CurrentBlue KCPolicy POL-PP-248

Clinical Trials — Routine Cost Reimbursement

Governs reimbursement and billing requirements for routine costs related to approved clinical trials for Blue KC lines of business and provider types indicated. Affects providers submitting claims for services performed in clinical research.

Policy Summary

PayerBlue KC

PolicyClinical Trials — Routine Cost Reimbursement

Policy CodePolicy POL-PP-248

Change TypeNo material changes

Effective DateJul 15, 2024

Next Review DateN/A

Key ActionBill clinical trial services with modifier Q0 or Q1 and include ICD-10 Z00.6 plus the 8-digit clinical trial number on the claim.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Q0/Q1 requiredModifier requirement for clinical trial services

Z00.6 requiredICD-10 diagnosis code to accompany claim

Rev code 0624Inpatient investigational device

30Condition code for 837I

MultipleLines of business impacted

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Coverage for Routine Clinical Trial Costs

Coverage for routine clinical trial costs

Covered when ALL of the following are met:

ALL of the following

Member is enrolled in a plan subject to PPACA/ACA requirements or the plan's benefit terms that allow coverage for routine costs related to certain clinical trials (per federal law).
The service billed is a routine patient cost associated with a clinical trial (clinical trials defined as scientific studies to prevent, screen for, diagnose, or treat disease).
Services provided as part of a clinical trial are billed with modifier Q0 or Q1.
The claim includes ICD-10 diagnosis code Z00.6 in either the primary or secondary diagnosis position.
The 8-digit clinical trial number is reported on the claim: for 837I use Value Code D4 with the 8-digit trial number; reporting the clinical trial number on the 837I or 837P 2300 loop is mandatory for items/services provided in clinical trials, registries, or under CED.
For inpatient claims involving an investigational device, revenue code 0624 is present and the IDE number is included in line-level detail (Loop 2300).
837I claims contain condition code 30 for non-research services provided to patients enrolled in a qualified clinical trial.
Documentation must clearly identify and support the procedures performed; complete documentation must be submitted with an appeal if a denial is appealed.

Clinical Trial Billing and Coding Requirements

Clinical trial billing codesmixed

Q0	Investigational clinical service provided in a clinical research study that is in an approved clinical research study
Q1	Routine clinical service provided in a clinical research study that is in an approved clinical research study
Z00.6	Encounter for examination for normal comparison and control in clinical research program
G0293	Clinical trial related code (informational list)
G0294	Clinical trial related code (informational list)
S9988	Clinical trial related code (informational list)
S9990	Clinical trial related code (informational list)
S9991	Clinical trial related code (informational list)
S9992	Clinical trial related code (informational list)
S9994	Clinical trial related code (informational list)

1–10 of 12

1/2

ModifiersModifier

Q0	Investigational clinical service provided in a clinical research study that is in an approved clinical research study
Q1	Routine clinical service provided in a clinical research study that is in an approved clinical research study

Clinical trial number reporting

RequirementMandatory to report the clinical trial number on 837I or 837P claims in the 2300 loop for items/services provided in clinical trials, studies, registries, or under CED.

837I Value CodeInclude Value Code D4 with the 8-digit clinical trial number on 837I claims.

Condition code (837I)837I inpatient claims must contain condition code 30 for non-research services provided to patients enrolled in a qualified clinical trial.

Inpatient-specific requirementFor inpatient claims include revenue code 0624 and the IDE number in line-level detail (Loop 2300).

Diagnosis codeInclude ICD-10 code Z00.6 in the primary or secondary diagnosis position when billing clinical trial services.

Claim Submission and Provider Billing Actions

Billing Rule

Claim submission and documentation requirements for clinical trial services

Bill all services provided as part of a clinical trial with modifier Q0 (investigational) or Q1 (routine). Include ICD-10 code Z00.6 in the primary or secondary diagnosis position, and report the 8-digit clinical trial number in 837I Value Code D4 (2300 loop). For inpatient claims, include revenue code 0624 and the IDE number in line-level detail; 837I claims must also contain condition code 30. Documentation must clearly identify and support procedures performed and must be submitted with any denial appeal.

Use modifier Q0 or Q1 on all clinical trial service claims (e.g., S9988, S9990, S9991, S9992, S9994, S9996, G0293, G0294).
Include ICD-10 diagnosis code Z00.6 in primary or secondary diagnosis position.
Report the 8-digit clinical trial number in 837I Value Code D4 (2300 loop); clinical trial number reporting is mandatory on 837I or 837P 2300 loop.
Inpatient claims must include revenue code 0624 and the IDE number in line-level detail; 837I claims must contain condition code 30.
Maintain complete documentation that clearly identifies and supports procedures; submit complete documentation with any denial appeal.

Definitions Related to Clinical Trials

Clinical trials (definition)

DefinitionClinical trials are scientific studies conducted to find better ways to prevent, screen for, diagnose, or treat disease; they may also determine which approaches work best for certain illnesses or groups and produce high-quality data for healthcare decision making.

ScopeApplies to services provided as part of approved clinical trials and affects billing and documentation requirements.

Billing implicationServices provided as part of a clinical trial must be billed with modifier Q0 or Q1 and accompanied by ICD-10 Z00.6 and the clinical trial number as specified.

Q0 and Q1 modifiers

Q0Modifier Q0 — Investigational clinical service provided in a clinical research study that is in an approved clinical research study.