CurrentBlue Cross Blue Shield of VermontPolicy 10.01.VT201

Clinical Trials Corporate Medical Policy

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This policy defines Blue Cross VT benefit responsibilities for medically necessary routine patient care services provided during approved clinical trials for qualified individuals receiving treatment for cancer or another life-threatening disease or condition. Coverage is subject to the member’s contract, applicable federal and Vermont mandates, and the requirements in this policy.

Policy Summary

PayerBlue Cross Blue Shield of Vermont

PolicyClinical Trials Corporate Medical Policy

Policy CodePolicy 10.01.VT201

Change TypeNo material change

Effective DateDecember 1, 2026

Last ReviewAug 1, 2026

Next Review DateAugust 1, 2027

Key ActionDocument the patient’s eligibility under the approved clinical trial protocol and the trial’s approval by an eligible entity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

AllEligible trial phases

8Exclusion categories

7Qualifying approval entities

2Claim modifiers

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CurrentBlue Cross Blue Shield of VermontPolicy 10.01.VT201

Clinical Trials Corporate Medical Policy

Customize your policy alerts

Sign up for bcbsvermont Policy 10.01.VT201 alerts

Get alerted when Policy 10.01.VT201 changes without checking for updates manually.

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Policy Summary

PayerBlue Cross Blue Shield of Vermont

PolicyClinical Trials Corporate Medical Policy

Policy CodePolicy 10.01.VT201

Change TypeNo material change

Effective DateDecember 1, 2026

Last ReviewAug 1, 2026

Next Review DateAugust 1, 2027

Key ActionDocument the patient’s eligibility under the approved clinical trial protocol and the trial’s approval by an eligible entity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

AllEligible trial phases

8Exclusion categories

7Qualifying approval entities

2Claim modifiers

Trial diagnosis code

Routine Patient Care Coverage in Approved Clinical Trials

Routine patient care in approved clinical trials

Covered when all applicable requirements are met.

Routine patient care coverage

Approved trial and qualified individual: The individual is eligible under the trial protocol and the trial meets the approved clinical trial requirements.
Routine care service: The service is an otherwise covered, medically necessary physician service, diagnostic or laboratory test, hospitalization, or other service for the condition, a complication, or a treatment complication, and is consistent with the usual and customary standard of care.
Participating provider: Providers participating in the clinical trial are participating providers.

Approved clinical trial qualification

An approved clinical trial must satisfy all of the following requirements.

Approved clinical trial requirements

Qualified facility and personnel: The trial is conducted by a facility and personnel capable of conducting it based on experience, training, and patient volume.
No clearly superior alternative: The trial enrolls only patients for whom there is no clearly superior non-investigational treatment alternative, and available clinical or preclinical data reasonably expect the trial treatment to be at least as effective as the non-investigational alternative.
Informed consent: Fully informed written consent is obtained from the patient or legally authorized representative in accordance with current legal and ethical standards.
Eligible protocol approval: The peer-reviewed protocol is approved by an eligible entity.
Eligible entities are the National Institutes of Health; an NIH-affiliated cooperative group with an established NIH-approved peer review program; the FDA through an investigational new drug application or exemption; the federal Departments of Veterans Affairs or Defense; the Centers for Disease Control and Prevention; the Agency for Healthcare Research and Quality; or the Centers for Medicare & Medicaid Services.

Routine patient care coverage excludes investigational new drugs that have not been approved for marketing by the FDA for any indication, as well as drugs studied under an FDA-approved investigational new drug exemption to expand labeled indications. It also excludes non-health care services, clinical-trial operating and research-management costs, data collection and analysis, otherwise noncovered non-investigational services, products or services supplied or paid for by the trial sponsor, and the investigational item, device, or service itself unless it would otherwise be covered outside the trial.

Transport, lodging, meals, and sales tax associated with a clinical trial are denied as benefit exclusions. The applicable HCPCS codes are S9992 for transport costs, S9994 for lodging costs, S9996 for meals, and S9999 for sales tax.

Services that are clearly inconsistent with widely accepted and established regional or national standards of care for the applicable diagnosis are excluded from coverage.

Clinical Trial Coding

HCPCS ModifiersModifier

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

Clinical Trial Specific DiagnosisICD-10

Z00.6

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

Benefit ExclusionsHCPCSNot Covered

S9992	Transport costs for clinical trial.
S9994	Lodging costs for clinical trial.
S9996	Meals for clinical trial.
S9999	Sales Tax.

Documentation, Eligibility, and Billing Responsibilities

Documentation Required

Obtain Written Informed Consent

Document fully informed written consent before the approved clinical trial begins. Consent must be obtained from the patient or the patient's legally authorized representative in a manner consistent with current legal and ethical standards and requirements.

Documentation Required

Verify Trial Approval and Patient Eligibility

Confirm trial approval and patient eligibility and retain documentation showing that the trial meets the policy definition of an approved clinical trial and that the individual is eligible under the trial protocol.

The trial must be conducted by a capable facility and qualified personnel.
The trial must enroll patients for whom there is no clearly superior non-investigational alternative, with a reasonable expectation that the trial treatment will be at least as effective.
The protocol must be peer-reviewed and approved by an eligible entity: NIH; an NIH-affiliated cooperative group; FDA through an investigational new drug application or exemption; the federal Departments of Veterans Affairs or Defense; CDC; AHRQ; or CMS.

Policy Background

This policy supports coverage of medically necessary routine patient care costs provided during all phases of an approved clinical trial for a qualified individual receiving treatment for cancer or another life-threatening disease or condition. Covered routine care may include physician services, diagnostic or laboratory testing, hospitalization, and services for the condition, its complications, or treatment complications that would ordinarily be covered outside the trial. Coverage does not extend to the investigational intervention itself or to costs of conducting or managing the research, and remains subject to the member’s benefit plan and applicable coverage requirements.

Key Policy Definitions

Medically necessary care

Scope of servicesHealth care services, including diagnostic testing, preventive services, and aftercare.

AppropriatenessAppropriate in terms of type, amount, frequency, level, setting, and duration for the member’s diagnosis or condition.

Practice standardConsistent with generally accepted practice parameters as recognized by health care providers in the same or similar specialty as typically treat or manage the diagnosis or condition.

PurposeHelps restore or maintain health; prevents deterioration of or palliates the condition; or prevents the reasonably likely onset of a health problem or detects an incipient problem.

Routine patient care services

Benefit responsibilityHealth care services for which Blue Cross VT, subject to the regulation, is otherwise responsible under the patient’s health benefit plan.

Policy Summary

PayerBlue Cross Blue Shield of Vermont

PolicyClinical Trials Corporate Medical Policy

Policy CodePolicy 10.01.VT201

Change TypeNo material change

Effective DateDecember 1, 2026

Last ReviewAug 1, 2026

Next Review DateAugust 1, 2027

Key ActionDocument the patient’s eligibility under the approved clinical trial protocol and the trial’s approval by an eligible entity.

SourceLink

On This Page

Protocol eligibility: The individual is eligible to participate according to the trial protocol.

The individual must be eligible to participate according to the trial protocol.

Billing Rule

Code Clinical-Trial Claims Correctly

Apply the required clinical-trial coding to claims for services furnished in an approved clinical research study. Use Q0 for investigational clinical services and Q1 for routine clinical services.

Q0 — Investigational clinical service provided in an approved clinical research study.
Q1 — Routine clinical service provided in an approved clinical research study.
Report Z00.6, Encounter for examination for normal comparison and control in clinical research program, as the clinical-trial-specific diagnosis in the primary or secondary position when applicable.

Denial Risk

Exclude Clinical-Trial Costs

Do not bill excluded clinical-trial costs as routine patient care services. These costs are excluded from coverage under this policy unless otherwise covered outside the trial.

Investigational new drugs not approved by the FDA for any indication, or drugs studied under an FDA-approved investigational new drug exemption to expand labeled indications.
Non-health care services required as a result of treatment provided for the approved trial.
Services clearly inconsistent with widely accepted regional or national standards of care.
Costs of running the trial, including data collection and analysis, and costs of managing the research.
Non-investigational treatments and services that would not otherwise be covered under the member's benefit plan.
Products or services paid for or supplied by the trial sponsor.
The investigational item, device, or service itself, unless otherwise covered outside the trial.

Denial Risk

Use Participating Clinical-Trial Providers

Verify participating-provider status for every provider furnishing services in the clinical trial. Benefits under this policy are available only when the clinical-trial providers are participating providers.

Denial Risk

When the Trial or Member Does Not Qualify

Do not assume coverage under this policy when the trial or individual fails the qualification requirements. The policy's clinical-trial protections apply to an approved clinical trial and a qualified individual; if either requirement is not met, benefits for the trial services may be unavailable or subject to applicable exclusions and plan terms.

The trial must be an organized, systematic, scientific study addressing treatment, palliation, or prevention of a life-threatening disease or condition and a credible, specific medical or scientific question.
The trial must satisfy the facility, treatment-alternative, informed-consent, peer-review and eligible-approval requirements.
The individual must be enrolled in or participating in the health plan and eligible under the trial protocol.
Life-threatening conditions are diseases or conditions from which death is probable unless the course is interrupted.

Note

Apply the Member Benefit Plan

Verify the member's applicable contract or employer benefit plan before providing services. Benefits remain subject to all contract terms, limitations, and conditions, and the member contract or employer benefit plan takes precedence over this medical policy when there is a conflict.

Coverage varies by group or individual contract; not all groups are required to follow Vermont legislative mandates.
NEHP/ABNE and Federal Employee Program members may have different benefits; confirm coverage with the applicable customer service department or benefit materials.
For Administrative Services Only groups, consult the employer benefit plan documents because benefits may vary or not apply.
Confirm whether a specific exclusion applies before providing the service.

Trial-related careIncludes medically necessary health care services incurred as a result of treatment provided to the patient for the purposes of an approved clinical trial.

Included servicesIncludes physician services, diagnostic or laboratory tests, hospitalization, and other services provided during treatment in an approved clinical trial.

Covered condition or complicationServices may address the condition, one of its complications, or a complication of treatment provided during an approved clinical trial.

Coverage standardThe service must be consistent with the usual and customary standard of care and would be covered even if the patient were not enrolled in an approved clinical trial.

Qualified individual

Health plan statusAn individual who is enrolled or participating in a health plan or coverage.

Protocol eligibilityThe individual is eligible to participate in an approved clinical trial according to the trial protocol.

Covered treatmentThe trial participation concerns treatment of cancer or another life-threatening disease or condition.

Life-threatening condition

DefinitionA disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted.

ApplicabilityThe definition applies to diseases or conditions addressed through approved clinical trial treatment.

Required circumstanceDeath must be probable unless the disease or condition’s course is interrupted.

Approved clinical trial

Study typeAn organized, systematic, scientific study of therapies, tests, or other clinical interventions for treatment, palliation, or prevention of life-threatening diseases in human beings.

Scientific purposeThe study must seek to answer a credible and specific medical or scientific question for the purpose of advancing care.

Qualified personnel and facilityThe trial is conducted by a facility and personnel capable of conducting it by virtue of experience, training, and volume of patients treated to maintain expertise.

No superior alternativeThe trial enrolls only patients for whom there is no clearly superior, non-investigational treatment alternative, and available clinical or preclinical data provide a reasonable expectation that the trial treatment will be at least as effective as the non-investigational alternative.

Informed consentThe trial is conducted only after fully informed, written consent is obtained from the patient or the patient’s legally authorized representative in a manner consistent with current legal and ethical standards and requirements.

Peer-reviewed protocolThe trial is conducted under the auspices of a peer-reviewed protocol approved by NIH; an NIH-affiliated cooperative group with an established NIH-approved peer review program; FDA through an investigational new drug application or exemption; the federal Departments of Veterans Affairs or Defense; CDC; AHRQ; or CMS.

Participant eligibilityThe individual must be eligible to participate in the approved clinical trial according to the trial protocol.