CurrentCignaPolicy A003

Coverage of routine patient care costs for clinical trials

Defines Cigna's administration of coverage for routine patient care costs/services associated with approved clinical trials for qualified individuals under standard benefit plans; applies to administration (not clinical guidance).

Policy Summary

PayerCigna

PolicyCoverage of routine patient care costs for clinical trials

Policy CodePolicy A003

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionEnsure individuals are eligible per the trial protocol and obtain referral from a participating provider or supporting medical/scientific documentation to determine coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Coveredcoverage stance for qualified individuals

Excludedinvestigational item/service

S9988codes eligible

Excludedparticipant expenses

ACA since 2014regulatory background

Coverage Criteria for Clinical Trials

Policy Summary

PayerCigna

PolicyCoverage of routine patient care costs for clinical trials

Policy CodePolicy A003

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionEnsure individuals are eligible per the trial protocol and obtain referral from a participating provider or supporting medical/scientific documentation to determine coverage.

SourceLink

On This Page

Coverage criteria for routine patient care costs in clinical trials

Covered when ALL of the following are met:

ALL of the following

Individual is a Qualified Individual eligible to participate according to the trial protocol
AND either
- Referring health care professional is a participating provider and has concluded that the individual's participation would be appropriate
- Individual provides medical and scientific information establishing that participation in the qualified trial would be appropriate
The trial is a phase I, II, III, or IV clinical trial conducted for prevention, detection, or treatment of cancer or other life‑threatening disease or condition and meets at least one of the following criteria: federally funded; conducted under an FDA investigational new drug (IND) application; or is a drug trial exempt from an IND

Coding and Billing Guidance

Codes eligible for coveragemixedCovered

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.
Z00.6	Encounter for examination for normal comparison and control in clinical research program.

Codes considered not coveredmixedNot Covered

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 electroconvulsive therapy (ECT, current covered gold standard) or magnetic seizure therapy (MST, noncovered experimental therapy), performed in an approved IDE-based clinical trial, per treatment session.
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.

Coding currency note

Coding currency noteCode lists may not be all-inclusive; AMA and CMS code updates may occur more frequently than policy updates. Deleted codes and codes not effective at time of service may not be eligible for reimbursement.

Update responsibilityCigna policy may lag behind external code set updates; providers should verify code currency with AMA/CMS prior to billing.

Eligibility of deleted codesDeleted codes and codes not effective when the service is rendered may not be eligible for reimbursement.

Provider / Referral Requirements

Note

Provider/Referral Requirements for Qualified Individual

A qualified individual may be referred to a clinical trial either by a participating health care professional who has determined the trial is appropriate, or by the individual submitting medical and scientific information establishing that participation would be appropriate. For in‑network only plans, Cigna may require participation through a participating health care professional if one will accept the individual. If the approved clinical trial is conducted outside the member’s resident state, coverage for routine patient care costs/services will be allowed.

Referral may come from a participating health care professional who concludes participation is appropriate
Alternatively, the individual may provide medical and scientific information establishing appropriateness of participation
For in‑network only plans, Cigna may require use of participating health care professionals when available
Approved clinical trials conducted outside the member's resident state remain eligible for coverage of routine patient care costs/services

Key Definitions

Routine Patient Care Costs/Services

DefinitionRoutine Patient Care Costs/Services are health care items and services otherwise covered by Cigna for a covered individual not enrolled in a trial, including services required for clinically appropriate monitoring, prevention of complications, and reasonable and necessary care arising from the investigational therapy.

Included examplesRadiological services, laboratory services, intravenous therapy, anesthesia services, hospital services, physician services, office visits, room charges and related clinical services.

ScopeApplies to routine care that would be covered under the member's standard benefit plan when provided as part of an approved clinical trial for a qualified individual.

Exclusions (summary)Does not include the investigational drug/device/item/service itself or items/services provided solely for data collection or analysis unless otherwise covered by the plan.

Qualified Individual

Qualified Individual (definition)A participant or beneficiary in a health plan who is eligible to participate in an approved clinical trial according to the trial protocol for prevention, detection, or treatment of cancer or other life‑threatening disease or condition.

How eligibility is establishedBy meeting the trial protocol criteria and through referral by a participating health care professional or by providing medical and scientific information establishing appropriateness.

Network participation requirementFor in‑network only plans, Cigna may require participation through participating health care professionals if a participating provider will accept the individual as a trial participant.

Out-of-state trialsIf the approved clinical trial is conducted outside the member's resident state, coverage for routine patient care costs will be allowed.

Life‑Threatening Disease or Condition

DefinitionLife‑Threatening Disease or Condition means any disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted (per ACA definition).

RelevanceQualification for participation in an approved clinical trial may be based on the presence of a life‑threatening disease or condition as defined above.

Policy contextThe ACA requirement to cover routine patient care costs applies for trials related to prevention, detection, or treatment of cancer or other life‑threatening diseases or conditions.