Post Market Studies and Post Market Extension Studies - JE Part B
Post Market Studies and Post Market Extension Studies - Percutaneous Transluminal Angioplasty (PTA) with Carotid Stenting and Embolic Protection
Post Market Studies
Coverage and reimbursement for specific "post-marketing studies" may be approved by Medicare contractors. These studies all involve the use of percutaneous transluminal angioplasty (PTA) with carotid stenting and embolic protection. Providers must submit an application for approval that includes the following:
- FDA acknowledgement letter with assigned "P" number;
- IRB approval
- Patient Consent form
CMS issued instructions on October 12, 2004, for processing claims for carotid artery stenting procedures performed as part of a Food and Drug Administration (FDA) approved post-approval studies, such as CAPTURE. As the post-approval studies began to come to an end, CMS reviewed extension requests and determined that contractors may grant coverage approval for extension studies if providers complete the defined steps.
Post Market Extension Studies
Providers must submit the following:
- The FDA acknowledgement letter and the original Post-Market Approval (PMA) number from the original FDA post-approval study,
- The CMS letter providing coverage for the extension study,
- IRB approval, and
- The Patient Consent form.
All of the above items must be received prior to review and coverage determination. This information must be submitted to the following address:
Noridian Medicare Part B JE
Attn: IDE JE
PO Box 6783
900 42nd Street South
Fargo, ND 58103-6783
You may also use the new e-mail address: email@example.com.
After receiving this required information, Noridian will issue a letter to the provider assigning an effective date for coverage. Providers may bill for procedures performed in the post-marketing or the post-marketing extension study for dates of service on or after the assigned effective date. Providers must bill in accordance to CMS regulations for these studies.
- FDA Approved Carotid PTA with Stent Post Market Studies and Post Market Extension Studies Pre-Approval Data Submission Request Form [PDF]
- CMS Change Request 5088
- CMS Change Request 3489
- CMS Internet Only Manual (IOM) Medicare Claims Processing Manual, Publication 100-04, Chapter 32, Section 160.2.1
Last Updated Wed, 12 Feb 2020 12:27:56 +0000