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.
There are special rules for individuals enrolled in a Medicare Advantage Organization (“MAO”) who may also participate in a qualifying trial. These rules are even more complex than those for individuals who participate in Medicare fee-for-service.
Be sure you understand the specific coverage allowance and billing requirements of a subject’s insurer before billing any clinical trial services to a Medicare Advantage Plan.
For additional information about clinical trial billing to MAOs, please see:
http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R107MCM.pdf (Section 10.8- Clinical Trials)