NCD 310.1

Medicare: What is it and How Does it Apply to Clinical Trials?

For the average person, understanding Medicare can be confusing and complicated. However, for people in the world of clinical research administration, understanding Medicare is a necessity in order to maintain billing compliance. Medicare rules are the foundation for clinical trial billing compliance, so understanding how Medicare can impact your research is crucial. To understand how Medicare impacts clinical trials, you must first understand what Medicare is, how it is broken up, and what makes a clinical trial qualified to receive Medicare coverage.

NCDs and LCDs 101

National and Local Coverage Determinations (NCDs and LCDs) are two of the most important aspects of Medicare coverage. Both NCDs and LCDs are released by Centers for Medicare and Medicaid Services (CMS) to standardize Medicare coverage for certain medical tests and procedures. These determinations outline the conditions in which a service is considered to be covered by Medicare.

NCD 310.1: Medicare's Clinical Trial Policy

In the early 1960’s, changes in federal regulations sparked a revolution in drug research and development, particularly in regard to clinical trial testing when Investigational New Drug designations (INDs) and New Drug Applications were implemented.

Then in 1965, Medicare, the national social insurance program, was established.