CurrentAlliance HealthPolicy 1A-39

Routine patient costs for qualifying clinical trials (NC Medicaid)

Defines NC Medicaid coverage of routine patient costs furnished in connection with beneficiary participation in qualifying clinical trials, including eligibility, covered and non-covered items, prior approval rules, attestation and billing requirements. Applies to Medicaid beneficiaries and incorporates EPSDT exceptions for those under 21.

Policy Summary

PayerAlliance Health

PolicyRoutine patient costs for qualifying clinical trials (NC Medicaid)

Policy CodePolicy 1A-39

Change TypeRevisions and additions (attestation, definitions, statutory update)

Effective DateJan 1, 2004

Next Review DateN/A

Key ActionComplete and maintain a Medicaid Attestation Form in the beneficiary's health record signed by the principal investigator and health care provider; electronic signatures allowed.

POLICY UPDATE CHANGES

Policy updated to reflect Division CC, Title II, Section 210 of the Consolidated Appropriations Act, 2021 adding routine patient costs benefit effective January 1, 2022 and updated definitions of qualifying clinical trial and routine costs.

Removed requirement that beneficiary have a current diagnosis with a grave prognosis and updated to 'life-threatening condition'.

Added definition and requirement for Principal Investigator and attestation form maintenance.

Requires attestationAttestation requirement

Travel/lodging/mealsCommon excluded items

Depends on underlying service

Prior authorization rule

All phases if qualifyingEligible trial phases

Coverage Summary

Scope: NC Medicaid defines coverage for routine patient costs furnished in connection with beneficiary participation in qualifying clinical trials, including eligibility, covered and non-covered items, prior approval rules, attestation and billing requirements. The policy applies to Medicaid beneficiaries and incorporates EPSDT exceptions for beneficiaries under 21 years of age.

High-level summary: NC Medicaid implements the federal mandate added by Division CC, Title II, Section 210 of the Consolidated Appropriations Act, 2021 to require coverage of routine patient costs for qualifying clinical trials. The policy was posted 07/01/2023 with an effective date of 04/01/2023 and earlier original effective dates beginning January 1, 2004, and includes the most recent review on 07/01/2023.

Policy Number1A-39

StatusCURRENT

Effective Date2004-01-01

Last Review2023-07-01

PayerAlliance Health

SubjectRoutine patient costs for qualifying clinical trials (NC Medicaid)

Medical-Necessity & Coverage Criteria

General Medical Necessity Criteria

Medicaid covers routine patient costs when medically necessary and all of the following are met:

ALL of the following

The procedure, product, or service is individualized, specific, and consistent with symptoms or confirmed diagnosis and not in excess of the beneficiary's needs.
The procedure, product, or service can be safely furnished, and no equally effective and more conservative or less costly treatment is available statewide.
The procedure, product, or service is not primarily for the convenience of the beneficiary, caretaker, or provider.

Specific Criteria for Coverage of Routine Patient Costs in Qualifying Clinical Trials

Medicaid will cover routine patient costs furnished in connection with participation in a qualifying clinical trial when ALL of the following are met:

Provider Actions & Billing Rules

Documentation Required

Medicaid Attestation Form requirement

A completed Medicaid Attestation Form on the Appropriateness of the Qualified Clinical Trial must be completed by both the principal investigator and the health care provider and maintained in the beneficiary's health record. Electronic signatures are permitted on the attestation form. If a completed attestation form signed by the Principal Investigator and Health Care Provider is not present in the record prior to participation, all associated costs will be recouped.

Prior Authorization

Prior approval rules

No prior approval is required for routine patient costs furnished in connection with qualifying clinical trials except when the underlying service, product, or procedure normally requires prior approval. Enrollment in a qualifying clinical trial does not waive or eliminate any prior approval requirement for the underlying service, product, or procedure.

Coding & Claims Guidance

Claims / Billing guidancemixed

No codes listed

Claim Typesmixed

CMS-1500	Professional claim form / 837P transaction
UB-04	Institutional claim form / 837I transaction

Providers must report the most specific CPT, HCPCS, and ICD-10 codes that accurately and completely describe the procedure, product, or service; if no specific code exists, use appropriate unlisted codes with a special report. Use the highest level of specificity that supports medical necessity.

Accepted claim forms are the professional claim form CMS-1500 (837P) and the institutional claim form UB-04 (837I) as the designated claim types for billing.

Background & Definitions

Background: This policy implements the federal mandate in Section 1905(a)(30) and 1905(gg) of the Social Security Act, as amended by Division CC, Title II, Section 210 of the Consolidated Appropriations Act, 2021, requiring Medicaid coverage of routine patient costs for beneficiaries participating in qualifying clinical trials. Routine costs are items or services provided to the individual under the qualifying clinical trial that would otherwise be covered under the state plan, including services to prevent, diagnose, monitor, or treat complications from trial participation, and items required solely for provision of an investigational item (for example, administration). The policy excludes investigational items that are the subject of the trial and not otherwise covered, items or services provided solely for data collection and analysis that are not used in direct clinical management, and non-covered items such as travel, lodging, and meals.

Term	Definition
Qualifying Clinical Trial	A clinical trial in any phase of development conducted in relation to the prevention, detection, or treatment of any serious or life‑threatening disease or condition that meets the statutory criteria in Section 1905(gg)(2), including trials approved, conducted, or supported by entities such as NIH, CDC, AHRQ, CMS, cooperative groups, DoD/VA, qualified non‑governmental research entities, or trials under IND/IDE or comparable peer‑reviewed funding entities.
Routine Costs	Items or services provided to the individual under the qualifying clinical trial that would otherwise be covered under the state plan, including items to prevent, diagnose, monitor, or treat complications from trial participation; excludes investigational items not otherwise covered and items provided solely for data collection and analysis not used in the direct clinical management of the beneficiary.
Principal Investigator	The person responsible for the scientific and technical direction of the entire clinical study.
Informed Consent	The process by which a beneficiary learns about and understands the purpose, benefits, and potential risks of the clinical trial and then agrees to participate; generally requires the beneficiary or responsible party to sign a statement confirming understanding of risks and benefits.

Revision History

2023-07-01materialLatest

Requirement added that provider and principal investigator complete and retain Medicaid Attestation Form; electronic signatures allowed. Policy posted 7/1/2023 with effective date 4/1/2023; updated template language due to North Carolina Health Choice Program's move to Medicaid.

2023-05-01material

Revisions to align with Division CC, Title II, Section 210 of the Consolidated Appropriations Act, 2021: updated definitions for qualifying clinical trial and routine costs, added definition for principal investigator, and added requirement that provider and principal investigator complete and maintain the Medicaid Attestation Form in the beneficiary's health record.

2019-07-01

Policy Summary

PayerAlliance Health

PolicyRoutine patient costs for qualifying clinical trials (NC Medicaid)

Policy CodePolicy 1A-39

Change TypeRevisions and additions (attestation, definitions, statutory update)

Effective DateJan 1, 2004

Next Review DateN/A

Key ActionComplete and maintain a Medicaid Attestation Form in the beneficiary's health record signed by the principal investigator and health care provider; electronic signatures allowed.

On This Page

ALL of the following

The beneficiary meets all eligibility criteria of the qualifying clinical trial.
The beneficiary is enrolled in the qualifying clinical trial.
The beneficiary has provided informed consent.
The beneficiary is treated according to the qualifying clinical trial's protocol.
The health care provider and principal investigator complete the Medicaid Attestation Form on the Appropriateness of the Qualified Clinical Trial and the completed attestation is maintained in the beneficiary's health record (subject to audit).
Electronic signatures allowed; failure to maintain a completed attestation signed by the Principal Investigator and Health Care Provider prior to participation may result in recoupment.

General Non-Coverage Criteria

Medicaid shall not cover when ANY of the following apply:

ANY of the following

The beneficiary does not meet Medicaid eligibility requirements.
The beneficiary does not meet the criteria listed in Section 3.0 (coverage criteria).
The procedure, product, or service duplicates another provider's procedure, product, or service.
The procedure, product, or service is experimental, investigational, or part of a clinical trial (i.e., the investigational item or service that is the subject of the qualifying clinical trial and not otherwise covered under the state plan).

Specific Non-Coverage for Clinical Trial Services

Medicaid shall not cover the following clinical trial services:

ALL of the following

Services that are not health care services.
Any item or service provided solely to satisfy data collection and analysis for the qualifying clinical trial that is not used in the direct clinical management of the beneficiary and is not otherwise covered under the state plan, waiver, or demonstration project.
Any investigational item or service that is the subject of the qualifying clinical trial and is not otherwise covered outside of the clinical trial under the state plan, waiver, or demonstration project.
Investigational drugs that do not have unrestricted market approval from the FDA for any diagnosis or treatment.
After the clinical trial ends, coverage is not provided for non-FDA approved drugs that were provided or made available to an enrollee during a qualifying clinical trial.
Travel, lodging and meals.
Clinical trial services for which costs have been or are funded by governmental or national agencies, foundations, commercial manufacturers, distributors, charitable grants or other research sponsors of the individual trial (i.e., services already funded by trial sponsors).
If the service provided includes a transplant, coverage is not provided for organs sold rather than donated to a beneficiary.

Documentation Required

Eligibility verification

Providers must verify each Medicaid beneficiary's eligibility each time a service is rendered. Providers may bill only for procedures, products, and services that are within the scope of their clinical practice and for which they meet Medicaid participation qualifications.

Billing Rule

Bundled charges and separation

If charges related to covered clinical trial services cannot be separated from charges for non-covered services, those charges are not reimbursable and will not be paid.

Billing Rule

Coding specificity

Report the most specific CPT, HCPCS, and ICD-10-CM/PCS codes and billing units that accurately and completely describe the procedure, product, or service. If no specific CPT or HCPCS code exists, use the appropriate unlisted procedure or service code and submit the required special report per CPT/HCPCS instructions.

Documentation Required

Record retention and audits

The completed attestation form and all supporting records must be maintained in the beneficiary's health record and are subject to audit for compliance at any time. Failure to have a completed, signed attestation in the record prior to participation may result in recoupment of associated costs.

Changed coverage criteria: removed requirement that beneficiary have a current diagnosis with a grave prognosis (life expectancy less than 2 years) and replaced with 'beneficiary must have a life-threatening condition'; added/updated definitions and other clarifying revisions to trial phases and non-coverage (including travel, lodging, meals and post-trial non-FDA approved drugs).