Investigational Device Submission Requirements
The following submission requirements apply to providers who bill to Cahaba GBA (i.e. Alabama Part A & B; Georgia Part B; and Mississippi Part B).
IDE Category B and Post Pay Market Approval (PMA) are the only devices requiring contractor notice. Other devices and clinical trials do not require contractor notification.
For details regarding coverage and billing, please reference the Medicare
Benefit Policy Manual, 
Chapter 14 and the Medicare
Claims Processing Manual, Chapter 32, Section 69.
Alabama providers may combine Part A and Part B requests into a single submission utilizing the process below.
When submitting a request, please submit the following information/documentation:
- Completed Investigational Device Cover Form (Please note: There have been recent changes to the form)
- A signed copy of the final FDA approval letter demonstrating device status and approval from the FDA to the participating company or manufacturer.
- A copy of the protocol you intend to follow when performing the procedure utilizing the device.
- A copy of the agreement between the company or manufacturer and the provider, furnishing the details of provider participation in the study.
- Any product literature illustrating the device and/or the procedure.
- A list of any alternative devices, therapies, etc, that may be available to treat the indicated disease.
- A copy of the protocol used for obtaining informed consent from beneficiaries for their participation in the study.
- An institutional review board approval letter or a statement from the provider assuring the approval has been obtained from the study institution.
Any changes to the submitted information (including a change in providers) should be submitted as soon as possible. Change includes a change to the IRB study approval end date; services beyond this date will be denied.
Once the device packet has been completed, please forward the entire packet to the Contractor Medical Director as follows:
Contractor Medical Director
Cahaba Government Benefit Administrators®, LLC
Post Office Box 13384
Birmingham, AL 35202-3384
OR e-mail
Once the packet has been reviewed, an appoval letter will be e-mailed to the contact person listed on the device cover form.
Trial Extensions - If the trial extends beyond the date of the original ‘IRB approval end date’ please submit the following items to the contact information above:
- IRB Extension Notice
- Original Approval Letter from Cahaba
- Contact Information-name, email, phone number, etc.
Once the packet has been reviewed an approval letter for the extension will be emailed to the contact person provided.
Page last updated: November 11, 2008
