Summary Of Evidence

N/A

Analysis of Evidence

N/A

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

Non-invasive vascular diagnostic studies utilize ultrasonic Doppler and physiologic principles 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.” (AMA 2018 CPT book, page 654). 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.

A duplex scan combines Doppler spectrum analysis and conventional ultrasound, to visualize the structure of blood vessels, how the blood is flowing through the vessels, and whether there is any obstruction in the vessels.

A non-invasive physiologic study implies functional measurement procedures including Doppler waveform analysis, blood pressure measurements, or plethysmography.

Plethysmography implies volume measurement procedures including air, impedance, or strain gauge methods.


Covered Indications

1. Deep Vein Thrombosis (DVT)

Due to the risk of DVT associated with pulmonary embolism (PE), objective testing of venous function is considered reasonable and necessary in patients that are candidates for anticoagulation or invasive therapeutic procedures for any one of the following:

• To evaluate clinical signs or symptoms suggestive of acute or new onset DVT such as extremity swelling, tenderness, inflammation or erythema.
• Investigation for DVT as the source of a suspected or confirmed pulmonary embolism.
• Evaluation of unexplained extremity edema, especially unilateral or asymmetric, in an individual at risk for DVT (e.g., immobile, status-post major surgical procedure, indwelling vascular catheter or prosthesis, or postpartum). Bilateral or symmetric limb edema is more likely to result from a systemic disorder (e.g., congestive heart failure, hypoalbuminemia, arthritis) or certain drugs. Therefore, bilateral limb edema is considered reasonable and necessary for venous studies in individuals at risk for DVT when there is no otherwise plausible cause.
• Follow-up for patients with known venous thrombosis to monitor for progression, determine course of treatment or the need to alter treatment based on new symptoms.

2. Chronic Venous Insufficiency

Chronic venous insufficiency is impaired venous return which may cause lower extremity symptoms. Objective testing of venous function is considered reasonable and necessary in patients that are candidates for anticoagulation or invasive therapeutic procedures for any one of the following:

• Evaluation of Postthrombotic (Postphlebitic) Syndrome (PTS) in patients with symptoms of PTS (e.g., chronic leg pain, leg heaviness, leg swelling, leg itching or ulcers on the leg).
• Evaluation of suspected valvular incompetence in patients with symptomatic chronic venous insufficiency or symptomatic varicose veins (e.g., significant pain or edema of the lower leg, ulceration, thickening and discoloration) suspected to be secondary to venous insufficiency in order to confirm this diagnosis prior to treatment.
• Post-procedural assessment of venous ablation. If a great or small saphenous vein undergoes ablation, a duplex scan of the affected side is considered reasonable and necessary postoperatively within 72 hours after the procedure, to assess the result of the surgery and the possibility of propagation of a thrombus.

Please see the companion article Billing and Coding: Non-Invasive Peripheral Venous Studies, A52993, for ICD-10-CM code(s) to describe a limited venous duplex performed within 72 hours of a saphenous vein ablation procedure.

Note: Additional coverage information pertinent to the treatment of varicose veins and ablation therapy is located in LCD L34924, Treatment of Chronic Venous Insufficiency of the Lower Extremities.

3. Preoperative Examinations

Non-Invasive Peripheral Venous Studies are considered reasonable and necessary for select preoperative examinations that meet criteria for coverage as follows:

• Bypass surgery - Duplex scan of extremity veins including responses to compression and other maneuvers; unilateral or limited study is indicated for the preoperative examination of potential harvest vein grafts to be utilized during bypass surgery. This service is considered reasonable and necessary when the results of the study are needed to locate suitable graft vessels. The need for bypass surgery must be determined prior to performance of the test.
• Hemodialysis access surgery - Vessel mapping for hemodialysis is indicated for the preoperative examination of vessels prior to hemodialysis access site surgery in patients with end stage renal disease (ESRD). This service is considered reasonable and necessary when the results of the study are needed to determine appropriate vessel utilization (i.e., when the patient’s clinical evaluation does not readily lead to the selection of a vein that is suitable for creating a dialysis fistula). The need for a hemodialysis access site must be determined prior to performance of the test.

Limitations

1. Objective testing of peripheral venous function is considered not reasonable and necessary and therefore non-covered for any one of the following:

• Asymptomatic varicose veins
• Routine screening tests

Note: Please see the billing and coding article for Non-Invasive Peripheral Venous Studies, A52993, for appropriate ICD-10-CM diagnosis code(s) used to indicate screening tests performed in the absence of a specific sign, symptom, or complaint. Screening tests performed in the absence of a specific sign, symptom, or complaint will result in the denial of claims as non-covered screening services.

2. Non-invasive vascular studies are considered not reasonable and necessary if the results are not needed for clinical decision making. If the study results will have no impact on the decision for further diagnostic or therapeutic procedures or will not provide any unique diagnostic information that would impact patient management, then the non-invasive studies are not reasonable and necessary. For example, if it is evident 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 reasonable and necessary.

3. The following limitations apply to multiple non-invasive studies on the same encounter or same day:

• Performance of both non-invasive extracranial arterial studies and non-invasive evaluation of extremity veins during the same encounter is rarely medically necessary. Documentation must clearly support the medical necessity if both procedures are performed during the same encounter, and be made available upon request.
• Because 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 is rarely medically necessary. Consequently, documentation must clearly support the medical necessity of both procedures if performed during the same encounter, and be made available upon request.
• It is rarely medically necessary to perform lower extremity and upper extremity studies on the same day. Documentation must clearly support the medical necessity of both upper and lower extremities if performed on the same day, and be made available upon request.

4. "The use of a simple hand-held or other Doppler device that does not produce hard copy data 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.” (AMA 2018 CPT Book, Page 654) Doppler procedures performed with zero-crossers (i.e., analog [strip chart recorder] analysis) are also included in any other E/M service. Therefore, it is not reasonable and necessary to report these procedures as separate services.

5. Please refer to NCD 20.14, for a list of plethysmorgraphy methods that are not covered.

Training Requirements/Certifications

The accuracy of non-invasive diagnostic testing studies depends on the knowledge, skill and experience of the physician and/or technologist performing and interpreting the study. Documentation of applicable training and experience must be maintained and made available upon request. Services will be considered reasonable and necessary only if performed by appropriately trained personnel. Please see CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 80, for supervision definitions and requirements for diagnostic tests.

All non-invasive vascular studies must be:

1. Performed by a qualified physician; or
2. Performed under the general supervision of a qualified physician by a licensed* technologist who is certified in vascular technology; or
3. Performed in an accredited vascular laboratory.

*State licensure for a technologist is required in addition to appropriate recognized certification. Documentation of current, active licensure must be maintained and made available upon request. In the absence of a state/federal district licensing board, the requirement for licensure is waived.

A qualified physician for this service/procedure is defined as:

1. Physician is properly enrolled in Medicare; and
2. 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.

Appropriate technologist certification is limited to American Registry of Diagnostic Medical Sonographers (ARDMS) certification as a Registered Vascular Technologist (RVT), Cardiovascular Credentialing International (CCI) certification as a Registered Vascular Specialist (RVS) or Registered Phlebology Sonographer (RPhS), and the American Registry of Radiologic Technologists (ARRT) certification in Vascular Sonography (VS). Appropriate laboratory accreditation is limited to the American College of Radiology (ACR) Vascular Ultrasound Program, and the Intersocietal Accreditation Commission (IAC) division of Vascular Testing.

The contractor does not establish a credentialing service but the contractor is authorized to determine which organizations it recognizes. For example, the use of the word “national” in the organization’s name does not, in itself, meet Medicare standards for national credentialing.

Note: For services performed in an Independent Diagnostic Testing Facility (IDTF), please refer to Local Coverage Determination (LCD) L35448, Independent Diagnostic Testing Facility (IDTF), and related Local Coverage Article A53252, Independent Diagnostic Testing Facility (IDTF), for additional information.

This LCD imposes frequency limitations. For frequency limitations please refer to the Utilization Guidelines section below.

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.