Humana Peripheral Artery Disease of the Lower Extremities Angiography, Screening and Exercise Rehabilitation Form

Description

Peripheral artery disease (PAD) is a chronic circulation disorder in which the arteries that supply blood to the extremities (arms, legs) are abnormally narrow and cannot keep up with demand. PAD of the lower extremities is a common cause of impaired ambulation and is a leading cause of lower extremity wounds and amputations. It is also associated with accumulation of fatty deposits called plaques (atherosclerosis) and causes disease of the coronary, cerebral and peripheral arteries. Thus, individuals with PAD are at significantly increased risk of cardiovascular and cerebrovascular events and mortality.

Peripheral Artery Disease of the Lower Extremities Angiography, Screening and Exercise Rehabilitation

Effective Date: 02/02/2023

Revision Date: 02/02/2023

Review Date: 02/02/2023

Policy Number: HUM-0620-000

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

The arteries that may be involved in PAD include the aortoiliac (common iliac, external iliac), infrainguinal (femoral, popliteal or infrapopliteal [tibial, peroneal or pedal]). Affected arteries may become limited in their ability to supply blood to tissues from plaque buildup or completely blocked due to the plaques rupturing or forming clots.

More advanced PAD symptoms in the lower extremities indicating a significant or complete artery blockage include the following:

• Claudication, also known as intermittent claudication, is characterized by fatigue, discomfort, cramping or pain of vascular origin in the muscles of the lower extremities that is consistently caused by exercise and consistently relieved by rest (within 10 minutes).
• Critical/chronic limb ischemia (CLI) characterized by chronic (greater than two weeks) ischemic rest pain, nonhealing wound/ulcers or gangrene in one or both legs attributable to objectively proven arterial occlusive disease by ankle-brachial index (ABI), toe-brachial index (TBI), transcutaneous oximetry or oxygen tension measurement (TcPO2) or skin perfusion pressure testing.

The management of individuals with lower extremity PAD is aimed at relieving symptoms and lowering the risk of cardiovascular disease progression and complications. Medical management involves cardiovascular risk factor reduction, lifestyle modification, and other pharmacologic therapies.

Supervised structured exercise therapy or rehabilitation is considered an important element of care for an individual with PAD. Individuals with peripheral vascular disease have impaired muscle strength and walking ability, resulting in progressive functional impairment and poorer quality of life. Leg strength is linearly correlated with lower extremity ankle-brachial index and with functional performance in individuals with peripheral artery disease.

There are several mechanisms by which exercise training may improve claudication, including but not limited to, increased calf blood flow, improved muscular endurance, strength and increased exercise pain tolerance.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Lower extremities when a narrowed or a blocked artery may be suspected in an effort to diagnose and treat peripheral artery disease. During the procedure, a needle puncture is made through the skin and artery to insert a thin flexible catheter. Dye is then injected into the catheter to allow a narrowed or blocked section of the artery to be identified on an X-ray.

Automated plethysmography, QuantaFlo device, is a volume-based plethysmograph intended to aid in the diagnosis of PAD. The portable system consists of a sensor, computer or tablet and a small printer. The sensor utilizes a transducer to detect changes in and measure the arterial blood volume on each upper and lower extremity. This signal is digitized and sent to the computer/tablet, which runs a proprietary algorithm to calculate the degree of flow obstruction in the lower extremities relative to the upper extremities and produces a ratio of leg-to-arm pulse volume. (Refer to Coverage Limitations section)

Hyperspectral imaging is a noninvasive technique for transcutaneous measurements of tissue perfusion and reports an approximate value of oxygen saturation, oxyhemoglobin and deoxyhemoglobin levels in superficial tissue. Two-dimensional, color-coded images are generated of tissue oxygenation of the scanned surface (skin) to create an oxygenation map. An example of a US Food & Drug Administration (FDA) approved device is the HyperView hyperspectral tissue oxygenation measurement system. (Refer to Coverage Limitations section)

For those with significant or disabling symptoms of claudication unresponsive to lifestyle adjustment and pharmacologic therapy, intervention (percutaneous, surgical) may be reasonable. For more information regarding revascularization procedures for PAD, please refer to Peripheral Artery Revascularization of the Lower Extremities Medical Coverage Policy.

Coverage Determination

Rehabilitation Humana members may be eligible under the Plan for medically supervised exercise therapy (SET) for symptomatic (noncritical limb ischemia) PAD (intermittent claudication) when the following criteria are met:

• Intermittent claudication characterized by fatigue, discomfort, cramping or pain of vascular origin in the muscles of the lower extremities that is consistently caused by exercise and consistently relieved by rest (within 10 minutes); AND

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• Positive exercise ABI that is a 30% decrease from baseline (e.g., a 0.80 baseline ABI and 0.50 ABI after walking to the point of symptoms) AND
• a program description as follows:

1. Be under direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist trained in both basic and advanced life support; AND
2. Conducted in a hospital outpatient setting or physician's office; AND
3. Consists of sessions lasting 30-60 minutes comprising of therapeutic exercise training for individuals with PAD with claudication; AND
4. 36 sessions over a consecutive 12 week period; AND
5. Delivered by qualified auxiliary personnel to ensure benefits exceeds harms and who are trained in exercise therapy for PAD; AND
6. Must have a face to face visit with the physician responsible for PAD treatment for referral to SET program and at this visit, individual must receive information regarding cardiovascular disease, PAD risk factor reduction (education, counseling, behavioral interventions and outcome assessments); AND
7. Verified smoking cessation counseling

Peripheral Angiography

This policy does not address use of peripheral angiography for emergencies or postprocedural vascular complications.

Humana members may be eligible under the Plan for peripheral angiography for aortoiliac disease only, for whom revascularization is considered when the following criteria are met:

• Lifestyle limiting claudication (impairment of activities of daily living and work); AND
• Inadequate response to three consecutive months of conservative therapy within the past 12 months with ALL of the following:
• Individual has undergone supervised exercise therapy; AND
• Pharmacological therapy (e.g., antiplatelet medication, cilostazol) if medically appropriate and not contraindicated; AND
• Verified smoking cessation; AND
• Positive exercise ABI; AND
• Absence of other conditions that limit ability to ambulate/exercise (e.g., angina, chronic obstructive pulmonary disease, heart failure, orthopedic limitations); AND
• Noninvasive imaging (CTA, duplex ultrasound or MRA) confirmation of anatomic location and stenosis severity of 70% or greater

Humana members may be eligible under the Plan for peripheral angiography for chronic/critical limb ischemia (CLI) when the following criteria are met:

• Noninvasive imaging (CTA, duplex ultrasound or MRA) confirmation of anatomic location and stenosis severity of 70% or greater; AND
• One of the following:
• Ankle-brachial index of 0.40 or less; OR
• Toe pressure less than 30mmHg (TBI testing); AND
• One of the following:
• Gangrene; OR

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Ischemic rest pain; OR

• Nonhealing wound or ulcer from ischemia

Coverage Limitations

Humana members may NOT be eligible under the Plan for peripheral angiography of the lower extremities for any indications other than those listed above including, but may not be limited to, the following:

• Asymptomatic PAD

This is considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for screening to detect PAD or cardiovascular disease (CVD) risk in asymptomatic individuals using ankle-brachial index measurements. This technology is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for hyperspectral imaging or QuantaFlo device for any indication. These technologies are considered experimental/investigational they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Additional information about peripheral artery disease may be found from the following websites:

• American Heart Association
• National Library of Medicine
• Society of Vascular Surgery

Peripheral Artery Disease of the Lower Extremities Angiography, Screening and Exercise Rehabilitation Effective Date: 02/02/2023 Revision Date: 02/02/2023 Review Date: 02/02/2023 Policy Number: HUM-0620-000 Page: 7 of 11

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Medical Alternatives

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Humana may offer a disease management program for this condition. The member may call the number on his/her identification card to ask about our programs to help manage his/her care.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.