CurrentExcellus Health Plan IncPolicy 11.01.10

Clinical Trials

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This policy governs coverage requests for member participation in approved clinical trials and identifies the routine costs eligible for coverage. It applies to providers submitting clinical trial participation requests, with special coordination guidance for Medicare Advantage members.

Policy Summary

PayerExcellus Health Plan Inc

PolicyClinical Trials

Policy CodePolicy 11.01.10

Change TypeAnnual reviewno material changes

Effective DateSeptember 17, 2026

Next Review DateSeptember 1, 2027

Key ActionSubmit the clinical trial protocol, including institutional review board approval, to the Health Plan.

SourceLink

POLICY UPDATE CHANGES

The policy underwent an annual review with policy intent unchanged.

4Eligible clinical trial phases

ALLParticipation criteria

5Eligible routine-cost categories

6Ineligible non-routine cost examples

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CurrentExcellus Health Plan IncPolicy 11.01.10

Clinical Trials

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Sign up for excellus_health_plan_inc Policy 11.01.10 alerts

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Policy Summary

PayerExcellus Health Plan Inc

PolicyClinical Trials

Policy CodePolicy 11.01.10

Change TypeAnnual reviewno material changes

Effective DateSeptember 17, 2026

Next Review DateSeptember 1, 2027

Key ActionSubmit the clinical trial protocol, including institutional review board approval, to the Health Plan.

SourceLink

POLICY UPDATE CHANGES

The policy underwent an annual review with policy intent unchanged.

4Eligible clinical trial phases

ALLParticipation criteria

5Eligible routine-cost categories

6Ineligible non-routine cost examples

Clinical Trial Participation and Cost Eligibility

Clinical Trial Participation Coverage Criteria

Clinical trial participation coverage requests are covered only when ALL of the following criteria are met.

ALL of the following

The member is eligible under the clinical trial protocol to participate.
A copy of the clinical trial protocol, including institutional review board (IRB) approval, is provided to the Health Plan.
The clinical trial is an approved clinical trial meeting ALL of the following
- The trial is a Phase I, II, III, or IV clinical trial.
- The trial is conducted in relation to the prevention, detection, or treatment of cancer or another life-threatening disease or condition.
- The trial is approved or funded by at least ONE of the following
  - The National Institutes of Health (NIH).
  - A qualified nongovernmental research entity identified in guidelines issued by the NIH for center support grants.
  - The Centers for Disease Control and Prevention (CDC).
  - The Agency for Health Care Research and Quality (AHRQ).
  - The Centers for Medicare & Medicaid Services (CMS).
  - An investigational new drug (IND) application reviewed by the U.S. Food and Drug Administration (FDA).

Eligible Routine Clinical Trial Costs

Routine costs associated with approved clinical trials are eligible for coverage when they are items or services that would otherwise be covered in the absence of the clinical trial or are required to administer the investigated item or service.

Eligible routine clinical trial costs include

Items and/or services that would be provided if there were no clinical trial, such as conventional care including hospital services, room and board, physician services, office visits, laboratory tests, and diagnostic tests.
Items and/or services required to administer the item or service being investigated, such as administration of a chemotherapy drug being tested.

Covered Routine Clinical Trial Costs

Routine costs associated with approved clinical trials that are eligible for coverage include the following covered categories.

Covered routine clinical trial costs

Items and/or services that would be provided if there were no clinical trial, such as conventional care including hospital services, room and board, physician services, office visits, laboratory tests, and diagnostic tests.
Items and/or services required to administer the item or service being investigated, such as administration of a chemotherapy drug being tested.
Clinical monitoring of the effects of the item and/or service being investigated.
Items and/or services for the prevention of complications.
Other reasonable and necessary items and/or services arising from the trial, such as diagnosis or treatment of complications.

Ineligible Non-Routine Clinical Trial Costs

Non-routine costs associated with approved clinical trials are ineligible for coverage when they fall into any of the following categories.

Ineligible non-routine clinical costs include, but are not limited to

The item and/or service being investigated.
Items and/or services provided only to satisfy the collection and analysis of data for the trial and not used in the direct clinical management of the patient, such as monthly CT scans when only a single scan would be medically necessary.
Non-health-care services, such as transportation, lodging, and meal expenses.
Items and/or services inconsistent with the established standard of care for the patient's diagnosis, such as study of a new combination of drugs to determine their safety and efficacy when used in combination.
Items and/or services provided by the research sponsors free of charge.

The item and/or service being investigated is not eligible as a routine clinical trial cost.

Items and/or services provided only to satisfy the collection and analysis of data for the trial, which are not used in the direct clinical management of the patient, are not eligible as routine clinical trial costs. For example, monthly CT scans are not eligible when only a single scan would be medically necessary.

Non-health-care services, including transportation, lodging, and meal expenses, are not eligible as routine clinical trial costs.

Items and/or services inconsistent with the established standard of care for the patient's diagnosis are not eligible as routine clinical trial costs.

Items and/or services provided by research sponsors free of charge are not eligible as routine clinical trial costs.

Duplicative items and/or services are not eligible as routine clinical trial costs.

Clinical Trial Billing Codes

CPT CodesCPT

No codes listed

HCPCS CodesHCPCS

S9988	Services provided as part of a Phase I clinical trial
S9990	Services provided as part of a Phase II clinical trial
S9991	Services provided as part of a Phase III clinical trial
S9992	Transportation costs to and from trial location and local transportation costs (e.g., fares for taxicab or bus) for clinical trial participant and one caregiver/companion
S9994	Lodging costs (e.g., hotel charges) for clinical trial participant and one caregiver/companion
S9996	Meals for clinical trial participant and one caregiver/companion

ModifiersModifier

FB	Item provided without cost to provider, supplier or practitioner, or full credit received for replaced device (examples, but not limited to covered under warranty, replaced due to defect, free samples)
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

ICD-10 CodesICD-10

Z00.6

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

Submission Requirements and Coverage Risks

Prior Authorization

Clinical Trial Participation Authorization Required

Obtain authorization before requesting coverage for clinical trial participation. The coverage request must satisfy all applicable member, trial, approval, and documentation requirements.

The member must be eligible under the trial protocol.
The trial must be an approved Phase I, II, III, or IV clinical trial conducted for the prevention, detection, or treatment of cancer or another life-threatening disease or condition.
The trial must be approved or funded by an eligible entity, including the NIH, a qualified non-governmental research entity identified in NIH center-support-grant guidelines, CDC, AHRQ, CMS, or a qualifying NIH, CDC, AHRQ, CMS, DOD, or VA cooperative group or center.
The trial may be conducted under an FDA-reviewed investigational new drug (IND) application or may be a drug trial exempt from the FDA IND process.
A VA, DOD, or DOE study may qualify when approved through a peer-review process using NIH system studies and investigations and ensuring an unbiased review by qualified individuals with no conflicts of interest regarding the outcome.

Policy Scope and Purpose

This policy addresses coverage for member participation in approved clinical trials involving the prevention, detection, or treatment of cancer or another life-threatening disease or condition. Coverage requests must satisfy all applicable participation, protocol documentation, trial phase, and approval or oversight requirements. Eligible trials may be Phase I, II, III, or IV, and coverage is focused on routine costs associated with the approved trial.

Clinical Trial Terms

Clinical Trial

DefinitionResearch studies conducted with patients to answer scientific questions and evaluate the safety and efficacy of new investigational treatments compared with standard or conventional treatments.

PurposeClinical trials evaluate the safety and efficacy of treatments.

Investigational treatmentsClinical trials may or may not involve investigational treatments.

Phase I

DefinitionThe initial phase of testing an experimental drug or treatment.

PurposeEvaluates safety, determines a safe dosage range, and identifies side effects.

Approximate participants

Policy Summary

PayerExcellus Health Plan Inc

PolicyClinical Trials

Policy CodePolicy 11.01.10

Change TypeAnnual reviewno material changes

Effective DateSeptember 17, 2026

Next Review DateSeptember 1, 2027

Key ActionSubmit the clinical trial protocol, including institutional review board approval, to the Health Plan.

SourceLink

On This Page

A drug trial exempt from the FDA's IND application process.

A cooperative group or center of the NIH, CDC, AHRQ, CMS, Department of Defense (DOD), or Department of Veterans Affairs (VA).

A VA, DOD, or Department of Energy (DOE) study or investigation approved through a peer review process

The peer review process includes system studies and investigations used by the NIH.
The peer review process ensures an unbiased review of the highest scientific standards by qualified individuals with no conflicts of interest regarding the outcome.

Duplicative items and/or services.

Documentation Required

Protocol and IRB Approval Required

Submit the complete clinical trial protocol and institutional review board (IRB) approval to the Health Plan with the clinical trial participation coverage request.

Include a copy of the trial protocol.
Include documentation of IRB approval.

Denial Risk

Trial Eligibility or Approval Failure Risks Denial

Coverage may be denied when the member is not eligible under the trial protocol or when the trial does not meet the required clinical-trial phase, disease or condition, approval, funding, IND, exemption, cooperative-group, or peer-review requirements.

Confirm member eligibility before submitting the request.
Confirm that the trial qualifies as an approved clinical trial under the policy requirements.

Denial Risk

Missing Protocol or IRB Approval Risks Denial

Missing required documentation creates a denial risk. A clinical trial participation coverage request must include the trial protocol and IRB approval for Health Plan review.

Do not submit the request without both the clinical trial protocol and IRB approval.

Billing Rule

Investigational and Data-Collection Costs Excluded

Do not bill non-routine investigational or data-collection costs as covered clinical trial services. These costs are ineligible when the item or service is being investigated or is provided only to collect or analyze trial data rather than to directly manage the patient.

The item or service being investigated is ineligible.
Data-only items or services that are not used in direct clinical management are ineligible, such as recurring CT scans when only one scan is medically necessary.

Denial Risk

Non-Standard or Non-Health-Care Services Excluded

Non-routine items and services are ineligible when they are not health-care services or when they are inconsistent with the established standard of care for the patient's diagnosis.

Non-health-care services such as transportation, lodging, and meals are excluded.
Items or services outside the established standard of care are excluded, including investigational combinations of drugs studied to determine safety and efficacy.

Unsupported block type: billing_rule

Note

Verify Product Benefit Coverage

Verify the member's product benefits before applying this policy. Services are contract dependent, and medical policy criteria apply only when the applicable product covers the service, subject to the product-specific Medicare and Medicaid rules.

If a product does not cover the service, medical policy criteria do not apply.
For Medicare products, check for an applicable national or local Medicare coverage decision; for Medicare DSNP products that do not cover the service, refer to the Medicaid Product coverage line.

Phase II

DefinitionA clinical trial phase involving a larger group of people after the initial testing phase.

PurposeAssesses efficacy and further evaluates the safety of experimental drugs or treatments, including side effects.

Approximate participants100-300 people.

Phase III

DefinitionA large-scale clinical trial phase.

PurposeConfirms efficacy, monitors side effects, compares the intervention with commonly used treatments, and collects information for safe use.

Approximate participants1,000-3,000 people.

Phase IV

DefinitionPost-marketing studies conducted after market approval.

PurposeGather data on long-term safety, efficacy, and best practices for use.

Safety surveillanceDetects rare or delayed side effects and supports ongoing safety across a wider population.

Coverage with Evidence Development (CED)

DefinitionA Medicare policy that allows coverage of a treatment or technology while evidence is being gathered.

Evidence sourceEvidence is gathered through a clinical trial or registry.

PurposeDetermines the effectiveness of the treatment or technology.

Life-threatening

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

OutcomeDeath is probable without interruption of the disease or condition.

InterruptionThe course of the disease or condition must be interrupted to prevent the probable death outcome.

Life-threatening

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

LikelihoodThe likelihood of death is probable without interruption of the disease or condition.

InterruptionThe course of the disease or condition must be interrupted to address the probable likelihood of death.