Which organization is primarily responsible for overseeing Medicare billing practices in clinical trials?

The Centers for Medicare and Medicaid Services (CMS) is the correct answer because this organization plays a pivotal role in administering the nation's major healthcare programs, including Medicare. Specifically, CMS establishes and oversees regulations and policies regarding billing practices related to clinical trials involving Medicare beneficiaries. This oversight ensures that clinical trials are compliant with Medicare's requirements and that beneficiaries' rights and coverage are protected.

CMS’s responsibilities include determining which clinical trial services are covered under Medicare, defining what constitutes a clinical trial, and setting payment rates for covered services. This makes CMS central to the billing practices associated with clinical trials, distinguishing it from other organizations like the Department of Health and Human Services, which has a broader mandate over health and social services but does not specifically focus on billing practices for trials.

The Food and Drug Administration (FDA) primarily governs the safety and efficacy of drugs and medical devices rather than billing practices, while the National Institutes of Health (NIH) is focused on medical research and funding and does not handle Medicare billing. Thus, CMS's specific roles and responsibilities establish it as the key organization overseeing Medicare billing in the context of clinical trials.