2024 Evidence of Coverage for WA PEBB Kaiser Permanente Senior Advantage 47 Chapter 3: Using our plan for your medical services Section 5 — How are your medical services covered when you are in a clinical research study? Section 5.1 – What is a clinical research study? A clinical research study (also called a clinical trial) is a way that doctors and scientists test new types of medical care, like how well a new cancer drug works. Certain clinical research studies are approved by Medicare. Clinical research studies approved by Medicare typically request volunteers to participate in the study. Once Medicare approves the study, and you express interest, someone who works on the study will contact you to explain more about the study and see if you meet the requirements set by the scientists who are running the study. You can participate in the study as long as you meet the requirements for the study, and you have a full understanding and acceptance of what is involved if you participate in the study. If you participate in a 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. When you are in a clinical research study, you may stay enrolled in our plan and continue to get the rest of your care (the care that is not related to the study) through our plan. If you want to participate in any Medicare-approved clinical research study, you do not need to tell us or to get approval from us or your PCP. The providers that deliver your care as part of the clinical research study do not need to be part of our plan's network of providers. Please note that this does not include benefits for which our plan is responsible that include, as a component, a clinical trial or registry to assess the benefit. These include certain benefits specified under national coverage determinations (NCDs) and investigational device trials (IDE) and may be subject to prior authorization and other plan rules. Although you do not need to get our plan's permission to be in a clinical research study, covered for Medicare Advantage enrollees by Original Medicare, we encourage you to notify us in advance when you choose to participate in Medicare-qualified clinical trials. If you participate in a study that Medicare has not approved, you will be responsible for paying all costs for your participation in the study. Section 5.2 – When you participate in a clinical research study, who pays for what? Once you join a Medicare-approved clinical research study, Original Medicare covers the routine items and services you receive as part of the study, including: • Room and board for a hospital stay that Medicare would pay for even if you weren't in a study. • An operation or other medical procedure if it is part of the research study. 1-877-221-8221 (TTY 711), 7 days a week, 8 a.m. to 8 p.m.