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Mandatory Medicaid Coverage of Routine Patient Costs in Qualifying Clinical Trials (for New Mexico Only)
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Defines UnitedHealthcare Community Plan coverage requirements for routine patient costs when a Medicaid member in New Mexico participates in a qualifying clinical trial, and explains documentation and applicability rules for providers and reviewers.
Medical Records Documentation Used for Reviews section added language requiring documentation that fully supports medical necessity and noting that documentation may be required to assess whether the member meets clinical criteria.
References section updated to reflect current information and the previous policy version CS018NM.C was archived.
Coverage Criteria for Qualified Clinical Trials
Qualified Clinical Trial coverage criteria
Covered when the clinical trial meets the Qualified Clinical Trial definitions and additional requirements
Reflects enumerated acceptable trial authorities and peer-review requirement
Trial phase and clinical relevance requirements
Provider and principal investigator attestation required
State SPA governs administrative specifics
Excluded from routine patient costs are investigational items or services that are the subject of the qualifying clinical trial when those items/services are not otherwise covered outside the trial. Also excluded are items and services provided solely to satisfy data collection and analysis for the trial that are not used in the direct clinical management of the member (for example, laboratory tests or imaging performed at frequencies dictated only by protocol and not by signs, symptoms, or standard of care). Items and services provided free of charge by research sponsors for trial participants are likewise excluded.
Medical records documentation may be required to assess whether the member meets the clinical criteria for coverage; the presence of documentation alone does not guarantee coverage. The patient's medical record must contain documentation that fully supports the medical necessity of the requested services, including relevant medical history, physical examination findings, and results of pertinent diagnostic tests or procedures. Documentation should be legible, maintained in the medical record, and made available upon request.
Applicable Trial and Related Billing Codes
| Q0 | Investigational clinical service provided in a clinical research study |
| Q1 | Routine clinical service provided in a clinical research study |
| Modifier 1 | Description. be a Clinical Trial claim. |
| G0276 | Covered When Criteria Are Met Blinded procedure for lumbar stenosis, percutaneous image-guided lumbar decompression (PILD) or placebo-control, performed in an approved coverage with evidence development (CED) clinical. |
| G0293 | Noncovered surgical procedure(s) using conscious sedation, regional, general, or spinal anesthesia. |
| G0294 | Noncovered procedure(s) using either no anesthesia or local anesthesia only, in a Medicare qualifying clinical trial, per day. |
| S9990 | Services provided as part of a Phase I clinical trial. |
| S9991 | Services provided as part of a Phase II clinical trial. |
| 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. |
Provider Attestation, Documentation, and Billing Requirements
Attestation and claim coding requirements
Coverage determinations for routine patient costs in qualifying clinical trials will be based on an attestation by the treating health care provider and the principal investigator using the Secretary’s streamlined uniform form; the form may reference publicly available trial information (e.g., ClinicalTrials.gov). Claims for services furnished in connection with a qualifying clinical trial should include applicable trial modifiers and codes (examples in policy include Q0, Q1, Modifier 1 and listed CPT/HCPCS trial-related codes).
- Provider and principal investigator must complete the Secretary’s uniform attestation form.
- Include appropriate trial modifiers/codes on claims (e.g., Q0, Q1, Modifier 1 and other trial-specific codes listed in the policy).
Provider actions required for coverage and billing
Providers must ensure clinical trial participation and billing comply with the policy’s coverage criteria and exclusions and follow the attestation and coding requirements described in policy; failure to meet these obligations may affect coverage determinations.
- Confirm the trial meets Qualified Clinical Trial definitions and additional requirements before billing.
- Complete the Secretary’s streamlined uniform attestation form as required.
- Use appropriate trial modifiers and codes on claims as applicable.
Medical record documentation requirements
The patient’s medical record must fully support medical necessity for requested services, including relevant medical history, physical examination findings, and results of pertinent diagnostic tests or procedures; documentation should be legible, maintained in the record, and made available upon request for review.
- Document history, physical exam, and diagnostic results that justify the service.
- Ensure records are legible, retained in the patient chart, and produced on request for reviewers.
- Understand that documentation may be required to assess whether the member meets clinical criteria but does not guarantee coverage.
Coverage exclusions that trigger denial
Do not bill for items or services that are excluded from routine patient costs: investigational items that are the subject of the trial and not otherwise covered, services provided solely for data collection (not used in direct clinical management), or items/services provided free of charge by research sponsors — such items may be denied.
- Investigational item or service that is the subject of the qualifying clinical trial and not otherwise covered outside the trial.
- Items/services provided solely to satisfy data collection and analysis needs and not used in direct clinical management (examples: lab tests or imaging done at protocol-driven frequency inconsistent with standard care).
- Items/services provided free of charge by research sponsors.
Background on Clinical Trials
Clinical trials are research studies that evaluate interventions—such as drugs, devices, procedures, or behavioral changes—in human volunteers to determine safety and efficacy and to inform clinical practice. Across trial phases (from early phase work through Phase 4), routine patient costs—those services normally covered outside a trial—may be billed to the plan when the trial qualifies under the policy criteria; however, investigational items, services provided only for data collection and items provided free by sponsors are not considered routine patient costs and are excluded.
Clinical Trial Phase Definitions
Policy Revision History & Changes
Added 'Medical Records Documentation Used for Reviews' language requiring documentation that fully supports medical necessity (history, physical exam, diagnostic results) and noting documentation may be required to assess whether member meets clinical criteria.
Updated References section to reflect current information and archived prior policy version CS018NM.C.
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