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:

  1. FDA acknowledgement letter with assigned "P" number;
  2. IRB approval
  3. 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:

  1. The FDA acknowledgement letter and the original Post-Market Approval (PMA) number from the original FDA post-approval study,
  2. The CMS letter providing coverage for the extension study,
  3. IRB approval, and
  4. 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
4510 13th Ave S
PO Box 6783
Fargo, ND 58103

You may also use the new email address: iderequests@noridian.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.

References

 

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