CGS J-15 A/B MAC

Investigational Device Exemption Request Form

The following completed form (page 1) should be included when submitting the request to CGS.

REQUESTS CAN BE SUMITTED VIA E-MAIL TO

  1. Point of Contact:______
  2. Address:______

______

______

  1. Phone number:______
  2. Email address:______
  3. IDE number:______
  4. Study Name:______
  5. Trade name (device):______
  6. Device Common name: ______

Facilities where service will be provided:

Facility Name / Address / NPI

Participating practitioner (s):

Name / (MD/DO) / NPI
PI
Sub
Sub
Sub
Sub
Sub

Number of enrollees anticipated at the facility:

Anticipated bill type: (inpatient, outpatient, or both):

CGS is now accepting IDE requests for J-15 Part A and Part B for Kentucky and Ohio and Home Health and Hospice. We look forward to serving you.

The following documentation is required for submission. Please submit all documents at the same time. NOTE: Failure to submit all documentation will result in rejection of your submission and require re-submission of all items.

  1. The name of the device (both trade, common or usual and classification name) and a narrative description of the device. Include a statement as to the devices similarities and differences from other products if not explicitly and clearly indicated in submitted documents.
  2. An un-redactedcopy of FDA approval letters provided to the provider and/or the sponsor or manufacturer of the device.
  3. A copy of the approval letter from the provider's Institutional Review Board (IRB). (A copy of the approval letter for any time extension or other update must also be submitted as the approval occurs.)
  4. If necessary a description of action(s) taken to conform to any applicable FDA and/or IRB special controls and /or other requirements.
  5. A full copy of the study protocol, including patient inclusion criteria.
  6. A copy or description of the provider's protocol for obtaining informed consent from patients participating in the device trial.
  7. A sample of the patient consent form (must clearly describe the patient's financial responsibility if any).
  8. Copies of all agreements between the sponsor and the provider especially, but not limited to, financial agreements.
  9. The Principal Investigator's (PI) budget for the study, showing allocation of all funds from all sources.
  10. A description of the facility's processes/procedures for ensuring that Medicare is not billed for any non-clinical study costs and sponsor or other reimbursed costs.

All IDE approvals will expire after one calendar year or the expiration of the IRB approval whichever is shorter.

Extension or modification requests should include

  1. A letter signed by the PI requesting the extension/modification and reason for the extension/modification, any changes to the protocol (if so also need copy of the modifications) and any significant adverse effects;
  2. A current IRB showing approval of the extension and any modifications;
  3. If adding sub-investigators include name, professional designator (MD/DO) and NPI.

These items shall be submitted at least thirty days prior to expiration of approval or need for the modification. Any time the protocol changes significantly or a major adverse effect occurs CGS expects notification within thirty days of the event. CGS may from time to time request medical records, claims data and other documentation necessary to demonstrate adherence to the protocol and proper billing of Medicare claims related to the IDE request.

Preferably, if possible all items should be e-mailed to .

Alternatively, the above documentation may be mailed to:

CGS Administrator LLC

ATTN: Julene Mull, IDE Request

Two Vantage Way

Nashville, TN 37228

CGS IDE Request Revised 07/31/2012 Page1

© 2012 Copyright, CGS Administrators, LLC