CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Coverage for routine costs of qualifying clinical trials

Governs reimbursement and claim handling for routine patient costs and related items/services for members participating in approved clinical trials for Neighborhood Health Plan of Rhode Island across Medicaid, INTEGRITY, and Commercial lines.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCoverage for routine costs of qualifying clinical trials

Policy CodePolicy N/A

Change TypeClarified operational requirement

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionInclude the clinical trial identifier on professional and institutional claims in the specified form fields.

SourceLink

POLICY UPDATE CHANGES

Added language requiring the clinical trial number on claims per CMS mandate.

4phases of clinical trials described

Q0, Q1clinical trial modifiers listed

Z00.6primary diagnosis code required

3applicable plan lines

Coverage Criteria for Routine Costs in Clinical Trials

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Covered routine costs

Covered when ALL of the following are met:

Coverage for routine clinical trial costs: Coverage applies when services are routine patient costs for a qualified individual participating in an approved clinical trial and the services are otherwise generally available to Neighborhood members or are required for provision/monitoring of the investigational item or for diagnosis or treatment of complications arising from participation in the trial.

Excludes the investigational item/service itself and services provided solely for data collection and analysis that are not used in direct clinical management.

Neighborhood excludes from coverage the investigational item, device, or service itself when billed as part of a clinical trial. This exclusion aligns with Rhode Island statute that specifies routine patient costs do not include the investigational item, device or service itself. Examples include the study drug or device that is the subject of the research when it is not otherwise covered outside the trial.

The policy also excludes items and services that are provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient. Such services are not considered routine patient costs (for example, extra imaging performed only for protocol data collection when not clinically indicated).

Additionally, services that are clearly inconsistent with widely accepted standards of care for a particular diagnosis, lodging and transportation, expenses covered by the approved trial sponsor, non‑covered items, and any service billed with a Q0 modifier are excluded from reimbursement.

Services and items furnished solely for data collection that do not contribute to direct clinical management are explicitly excluded from routine‑cost coverage. The policy gives the example of protocol-driven procedures performed more frequently than would be clinically indicated (e.g., monthly CT scans when only a single scan is typical) as non‑routine and non‑reimbursable.

The investigational product itself remains non‑covered under this policy unless it is otherwise covered outside the clinical trial. Neighborhood will not reimburse sponsor‑provided items or any expenses that the approved trial covers.

Rhode Island law reinforces these exclusions, stating routine patient costs do not include the investigational item or services provided solely for data collection and analysis, and allows the carrier to limit coverage consistent with statutory provisions.

Billing, Modifiers, and Diagnosis Coding

Clinical trial modifiersModifier

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

Primary diagnosis code for clinical trial claimsICD-10

Z00.6

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

Claim fields for clinical trial number — professional and institutional claim field locations

Professional claim fieldCMS-1500 form: Box 19 (or electronic equivalent: 837P Loop 2300)

Institutional claim fieldUB-04: value code D4 (or electronic equivalent: 837I Loop 2300)

Inpatient institutional requirementInclude Condition Code 30 on inpatient institutional claims

CMS mandate notePer CMS mandate, include the clinical trial number on all clinical trial claims in the specified fields

Provider Responsibilities, Authorization, and Documentation

Prior Authorization

Medical necessity and prior authorization — provider responsibilities to verify eligibility and authorization

All services must be medically necessary to qualify for reimbursement. It is the provider's responsibility to verify eligibility, coverage, and authorization criteria prior to rendering services. Neighborhood may use NCDs, LCDs, industry-accepted criteria (e.g., InterQual), Rhode Island EOHHS recommendations, and Neighborhood Clinical Medical Policies to determine medical necessity. For plan-specific prior authorization requirements, refer to Neighborhood's Prior Authorization Reference page or contact Provider Services at 1-800-963-1001.

Denial Risk

Statutory denial triggers and limits

Providers must follow applicable statutory limits and nondiscrimination requirements when furnishing services related to clinical trials. Under R.I. Gen. Laws § 27-20-60, plans shall not deny, limit, or impose additional conditions on coverage of routine patient costs for items and services furnished in connection with participation in an approved clinical trial, nor discriminate against individuals for trial participation. Routine costs include items/services typically provided outside a trial, those required solely for provision or monitoring of the investigational item/service, and care needed to diagnose or treat complications arising from the investigational intervention.

RIGL § 27-20-60: prohibition on denial/limits for routine patient costs for approved clinical trials
Routine costs definition: conventional care; monitoring/administration related to investigational service; care for complications

Billing Rule

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Claims for clinical trial–related services must include required modifiers and identifiers. Use Q0 for investigational clinical services paid by the sponsor (no reimbursement expected) and Q1 for routine clinical services in an approved clinical study. Per CMS, include the clinical trial number on claims (professional and institutional). Inpatient institutional claims should also include condition code 30.

Modifiers: Q0 (investigational, sponsor-paid — not reimbursed), Q1 (routine clinical service)
Professional claims: include clinical trial number (CMS 1500 box 19; 837P Loop 2300)
Institutional claims: include clinical trial number (UB-04 value code 'D4'; 837I Loop 2300) and inpatient condition code 30

Documentation Required

Medical record and claim documentation — retention and requestability by Neighborhood

Neighborhood reserves the right to request medical records for any billed service. Documentation in the medical record must support the services billed and their medical necessity. Neighborhood follows CMS standards for proper documentation and expects providers to retain records and produce them upon request.

Maintain medical records that justify billed services and medical necessity
Provide records upon Neighborhood's request; Neighborhood may audit or request documentation to substantiate claims
Documentation standards follow CMS guidance

Key Definitions

Definition of Approved clinical trial / Qualified individual

Definition of Approved clinical trialA phase I–IV clinical trial related to the prevention, detection, or treatment of cancer or a life‑threatening disease or condition that is described in specified approvals or funding sources (e.g., NIH, CDC, AHRQ, CMS, qualifying cooperative groups, certain federal departments) as set forth in RIGL § 27-20-60.

Definition of Qualified individualAn individual eligible to participate in an approved clinical trial according to the trial protocol and deemed appropriate by a participating/referring provider or based on providing medical or scientific information, subject to any requirement that the carrier may require participation through a participating provider when applicable.

LimitationsRoutine patient cost protections do not require coverage for investigational items/devices/services themselves, items solely for data collection, services inconsistent with accepted standards of care, or coverage outside network unless out‑of‑network benefits apply.

Background and Context

Clinical trials progress through standard phases (I–IV) that evaluate safety, dosing, efficacy, and post‑marketing effects. Within this policy, routine patient costs are defined as items and services that would typically be provided to members outside of a trial and that are necessary for clinical management or monitoring of trial interventions, including diagnosis and treatment of complications arising from participation.

Routine costs include services provided in either the experimental or control arms that are otherwise generally available to Neighborhood members, except for specifically excluded items (see exclusions). Routine costs do not include the investigational item or any services provided solely for data collection and analysis that do not affect direct patient care.

Rhode Island statute cited in this policy establishes these distinctions and permits the carrier to apply coverage limits consistent with the law; it also clarifies that the statute does not require coverage for services outside the plan’s network unless out‑of‑network benefits are otherwise provided.

OpenPayer