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Clinical Trials — Routine Patient Care Costs/Services
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Defines coverage of routine patient care costs/services for qualified individuals participating in approved clinical trials under standard Cigna benefit plans, and lists related exclusions and coding. Applies to administration of Cigna plans where not superseded by the customer's benefit plan or applicable law.
Coverage Criteria — Routine Patient Care Costs for Clinical Trials
Routine Patient Care Coverage Criteria
Covered when ALL of the following are met
derived from ACA definition
both options acceptable
see policy for full list of qualifying sponsors and peer‑review requirements
The policy excludes services that are not considered routine patient care costs/services. Specific exclusions include the investigational drug, device, item, or service itself; any item or service provided solely to satisfy data collection and analysis needs; items not used in the direct clinical management of the participant; services clearly inconsistent with widely accepted standards of care; and items provided free of charge by research sponsors. Additionally, routine patient costs obtained out-of-network are not covered when non‑network benefits do not exist under the plan.
Transportation, lodging, and meals for clinical trial participants and companions are considered not covered. Examples referenced in the policy include fees for personal vehicle, rental car, taxi, medical van, ambulance, commercial airline, and train, as well as mileage reimbursement for personal vehicle use, hotel lodging charges, and meals. HCPCS codes listed for these non‑covered services include S9992 (transportation costs), S9994 (lodging costs), and S9996 (meals).
Coding — Eligible and Non-covered Codes
| G0276 | Blinded procedure for lumbar stenosis, percutaneous image-guided lumbar decompression (PILD) or placebo-control, performed in an approved coverage with evidence development (CED) clinical trial |
| G0293 | Noncovered surgical procedure(s) using conscious sedation, regional, general, or spinal anesthesia in a Medicare qualifying clinical trial, per day |
| G0294 | Noncovered procedure(s) using either no anesthesia or local anesthesia only, in a Medicare qualifying clinical trial, per day |
| G2000 | Blinded administration of convulsive therapy procedure, either ECT or MST, performed in an approved IDE-based clinical trial, per treatment session |
| S9992 | Transportation costs to and from trial location and local transportation costs for clinical trial participant and one caregiver/companion |
| S9994 | Lodging costs for clinical trial participant and one caregiver/companion |
| S9996 | Meals for clinical trial participant and one caregiver/companion |
Provider Actions — Eligibility, Documentation, and Denial Triggers
Clinical trial eligibility and network participation
Coverage of routine patient care costs for a Qualified Individual requires that the individual be eligible to participate according to the trial protocol and either (1) the referring health care professional is a participating health care provider who has concluded participation is appropriate, or (2) the individual provides medical and scientific information establishing that participation is appropriate. For in‑network only benefit plans, Cigna may require participation through participating health care professionals when a participating provider will accept the individual as a participant in the trial; however, coverage will be allowed if the approved clinical trial is conducted outside the resident state of the Qualified Individual.
- Individual must meet trial protocol eligibility.
- Either a participating referring provider must have concluded participation is appropriate, or the member must supply medical/scientific justification.
- In-network plans may require participation through participating providers when available; exception when trial is outside member's resident state.
Provide documentation of eligibility and referral basis
Document the Qualified Individual's eligibility under the trial protocol and the basis for referral or participation. Specifically, record that the individual is eligible per the trial protocol and either (a) the referring participating health care professional concluded participation is appropriate, or (b) the individual provided medical and scientific information establishing appropriateness.
- Document trial protocol eligibility for the individual (Qualified Individual).
- Document referring participating provider's conclusion of appropriateness OR attach medical/scientific information provided by the individual supporting participation.
Eligibility documentation requirements
The provider must document that the individual is a Qualified Individual eligible per the trial protocol and must include either a referring participating health care professional's conclusion that participation is appropriate or the member’s medical and scientific information establishing appropriateness.
- Record Qualified Individual status tied to trial protocol eligibility.
- Include referring participating provider's statement OR the individual's supporting medical/scientific documentation.
Triggers for denial — non‑routine services and examples
Do not bill or expect coverage for services that are not routine patient care; these items are considered not covered and may trigger denial.
- Investigational drug, device, item, or service itself.
- Items provided solely to satisfy data collection and analysis.
- Items not used in the direct clinical management of the individual.
- Services clearly inconsistent with widely accepted standards of care for the diagnosis.
- Items provided free by research sponsors.
- Travel and transportation (including mileage, taxis, commercial travel), lodging, and meals.
- Routine patient costs obtained out-of-network when non-network benefits do not exist.
Background
Routine Patient Care Costs/Services are health care items and services that would be covered for beneficiaries not enrolled in a trial, including services needed to monitor investigational interventions and to prevent, diagnose, or treat complications arising from those interventions. Coverage of these costs applies when the individual is a Qualified Individual eligible per the trial protocol, and when the trial meets qualifying criteria (e.g., Phase I–IV trials that are federally funded/approved, conducted under IND or meet specified peer‑review standards). Providers must also meet referral or documentation requirements to establish appropriateness for participation.
Definitions
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