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Q/A: Reporting a HCPCS code for medications without an LCD

Q: The rule our institution has followed with respect to HCPCS coded medications without a local coverage determination (LCD) is to limit prescribing to the FDA-approved indications. The question that arises is how closely do the physicians need to follow the package insert?

For example, the drug basiliximab does not have an LCD and the FDA indication is:

For acute kidney transplant rejection prophylaxis when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.

 
 
Generally, physicians performing transplants at our institution do not use steroids or cyclosporine.
 
They use tacrolimus, sirolimus, mycophenolate mofetil, and/or mycophenolate sodium. If the physician performs a transplant without cyclosporine or steroids, do we need to have the patient sign an advanced beneficiary notice?

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