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Clinical Trials, Coverage of Routine Patient Care Costs
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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.
No material clinical or coverage changes in this revision.
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:
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.
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
| 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. |
| 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
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
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 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
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
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