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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 CFR 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 411.15 and 411.15(o).
The rules say that 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 more than 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 more than 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).
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 non-disabling 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 &#8805; 3) shall be excluded from coverage.
The determination that a patient is at high risk for CEA and the patient's 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. You can find this information in the National Coverage Determination (NCD) for Percutaneous Transluminal Angioplasty (PTA) (20.7).
If you want to read these Medicare rules, you can go to this web site www.medicareappeal.com.
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.