CATEGORY B INVESTIGATIONAL DEVICE EXEMPTION (IDE)
BILLING REQUIREMENTS FOR PROVIDERS BILLING ROUTINE COSTS OF CLINICAL TRIALS INVOLVING A CATEGORY B IDE
Professional providers are responsible for checking the CMS Coverage Website to identify whether CMS (or its designated entity) has approved the study for purposes of Medicare coverage, prior to billing for the routine costs of a clinical trial and the Category B IDE device. If Original Medicare determined that the device did, in fact, meet the requirements of coverage, and the clinical trial is approved, the MA plan will be responsible for payment of the routine costs associated with a qualifying clinical trial and the category B IDE device.
A list of IDE studies meeting CMS’ standards for coverage are listed and maintained on the CMS Coverage website at https://www.cms.gov/Medicare/Coverage/IDE/Approved-IDE-Studies.html.
Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 310.1 Routine Costs of Clinical Trials. 07/09/2007. [CMS Web site]. Available at : https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=1&ncdver=2&bc=BAABAAAAAAAA. Accessed August 4, 2016.
Q0 Investigational clinical service provided in a clinical research study that is in an approved clinical research study
Q1 Routine clinical service provided in a clinical research study that is in an approved clinical research study