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 off 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 5 to 10 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 2-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.3,4,6,7,8,10,11,12,13 **OR**
    * Investigation for DVT as the source of a suspected or 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.1,16,17,18 **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 following11,14: 
    * 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 L35448, Independent Diagnostic Testing Facility
(IDTF), and related Local Coverage Article A53252, 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.30,32,33,34,35,36,37,38,39,40

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.