CurrentAetnaPolicy 0466

Clinical Trials, Coverage of Routine Patient Care Costs

This bulletin governs Aetna's coverage of medically necessary routine patient care costs for members participating in clinical trials, including limitations, exclusions, and applicable plan requirements.

Policy Summary

PayerAetna

PolicyClinical Trials, Coverage of Routine Patient Care Costs

Policy CodePolicy 0466

Change TypeNo material changes

Effective Date08/03/2001

Next Review DateMay 9, 2024

Key ActionEnsure members meet all applicable plan requirements for precertification, registration, and referrals before billing routine patient care in clinical trials.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

All applicable plan limitsPlan limits still apply

CoveredComplication coverage

S9992/S9994/S9996Travel/lodging/meals

Q0/Q1Research modifiers

Coverage Criteria for Routine Patient Care in Clinical Trials

Covered routine patient care in clinical trials

Aetna covers medically necessary routine patient care costs in clinical trials when all of the following limitations are met:

Plan limits and rules: All applicable plan limitations for coverage of out-of-network care will apply to routine patient care costs in clinical trials; and all utilization management rules and coverage policies that apply to routine care for members not in clinical trials will also apply to routine patient care for members in clinical trials; and members must meet all applicable plan requirements for precertification, registration, and referrals.

Trial governance: To qualify, a clinical trial must have a written protocol that describes a scientifically sound study and have been approved by all relevant institutional review boards (IRBs) before participants are enrolled.

Providers will not routinely be required to submit documentation about the trial to Aetna, but Aetna may request such documentation at any time to confirm scientific merit and IRB approval.

Coverage for complications:

Policy Summary

PayerAetna

PolicyClinical Trials, Coverage of Routine Patient Care Costs

Policy CodePolicy 0466

Change TypeNo material changes

Effective Date08/03/2001

Next Review DateMay 9, 2024

Key ActionEnsure members meet all applicable plan requirements for precertification, registration, and referrals before billing routine patient care in clinical trials.

SourceLink

On This Page

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Aetna covers costs of medically necessary treatments for conditions that result as unexpected consequences (complications) of clinical trials.

Excluded trial costs: Aetna does not cover: costs of data collection and record keeping that would not be required but for the clinical trial; items and services provided by the trial sponsor without charge; the experimental intervention itself (except certain investigational devices and promising interventions per Aetna policy); travel, lodging, and meals; and other services necessary solely to satisfy protocol data-collection needs.

Costs that are not covered under this policy include: data collection and record-keeping costs that would not be required but for the clinical trial; items and services provided by the trial sponsor without charge; the experimental intervention itself (see exceptions noted elsewhere in the policy); travel, lodging, and meals; and other services necessary solely to satisfy data collection needs of the clinical trial ("protocol-induced costs"). Example HCPCS codes listed for travel, lodging, and meals include S9992, S9994, and S9996.

The policy specifies that the experimental intervention itself is not covered. Limited exceptions are noted for certain medically necessary Category B investigational devices and for promising experimental and investigational interventions for terminal illnesses where Aetna's terminal illness policy applies; details of those exceptions are addressed in benefit plan descriptions and related Aetna policies. Modifier guidance for documenting investigational versus routine clinical research services is provided (Q0 = investigational, Q1 = routine).

HCPCS Codes and Modifiers

HCPCS codes - travel, lodging, mealsHCPCSNot Covered

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.

HCPCS codes - trial phase servicesHCPCS

S9988	Services provided as a part of a phase I clinical trial.
S9990	Services provided as a part of a phase II clinical trial.
S9991	Services provided as a part of a phase III clinical trial.

Modifiers for clinical research servicesModifier

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.

Provider Requirements and Actions

Prior Authorization

Plan prerequisites required

Members must meet all applicable plan requirements for precertification, registration, and referrals before routine patient care costs associated with a clinical trial will be considered for coverage.

Precertification, registration, and referrals as required by the member's plan

Note

Provider action required

Providers should be prepared to submit any additional documentation Aetna requests to verify coverage eligibility or to support claims for routine patient care costs in a clinical trial.

Be responsive to requests for documentation about the clinical trial protocol and member eligibility

Documentation Required

Documentation may be requested

Aetna may request the clinical trial protocol and evidence of institutional review board (IRB) approval to confirm that the trial meets scientific merit and IRB requirements prior to or after claims submission.

Submit trial protocol and IRB approval documentation upon request

Denial Risk

Noncompliance may affect payment

Failure to meet plan prerequisites (such as precertification, registration, or referral requirements) or to provide requested documentation may result in denial of coverage or reduced payment for routine patient care costs associated with a clinical trial.

Noncompliance with plan precertification/registration/referral rules may lead to claim denial or reduced reimbursement

Policy Background

This policy was adapted from Centers for Medicare & Medicaid Services (CMS) guidance and aligns Aetna coverage with CMS and Patient Protection and Affordable Care Act (PPACA) requirements. It affirms that medically necessary routine patient care costs in qualifying clinical trials are covered in the same manner as routine care for members not enrolled in trials, subject to all applicable plan limitations, utilization management rules, and IRB and scientific merit requirements; Aetna may request trial documentation as needed to confirm those standards.

Key Definitions

Clinical trial definition (study, protocol, IRB, documentation)

Study documentationA clinical trial must have a written protocol that describes a scientifically sound study.

IRB approvalThe trial must have been approved by all relevant institutional review boards (IRBs) before participants are enrolled.

Provider documentation requestsProviders will not routinely be required to submit trial documentation, but Aetna may request the protocol and IRB approval at any time to confirm scientific merit and approvals.

Scope of covered careAetna covers medically necessary routine patient care costs in clinical trials in the same way it reimburses routine care for members not in trials, subject to plan limits and utilization management rules.

Exclusions related to trialsCosts not covered include data collection/record-keeping required only for the trial; items/services provided by the trial sponsor without charge; and the experimental intervention itself (with limited exceptions per Aetna policy).