CurrentUnitedHealthcarePolicy CS018NM.C

Mandatory Medicaid Coverage of Routine Patient Costs in Qualifying Clinical Trials (for New Mexico Only)

Specifies New Mexico Medicaid coverage requirements for routine patient costs associated with qualifying clinical trials and the criteria that define eligible trials; applies to providers and Medicaid beneficiaries in New Mexico.

Policy Summary

PayerUnitedHealthcare

PolicyMandatory Medicaid Coverage of Routine Patient Costs in Qualifying Clinical Trials (for New Mexico Only)

Policy CodePolicy CS018NM.C

Change TypeNo material change

Effective DateSep 1, 2025

Next Review Date

Key ActionFollow New Mexico administrative requirements (see SPA 22-0009) and include applicable clinical trial modifiers and codes on claims for routine patient costs.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

State-specificapplies only to New Mexico

Phases I–IVclinical trial phases defined

Z00.6listed clinical trial diagnosis code

Q0/Q1clinical trial modifiers listed

SPA 22-0009

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Coverage Criteria for Routine Patient Costs in Clinical Trials

Indications for Coverage / Qualified Clinical Trial criteria

Covered when the clinical trial meets ALL of the following Qualified Clinical Trial criteria:

Trial sponsor/authority: The study or investigation is approved, conducted, or supported (which may include funding through in-kind contributions) by one or more of the following: National Institutes of Health (including NCI); Centers for Disease Control and Prevention; Agency for Healthcare Research and Quality; Centers for Medicare and Medicaid Services; a cooperative group or center of any of these entities or the Department of Defense or the Department of Veterans Affairs; a qualified non-governmental research entity identified in NIH guidelines for center support grants; or the Department of Veterans Affairs, the Department of Defense, or the Department of Energy when reviewed and approved through a Secretary‑determined peer review system comparable to NIH and ensuring unbiased, high‑quality review.

See policy chunk 2 for full list and peer review requirements

Regulatory exemptions: Or the study or investigation is conducted under an investigational new drug exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act, or under the section 351(a)(3) exemption for biological products.

See policy chunk 2

Trial phase and purpose: The trial is a Phase I, Phase II, Phase III, or Phase IV clinical trial and is conducted in relation to the prevention, detection, or treatment of a serious or life‑threatening disease or condition.

See policy chunk 4

Coverage excludes items and services that are the investigational item or service that is 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 member’s direct clinical management (for example, protocol-driven laboratory tests or imaging performed at nonstandard frequencies). Additionally, items and services provided free of charge by research sponsors for trial participants are not considered routine patient costs and are excluded from coverage. Refer to federal, state, and contractual requirements for full details.

Coding — Modifiers, Procedure and Diagnosis Codes

Clinical Trial ModifiersModifier

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

Applicable HCPCS/CPT/Status Codesmixed

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.
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.
S9996	Meals for clinical trial participant and one caregiver/companion.

Diagnosis CodesICD-10

Z00.6

Encounter for examination for normal comparison and control in clinical research program

Provider Actions, Billing, and Documentation Requirements

Billing Rule

Coding and submission expectations

For New Mexico Medicaid claims, follow State Plan Amendment (SPA) 22-0009 and applicable clinical trial coding rules and modifiers when billing routine patient costs during qualifying clinical trials.

Use applicable clinical trial modifiers and coding rules as required by New Mexico.
Claims for routine patient costs must follow New Mexico administrative requirements (see SPA 22-0009).

Documentation Required

Attestation and documentation requirement

Coverage determinations will be made based on an attestation by the treating health care provider and the trial principal investigator using the Secretary’s streamlined uniform form. The attestation may reference publicly available trial information (for example, ClinicalTrials.gov). Maintain documentation of the attestation and any supporting materials in the patient’s medical record.

Background

Clinical trials are research studies involving human participants designed to evaluate medical interventions—such as drugs, devices, procedures, or behavioral strategies—to determine their safety and effectiveness. Trials compare new approaches to standard treatments, placebos, or no intervention and are conducted in sequential phases from early exploratory studies through later-stage efficacy and post‑marketing surveillance. The primary purpose of these studies is to generate evidence about whether an intervention prevents, detects, or treats disease and to inform clinical care and regulatory decisions.

Definitions

Qualified Clinical Trial — definition and scope

DefinitionQualified Clinical Trial: Phase I, Phase II, Phase III, or Phase IV clinical trial conducted in relation to the prevention, detection, or treatment of any serious or life‑threatening disease or condition.

Scope (phases)Includes Phase I–IV clinical trials.

PurposeTrials must be conducted for prevention, detection, or treatment of serious or life‑threatening conditions.

ComplianceMust meet the policy's Criteria for Qualified Clinical Trials to qualify for coverage of routine patient costs.

Clinical trial phases — definitions

Early Phase 1Exploratory trials before traditional Phase 1 to investigate how or whether a drug affects the body; very limited human exposure; no therapeutic or diagnostic goals (e.g., screening studies, microdose studies).