Starting January 1, 2015, Sponsors, that wish to seek Medicare coverage related to Category A or B IDE studies, are required to submit to CMS for reimbursement approval. In order to receive reimbursement approval for your study, the protocol must describe how Medicare beneficiaries may be affected by the device, and how the study results are or are not expected to be generalizable to the Medicare beneficiary population.

We, at Da Vinci, will guide you through the submission process by assisting with the development of your protocol and submitting the request on your behalf.

By moving this requirement from the site to the sponsor, there will be an increased need for communication regarding coding and claim submissions for your study. Our overall goal is to increase timely enrollment for your study.

​During study start up, we will work with your sites to ensure that the appropriate codes are circulated. This will decrease your start-up time by ensuring that the sites are aware of the billing implication of the study, prior to enrollment. If necessary, we will also guide your sites on setting up the device in their CDM to ensure that there is not a delay in start up.

Da Vinci's continued support, during enrollment, will allow your sites to quickly obtain billing guidance that may determine a patient's willingness to participate in your study. We will also work with your sites' billing departments to provide guidance and template letters for appeals when claims are denied.

The hands on support that Da Vinci provides will boost your enrollment rate by providing you and your sites with the security of having reimbursement experts on your team.

CMS Releases Final Rule for A Centralized IDE Coverage Review ProcesS

IDE Reimbursement guidance and Services