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Mandatory Medicaid Coverage of Routine Patient Costs in Qualifying Clinical Trials (for New Jersey Only)
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Defines UnitedHealthcare Community Plan coverage of routine patient costs related to qualifying clinical trials for New Jersey Medicaid members, including eligible trial types, covered routine services, and exclusions. Affects providers submitting claims for New Jersey Medicaid members participating in qualifying clinical trials.
Medical Records Documentation Used for Reviews section added language specifying documentation requirements to support medical necessity.
Removed notation indicating HCPCS code G0276 is not on the State of New Jersey Medicaid Fee Schedule and therefore may not be covered by the State of New Jersey Medicaid Program.
Medical Records Documentation Used for Reviews: added language clarifying that benefit coverage is determined by federal, state, or contractual requirements and that medical records may be required to assess whether the member meets clinical criteria.
Updated References section to reflect the most current information and archived previous policy version CS018NJ.R.
Coverage Criteria — Routine Patient Costs in Qualifying Clinical Trials
Qualified Clinical Trial and Attestation Requirements
Covered when ALL of the following are met:
See chunk 4 for the enumerated entities and peer‑review requirements.
Defined in chunk 6.
Chunk 8.
Covered Routine Patient Costs
Covered routine patient costs include items or services provided to the individual under the qualifying clinical trial to the extent they would otherwise be covered outside the trial, including:
Chunk 9 lists examples and scope.
Coverage excludes the investigational item or service when that item/service is the subject of the qualifying clinical trial and would not be covered outside the trial. Also excluded are items and services provided solely to satisfy the trial’s data collection and analysis needs that are not used in the direct clinical management of the member (for example, laboratory tests or imaging studies performed at protocol‑dictated frequencies that are not consistent with signs/symptoms or accepted standards of care). Items and services provided free of charge by research sponsors for trial participants are likewise not considered routine patient costs and are not covered.
Coverage determinations under this policy are subject to applicable federal, state, or contractual requirements. Those requirements may differ from this policy and, in the event of conflict, federal, state, or contractual terms govern. Always check the controlling federal, state, or contractual benefit provisions before applying this policy.
Services provided solely for data collection and analysis that are not used in direct clinical management are not routine patient costs and are excluded from coverage. Examples include protocol‑dictated laboratory tests and imaging studies performed at frequencies inconsistent with the member’s signs/symptoms or standard care for the diagnosis or treatment, and other trial‑required assessments that exist only to meet research objectives rather than to inform clinical care.
Referenced Modifiers and Codes
| 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. |
| 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. |
| 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. |
| 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. |
| G0276 | HCPCS code G0276 — notation regarding State of New Jersey Medicaid Fee Schedule removed |
Provider Attestations, Documentation & Billing Actions
Attestation and claim identification required
Coverage determinations are based on an attestation by the health care provider and the principal investigator using the Secretary's streamlined uniform form; claims should include appropriate modifiers or codes identifying clinical trial services as applicable.
- Attestation may reference information on ClinicalTrials.gov or other Secretary-maintained sites.
Verify applicable coverage rules first
Before applying this policy to a member's care, verify federal, state, or contractual benefit plan requirements because those requirements govern in the event of a conflict and may differ from this policy.
- Check applicable federal, state, and contractual coverage rules for New Jersey Medicaid prior to billing or relying on this policy.
Include attestation and trial identifiers on claims
Ensure claims for routine patient costs related to qualifying clinical trials include the attestation and any required clinical-trial identifiers or modifiers per the Secretary's form and payer instructions.
- Include appropriate HCPCS/CPT modifiers or trial-specific codes as indicated by the attestation requirements.
Provide requested documentation promptly
Follow payer instructions to submit any additional documentation requested to support coverage determinations; retain and provide records promptly upon request to avoid delays.
- Respond to requests for records in a timely manner to facilitate coverage review.
Medical record must fully support medical necessity
The patient's medical record must contain documentation that fully supports medical necessity, including relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures; documentation must be legible, maintained in the record, and made available upon request.
- Document relevant medical history and rationale for trial-related services.
- Record physical exam findings and any clinical signs prompting services.
- Include results of pertinent diagnostic tests or procedures used to justify services.
Required contents and availability of medical records
Required medical record documentation should include relevant medical history, physical examination findings, and results of pertinent diagnostic tests or procedures and must be legible, maintained in the patient's record, and available upon request to support coverage review.
- Maintain all supporting documents in the patient's medical record.
- Ensure documentation is legible and accessible for payer review.
Denial risk if documentation is incomplete or not provided
Lack of medical record documentation supporting medical necessity or failure to provide requested records may result in denial of coverage or inability to confirm coverage; documentation alone does not guarantee coverage.
- Medical records may be required to assess whether the member meets clinical criteria but do not guarantee coverage.
- Failure to provide records when requested may result in denial or recoupment.
Coverage denial risk for missing documentation
Failure to provide medical records that fully support the medical necessity for requested services may result in coverage denial or other adverse actions, including recoupment, per payer review.
- Ensure documentation is complete and available to avoid coverage denial.
Background — Clinical Trials and Scope
Clinical trials test an intervention (such as a drug, device, procedure, or behavioral change) in human volunteers according to a research protocol to evaluate safety and effectiveness. Trials follow a predefined protocol and may include multiple phases (for example, early exploratory studies through Phase 4 post‑marketing research); they may compare a new approach with standard care, placebo, or no intervention and often include procedures performed solely to meet research objectives.
Clinical Trial Phase Definitions
Policy Revision History
Added 'Medical Records Documentation Used for Reviews' language clarifying that benefit coverage is governed by federal, state, or contractual requirements; that medical records may be required to assess clinical criteria; and specifying required documentation elements (medical history, physical exam, pertinent diagnostic results) and that documentation must be legible and available upon request; removed notation regarding HCPCS G0276 applicability to the New Jersey Medicaid fee schedule; updated References; archived prior policy version CS018NJ.R.
Archived prior policy version CS018NJ.R.
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