For Texas Providers:

Please note: the information provided here refers to Category B IDEs, which makes up the majority of IDEs. If the study IDE falls into the Category A IDE, please contact CORA.

PART A & B

As a courtesy, CORA will submit the full Part A and Part B Cover Letter to Texas' Medicare Intermediary Novitas Solutions. The link provided here details Novitas' required information and documentation for submission. CORA may request documents listed on the, "FDA-Approved Clinical Trial/Device Request Submission Checklist."

View the requirements.

Please identify and provide CORA with a point of contact for this process. The ultimate responsibility for Part B submission lies with the investigator.