Peripheral Venous Ultrasound

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for peripheral venous ultrasound. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for peripheral venous ultrasound and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:

IOM Citations:

• CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
  • Chapter 15, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests
• CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, 
  
  • Part 1, Section 20.14 Plethysmography
  • Part 4, Section 220.5 Ultrasound Diagnostic Procedures 
• CMS IOM Publication 100-04, Medicare Claims Processing Manual, 
  
  • Chapter 13 Radiology Services and Other Diagnostic Procedures, Section 10 ICD Coding for Diagnostic Tests and Section 20 Payment Conditions for Radiology Services
• CMS IOM Publication 100-08, Medicare Program Integrity Manual,
  • Chapter 13, Section 13.5.4 Reasonable and Necessary Provisions in LCDs

Social Security Act (Title XVIII) Standard References:

• Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment may be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
• Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Compliance with the provisions in this LCD 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 2023 CPT book, page 788)

For the purpose of this LCD, we utilize the general term Venous Ultrasound which includes the following terminology: ultrasound doppler venous studies, compression ultrasound, whole leg ultrasound, limited ultrasound, two point ultrasound or two region ultrasound, and three point ultrasound or three region ultrasound.

Definitions

• Ultrasound doppler venous studies – Combines B-mode imaging of the deep and superficial veins with pulsed Doppler assessment of flow direction with provocative maneuvers.¹
• Compression ultrasound – Venous compression is applied every two centimeters or less in the transverse (short-axis) plane with adequate pressure on the skin to completely obliterate the normal vein lumen. The fullest visible extent of the common femoral, femoral, popliteal, and posterior tibial and peroneal veins must be scanned by an optimal grayscale compression technique. The deep femoral vein should also be examined at the confluence with the femoral vein. The great saphenous vein is examined at the saphenofemoral junction.² Compression ultrasound (US) evaluates the compressibility, or lack thereof, of a venous segment to diagnose thrombosis and is commonly coupled with a color Doppler to assess blood flow. Compression US may be limited to the proximal leg veins (usually popliteal-trifurcation and more proximally).³
• Whole leg ultrasound – Extended imaging including the calf veins.⁴ Defined as an examination of both the proximal and distal deep venous system of the leg, including the femoral veins, the popliteal vein, the posterior and anterior tibial vein, and the peroneal vein. It may include the muscular veins (gastrocnemius or soleus).⁵ Compression US evaluates the compressibility, or lack thereof, of a venous segment to diagnose thrombosis and is commonly coupled with a color Doppler to assess blood flow. Compression US may be performed on the entire leg (whole-leg US).³ Whole-leg venous ultrasound or complete venous ultrasound is extended imaging of inferior vena cava, iliac and femoral veins, and calf veins.⁶
• Limited ultrasound – Defined as either a two-point or (extended) proximal approach. The two-point technique includes an examination of two venous segments, i.e. the common femoral vein at the level of the inguinal ligament and the popliteal in the popliteal fossa. The (extended) proximal strategy examines additional segments of the proximal venous system, and may include the common and superficial femoral veins, the popliteal vein, and sometimes includes the confluence of the deep calf veins (i.e. calf trifurcation). Limited compression ultrasonography (CUS) comprises either a single or a serial examination in which a second assessment is performed after five to ten days.⁵
• Two point ultrasound or two region ultrasound is a limited protocol that has compression of the femoral and popliteal regions. It is sometimes described as two-point ultrasound, but this term is misleading because the proper protocol is two areas rather than two compressions.⁷ For two point compression ultrasound scanning the deep vein patency is only assessed in two venous territories (usually the common femoral vein and the popliteal vein).⁸ Two-point/two region compression venous ultrasonography or limited compression venous ultrasonography examines the popliteal and common femoral veins only.⁶
• Three point ultrasound or three region ultrasound tests the compressibility of the common femoral vein (CFV), superficial femoral vein (SFV) and the popliteal vein (PV), as well as detects isolated SFV thrombosis of lower extremity deep vein thrombosis.⁹ For three point compression ultrasound scanning the deep vein patency is only assessed in three venous territories (usually the common femoral vein, the popliteal vein, and the femoral vein).⁸

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 medically reasonable and necessary in any of the following situations:

   • To evaluate clinical signs or symptoms suggestive of acute or new onset DVT such as extremity swelling, tenderness, or erythema. Both clinical evaluation and objective tests are required to make a diagnosis for venous thromboembolism (VTE). Wells score is a validated clinical decision rule to estimate the pretest probability for acute DVT in ambulatory settings.^{3,4,6-8,10-13} OR
   • Investigation for DVT as the source of a confirmed PE.^2,10,14 OR
   • To follow-up patients with known venous thrombosis on therapy and who undergo a clinical change and where a change in the thrombus burden will alter treatment.^2,14
2. Chronic Venous Insufficiency

   Chronic venous insufficiency is impaired venous return which may cause lower extremity symptoms. Objective testing of venous function is considered medically reasonable and necessary in any one of the following situations:

   • 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).^8,15 OR
   • 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, itching, aching, thickening and discoloration) suspected to be secondary to venous insufficiency in order to confirm this diagnosis prior to treatment.^1,16,18 OR
   • Post-procedural assessment of venous ablation.^2,14,19,20
   
   Note: Additional coverage information pertinent to the treatment of varicose veins and ablation therapy is located in JH/JL LCD L34924, Treatment of Chronic Venous Insufficiency of the Lower Extremities and JN LCD L38720 Treatment of Chronic Venous Insufficiency of the Lower Extremities.
3. Preoperative Examinations

   Venous ultrasound studies are considered medically reasonable and necessary for select preoperative examinations that meet criteria for coverage as follows:

   • Bypass surgery –Venous ultrasound 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 medically reasonable and necessary when the results of the study are needed to locate suitable graft vessels.^14,21,22

Limitations

The following are considered not medically reasonable and necessary:

1. Objective testing of peripheral venous function for any one of the following^11,14:
   • Asymptomatic varicose veins
   • Routine screening tests
2. Venous ultrasound performed when the 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. 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 venous ultrasounds are not reasonable and necessary.^11,14
3. Imaging while on adequate anticoagulation is unwarranted unless it will change the patient’s treatment.^2,7,23
4. Performance of multiple duplex scans and multiple duplex plus noninvasive physiologic studies of the upper and lower extremities on the same day. There may be rare occurrences where this may be appropriate. In such circumstances, individual consideration will be made on redetermination.
5. In the outpatient setting in non-active cancer patients, if the clinical decision score (Wells score) is less than two, a positive D-dimer must be obtained prior to ordering an ultrasound.^4,6,7,13
6. Please refer to NCD 20.14, for a list of plethysmography methods that are not covered.

Provider Qualifications

Services will be considered medically reasonable and necessary when all aspects of care are within the scope of practice of the provider’s professional licensure, when performed according to the supervision requirements per state scope of practice laws, and when all procedures are performed by appropriately trained providers in the appropriate setting.

Please see CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 80, for supervision definitions and requirements for diagnostic tests.

Note: For services performed in an Independent Diagnostic Testing Facility (IDTF), please refer to LCD L33910, Independent Diagnostic Testing Facility (IDTF), and related Local Coverage Article A57807, Independent Diagnostic Testing Facility (IDTF), for additional information.

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.

Methods

We searched PubMed, MedlinePlus, and Google Scholar for peer-reviewed meta-analyses, systematic reviews, randomized controlled trials and clinical guidelines published between 2014 to April 2023. Search key words included: non-invasive peripheral venous studies, non-invasive evaluation of extremity veins, vascular studies, vascular, indications for venous doppler study, deep venous thrombosis, guideline for venous ultrasound prior to bypass surgery, venous ultrasound prior to bypass surgery, duplex venous ultrasound, cardiac bypass surgery, preoperative extremity venous doppler ultrasound studies, and venous doppler ultrasound. The literature search was filtered to locate articles within 5-10 years and full-text articles.

Our search strategy yielded 30 publications including peripheral venous ultrasound studies. Of the 30 publications identified, two were excluded for the following reasons: One publication was a continuing education activity.²⁴ One study evaluated the utilization of duplex ultrasound for ICU trauma patients and was not relevant to the local coverage determination.²⁵ We also reviewed the literature provided for reconsiderations. Those included one systematic review,²⁶ three clinical guidelines,^27-29 11 informational guides,^30-40 three observational studies,^41-43 one cohort study,⁴⁴ one consensus document,⁴⁵ one cross-sectional study,⁴⁶ and two retrospective studies.^47,48

The evidence for the use of US as the first line imaging test in the evaluation of DVT is supported by seven practice guidelines,^{2,7,8,10,11,14,23} three literature reviews,^4,12,49 three systematic reviews/meta-analyses,^3,5,9 one clinical trial,¹³ one current opinion,⁶ and one author manuscript.⁵⁰

The evidence for the use of US in the evaluation of chronic venous insufficiency is supported by five clinical guidelines,^{2,14,15,16,18} two meta-analyses,^51,52 and two literature reviews.^1,17

The evidence for the use of US for preoperative evaluation is supported by three clinical guidelines,^2,14,53 two systematic reviews,^22,51 one prospective randomized trial,²¹ and one literature review.¹²

The evidence for the use of US in the post procedure assessment following venous ablation is supported by one systemic review/meta-analysis¹⁹ and one author manuscript.²⁰

Reconsiderations

The Contractor received two requests for LCD reconsideration: 1. Lifting the 72-hour requirement for a duplex ultrasound postoperatively after ablation. The request is based on observational studies by Shutze et al and Ryers et al. 2. Removing the limitations for the performance of multiple non-invasive studies on the same encounter with submission of twenty-one articles for review. (See Analysis section)

Venous Ultrasound

Duplex ultrasound (DUS) examination is based on a combination of ultrasound imaging and pulsed wave Doppler with which information can be obtained on both the anatomy and the hemodynamic features of the venous system. Additional color flow imaging is routinely employed to quicken and improve DUS accuracy.¹

Ultrasound for the evaluation of deep vein thrombosis (DVT)

The annual incidence of a first episode of symptomatic DVT in the adult population ranges from 50 to 100 per 100,000 population.⁸ Risk factors for VTE, such as older age, malignancy, inflammatory disorders, and inherited thrombophilia, are associated with higher risk of VTE.⁴⁹ Sixty percent of all VTE events occur in patients aged > 65 years.⁵⁰ Deep vein thrombosis of the lower extremities can be associated with significant morbidity and may progress to pulmonary embolism and post thrombotic syndrome. Early diagnosis and treatment are important to minimize the risk of these complications.³

Karande et al¹² conducted a review of advanced imaging in acute and chronic deep vein thrombosis. Deep venous thrombosis affecting the extremities is a common clinical problem. Prompt imaging aids in rapid diagnosis and adequate treatment. Deep venous thrombosis is a major cause of morbidity and mortality all over the world. It commonly occurs in the lower extremity and is associated with life threatening complication of PE referred together as VTE. The main cause of DVT is stasis of the blood flow.

Venous ultrasonography is the first-line imaging test when DVT is suspected.^3-7 Ultrasonography findings in the presence of DVT include venous non-compressibility, direct thrombus visualization with venous dilation, and abnormal spectral and color Doppler blood flow.^3,4

One study evaluated the diagnostic accuracy of various ultrasonography methods in the emergency room. Both 2-point and 3-point point-of-care compression ultrasound (POCUS) techniques showed excellent performance for the diagnosis of DVT.⁹

Bhatt et al³ and Kraaijpoel et al⁵ conducted two systematic reviews that were similar in their focus, study population and yielded similar results. The sensitivity and specificity for three different ultrasound techniques (limited compression ultrasound [CUS] serial ultrasound, and whole leg CUS) were above 90%. They share the same strength of evaluation on US in DVT in a large patient population. Weaknesses: the gold standard varied across studies, older studies using venography and newer studies using clinical follow-up. The authors also pointed out the large heterogeneity across studies including different DVT prevalence, experience of the ultrasonographers and ultrasonography technology.

Ortel et al documented the evidence-based guidelines from the American Society of Hematology (ASH) for management of venous thromboembolism and treatment of deep vein thrombosis and pulmonary embolism. For patients with unprovoked deep vein thrombosis and/or pulmonary embolism, the ASH guideline panel suggests against routine use of prognostic scores, D-dimer testing, or ultrasound to detect residual vein thrombosis to guide the duration of anticoagulation.²³ Follow-up US can be obtained in patients with known venous thrombosis on therapy and who undergo a clinical change and where a change in thrombus burden will alter treatment.^2,14

DVT could be asymptomatic, is usually unilateral and is clinically suspected in patients presenting with acute-onset pain, swelling, erythema and/or warmth of the lower extremity involved.^3,10 The American Institute of Ultrasound in Medicine (AIUM) published a paper with practice parameters for the performance of point-of-care ultrasound examinations. Limitations of the point-of-care examination of the lower extremity are body habitus and the inability to identify key anatomic points. Any uncertainty in the examination should prompt a full lower extremity Doppler examination. The main limitation of the point-of-care examination is its operator dependency. The operator must be knowledgeable in its clinical use and be appropriately trained in image acquisition and in interpretation of the findings.²

Both clinical evaluation and objective tests are required to make a diagnosis of VTE. Wells score is a validated clinical decision rule to estimate the pretest probability for acute DVT in ambulatory settings. It is intended to be combined with ultrasound or D-dimer for suspected cases. The score ranges from less than two (low risk) to above two (intermediate/high risk) and is combined with D-dimer determination.^4,6,7,13

Venous US should be performed in the investigation of confirmed PE.^2,6,10,14

Currently recommendations are mostly based on the efficiency and safety of the individual strategies and society guidelines, as randomized controlled trials (RCTs) with direct comparisons between strategies are scarce. From a practical point of view, a single diagnostic examination may be preferred over a serial approach as the latter implies that the patient must return for a second examination when the first examination was negative for DVT. However, performing whole-leg CUS may not always be feasible, for example at the emergency department with limited time to examine the patient or when CUS is performed at the bedside by less experienced ultrasonographers.³ The only recent RCTs are addressing performance of point-of-care US, a rapidly evolving field due to technological advances of US and wide adoption by non-radiologists.^3,5

In summary, the body of peer-reviewed literature concerning peripheral venous ultrasound to diagnose deep vein thrombosis is sufficient to establish the analytic validity, clinical validity, and clinical utility of this test in the Medicare population.

US for the evaluation of chronic venous insufficiency (CVI) and chronic venous disease (CVD)

In the United States, approximately 25% of adult people are impacted by CVD. Several diagnostic and treatment modalities have been implemented over the past decade. Prospective, randomized studies comparing a hand-held Doppler (HHD) examination with DUS examination have not been performed since DUS examination became the standard of care in the 1980s. However, the studies in this current systematic review do confirm that DUS examination provides more objective, reproducible information for treatment and is more useful regarding the location of superficial reflux, the extent of the reflux, the size of the refluxing vein throughout its course, the depth of the entire vein, and whether it is above or below the superficial fascia.⁵¹

Farah et al⁵¹ conducted a systematic review that included DUS examination to diagnose saphenous vein incompetence in patients with varicose veins. They only included two old comparative observational studies that included 110 patients (151 limbs), a mean age of 45.5 years. The primary outcomes were the incompetence of the saphenofemoral junction (SFJ), sapheno-popliteal junction, great saphenous vein, which was defined as (retrograde flow in the great saphenous vein of >500 ms). The evidence supports duplex scanning for evaluation of patients with varicose veins and confirms that high ligation and stripping (HL/S) resulted in similar long-term saphenous vein closure rates as endovenous laser ablation (EVLA) and in better rates than radiofrequency ablation and ultrasound-guided foam schlerotherapy (UGFS). Thermal interventions were associated with inferior general quality of life scores than nonthermal interventions, but had a lower risk of recurrent incompetence than UGFS. The quality of evidence was rated as B due to small sample size, however we believe that it should have been rated C as there were no randomized controlled studies included in the analysis.

Chronic venous insufficiency is a common but underdiagnosed cause of leg pain and swelling, and it is frequently associated with varicose veins. The effects of CVI can cause changes in the skin and subcutaneous tissues, such as edema, hyperpigmentation, and lipodermatosclerosis. It is a consequence of the dysfunction of the valve of the veins, associated with an impaired circulation of blood in the leg veins. The most accurate exam is a venous duplex ultrasound scan, that provides an accurate image of the vein, so that any blockage caused by blood clots or improper vein valve function can be detected. Clinical signs/symptoms can include pain and edema of the lower extremities, venous stasis ulcers, aching, itching, lipodermatosclerosis, and skin pigmentation. Duplex scanning of the lower extremities is recommended as a first line diagnostic test in all patients with chronic venous insufficiency. Venous duplex imaging is currently the most common technique used to confirm the diagnosis of CVI and assess its etiology and anatomy and is highly recommended in the Clinical Practice Guidelines (CPG) of the Society of Vascular Surgery and American Venous Forum of 2011. Duplex ultrasonography is a simple, noninvasive, painless, and readily available modality that can assess the anatomy and physiology of the lower extremity venous system.^{1,15,16,17,18}

The American Institute of Ultrasound in Medicine (AIUM), The American College of Radiology (ACR), the Society for Pediatric Radiology (SPR), and the Society of Radiologists in Ultrasound (SRU) and the Society for Vascular Ultrasound (SVU) published papers with performance guidelines that support lower extremity venous duplex ultrasound is an appropriate evaluation of varicose veins.^2,14,16,52

In summary, the body of peer-reviewed literature concerning peripheral venous ultrasound to diagnose chronic venous insufficiency and chronic venous disease is sufficient to establish the analytic validity, clinical validity, and clinical utility of this test in the Medicare population.

Preoperative US Examinations

The venous DUS study provides data not only on reflux time and the size of each superficial vein, but also anatomic location, helping to differentiate between a duplicated superficial truncal vein and an accessory vein, as well as the depth and extent of the reflux. In addition, a DUS examination can identify perforating veins along the path of the truncal vein. All this additional information may have important therapeutic implications.⁵¹

Advantages of extremity venous Duplex US are that it is readily available, quick, cost effective, noninvasive, devoid of ionizing radiation, lacks need for intravenous contrast and can be portable for critically ill patients prone for developing DVT.¹²

The AIUM published a practice guideline that recommended peripheral venous ultrasound examinations for venous mapping before surgical procedures.^2,14

Limitations include operator dependency, technical difficulties and decreased sensitivity in patients with obesity, edema, tenderness, recent hip or knee arthroplasty, cast, overlying bandages and immobilization devices. It also has limitations in patients who had previous DVT and have new symptoms shortly after treatment.¹²

The ACR-SPR-SRU guidelines indicate that venous US is intended for use by health care providers. Diagnostic ultrasound examinations should be performed only when there is an appropriate clinical indication.⁵³ They recommend a permanent record of the ultrasound examination and its interpretation.¹⁴ All diagnostic ultrasound examinations should be supervised and interpreted by trained and qualified physicians.⁵³

Linni et al²¹ conducted a prospective randomized trial to study the effect of preoperative duplex vein mapping (DVM) of the great saphenous vein (GSV) prior to cardiac bypass surgery. The study found that preoperative DVM in patients undergoing infrainguinal bypass surgery does not speed up surgery, shorten incisions, avoid technical errors, or improve bypass patency. However, preoperative DVM and marking of the ipsilateral GSV does avoid unnecessary surgical exploration and an intraoperative change of surgical strategy, which leads to a significant reduction of postoperative major surgical site infections (SSIs) and consecutive readmissions. The method should become standard technique in the preoperative diagnostic setting of patients undergoing infrainguinal bypass grafting. Routine DVM should be recommended for infrainguinal bypass surgery. The study found that preoperative DVM significantly avoids unnecessary surgical exploration, development of major SSI, and reduces frequency of readmissions for SSI treatment.

Media et al²² performed a systematic literature review to evaluate the effect of preoperative ultrasound mapping of the saphenous vein on leg wound complications after coronary artery bypass surgery. A systematic literature search was conducted in PubMed, Cochrane, and Embase databases. Extraction of relevant data was performed including study characteristics, patient characteristics, and all reported outcomes. Ultrasonography for preoperative vein mapping has been used to assess and determine the anatomical course of the long saphenous vein (LSV), thereby facilitating rapid and accurate location of the vein during surgery. Furthermore, preoperative vein mapping has been suggested to be of value in patients whose veins are not evident by physical examination due to edema, multiple varicosities, or complex saphenous vein anatomy. Thus, unnecessary incisions can be avoided reducing complications at incision sites and wound healing disturbances. The primary outcome was occurrence of leg wound complications following harvest of the saphenous vein. The secondary outcome was additional leg incision, leg incision length, and harvest time. Of 4,514 papers screened in this systematic review, 36 papers underwent full-text assessment with final inclusion of five studies: three observational studies, and two randomized trials. The two RCTs showed no effects of preoperative ultrasound. Data from the three non-randomized studies was pooled in a meta-analysis, which suggested a significant reduction in the risk of harvest wound complications by ultrasound mapping prior to surgery (RR 0.32; 95%CI = [0.19–0.55]). The findings indicate that preoperative vein mapping leads to a better preoperative qualitative assessment of the LSV thus possibly reducing harvest site infection, incision lengths, the need for additional incisions, and harvesting times as compared to blind leg incision.

In summary, the body of peer-reviewed literature concerning peripheral venous ultrasound for preoperative examination prior to bypass surgery is sufficient to establish the analytic validity, clinical validity, and clinical utility of this test in the Medicare population.

Post-procedure assessment of venous ablation

Healy et al¹⁹ conducted a systematic review and meta-analysis to determine the incidence of thrombotic events following GSV endovenous thermal ablation (EVTA). Eligible studies were RCTs and case series that included at least 100 patients who underwent GSV EVTA (laser ablation or radiofrequency ablation [RFA]) with duplex ultrasound (DUS within 30 days). The systematic review focused on the complications of endovenous heat induced thrombosis (EHIT), DVT, and PE. There were 52 studies analyzed (16,398 patients). A total of 731 records were selected after screening. Regarding study participants, females outnumbered males and the mean age of participants in the studies ranged from 38 years to 61 years. The timing of the first DUS ranged from one day to one month. Considerable variation regarding the timing of postprocedural DUS was noted. Forty-two of the included studies in this review reported that the first postprocedural DUS took place within one week. The optimal timing of post-procedural DUS for the most efficient and accurate detection of EHIT remains unclear but may become apparent as understanding of the natural history of EHIT improves.

In an author manuscript, Itoga et al²⁰ reviewed data in the Truven Health Marketscan Database, a comprehensive national private insurance claims database, to identify patients who underwent RFA or laser ablation (LA). The authors sought to describe the risk factors for, and incidence of DVT after RFA and LA. Despite the relative safety of these techniques, LA and RFA may cause EHIT which can cause the clot to extend or propagate leading to DVT. In rare cases LA and RFA procedures may also lead to PE. A total of 256,999 patients underwent 433,286 ablation procedures: 192,195 (44.4%) RFA and 241,091 LA. Of these, 8,203 (1.9%) had a newly diagnosed DVT within seven days and 13,347 (3.1%) within 30-days of the procedure. Lower extremity ablation procedures were included if they had a follow-up duplex ultrasound within 30 days of an ablation procedure. The incidence of newly diagnosed DVT within 30-days of an ablation procedure was 3.2%. The risk for DVT decreased in recent years and LA was associated with an 18% decreased risk compared to RFA. Results suggest that the timing postoperative screening might affect reports of thromboembolic complications. Currently, guidelines recommend routine duplex ultrasound within two to three days of surgery to screen for thromboembolic complications; others recommend screening within a week of surgery.

In summary, the body of peer-reviewed literature concerning peripheral venous ultrasound for post procedure assessment following venous ablation is sufficient to establish the analytic validity, clinical validity, and clinical utility of this test in the Medicare population.

Reconsideration Literature

Post Procedure Assessment of Venous Ablation

Shutze et al⁴² conducted a retrospective observational study of patients that underwent EVLA in the outpatient setting. Their hypothesis was that the incidence of EHIT depends on the laser wavelength used in EVLA of the saphenous veins. There were 1,439 veins ablated in 1,109 patients. Patients may develop postablation thrombosis of the common femoral vein after EVLA or RFA of the GSV. It can also occur in the popliteal vein after treatment of the small saphenous vein (SSV). This type of venous thrombosis has been termed EHIT to differentiate it from DVT because it has a different etiology, ultrasound characteristic, and course. Postoperatively, patients were placed in compression bandages or stockings. Ultrasound was done immediately and again approximately one week following the procedure to confirm the absence of thrombus in the adjacent deep vein system. The authors concluded that laser wavelength has a more significant effect on EHIT than the amount of energy delivered – linear endovenous energy density (LEED). A higher LEED is associated with higher closure rates. LEED and laser wavelength are independent factors.

Ryer et al⁴³ conducted a retrospective observational study to evaluate patients that underwent endothermal ablation of the GSV. Endothermal ablation of the GSV is associated with a small but definite risk of EHIT extending into the common femoral vein. Follow-up duplex ultrasound imaging to detect EHIT after ETA is considered standard of care, although the exact timing of duplex ultrasound imaging to detect EHIT after ETA remains unclear. The authors hypothesized that an additional duplex ultrasound assessment one week after ETA would not identify a significant number of patients with EHIT and would significantly increase health care costs. Once the vein was treated, patients were placed in a compressive dressing. All patients (n=842) underwent preoperative and at least one postoperative ultrasound assessment on clinic day one, and 662 patients (79%) underwent a second delayed duplex ultrasound scan one week later. In the study of 842 consecutive GSV ETAs, the authors identified 43 with EHIT requiring anticoagulation. Of the 43 patients with EHIT, 20 (47%) were found on the initial ultrasound assessment performed 24 hours postprocedure, but 19 patients (44%) with EHIT were found on ultrasound assessment one week later. The authors concluded that a significant number of EHIT cases involving the common femoral vein are not identified with a single day 1 postprocedural duplex examination. Delayed duplex ultrasound scanning after GSV ETA comes with associated health care costs but does yield a significant number of patients with progression to EHIT.

In summary, the submitted literature submitted by the provider supported that post procedure assessment with venous ultrasound can be performed one week following a vein ablation procedure. The literature supports removing the 72 hour guideline.

Performance of Multiple Non-invasive Studies on the Same Encounter or Same Day

Ten publications were informational guides or articles that did not support the performance of multiple non-invasive studies on the same day. The informational guides discussed vascular anatomy, duplex ultrasound mechanics, patient information, chronic venous disease, peripheral artery disease, treatment of varicose veins, ankle-brachial index, deep vein thrombosis, and other diagnostic tests such as venography.^30,32-40

Two publications were guidelines that had no new information to support the performance of multiple non-invasive studies on the same day or had outdated information. The guidelines included a patient guide for the venous ultrasound procedure and clinical recommendations for physicians for the diagnosis and treatment of peripheral artery disease.^28,31

One publication was a single-center retrospective study that analyzed patients with type 2 diabetes mellitus who concurrently underwent ankle-brachial index (ABI) testing and carotid intima-media thickness (CIMT) measurements and color Doppler ultrasonography.⁴⁸

One publication was a practice guideline from the American College of Cardiology (ACC) and the American Heart Association (AHA) to provide recommendations applicable to patients with or at risk of developing cardiovascular disease. The guideline included clinical assessment, diagnostic testing, screening, medical therapy, structured exercise therapy, and other treatments for peripheral arterial disease (PAD).²⁷

One publication was a cross-sectional study that evaluated the use of a handheld doppler to obtain ABI to evaluate for PAD. The study was conducted greater than 10 years ago.⁴⁶

One publication was a systematic review and evidence report that reviewed the evidence on the benefits and harm of screening for PAD using the ABI. The publication did not evaluate utilization, indications, or benefits of the venous ultrasound for diagnosis of vascular abnormalities.²⁶

One publication was a review article that evaluated the basic scanning techniques of color and pulsed-wave Doppler US for the lower extremity arteries and the spectral analysis of normal and stenotic arteries on pulsed-wave Doppler US.²⁹

One publication was a longitudinal observational study to evaluate the association between large-vessel PAD with mortality due to coronary heart disease, cardiovascular disease, and all causes. The study was performed in 1992 and does not support current evidence.⁴¹

Leng et al⁴⁴ published a cohort study with 1,592 subjects that aimed to determine whether low ankle pressure ABI was associated with an increased risk of cardiovascular events and death and whether the prediction of such events could be improved by including this index. The study was published in 1996 and is too outdated to be used as a source of evidence-based practice.

Nicolaides⁴⁵ published a consensus document that provides an explanation of the various methods available for the investigation of CVI of the lower limbs, with an outline of their history, usefulness, and limitations. The document describes several methods that can be used to perform duplex scanning for the diagnosis of deep vein thrombosis. The authors conclude that there is no one test that can give all the answers needed but do not specify the timeline of testing or the use of noninvasive venous testing together on the same day.⁴⁵

AbuRahma et al⁴⁷ published a retrospective review that analyzed the resting ABI in the diagnosis of symptomatic PAD. The conclusions of the study suggest that further testing may be needed for patients with PAD than just ABI, toe-brachial index (TBI), or doppler US testing. It does not suggest or recommend against multiple tests in one day, lower and upper extremity testing at the same time (minus ABI use), and it excluded patients with arterial occlusive disease.

In summary, the literature submitted by the provider included information on the symptoms, diagnosis, and treatment of PAD and venous thromboembolic disease. The literature lacked any strong or current evidence to support the performance of multiple non-invasive studies on the same day. There is no literature to support the use of peripheral venous ultrasound studies with arterial studies on the same day.

Conclusion

Our literature search supports the use of ultrasound venous studies in the evaluation of the following clinical scenarios: deep venous thrombosis, chronic venous insufficiency, preoperative vein mapping and post procedure assessment of venous ablation. Systematic reviews, clinical guidelines and RCTs support the use of venous ultrasound as the standard test to identify irregularities in blood flow in the venous system. There is a paucity of new RCTs in the literature.

Refer to the Local Coverage Article: Billing and Coding: Peripheral Venous Ultrasound, A57125, for documentation requirements, utilization parameters and all coding information as applicable.

Contractor Medical Directors

This bibliography presents those sources that were obtained during the development of this policy. The Contractor is not responsible for the continuing viability of Website addresses listed below.

1. Eberhardt RT, Raffetto JD. Chronic Venous Insufficiency. Circulation. 2014;130(4):333-346.
2. American Institute of Ultrasound in Medicine. AIUM Practice Parameter for the Performance of a Peripheral Venous Ultrasound Examination. J Ultrasound Med. 2020;39:E49-E56.
3. Bhatt M, Braun C, Patel P, et al. Diagnosis of deep vein thrombosis of the lower extremity: a systematic review and meta-analysis of test accuracy. Blood Advances. 2020;4(7):1250-1264.
4. Chopard R, Albertsen I, Piazza G. Diagnosis and Treatment of Lower Extremity Venous Thrombembolism. JAMA. 2020;234;1765-1776.
5. Kraaijpoel N, Carrier M, Le Gal G, et al. Diagnostic accuracy of three ultrasonography strategies for deep vein thrombosis of the lower extremity: A systemic review and meta-analysis. PLoS ONE. 2020;15(2):1-16.
6. Mazzolai L, Aboyans V, Ageno W et al. Diagnosis and management of acute deep vein thrombosis: a joint consensus document from the European Society of Cardiology working groups of aorta and peripheral vascular diseases and pulmonary circulation and right ventricular function. European Heart Journal. 2018;39:4208-4218.
7. Needleman L., Cronan J., Lilly M., et al. Ultrasound for Lower Extremity Deep Venous Thrombosis: Multidisciplinary Recommendations From the Society of Radiologist in Ultrasound Consensus Conference. Circulation. 2018;137:1505-1515.
8. Kakkos S, Gohel M, Baekgaard N et al. European Society for Vascular Surgery (ESVS) 2021 Clinical Practice Guidelines on the Management of Venous Thrombosis. Eur J Vasc Endovas Surg. 2021;61:9-82.
9. Lee J, Lee S, Yun S. Comparison of 2-point and 3-point point-of-care ultrasound techniques for deep vein thrombosis at the emergency department – A meta-analysis. Medicine. 2019;98(22):1-11.
10. Society for Ultrasound. Lower Extremity Venous Duplex Evaluation for Thrombosis. Vascular Professional Performance Guideline. 2019:1-8.
11. American Institute of Ultrasound in Medicine. AIUM Practice Parameter for the Performance of Point-of-Care Ultrasound Examinations. J Ultrasound Med. 2019;38:833-849.
12. Karande GY, Hedgire SS, Sanchez Y, et al. Advanced imaging in acute and chronic deep vein thrombosis. Cardiovasc Diagnosis and Therapy. 2016; Dec 6(6):493-507.
13. Silveira P, Ip I, Goldhaber S, et al. Performance of Wells Score for Deep Vein Thrombosis in the Inpatient Setting. JAMA Inter Med. 2015;175(7):1112-7.
14. ACR-AIUM-SPR-SRU Practice Parameter for the Performance of Peripheral Venous Ultrasound Examination. American College of Radiology. Revised 2019 (Resolution 29):1-11.
15. Society for Vascular Surgery. Lower Extremity Venous Disease and Treatment of Post-Thrombotic Syndrome. https://vascular.org/pmg/vascular-conditions/lower-extremity-venous-disease-and-treatment-post-thrombotic-syndrome. 2023. Accessed April 18, 2023.
16. Society for Ultrasound. Lower Extremity Venous Duplex Evaluation for Insufficiency. Vascular Professional Performance Guideline. 2019:1-8.
17. Raetz J, Wilson M, Collins K. Varicose Veins: Diagnosis and Treatment. American Family Physician. 2019;99:682-688.
18. Spiridon M, Corduneanu D. Chronic Venous Insufficiency: a Frequently Underdiagnosed and Undertreated Pathology. Maedica. 2017; Jan 12(1):59-61.
19. Healy D, Kimura S, Power D, et al. A Systematic Review and Meta-analysis of Thrombotic Events Following Endovenous Thermal Ablation of the Great Saphenous Vein. Eur J Vasc Endovasc Surg. 2018;56:410-424.
20. Itoga N, Rothenberg K, Deslarzes-Dubuis C, et al. Incidence and Risk Factors for Deep Vein Thrombosis after Radiofrequency and Laser Ablation of the Lower Extremity Veins. Ann Vasc Surg. 2020;62:45-50.
21. Linni K, Mader N, Aspalter M, et al. Ultrasonic vein mapping prior to infrainguinal autogenous bypass grafting reduces postoperative infections and admissions. Journal of Vascular Surgery. 2012;56(1):126-133.
22. Media A, Rajendran R, Kimose H, et al. Effect of preoperative ultrasound mapping of the saphenous vein on leg wound complications after coronary artery bypass surgery: a systematic review. The Cardiothoracic Surgeon. 2022;30(21);1-9.
23. Ortel T, Neumann I, Ageno W, et al. American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism. Blood Advances. 2020;4(19):4693-4738.
24. Nasra K, Negussie E. Sonography Vascular Peripheral Vein Assessment, Protocols, And Interpretation. 2023 Feb 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing.2023.
25. Andrade A, Tyroch A, McLean S, et al.Trauma patients warrant upper and lower extremity venous duplex ultrasound surveillance. J Emerg Trauma Shock. 2017;10(2):60-63.
26. Guirguis-Blake JM, Evans CV, Redmon N, Lin JS. Screening for peripheral artery disease using the ankle-brachial index: updated evidence report and systematic review for the US Preventative Services Task Force. JAMA. 2018;320(2):184-196.
27. Gerhard-Herman MD, Gornick HL, Barret C, Barshes NR, et al. 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation.2017;135(12):1-64.
28. Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, and abdominal aortic): a collaborative report from the American Association of Vascular Surgery/Society for Vascular Surgery, Society of Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines. Circulation. 2006;113(11):e4634.
29. Hwang JY. Doppler ultrasonography of the lower extremity arteries: anatomy and scanning guidelines. Ultrasonography. 2017 Apr;36(2):111-119.
30. Duplex Ultrasound: Medlineplus medical encyclopedia. MedlinePlus. https://medlineplus.gov/ency/article/003433.htm. Updated March 21 2022. Accessed January 12, 2022.
31. Ultrasound- Venous (Extremities). RadiologyInfo.org. https://www.radiologyinfo.org/en/info/venousus. Reviewed February 5, 2019. Accessed February 05, 2019.
32. Kabnick LS, Scovell S. Overview of lower extremity chronic venous disease. UpToDate. https://www.uptodate.com/contents/overview-of-lower-extremity-chronic-venous- disease. Updated September 22, 2020.
33. Mark A, Joseph L. Arterial Diseases of the Extremities. In Kasper D, Fauci A, Hauser S, Longo D, Jameson J, Loscalzo J. eds. Harrison's Principles of Internal Medicine, 19e 302: Arterial Diseases of the Extremities. McGraw Hill; 2014.
34. Yadav MK, Mohaammed AKM, Puramadathil V, Geetha D, Unni M. Lower extremities arteries. Cardiovasc. Diagn. Ther. 2019 Aug;9(Suppl 1):S174-S182.
35. Mayo Clinic. Peripheral artery disease (PAD). https://www.mayoclinic.org/diseases- conditions/peripheral-artery-disease/diagnosis-treatment/drc-203505631. 2022.
36. Patel SK, Surowiec SM. Venous Insufficiency. [Updated 2021 Aug 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from https://www.ncbi.nlm.nih.gov/books/NBK430975/.
37. Varicose Veins- Treatment. NHS. https://www.nhs.uk/conditions/varicose- veins/treatment/. Reviewed May 07, 2020.
38. Deep Vein Thrombosis (DVT). Mayo Clinic. https://www.mayoclinic.org/diseases- conditions/deep-vein-thrombosis/symptoms-causes/syc-20352557. Accessed December 22, 2020.
39. Hirsh J, Hull RD, Raskob GE. Clinical features and diagnosis of venous thrombosis. J Am Coll Cardiol. 1986;8(6 Suppl B):114B-127B.
40. Diagnosis and Treatment of Venous Thromboembolism. Centers for Disease Control and Prevention. https://www.cdc.gov/ncbddd/dvt/diagnosis-treatment.html. February 07, 2020.
41. Criqui MH, Langer RD, Fronek A, et al. Mortality over a period of 10 years in patients with peripheral arterial disease. N. Engl. J. Med. 1992;326(6):381.
42. Shutze WP, Kane K, et al. The effect of wavelength of endothermal heat-induces thrombosis incidence after endovenous laser ablation. Journal of Vascular Surgery Venous and Lymphatic Disorders. 2016;4(1):36-44.
43. Ryer E, Elmore J, Garvin R, et al. Value of delayed duplex ultrasound assessment after endothermal ablation of the great saphenous vein. Journal of Vascular Surgery, 2016;64(2):446-451.
44. Leng GC, Fowkes FG, Lee AJ, Dunbar J, Housely R, Ruckley CV. Use of ankle pressure index to predict cardiovascular events and death: a cohort study. BMJ. 1996;313(7070):1440.
45. Nicolaides AN; Cardiovascular Disease Educational and Research Trust; European Society of Vascular Surgery; The International Angiology Scientific Activity Congress Organization; International Union of Angiology; Union Internationale de Phlebologie at the Abbaye des Vaux de Cernay. Investigation of chronic venous insufficiency: A consensus statement (France, March 5-9, 1997). Circulation. 2000;102(20):E126-E163.
46. McDermott MM, Kerwin DR, Liu K, et al. Prevalence and significance of unrecognized lower extremity peripheral arterial disease in general medicine practice. J Gen Intern Med. 2001;16(6):384–390.
47. AbuRahma AF, Adams E, AbuRahma, et al. Critical analysis and limitations of resting ankle-brachial index in the diagnosis of symptomatic peripheral arterial disease patients and the role of diabetes mellitus and chronic kidney disease. J. Vasc. Surg. 2020;71(3):937-945.
48. Hur KY, Jun JE, Choi YJ, et al. Color Doppler Ultrasonography Is a Useful Tool for Diagnosis of Peripheral Artery Disease in Type 2 Diabetes Mellitus Patients with Ankle-Brachial Index 0.91 to 1.40. Diabetes Metab J. 2018;42(1):63-73.
49. Heit J, Spencer F, White R. The Epidemiology of Venous Thromboembolism. J Thromb Thrombolysis. 2016;41(1):3-14.
50. Bell E, Lutsey P, Basu S et al. Lifetime Risk of Venous Thromboembolism in Two Cohort Studies. The American Journal of Medicine, 2016;129(3):339.e19-339.e26.
51. Farah M, Nayfeh T, Urtecho M, et al. A systematic review supporting the Society for Vascular Surgery, the American Venous Forum, and the American Vein and Lymphatic Society guidelines on the management of varicose veins. J Vasc Surg Venous Lymphat Disord. 2022;10(5):1155-1171.
52. Gloviczki P, Lawrence P, Wasan S et al. The 2022 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part I. Duplex Scanning and Treatment of Superficial Truncal Reflux: Endorsed by the Society for Vascular Medicine and the International Union of Phlebology. J. Vasc Surg Venous Lymphat Disord. 2023;11(2):231-261.
53. ACR-SPR-SRU Practice Parameter for the Performing and Interpreting Diagnostic Ultrasound Examinations. American College of Radiology. Revised 2017 (Resolution 32):1-6.
54. American Institute of Ultrasound in Medicine. AIUM Practice Parameter for Documentation of an Ultrasound Examination.2020. J Ultrasound Med;39:E1-E4.