March 20, 2008
Investigational Device Exemption coding and cost information form
Date:
Investigators:
Reimbursement information relating to a request to submit claims to the Medicare contractor for certain beneficiaries in a clinical trial (Investigational Device Exemption)
Device and IDE#:
Name of Study:
Claims for day of device implant or initial use
Physician Services (claims submitted to the carrier for day of device implant or initial use.)
a) Are these services reimbursed by the sponsor?
• Yes
If yes, services should not be billed to the Carrier since sponsor paid.
• No
If no proceed to b)
b) All CPT code(s) submitted on day of procedure, short descriptor. You must code to specificity. If unlisted code, Cat III code, or no fee schedule payment, suggest a similar code based on RVUs or provide information on RVUs for contractor consideration.
Code (on the claim) with Q0 modifier (item or service in an approved clinical study) |
Short descriptor |
For unlisted code or Cat III code, suggest a similar code based on RVUs or provide information on RVUs. Do not submit this on the claim. |
|---|---|---|
Note: Please add additional page if needed or use your own electronic form, but follow this format.
Facility Services (claims submitted by the hospital to the FI for day of device implant or initial use)
a) Name of facility:
b) Is the cost of the device covered by the sponsor?
• Yes
If yes, claims to the FI must be adjusted to reflect this.
• No
c) Inpatient Claim
List ICD-9 diagnosis code(s) and DRG:
d) If applicable- Outpatient Hospital claim
List ICD-9-CM diagnosis code(s):
e) List all procedure codes on day of device implant or initial use
Procedure code (inpatient ICD-9; outpatient CPT, HCPCS) |
Short descriptor |
|---|---|
Note: If a non hospital facility place of service (ASC or other setting), designate the site of service and address coding and billing as above. The site of service must allow similar device procedures to be billable to Medicare. Also note if the cost of the device is covered by the sponsor.
Signature of Investigator and/or Manager, Clinical Trial
