Want to know whether a specific clinical trial is approved or not? Generally, the trials for which routine costs are reimbursed are listed on http://www.clinicaltrials.gov, a website sponsored by the U.S. National Institutes of Health.
Novitas Solutions is looking for 5 Key Submission Components when reviewing an IDE application requesting approval to bill Medicare for routine costs associated with a clinical trial. They are as follows:
1. Institutional Review Board (IRB) Approval Letter with expiration date.
2. Informed Patient Consent form with patient signature page.
3. Protocol, which includes “Therapeutic Intent”.
4. FDA Letter – Un-redacted, no white out or black outs and must include the Signature Page. FDA Approval must be prior to January 1, 2015.
5. Submission Checklist
which includes the Principle Investigators (PI) Signature or signed on behalf of the PI.
A copy of the approval letter from the Institutional Review Board (IRB) that shows the expiration date.
Identifiers of the PI and sponsor listed.
A copy of the IRB-approved informed patient consent form.
Include PI and sponsor identifiers listed on the informed patient consent form.
A copy of the complete study protocol or summary containing “Therapeutic Intent”.
Summaries are acceptable, but must contain “Therapeutic Intent”.
A copy of the complete FDA approval letter(s) with signature page that has been provided to the PI and/or the sponsor or manufacturer of the device.
Only Category A and B IDE studies approved
by the FDA before
January 1, 2015, will continue to be submitted to Novitas for review and approval Category A and B IDE studies approved
by the FDA on or after January 1, 2015 must be submitted to CMS for review and approval. IDE studies sent to Novitas for review and approval in error will be returned to the requestor. Additional information regarding submission of Category A and B IDE study review requests to CMS, along with the list of CMS-approved studies is available on the CMS Coverage Website
Redacted letters, which are letters with blacked-out, whited-out or missing text areas, are not acceptable.
Conditional Approval FDA letters are accepted if all patient safety issues have been addressed.
Sending only page one of the FDA letter is not acceptable.
Each site (hospital/clinic) requesting an IDE must provide the entire FDA letter
The signature page of the approved FDA letter must be included.
All FDA letters must be submitted by the Institution or person requesting approval, not a 3rd party representative, such as a sponsor.
Jurisdiction L (JL) Region:
Delaware, District of Columbia, Maryland, New Jersey, and Pennsylvania. For Part B services, JL includes the Counties of Arlington and Fairfax in Virginia and the City of Alexandria in Virginia.
Jurisdiction H (JH) Region:
Arkansas, Colorado, Louisiana, Mississippi, New Mexico, Oklahoma, Texas, Indian Health and Tribal facilities as well as Veterans Affairs.
Faxed Documents Only
Incomplete Applications are not acceptable. Please see the Submission Checklist for requirements. Corrected documentation must be re-submitted before the application is to be approved.
Please fax the complete IDE application to (410) 891-5231
Mailed or e-mailed documents are not acceptable, unless otherwise specified
An emergency request for an IDE approval must be submitted with the same criteria as mentioned above; however, we ask that you contact us immediately so that we may begin to expedite the process at (717) 526-6393.
If services are performed prior to approval and routine costs are denied, you have the right to an appeal.
You may add additional physicians and/or facilities to an approved IDE study by sending in a copy of the Novitas approval letter and completing Submission Checklist
To check the status of a request, please send an email to: IDE_Status@novitas-solutions.com. You will receive a response within 10 business days.