Appendix E - National Coverage Determinations Manual / Percutaneous Transluminal Angioplasty (PTA)

Why This Topic Matters

The policy affects reimbursement and coverage review for multiple vascular intervention scenarios and includes CMS-specific requirements for qualifying facilities, registries, and reporting. It helps organizations determine whether a procedure falls within a covered category or remains outside national coverage guidance.

Article Sections

1. A. General

   Provides a general overview of the procedure and the broad vascular settings addressed by the policy.

2. B. Nationally Covered Indications

   Lists the major covered indication categories discussed in the manual, including peripheral, renal, dialysis access, carotid, and intracranial contexts. Also addresses related facility, trial, and registry requirements.

3. 1. Treatment of Atherosclerotic Obstructive Lesions

   Describes the vascular territories and broad clinical situations included under this covered indication category.

4. 2. Concurrent with Carotid Stent Placement in Food and Drug Administration (FDA)-Approved Category B Investigational Device Exemption (IDE) Clinical Trials

   Discusses coverage in the setting of FDA-approved clinical trials for carotid stent placement.

5. 3. Concurrent with Carotid Stent Placement in FDA-Approved Post Approval Studies

   Discusses coverage in the setting of FDA-approved post-approval studies for carotid stent placement.

6. 4. Concurrent with Carotid Stent Placement in Patients at High Risk for Carotid Endarterectomy (CEA)

   Covers carotid stent-related policy for patients identified as high risk for CEA, including documentation, facility standards, and monitoring requirements.

7. National Registries

   Summarizes CMS expectations for national registry functions, data collection, and reporting related to carotid artery stenting.

8. 5. Concurrent with Intracranial Stent Placement in FDA-Approved Category B IDE Clinical Trials

   Addresses coverage for intracranial PTA and stenting in the context of FDA-approved category B IDE clinical trials.

9. C. Nationally Noncovered Indications

   Identifies broad categories of procedures and vascular territories that remain outside coverage under this policy.

10. D. Other

    States that indications not specifically covered by CMS remain noncovered.