS M1404: Patients on a Therapeutic Clinical Trial