CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Coverage for routine patient costs in approved clinical trials

Governs coverage requirements under Rhode Island law (RIGL §27-20-60) and federal PPACA Sec. 2709 for commercial products, specifying routine cost coverage for qualified individuals participating in approved clinical trials and billing modifiers for clinical trial services.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyCoverage for routine patient costs in approved clinical trials

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2014

Next Review DateN/A

Key ActionConfirm and obtain prior authorization when services billed with modifier Q1 require it to ensure proper reimbursement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Phase I-IVclinical trial phases defined

Q0, Q1clinical trial billing modifiers specified

2014statutory effective date

Commercialmarket applicability

Coverage Criteria for Routine Patient Costs

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Routine patient cost coverage

Covered when ALL of the following are met:

Qualified individual and approved trial: Individual is a 'qualified individual' eligible for an approved clinical trial (phase I–IV) for treatment of cancer or a life‑threatening disease or condition as defined by RIGL §27-20-60 and PHS Act sec. 2709.

See RIGL §27-20-60 and PHS Act sec. 2709

Participation and provider conditions: Either the referring healthcare professional is a participating provider who has concluded the individual's participation in the trial would be appropriate, or the participant/beneficiary provides medical and scientific information establishing that participation would be appropriate.

Per PHS Act section 2709(b)

Coverage scope: Routine patient costs include items and services typically covered for a similarly situated patient not enrolled in the clinical trial, furnished in connection with participation in the trial and subject to the member's benefit limitations and exclusions.

Benefits may vary by contract; refer to member's benefit booklet

Excluded from routine patient cost coverage are: (1) the investigational item, device, or service itself; (2) items and services provided solely to satisfy data collection and analysis needs and not used in the direct clinical management of the patient; and (3) any service clearly inconsistent with widely accepted and established standards of care for the diagnosis. Additionally, statutory exclusions and plan-type limitations apply (for example, Rhode Island–mandated benefits do not apply to Medicare Advantage plans and certain limited-benefit or grandfathered plans may be excluded).

Benefits and coverage details may vary by group or contract; refer to the applicable Benefit Booklet or Subscriber Agreement for specifics about experimental/investigational services and any network or out-of-network provisions.

This medical policy is provided for informational purposes only and is not a guarantee of payment. Benefits and eligibility are determined by the member's subscriber agreement, member certificate, or employer agreement, which supersede this policy. If services are determined to be not medically necessary (or are non-covered benefits), providers may not charge the member for those services unless the member has been informed and has agreed in writing in advance to pay out-of-pocket. BCBSRI reserves the right to review and revise this policy at any time.

Provider Responsibilities and Billing Guidance

Denial Risk

Denial triggers

Note: Items, drugs, or services billed with modifier Q0 indicate the investigational item or sponsor‑reimbursed service and will not be reimbursed by the plan. Providers should append modifier Q0 when payment is not expected from the plan because the clinical trial sponsor will cover the cost. Failure to append the correct modifier or billing investigational items as sponsor‑reimbursed may result in claim denials.

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

Documentation Required

Qualification documentation

Providers must document qualifying status for members participating in an approved clinical trial. Acceptable documentation includes: the trial protocol or documentation showing the member meets trial eligibility, and a statement from the referring healthcare professional confirming the member is eligible and that participation is appropriate. Retain and submit this documentation with prior authorization requests or upon request to support coverage of routine patient costs.

Documentation of trial eligibility (protocol or sponsor letter)
Referring provider statement confirming eligibility and appropriateness

Prior Authorization

Provider action: prior authorization and billing modifiers

Providers must confirm whether items, drugs, or services associated with a clinical trial require prior authorization and obtain authorization when applicable. When the trial does not sponsor the service (Q1), routine services may still require prior authorization per the member's benefit plan — contact the plan or check the benefit booklet before billing. Append modifier Q1 for routine clinical services in an approved trial when payment is expected; append Q0 when payment is expected from the sponsor.

Q1 — Routine clinical service provided in a clinical research study that is in an approved clinical research study
Confirm prior authorization requirements with the member's benefit booklet or plan; obtain authorization when required

Background

Clinical trials are research studies designed to evaluate the safety and effectiveness of interventions and generally proceed through phases I–IV, from initial human safety testing through post‑marketing surveillance. Under Rhode Island law (RIGL §27-20-60) and applicable federal law, routine patient costs for qualified individuals participating in an approved clinical trial (phase I–IV) may be covered when statutory conditions are met. The state statute describes trial-related exclusions, participation and provider conditions, and plan‑type applicability, and also specifies that the requirement is effective for plan years beginning on or after January 1, 2014.

Key Definitions

Approved clinical trial — definition

DefinitionA phase I, II, III, or IV clinical trial conducted in relation to the prevention, detection, or treatment of cancer or a life‑threatening disease or condition.

Acceptable approval/funding sourcesNIH, CDC, AHRQ, CMS, cooperative groups/centers, qualified non‑governmental research entities, DoD, VA, or studies under an FDA investigational new drug application (or certain exempt drug trials).

Trials includedTrials approved/funded or conducted under FDA investigational new drug applications, or certain exempt drug trials; peer‑reviewed federal studies as specified in statute.

Qualified individual — definition

DefinitionA participant or beneficiary who is eligible to participate in an approved clinical trial according to the trial protocol for treatment of cancer or another life‑threatening disease or condition.

Provider referral conditionEligibility requires that the referring healthcare professional is a participating provider who has concluded participation is appropriate per the protocol, or the participant provides medical/scientific information establishing appropriateness.

Participating provider — definition

DefinitionA healthcare provider that, under contract with the health carrier (or its contractor/subcontractor), has agreed to provide healthcare services to covered persons with an expectation of receiving payment directly or indirectly from the health carrier.

Expectation of paymentIncludes expectation of payment other than coinsurance, copayments, or deductibles; payment may be direct or indirect.

OpenPayer

Coverage for routine patient costs in approved clinical trials

Coverage Criteria for Routine Patient Costs

Coding and Modifiers

Provider Responsibilities and Billing Guidance

Background

Key Definitions

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