Non-invasive peripheral arterial studies include two types of testing, non-invasive physiologic studies and duplex scans.

Non-invasive peripheral arterial studies are performed to establish the level and/or degree of peripheral arterial occlusive disease.

Non-invasive peripheral arterial studies are considered medically necessary if the ordering physician has reasonable expectation that their outcomes will potentially impact the clinical management of the patient. Further, it is expected that the studies are not redundant of other diagnostic procedures that must be performed.

 In general, non-invasive peripheral arterial studies of the extremities are indicated when endovascular or other invasive surgical correction is contemplated, but not to follow non-invasive medical treatment regimens or to monitor unchanged symptomatology. The latter may be followed with physical findings, including ankle/brachial indices, and/or progression or relief of signs and/or symptoms.

In order for a non-invasive physiologic study to be reimbursed, it must include a Doppler waveform analysis or volume plethysmography.

Studies are considered eligible for coverage as medically necessary if one or more of the following criteria are present:

1. To ensure appropriate detection in the diabetic patient, or the patient who has significant peripheral neuropathy from other causes: symptoms of leg ischemia such as typical claudication (reproducible leg pain that occurs with exercise, does not occur at rest, and is relieved within 10 minutes of rest); or more atypical symptoms such as fatigue, heaviness, tiredness, or cramping in the leg muscles, that occur during activity and resolve with cessation of the activity and rest. Another atypical presentation may be the inability to walk at normal speed (slowing of gait).
2. Rest pain, (typically including the forefoot), usually associated with absent pulses, which may become increasingly severe with elevation and may diminish with placement of the extremity in a dependent position.  
3. Signs of vascular compromise on physical examination may include findings such as the presence of a femoral bruit, absent or reduced pulses, cool skin in the symptomatic patient, an abnormal ankle brachial index (ABI), wounds or ulcers that are not healing normally with proper treatment, and in the diabetic patient - dependent rubor and/or pallor of the foot with elevation, absence of hair growth, and dystrophic toenails.
4. Tissue loss such as gangrene or pre-gangrenous changes of the extremity, or ischemic ulceration of the extremity occurring with reduced or absent pulses.
5. Aneurysmal disease of the extremity.
6. Evidence of thromboembolic events in an extremity.
7. Blunt or penetrating trauma (including complications of diagnostic and/or therapeutic procedures) of an extremity.
8. For radial artery evaluation in a patient scheduled for coronary artery bypass graft (CABG) surgery.

Repeat arterial studies are eligible for coverage for the following indications:

1. Following revascularization surgery, a baseline study may be performed prior to discharge.
2. In the immediate post-operative period, patients may be studied if re-established pulses are lost, become equivocal, or if the patient develops related signs and/or symptoms of ischemia with impending repeat intervention.
3. Following lower extremity bypass surgeries, a study is usually performed at three month intervals during the first year, six month intervals during the second year and annually thereafter when clinically indicated. If there is a change such that the patient develops signs and/or symptoms of ischemia as described in the indications and limitations of coverage above, more frequent testing may be considered eligible for coverage.
4. Following angioplasty with or without stent placement, follow-up studies are typically performed at three months, six months, one year, and annually thereafter when clinically indicated. More frequent studies may be indicated if there is clinical evidence of recurrence of signs or symptoms of vascular disease.

Post-interventional follow-up duplex studies are typically limited in scope, and are unilateral in nature.  Consequently, the "complete" duplex scan codes (codes 93925 or 93930) should seldom be used, while the "unilateral or limited study" codes (codes 93926 or 93931) should typically be used for follow-up testing.

Limitations

Screening of an asymptomatic patient for peripheral arterial occlusive disease, even in the presence of risk factors such as smoking, hypertension, hypercholesterolemia, or diabetes mellitus is not covered. A participating, preferred, or network provider can bill the member for the non-covered service.

The use of a simple hand-held or other Doppler device and ankle/brachial indices (ABI) that do not produce hard copy output, or produce a record that do not permit analysis of bidirectional vascular flow, are considered to be part of the physical examination of the vascular system. Doppler procedures performed with zero-crossers {e.g., analog (strip chart recorder) analysis} are also included in the office visit. 

Performance of both the physiologic studies and duplex study during the same encounter is not medically necessary. Duplex scanning and physiologic studies will be covered during the same encounter for initial evaluations only if the physiologic studies are abnormal and/or to evaluate vascular trauma, thromboembolic events or aneurysmal disease. If it is determined that both studies are not medically necessary, the duplex scan will be denied. For repeat studies, duplex scanning is the preferred method. If it is determined that both studies are not medically necessary, the repeat physiologic study will be denied.

Coverage of non-invasive peripheral arterial studies is limited to the vascular distribution specific to the presenting symptoms (e.g., duplex scan of the upper extremities for symptoms of upper extremity obstruction). Findings of obstruction or occlusion in other areas of the body do not warrant peripheral testing without signs and/or symptoms specific to the extremity.

Non-invasive peripheral arterial testing must be specifically ordered by the physician treating the patient and the medical necessity criteria specified in this policy must be met.

Non-invasive peripheral arterial studies are not indicated and considered not medically necessary for the following conditions:

• Continuous burning of the feet is considered to be a neurologic symptom.
• “Nonspecific leg pain” and “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.

Non-invasive peripheral arterial studies can be provided in the following places of service:

1. Physician’s office and physician-directed clinic.
2. Outpatient and inpatient hospital.
3. Nursing facilities.

Reasons for Noncoverage

Services that do not meet the medical necessity criteria in this policy may be denied as not medically necessary. A participating, preferred, or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider's records.

 Description

Non-invasive peripheral arterial studies include two types of testing, non-invasive physiologic studies and duplex scans. Non-invasive physiologic studies are functional measurement procedures that include Doppler ultrasound studies, blood pressure measurements, transcutaneous oxygen tension measurements, or plethysmography. These studies are useful to confirm and document arterial insufficiency.

Duplex scanning is a technique that combines the information provided by two-dimensional imaging with pulsed-wave Doppler techniques which allows sampling of a particular imaged blood vessel with analysis of the blood flow velocity.

Vascular studies include supervision of the study and interpretation of study results with copies for patients’ records of hard copy output with analysis of all data, including bidirectional vascular flow or imaging when provided. (A hard copy, or a soft copy convertible to a hard copy, provides a permanent record of the study performed and must be of a quality that meets accepted radiologic standards.) These studies also include patient care required to perform the studies.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits or a contract. Benefits are determined by the Federal Employee Program.

CMS Online Manual Pub. 100-3, Chapter 1, Section 20.14 is specific to plethysmography.

CMS Online Manual Pub. 100-3, Chapter 1, Section 220.5 is specific to ultrasound diagnostic procedures.

Highmark Medicare Services. Non-invasive Peripheral Arterial Studies. Local Coverage Determination L30827. Effective July 22, 2010.

Screening for Peripheral Arterial Disease: A Brief Evidence Update for the U.S. Preventive Services Task Force (USPSTF). AHRQ Publication No. 05-0583-B-EF, August 2005. Agency for Healthcare Research and Quality, Rockville MD. Accessed on 02/22/2011 through website - http://www.ahrq.gov/clinic/uspstf05.

Al-Qaisi M, Nott DM, King DH, Kaddoura S. Ankle brachial pressure index (ABPI): An update for practitioners. Vasc Health Risk Manag. 2009;5:833-41. Epub 2009 Oct 12.

Kasapis C, Gurm HS. Current approach to the diagnosis and treatment of femoral-popliteal arterial disease. A systematic review. Curr Cardiol Rev. 2009 Nov;5(4):296-311.

ACR Practice Guideline for Performing and Interpreting Diagnostic Ultrasound Examinations. Accessed on 2/22/2011, through website - http://www.acr.org.