**History/Background and/or General Information**

Noninvasive peripheral arterial studies include two types of testing,
noninvasive physiologic studies and duplex scans. Noninvasive physiologic
studies are functional measurement procedures that include Doppler ultrasound
studies, blood pressure measurements, transcutaneous oxygen tension
measurements or plethysmography. A complete extremity physiologic study
includes pressure measurements and an additional physiologic technique, e.g.,
Doppler ultrasound study or plethysmography.

Plethysmography implies volume measurement procedures including air impedance
or strain gauge methods. Plethysmography involves the measurement and
recording (by one of several methods) of changes in the size of a body part as
modified by the circulation of blood in that part.

Noninvasive physiologic studies are performed using equipment separate and
distinct from the duplex scanner. Duplex scanning combines the information
provided by two-dimensional imaging with pulsed-wave doppler techniques which
allows analysis of the blood flow velocity.

Vascular studies include patient care required to perform the studies,
supervision of the studies and interpretation of study results with copies for
patient records of hard copy output with analysis of all data, including
bidirectional vascular flow or imaging when provided. The display may be a
two-dimensional image with spectral analysis and color flow or a
plethysmographic recording that allows for quantitative analysis.

**Covered Indications**

In general, noninvasive arterial studies are indicated when endovascular or
other invasive correction is contemplated, but not to follow noninvasive
medical treatment regimens or to monitor unchanged symptomatology. The latter
may be followed with physical findings, including Ankle/Brachial Indices
(ABIs), and/or progression or relief of signs and/or symptoms.

Duplex scanning of the lower extremity arteries performed to establish the
level and/or degree of arterial occlusive disease, will be considered
medically necessary if a) significant signs and/or symptoms indicate a high
likelihood of limb ischemia, and b) the patient is a candidate for invasive
therapeutic procedures under any of the following circumstances:

  * The patient has symptoms of peripheral vascular ischemia and is found on physical examination to have absence or marked diminution of pulses (suspected to be secondary to obstruction of lower extremity arteries) of one or both lower extremities. 
  * The patient has developed sudden pallor, numbness, and coolness of an extremity and vascular obstruction (embolism or thrombosis) is suspected. 
  * Claudication of less than one block or of such severity that it interferes significantly with the patient's occupation or lifestyle.
  * The patient has an aneurysm or arteriovenous malformation of a lower extremity artery.
  * The patient has sustained lower extremity trauma with possible vascular injury or the patient has sustained iatrogenic vascular injury.
  * Rest pain of ischemic origin (typically including the forefoot), associated with absent pulses, which becomes increasingly severe with elevation and diminishes with placement of the leg in a dependent position.
  * Tissue loss defined as gangrene or pre-gangrenous changes of the extremity, or ischemic ulceration of the extremity occurring in the absence of pulses.
  * Follow-up studies post-operative conditions: 
    * In the immediate post-operative period if re-established pulses are lost, become equivocal, or if the patient develops related signs and/or symptoms of ischemia with impending repeat intervention.
    * Following bypass surgery or post-angioplasty with or without stent placement at three months, six months and one year when clinically indicated.
  * Subsequent studies may be allowed if there is clinical evidence of recurrent vascular disease evidenced by signs (i.e. decreased ABI from previous exam) or symptoms (i.e., recurrence of claudication symptoms that interfere significantly with the patient's occupation or lifestyle). For postoperative surveillance, either a limited Duplex or multi-level Doppler with pressures is usually sufficient, but it is not considered necessary to do both.

**Limitations**

A routine history and physical examination, which includes Ankle/Brachial
Indices (ABIs), can readily document the presence or absence of ischemic
disease in a majority of cases. It is not medically necessary to proceed
beyond the physical examination for minor signs and symptoms such as hair
loss, absence of a single pulse, relative coolness of a foot, shiny thin skin,
or lack of toe nail growth unless related signs and/or symptoms are present
which are severe enough to require possible invasive intervention.

An ABI is not a separately reimbursable procedure when performed by itself and
would be considered part of the physical examination. When the ABI is abnormal
(i.e., <0.9 at rest), it must be accompanied by another appropriate indication
before proceeding to more sophisticated or complete studies, except in
patients with severely elevated ankle blood pressure).

Examples of additional signs and symptoms that do not indicate medical
necessity include:

  * Continuous burning of the feet is considered to be a neurologic symptom.
  * "Leg pain, nonspecific" or "Pain in limb" as single diagnoses are too general to warrant further investigation unless they can be related to other signs and symptoms.
  * Edema rarely occurs with arterial occlusive disease unless it is in the immediate postoperative period, in association with another inflammatory process or in association with rest pain. 
  * Absence of relatively minor pulses (eg, dorsalis pedis or posterior tibial) in the absence of ischemic symptoms. The absence of pulses is not an indication to proceed beyond the physical examination unless related signs and/or symptoms are present which are severe enough to require possible invasive intervention.
  * Screening of an asymptomatic patient is not covered.

In general, non-invasive studies of the arterial system are to be utilized
when invasive correction is contemplated, but not to follow non-invasive
medical treatment regimens (e.g., to evaluate pharmacologic intervention) or
to monitor unchanged symptomatology. The latter may be followed with physical
findings including ABIs and/or progression or relief of signs and/or symptoms.

Noninvasive vascular testing studies are medically necessary only if the
outcome will potentially impact the clinical management of the patient. For
example, if a patient is (or is not) proceeding on to other diagnostic and/or
therapeutic procedures regardless of the outcome of non-invasive studies, and
non-invasive vascular procedures will not provide any unique diagnostic
information that would impact patient management, then the non-invasive
procedures are not medically necessary. If it is obvious from the findings of
the history and physical examination that the patient is going to proceed to
angiography, then non-invasive vascular studies are not medically necessary.
It is also expected that the studies are not redundant of other diagnostic
procedures that must be performed.

When an uninterpretable study (i.e., poor quality or not in accordance with
regulatory standards) results in performing another type of study, only the
successful study should be billed. For example, when an uninterpretable non-
invasive physiologic study is performed which results in performing a duplex
scan, only the duplex scan should be billed.

Noninvasive vascular procedures will not be covered when performed based on
internal protocols of the testing facility; a referral for one noninvasive
study is not a blanket referral for all studies. Each procedure must be
specifically ordered by the physician/nonphysician practitioner treating the
patient and the medical necessity criteria specified in this LCD must be met.

Typically, it is appropriate for follow-up studies post-angioplasty, with or
without stent placement to be performed at three months, six months and one
year. Subsequent studies may be allowed if there is clinical evidence of
recurrent vascular disease evidenced by signs (i.e., decreased ABI from
previous exam) or symptoms (i.e., recurrence of claudication). For
postoperative surveillance, either a limited Duplex or multi-level Doppler
with pressures is usually sufficient, but it is not considered necessary to do
both.

Performance of both a physiological test and duplex scanning of extremity
arteries during the same encounter would not generally be expected.
Consequently, documentation must clearly support the medical necessity if both
procedures are performed during the same encounter, and be available upon
request. Note: Reimbursement of physiologic testing will not be allowed after
a duplex scan has been performed.

Since the signs and symptoms of arterial occlusive disease and venous disease
are so divergent, the performance of simultaneous arterial and venous studies
during the same encounter should be rare. Consequently, documentation must
clearly support the medical necessity of both procedures if performed during
the same encounter.

Performance of both non-invasive extracranial arterial studies and non-
invasive evaluation of extremity arteries during the same encounter is not
appropriate as a general practice or standing protocol, and therefore, would
not generally be expected. Consequently, documentation must clearly support
the medical necessity if both procedures are performed during the same
encounter, and be available upon request.

The use of a simple hand-held or other Doppler device that does not produce
hard copy output, or that produces a record that does not permit analysis of
bidirectional vascular flow, is considered to be part of the physical
examination of the vascular system and is not separately reported. The
appropriate assignment of a specific ultrasound CPT code is not solely
determined by the weight, size, or portability of the equipment, but rather by
the extent, quality, and documentation of the procedure. If an examination is
performed with hand-carried equipment, the quality of the exam, printout, and
report must be in keeping with accepted national standards.

Generally, it is not expected that these services would be performed more than
once in a year, excluding inpatient hospital and emergency room places of
service.

Note: This LCD imposes utilization guideline limitations. Each patient's
condition and response to treatment must medically warrant the number of
services reported for payment. The medical necessity for each service reported
is required to be clearly demonstrated in the patient's medical record. It is
expected that patients will not routinely require the maximum allowable number
of services.

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.

**Provider Qualifications**

The accuracy of non-invasive vascular diagnostic studies depends on the
knowledge, skill and experience of the technologist and the physician
performing the interpretation of the study. Consequently, the technologist and
the physician must maintain proof of training and experience.

All non-invasive vascular diagnostic studies must be: (1) performed by a
qualified physician, or (2) performed under the general supervision of a
qualified physician by a technologist who has demonstrated minimum entry level
competency by being credentialed in vascular technology, and/or (3) performed
in a laboratory accredited in vascular technology.

Examples of certification in vascular technology for non-physician personnel
include:

  * Registered Vascular Technologist (RVT) credential
  * Registered Vascular Specialist (RVS) credential

These credentials must be provided by nationally recognized credentialing
organizations such as:

  * The American Registry of Diagnostic Medical Sonographers (ARDMS) which provides RDMS and RVT credentials
  * The Cardiovascular Credentialing International (CCI) which provides RVS credential

However, if the facility has a documented process for grand-fathering
experienced technicians who have performed the services referenced in this LCD
(a process addressing years of service and experience with number of
supervised cases), this documentation should be available upon request;
otherwise the provider must have documentation available upon request which
indicates that the technician meets the credentialing requirements as stated
above or is in the process of obtaining this credentialing.

Appropriate nationally recognized laboratory accreditation bodies include:

  * Intersocietal Commission for the Accreditation of Vascular Laboratories (ICAVL)
  * American College of Radiology (ACR)

For guidelines regarding general supervision during performance of a
procedure, please refer to 42 CFR 410.32 Diagnostic x-ray tests, diagnostic
laboratory tests, and other diagnostic tests: Conditions.

For guidelines regarding studies performed in an Independent Diagnostic
Testing Facility (IDTF), please refer to 42 CFR 410.33 Independent diagnostic
testing facility.