Hello folks - I've got a clinical trial question for you.

We have a rogue department trying to say that while the study drug is
obviously study related, the method to inject the drug (IV, conscious
sedation (for babies/children), etc.) is standard of care and the
department is trying to bill insurance/medicare for these costs.  To me,
this seems inappropriate.

The rationale provided by the department is that in the absence of the
study drug, the patient would have received a non-study drug, and so the
method of injection should be SOC (standard of care).

1.  What are your opinions on this situation?
2.  Can anyone cite a source backing up their viewpoint?

Thank you all for any input you can provide!!

Linda Ward, MBA
Sr. Accountant
Research Administration  35-123A
Children's Hospitals and Clinics
2910 Centre Pointe Dr.
Roseville, MN 55113
651-855-2603
651-855-2690 Fax
email: xxxxxx@childrenshc.org
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