Device Studies

Medicare Approval for Investigational Device Exemption (IDE) Clinical Trials

What

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

• 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.

CMS approved IDE trials are posted on CMS.gov.

• Study Title
• Sponsor Name
• NCT identifier, with link to clinicaltrials.gov
• IDE number
• CMS approval date
• Device Category designation

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

How

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

1. Centers for Medicare & Medicaid Services (CMS) approval
2.  Local Medicare Administrative Contractor (MAC) approval

1. CMS Approval – Investigator Initiated IDE clinical trials

Investigators of PI-initiated IDE trials are considered the ‘sponsor’ of the trial and it is the responsibility of the investigator to assure that submission to and receipt of approval for coverage from CMS has been obtained.  Details of submission requirements can be found at: https://www.cms.gov/Medicare/Coverage/IDE/index.html

2. Local Medicare Administrative Contractor (MAC)

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

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

• Initial notification of participation in IDE study – documents required:
  • CMS approval
  • NCT#
  • IRB Initial approval letter
  • PI’s National Provider Identifier (NPI) #
• Annual Continuation notification of participation – documents required:
  • IRB Continuation approval letter

IRB Approved Non-Significant Risk Devices 

For non-significant risk device clinical trials that do not require an FDA approved IDE and are the responsibility of the hospital’s IRB, the Medicare contractors are responsible for making the coverage determination.

When

MAC Approval – 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).

Questions

Contact Debra Fitzpatrick.

Further Resources

FDA Device Advice: Comprehensive Regulatory Assistance