Clinical Trials Form

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Clinical Trial - Medical Policy
Updated Revision Effective: 10/1/2025 Policy Number:

UM383POL

Approval Date: 8/5/2025

Line(s) of Business: Commercial
Medicare Advantage
Medicaid (BeHealthy)

Description

Clinical trials (or clinical research studies) are scientific investigations of treatment alternatives designed to help compare the safety and efficacy of new, untested or nonstandard treatments to standard currently accepted treatments. Clinical trials are intended to improve the clinicians' knowledge about a treatment and clinical outcomes for future members. Improvement of health outcomes for members enrolled in clinical trials is a desirable but secondary consideration.

Clinical trials generally proceed through four (4) phases:

Phase I clinical trials - the study of a drug or treatment that is given to a small group of people for the first time to evaluate its safety, determine a safe dosage range and to identify side effects.

Phase II clinical trials - the study of a drug or treatment that is given to a large group of people that have certain diseases or conditions to see if it is effective and to further evaluate its safety.

Phase III clinical trials - the study of a drug or treatment that is given usually to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the drug or treatment to be used safely.

Phase IV clinical trials - studies performed after the marketing of the drug or treatment to collect information about its effects in various populations and any side effects associated with long-term use.

 Line of Business

Commercial:
• Refer to criteria under the Policy section in this medical policy.

Medicaid – BeHealthy:
• Refer to criteria under Policy section in this medical policy.
• There are no MassHealth guidelines for Clinical Trial.

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Medicare:
• Health New England follows National Coverage Determination (NCD) 310.1, Routine Costs in Clinical Trials for Clinical Trials for the Medicare line of business. https://www.cms.gov/medicare-coverage- database/search.aspx

Policy

I. Criteria for Approval - for Commercial and Medicaid

A. Clinical Trials are covered when the following criteria, 1-5, are ALL met:

1. The trial must meet the definition of a “qualified clinical trial” as contained in Massachusetts General Laws Chapter 175: Section 110L, https://malegislature.gov/Laws/GeneralLaws/PartI/TitleXXII/Chapter175/Section110L
   and be consistent with Centers for Medicare & Medicaid Services (CMS.gov) and
   Patient Protection and Affordable Care Act (PPACA) requirements; AND

2. The trial is preauthorized and reviewed by the Health Services Utilization Management Department; AND

3. The referring health care professional is a participating provider and has concluded that the individual’s participation in such trial would be appropriate; OR the participant or beneficiary provides medical and scientific information establishing that the individual’s participation in such trial would be appropriate; AND

4. Clinical trial medications are to be provided by the clinical trial study with no cost to member or to Health New England; AND

5. Clinical trial provides a reasonable expectation of medical benefit with a therapeutic intent.

   B. What is Not Covered?

6. The health insurance plan does not cover experimental or investigational treatments, drugs, or procedures.

7. An investigational drug or device paid for by the manufacturer, distributor, or provider of the drug or device.

8. Trials designed to exclusively test toxicity or disease pathophysiology. It must have therapeutic intent.

9. Trials on healthy volunteers.

10. Members who are not clinically eligible or qualified for participation in the clinical trial.

11. Members who have not provided informed consent for trial participation.

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7. Non-healthcare services that a member may be required to receive as a result of being enrolled in the clinical trial (i.e., meals, transportation, lodging, personal care services).

8. The costs of services which are provided primarily to meet the needs of the trial, including, but not limited to, tests, measurements and other services which are typically covered but which are being provided at a greater frequency, intensity or duration. (e.g., monthly CT scans for a condition usually requiring only a single scan).

9. Services or items that are specifically excluded in member’s Explanation of Coverage.

10. Services or items that would not be covered if a member was not enrolled in a clinical trial.

11. 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 covered clinical trial.

12. Non-covered items and services, including items and services that are statutorily prohibited.

    Policy Guidelines and Definitions

    Policy Guidelines

    I. Required Documentation - for Commercial and Medicaid.

    A. Copy of the study protocol including the documented therapeutic intent.

    B. Detailed outline of what is covered and provided by the trial, and what services are requested for coverage by the health insurance plan.

    C. Documentation of informed consent for participation in the clinical trial in a manner consistent with current legal and ethical standards.

    II. Limitations

    A. All applicable plan limitations for coverage of out-of-network care will apply to routine patient care costs in clinical trials.

    Definitions

    Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. Informed consent must be documented in written form, in the language of the enrollee's choice.

    Food and Drug Administration Definitions for types of device approval:

    A. FDA 510(k) Device Clearance: Device manufacturers notify the FDA within ninety (90) days of intent to market a device, allowing the FDA time to research the device and categorize it. This type of premarket submission demonstrates that a device is at least as safe and effective to another legally marketed device.

    B. Premarket Approval (PMA): Involves a more stringent review of the device and whether the research contain sufficient scientific evidence that provides reasonable assurance that the device is safe and effective for the intended uses.

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C. Humanitarian Use Device (HUD): a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year (Section 3052 of the 21st Century Cures Act (Pub. L. No. 114-255).

D. Humanitarian Device Exemption (HDE): a marketing application for an HUD (Section 520(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)). An HDE is exempt from the effectiveness requirements of Sections 514 and 515 of the FD&C Act and is subject to certain profit and use restrictions.

Placebo is an inactive medication or treatment that has no intended therapeutic value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.

Original Medicare: This is referring to Medicare “fee for service”.

Coding Guidance

Code
Description
HCPCS Codes Related to Clinical Trial G0293 Non-covered surgical procedure(s) using conscious sedation, regional, general or spinal anesthesia in a Medicare qualifying clinical trial, per day. G0294 Non-covered surgical procedure(s) using either no anesthesia or local anesthesia only, in a Medicare qualifying clinical trial, per day. S9988 Services provided as part of Phase I trial. S9990 Services provided as part of a phase II clinical trial. S9991
Services provided as a part of Phase III clinical trial.

CPT® Copyright 2025 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Note: CPT/HCPCS codes are included for informational purposes and may not be all inclusive. Inclusion or exclusion of a CPT/HCPCS code(s) does not signify or imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member’s specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee of payment. Other policies and coverage determination guidelines may apply.

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References

The Basics. (2017, October 20).

https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics

Clinical trials.gov. (n.d.).

https://clinicaltrials.gov/

Chapter 257: AN ACT PROVIDING FOR INSURANCE COVERAGE OF CERTAIN CLINICAL TRIALS. (2020).

https://malegislature.gov/Laws/SessionLaws/Acts/2002/Chapter257

The Patient Protection and Affordable Care Act (PPACA) Section 2709, March 23, 2010.

https://www.dpc.senate.gov/healthreformbill/healthbill53.pdf

42 USC 300gg-8: Coverage for individuals participating in approved clinical trials.

https://uscode.house.gov/view.xhtml?req=(title:42%20section:300gg-8%20edition:prelim)

What Are Cancer Clinical Trials?

https://www.cancer.gov/about-cancer/treatment/clinical-trials/what-are-trials

Cancer Clinical Trials at the NIH Clinical Center. (2019, September 6).

https://www.cancer.gov/about-cancer/treatment/clinical-trials/what-are-trials/where/clinical- center#international-participants

Commissioner, O. of the. (n.d.). Clinical Trials Guidance Documents.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance- documents

Commissioner, O. of the (2020, March 18). Clinical Trials and Human Subject Protection.

https://www.fda.gov/science-research/science-and-research-special-topics/clinical-trials-and-human- subject-protection

Medicare Managed Care Manual (MMCM), Clinical Trials Chapter 4, Section 10.7:

http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/mc86c04.pdf

National Coverage Determination (NCD) for routine costs in clinical trials. http://www.cms.gov/Medicare/Coverage/ClinicalTrialPolicies/index.html

Medicare National Coverage Determination Manual.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/ncd103c1_Part4.pdf

National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1).

https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=1&ncdver=2&fromdb=true

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Policy Implementation

Approved by the Medical and Pharmacy Policy Committee

Kate McIntosh MD MBA

Chief Medical Officer

Saad Usmani MD MBA

Medical Director

Date Update 2/8/2011 Initial Policy Date 05/2023 Minor changes to policy language. Clinical Trial policy for Medicare merged with Commercial and Medicaid policy. 1/2024 Added Line of Business section 7/2024 Reviewed with no changes 06/2025 Definitions updated.

Medical Criteria Disclaimer

Property of Health New England. All rights reserved. The treating physician or primary care provider must submit to Health New England the clinical evidence that the patient meets the criteria for the treatment, testing or surgical procedure. Without this documentation and information, Health New England will not be able to properly review the request for prior authorization. The clinical review criteria reflect how Health New England determines whether certain services or supplies are medically necessary. Health New England established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Health New England expressly reserves the right to revise these conclusions as clinical information changes and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by Health New England, as some programs exclude coverage for services or supplies that Health New England considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. Health New England has adopted the herein policy in providing management, administrative and other services to its Health Plan.