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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101.

The rules state that effective for items and services furnished on or after July 9, 2007, Medicare covers the routine costs of qualifying clinical trials, as such costs are defined below, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials. All other Medicare rules apply.

Routine costs of a clinical trial include all items and services that are otherwise generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, and there is not a national non-coverage decision) that are provided in either the experimental or the control arms of a clinical trial except:

1. The investigational item or service, itself unless otherwise covered outside of the clinical trial;
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); and
3. Items and services customarily provided by the research sponsors free-of-charge for any enrollee in the trial.

You can find this rule in the Centers for Medicare and Medicaid Services, National Coverage Determination (NCD) for Routine Costs in Clinical Trials, Section 310.1.

The rules state that for dates of service on or after September 19, 2000, and until notified otherwise by CMS, Medicare contractors will pay for covered clinical trial services furnished to beneficiaries enrolled in managed care plans. Providers who furnish covered clinical trial services to managed care beneficiaries must be enrolled with Medicare in order to bill on a fee-for-service basis. Providers that wish to bill fee for service but have not enrolled with Medicare must contact their local carrier, intermediary, regional home health intermediary or National Supplier Clearinghouse, as appropriate, to obtain an enrollment application.

You can find this rule in the Centers for Medicare and Medicaid Services, Medicare Claims Processing Manual, Chapter 32, Section 69.9.

If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.

The Plan contract says that the Plan covers items and services in accordance with Medicare rules. The Plan contract says that if you participate in any Medicare-approved study, Original Medicare pays most of the costs for the covered services you receive as part of the study. If you tell us that you are in a qualified clinical trial, then you are only responsible for the in-network cost sharing for the services in that trial. If you paid more, for example, if you already paid the Original Medicare cost-sharing amount, we will reimburse the difference between what you paid and the in-network cost sharing. However, you will need to provide documentation to show us how much you paid. You can find this information on page 40 of the Plan's 2023 Evidence of Coverage.