The Centers for Medicare & Medicaid Services (CMS) issued the Clinical Trial Policy (CTP) and the National Coverage Determination (NCD) 310.1 Routine Costs in Clinical Trials on Sept. 19, 2000. NCD 310.1 allows for coverage of routine care costs in the context of a qualifying clinical trial (QCT). This includes coverage of reasonable and necessary items and services to diagnose and treat complications arising from participation in a qualifying clinical trial.

The Froedtert Health Office of Clinical Research and Innovative Care Compliance (OCRICC) program staff is responsible for facilitating clinical research billing compliance activities for all of the Froedtert Health entity locations.

Why is this important?

Governmental agencies are increasing their scrutiny of health care providers, medical device manufacturers and pharmaceutical companies in an effort to prevent and/or detect potential health care fraud and abuse. Audits and investigations have found that research billing can result in “double billing”, billing for services that are non-covered, or are not medically necessary according to NCD 310.1. These examples could all lead to allegations of false claims, which could result in criminal and/or civil penalties, exclusion from participating in federal health care programs, Corporate Integrity Agreements, temporary suspension of research, and/or settlement agreements resulting in high fines.

You can access NCD 310.1 - Routine Costs in Clinical Trials via this link:…;

How does Froedtert Health meet these regulatory requirements?

Froedtert Health OCRICC is responsible for performing a Medicare Coverage Analysis (MCA) for any services billed by a Froedtert Health Affiliate. The MCA is a critical activity to prevent Froedtert Health from billing noncompliant and false claims. Medicare requires that you only bill for services that meet their requirements. The only way we know that is to perform an MCA against their policies and requirements. Get additional guidance related to Froedtert Health OCRICC’s MCA process.

Researchers are accountable for the requirements outlined in their project-specific Froedtert Health Administrative Approval Letter. Post-approval, OCRICC manages claims as identified on the agreed-upon MCA/Billing Plan. Researchers must communicate any changes to the project that impact the agreed-upon MCA/Billing Plan to prevent fraudulent claims from being billed.

It is the research team’s responsibility to have a thorough verbal informed consent discussion that includes a detailed discussion about out-of-pocket costs to the participant. In order to make sure that participants understand their out-of-pocket expenses and what may or may not be covered by their insurance, study teams should encourage patients to check with their insurer for details. Uninsured participants should be informed that they are responsible for all costs not provided free by the study.

Patients are always responsible for their copay, deductibles and/or co-insurance amounts for the routine care services as part of the trial.

If study team is going to hold the participant liable for a non-covered service, it is the responsibility of the Principal Investigator, or delegate, to inform the participant of their liability and to partner with the clinical department to obtain a Notice of Non-Coverage/Advanced Beneficiary Notice (ABN) or Hospital Issued Notification of Non-coverage (HINN) for all Medicare patients. If an ABN or HINN is required and one is not obtained, the study will be liable.

IMPORTANT NOTE: All clinical research related billing activities for any Froedtert Health entity must be coordinated and managed through Froedtert Health OCRICC.

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