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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 say that medically necessary services are those that are reasonable and necessary for the diagnosis or 
treatment of an illness or injury. Medically necessary services include services to improve the functioning of a 
malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A). 
 
The rules say that services that are not medically necessary are not covered. The rules also say that 
experimental and investigational devices are not covered. You can find this rule at 42 CFR Sections 411.15 and 
411.15(o). 
 
The rules say 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 ), 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 = 80%, 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. 
 
You can find this information in Medicare's 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.