Percutaneous Transluminal Angioplasty (PTA)

CMS National Coverage Determination | ncd_id=201 | manual_section=20.7 | coverage_level_code=2 | national_coverage_type=True | under_review=True | lab_ncd=False

B. Nationally Covered Indications The PTA is covered when used under the following conditions: 1. Treatment of Atherosclerotic Obstructive Lesions -In the lower extremities, i.e., the iliac, femoral, and popliteal arteries, or in the upper extremities, i.e., the innominate, subclavian, axillary, and brachial arteries. The upper extremities do not include head or neck vessels. -Of a single coronary artery for patients for whom the likely alternative treatment is coronary bypass surgery and who exhibit the following characteristics: Angina refractory to optimal medical management; Objective evidence of myocardial ischemia; and Lesions amenable to angioplasty -Of the renal arteries for patients in whom there is an inadequate response to a thorough medical management of symptoms and for whom surgery is the likely alternative. PTA for this group of patients is an alternative to surgery, not simply an addition to medical management. -Of arteriovenous dialysis fistulas and grafts when performed through either a venous or arterial approach. 2. Concurrent with Carotid Stent Placement in Food and Drug Administration (FDA)-Approved Category B Investigational Device Exemption (IDE) Clinical Trials Effective July 1, 2001, Medicare covers PTA of the carotid artery concurrent with carotid stent placement when furnished in accordance with the FDA-approved protocols governing Category B IDE clinical trials. PTA of the carotid artery, when provided solely for the purpose of carotid artery dilation concurrent with carotid stent placement, is considered to be a reasonable and necessary service when provided in the context of such a clinical trial. 3. Concurrent with Carotid Stent Placement in FDA-Approved Post-Approval Studies Effective October 12, 2004, Medicare covers PTA of the carotid artery concurrent with the placement of an FDA-approved carotid stent and an FDA-approved or –cleared embolic protection device (effective December 9, 2009) for an FDA-approved indication when furnished in accordance with FDA-approved protocols governing post-approval studies. The Centers for Medicare & Medicaid Services (CMS) determines that coverage of PTA of the carotid artery is reasonable and necessary in these circumstances. 4. Concurrent with Carotid Stent Placement Effective October 11, 2023, CMS covers PTA of the carotid artery concurrent with stenting with the placement of an FDA-approved carotid stent with an FDA-approved or cleared embolic protection device, for Medicare beneficiaries under the following conditions: A. Patients with symptomatic carotid artery stenosis ≥50%; and, B. Patients with asymptomatic carotid artery stenosis ≥70%. For both A and B above: 1. Neurological assessment by a neurologist or NIH stroke scale (NIHSS) certified health professional before and after CAS must be performed. 2. First-line evaluation of carotid artery stenosis must use duplex ultrasound. 3. Computed tomography angiography or magnetic resonance angiography, if not contraindicated, must be used to confirm the degree of stenosis and provide additional information about the aortic arch, and extra- and intra-cranial circulation. 4. Intra-arterial digital subtraction (catheter) angiography may be used only when there is significant discrepancy between non-invasive imaging results, or in lieu of computed tomography angiography or magnetic resonance angiography if these are contraindicated. Prior to furnishing CAS, the practitioner must engage in a formal shared decision-making interaction with the beneficiary. The shared decision-making interaction must include: Discussion of all treatment options including carotid endarterectomy (CEA), CAS (which includes transcarotid artery revascularization (TCAR), and optimal medical therapy (OMT)). Explanation of risks and benefits for each option specific to the beneficiary’s clinical situation. Integration of clinical guidelines (e.g., patient comorbidities and concomitant treatments). Discussion and incorporation of beneficiary’s personal preferences and priorities in choosing a treatment plan. Facilities must establish and maintain institutional and physician standards to support a dedicated carotid stent program. These standards must at least include and ensure the following: Facilities have a clearly delineated program for granting carotid stent privileges and for monitoring patient outcomes for individual physicians and the program as a whole. The oversight committee for this program shall be empowered to identify the minimum case volume for a physician to maintain privileges, as well as the (risk-adjusted) threshold for complications that the institution will allow before suspending privileges or instituting measures for remediation. Committees are encouraged to apply published standards from specialty societies and widely-used, published professional society guidelines to determine appropriate physician qualifications. Facilities have appropriately trained staff capable of fulfilling roles and responsibilities as delineated under the dedicated carotid stent program. Facilities have appropriate supporting personnel and equipment for imaging, emergency management, advanced physiologic monitoring, and other ancillary care. Facilities must ensure continuous quality improvement by assessing procedural outcomes and making necessary programmatic adjustments to assure patient safety. 5. Concurrent with Intracranial Stent Placement in FDA-Approved Category B IDE Clinical Trials Effective November 6, 2006, Medicare covers PTA and stenting of intracranial arteries for the treatment of cerebral artery stenosis ≥50% in patients with intracranial atherosclerotic disease when furnished in accordance with the FDA-approved protocols governing Category B IDE clinical trials. CMS determines that coverage of intracranial PTA and stenting is reasonable and necessary under these circumstances. C. Nationally Non-Covered Indications All other indications for PTA with or without stenting to treat obstructive lesions of the vertebral and cerebral arteries remain non-covered. All other indications for PTA without stenting for which CMS has not specifically indicated coverage remain non-covered. D. Other In addition to the national coverage described above, Medicare Administrative Contractors (MACs) may make reasonable and necessary determinations under section 1862(a)(1)(A) of the Social Security Act for any other beneficiary seeking coverage for PTA of the carotid artery concurrent with stenting. Coverage of PTA with stenting not specifically addressed or discussed in this NCD is at the discretion of the MACs. (This NCD last reviewed October 2023)