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How do I bill outpatient Routine Costs of a Qualified Clinical Trial (including approved device studies and CEDs) for Managed Care enrollees?

Medicare fee-for-service contractors will pay for covered clinical trial services furnished to the Managed Care Enrollee. The coding requirements are the same as for Medicare as noted above, however institutional providers must not bill outpatient clinical trial services and non-clinical trial services on the same claim. These must be split-billed. For additional guidance, see Medicare Claims Processing Manual Chapter 32 Section 69.9.

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