IDE Preauthorization Guidance

1. For industry sponsored studies, the research team confirms CMS approval with study/industry sponsor and informs the Research Process Manager of approval.

2. Research team submits the following documents to: Marija Cerelli, SHC Stanford Patient Financial Services (PFS), at MCerelli@stanfordhealthcare.org and emails a copy to the appropriate CT/RPM. Email subject line must state “IDE Preauth Request: IDE #..., SPO#....”

• Completed Medicare IDE Pre-Auth Notification Cover letter for IDE post 1.1.15
• Documentation of CMS Approval from Sponsor

3. Note: IRB letter is not required for submission. SHC forwards documentation to Noridian, SHC’s Medicare Administrative Contractors (MAC)or Fiscal Intermediaries (FI) as notification of Stanford’s participation in the trial.

4. Noridian provides a letter (may take up to 4-6 weeks) to SHC confirming notification and entry of study physician(s) into the Medicare claims payment system, type of coverage (e.g. Medicare Part A and B Coverage) and effective date.

5. Please note that Clinical Trial Agreement (CTA) may not be executed until letter has been received by SHC.

1. FDA issues IDE number and identifies the CMS category for the investigational device.

2. Research team reviews the Medicare Coverage IDE Study Criteria checklist and Study Criteria Crosswalk Table and collects all required documents. This process can take several weeks, depending on the stage of the project. Before the packet can be completed the following must occur.

• IRB approval must be obtained
• Budget and Billing Workbook must be initiated
• Device description information must be obtained (typically from device manufacturer)
• Study must be registered on ClinicalTrials.gov and NCT number obtained

3. Research team completes the Medicare IDE Preauth CoverLtr_PI to CMS to Central CMS.

4. Research team emails completed cover letter, Central CMS Study Criteria Crosswalk checklist and all related documents to clinicalstudynotification@cms.hhs.gov

• For more information see: Medicare Coverage Related to Investigational Device Exemption (IDE) Studies 

5. Once Medicare approval is obtained from Central CMS, Research team submits the following documents to to Marija Cerelli, SHC Stanford Patient Financial Services, at MCerelli@stanfordhealthcare.org and emails a copy to the appropriate CT/RPM. Email subject line must state “IDE Preauth Request: IDE #..., SPO#....” SHC forwards documentation to Noridan as notification of Stanford’s participation in the trial.

• Medicare IDE Pre-auth Cover letter for IDE dated after 1.1.15 (see template)
• Documentation of CMS Approval
• FDA acknowledgement letter
• IRB approval letter