CMS Aortography and peripheral angiography Form

Summary Of Evidence

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Analysis of Evidence

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History/Background and/or General Information

Diagnostic angiography (arteriography) is an invasive procedure for the purpose of evaluating the inside of blood vessels and the vasculature to organs of the body and the chambers of the heart. The process involves passing a needle or catheter into an artery followed by injection of contrast material and imaging of the vascular area or organ in question using digital imaging.

With modern noninvasive imaging techniques (e.g., duplex ultrasonography, magnetic resonance angiography [MRA], contrast-enhanced computed tomographic angiography [CTA]), the need for invasive diagnostic angiography has been significantly reduced. Currently, invasive angiography is mainly used to clarify contradictory findings of noninvasive studies or in conjunction with therapeutic procedures.

Covered Indications

I. Indications for renal angiography

Selective renal angiography (stand-alone renal angiography):

Selective renal angiography is considered medically reasonable and necessary for any of the following:

• renovascular occlusive disease* (e.g., renal artery stenosis (RAS), severe or difficult to control renal hypertension, resistant hypertension, or progressive renal insufficiency)
• renal aneurysm
• renovascular trauma
• primary vascular abnormalities, including aneurysms, vascular malformations, and vasculitis
• renal neoplasm
• hematuria of unknown cause
• pre- and postoperative evaluations for renal transplantation
• other intrinsic defects prior to interventional procedures on the renal arteries
• abnormal kidney imaging involving radioisotopes
• prior to interventional procedures on the renal arteries

*According to the American Heart Association (AHA), a blood pressure is considered normal for adults with a systolic blood pressure of less than 120 mmHg and a diastolic blood pressure of less than 80 mmHg. Resistant or refractory hypertension generally refers to uncontrolled high blood pressure (often with systolic blood pressure (SBP) of 160 mm Hg or more and diastolic blood pressure (DBP) of 100 mm Hg or more) despite the use of at least three different antihypertensive medication classes including a diuretic.

Non-selective renal angiography performed at the time of a different interventional procedure (e.g., cardiac catheterization with coronary angiography):

While withdrawing the catheter during a cardiac catheterization procedure, providers often inject a small amount of dye to examine the renal arteries.

Renal angiography, non-selective, performed at time of cardiac catheterization will be considered medically reasonable and necessary when the clinical index of suspicion for atherosclerotic renal artery stenosis (RAS) is high, as defined by the criteria listed below, AND there are reasonable anticipated therapeutic implications for which the results of this angiogram will be used AND when the results of noninvasive imaging studies cannot be obtained or are inconclusive:

• Onset of severe hypertension before age 30 or severe hypertension after age 55
• Exacerbation of previously well-controlled hypertension
• Resistant hypertension (i.e., failure to achieve goal blood pressure in patients who are adhering to full doses of an appropriate 3-drug regimen that includes a diuretic)
• Malignant hypertension (hypertension with coexistent evidence of acute end-organ damage; i.e., acute renal failure, acutely decompensated congestive heart failure, new visual or neurological disturbance, and/or advanced [grade III to IV] retinopathy)
• New azotemia or worsening renal function after the administration of an ACE inhibitor or an angiotensin receptor- blocking agent
• Unexplained atrophic kidney (7 to 8 cm) or a discrepancy in size between the two kidneys of greater than 1.5 cm. Note: The atrophy should be otherwise unexplained with lack of a prior history of chronic pyelonephritis, reflux nephropathy, trauma, etc. When such a history is present, there is usually not an indication for additional renal diagnostic tests to define RAS.
• Sudden, unexplained pulmonary edema (especially in azotemic patients)
• Unexplained renal failure, including patients starting renal replacement therapy (dialysis or renal transplantation)

Diagnostic evaluation for renal hypertension is indicated for hypertension that is refractory, of recent onset, or requires a sudden increase in antihypertensive medication to control.

II. Indications for iliac angiography or lower extremity angiography performed at the time of a different interventional procedure (for example, cardiac catheterization with coronary angiography)

Diagnostic lower extremity angiography performed at the time of an interventional procedure is separately reportable if at least one indication for medical necessity for a stand-alone lower extremity is met AND one of the following is also met:

• No prior catheter-based angiographic study is available and a full diagnostic study is performed, and the decision to intervene is based on the diagnostic study, or
• A prior study is available, but as documented in the medical record:
• the patient’s condition with respect to the clinical indication has changed since the prior study; or
• there is inadequate visualization of the anatomy or pathology; or
• there is a clinical change during the interventional procedure that requires new evaluation outside the target area of intervention.

III. Indications for stand-alone iliac or lower extremity angiography must be documented by pre-procedure clinical assessment. This assessment should include the following:

1. Documentation that an invasive intervention is planned, AND
2. Documentation that a prior non-invasive study was completed and indicates further study is needed by angiography for the planned intervention, AND
3. Documentation of one of the following conditions: arterial embolism, acute or chronic ischemia, peripheral vascular disease (includes claudication), or aneurysm.

IV. Indications for abdominal aortography/angiography

Acute traumatic abdominal injury

Aneurysm and other primary vascular abnormalities

Occlusive disease, including evaluation for acute or chronic intestinal ischemia

Acute GI hemorrhage

Congenital anomaly

Prior to arterial interventional procedures or open surgical procedures

V. Indications for thoracic aortography and carotid, vertebral, and subclavian angiography

Documented symptoms of ischemic cerebral disease

Documented results from previous noninvasive test(s) indicating severely stenotic carotid disease or severely ulcerated carotid disease

Medical history consistent with known or suspected trauma, tumor, or other intracranial anomalies

Medical history consistent with upper extremity claudication, acute or chronic arterial trauma, thoracic outlet obstruction disease, certain vasculitis, and subclavian steal

Surgical or percutaneous correction of the occlusive disease must be beneficial to the candidate’s clinical status.

Limitations

The following are not considered reasonable and necessary and therefore will be denied:

Catheter-based renal angiography, the longstanding “gold standard” for the diagnosis of renal artery stenosis (RAS), has been largely replaced as a practical first-line modality by noninvasive imaging studies (e.g., duplex ultrasonography, magnetic resonance angiography (MRA), computed tomographic angiography (CTA)). Renal angiography services will be denied without a prior non-invasive renal artery study that is inconclusive or unavailable. Exceptions to this rule may occur in patients with fibromuscular dysplasia or renal artery aneurysms where there may be branch involvement.

Routine non-selective renal arteriography, pejoratively called “drive-by angiography,” performed at the time of cardiac catheterization in the absence of accepted clinical indications that support medical necessity, as mentioned in this LCD, will be denied as such services are generally not indicated. In addition, the treating physician must specifically request this extra-cardiac angiographic service.

There are no absolute contraindications to diagnostic aortography/angiography. Relative contraindications include but are not limited to:

1. Severe hypertension
2. Uncorrectable coagulopathy or thrombocytopenia 
3. Clinically significant sensitivity to iodinated contrast material
4. Renal insufficiency based on the estimated glomerular filtration rate (eGFR)
5. Congestive heart failure
6. Certain connective tissue disorders which may indicate increased risk for complications at the puncture site

Diagnostic angiography performed at a separate session from an interventional procedure may be separately reportable. If a diagnostic angiogram was performed prior to an interventional procedure, a second diagnostic angiogram performed at the time of an interventional procedure is separately reportable when documentation supports it is medically reasonable and necessary to repeat the study to further define the anatomy and pathology. If the prior diagnostic angiogram was performed, a second angiogram (e.g., for the contrast injections necessary to perform the interventional procedure) is not separately reportable.

The localization or guidance is integral to an interventional procedure and is not separately reportable unless CPT instructions specify otherwise.

In addition to the initial procedure, an appropriate frequency of repeat procedures can be allowed as long as medical necessity is clearly established and documented. It is expected that important diagnostic information will be obtained from the angiography, which will assist in patient management and treatment. Repeat angiography may be medically reasonable and necessary if there is documentation of new and incapacitating symptoms.

Renal angiography performed at the time of cardiac catheterization in the absence of accepted clinical indication that support medical necessity will be denied as such services are generally not indicated, as mentioned in this LCD.

Appropriate non-invasive tests should be performed prior to a repeat angiography. A trial of or a change in medical management would be expected prior to repeat angiography unless the patient is deemed unstable and in need of some type of surgical intervention.

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.

Place of Services (POS)

Angiography services described in this LCD are considered reasonable and necessary when performed in the following places of service (POS):

• POS 11 Office
• POS 19 Off Campus – Outpatient Hospital
• POS 21 Inpatient Hospital
• POS 22 Outpatient Hospital
• POS 23 Emergency Room – Hospital
• POS 24 Ambulatory Surgical Center

Mobile units and all other locations are non-covered.