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
1800Center Street Camp Hill, PA 17089-0089
Attention: JH IDE Applications
Email inquiries regarding IDE requests can be sent to:
For more information - https://www.novitas-solutions.com/refman/chapter-7.html
Debra Patterson, MD
Charles Haley, MD
CLINICAL RESEARCH UNITS (CRU) | BERD | REDCap
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS |ANIMAL RESEARCH | ENVIRONMENTAL HEALTH & SAFETY | CORE LABORATORIES | SPONSORED PROJECTS | TECHNOLOGY MANAGEMENT
OFFICE OF RESEARCH
Clinical Trials Resource Center (CTRC)
7000 Fannin Street, Suite 795
Houston, Texas 77030
last modified October, 2013
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