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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules state that 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. 
Indications and Limitations of Coverage 
 
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 in Patients at High Risk for Carotid Endarterectomy (CEA) 
 
Effective March 17, 2005, Medicare covers PTA of the carotid artery concurrent with the placement of an 
FDA-approved carotid stent with embolic protection for the following: 
 
Patients who are at high risk for CEA and who also have symptomatic carotid artery stenosis  70%. Coverage 
is limited to procedures performed using FDA-approved carotid artery stenting (CAS) systems and FDA-
approved or -cleared (effective December 9, 2009) embolic protection devices. If deployment of the embolic 
protection device is not technically possible, and not performed, then the procedure is not covered by Medicare 
(effective December 9, 2009); patients who are at high risk for CEA and have symptomatic carotid artery 
stenosis between 50% and 70%, in accordance with the Category B IDE clinical trials regulation (42 CFR 
405.201), as a routine cost under the clinical trials policy (Medicare National Coverage Determination (NCD) 
Manual 310.1.  
 
Coverage is limited to procedures performed using an FDA-approved CAS, stents and FDA-approved or -
cleared embolic protection devices. 
 
The use of an FDA-approved or cleared embolic protection device is required. If deployment of the embolic 
protection device is not technically possible, and not performed, then the procedure is not covered by Medicare. 
 
Patients at high risk for CEA are defined as having significant comorbidities and/or anatomic risk factors (i.e., 
recurrent stenosis and/or previous radical neck dissection) and would be poor candidates for CEA. Significant 
comorbid conditions include but are not limited to: 
 
    Congestive heart failure (CHF) class III/IV; 
    Left ventricular ejection fraction (LVEF) < 30 %; 
    Unstable angina; 
    Contralateral carotid occlusion; 
    Recent myocardial infarction (MI); 
    Previous CEA with recurrent stenosis; 
    Prior radiation treatment to the neck; and 
    Other conditions that were used to determine patients at high risk for CEA in the prior carotid artery stenting        
trials and studies, such as ARCHER, CABERNET, SAPPHIRE, BEACH, and MAVERIC II. 
 
Symptoms of carotid artery stenosis include carotid transient ischemic attack (distinct focal neurological 
dysfunction persisting less than 24 hours), focal cerebral ischemia producing a nondisabling stroke (modified Rankin scale < 3 with symptoms for 24 hours or more), and transient monocular blindness (amaurosis fugax). 
Patients who have had a disabling stroke (modified Rankin scale  3) shall be excluded from coverage. 
 
The determination that a patient is at high risk for CEA and the patients symptoms of carotid artery stenosis 
shall be available in the patient medical records prior to performing any procedure. 
 
The degree of carotid artery stenosis shall be measured by duplex Doppler ultrasound or carotid artery 
angiography and recorded in the patient's medical records. If the stenosis is measured by ultrasound prior to the 
procedure, then the degree of stenosis must be confirmed by angiography at the start of the procedure. If the 
stenosis is determined to be < 70% by angiography, then CAS should not proceed. 
 
In addition, CMS has determined that CAS with embolic protection is reasonable and necessary only if 
performed in facilities that have been determined to be competent in performing the evaluation, procedure and 
follow-up necessary to ensure optimal patient outcomes. Standards to determine competency include specific 
physician training standards, facility support requirements and data collection to evaluate outcomes during a 
required reevaluation. 
 
The CMS has created a list of minimum standards modeled in part on professional society statements on 
competency. All facilities must at least meet CMSs standards in order to receive coverage for CAS for high-
risk patients. 
 
Facilities must have necessary imaging equipment, device inventory, staffing, and infrastructure to support a 
dedicated carotid stent program. Specifically, high-quality x-ray imaging equipment is a critical component of 
any carotid interventional suite, such as high-resolution digital imaging systems with the capability of 
subtraction, magnification, road mapping, and orthogonal angulation. 
 
Advanced physiologic monitoring must be available in the interventional suite. This includes real time and 
archived physiologic, hemodynamic, and cardiac rhythm monitoring equipment, as well as support staff who 
are capable of interpreting the findings and responding appropriately. 
 
Emergency management equipment and systems must be readily available in the interventional suite such as 
resuscitation equipment, a defibrillator, vasoactive and antiarrhythmic drugs, endotracheal intubation 
capability, and anesthesia support. 
 
Each institution shall have a clearly delineated program for granting carotid stent privileges and for monitoring 
the quality of the individual interventionalists and the program as a whole. The oversight committee for this 
program shall be empowered to identify the minimum case volume for an operator 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 national specialty societies recognized by the American Board of Medical Specialties to determine 
appropriate physician qualifications. Examples of standards and clinical competence guidelines include those 
published in the December 2004 edition of the American Journal of Neuroradiology, and those published in the 
August 18, 2004 Journal of the American College of Cardiology. You can find this information in the Medicare 
National Coverage Determination (NCD)-20.7, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY 
(PTA). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.