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ORA FAQs
What are routine costs in clinical trials?

For qualifying clinical trials, Medicare only potentially covers items and services considered to be “routine costs.”  Routine costs in clinical trials include:

  • Items or services that are typically provided absent a clinical trial (e.g., conventional care);
  • Items or services required solely for the provision of the investigational item or service (e.g., administration of a noncovered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and
  • Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service in particular, for the diagnosis or treatment of complications.

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