Appeal type: unknown
Decision: unknown

 
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 say that the percutaneous transluminal angioplasty (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 equals 70 
percent. 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 percent and 
70 percent, 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), or in 
accordance with the NCD on (CAS) post-approval studies (Medicare NCD Manual 20.7); 
Patients who are at high risk for CEA and have asymptomatic carotid artery stenosis equals 80 percent, in 
accordance with the Category B IDE clinical trials regulation (42 CFR 405.201), as a routine cost under the 
clinical trials policy (Medicare NCD Manual 310.1), or in accordance with the NCD on CAS post- approval 
studies (Medicare NCD Manual 20.7). 
 
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) less than 30 percent; 
    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 less than 3 with symptoms for 24 hours or more), and transient monocular blindness (amaurosis fugax). Patients who have had a disabling stroke (modified Rankin scale equals 3) shall be excluded from 
coverage. 
 
The determination that a patient is at high risk for CEA and the patientfs 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 less than 70 percent by angiography, then CAS should not proceed. 
 
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 equals 50 percent 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 noncovered. 
 
All other indications for PTA without stenting for which CMS has not specifically indicated coverage remain 
noncovered. 
 
D. Other 
 
Coverage of PTA with stenting not specifically addressed or discussed in this NCD is at local Medicare 
Administrative Contractor discretion. You can find these rules in National Coverage Determination (NCD) 
Percutaneous Transluminal Angioplasty (PTA) (20.7). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.