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This expectation is based on language from Medicare’s National Coverage Decision, the Patient Protection and Affordable Care Act, and from state laws mandating clinical trial coverage.
This omission has led to varying interpretations of HCFA's intent by its fiscal intermediaries and carriers who process claims, as well as by providers submitting claims.
Clinical trials have become an essential component of modern medical care.
The breakneck speed of medical advances and the increased effort to base clinical decisions on reliable evidence place clinical trials in an ever more prominent position between medical innovation and medical practice.
Traditionally, cancer programs should expect a third party payer to cover the routine cost of cancer care for patients enrolled in a clinical trial.
Routine care is typically defined as items and services consistent with the coverage that would be provided to a patient if that patient were to not participate in a clinical trial.