Before You Begin

Contact Inna Bender or Paulette Palmer for the specific procedures required for device trials.

Medicare Approval for Investigational Device Exemption (IDE) Clinical Trials

Medicare approval for IDE trials is a two-step process that includes:

  1. Centers for Medicare & Medicaid Services (CMS) Approval – Submitted by the Industry Sponsor
  2. Local Medicare Administrative Contractor (MAC) Approval – Must be submitted by the study team PRIOR TO PATIENT ENROLLMENT.

Step 1: Centers for Medicare & Medicaid Services (CMS) Approval - Submitted By Industry Sponsor

How

As of January 1, 2015, industry sponsors are required to submit to and receive approval for coverage from the Centers for Medicare & Medicaid Services (CMS) for all IDE trials.

IDE Device Types:
  • IDE devices that have an FDA designated IDE number beginning with “G” and a CMS category B (B1, B2, B3, or B4)
    • An approval for a Category B (Nonexperimental/investigational) IDE study will allow coverage of the Category B device and the routine care items and services in the trial.
  • IDE devices that have an FDA designated IDE and CMS category A
    • An approval for a Category A (Experimental) IDE study will allow coverage of routine care items and services furnished in the study, but not of the Category A device, which is statutorily excluded from coverage.

CMS approved IDE trials are posted on CMS.gov.

Individual studies posted will include:
  • Study Title
  • Sponsor Name
  • NCT identifier, with link to clinicaltrials.gov
  • IDE number
  • CMS approval date
  • Device Category designation

Who

Industry Sponsors

Device Studies That DO NOT Require Medicare Approval
  • FDA approved Post Market studies
  • FDA approved Registry studies
  • PI initiated studies using FDA approved devices
  • Use of HDE devices – which require IRB approval, but not Medicare approval

EXCEPTION:  Post-market approval studies or registries of carotid stents require Medicare approval.

Step 2: Local Medicare Administrative Contractor (MAC) Approval - Submitted by the Study Team PRIOR TO PATIENT ENROLLMENT

How

MAC for Mount Sinai is the National Government Services (NGS). Notice of participation in IDE trials is mandatory and is managed centrally by Debra Fitzpatrick.

Notifications are sent to NGS IDE Requests-Wellpoint (Shared Mailbox) – NGSIDERequests@anthem.com.

Initial Notification of Participation in IDE Study – documents required to be submitted:
  • CMS approval
  • NCT#
  • IRB Initial approval letter
  • PI’s National Provider Identifier (NPI) #
Annual Continuation Notification of Participation – documents required to be submitted:
  • IRB Continuation approval letter

Who

Mount Sinai Study Team

When

Initial notifications must be submitted as soon as IRB approval is received. Patients should NOT be scheduled for a procedure under an IDE protocol until ISMMS has received acknowledgement and approval from the National Government Services (NGS).

Annual continuation notifications are required.

Questions

Contact Debra Fitzpatrick.

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