Under FDA regulations 42 CFR § 405 Subpart B, investigational device trials require approval from CMS (Centers for Medicare & Medicaid Services). Information specific to these requirements can be found on the CMS.gov website here. CMS approvals are issued at a local level by the Medicare Administrative Contractor (MAC) or are reviewed an approved through a centralized process by CMS. Studies approved through the centralized process are listed here.
Research Billing Compliance in UIHC will document CMS approval in the HawkIRB application via one of three approval methods. There are three possible “approval” scenarios that a researcher will see in the "Other Review" section of the HawkIRB application when CMS approval is required:
- Exempt – if a project involving an IDE device does not require the University of Iowa Hospitals and Clinics(UIHC) to obtain CMS approval the checkbox under Exempt will be selected. An Exemption from CMS approval could be for a variety of reasons such as:
- the sponsor will provide or pay for all of the tests, procedures, items and/or services required by the study protocol.
- CMS Approval – if a project involving an IDE device does require UIHC to obtain CMS approval the “date received” field will be populated when the CMS grants approval.
- CMS Exception – if a project involving an IDE device does require UIHC to obtain CMS approval but a non-Medicare patient is encountered after IRB approval, but prior to CMS approval, RBC can issue a CMS exception. This allows for IRB approved materials to be released to the researcher to enroll the non-Medicare patient\subject. Once “CMS Exception” is selected, the “date received” field will auto populate. The research team must contact the RBC if they wish to enroll a non-Medicare patient prior to CMS approval.
The Human Subjects Office will be notified once CMS approval has been granted so the HawkIRB application can be released if all other HRPP committee approvals are in place.
Questions regarding the policy and/or procedures can be directed to the Research Billing Compliance at:
firstname.lastname@example.org(link sends e-mail) or via phone (see phone directory here).