Response to Comments: Non-invasive Arterial Duplex Ultrasound of the Upper and Lower Extremities

A comment was received that upper and lower extremities should pay separately as they are two distinct areas of the body.

Thank you for your comment. Clinical scenarios requiring arterial duplex ultrasound (DUS) imaging of both upper and lower extremities on the same day or within a short interval are rare. Therefore, the routine performance of multiple arterial DUS services is not covered. Testing in limb(s) without signs or symptoms of arterial occlusive disease is considered screening. Screening and preventative services are covered by statutes (e.g., Social Security Act) or by CMS National Coverage Determinations (NCDs); thus, they are outside of the scope of part A/B MACs LCDs.

However, in response to stakeholder comments, coverage has been extended to allow arterial DUS for the appropriate clinical circumstances where multiple limbs may exhibit signs or symptoms concerning for arterial occlusive disease, thus reasonable and necessary for arterial DUS testing. In these cases:

• Providers must attest to compliance with the LCD provisions when submitting claims; AND
• Documentation must identify the distinct clinical circumstances suspected and may be requested to confirm compliance with the requirements outlined in this policy.

Please see the related Billing and Coding Article, Non-invasive Arterial Duplex Ultrasound of the Upper and Lower Extremities (A60315), for applicable attestation guidance.

Multiple comments were received concerning the limitation on performing arterial and venous duplex studies on the same day or within a short timeframe. One commenter requested clarification of scenarios in which documentation submitted for redetermination would support the medical necessity of performing both studies on the same limb during the same date of service. Another commenter noted an inconsistency between the LCD, which allowed such studies when reasonable and necessary, and the associated billing and coding article, which prohibited billing both studies on the same date of service.

Thank you for your comments. The specified limitation acknowledges that, although uncommon, both venous and arterial DUS studies may occasionally be reasonable and necessary on the same limb during the same date of service or within a short timeframe. To address these exceptional clinical scenarios where there are contemporaneous signs or symptoms of arterial and venous pathology, the limitation has been revised to allow coverage for when all applicable criteria are met at the time of initial claim submission.

When both venous and arterial DUS are medically necessary:

• Providers must attest to compliance with all applicable LCD requirements when submitting claims (see related LCD documents); AND
• Documentation must clearly identify the distinct pathologies suspected and explain how the results will guide patient management.

The billing and coding article has also been revised to include guidance on submitting provider attestation of compliance with all relevant LCDs at the time of initial claim submission. As detailed in the mentioned limitation, any documentation that demonstrates the necessity for both venous and arterial duplex studies must be available upon request for review to confirm that the services were reasonable and necessary.

We received a comment stating there should be a provision for peripheral artery disease (PAD) evaluation of high-risk individuals. A table excerpt of three grouped organizations and their screening recommendations, including beginning age points and associated risk factors for PAD was provided, but without reference. Additional full-text literature from the named organizations were submitted as follows: The 2016 American Heart Association (AHA)/American College of Cardiology (ACC) Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease: Executive Summary: A Report of the ACC/AHA Task Force on Clinical Practice Guidelines; A consensus statement published in 2003 from the American Diabetes Association (ADA) titled Peripheral Arterial Disease in People With Diabetes; and 2017 European Society of Cardiology (ESC) Guidelines on the Diagnosis and Treatment of Peripheral Arterial Disease, in collaboration with the European Society for Vascular Surgery (ESVS).

Thank you for your comment and literature submission. All submitted literature is carefully evaluated for relevancy, evidence-based material, and certainty of evidence. The evidence used in the development of this LCD is referenced in the bibliography which includes the most up to date guidelines and recommendations from the AHA/ACC, ESC, and ESVS as well as the aggregated opinions of subject matter experts (SMEs) outlined in the CAC meeting summary. While the guidelines and consensus statements you provided are appreciated, they do not align with the most recent recommendations represented in our summary and policy evidence analysis.

Coverage policies for screening and preventive services are established by the Social Security Act and CMS NCDs—not by Medicare A/B MACs. MACs may issue LCDs, but only within the confines of existing NCDs and cannot override or independently add coverage for screening or preventive services.

This LCD supplements the provisions established in the NCD publication 220.5, Ultrasound Diagnostic Procedures, which allows for peripheral doppler arterial flow studies. It is this contractor’s expectation that arterial DUS will be utilized where it provides significant clinical value established by the most current, evidence-based recommendations or guidelines, rather than as a routine screening or surveillance method for asymptomatic, low-risk groups.

A comment was received that some of the services outlined in the coverage indications and limitations sections of the LCD would overly restrict patient access to care.

Limitation #4, addressing the absence of peripheral pulses as a solitary finding not necessary for further testing beyond the physical exam, is believed to overlook a significant number of patients with vascular disease. The comments from the SMEs in the CAC meeting indicate peripheral pulselessness may be a sign of PAD and suggest the use of physiologic testing as a first line diagnostic exam. The commenter recommends this limitation reflect that ultrasound should be performed if abnormal physiologic testing in a pulseless patient following a physical exam is construed.

Moreover, the commenter states that there should be an exception to any limitation to diagnostic ultrasound if there is no patient access to any nearby physiologic testing but in an area that ultrasound is available.

Thank you for your comments. The evidence supporting covered indications and limitations is cited in the bibliography, as well as the consolidated opinions of SMEs documented in the CAC meeting summary.

The covered indications and limitations stated in this policy are focused in scope on the use of arterial duplex ultrasound testing. The appropriate use of testing is to impact clinical decision-making and to direct therapeutic interventions. To provide clarity of the policy topic, the limitation for absence of peripheral pulses, has been revised in the final LCD to state the following: “The absence of peripheral pulses (e.g., dorsalis pedis or posterior tibial) alone is not sufficient to validate arterial duplex ultrasound (DUS) imaging as reasonable and necessary. Imaging must only be performed when absent pulses are accompanied by other signs or symptoms indicating clinically significant arterial occlusive disease as well as documented intent to intervene.”

Comments were received to revise the definition of claudication in the fourth covered indication, stating that the current language is overly restrictive and should encompass all appropriate patients with PAD. One commenter stated minimal exercise can cause claudication. The suggested definition, originally written by Hiatt et al in the 2008 conference consensus article, Atherosclerotic Peripheral Vascular Disease Symposium II: Nomenclature for Vascular Diseases, and later adopted by the AHA, was proposed as a practical definition not limited by walking distance. The definition of claudication, as cited from the 2024 AHA/ACC PAD Guideline, is: reproducible lower extremity pain, fatigue, or cramping induced by physical exertion, leading to reduced walking distance and exercise tolerance, and relieved by approximately 10 minutes of rest. Another commenter argued that the current threshold of one block or less would exclude at-risk individuals with higher baseline tolerance, such as fit patients and athletes.

Thank you for your comments and literature submission. All submitted text is carefully evaluated for relevancy, evidence-based material, and certainty of evidence. The evidence supporting covered indications and limitations is cited in the bibliography, which includes 2024 AHA/ACC PAD Guidelines and recommendations. The referenced conference consensus article underwent careful examination in relation to the evidence-based standards mentioned earlier. The committee’s proposal for universal nomenclature does not imply an endorsement or widespread adoption of the recommended vocabularies and their associated manifestations pertaining to atherosclerotic vascular diseases. Furthermore, the consensus article, circulated in 2008, has become less credible due to evolving societal standards and the proliferation of contemporary peer-reviewed literature over the past decade. The committee article further emphasizes that the nomenclature process should remain dynamic to incorporate ongoing scientific and clinical advancements in the diagnosis and management of vascular disorders.

Claudication per the 2024 AHA/ACC PAD Guideline is stated as the following: fatigue, cramping, aching, pain, or other discomfort of vascular origin in the muscles of the lower extremities that is consistently induced by walking and consistently relieved by rest (usually within approximately 10 min). After review of submitted literature and current AHA/ACC guidelines, this MAC acknowledges that the proposed definition of claudication is inconsistent with contemporary standards. Therefore, to improve accuracy and provide clarity, the claudication definition has been updated in the final policy to align with the reference above. This revision does not alter coverage or limitations. Providers remain responsible for thorough history and physical assessment per specialty standards, and accurate documentation supporting the indication must be maintained for review or audit as necessary.

Multiple comments were received requesting clarification on what information should be entered in claim box 19 when the surgery date is unknown, such as when the ordering provider did not perform the procedure.

Thank you for your comments. Prior surgical dates are a routine and essential component of the history and physical exam documentation. This information must be documented in the medical record or noted directly on the order by the ordering provider to support clinical decision-making and ensure sufficient documentation for claim submission and for payment of surveillance DUS imaging. While dates can be obtained from the patient, a caregiver, the referring provider, or the primary care provider, they must be recorded. Failure to include this information will result in insufficient documentation and may lead to claim denial.

A comment recommended removing or revising the fourth limitation regarding absence of pulses to avoid coverage denial for appropriate PAD patients. The commenter noted that the current language would exclude patients without physical exam findings who have occlusive or high-grade stenosis compensated by collaterals and present only with claudication. A suggestion was provided to include specificity of signs and symptoms; however, no supporting literature accompanied the comment.

Thank you for your comment. The fourth limitation indicates non-coverage of arterial DUS in the absence of peripheral pulses with no other physical exam findings. Please see the response to comment #4 for more details. Once the LCD becomes effective, full-text articles may be submitted following our reconsideration process.

Multiple comments were submitted from representatives of the American College of Cardiology, the Outpatient Endovascular and Interventional Society, and the Society of Interventional Radiology. They recommend updating the definition of claudication and adopt the modernized language written in the 2024 AHA/ACC PAD Guideline. Additionally, they supported extending coverage for upper extremity duplex ultrasound in the setting of cardiac catheterization procedures, preprocedural mapping, and assessment of complications post-intervention. They also expressed concerns with verbiage in the fourth limitation for absence of peripheral pulses-proposed supplementing feet, nonhealing wounds, bruits), physiologic testing with ABI and/or TBI is appropriate. Duplex ultrasound should be performed only if physiologic results are abnormal, non-compressible (ABI > 1.40), or inconsistent with clinical findings.” They also indicated that the frequency of post-operative surveillance should be changed to 1 month after the index procedure; every 3 months during the first year; every 6 months during the second year; and annually thereafter if stable and asymptomatic. Lastly, they recommend that this contractor not impose mandatory accreditation requirements, treat IAC/ACR accreditation as voluntary best practice, and eliminate specific interpretation credential mandates as they believe competency should be established by training, experience, and CME rather than proprietary certification.

Thank you for your comments and literature submission. The claudication definition is revised in the final LCD as requested. The policy indications and limitations encompass both upper and lower extremity arterial duplex studies. While coverage for upper extremity DUS is addressed in the LCD, the term 'upper extremities' was inadvertently omitted in that section, but is included in the final LCD.

We have clarified the limitation involving the absence of pulses. Please see the response to comment #4 for more details.

The frequency limitations for arterial DUS imaging align with the analyzed evidence as well as the consolidated opinions of subject matter experts documented in the CAC meeting summary. We note that post-procedural surveillance is a distinct clinical indication from for-cause testing, which we have clarified in the final policy. The testing schedule for surveillance testing aligns with the best available publicly available peer-reviewed literature reviewed. Additionally, all submitted texts are carefully evaluated for relevancy, evidence-based material, and certainty of evidence. The evidence supporting covered indications and limitations is cited in the bibliography.

In the absence of a publicly available consensus from the medical community outlining accepted alternative pathways for defining competency (e.g., specific criteria for training, experience, or CME) this contractor must adhere to what is currently recognized as best practice, which is represented in the final policy.

Representatives from the Society for Vascular Surgery and the Society for Vascular Ultrasound submitted comments in support of the coverage criteria and attention to provider qualifications for test performance and interpretation.

Their comments of concern in the Proposed LCD focused on the following summarized content: recognition of freestanding vascular laboratories as approved testing places of service (POS); clarification of the qualifying rare circumstances and clinically appropriate scenarios that may necessitate imaging of multiple limbs and/or multiple services, including how such circumstances align with established frequency limitations, as well as concern that the overly restrictive application of these limitations may unintentionally exacerbate health disparities, particularly by limiting access to care for patients with complex disease presentations, delayed access to services, or geographic and socioeconomic barriers; and lastly, guidance on the required documentation in Box 19 of the claim form when exact surgery dates are unavailable or unknown.

Thank you for your comments. The policy and the referenced CMS IOM publication provide detailed specifications regarding provider qualifications and facility requirements. We believe these resources adequately address the necessary standards.

We added language to distinguish for-cause testing from surveillance. See response #8 for further details.

Submission of the surgical date as stipulated in the policy is required to validate that surveillance services are reasonable and necessary. Please see response #6 for further details.

This contractor acknowledges that there are clinical circumstances where multi-limb arterial DUS or arterial and venous DUS imaging are reasonable and necessary; therefore, this limitation has been revised. Please see responses #1 and #2 for further details.

Multiple commenters expressed concerns regarding the limitation indicating that ABI alone or when part of the physical examination and not as part of the limited or complete bilateral physiologic studies as not reasonable and necessary.

We agree with the concerns for including this limitation. ABI testing is outside the scope of this LCD; consequently, the ABI limitation has been removed.