Clinical Trial Submissions
- Clinical Trial Submission – AFTER JANUARY 1, 2015
- Clinical Trial Submission – BEFORE JANUARY 1, 2015
- Clinical Trial Submission – Extensions & Changes
- UPDATE to IDE (Investigational Device Exemption) Submission Process
- Humanitarian Device Exemption Approvals
- CGS IDE Submission Form
Resources
- Medicare Coverage Document – Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development
- CMS Coverage with Evidence Development
- MLN Matters MM8401 – Mandatory Reporting of an 8-Digit Clinical Trial Number on Claims
- CMS Internet Only Manual (IOM), Publication 100-04, Medicare Claims Processing Manual, Chapter 4, Section 61.3.5
- Sec 60: Billing for Devices Eligible for Transitional Pass-Through Payments and Items Classified in "New Technology" APCs
- Sec 61: Billing for Devices under the OPPS
- Sec 61.3: Billing for devices Furnished Without Cost to an OPPS Hospital or Beneficiary or for Which the Hospital Receives a Full or Partial Credit and Payment for OPPS Services Required to Furnish the Device
- CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 32, Section 69.6
- Sec 67: No Cost Claims
- Sec 68: Investigational Device Exemption (IDE) Studies
- Sec 69: Qualifying Clinical Trials
- Sec 70 Billing Requirement for Islet Cell Transplantation for Beneficiaries in a National Institutes of Health (NIH) Clinical Trial
- CMS Mandatory Reporting of National Clinical Trial (NCT) Identifier Numbers on Medicare Claims – Q&A
- CMS Medicare Coverage Related to Investigational Device Exemption (IDE) Studies