CurrentCignaPolicy A003

Coverage of Routine Patient Care Costs for Clinical Trials (Administrative Policy)

Defines Cigna's administrative policy on coverage of routine patient care costs/services related to approved clinical trials for qualified individuals under standard benefit plans, and explains exclusions and coding guidance. Affects covered individuals under Cigna-administered standard benefit plans.

Policy Summary

PayerCigna

PolicyCoverage of Routine Patient Care Costs for Clinical Trials (Administrative Policy)

Policy CodePolicy A003

Change TypeNo material change

Effective DateDec 15, 2023

Next Review DateDec 15, 2024

Key ActionRefer eligible individuals to an approved clinical trial only when they meet trial protocol eligibility and a participating provider confirms appropriateness or the member provides medical/scientific evidence.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

A003policy id

2023-12-15effective

2024-12-15next review

S9988,S9990,S9991,Z00.6covered codes

S9992,S9994,S9996not covered codes

Policy Summary

PayerCigna

PolicyCoverage of Routine Patient Care Costs for Clinical Trials (Administrative Policy)

Policy CodePolicy A003

Change TypeNo material change

Effective DateDec 15, 2023

Next Review DateDec 15, 2024

SourceLink

On This Page

Coverage Criteria and Exclusions

Coverage criteria and exclusions for routine patient care in clinical trials

Covered when ALL of the following conditions are met:

Individual is a Qualified Individual eligible to participate according to the trial protocol

Qualified Individual defined by trial protocol and plan eligibility

ALL of the following

ONE of
- Referring health care professional is a participating health care provider and has concluded that the individual's participation in the trial would be appropriate
- The 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 in relation to the prevention, detection, or treatment of cancer or other life‑threatening disease/condition and meets federal criteria for an approved clinical trial

Coding Guidance

Eligible for CoverageHCPCS | ICD-10Covered

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

Considered Not CoveredHCPCSNot 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

Provider Referral, Eligibility, and Billing Actions

Prior Authorization

Provider referral and eligibility requirements

Participation in an approved clinical trial requires the individual to be a Qualified Individual (eligible per the trial protocol) and either be referred by a participating health care professional who has concluded participation is appropriate, or provide medical and scientific information establishing that participation is appropriate. For in‑network only plans, Cigna may require participation through participating providers unless the approved trial is conducted outside the member's resident state.

Individual must be eligible to participate according to the trial protocol.
Either a participating referring provider must conclude participation is appropriate, or the individual must supply medical/scientific information showing appropriateness.
In-network-only plans may require participation through participating health care professionals unless the trial is outside the member's resident state.

Key Definitions

inv-05: 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 clinical trial, including services required for clinically appropriate monitoring of the investigational item, prevention of complications, and reasonable and necessary care arising from the investigational item (e.g., radiology, lab services, IV therapy, anesthesia, hospital and physician services, office visits, room and board, medical supplies).

Exclusions — investigational itemDoes not include the investigational drug, device, item or service itself.

Exclusions — sponsor-provided or data-only itemsDoes not include items provided free by research sponsors or items used solely to satisfy data collection/analysis and not used in direct clinical management.

Exclusions — network and standard-of-careDoes not include items obtained out-of-network when non-network benefits do not exist under the plan or items clearly inconsistent with widely accepted standards of care for the diagnosis.

ExamplesRadiological services, laboratory services, IV therapy, anesthesia, hospital services, physician services, office visits, room and board, medical supplies.

inv-06: Qualified Individual

DefinitionQualified Individual: 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.

Eligibility pathway — referralAn individual may qualify based on a referral from a health care professional participating in the trial.

Eligibility pathway — documentationAlternatively, the individual may provide medical and scientific information establishing that participation would be appropriate.

Network conditionFor in‑network‑only plans, Cigna may require participation through participating health care professionals if a participating professional will accept the individual; exception allowed if the approved trial is conducted outside the member's resident state.

inv-07: Life-Threatening Disease or Condition

Definition (ACA) Life‑Threatening Disease or Condition: any disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted.

Relevance to trialsQualified Individuals may enroll in approved clinical trials for prevention, detection, or treatment of cancer or other life‑threatening diseases/conditions.

Participation determinationEligibility may be established by referral from a participating health care professional or by submission of medical/scientific information showing participation is appropriate.

inv-08: Clinical Trial Phases

Phase IStudies usually conducted with healthy volunteers that emphasize safety and identify the drug's most frequent and serious adverse events and how it is metabolized/excreted.

Phase IIStudies that gather preliminary data on effectiveness (whether the drug works) while continuing safety evaluation and short‑term adverse event study.

Phase IIILarger studies that gather more information about safety and effectiveness by studying different populations, dosages, and combinations with other drugs.

Phase IVPostmarketing studies after FDA approval that gather additional information about a drug's safety, efficacy, or optimal use (including required or agreed‑to postmarket studies).