1. Medicare Submission for Pre-Approval in Clinical Research Ronda Sharp, R.N., B.S.N., C.C.R.C. Clinical Research Facilitator Methodist Research Institute

2. History of Pre-Approval Process At Methodist Research Institute, we have been submitting for pre-approval for IDE trials since 1999. The process has evolved from sending in 2- 3” binders of information to CMS on every IDE trial to a very streamlined process. The timeframe for pre-approval has decreased from 2-3 months to a matter of 2-3 weeks.

3. Goal of Pre-Approval Process To provide CMS with information about specific IDE clinical trials to assure reimbursement for Standard of Care Services for subjects enrolled in these trials. To comply with CMS guidelines.

4. IDE IDE- Investigational Device Exemption

5. IDE Classification Eligible for Pre- Approval Category B Certain Category A

6. Definition of Category B Device Non-experimental/ Investigational Devices, regardless of classification, under investigation to establish substantial equivalence to previously/ currently legally marketed device, or Class III devices whose technological characteristics and indications for use are comparable to a PMA-approved device, or Class III devices with technological advances compared to a PMA-approved device (generational changes), or Class III devices that are comparable to a PMA-approved device which are under investigation for a new indication for use. No significant modifications to the device were required, or

7. Definition of Category B Device Non-experimental/ Investigational Class III devices that become the subject of an IDE after FDA requires pre-market approval (no PMA was submitted or the PMA was denied), or Non-significant risk device investigations for which FDA required the submission of an IDE.

8. Definition of Category A Device Experimental Class III devices of a type for which no marketing application has been approved through the pre- market approval (PMA process for any indication for use. Class III devices that would otherwise be in Category B but have undergone significant modification for a new indication for use.

9. CMS Centers for Medicare and Medicaid Services

10. Divisions of CMS Part A- Inpatient Services Part B- Physician and Outpatient Services

11. Submission Requirements Provider name and number (for Part A it would be the institution name and number, for Part B it would be the PI provider number along with the mailing address) For Part B, all co-investigators that will bill for services must also be listed with the submission.

12. Submission Requirements (continued) Name and Number of the investigational device(s) utilized in the trial. A narrative description of the device(s).

13. Submission requirements (continued) Signed copy of the FDA-approval letter demonstrating category A or B IDE status. The FDA letter containing the most current approved number of institutions and subjects (may be 2 separate letters).

14. Submission Requirements (continued) Number of Medicare cases planned for the study at the specific institution. A copy of the final protocol from the sponsor.

15. Additional items to be maintained at the site and readily available The agreement between the company or manufacturer and the provider, furnishing the details of the provider participation. At least 2 peer-review publications. Any product literature illustrating the device and/or procedure. IRB-approval for the protocol to be carried out at the institution.

21. Medicare Part A Intermediary Richard Baer, M.D. Medical Director AdminaStar Federal 255 N. Michigan Ave. 22 nd Floor AFCH-85 Chicago, IL 60601-7601 richard.baer@anthem.com (312) 297-4541

22. Medicare Part B Intermediary Carolyn Cunningham, M.D. Medical Director AdminaStar Federal 8115 Knue Rd.- AF10 Indianapolis, IN 46250-1936 carolyn.cunningham@anthem.com (317) 595-4984

23. CMS Website www.cms.hhs.gov

24. Questions? If there are any unanswered questions, I will go to the appropriate person to obtain the answer. My email address: rlsharp@clarian.org