Clinical Policy: Clinical Trials Form

CENTENE Corporation

Clinical Policy: Clinical Trials Reference Number: CP.MP.94 Date of Last Revision: 06/25 Revision Log

See Important Reminder at the end of this policy for important regulatory and legal information.

Description Medical necessity guidelines for routine costs of clinical trials in accordance with Centers for Medicare & Medicaid (CMS) and the Patient Protection and Affordable Care Act (PPACA) requirements.

Note: For experimental technologies, refer to CP.MP.36 Experimental Technologies.

Policy/Criteria I. It is the policy of health plans affiliated with Centene Corporation® and Centene Advanced

Behavioral Health that routine costs of a qualifying clinical trial and services used to
diagnose and treat complications arising from participating in a qualifying clinical trial are
medically necessary based upon the following guidelines and limitations.¹²

A. Routine costs in a clinical trial include all items and services generally considered

medically necessary and a covered benefit to Plan members/enrollees that are provided in
either the experimental or control arms and include:
1.  Items or services that are typically provided absent a clinical trial;
2.  Items or services required solely for the provision of the investigational item or
    service (e.g., administration of a non-covered chemotherapy agent), the clinically
    appropriate monitoring of the effects of the item or service, or the prevention of
    complications;
3.  Items or services needed for reasonable and necessary care arising from the provision
    of an investigational item or service – in particular, for the diagnosis or treatment of
    complications;

B. Excluded costs/services:

1.  The investigational item or service itself;
2.  Items and services provided solely to satisfy data collection and analysis needs and
    that are not used in the direct clinical management of the patient (e.g., monthly CT
    scans for a condition usually requiring only a single scan);
3.  Items and services customarily provided by the research sponsors free of charge for
    any enrollee in the trial;

C. Administrative limitations:

1.  All applicable Plan limitations for coverage of out-of-network care applies to routine
    costs in a clinical trial;
2.  All existing utilization management guidelines apply to routine care for
    members/enrollees in clinical trials, including prior-authorization and notification
    requirements;

Background This policy was adapted from Medicare Coverage ~ Clinical Trials, Final National Coverage Decision policy.

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References

1. National coverage determination: routine costs in clinical trials (310.1). Centers for Medicare and Medicaid Services Web site. https://www.cms.gov/medicare-coverage- database/search.aspx. Published May 27, 2024. Accessed April 22, 2025.
2. Office of the Legislative Counsel for the use of the U.S. House of Representatives. Compilation of Patient Protection and Affordable Care Act. https://www.hhs.gov/sites/default/files/ppacacon.pdf?language=es. Published June 09, 2010. Accessed May 16, 2025.
3. National Institutes of Health U.S. National Library of Medicine. ClinicalTrials.gov. https://clinicaltrials.gov. Accessed May 19, 2025.
4. U.S. Department of Energy. Protection of Human Research Subjects. https://www.directives.doe.gov/directives-documents/400-series/0443.1-B-Order- c/@@images/file/~(1)%20No%20HSR%20conducted%20with%20the%202010%20CFR %20Part%20745.103. Published November 26, 2019. Accessed May 21, 2025.

Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. “Health Plan” means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable.

The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures.

This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan

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retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time.

This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members/enrollees. This clinical policy is not intended to recommend treatment for members/enrollees. Member/enrollees should consult with their treating physician in connection with diagnosis and treatment decisions.

Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan.

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members/enrollees and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members/enrollees and their representatives agree to be bound by such terms and conditions by providing services to members/enrollees and/or submitting claims for payment for such services.

Note: For Medicaid members/enrollees, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy.

Note: For Medicare members/enrollees, to ensure consistency with the Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs, LCDs, and Medicare Coverage Articles should be reviewed prior to applying the criteria set forth in this clinical policy. Refer to the CMS website at http://www.cms.gov for additional information.

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