CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Clinical Trials Payment Policy – Archive 4

Defines Neighborhood Health Plan of Rhode Island reimbursement and billing requirements for routine costs and related services for members participating in approved clinical trials across Medicaid, INTEGRITY, and Commercial lines.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyClinical Trials Payment Policy – Archive 4

Policy CodePolicy N/A

Change TypeClarified & Revised (alignment to CMS; claim trial number added)

Effective Date

Next Review Date

Key ActionProviders must maintain medical record documentation supporting billed services and medical necessity; Neighborhood may request records and follows CMS documentation standards.

SourceLink

POLICY UPDATE CHANGES

Added language around clinical trial number requirement on claims (noted in 09/05/2023 history).

Policy reviewed and revised to align with CMS requirements on 11/15/2022.

Annual reviews on 09/17/2024 and 10/27/2025 contained no content changes (2025 updated RIGL link).

1Required Primary Diagnosis Code

2Clinical Trial Modifiers (Q0/Q1)

3Excluded Categories Listed

Policy overview & scope

This policy governs reimbursement of routine patient costs and reasonable and necessary items and services to diagnose and treat complications arising from participation in clinical trials. It follows the definition and coverage requirements in RIGL §27-19-64 for approved clinical trials (phases I–IV) and the CMS clinical trial guidance for routine cost coverage and billing practices.

The policy applies to Neighborhood Health Plan lines: Medicaid, INTEGRITY, and Commercial, and defines routine patient costs as items/services typically covered for a qualified individual not enrolled in a trial while excluding investigational items, data-collection-only items, sponsor-covered costs, and services inconsistent with accepted standards of care.

Policy Metadata

PayerNeighborhood Health Plan of Rhode Island

PolicyClinical Trials Payment Policy (Archive 4)

Policy NumberN/A

StatusCURRENT

Last Review2025-10-27

Effective Date

Next Review

Reimbursement eligibility and trial definitions

General Reimbursement Eligibility

Services reimbursed when ALL of the following are met:

ALL of the following

Service is medically necessary.
Member is participating in an approved clinical trial as defined by RIGL §27-19-64 (phase I-IV) related to prevention, detection, or treatment of cancer or a life‑threatening disease or condition.
Routine patient costs are those items/services typically covered for a qualified individual not enrolled in a clinical trial, excluding investigational items, data-collection-only items, and services inconsistent with accepted standards of care.
Services are not otherwise excluded (see Exclusions).

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Definition of Approved Clinical Trial (per RIGL §27-19-64)

An approved clinical trial meets ANY of the following descriptions:

ANY of the following

The study or investigation is approved or funded (including in-kind) by NIH, CDC, AHRQ, CMS, a cooperative group/center of those entities, DoD, or VA, or a qualified nongovernmental research entity identified by NIH, or reviewed/approved through peer review comparable to NIH standards.
The study or investigation is conducted under an investigational new drug (IND) application reviewed by the FDA.
The drug trial is exempt from having an IND application.

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Routine Costs Included

Routine costs include ALL of the following when provided as part of the trial:

ALL of the following

Items or services typically provided absent a clinical trial (conventional care).
Items/services required solely for provision of the investigational item or service, clinically appropriate monitoring of its effects, or prevention of complications (e.g., administration of a noncovered chemotherapeutic agent).
Items/services needed for reasonable and necessary care arising from the investigational item/service, including diagnosis or treatment of complications.

Routine Costs Excluded

Routine costs do NOT include any of the following (ANY of):

ANY of the following

The investigational item, device, or service itself (unless otherwise covered outside of the clinical trial).
Items and services provided solely to satisfy data collection and analysis needs and not used in the direct clinical management of the patient (e.g., monthly scans when not clinically indicated).
A service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis.
Lodging and transportation.
Any expenses that the approved trial covers (sponsor-covered costs).

Required codes, modifiers, and claim reporting

Clinical Trial ModifiersHCPCS

Q0	Investigational clinical service provided in a clinical research study that is in an approved clinical research study (append when sponsor reimburses; services filed with Q0 will not be reimbursed).
Q1	Routine clinical service provided in a clinical research study that is in an approved clinical research study.

Required Primary Diagnosis for Clinical Trial ClaimsICD-10

Z00.6

Encounter for examination for normal comparison and control in clinical research program

Institutional Claim Value Code / Condition Code Requirementsmixed

Value code D4	Clinical trial number required on UB-04 (837I Loop 2300)
Condition code 30	Inpatient institutional claims should include condition code 30

Operational billing requirement: per CMS mandate, include the clinical trial number on professional claims in CMS-1500 box 19 (or 837P Loop 2300) and on institutional claims using UB-04 value code D4 (or 837I Loop 2300). Append modifier Q1 for routine services (use Q0 when the sponsor reimburses; Q0 lines will not be reimbursed).

Inpatient institutional claims for clinical trial participants must also include Condition code 30. Providers must maintain documentation supporting billed services and medical necessity and submit claims within timely filing guidelines following CPT, ICD-10-CM, and HCPCS coding standards.

Billing, documentation, and operational requirements

Billing Rule

Append clinical trial modifier and include trial number

Append modifier Q1 for routine clinical services provided in an approved clinical research study. If the sponsor reimburses the service, append modifier Q0 (services filed with Q0 will not be reimbursed). Include the clinical trial number on professional claims (CMS 1500 form box 19 or 837P Loop 2300) and on institutional claims (UB-04 value code D4 or 837I Loop 2300).

Affected codes: Q1, Q0, D4, Z00.6
Note: Lines billed with modifier Q0 will not be reimbursed.
Where to report trial number: CMS 1500 box 19 or 837P Loop 2300; UB-04 value code D4 or 837I Loop 2300

Billing Rule

Inpatient claims condition code

For inpatient institutional claims related to clinical trial participants, include condition code 30 on the claim.

Documentation Required

Support medical necessity and service billed

Maintain medical record documentation that supports the services billed and the medical necessity of those services. Neighborhood may request medical records for any billed service. Documentation must follow CMS standards for proper documentation requirements.

Prior Authorization

Verify eligibility and authorizations prior to services

Verify member eligibility, coverage, and any required authorizations prior to rendering services. Providers are responsible for confirming these criteria and should reference the plan-specific Prior Authorization Reference page and Neighborhood's Clinical Medical Policies.

Billing Rule

Timely filing and coding standards

Submit complete claims within contractually determined timely filing guidelines and use standard coding per CPT, ICD-10-CM, and HCPCS coding systems.

Submit within timely filing guidelines per provider contract.
Use CPT, ICD-10-CM, and HCPCS coding standards.

Key terms

Definitions

Approved clinical trialA phase I–IV clinical trial related to cancer or a life‑threatening disease that meets criteria in RIGL §27-19-64 (approved/funded by NIH, CDC, AHRQ, CMS, cooperative groups, DoD, VA; conducted under an FDA IND; exempt drug trials; or peer-reviewed studies comparable to NIH).

Routine patient costsItems and services consistent with coverage typically provided to a qualified individual not enrolled in a trial; includes conventional care, services required to provide or monitor investigational items, and care to diagnose or treat complications; excludes the investigational item itself, data-collection-only items, services inconsistent with standard care, sponsor‑covered costs, and services billed with Q0.

Policy revision timeline

11/15/2022revision

Policy reviewed and revised to align with CMS requirements (material change).

09/05/2023clarification

Clarified requirement to include the clinical trial number on claims and specified reporting locations on professional and institutional claim forms (CMS 1500 box 19 or 837P Loop 2300; UB-04 value code D4 or 837I Loop 2300) (material change).

09/17/2024annual_review

Annual review with no clinical policy statement changes.

10/27/2025annual_reviewLatest

Annual review with no clinical policy statement changes; updated RIGL link.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyClinical Trials Payment Policy – Archive 4

Policy CodePolicy N/A

Change TypeClarified & Revised (alignment to CMS; claim trial number added)

Effective Date

Next Review Date

Key ActionProviders must maintain medical record documentation supporting billed services and medical necessity; Neighborhood may request records and follows CMS documentation standards.

SourceLink

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