Summary Of Evidence

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Analysis of Evidence

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History/Background and/or General Information

Non-invasive vascular diagnostic studies utilize ultrasonic Doppler to assess irregularities in blood flow in the venous system. 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.

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 (CPT code book 2010). 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.

Definitions

A duplex scan is an ultrasonic scanning procedure with display of both two-dimensional structure and motion with time and Doppler ultrasonic signal documentation with spectral analysis and/or color flow velocity mapping or imaging.

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.

Covered Indications

Non-invasive evaluation of extremity veins will be considered to be medically necessary under any of the following circumstances:

• The patient has deep venous thrombophlebitis or has clinical findings (otherwise unexplained limb pain, swelling) which suggest the possibility of acute deep venous thrombophlebitis.
• The patient presents with signs and symptoms of pulmonary embolism (PE) indicated by dyspnea, chest pain, and/or hemoptysis.
• The patient has acute pulmonary embolism.
• Evaluation of patient with symptomatic varicose veins such as stasis ulcer of the lower leg, significant pain and significant edema that interferes with activities of daily living that have not resolved following three months of conservative therapy, and symptoms are suspected to be secondary to venous insufficiency, and testing is performed to confirm this diagnosis by documenting venous valvular incompetence prior to an invasive therapeutic intervention, which meets criteria for medical necessity as outlined in the LCD L38720 for Treatment of Chronic Venous Insufficiency of the lower extremities.
• The patient has chronic venous insufficiency, post phlebitic syndrome, or lymphedema.
• The patient has sustained trauma and injury of the venous system is suspected, making evaluation of the venous system of extremities necessary.
• Venous mapping for the selection of a vein suitable for creating a dialysis fistula or prior to revascularization.
• Evaluation of possible venous obstruction or thrombosis in hospitalized patients who have recently undergone procedures, which predispose them to thrombosis and who would not have been therapeutically anti-coagulated otherwise (e.g., hip replacements, knee replacements).

Venous mapping is not always indicated as a routine pre-operative study. However, this procedure may be useful prior to surgical revascularization or creation of a dialysis fistula as part of the patient’s clinical evaluation in determination of an adequate venous conduit

Limitations

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, and be available upon request.

Non-invasive vascular studies are considered medically necessary only if the outcome will potentially impact the clinical course 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.

Performance of both non-invasive extracranial arterial studies and non-invasive evaluation of extremity veins during the same encounter is not appropriate as a general practice or standing protocol, and therefore, would not generally be expected (American College of Radiology, 2010). Consequently, documentation must clearly support the medical necessity if both procedures are performed during the same encounter, and be available upon request.

It is not considered medically reasonable and necessary to study asymptomatic varicose veins.

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

Please refer to the CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 1, Section 20.14 Plethysmography for covered and noncovered procedures.

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.

The CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 outlines that “reasonable and necessary” services are “ordered and/or furnished by qualified personnel.” Services will be considered medically reasonable and necessary only if performed by appropriately trained providers.

A qualified physician for this service/procedure is defined as follows: A) Physician is properly enrolled in Medicare. B) Training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/subspecialty in the United States or must reflect equivalent education, training, and expertise endorsed by an academic institution in the United States and/or by the applicable specialty/subspecialty society in the United States.

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

• Registered Vascular Technologist (RVT) credential
• Registered Vascular Specialist (RVS) credential 
• Registered Phlebology Sonographer (RPhS)
• Registered Technologist in Vascular Sonography (R.T. [VS])

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 and RPhS credentials
• The American Registry of Radiologic Technologists (ARRT)

Appropriate nationally recognized laboratory accreditation bodies include:

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

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.