OHSU

Devices

8667804-the-medical-device-for-blood-pressure-and-pulse-measurement

 The use of investigational (IDE) or humanitarian (HUD/HDE) devices at OHSU requires IRB approval and the use of an IRB-approved consent, as well as approval from our Medicare Administrative Contractor in order to use the device in Medicare beneficiaries.


 

PRE-APPROVAL MUST BE OBTAINED FROM THE MEDICARE ADMINISTRATIVE CONTRACTOR PRIOR TO THE USE OF ANY IDE, HDE, OR CAROTID PMA DEVICE IN MEDICARE PATIENTS.   IN ADDITION, PATIENT SPECIFIC APPROVAL IS REQUIRED FOR ALL MEDICARE PATIENTS RECEIVING A HUD/HDE DEVICE PRIOR TO OR WITHIN 3 DAYS OF IMPLANTATION.

 

Investigational/Humanitarian Device Medicare Preapproval

 If your study involves an IDE or HDE, an Investigational and Humanitarian Device Medicare Pre-Approval Form must be completed and submitted to Clinical Research Billing Compliance Office (CRBO) via interoffice mail, along with all the required documents in triplicate. The CRBO will send this pre-approval packet to our Medicare Administrative Contractor for approval. No subjects with Medicare or Medicare Advantage may be enrolled in the study or receive the device until approval of coverage has been received from our Fiscal Intermediary.

Once the approval letter is received from our Administrative Contractor, a device initiation meeting will be set up by the study staff. This should include the CRBO, appropriate study team personnel, and hospital and professional billing representatives, as well as a representative from Logistics if necessary. This meeting should take place prior to enrollment of any research subjects on the trial.

HDE Patient-specific approval: Medicare beneficiaries receiving an HDE device must be approved by Medicare prior to, or within a reasonable time period after, the procedure utilizing the device. Additional info is available here. Clinical documentation of the approved indication should be faxed to our Administrative Contractor, Noridian using the Request for HDE Treatment Approval form.

 

Investigational Device Exemption

Humanitarian Device Exemption

Premarket Approval 

 

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