**Overview**  
Non-invasive abdominal/visceral vascular studies utilize ultrasonic Doppler
and physiologic principles to assess the irregularities in blood flow in
renal, iliac, and femoral artery systems. These tests are also used to
diagnose aortic aneurysms. Noninvasive abdominal/ visceral vascular studies
include the patient care required to perform the studies, supervision of the
studies, and interpretation of study results, with copies for patient records
of test results and analysis of all data, including bi-directional vascular
flow or imaging when provided.

Diagnostic tests must be ordered by the physician who is treating the
beneficiary and who will use the results in the management of the
beneficiary's specific medical problem. Services are deemed medically
necessary when all of the following conditions are met:

1\. Signs/symptoms of ischemia or altered blood flow are present;  
2\. The information is necessary for appropriate medical and/or surgical
management;  
3\. The test is not redundant of other diagnostic procedures that must be
performed. Although, in some circumstances, non-invasive vascular tests are
complimentary, such as MRA and duplex, where the latter may confirm an
indeterminate finding or demonstrate the physiologic significance of an
anatomic stenosis such as in renal, iliac, and/or femoral arteries.

**Definitions:**  
 **Duplex Scans:** Duplex combines Doppler and conventional ultrasound,
allowing the structure of blood vessels, how the blood is flowing through the
vessels, and whether there is any obstruction in the vessels to be seen. Color
Doppler produces a picture of the blood vessel, and a computer converts the
Doppler sounds into colors overlaid on the image, representing information
about the speed and direction of blood flow. Using spectral Doppler analysis,
the duplex scan images provide anatomic and hemodynamic information,
identifying the presence of any stenosis or plaque in the arteries. Duplex
scans are in real-time.

**I. Abdominal/Visceral Vascular Studies**  
Abdominal/visceral non-invasive vascular studies are indicated in the
evaluation and /or management of vascular disease along with, the narrowing or
blockage of arteries that supply blood to the abdomen including intestines
(mesenteric vascular disease), pelvic and scrotal contents, and/or
retroperitoneal organs including the kidneys (renal vascular disease).

**A. Abdominal, Retroperitoneal and Pelvic Organs  **  
 **Indications:**

1\. Uncontrolled hypertension.  
2\. Stenosis of visceral artery (atherosclerotic, fibromuscular dysplasia,
vasculitis, functional).  
3\. Aneurysm of visceral artery.  
4\. Portal hypertension, with or without ascites.  
5\. Cirrhosis of the liver.  
6\. Venous embolism, hemorrhage, infection, and/or thrombosis of visceral vein
(renal,  
hepatic, mesenteric, portal or splenic).  
7\. Stenosis of visceral vein (renal, hepatic, mesenteric, portal or splenic).  
8\. Complications of internal (biological) (synthetic) prosthetic device
implant and/or graft.  
9\. Complications in abdominal organ or tissue transplant.  
10\. Pain or swelling of scrotal contents which may be a result of suspected
obstruction in  
arterial inflow or venous outflow to testicles or related structure.  
11\. Torsion of the spermatic cord; acute epididymitis or epididymoorchitis;
or torsion of the  
testicular appendages.  
12\. Hypertension and normotensive renovascular disease with impaired renal
function  
which could be acute kidney failure, chronic kidney disease, end stage renal
disease, or  
other vascular disorders of the kidneys.  
13\. Pain or swelling of the female genital organs which may be the result of
torsion of the  
ovaries, ovarian pedicle, or fallopian tube.  
14\. Trauma to the abdominal, retroperitoneal and/or pelvic organs, arteries,
and /or veins.

**B. Aorta, Inferior vena cava, Iliac Vasculature and Bypass grafts  **  
 **Indications:**

1\. Atherosclerosis of aorta.  
2\. Atherosclerosis of the extremities with intermittent claudication.  
3\. Atherosclerosis of other specified arteries.  
4\. Aortic aneurysm and dissection.  
5\. Aneurysm of iliac artery.  
6\. Thromboangiitis obliterans (Buerger's disease).  
7\. Peripheral vascular disease unspecified.  
8\. Arterial embolism and thrombosis of abdominal aorta.  
9\. Arterial embolism and thrombosis of iliac artery.  
10\. Phlebitis and thrombophlebitis of iliac vein.  
11\. Venous embolism and thrombosis of vena cava.  
12\. Complications related to surgical procedures involving prosthetic device
implant, graft, and/or shunts.  
13\. Complications of organ or tissue transplant.  
14\. Trauma to the chest wall and /or abdomen resulting in a possible injury
to the aorta, inferior vena cava and/or iliac vasculature.

**Limitations:**

1\. Vascular studies are not the initial diagnostic modality for the
evaluation of abdominal pain/tenderness. There must be a high index of
suspicion that the pain is caused by a vascular disorder, such as mesentery
ischemia.  
2\. Routine imaging of the iliac veins is not medically necessary. Exceptions
will be made for specific medical indications of possible propagation of a
known thrombus for consideration for placement of a vena cava filter device
via the femoral approach. The medical necessity must be documented in the
medical record.  
3\. Abdominal aortic aneurysms > four cm in diameter may be followed with
abdominal ultrasound every six months. Documentation of medical necessity
needs to be provided for studies performed more frequently.  
4\. The outcome must impact the clinical management of the patient. For
example, if a patient is going to proceed on to other diagnostic and/or
therapeutic procedures regardless of the outcome of the noninvasive studies,
the non-invasive vascular studies are usually not medically necessary. That
is, if it is obvious from the findings of the history and physical examination
that the patient is going to proceed to angiography, then noninvasive vascular
studies may not be medically necessary.

  
**II. Penile Vascular Studies**  
Duplex scans of the arterial inflow and venous outflow of penile vessels have
no therapeutic implications. Therefore, they are considered **not** medically
reasonable or necessary, except in a patient with treatment failure who has
sustained a documented groin injury where a vascular etiology for impotence is
suspected.

**Credentialing and Accreditation Standards**  
The accuracy of non-invasive vascular diagnostic studies depends on the
knowledge, skill, and experience of the technologist and interpreter.
Consequently, the physician performing and/or interpreting the study must be
capable of demonstrating documented training and experience. A vascular
diagnostic study may be personally performed by a physician, a certified
technologist, or in a certified vascular testing lab.

Services will be considered medically reasonable and necessary only if
performed by appropriately trained providers.

1\. All non-invasive vascular diagnostic studies must be performed meeting at
least one of the following:

a. performed by a licensed qualified physician, **or**  
b. performed by a technician who is certified in vascular technology, **or**  
c. performed in facilities with laboratories accredited in vascular
technology.

2\. A licensed qualified physician for these services is defined as:

a. Having trained and acquired expertise within the framework of an accredited
residency **or** fellowship program in the applicable specialty/subspecialty
in ultrasound (US) **or** must reflect equivalent education, training, and
expertise endorsed by an academic institution in ultrasound **or** by
applicable specialty/subspecialty society in ultrasound, **or**  
b. Has the Registered Vascular Technologist (RVT), Registered Physician
Vascular Interpretation (RPVI), or ASN: Neuroimaging Subspecialty
Certification; **and**  
c. Is able to provide evidence of proficiency in the performance and
interpretation of each type of diagnostic procedure performed.

3\. Nonphysician personnel performing tests must demonstrate basic
qualifications to perform tests and have training and proficiency as evidenced
by licensure or certification by an appropriate State health or education
department. In the absence of a State licensing board, non-physician personnel
must be certified by an appropriate national credentialing body.

Appropriate personnel certification includes the American Registry of
Diagnostic Medical Sonographers (ARDMS), Registered Vascular Technologist
(RVT) credential; or Cardiovascular Credentialing International's Registered
Vascular Specialist (RVS).

4. Laboratories must be certified by one of the following:

  *     * Intersocietal Accreditation Commission (IAC),
    * American College of Radiology (ACR),
    * Joint Commission (Vascular lab certification would need to be noted under the main certification either under inpatient or ambulatory care depending on where the test is being performed), or
    * DNV-GL (specific for hospitals only)

According to which certifying body listed above is selected, that accrediting
body's standards must be followed.

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