Please direct feedback and questions to the Clinical Trials Task Force via e-mail.
Device Trial Instructions
Prior to enrolling ANY MEDICARE PATIENTS in IDE or HUD/HDE device studies, you must secure written approval for both Part A and Part B Medicare coverage (Facility and Provider).
Medicare may provide reimbursement for some investigational devices and related services. Services may be furnished in preparation for device use, contemporaneously with, and necessary to the use of the device, and as follow-up care after device use. Coverage is contingent on the Medicare contractor's approval of the application for reimbursement. Our local Medicare Contractor is Noridian. For additional information please visit the following websites:
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Noridian IDE coverage
- Medicare Part B Newsletter pgs. 51-53
- Humantiarian Devices require Contractor Approval
- Medicare National Coverage Decision
- Category B IDE or HDE Medicare Coverage Request Template
- Category A Device Medicare Part A Request Template
- Category A Device Medicare Part B Request Template
- Copy of the FDA "IDE Approval Letter" that demonstrates a CMS Reimbursement Category status, OR FDA HDE letter
- Copy of IRB approval
- Protocol/Billing Grid
- Copy of Clinical Protocol
- Copy of IRB approved Patient Consent Form
- Copy of all Agreements between sponsor and PI
- Copy of Internal (PI) budget
Step 1. Complete Appropriate Cover Letter below.
Step 2. Prepare two two packets (one for Medicare Part A and one for Medicare Part B) including the information below.
Detailed instructions can be found: Noridian Device Request check-list
Step 3. Review and Signatures
Please provide the completed packets to Clinical Research Compliance and Education for review and signature. Attn. Sadie Quinn at Medical Research and Education Building Room 207 Phone #: 801-213-3602 Applications should be signed by the PI and Dr. Richard Sperry, VP for Health Sciences. Sadie will obtain Dr. Sperry's signature and return packet to you.Step 4. Mail to Noridian.
Suggest Fed/Ex or Registered Overnight (something trackable).Step 5. Approval
Approvals should be sent to the Clinical Research Compliance and Education office and a copy will be provided to the PI.Step 6. Amendments and Renewals
A copy of the approval letter for any time extension or other update must also be submitted after the initial approval occurs.Questions? I'm guessing the answer is yes! Contact Sadie Quinn, Clinical Research Compliance and Eduction Coordinator.
University of Utah Health Sciences Center
Medical Research and Education Building Room 207, Salt Lake City, Utah 84132
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