CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Clinical trial routine cost reimbursement

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

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyClinical trial routine cost reimbursement

Policy CodePolicy N/A

Change TypeMinor wording & coding guidance updates

Effective DateN/A

Next Review DateN/A

Key ActionVerify eligibility, coverage and authorization criteria prior to rendering services and refer to the plan-specific Prior Authorization Reference page or contact Provider Services at 1-800-963-1001.

SourceLink

POLICY UPDATE CHANGES

Added language around clinical trial number requirement on claims.

Policy reviewed and revised to align with CMS requirements.

4clinical trial phases described (I-IV)

3claim locations required for trial number

2clinical trial modifiers listed

2014-01-01statute effective date

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Coverage Criteria

Coverage applies when the clinical trial is an approved clinical trial and services are medically necessary. Routine costs are covered subject to the criteria below.

ALL of the following

The clinical trial is an 'approved clinical trial' as defined by RIGL § 27-20-60 and meets one or more of the federal or qualifying funding/approval sources (e.g., NIH, CDC, AHRQ, CMS, Department of Defense, Department of Veterans Affairs, qualified non-governmental research entities, or peer-reviewed Department of Energy/VA/DoD studies).
Legal definition per RIGL § 27-20-60.
The member is enrolled in the approved clinical trial and the services requested are medically necessary for the member’s care outside of investigational purposes.
Routine care must be consistent with services typically covered for a qualified individual not enrolled in a trial.
Routine costs covered include:
- Items or services that would typically be provided absent a clinical trial (conventional care).
- Items or services required for provision of the investigational item or service, clinically appropriate monitoring of effects, or prevention of complications (e.g., administration and monitoring).
- Items or services needed to diagnose or treat complications arising from participation in the investigational item or service.
Routine costs do NOT include (coverage exclusions):
- The investigational item, device or service itself, unless it is otherwise covered outside the trial.
- Items and services provided solely to satisfy data collection and analysis needs and not used in the direct clinical management of the member (e.g., extra research-only imaging).
- Items and services customarily provided free-of-charge by the research sponsor to any enrollee in the trial.
- Services or items clearly inconsistent with widely accepted and established standards of care for the diagnosis.
- Lodging, transportation, and other non-medical expenses.
- Any expenses the approved trial covers or any service billed with modifier Q0.
Neighborhood Health Plan will cover reasonable and necessary items and services used to diagnose and treat complications arising from participation in clinical trials.
Per CMS clinical trial coverage guidance.
Claims for clinical trial services should include the clinical trial identifier on claims per CMS instructions (professional: CMS-1500 box 19 or 837P Loop 2300; institutional: UB-04 value code 'D4' or 837I Loop 2300). Inpatient institutional claims should also include condition code 30.
Operational billing requirement.
Use modifiers Q1 for routine clinical services in an approved clinical research study and Q0 for investigational clinical services provided in a clinical research study when the item/drug/service is not expected to be reimbursed by the sponsor. Services billed with Q0 will not be reimbursed by the plan.
Billing modifier guidance.

Coding and Claim Elements

Clinical trial modifiers and diagnosis codeCPT | HCPCS | ICD-10Covered

Q0	Investigational clinical service provided in a clinical research study (use when sponsor reimburses and payment not expected); services filed with Q0 will not be reimbursed.
Q1	Routine clinical service provided in a clinical research study.
Z00.6	Encounter for examination for normal comparison and control in clinical research program (primary diagnosis code required for clinical trial claims).

Inpatient condition code — inv-03: Include condition code 30 on inpatient institutional claims

RequirementInclude condition code 30 on inpatient institutional claims

ScopeApplies to inpatient institutional claims for members participating in approved clinical trials

ReferencePer CMS mandate and Neighborhood policy coding requirements

Claim element - professional — inv-04: Include clinical trial number on CMS 1500 form box 19 or 837P Loop 2300

RequirementInclude the clinical trial number on professional claims in CMS 1500 form box 19 or 837P Loop 2300

When to ReportFor routine clinical services provided to qualified individuals enrolled in an approved clinical trial

PurposeSupports claim adjudication per CMS clinical trial billing guidance

Claim element - institutional — inv-05: Include clinical trial number using UB-04 value code 'D4' or 837I Loop 2300

RequirementInclude the clinical trial number on institutional claims using UB-04 value code 'D4' or 837I Loop 2300

Inpatient NoteInpatient institutional claims must also include condition code 30 in addition to the D4/837I trial identifier

When to ReportFor routine clinical services and other covered institutional services for qualified individuals in approved clinical trials

Provider Actions and Requirements

Prior Authorization

Pre-service verification

Verify eligibility, coverage, and any required authorizations prior to rendering services. All services must be medically necessary to qualify for reimbursement; Neighborhood may use NCDs, LCDs, industry-accepted criteria (e.g., InterQual), Rhode Island EOHHS recommendations, and Neighborhood Clinical Medical Policies when determining medical necessity. For plan-specific prior authorization rules, refer to Neighborhood's Prior Authorization Reference page and Clinical Medical Policies. Contact Provider Services at 1-800-963-1001 with questions.

Verify eligibility and coverage before scheduling services
Obtain prior authorization when required per plan-specific Prior Authorization Reference
Document medical necessity per accepted criteria to support claims

Note

Provider participation requirement

Providers must not deny or limit coverage of routine patient costs, nor discriminate against individuals, solely because they participate in an approved clinical trial, consistent with RIGL § 27-20-60. Carrier may require that services be furnished by a participating provider if providers in the clinical trial will accept the individual — ensure that participation requirements are confirmed and documented prior to referral or scheduling.

Confirm whether the trial site/provider is participating with Neighborhood before authorizing or referring
Do not impose additional conditions or discriminate based on trial participation when billing for routine patient costs
Document trial participation and any carrier-directed provider participation requirements in the medical record

Definitions

Approved clinical trial — inv-08

DefinitionAn 'approved clinical trial' is a phase I, II, III or IV clinical trial related to prevention, detection or treatment of cancer or a life‑threatening disease or condition that meets criteria such as funding/approval by NIH, CDC, AHRQ, CMS, a qualifying cooperative group or center, review by FDA under an investigational new drug application, or specified exemptions.

Phases IncludedPhase I, Phase II, Phase III, Phase IV clinical trials are encompassed by this definition.

Statutory BasisDefined in RIGL § 27-20-60 governing coverage for individuals participating in approved clinical trials.

Qualified individual — inv-09

DefinitionA 'qualified individual' is a participant or beneficiary who is eligible to participate in an approved clinical trial per the trial protocol and either is referred by a participating provider who has concluded participation is appropriate or provides medical/scientific information establishing appropriateness.

Referring Provider RoleReferring health care professional must ordinarily be a participating provider when concluding that trial participation is appropriate.

Alternative EvidenceThe individual may self-establish appropriateness by providing medical and scientific information if not referred by a participating provider.

Routine patient costs — inv-10

Definition'Routine patient costs' are items and services typically provided absent a clinical trial (e.g., conventional care), items required for provision or clinically appropriate monitoring of the investigational item or service, and care needed to diagnose or treat complications arising from the investigational item or service—excluding the investigational item/device itself and services provided solely to satisfy data collection requirements.

Included ExamplesConventional care, administration/monitoring related to investigational therapies, prevention and treatment of complications.

ExclusionsThe investigational item/device itself and services solely for data collection are not considered routine patient costs.