National Coverage Analysis: Key Resource for Clinical Trials

Before 2016, determining insurance coverage for multisite cancer clinical trials was fraught with problems. Individual sites deciding which tests, procedures, and interventions were billable to third-party payers and which were not often resulted in system-wide redundancies, financial risks to patients, problems in recruiting patients, and costly administrative burdens

“It was a tedious and time-consuming task for individual sites to perform a coverage analysis to determine which procedures would be covered by insurance in their trials,” says Lucille Patrichuk, Westat Assistant Project Director for the National Cancer Institute’s (NCI’s) Cancer Trial Support Unit (CTSU). The CTSU facilitates access to NCI-funded oncology clinical trials for qualified clinical sites.

“Each site had to rely on experienced staff to carry out this function, and not all sites had access to this expertise,” notes Ms. Patrichuk. “In addition, this administrative burden often meant that a trial’s opening was delayed until the coverage analysis was completed. The delay had the potential of affecting patient enrollment, and the lack of expertise created the possibility of putting hospitals and patients at financial risk.”

Creating a Centralized Resource

To address this problem, NCI began working with Westat, the American Society of Clinical Oncology, and the Centers for Medicare & Medicaid Services (CMS) to create a centralized resource for oncology researchers. The National Coverage Analysis (NCA) Initiative was born out of this collaboration. In 2016, it was launched to support the National Clinical Trials Network (NCTN)—NCI’s funding arm supporting cancer research organizations wanting to conduct clinical trials. The NCA Initiative expanded Westat’s long-term role with NCI’s CTSU.

Lawrence Ragard, M.D., a Westat Senior Study Director, helped develop the Initiative’s processes and procedures. He is the primary point of contact for NCA issues as the sites continue to perform their local coverage reviews.

“To make the determination, we apply CMS regulations and evidence-based guidelines,” Dr. Ragard explains. “This involves a thorough review of the protocol, the informed consent forms, and the cancer type and stage to assess potential billing problems based on established guidelines. Time is then allowed for the clinical study team to discuss and review the analyses before study activation.” Therefore, once the trial activates with a completed NCA, the CTSU’s work has expedited this step for all the participating trial sites to focus their review on local coverage issues and their institutions’ billing practices.

Dr. Ragard adds that although Medicare regulations generally drive what will be covered in a clinical trial, “we also review the guidelines of a number of other resources, including the cancer-specific National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (the gold standard), the NCCN Drug Compendium, and those of commercial payers to determine whether the intervention is billable as a routine cost or if there will be potential coverage issues.”

Additional Benefits from the NCA Initiative

“Our NCA support for NCI clinical trials has put us in the forefront for this kind of work,” says Ms. Patrichuk. “Our analyses are accessed by hundreds of institutions across the NCTN that depend on this service to activate their trials. With the rollout of the NCA Initiative, researchers reported numerous benefits.”

These benefits include:

• Increased trial funding transparency
• Early detection of the need for additional funding or protocol modifications
• Ensuring participating patients would not be billed for tests or services
• Greater efficiency in activating new NCTN trials
• Fewer administrative burdens—both financial and time-related
• Prevention of inaccurate billing of tests to Medicare or third-party payers
• Heightened awareness of CMS and insurance coverage policies

To further support researchers, Westat hosts quarterly meetings with NCI and CTSU stakeholders to discuss potential coverage issues and share best practices.

“This proactive approach to facilitating clinical trials is making a huge difference to institutions activating NCI trials and to patients wanting to participate in them,” says Dr. Ragard. “It is rewarding work.”