Device Trials

Device trials can be complicated. The HRPP/CTMT provides the following guidance for initiating sponsored Device Trails.

Device studies may require approval by CMS depending on the study. Please discuss with the contracts and CTMT coordinators to ensure submissions are made in a timely manner.

Which Device Studies Require CMS Pre-Approval?

All category A and B device trials where there are plans to bill routine care costs to Medicare or other insurance payors must be submitted to the Centers for Medicare & Medicaid Services (CMS) requesting review and approval to the bill CMS for the identified routine care services associated with the clinical trial, and as a method to cnfirm routine care costs for all studies regardless of medical insurance payor. Additionally such studies require approval from teh IRB and the UHRIC prior to study enrollment regardless of funding sponsor.

Additional Considerationspacemaker.

We ask that you consider the following issues, and contact us for any additional questions.

  • Is the device experimental for the population or indication?
  • IF experimental, does it have an IDE and Category B designation?
  • Is the Sponsor providing the device?
  • If the device is experimental, does the company provide billing/reimbursement specialists to help map appropriate billing codes and provide information for submission to the Local Medicare Carrier?
  • Is it being provided at no cost or at some other rate (standard market value, Medicare-accepted rate, etc.) 
  • IF the device has to be purchased, is it done through standard hospital purchasing or does some special process need to be set up?
  • Does the device have appropriate billing codes already established in the hospital system? If not, Patient Revenue must be contacted immediately to start this process.
  • If these devices are indicated to be billed to insurance/Medicare, have they been covered before? If not, the hospital may not accept billing other than to the study account.

If you have any questions regarding Device Trials or need assistance, please contact us at shvhrpp@lsuhsc.edu or CTMT@lsuhsc.edu.