CurrentMass General Brigham Health PlanPolicy N/A

Provider Payment Guidelines — Routine Costs in Qualified Clinical Trials

Defines Mass General Brigham Health Plan's reimbursement approach for routine patient costs associated with qualified clinical trials and the billing/documentation expectations for providers; applies to providers submitting claims for members in clinical trials across applicable lines of business.

Policy Summary

PayerMass General Brigham Health Plan

PolicyProvider Payment Guidelines — Routine Costs in Qualified Clinical Trials

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2024

Next Review DateN/A

Key ActionObtain and document prior authorization or referrals when required and make medical records available upon request to support claims for routine clinical trial costs.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

routine costs coveredcoverage stance for qualified clinical trials

Q0/Q1 requiredmodifier guidance

Z00.6 requireddiagnosis code guidance

edits & auditsclaims processing controls

Commercial & MAlines of business

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Routine Clinical Trial Cost Coverage

Routine cost coverage criteria and exclusions

Mass General Brigham Health Plan will reimburse routine patient costs when medically necessary and consistent with the member's benefit plan if the member participates in a qualified clinical trial. Routine costs and exclusions are defined below.

Reimbursement applies when services are medically necessary and consistent with the member's benefit plan for a member participating in a qualified clinical trial.

Routine costs include

Items or services typically provided absent a clinical trial (conventional care).
Items or services solely for the provision of the investigational item or service that are not statutorily excluded from coverage (e.g., cosmetic surgery).
Clinical monitoring for the effects of the investigational item or service.
Prevention and management of complications related to the investigational item or service.
Items or services for reasonable and necessary care that may occur from the provision of an investigational service or item.
Actual costs of the device or drug when not paid for by the manufacturer, distributor, or provider, pursuant to MGL 175 Section 110L(a)(1).

Exclusions (routine costs do NOT include any of the following)

The investigational item, device, or service itself when paid for by the manufacturer, distributor, or provider of the drug/device (MGL 175 Section 110L(a)(1)).
Items and services provided solely to satisfy data collection or analysis needs that are not used in the direct clinical management of the member.
Any item, service, or cost that is reimbursed or provided by the sponsors of the clinical trial.
Non-health care services that a member may receive as a result of being enrolled in the qualified clinical trial.
Services or costs that are not covered under the member's benefit plan.

Modifier, Diagnosis, and Code List Guidance

Clinical trial modifiersModifier

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

Clinical trial diagnosis codeICD-10

Z00.6

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

Code list completeness

Scope of code listCodes are provided for informational purposes only and do not guarantee member coverage or provider reimbursement

CompletenessThe code list may not be all-inclusive; additional relevant codes may exist

Inactive/deleted codesDeleted codes and codes not effective at the time of service may not be eligible for reimbursement

Verification recommendedProviders should verify code validity and applicability at time of claim submission

Referral, Prior Authorization, and Medical Record Requirements

Note

Referral, prior authorization, and medical record requirements

Various services and procedures may require a referral and/or prior authorization; providers must follow the plan's referenced location for those requirements. Providers must maintain medical records that document services were medically necessary and make all documentation available to Mass General Brigham Health Plan upon request. Failure to produce requested records may result in denial or retraction of payment. Claims are subject to payment edits and audits per the plan's reimbursement rules.

Check the plan's referral and prior authorization requirements at the referenced location before rendering services.
Document medical necessity in the member's medical record for all services rendered.
Provide requested medical records to Mass General Brigham Health Plan promptly upon request.
Be aware claims are subject to payment edits and the plan may audit services regardless of provider participation status; inability to produce records can lead to denial or retraction of payment.

Key Definitions

Clinical trial

DefinitionA clinical trial is a prospective biomedical or health-related research study of human subjects designed to test new methods of screening, prevention, diagnosis, or treatment of a disease

PurposeConducted to determine safety and efficacy of products, devices, drugs, treatments, procedures, or therapies to improve health

PhasesClinical trials are conducted in phases (I–IV) that answer different scientific questions about safety, effectiveness, and long-term effects

Qualified individual

Qualified individual — definitionAn individual eligible to participate in an approved clinical trial according to the trial protocol and for whom participation is appropriate as determined by the individual's doctor or by provision of medical and scientific information establishing appropriateness

Eligibility basis