IDE Preauthorization Guidance

Medicare allows payment of routine care costs furnished to Medicare beneficiaries in certain categories of Investigational Device Exemption (IDE) studies.  In order to determine whether billing of routine care costs (and in some cases the cost of the device itself) is permitted, a request for preauthorization (“pre-auth”) must be submitted to Medicare by the regulatory sponsor.

FDA and Medicare collaborate to ensure proper billing of research devices. FDA issues IDE number and identifies the CMS category for the investigational device. Any research study conducted under an FDA-issued IDE number must receive Medicare IDE Preauthorization before research participants receive treatment with investigational devices.  However, preauthorization is not required when sponsor has provided documentation that they will cover all protocol required clinical care/hospital costs.

The date the IDE was issued and whether or not the IDE is held by a Stanford PI will determine which of the following processes must be followed.

• For industry-sponsored clinical studies, the industry-sponsor provides the IDE letter to the research team.
• For PI-initiated studies, the IDE letter is issued by FDA to the Stanford PI or another PI from another academic center/non-profit-center.

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: https://www.cms.gov/Medicare/Coverage/IDE/

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
  

1. Research team downloads and completes “Preauth Packet”:

• Medicare Preauth Pre IDE before 1.1.15 Checklist
• MedPreauth CoverLtr_ IDE before 1.1.15

2. Research team 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 and see “Preauthorization Checklist” for a complete list.

• IRB approval must be obtained
• Informed consent document must include required financial relationship statement
• Device description information must be obtained (typically from device manufacturer)
• Device procedure codes must be obtained even if procedure is standard of care (typically from device manufacturer)

3. Research team emails completed “Preauth Packet” to Marija Cerelli, SHC Stanford Patient Financial Services, at MCerelli@stanfordhealthcare.org and cc’s the the appropriate CT/RPM.
Email subject line must state “IDE Preauth Request: IDE #..., SPO#....” Stanford Hospital and Clinics (SHC) corresponds with the Medicare Fiscal Intermediary (FI) to obtain preauthorization.

4. SHC Patient Financial Services reviews packet for completeness and tracks submission.

5. SHC Patient Financial Services submits packet to Medicare FI, manages correspondence with FI, and communicates FI response to the research team.

6. Research team notifies RPM of FI response.