Clinical Trials Resource Center

CMS Device Coverage

When research at Memorial Hermann Healthcare System(MHHS) involves devices, please contact MHHS - Clinical Innovation and Research Institute -  Susmitha Gadde, Director of Research Operations at Susmitha.Gadde@memorialhermann.org  or  713-704-3430 as soon as possible.

• MHHS will start the process to check if the vendor is approved, if not they'll start the process for vendor approval.  Simultaneously a determination of whether a Hospital Site Agreement/ Facility Use Agreement is required will be made. Please provide the hospital with sponsor/CRO contact information to expedite the vendor vetting process. 
• MHH staff will also determine if an NCD is required.  MHH staff will also determine if local Medicare Administrative Contractor's(MAC) - Novitas Solutions, coverage determination is required. Please provide unredacted FDA approval letter for review.
• If approval from CMS is required, MHH staff will guide the coordinator to submit to Novitas for approval.

 

For Category A Devices – Provider or coordinator will submit the following: 

• Notify their CMS contractor that a Category A IDE device is a part of the qualified clinical trial before routine costs of that clinical trial can be billed. 
• After the contractor receives information about the clinical trial, the contractor will then determine if the Category A IDE that is used in the trial is used to diagnose, monitor, or treat any immediately life-threatening disease or condition. 
• If the contractor determines that the device does meet these requirements then the provider may begin billing the routine costs of the clinical trial.

 

 For Category B Devices -  The provider who is participating in the study of the IDE Category B device must submit the following information about the device, the study, the participating Medicare beneficiaries, and the site where the study will be conducted prior to its use:

• A copy of the most recent un-redacted/unconditional FDA-approved letter sent to the sponsor or manufacturer of the device.  The IDE number must be included in the letter
• Verification of Institutional Review Board approval
• Name of the device (both trade, common or usual, and classification name)
• Any action taken to conform to any applicable IDE special controls (Study specific, depends on device classification and protocol design. Sponsor should be able to provide this information).
• A narrative description of the device that tells how the device is similar or different from other comparable devices
• Indication if the device will be billed in an outpatient or inpatient setting
• A brief summary of the study design or a copy of the actual study protocol
• The provider's protocol for obtaining informed consents from the beneficiaries that are participating in the trial.
• The provider's NPI number.

 

All documentation must be sent to:

Office of the Contractor Medical Director

Novitas Solutions

1800Center Street Camp Hill, PA 17089-0089

Attention: JH IDE Applications

 

Email inquiries regarding IDE requests can be sent to:

Patricia.reidenbach@highmarkmedicareservices.com

Phone: 469-372-0992

Fax: 469-312-2649

For more information - https://www.novitas-solutions.com/refman/chapter-7.html

 

MEDICAL DIRECTORS

Debra Patterson, MD

Charles Haley, MD