Clinical Research Billing Compliance

Medicare Coverage Analysis

Effective July 9, 2007, the Centers for Medicare and Medicaid Services (CMS), Clinical Trial Policy (CTP) National Coverage Determination (NCD) allows for Medicare reimbursement of routine care costs of qualifying clinical trials. The Medicare Coverage Analysis (MCA) is required for all non-device clinical research studies anticipating to enroll Medicare beneficiaries and billing of costs for items and services related to routine care. Routine costs of a clinical trial include:

  • Items or services that are typically provided absent a clinical trial (i.e., conventional care);
  • Items or services required solely for the provision of the investigational item or service (i.e., administration of a non-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.

In order to bill Medicare and/or Medicaid for routine care costs of items and services, a clinical trial must meet certain criteria to qualify for reimbursement. To determine whether your clinical trial meets the requirements for reimbursement by Medicare for routine costs, the MCA must be performed prior to enrolling study subjects and initiating clinical research procedures.

An online tool to determine whether your trial qualifies for reimbursement by Medicare is located in the 'Tool Kit' to the right.

The summary determination at the end of the MCA will be retained in the ORA MCA database and may be printed and maintained with the study budget files for research billing purposes.