CMS Pub. 100-03, ch. 1, § 20.7

Dates Below)

(Rev. 12571; Issued: 04-11-24; Effective: 10-11-23; Implementation: 05-13-24)

A. General

This procedure involves inserting a balloon catheter into a narrow or occluded blood

vessel to recanalize and dilate the vessel by inflating the balloon. The objective of

percutaneous transluminal angioplasty (PTA) is to improve the blood flow through the

diseased segment of a vessel so that vessel patency is increased and embolization is

decreased. With the development and use of balloon angioplasty for treatment of

atherosclerotic and other vascular stenoses, PTA with and without the placement of a

stent) is a widely used technique for dilating lesions of peripheral, renal, and coronary

arteries.

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)