Good morning!
I wanted to ask how other academic medical centers interpret the CMS policy (NCD 310.1) of sponsors in clinical trials providing supplies at no cost. We are looking at the language in CMS policy that states "Items and services customarily provided by the research sponsors free-of-charge for any enrollee in the trial." (NCD 310.1 - Routine Costs in Clinical Trials)
- If the study is FDA approved and in the process of obtaining CMS approval, can the sponsor supply a needed item at no cost until CMS finalizes the study for billing to Medicare?
- How do you interpret the language "customarily provided?"
Thank you in advance for your response!
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Laura Bushong
Director, Professional and Clinical Research Compliance
Duke Health System
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