Non-invasive Arterial Duplex Ultrasound of the Upper and Lower Extremities

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for non-invasive arterial duplex of the upper and lower extremities. 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 non-invasive arterial duplex of the upper and lower extremities 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 60 Services and Supplies Furnished Incident to a Physician/NPP professional service
  • 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
  • Chapter 1, Part 1, Section 20.29 Hyperbaric Oxygen Therapy
  • Chapter 1, Part 4, Section 220.5 Ultrasound Diagnostic Procedures
  • Chapter 1, Part 4, Section 220.11 Thermography
  • Chapter 1, Part 4, Section 300.1 Obsolete or Unreliable Diagnostic Tests
• CMS IOM Publication 100-04, Medicare Claims Processing Manual,
  • Chapter 35, Independent Diagnostic Testing Facility (IDTF)
• CMS IOM Publication 100-08, Medicare Program Integrity Manual,
  • Chapter 3, Section 3.2.3 Requesting Additional Documentation During Prepayment and Postpayment Review
  • Chapter 10, Section 10.2.2.4 Independent Diagnostic Testing Facilities (IDTFs)
  • Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

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.

Code of Federal Regulations (CFR) References:

• CFR, Title 42, Volume 2, Chapter IV, Part 410.32(a) Ordering diagnostic tests
• CFR, Title 42, Volume 2, Chapter IV, Part 410.32(d)(3) Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions
• CFR Title 42, Volume 2, Chapter IV, Part 410.33 Independent diagnostic testing facility.
• CFR, Title 42, Volume 2, Chapter IV, Part 414.50 Physician or other supplier billing for diagnostic tests performed or interpreted by a physician who does not share a practice with the billing physician or other supplier.
• CFR, Title 42, Volume 3, Chapter IV, Part 414.510 Laboratory date of service for clinical laboratory and pathology specimens.

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

Covered Indications

Non-invasive arterial DUS studies are used to diagnose vascular conditions, guide treatment decisions, and monitor surgical intervention effectiveness. DUS arterial studies are covered when:

1. Arterial endovascular or another invasive arterial revascularization or repair is planned OR;
2. Following an endovascular intervention for monitoring complications OR;
3. Surveillance in adherence with evidence-based, specialty society guidelines^1-5

DUS of the lower extremity arteries performed to establish the level and/or degree of arterial occlusive disease, will be considered reasonable and necessary if a) significant signs and/or symptoms indicate a high likelihood of limb ischemia, and b) the patient is a candidate for invasive therapeutic procedures under any of the following circumstances:

1. Tissue loss resulting from gangrene or pre-gangrenous changes of the extremity, or ischemic ulceration of the extremity occurring in the absence of pulses.^1,6
2. The patient has symptoms of peripheral vascular ischemia and is found on physical examination to have absence or marked diminution of pulses (suspected to be secondary to obstruction of lower extremity arteries) of one or both extremities.²
3. The patient has developed sudden pallor, numbness, and coolness of an extremity and vascular obstruction (embolism or thrombosis) is suspected.^2,7
4. Suspected arterial occlusive disease or stenoses with symptoms including claudication, rest pain, ischemic tissue loss, aneurysm, and/or arterial embolization.^2-4,8
   • Claudication is defined as pain occurring within 1 block or less of walking and/or of such severity that it interferes significantly with the patient's occupation or lifestyle.
   • Rest pain of ischemic origin (typically including the forefoot), associated with absent pulses, which becomes increasingly severe with elevation and diminishes with placement of the leg in a dependent position.
5. Evaluation of grafts or other vascular intervention when signs and symptoms of ischemia, rejection, and/or vascular disease are present.^2-5
6. The monitoring of sites of previous surgical interventions, including sites of previous bypass surgery with either synthetic or autologous grafts.^2-5
7. The monitoring of sites of various percutaneous interventions, including angioplasty, thrombolysis/thrombectomy, atherectomy, or stent placement.^2,4,5
8. Follow-up surveillance for progression of previously identified disease, such as documented stenosis in an artery that has not undergone intervention, aneurysms, atherosclerosis, or other occlusive diseases when signs and/or symptoms of worsening disease are present.^2-4
9. The evaluation of suspected vascular and perivascular abnormalities, including masses, aneurysms, pseudoaneurysms, arterial dissections, vascular injuries, arteriovenous fistulae, thromboses, emboli, or vascular malformations.^2,4,5
10. Mapping of arteries prior to surgical interventions.^2,3,8
11. Clarifying or confirming the presence of significant arterial abnormalities identified by other imaging modalities in the setting of signs or symptoms of arterial occlusion or stenosis or during the planning for surgical intervention.^2,9
12. Evaluation of arterial integrity in the setting of blunt or penetrating trauma with suspicion of vascular injury (including complications of diagnostic and/or therapeutic procedures).¹⁰
13. Follow-up studies post-operative conditions:^2-5,11,12
    • In the immediate post-operative period, if re-established pulses are lost, become equivocal, or if the patient develops related signs and/or symptoms of ischemia with impending repeat intervention.
    • Following bypass surgery or post-angioplasty with or without stent placement, exams at 1 month, 3 months, 6 months, and 12 months with a maximum of 4 studies in the initial post-operative year.
14. Monitoring for complications in arterial post-operative procedures:^2-5
    • Clinical evidence of recurrent vascular disease evidenced by signs (e.g., decreased ABI from previous exam) or symptoms (e.g., recurrence of claudication symptoms that interfere significantly with the patient’s occupation or lifestyle).

Limitations

The following are not reasonable and necessary:

1. Continuous burning of the feet as it is considered to be a neurologic symptom.
2. Nonspecific leg pain and pain in a limb as a single diagnosis, unless they are related to other signs and symptoms of arterial vascular disease.^2,3,5
3. Generalized or localized edema in the absence of clinically significant symptoms suggestive of arterial dysfunction, abnormal vascular exam, and/or abnormal physiologic testing.^2,3,5
4. Absence of peripheral pulses (e.g., dorsalis pedis or posterior tibial is not an indication to proceed beyond the physical examination unless the absent pulses can be related to other signs and/or symptoms.^2,3,5,8
5. DUS imaging of the extremities screening of asymptomatic patient.^2,3,5,8
6. Subsequent studies following post-operative intervention greater than annually for asymptomatic patients when stable disease has been established.^2-5
7. ABI alone or when part of the physical examination, and not as part of the limited or complete bilateral physiologic studies.^6,13
8. The use of a simple hand-held doppler device that does not produce a hard copy or that produces a record that does not permit analysis of bidirectional vascular flow.¹³
9. Performance of more than one duplex scan of the upper and lower extremities on the same day or over a short period of time. There may be rare occurrences where this may be appropriate. In such circumstances, a documentation review to validate that the services were reasonable and necessary will be made on redetermination.^2,14
10. Performance of venous and arterial DUS on the same limb(s) on the same day or over a short period of time. There may be rare occurrences where this may be appropriate. In such circumstances, a documentation review to validate that the services were reasonable and necessary will be made on redetermination.^2,14

Provider Qualifications

The accuracy of non-invasive arterial diagnostic studies depends on the knowledge, skill and experience of the technologist and the physician or qualified health provider performing the interpretation of the study.¹⁵ Consequently, the technologist or rendering qualified health provider must maintain proof of training and experience.

Services will be considered 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.

For the service to be considered reasonable and necessary, an arterial diagnostic study may be performed by a physician or a technologist when the following qualifications are met:¹⁵

1. Performed by a licensed qualified physician as defined by:
   • Having trained and acquired expertise within the framework of an accredited residency or fellowship program in the applicable specialty/subspecialty in ultrasound (US); or
   • Must reflect equivalent education, training, and expertise endorsed by an academic institution in ultrasound or by applicable specialty/subspecialty society in ultrasound; or
   • Has received a minimum of one of the following certifications from the respective accredited credentialing agency:
     • American Registry of Diagnostic Medical Sonographers (ARDMS) —Registered Vascular Technologist (RVT); and/or
     • Alliance for Physician Certification and Advancement (APCA)—Registered Physician in Vascular Interpretation (RPVI); and/or
   • Is able to provide evidence of proficiency in the performance and interpretation of each type of diagnostic procedure performed.
2. Performed under the general supervision of a licensed qualified physician by a technologist who has demonstrated minimum entry level competency by being credentialed in vascular technology by an appropriate national credentialing body. The acceptable agencies and certifications for non-physician personnel are as follows:
   • American Registry of Diagnostic Medical Sonographers (ARDMS)—Registered Vascular Technologist (RVT); and/or
   • Cardiovascular Credentialing International (CCI)—Registered Vascular Specialist (RVS).
3. Performed in facilities with laboratories accredited in vascular technology by one of the following agencies:
   • Intersocietal Accreditation Commission (ICA), or
   • American College of Radiology (ACR)

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

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.

History/Background and/or General Information

Arterial duplex ultrasound (DUS) is a safe and non-invasive imaging study that employs traditional ultrasound technology to identify vascular structures and characteristics, and high-frequency sound waves, to examine blood flow and velocity within the arteries. The term duplex refers to using 2 ultrasound modes concurrently: B-mode, which provides a 2-dimensional greyscale ultrasound image of the tissues; and doppler, which delivers a color photograph detecting the movement of blood. Arterial duplex scans, doppler ultrasounds, and physiologic studies, are diagnostic modalities used to investigate clinical findings indicative of suspected arterial dysfunction, arterial occlusion, and/or arterial aneurysms. Commonly assessed anatomy with duplex ultrasonography are the arteries of the neck, abdomen, and upper and lower extremities.

Non-invasive physiologic studies are functional measurement procedures including ankle-brachial index (ABI) measurement, blood pressure (BP) and physiologic waveforms, doppler ultrasound, segmental pressure measurements, BP measurements, transcutaneous oxygen tension measurements, exercise testing, provocative functional maneuver testing, and/or plethysmography. The physiologic testing is intended to examine bilateral upper or lower extremities at 1 or more levels. In some cases, unilateral testing can be performed.

The ABI test compares the BP measured at the ankle with the BP measured at the arm (brachial) using a doppler stethoscope and BP cuff.

Doppler ultrasound uses reflected sound waves called physiologic waveforms to evaluate the blood as it flows through an artery. The waveforms bounce off blood cells in a motion that causes a change in the pitch of the sound, called the doppler effect. These can be measured at a single level, or at segmental (various) limb levels. If there is no blood flow, the pitch does not change.

Exercise testing can be used to analyze the functional significance of vascular disease by reassessing the BP with the doppler stethoscope after completion of an appropriate amount of stress testing.

Plethysmography is a measurement of the volume of an organ or limb section, or flow rate, in response to inflation and deflation of a BP cuff.

Transcutaneous oxygen tension measurement may be done in any area of interest, usually the foot or calf. It measures the influx of blood that provides oxygen for diffusion to the skin.

Non-invasive physiologic studies are performed using equipment separate and distinct from the duplex scanner and are expected to precede the use of DUS in most cases. The appropriate use of testing is to impact clinical decision-making and to direct therapeutic interventions.

Search Protocol

Studies were identified by searching PubMed for peer-reviewed literature and Google and Google Scholar for society guidelines and recommendations. Initial searches were limited to studies published within 10 years of the search date, but if those searches didn’t identify literature, the 10-year limit was removed. Additional literature was identified within the bibliographies of guidelines and systematic reviews.

Number Of Articles Found/Included in Analysis

The search identified a total of fifty-one articles which were assessed as being relevant to this LCD, including 1 randomized controlled trial (RCT), 2 systematic reviews, and 5 meta-analyses. Additionally, there were twenty-nine observational studies, thirteen guidelines, 1 narrative, 1 non-systematic review, and 1 evidence-based consensus document.

Analytic and Clinical Validity

Arterial ultrasound has a history of established validity for uses such as detecting peripheral arterial disease (PAD) or guiding management decisions in patients with critical limb ischemia when compared with reference standards such as arteriography.

Studies show that combining waveform analysis with ABI improves diagnostic accuracy significantly.¹⁶ Duplex ultrasound offers high sensitivity and specificity for detecting femoropopliteal stenosis or occlusion, and contrast-enhanced ultrasound (CEUS) provides mapping data in cases where standard ultrasound is inconclusive.^17,18 However, performance varies with patient factors, particularly in those with diabetes and peripheral neuropathy, where ABI and waveform accuracy are diminished.¹⁹ In comparative studies, duplex ultrasonography performs well, though slightly less accurate than contrast-enhanced magnetic resonance angiography (CE-MRA).²⁰

Society Guidelines and Systematic Reviews

Multiple society guidelines and systematic reviews provide recommendations for the use of arterial ultrasound in the vascular evaluation of the extremities.

Practice guidelines from the Society of Vascular Surgery, published in 2015, recommend ABI as a first-line PAD diagnostic tool, imaging such as DUS, computed tomography angiography (CTA), or magnetic resonance angiography (MRA) for revascularization planning, and the use of DUS for graft monitoring.³ Additional guidelines were published in 2019 by the Society for Vascular Surgery, European Society for Vascular Surgery, and World Federation of Vascular Societies, which were endorsed by 10 other organizations, support ABI for chronic limb-threatening ischemia (CLTI), DUS as first-line imaging of the arteries, and ultrasound vein mapping for bypass candidates.⁸ Further guidelines from the Society of Vascular Surgery, recommend DUS for popliteal artery aneurysm(s) (PAAs) detection and post-repair monitoring including ABI and DUS at 3, 6, and 12 months during the post-operative year and annually DUS thereafter. They also recommend annual surveillance for untreated PAAs.⁴

Published in 2023, guidelines from the International Working Group on the Diabetic Foot, the European Society for Vascular Surgery, and the Society for Vascular Surgery give a conditional recommendation with low certainty for using doppler ultrasound and ABI to assess PAD in diabetic patients without foot ulcers, noting that no single test is definitive.⁶ A systematic review addressed in the guidelines found that doppler ultrasound, in combination with ABI and TBI, can help identify PAD, particularly when waveforms are abnormal and ABI or TBI values are outside normal ranges. In patients with diabetic foot ulcers or gangrene, the guidelines support using pedal doppler waveforms, alongside ABI and TBI, to assess for PAD and note that PAD is less likely, when doppler waveforms are triphasic or biphasic. The guidelines emphasize the value of combining doppler findings with other measures to improve diagnostic accuracy.⁶

Guidelines from the American College of Cardiology and American Heart Association, which were endorsed by 9 other organizations, define imaging roles in PAD and CLTI, recommending DUS post-intervention at 3, 6, and 12 months.² The Society for Vascular Surgery, in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine, published clinical practice guidelines in 2016 which recommend ABI and doppler waveforms for PAD detection in diabetic patients, with annual screening for high-risk individuals.¹ Consensus guidelines from the French Society of Vascular Medicine and the French Society for Vascular and Endovascular Surgery support ABI, TBI, or DUS for PAD screening over age fifty years in high-risk patients, and post-intervention monitoring with ABI/TBI and DUS at 6 months, 1 year, and 2 years.⁵ The concordance of these guidelines represents a consensus within the medical community regarding the frequency of post-intervention DUS imaging.

Additionally, guidelines from the National Institute for Health and Care Excellence (NICE), published originally in 2012 and updated in 2020, recommend DUS in the workup of patients with PAD when it will affect medical management.¹⁴ However, they also advise against imaging in PAD unless it influences medical decision-making.

Alternatively, in 2023 the American College of Radiology (ACR) published guidelines categorizing imaging appropriateness for lower extremity arterial disease, favoring CTA over ultrasound due to higher sensitivity and specificity.⁷ In 2019, the ACR also published guidelines categorizing imaging appropriateness for nonatherosclerotic PAD which generally favored CTA or MRA over DUS.²¹ However, this varied by suspected or known condition, with DUS being “usually appropriate” for suspected popliteal entrapment or suspected external iliac artery endofibrosis.

In 2023, the American College of Radiology, the Society for Pediatric Radiology, and the Society of Radiologists in Ultrasound, defined qualifications for physicians and sonographers performing ultrasound.¹⁵ Physicians must have a certification in radiology or nuclear medicine and ongoing training. Sonographers should have certification and continued education.

Finally, the Society of Hospital Medicine, recommend ultrasound guidance for vascular access, detailing evidence-based recommendations for technique and training.²² They note that ultrasound improves success rates, reduces complications, and enhances vessel assessment.

Contractor Advisory Committee (CAC) Meeting Summary

This contractor convened a multidisciplinary CAC meeting to discuss selected literature reporting clinical utility data for arterial DUS on February 18, 2025. Panelists, which included cardiology, podiatry, and vascular surgery, were provided with key clinical questions and related articles in advance to guide discussions. They were also invited to submit any literature they recommended to be included in our analysis. According to them, arterial duplex imaging is most appropriate when planning an intervention. Notably, our panelists indicated that lower extremity edema without pain is not an indication for arterial duplex scanning. The panelists unanimously agreed that non-invasive physiological testing, including ABI, TBI, and post-exercise ABI, are endorsed for both symptomatic and at-risk asymptomatic patients (e.g., those with diabetes, smoking history, hypertension, or atherosclerosis). These tests are valuable for early detection, monitoring disease progression, and guiding treatment decisions. For patients with diabetes, the panelists concluded that arterial DUS of the lower extremities is recommended only in symptomatic individuals and not as a first-line diagnostic tool.

Surveillance Testing

The CAC panelists also agreed that for patients post-endovascular or surgical intervention, a structured surveillance protocol is advised:

• Every 3 months during the first year
• Every 6 months in the second year
• Annually thereafter

The vascular surgeon commented that surveillance frequency may be adjusted based on the type of procedure and clinical findings. For example, vein bypass grafts require more frequent monitoring compared to prosthetic bypasses, and extracranial arterial duplexes should follow guideline-based intervals.

According to the panel, when diagnosing PAD, ABI remains the first-line test following physical examination. If ABI results are normal or borderline, but clinical suspicion persists (e.g., claudication), stress pulse volume recording (PVR) and arterial duplex imaging are appropriate next steps. In cases of suspected aneurysmal disease, direct imaging is warranted without preliminary physiological testing.

Interestingly, the non-interventionist panel members recommended that for asymptomatic patients with known PAD, routine arterial duplex imaging is not recommended. Instead, regular physiological testing is advised, particularly in individuals over age fifty or those with risk factors such as diabetes, renal disease, or smoking history.

Finally, the CAC panelists suggested annual ABI testing is appropriate for stable patients with a history of intervention, and concomitant use of DUS and physiological testing should be reserved for specific clinical indications rather than routine surveillance.

The expert panel provided clear guidance on the appropriate use of arterial DUS and non-invasive physiologic testing in patients with or at risk for PAD, diabetes, and related vascular conditions and:

Appropriateness of Combined Testing and Specific Indications

• Simultaneous arterial ultrasound and physiologic testing on the same date for the same diagnosis in asymptomatic patients is not recommended.
• Arterial DUS is not indicated for patients with isolated lymphedema without signs or symptoms of arterial insufficiency or stable intermittent claudication without progression or additional concerning features.

Use of CTA

• CTA is valuable for evaluating aortoiliac disease, particularly in patients lacking femoral pulses. However, it is not recommended for routine surveillance or repeated use due to limitations in visualizing infrainguinal vessels and the absence of a defined frequency for use.

Surveillance in High-Risk Populations

• Surveillance arterial DUS of the carotid arteries is considered reasonable for patients with diabetes (DM-2), PAD, or coronary artery disease (CAD), with at least a one-time screening advised. However, serial testing for the purposes of surveillance in asymptomatic patients was not recommended.
• For Medicare patients post-carotid intervention (endarterectomy or stenting), follow-up should include DUS every 6 months for 2 years, then annually until stability is confirmed (i.e., no restenosis in two consecutive annual scans).

Testing in Known PAD Patients

• Non-invasive physiologic testing (e.g., ABI, plethysmography/PVR is recommended for Medicare patients with known PAD to monitor disease progression and guide treatment.
• Arterial DUS should be performed by the interventionist planning the procedure, due to the operator-dependent nature of the test and the need for accurate interpretation.

Predictive Value of Physiologic Testing

• The CAC panelists recommended that initial assessments should include a physical examination, ABI, and PVR are effective in predicting ischemic events, assessing wound healing potential, and determining the need for amputation or intervention. They also serve as indicators of occult CAD.

Use of Intima-Media Thickness (IMT)

• Ultrasound measurement of carotid intima-media thickness (IMT) is not recommended for routine assessment in Medicare patients with transient ischemic attack (TIA) symptoms. IMT is now primarily used in research or to monitor statin therapy effectiveness, rather than clinical decision-making. Therefore, the panelists concluded that the available literature was insufficient to prove clinical utility for this imaging modality.

Lastly, the multidisciplinary consensus supports the implementation of qualifications for both individuals and institutions performing arterial ultrasounds to ensure diagnostic accuracy and clinical utility.

Of note, the initial evidentiary review was inclusive of arterial DUS of the extracranial arteries. However, upon further analysis, it was determined that this topic and abdominal aortic DUS are already addressed under one or more current local or national coverage determinations. Therefore, extracranial and abdominal aortic DUS have been intentionally removed from the scope of this LCD.

Analytic and Clinical Validity

Gale et al evaluated waveform analysis with and without segmental pressures in eighty-one patients against arteriography.¹⁶ The standalone waveform analysis yielded an accuracy of 64–83% across arterial segments. When ABI was added, accuracy improved significantly across all segments (e.g., from 64% to 70% at the popliteal level, P<0.01), indicating that ABI enhances analytic validity. However, segmental pressures beyond the ankle were not found to further improve diagnostic performance.

Polak et al reported that color-assisted duplex sonography achieved a sensitivity of 88%, specificity of 95%, and overall accuracy of 93% in detecting stenosis or occlusion in femoropopliteal arteries, suggesting high analytic validity in a clinical setting.²³ The twenty-nine-minute bilateral scan time also supports its utility for rapid preoperative triage.

Mestre et al demonstrated that CEUS resolved limitations of standard ultrasound in nearly half of eighty-six patients with CLTI who had inconclusive non-enhanced exams performed for surgical planning.¹⁷ CEUS altered surgical plans in 53.5% of these cases, improving agreement between imaging and surgical findings to 95.2% (k=0.823, P=0.00001). The study also found that basic ultrasound was sufficient in 85% of five hundred sixty-five CLTI patients. Even among those needing CEUS, only a marginal portion of participants (5.8%) required further arteriography.

Chuter et al found moderate diagnostic performance of DUS, with good specificity but variable sensitivity.⁹ They analyzed thirty-three studies and performed a Summary Receiver Operating Characteristic analysis, using angiography as the reference standard, which found a diagnostic odds ratio (DOR) of 9.06 [95% confidence interval (CI): 3.61-22.69], and area under the curve (AUC) of 0.76 (95% CI: 0.66-0.86). Bivariate analysis of the studies using DUS demonstrated mean sensitivity of 0.60 (95% CI: 0.48-0.71; P=0.097) and mean specificity of 0.87 (95% CI: 0.78-0.92; P<0.001) with a DOR of 9.76 (95% CI: 5.24-18.20; P<0.0001) and AUC 0.72. The strength of the correlation between sensitivity and specificity was moderate (r=−0.435). Global measures of diagnostic accuracy were indicative of good test performance.

A systematic review by Collins found duplex ultrasonography had a median sensitivity of 88% (range 80–98%) and specificity of 96% (89–99%) for detecting ≥50% stenosis, close to, but slightly lower than CE-MRA (sensitivity 95%, specificity 97%).²⁰ Despite these differences, the diagnostic performance of DUS was considered sufficient for treatment planning in most cases, suggesting that the difference in accuracy was not clinically meaningful.

Another systematic review and meta-analysis, from deSouza et al, evaluated the accuracy of various methods of diagnosing arterial injury following penetrating extremity trauma.¹⁰ They used the Quality Assessment Tool for Diagnostic Accuracy Studies (QUADAS-2) to evaluate bias and applicability of identified studies and calculated positive and negative likelihood ratios (LR+ and LR–, respectively) of physical examination, DUS, and ABI. The authors found that the majority of studies included had a low risk of bias and low concerns regarding their applicability. They found that DUS had a positive likelihood ratio (LR+) of 35.4 (95% CI: 8.3–151) and a negative likelihood ratio (LR–) of 0.24 (95% CI: 0.08–0.72), with a weighted prevalence of arterial injury of 18.9%. Based on these values, a positive DUS increased the post-test probability of arterial injury to 89%, well above the commonly cited threshold (72.9%) for proceeding directly to treatment or CTA. A negative DUS result reduced the post-test probability to 5%, still above the 0.14% testing threshold for CTA. However, when both the physical examination (absence of hard or soft signs) and ABI were normal, the LR– dropped to 0.01 (95% CI: 0.0–0.10), effectively lowering the post-test probability to 0%. These findings suggest that while normal physical exam and ABI together may be sufficient to rule out arterial injury in low-risk patients, DUS offers valuable diagnostic accuracy, particularly when either clinical signs or ABI are abnormal, and plays a critical role in guiding next steps in management.

Williams et al found that the sensitivity and specificity of ABI and foot pulses were substantially reduced in patients with diabetes and peripheral neuropathy.¹⁹ In contrast, the TBI and qualitative doppler waveform analysis performed better. Although the study did not evaluate full DUS, it highlights the limitations of relying on pulses or ABI alone in this high-risk group and supports the use of alternative modalities like TBI or doppler when neuropathy is present. For example, ABI sensitivity dropped from 71% to 38% in neuropathic limbs, while waveform analysis remained more reliable. Given the high prevalence of neuropathy among diabetic patients, this represents a significant limitation of ABI and supports the use of alternative techniques such as DUS.

Clinical Utility

Guidelines from the Society of Vascular Surgery, the American College of Cardiology and American Heart Association, and the French Society of Vascular Medicine, and the French Society for Vascular and Endovascular Surgery, consistently recommend DUS in both diagnostic and monitoring roles.^2-5,8 For symptomatic patients or those being considered for revascularization, DUS is recommended alongside ABI testing. It is also recommended in preoperative vein mapping, particularly in bypass planning, and in routine surveillance following interventions, especially within the first year and annually thereafter.

The ACC/AHA 2024 PAD Guideline, emphasizes the importance of physiological testing (ABI, toe pressures) for diagnosis, and notes that anatomic imaging (DUS, CTA, MRA, or angiography) is indicated when intervention is contemplated.² DUS is included as one of the recommended modalities for planning revascularization or investigating atypical symptoms. In these patients, the pre-test probability of disease is high, and DUS findings are likely to yield actionable information (e.g. identifying a femoral artery occlusion that could be stented).

The Society of Vascular Surgery, Sobieszczyk et al, and Venermo et al provide structured timelines for DUS surveillance post repair of PAAs and vein grafts.^4,11,12 The Society of Vascular Surgery also recommends follow-up with clinical examination including ABI and DUS at 3, 6, and 12 months during the post-operative year and annual DUS after.⁴ Venermo et al, is an evidence-based consensus document describing surveillance techniques post-revascularization, which outline that DUS should be conducted at 1, 3, 6, and 12 months and then yearly thereafter.¹² Sobieszczyk et al, a narrative review describing the use of DUS post-intervention, states that surveillance should occur at 1, 6, and 12 months and then annually thereafter following interventions in the aortoiliac arterial segment, femoropopliteal arterial segment, and tibial arteries.¹¹

DUS was also found to be reliable in surgical planning and surveillance. Ligush et al, Mofidi et al, Mestre et al, and Tielbeek et al reported high agreement between DUS and operative findings and found that DUS effectively identified lesions that influenced surgical decisions.^17,24-26 Similarly, Stone et al observed that early DUS-detected graft stenosis was predictive of outcomes and influenced reintervention timing and long-term patency.^27,28

Collins et al reported that DUS alone was sufficient to guide treatment plans in most patients with lower limb PAD and that outcomes did not differ significantly between those whose plans were based on DUS versus contrast angiography, though 22% of patients still required supplementary imaging.²⁰ While patients preferred MRA for comfort and safety, there was no clear patient preference between duplex ultrasound and angiography, indicating general acceptability.

Other studies also highlight the importance of timely and appropriate vascular testing in patients at risk for PAD. Varghese et al found that most patients undergoing major lower extremity amputations had evidence of severe atherosclerosis on pathology, yet fewer than 60% received vascular diagnostic evaluation, such as DUS, in the year prior.²⁹ This suggests missed opportunities for limb salvage through earlier identification and treatment of disease. Sebastianski et al further demonstrated that patients with PAD were at risk of more complex CAD and worse outcomes after revascularization, reinforcing the need for accurate identification of PAD.³⁰ Similarly, Lijmer et al found that while ABI is generally accurate for detecting proximal disease, additional testing, such as doppler waveform analysis, is needed to assess more complex or distal disease.³¹

Studies from Polak et al, Saarinen et al, and Lane et al further affirm DUS’s diagnostic accuracy and feasibility in post-operative monitoring.^23,32,33 Stone et al and Mofidi et al also noted that DUS-guided intervention correlated with improved limb salvage and patency.^25,27

DUS is not universally preferred. Guidelines from the American College of Radiology categorize it as “may be appropriate” in some scenarios, noting limitations in vessel accessibility and lower sensitivity compared to CTA, particularly in acute limb ischemia (ALI).⁷ Guidelines form the American College of Cardiology and American Heart Association also recommend CTA or MRA when evaluating complex or distal disease or when DUS yields inconclusive results.²

The guidelines from the American College of Cardiology and American Heart Association, published in 2024, in collaboration with nine additional organizations, ranked recommendations as Strong, Moderate, Weak, No Benefit, and Strong likelihood of harm; with evidence levels of A (high quality), B-R (moderate, randomized), B-N (moderate, non-randomized), C-LD (limited data), and C-EO (expert opinion).² Their recommendations regarding ultrasounds were:

• In patients with functionally limiting claudication with inadequate response to guideline-directed management and therapy (including structured exercise) for whom revascularization is being considered, DUS, CTA, MRA, or catheter angiography of the lower extremities is useful for assessment of anatomy and severity of disease and to determine potential revascularization strategy (Strong, B-NR)
• In patients with CLTI, DUS, CTA, MRA, or catheter angiography is useful to determine revascularization strategy (Strong, B-NR)
• In patients with suspected PAD (e.g., potential signs and/or symptoms) with inconclusive ABI and physiological testing, noninvasive imaging with DUS, CTA, or MRA may be considered to establish the diagnosis of PAD (Weak, C-EO)
• In patients with a confirmed diagnosis of PAD in whom revascularization is not being considered, CTA, MRA, or catheter angiography should NOT be performed solely for anatomic assessment (Strong likelihood of harm, B-NR)
• In patients with CLTI who are candidates for surgical bypass or endovascular revascularization, preoperative ultrasound mapping of the great saphenous vein is recommended (Strong, B-R)
• In patients with ALI who have a complicated history of revascularization procedures, it may be reasonable to obtain noninvasive imaging (i.e., DUS, CTA, or MRA) before deciding to proceed with revascularization (Weak, C-EO)
• In patients with PAD who have undergone lower extremity revascularization (i.e., surgical, endovascular, or both) with new lower extremity signs or symptoms, ABI and arterial DUS is recommended (Strong, C-LD)
• In patients with PAD who have undergone infrainguinal, autogenous vein bypass graft(s) without new lower extremity signs or symptoms, it is reasonable to perform ABI and arterial DUS surveillance within the first 1 to 3 months post-procedure, then repeat at 6 and 12 months, and then annually (Moderate, B-R)
• In patients with PAD who have undergone endovascular procedures without new lower extremity signs or symptoms, it is reasonable to perform ABI and arterial DUS surveillance within the first 1 to 3 months post-procedure, then repeat at 6 and 12 months, and then annually (Moderate, C-LD)
• In patients with PAD who have undergone infrainguinal, prosthetic bypass graft(s) without new lower extremity signs or symptoms, the effectiveness of ABI and arterial DUS surveillance is uncertain (Weak, B-NR)

A systematic review and a meta-analysis, Hoitz et al and McKenna et al, found that DUS surveillance post-intervention improves graft patency and reduces amputation rates, outperforming clinical exam or ABI follow-up alone.^34,35 Hoitz was a systematic review that assessed 5 studies and found a moderate certainty level of evidence to suggest a benefit of DUS surveillance compared with standard clinical surveillance. The DUS group demonstrated improved primary assisted patency (84% versus 76% at 12 months and 68% versus 38% at 36 months, P=0.008) and limb salvage (97% versus 83% at 12 months and 90% versus 50% at 36 months, P<0.001) compared with ABI follow-up. In 1 single-armed study, DUS surveillance showed a high sensitivity (91%) and specificity (100%) in detecting restenosis. ABI and clinical follow-up demonstrated a low sensitivity (55-67% and 52-64%, respectively) but reasonable specificity (80-85% and 82-88%, respectively) in detecting restenosis. McKenna only identified 2 studies which met their inclusion criteria but found that the combined surveillance group (DUS plus clinical surveillance) had significantly less likelihood of amputation than the clinical-only group at 12 months post-intervention for PAD of the lower extremities (10/275 [3.6%] vs 18/120 [15%], OR=0.22, 95% CI=0.10-0.48, I² 0). At twenty-four months 1 study reported a benefit while the other didn't. Meta-analyses identified a benefit but there was significant heterogeneity (I² 85%), OR=0.25, 95% CI:0.04-1.58. Only 1 study reported on primary-assisted patency which reported 12-, 24-, and 36-month rates of primary-assisted patency of 84%, 75%, and 68%, respectively, in the combined group versus 76%, 51%, and 38% in the clinical-only group. One study reported 12-, 24-, and 36-month mortality rates of 8%, 14%, and 16%, respectively, in the combined group versus 25%, 35%, and 60% in the clinical-only group. And the other study reported 90% survival after sixty months in the combined group vs 50% in the clinical-only group (P=0.017).

Sarpe et al on the other hand concluded that DUS may not improve limb salvage or patency rates in the short term but may increase reintervention and angiography rates.³⁶ In the short term, they found that DUS surveillance led to little or no difference in limb salvage rates (risk ratio [RR] 0.84, 95% CI: 0.49-1.45; I² 93%; 2 studies, nine hundred thirty-six participants; low-certainty evidence) and vein graft secondary patency (RR 0.92, 95% CI: 0.67-1.26; I² 57%; 3 studies, one thousand ninety-two participants; low-certainty evidence). However, they also found that DUS may increase re-intervention rates when considered any therapeutic intervention (RR 1.38, 95% CI: 1.05-1.81; 3 studies, one thousand ninety-two participants; low-certainty evidence) or angiogram procedures (RR 1.53, 95% CI: 1.12-2.08; 3 studies, one thousand ninety-two participants; low-certainty evidence).

Lundell et al, the sole RCT identified, reported higher graft patency rates with intensive DUS monitoring compared to routine surveillance.³⁷

Additional observational studies provide further evidence. Humphries et al found that abnormal early DUS after infrainguinal revascularization was associated with a higher risk of amputation and that DUS could detect residual stenoses missed by angiography.³⁸ Hardy et al also highlight DUS’s role in preoperative assessment to guide revascularization decisions and reduce amputation rates.³⁹ Crawford et al demonstrated that preoperative DUS was equivalent to angiography in managing peripheral arterial embolism, and Gale et al found that waveform analysis combined with ABI significantly improved diagnostic accuracy.^16,40 Gardner et al showed that ABI values are reproducible across measurement methods, while Lijmer et al validated ABI’s diagnostic precision using ROC analysis.^31,41

In diabetic populations, Fitridge et al and Chen et al show that combining DUS with ABI and TBI enhances PAD detection, especially in patients with normal ABI but significant disease.^6,42 Babaei et al, Hur et al, and Normahani et al confirm that waveform analysis and toe pressures improve sensitivity, and that DUS offers higher diagnostic accuracy than ABI and TBI alone.^13,43,44 Aubert et al found that pulse palpation combined with ABI outperformed ABI alone, and Williams et al found that DUS and TBI were more accurate than ABI in patients with neuropathy.^19,45 Tsai et al and Hsu et al observed that DUS-detected femoral plaque and waveform abnormalities were predictive of limb loss in patients with chronic kidney disease (CKD).^46,47

Similarly, multiple society guidelines emphasize the value of DUS for diagnosing PAD in diabetic patients and for assessing limb perfusion and healing potential in those with ulcers or gangrene.^1,5,6 However, they note no single diagnostic tool is definitive, and that DUS should be part of a multimodal approach. Additionally, we found no evidence to support the use of serial testing in the absence of new or worsening symptoms indicative of arterial insufficiency, such as increased claudication or declining functional capacity.

Studies by Kovacs et al, Nattero-Chávez et al, and Vriens et al support the role of exercise testing and waveform analysis in refining diagnostic accuracy.^48-50 Post-exercise indices such as TBI and tcpO2 significantly differentiated disease severity and predicted outcomes. An additional study from Corvino et al also confirmed DUS’s high sensitivity and specificity in identifying pseudoaneurysms.⁵¹

Rationale for Determination

Since only 1 non-U.S. based RCT was discovered in our search for DUS literature, coverage guidance is largely dependent on observational data, systematic reviews/meta-analyses, and evidence published in specialty society guidelines. However, based on the consistency of reported outcomes, the high level of diagnostic accuracy of mostly observational studies indicates a moderate certainty of evidence (upgraded from low certainty due to strong agreement and large effect sizes). Given the accessibility of the technology and the low risk of harm to patients, the available level of certainty provides sufficient evidence to support that limited coverage of DUS of extremity arteries is reasonable and necessary for PAD (including surgical planning and post-operative monitoring), peripheral aneurysms, and trauma-related injury.

Clinical Validity and Utility in PAD

DUS can establish PAD diagnosis, localize stenoses/occlusions, and grade severity of arterial narrowing, yielding more anatomical detail than an ABI test alone, which measures limb perfusion but not lesion location. DUS accuracy is affected by the arterial segment being imaged such that accuracy is lower in distal, below-knee vessels (e.g., sensitivity decreases below 70% for arterial segments distal to the tibial artery).

In high-risk patients (e.g., older adults, diabetics, smokers with claudication or non-healing foot wounds), DUS is a first-line imaging tool to confirm PAD and guide interventions. Multiple guidelines uniformly and strongly recommend using DUS (along with ABI) in the workup of PAD when it will affect medical management.^2,14 The ACC/AHA 2024 PAD Guideline emphasizes the importance of physiological testing (ABI, toe pressures) for diagnosis and notes that anatomic imaging (duplex, CTA, MRA, or angiography) is indicated when intervention is contemplated. DUS is included as one of the recommended modalities for planning revascularization or investigating atypical symptoms. In these patients, the pre-test probability of disease is high, and DUS findings are likely to yield actionable information (e.g. identifying a femoral artery occlusion that could be stented). In low-risk individuals with leg symptoms more suggestive of musculoskeletal causes, or those with normal ABI and pulses, routine duplex scanning is usually not necessary – a normal ABI essentially rules out significant PAD in most cases. In fact, NICE and ACR advise against imaging in PAD unless it influences medical decision-making. By identifying the location and degree of stenoses, DUS guides whether angioplasty or bypass surgery is feasible, and it can target which artery segment to treat. In many cases, DUS is the first-line imaging for revascularization planning, followed by confirmatory angiography or advanced imaging, if needed. Thus, this contractor expects DUS to be used where it adds clear value (i.e., diagnosing significant disease requiring intervention or planning procedures) and not as a general screening or surveillance tool in asymptomatic, low-risk populations. DUS is repeatable and can be used post-procedure to monitor graft patency or stent results, enabling early detection of reocclusion. In fact, vascular societies endorse routine duplex surveillance/monitoring after bypass grafting to catch treatable stenoses and improve long-term patency. Therefore, coverage is limited in frequency and to specific scenarios (e.g., abnormal ABI, post-intervention etc.) where PAD exclusion is clinically useful.

Several observational studies provide additional support for this framework. Polak demonstrated high diagnostic accuracy for color-assisted DUS in detecting femoropopliteal stenoses.²³ Collins found that DUS was sufficient for treatment planning in most patients with ≥50% stenosis, showing sensitivity and specificity close to that of CE-MRA.²⁰ The use of CEUS as described by Mestre illustrates the adaptability of ultrasound in resolving inconclusive findings, altering surgical plans in over half of patients evaluated.¹⁷ In patients with diabetic neuropathy, Williams showed that TBI and qualitative waveform analysis outperformed ABI alone, underscoring the value of tailored physiologic testing.¹⁹

Evidence from systematic reviews further substantiates the utility of DUS for surveillance. Hoitz et al and McKenna et al demonstrated improved graft patency and reduced amputation rates with DUS-based follow-up compared to ABI or clinical exam alone.^34,35 These findings support guideline recommendations for structured surveillance intervals following intervention.

While the body of evidence is subject to serious risk of bias due to limitations in study design (e.g., non-randomized), the large effect size and paucity of adverse risk reported by multiple studies supports a moderate to high likelihood of true benefit. Therefore, the upgraded certainty of evidence justifies limited coverage for surveillance in patients with recent interventions, such as vein bypass grafting or endovascular repair, but not in patients with stable PAD not under consideration for revascularization. Lundell, the only identified randomized trial, reinforces this by showing higher graft patency rates with intensive DUS monitoring.³⁷

In addition, studies like Humphries et al and Hardy et al highlight how abnormal early DUS findings correlate with increased amputation risk and can inform timely reintervention.^38,39 These outcomes demonstrate that DUS can impact long-term management decisions when used in targeted post-intervention settings.

Clinical Validity and Utility in Peripheral Aneurysms

DUS is widely used for both the detection and monitoring of these aneurysms in outpatient settings. In urgent care, point-of-care ultrasound can aid in the rapid identification of a suspected ruptured aneurysm. Ultrasound has a very high clinical validity for aneurysm detection.^2,4 The abdominal aorta is usually easily visualized; a standard abdominal DUS can measure aortic diameter to within a few millimeters of CT scan measurements. Clinical guidelines note that aortic ultrasound is the standard technique for detecting AAA, with high diagnostic accuracy.¹⁴ In fact, screening trials have reported that ultrasound sensitivity and specificity for AAA are 95–100% when performed by trained personnel (aneurysms appear as anechoic dilations; even small AAAs >3 cm are reliably identified). For peripheral extremity aneurysms such as PAAs, DUS is also the first-line modality.² These aneurysms are often detected on ultrasound as an enlarged arterial segment (often >1.5–2 cm for PAAs) with turbulent flow. Because popliteal aneurysms are superficial in the knee region, DUS can visualize them well. Clinical validity is high for identifying significant peripheral aneurysms or pseudoaneurysms and color doppler aids in distinguishing flowing blood from thrombus within the dilated vessel. In summary, the evidence base (including large screening studies for AAA and observational studies for peripheral aneurysms) indicates moderate certainty in DUS’s ability to accurately detect aneurysms.

In high-risk populations (e.g., men ≥65 with smoking history, or patients with a family history of AAA), one-time ultrasound screening is strongly indicated.⁵² These groups have a substantial prevalence of disease and proven benefit from screening. Consequently, patients with known small aneurysms (i.e. AAA or peripheral) should receive periodic ultrasound and limited coverage is granted per specialty society guideline.

Clinical Validity and Utility in Trauma

The diagnostic performance of DUS in trauma has been studied in several prospective and retrospective cohorts. A key systematic review analyzed 4 studies of DUS (one hundred seventy-three patients total) for penetrating extremity trauma.¹⁰ Authors reported that ultrasound had LR+ 35 and LR- 0.24. In practical terms, given a pre-test prevalence 19% in those studied, a positive duplex raised the post-test probability of arterial injury to 89%, while a negative duplex reduced the probability to about 5%. These figures indicate that a positive ultrasound is highly predictive of a real vascular injury, and a negative exam significantly lowers the chance of injury – though a small risk (5%) remains that could be clinically important. For context, physical exam alone for vascular injury can miss cases, and an ABI <0.9 is a known marker of arterial injury (the meta-analysis found a negative ABI had a post-test injury probability of 9%). Notably, when combined with clinical examination, the accuracy improves dramatically: patients with normal pulses and a normal ABI had essentially a 0% post-test probability of major arterial injury in the review. This implies that in very low-risk presentations, additional ultrasound may not add much – normal exam plus ABI is sufficiently reassuring. However, in cases with equivocal signs, ultrasound can clarify whether an arterial flow deficit exists. For nonatherosclerotic PAD (which covers trauma) indicates that for lower-extremity vascular trauma, CTA is “usually appropriate” as the first-line imaging. DUS is mentioned as an option but is not the preferred standalone in their summary for trauma. The ACR notes the appeal of ultrasound (portable, no contrast) but cautions that “significant injury to superficial soft tissues may limit its accuracy.”²¹ They cite the meta-analysis above, noting a positive ultrasound confers ~89% post-test probability of injury and a negative ~5%. The implication is that ultrasound can be used in trauma but should be reserved for specific scenarios (e.g. when CTA is contraindicated or as a preliminary exam), and if negative, one must still have a low threshold to proceed to CTA if clinical suspicion persists.

Conclusion

DUS is a low-risk, accessible, and accurate imaging modality for evaluating peripheral arteries in both the upper and lower extremities. It demonstrates moderate to high clinical validity and utility when appropriately applied across 3 key clinical scenarios: PAD, aneurysms, and nonatherosclerotic arterial conditions (e.g., trauma). Accordingly, DUS is considered reasonable and necessary for use in high-risk patient populations, particularly when guiding revascularization decisions, cardiac bypass planning, and post-procedural surveillance in accordance with clinical guidelines.

ABI and physiologic testing remain the first-line diagnostic tools for suspected PAD. However, when these tests yield inconclusive results, imaging modalities such as DUS, CTA, or MRA are recommended.

Serial DUS is strongly supported in patients presenting with signs or symptoms of arterial aneurysms and is therefore covered. In contrast, routine or annual DUS testing in patients with known PAD who are not being considered for revascularization is not supported by current specialty guidelines. As such, DUS is not considered reasonable or necessary for ongoing management of stable PAD and is not covered unless revascularization is actively being planned.

Please refer to the related Draft Local Coverage Article: Billing and Coding: Non-Invasive Arterial Duplex of the Upper and Lower Extremities (DA60315) for documentation requirements, utilization parameters, and all coding information as applicable.

N/A

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.

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52. Chaikof EL, Dalman RL, Eskandari MK, et al. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018;67(1):2-77. doi:10.1016/j.jvs.2017.10.044

• Creation of Uniform LCDs Within a MAC Jurisdiction

• peripheral artery disease
• duplex ultrasound
• limb ischemia
• revascularization planning
• arterial ultrasound
• arterial duplex