Response to Comments: Endovascular Management for Peripheral Arterial Disease of the Upper and Lower Extremities

We appreciate the opportunity to provide comments to Palmetto GBA on the Proposed Local Coverage Determination (LCD): Endovascular Management for Peripheral Arterial Disease of the Upper and Lower Extremities (DL40228). We commend Palmetto for recognizing that peripheral arterial disease (PAD) is a growing clinical problem due to the aging population in the United States and the role that endovascular revascularization plays in treating PAD. We also recognize the clinical need for this patient population who are at risk of amputation and mortality.

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As a leading medical technology and nutrition manufacturer, we seek to ensure that Medicare policies promote beneficiary access to high-quality healthcare innovations that address unmet medical needs and improve health outcomes in patients diagnosed with PAD.

Today, we are concerned that as proposed, this LCD would restrict coverage for medically necessary treatments for Medicare beneficiaries with PAD. We urge Palmetto to ensure that this LCD is consistent with current treatment guidelines and does not place inappropriate restrictions that limit physician decision making for this diverse and vulnerable patient population.

We therefore would like to offer our comments on the following provisions of the proposed LCD and provide additional information on our technologies that are considered in the proposed coverage criteria.

To ensure Medicare beneficiary access to appropriate treatment for PAD, we respectfully request Palmetto to:

1. Remove requirement of >50% two-year patency likelihood as a condition for coverage
2. Include hospital inpatient as an approved site of service
3. Remove the national accreditation requirement for office-based surgery centers
4. Incorporate a balanced approach in the evidence review process on LIFE-BTK trial and Esprit BTK Everolimus Eluting Resorbable Scaffold to treat patients with infrapopliteal chronic limb-threatening ischemia (CLTI)
5. Designate Diamondback orbital atherectomy as reasonable and necessary to treat patients with peripheral arterial disease

Our detailed comments follow:

1. Remove requirement of >50% two-year patency likelihood as a condition for coverage

The proposed LCD limits coverage for endovascular revascularization of the LE for patients with claudication to interventions with a “high likelihood of initial and long-term success.” The LCD proceeds to define success “as a more than 50% likelihood of sustained functional improvement, symptom relief and anatomic patency for at least 2 years.” We believe this condition for coverage is based on an outdated guideline and should be removed from the proposed LCD. Reintervention is dependent on multiple factors, including certain patient characteristics and lesions. The 2024 AHA/ACC/multisociety guideline endorses individualized decision-making in treating patients with intermittent claudication.

Recommendation

We recommend removing numeric thresholds and substituting a standard based on documented functional improvement and symptom relief. Specifically, Palmetto should make the following change to the proposed LCD:

Endovascular Revascularization for the LE

Section B

“The anatomic characteristics of the lesion(s) permit appropriate intervention at low risk with a high likelihood of initial and long-term success. Providers should consider published clinical data regarding risk of restenosis, durability, repeat interventions, and outcomes.³⁰ [Remove the following: Success is defined as a more than 50% likelihood of sustained functional improvement, symptom relief, and anatomic patency for at least 2 years.³⁰”]

2. Include hospital inpatient as an approved site of service

We thank Palmetto for the inclusion of ambulatory surgical center (ASC), hospital outpatient department, and office-based surgery center as the sites of service to perform endovascular procedures. It is still often necessary to perform endovascular procedures in the inpatient setting, such as for patients presenting with multiple comorbidities.

To ensure Medicare beneficiaries can access care in the most appropriate setting, we recommend that Palmetto include the hospital inpatient setting as a site of service to perform endovascular procedures to treat more complex PAD patients with significant comorbidities.

Patients diagnosed with chronic limb-threatening ischemia (CLTI) often present with multiple complications and comorbidities such as diabetes, chronic kidney disease, and coronary artery disease, and may warrant an inpatient admission. Based on a national cohort study of adults 65 years and older in the Vascular Quality Initiative and Centers for Medicare and Medicaid Services, over 70% of procedures for CLTI were performed as inpatient procedures, indicating the severity of the disease.

The evidence presented in the proposed LCD and its companion billing and coding guidelines (DA60247) support the delivery of care in a traditional hospital inpatient setting. We therefore recommend, for consistency and clarity, that the LCD include “inpatient” as a recognized and appropriate setting in the section “Provider Qualifications and Site of Service.”

Recommendation

Specifically, Palmetto should make the following changes to the LCD:

Provider Qualifications and Site of Service

Endovascular treatment for peripheral vascular disease can be considered reasonable and necessary to be performed in the following outpatient settings:

4. Hospital Inpatient Department

Additionally, we request that Palmetto include the relevant ICD-10-PCS codes in the LCD to reflect procedures performed in the hospital inpatient setting.

3. Remove the national accreditation requirement for office-based surgery centers

We appreciate Palmetto including office-based surgery centers as appropriate sites of service to perform endovascular procedures. However, we disagree with the requirement that these centers meet national accreditation standards. This requirement would pose unnecessary and duplicative regulatory and financial burdens for the owners and operators of such centers. We recommend the LCD be revised to acknowledge that office-based centers operating under existing CMS Conditions for Coverage, state licensure, and professional oversight mechanisms already meet high standards of safety and quality.

Numerous publications demonstrate that procedures performed in office-based centers are equally safe as those performed in hospital and ambulatory surgical center (ASC) settings, indicating that office-based centers already maintain rigorous and high safety standards to perform endovascular procedures, including credentialing, staff training, and emergency protocols, without the need for duplicative work that mandates additional accreditation.

Procedures performed in non-hospital settings such as office-based centers have demonstrated similar clinical outcomes to those performed in hospitals. When clinically appropriate, non-hospital settings are preferred by patients and save overall costs to the healthcare system. As Medicare is placing greater emphasis on value-based care, the care delivery in office-based centers supports this initiative. Additional benefit of non-hospital settings includes providing access to care in underserved and rural communities where patients may have limited access to hospitals. The availability of non-hospital setting to treat patients PAD increase patient access to endovascular procedures.

Recommendation

We recommend Palmetto remove any language suggesting that national accreditation is a coverage requirement for procedures performed in office-based centers.

4. Incorporate a balanced approach in the evidence review process on LIFE-BTK trial and Esprit BTK Everolimus Eluting Resorbable Scaffold to treat patients with infrapopliteal chronic limb-threatening ischemia (CLTI)

We appreciate Palmetto’s assessment of LIFE-BTK trial, highlighting the efficacy of Esprit BTK Everolimus Eluting Resorbable Scaffold (Esprit BTK System) compared to standard of care angioplasty at 1 year. We are concerned that the evidence assessment of LIFE-BTK is not accurate and would like to provide additional context.

We would also like to provide additional information regarding the applicability of LIFE-BTK to Medicare and real-world population and share newly published evidence on the 2-year outcomes of LIFE-BTK trial.

• Incorrect assessment of drug-eluting resorbable scaffold

The proposed LCD states that “a drug-eluting scaffold was approved by the FDA for BTK use after failed angioplasty; however, its clinical efficacy remains to be proven”.

We disagree with the assessment. Esprit BTK System is the only FDA-approved bioresorbable drug-eluting scaffold for BTK/infrapopliteal arteries, which received FDA approval on April 26, 2024. There are no other FDA-approved bioresorbable or drug-eluting scaffolds for BTK arteries. Esprit BTK has proven its efficacy compared to angioplasty for infrapopliteal arteries, as demonstrated in LIFE-BTK trial.

LIFE-BTK trial enrolled patients with de novo lesions (previously untreated) or restenotic (previously treated). Thus, LIFE-BTK is not only limited to patients who previously failed angioplasty.

• Applicability of LIFE-BTK data to real-world patients

The LIFE-BTK population was very representative of a CLTI population with several risk factors/co-morbidities, including >90% with hypertension, ~80% with hyperlipidemia, ~ 70% with diabetes, and half of the patients had wounds (RB5).

LIFE-BTK patients had an average lesion length of ~ 44 mm; there was also a subset of patients with longer lesions (lesion length over the entire population ranged from 3.8 to 148.4 mm, by core lab assessment). Lesion length tercile analysis showed that the scaffold performs just as well in longer lesions (53-148 mm) than in shorter lesions. (Varcoe et al, 2024, Supplementary Appendix, Tables S19A and S19B).

In LIFE-BTK, there were ~28% of lesions that had moderate calcification. Subgroup analysis showed that Esprit BTK also performs well in these moderately calcified lesions (DeRubertis et al, 2025. Supplementary Appendix, Figure S3).

In LIFE-BTK, severely calcified lesions in which a balloon angioplasty could not be expanded to nominal were excluded so not to introduce confounders linked to use of various methodologies for calcium modification. But in the real-world, calcium modification can be performed, and with good lesion preparation to ensure increased vessel compliance, it is expected that the scaffold will perform just as well as in LIFE-BTK.

• Applicability of LIFE-BTK data to Medicare population

Of the patients enrolled in LIFE-BTK trial, 76.2% (199 out of 261 patients) were ≥ 65 years old. A subgroup analysis on the primary efficacy endpoint was conducted for patients < 65 years vs patients ≥ 65 years. (Varcoe et al, 2024, Supplementary Appendix, Figure S7).

Esprit BTK performance, as compared to angioplasty, was similar in these 2 subgroups.

The LIFE-BTK trial enrolled a patient population whose race distribution was comparable to Centers for Medicare & Medicaid Services patients with a diagnosis of chronic limb-threatening ischemia undergoing endovascular procedures. Primary effectiveness and powered secondary endpoint results in the various race and ethnicity subgroups analyzed were consistent with the overall LIFE-BTK population. Therefore, LIFE-BTK data are applicable to the Medicare beneficiaries.

• Technical success rate

The rates of 91% for scaffold (Esprit BTK System) vs 70% for angioplasty refers to Acute Procedure Success in Table S13 of the Supplementary Appendix (Varcoe et al, 2024).

The definition of acute procedure success, per protocol, is “final diameter stenosis < 30% with final number of run-off vessels equivalent to or greater than number of run-off vessels at pre-procedure, with no residual dissection NHLBI grade ≥ type C, and no transient or sustained angiographic complications (e.g., distal embolization, perforation, thrombosis).”

The difference between scaffold and angioplasty arms was mainly driven by the component of “final diameter stenosis < 30%”. This result was expected as we know that one of the limitations of angioplasty is acute recoil of the vessel once the balloon is removed from the artery, and therefore the final diameter stenosis may be > 30%. And Esprit BTK prevents this acute recoil by providing support to the vessel.

• 2-Year Results from LIFE-BTK trial

We are sharing additional evidence on the 2-year outcomes of LIFE-BTK trial which was not included in the Proposed LCD evidence review.

At 2 years, Esprit BTK System demonstrated sustained patency which results in fewer reinterventions compared to angioplasty. The primary efficacy end point was observed in 68.8% of the scaffold group/Esprit BTK versus 45.4% of the angioplasty group. Limb salvage rates were 94.7% for scaffold group and 97.3% for angioplasty. Binary restenosis occurred in 28.5% of Esprit BTK patients versus 48.2% of angioplasty patients and clinically driven target lesion revascularization rates were 9.7% versus 18.6%, respectively. The primary safety end point was observed in 91.6% of the scaffold group versus 95.6% of the angioplasty group. Subgroup analyses demonstrated consistent efficacy across various patient populations.

The efficacy of Esprit BTK System demonstrated in LIFE-BTK trial, has shown to be superior at 1 year compared to angioplasty, the standard of care for CLTI intervention. At 2 years, Esprit BTK System has demonstrated sustained improvement for CLTI patients. The evidence available on Esprit BTK supports the utilization of this technology to improve outcomes in Medicare beneficiaries.

Patients diagnosed with CLTI are at high risk for leg amputation, cardiovascular complications, and mortality. Currently, there are no drug-coated balloons, bare metal stents, or drug-coated stents that are FDA-approved for infrapopliteal CLTI. Esprit BTK is the only FDA-approved bioresorbable scaffold for below-the-knee/ infrapopliteal arteries, which is superior compared to angioplasty.

Recommendation

We recommend Palmetto to revise the assessment of LIFE-BTK trial and Esprit BTK System to be better aligned with the clinical evidence.

5. Designate Diamondback orbital atherectomy as reasonable and necessary to treat patients with peripheral arterial disease.

We appreciate Palmetto considering atherectomy as reasonable and necessary to treat patients with PAD, however we are concerned with Palmetto’s assessment of the Diamondback orbital atherectomy as not reasonable and necessary due to lack of evidence. We believe this conclusion is based on the incomplete review of available evidence.

We are also concerned with the inconsistent terminology of the procedure and the technologies throughout the proposed LCD; Palmetto has considered atherectomy, which includes orbital atherectomy, as reasonable and necessary, however further stated that Diamondback orbital atherectomy is not reasonable and necessary.

We are sharing additional evidence supporting the efficacy of Diamondback orbital atherectomy and urging Palmetto to consider this technology as reasonable and necessary.

• LIBERTY 360 is a prospective, observational, multicenter study that examined PAD patients, treated with commercially available endovascular devices. The LIBERTY 360 sub-analysis evaluated the outcomes of 503 patients with peripheral artery disease presenting as claudication or chronic limb-threatening ischemia (CLTI) in the femoropopliteal and infrapopliteal lesions, treated with adjunctive Diamondback orbital atherectomy (OA) up to 3 years of follow-up. Analysis examined the association between Rutherford category (RC) stratified as RC 2-3, RC 4-5, or RC 6. After OA, balloon angioplasty was used in >98% of cases, with bailout stenting necessary in a small percentage. The 3-year freedom from major amputation was estimated as 100%, 95.3%, and 88.6%, respectively, with no additional unplanned major amputations reported after 2 years. The 3-year freedom from major adverse events was estimated at 74.1%, 64.3%, and 56.3%, respectively. Patients in LIBERTY 360 sub-analysis range from 67.9 – 70.4 years old, which is a representative of the Medicare population.

Angioplasty with adjunctive Diamondback OA in patients with CLTI or claudication is safe and associated with low major amputation rates after 3 years of follow-up. These results demonstrate the efficacy of Diamondback OA for patients across the spectrum of PAD.

• CONFIRM Registry series (CONFIRM I, CONFIRM II, and CONFIRM III) were prospective, multi-center registries to evaluate the use of orbital atherectomy in lower extremity peripheral arteries in 3,135 patients and to optimize the treatment technique using the device. Three generations of orbital atherectomy were utilized (Diamondback 360, Predator 360 and Stealth 360). Treatment with OA reduced stenosis from an average of 88% (pretreatment) to 10% (post-treatment). Shorter spin times and smaller crown sizes significantly lowered procedural complications which included slow flow (4.4%), embolism (2.2%), and spasm (6.3%), emphasizing the importance of treatment regimens that focus on plaque modification over maximizing luminal gain. The OA technique optimization, which resulted in a change of device usage across the CONFIRM registry series, demonstrate a lower incidence of adverse events.

Diamondback orbital atherectomy has demonstrated high efficacy for patients with peripheral arterial disease, particularly patients with calcified lesions. The real-world evidence available on Diamondback orbital atherectomy is consistent with other atherectomy technologies and supports the utilization of this technology to improve short and long-term patient outcomes.

We are sharing newly published evidence on peripheral atherectomy which was not included in the Proposed LCD evidence review.

• The recent publication Published evidence on peripheral atherectomy: A meta-analysis and systematic literature review of more than 300 original investigations from Carr and colleagues (2025) provides the most comprehensive overview of the evidence supporting peripheral atherectomy to date. The meta-analysis of over 300 articles demonstrates the clinical value of atherectomy, including orbital atherectomy, when used in appropriately selected patients as part of the endovascular treatment algorithm for PAD. This study highlights atherectomy’s favorable long-term outcomes: across 51 studies (4,806 patients), one-year patency averaged 75.4%, significantly higher than reported rates for uncoated balloon angioplasty (47.4%) and drug-coated balloons (DCBs) without atherectomy (67.6–67.9%). Atherectomy is associated with low complication rates: one-year target lesion revascularization (15.6%), major amputation (1.7%), and mortality (2.8%) rates were comparable or superior to outcomes for balloon angioplasty or drug-coated balloon (DCB) therapy.

The analysis underscores the strength of the existing evidence base and reaffirms the safety and efficacy of atherectomy when appropriately utilized for patients with (PAD).

Recommendations

• We recommend that Palmetto refers to general categories of procedures and technologies that are considered reasonable and necessary to ensure beneficiary access and preserve flexibility for future innovation. We believe that when technologies or procedures are mentioned, the industry-accepted general term should be used (i.e., atherectomy), not a term that is specific to any single product.

• We request that Palmetto remove the statement that Diamondback orbital atherectomy is not considered reasonable and necessary, based on evidence demonstrating the short and long-term safety and efficacy of this technology and to avoid unintentionally restricting beneficiary access.

• We recommend that Palmetto incorporate a more balanced approach of evidence review to provide an accurate assessment of the safety and efficacy of Diamondback orbital atherectomy.

We are committed to ensuring patient access to the endovascular revascularization procedures based on the variability of clinical presentation and severity of PAD. Limiting access to life-saving technologies can have detrimental impacts to patients who are at risk of amputation, complications, and subsequent decline in quality of life.

We respectfully request that Palmetto consider this information before finalizing the LCD.

References were provided for review.

Thank you for your comments.

1. In the absence of quality peer reviewed literature to cite that less than 50% improvement would be anticipated for the surgical outcome for claudication, it would not be reasonable and necessary to remove these expectations.
2. The current LCD does not restrict the performance of endovascular procedures in an inpatient setting.
3. All states in the JJ/JM jurisdictions have requirements for peer review, patient safety, quality of care and credentialing of providers when performing procedures in an office-based setting utilizing Level II (conscious or moderate) sedation or above. Therefore, compliance with either state certification or accreditation by a nationally recognized accrediting body will be required to perform these procedures requiring conscious sedation or above, based on the American Society of Anesthesiologists Physical Status Classification System (ASA-PS) ASA II and ASA III patients in the office-based setting.
4. The 2-year results of the LIFE-BTK Trial will be included in the summary of evidence for the use of drug-eluting resorbable stent for infrapopliteal disease. There were no restrictions on coverage for drug eluding stents, but this additional information will be added to the bibliography as well.
5. The LIBERTY 360 study and the earlier CONFIRM series had limitations including the patient population treated, selection criteria, device utilized, risk of bias and observational nature of the study due to lack of controls for procedural quality. The authors reported from multiple centers using a different generation of orbital atherectomy systems and did not randomize any of the patient populations and treated all who required treatment of their PAD in an “all comers” basis and this study does not control for bias or comparison to other techniques. Most patients treated in the study had angioplasty alone without stenting and there was no mention of specific atherectomy devices. In the final metanalysis study mentioned, the authors only included RCTs in 5.9% of the review articles and only looked at 12-month patency. While the data included orbital atherectomy, the authors noted that given these factors, as well as variations in imaging use (e.g., intravascular ultrasound) and adjunctive therapies (plain old balloon angioplasty (POBA) or drug coated balloon (DCB), comparison of results between atherectomy classes across inherently noncomparative studies must be interpreted with caution. In general, outcomes were similar across the 4 classes of devices. Despite the limitations in the studies, since Diamondback orbital atherectomy was included in all orbital atherectomy devices and has FDA approval, it may be reasonable and necessary when done with the proper medical documentation.

We support finalizing the proposed LCD, including intravascular lithotripsy (IVL) as a form of endovascular management for lower extremity (LE) peripheral artery disease (PAD) with additional edits and commentary illustrated in Addendum A below. We agree with Palmetto’s assessment and the supporting clinical evidence demonstrating the safety, efficacy and importance of IVL for the modification of arterial calcium.

In addition to the Shockwave IVL system addressed in the proposed LCD, we would like to inform Palmetto of the upcoming launch of SEISMIQ™ intravascular lithotripsy system. This technology utilizes the same mechanism of action as the currently available Shockwave IVL system, fracturing intravascular calcium plaques with acoustic pressure waves. This technology has received U.S. Food and Drug Administration clearance for use in the superficial and femoral and popliteal arteries.

We respectfully encourage Palmetto to finalize the proposed LCD with coverage that includes all IVL technologies within this class and this mechanism of action to ensure consistent patient access and physician choice in the treatment of PAD. Thank you for the opportunity to comment on the proposed LCD.

Addendum A was provided for review that included additional edits and commentary, including:

• Remove “only” from the sentence: “It is only reasonable to perform revascularization procedures (endovascular or surgical) to reconstruct diseased arteries if needed for the safety, feasibility, or effectiveness of other procedures (e.g., transfemoral aortic valve replacement, mechanical circulatory support, endovascular aortic aneurysm repair).^10-17” under Asymptomatic PAD.
• Verbiage changes to acoustic shockwave under Balloon Angioplasty section
• Remove limitation “Asymptomatic LE PAD EXCEPT if needed for the safety, feasibility, or effectiveness of other procedures” from the Limitations for Endovascular Revascularization section
• Under Provider Qualifications and Site of Service section, add “3. Inpatient department” and remove “that meets both national accreditation standards AND any additional state guidelines for office-based surgery” from 4. Office-based surgery center
• Verbiage changes to shockwave lithotripsy under the Summary of Evidence – Lower Extremity PAD Revascularization section
• Addition of verbiage “for most but not all asymptomatic patients” under Analysis of Evidence – Revascularization Lower Extremity PAD section
• Remove the sentence “Strategies to improve patient care delivery in OBLs include accreditations which serve as external validation of processes to ensure patient care and safety” from Analysis of Evidence – Site of Service section
• Disagree with the recommendation that these centers must meet national accreditation standards

Thank you for your comments.

1. The rationale for adding “only” is to allow for coverage that is both reasonable and necessary per SSA 1862(a)(1)(A). The use of the word only is to cover both reasonable and necessary. The examples given represent the majority of the potential reasons and others may be considered on a case-by-case basis for determination.
2. The inclusion of the verbiage shockwave lithotripsy is based specifically upon the supporting evidence in the peer reviewed literature and is not meant to be all inclusive of all shockwave technologies that are not currently supported by the peer reviewed literature (see also Limitations for Endovascular Revascularization).
3. Since the recommendation is 2a based upon the level of evidence, the limitation will remain as written Asymptomatic LE PAD EXCEPT if needed for the safety, feasibility, or effectiveness of other procedures. The change would not be considered reasonable and necessary and would only be considered on a case-by-case basis as a rare exception.
4. See Response 1B above.
5. See Response 1C above.

We are a leading hospital provider across multiple states within the Palmetto Jurisdictions JJ and JM. Our unwavering commitment to patient-centered care drives our active participation in numerous quality initiatives, including strict adherence to both local and national coverage determinations.

In this spirit, we respectfully submit comments regarding the proposed LCD DL40228 (Endovascular Management for Peripheral Arterial Disease of the Upper and Lower Extremities) and related LCA DA60247.

We commend Palmetto for developing a comprehensive and clinically sound document that reflects the complexity and nuance of vascular surgery. Our expert vascular surgeons have reviewed the proposed LCD and agree that it aligns well with current best practices.

However, we would like to raise a concern regarding the level of clinical detail included in the draft. While thorough, the document may present challenges for individuals and non-specialist providers in accurately interpreting and applying its guidance.

Additionally, there are clinically appropriate scenarios that fall outside the draft, for example a clinician may opt to intervene for asymptomatic left subclavian stenosis, such as in the event that a patient has a dominant left vertebral artery and may subsequently undergo thoracic aortic surgery that interrupts intercostals, such as with endograft. Another example of exceptions includes infrainguinal interventions to address volatile anatomic findings, such as plaques that have embolized or are associated with mobile material.

To ensure optimal patient outcomes and preserve the integrity of individualized care, we strongly recommend incorporating language that explicitly allows for physician judgment in cases not fully addressed by the LCD. This flexibility is essential to empower physicians to make informed decisions based on the unique needs of each patient.

We appreciate your thoughtful consideration of our feedback.

Thank you for your comments.

1. In the situation as described above, the asymptomatic treatment for the left subclavian stenosis would fall under the coverage criteria of Asymptomatic PAD due to the safety or feasibility of another procedure. In addition, with embolized plaques, safety would be an issue and therefore coverage criteria would be met for the same reason.
2. While surgical and professional judgement is appreciated, the proposed LCD allows for revascularization procedures to be done and provides guidelines based upon peer-reviewed and published literature consistent with CMS guidelines and with Section 1142 of the Social Security Act.

We appreciate the opportunity to provide comments on the draft Local Coverage Determination (LCD) for Endovascular Management for Peripheral Arterial Disease of the Upper and Lower Extremities (DL40228) and Billing and Coding: Endovascular Management for Peripheral Arterial Disease of the Upper and Lower Extremities (DA60247). We and CMS share a common goal – ensuring timely access for Medicare beneficiaries to preventive services, based on scientifically sound clinical evidence with appropriate safeguards.

Our member companies develop and produce a wide range of medical devices, diagnostic tests, and digital health solutions that transform care through earlier detection, less invasive approaches, and more effective disease management.

We commend Palmetto for recognizing that peripheral arterial disease (PAD) is growing as a clinical problem due to the aging population in the United States and the role that revascularization plays in treating PAD. Our members are on the forefront of developing innovative technologies and devices used for revascularization – technologies and devices that have been demonstrated to lower patient risk of complications and improve clinical outcomes. Our members, large and small, are united in their commitment to ensuring that Medicare beneficiaries have access to lifesaving and life-enhancing technologies, and we support the inclusion of these technologies as part of this proposed LCD.

We encourage Palmetto to carefully consider and revise aspects of the draft LCD in order to better align coverage with real-world clinical practice and to avoid unnecessary barriers to patient access to endovascular procedures.

Comments and Recommendations on Draft LCD

In reviewing the draft LCD, we have identified areas where clarification or modification would strengthen the policy and ensure alignment with current clinical practice and beneficiary needs. We respectfully offer the following comments and recommendations for your consideration. These revisions aim to refocus coverage on endovascular revascularization for patients with PAD, safeguard beneficiary access to the most up-to-date procedures, and reflect current evidence and practice standards. For each issue, we provide the rationale—supported by evidence, guidelines, and regulatory context—along with specific recommended changes to the LCD language.

1. Clarify Site of Service to Include Hospital Inpatient Setting

The Issue: The draft LCD does not explicitly reference hospital inpatient departments as an appropriate site of service for endovascular PAD procedures. This omission may create confusion regarding coverage for procedures performed in inpatient settings.

Rationale: While outpatient capabilities have expanded, inpatient settings remain essential for complex patients or those with significant comorbidities. Explicitly including inpatient settings will ensure clarity and prevent unintended coverage limitations.

Supporting Evidence:

• A national cohort study of adults aged 65 and older in the Vascular Quality Initiative and CMS data shows that over 70% of procedures for chronic limb-threatening ischemia (CLTI) are performed in inpatient settings, reflecting the severity of disease and complexity of care.
• The proposed LCD and its companion billing and coding guidelines (DA60247) support care delivery in hospital inpatient settings.

Recommended LCD Language:

Add the following to Provider Qualifications and Site of Service:

Endovascular treatment for peripheral vascular disease can be considered reasonable and necessary to be performed in the following settings:

4. Hospital Inpatient Department

Additionally, include relevant ICD-10-PCS codes in the associated article to reflect procedures performed in hospital inpatient settings.

2. Avoid Inadvertent Access Restrictions; Preserve Physician Clinical Judgment

We urge Palmetto to not inadvertently or inappropriately limit access to endovascular procedures for patients with PAD by removing the ability for clinicians to apply necessary clinical judgement. Experts recommend an individualized approach to revascularization to optimize patient outcomes, and we believe that this approach should be evidence-based. As stated in the ACC/AHA/Multisociety PAD Guideline (hereafter referred to as the Guideline), guidelines are designed to define practices that meet the needs of patients in most, but not all, circumstances, and they should never replace clinical judgement. We are concerned that this proposed LCD does not acknowledge the complexities of the population of patients with PAD and would unnecessarily limit beneficiary access to endovascular procedures.

The Issue: The draft LCD includes limitations that may unintentionally restrict access to endovascular procedures for patients with PAD by imposing subjective criteria and excluding investigational procedures.

The limitations section of the draft LCD includes criteria that rely on subjective assessments, such as 'irreversible disease,' 'high risk for percutaneous failure,' and 'procedures not supported by peer-reviewed literature.'

Rationale: Clinical guidelines emphasize individualized, evidence-based decision-making. Coverage policies should not override physician judgment or guideline consensus. Restrictive language could limit beneficiary access to appropriate care and conflict with CMS policy.

Concerns with Current Draft:

• Terms such as “irreversible disease,” “high risk for percutaneous failure,” and “procedures not supported by peer-reviewed literature” lack defined thresholds and may lead to inconsistent application. We respectfully submit several examples below where the language may be modified in order to better align with the Guidelines and preserve flexibility for treating clinicians to apply evidence-based clinical judgement. We note that this list is not exhaustive, but is representative of where we have concerns:
• Additionally, the exclusion of procedures lacking published evidence, without making exceptions for patients enrolled in Category A IDE studies may conflict with CMS policy under 42 CFR § 405 Subpart B, which allows coverage of Category A Investigational Device Exemption (IDE) studies. These studies are explicitly recognized by CMS as eligible for coverage when conducted under approved protocols, even in the absence of published literature. We recommend revising the limitations section to ensure alignment with CMS regulations and to avoid inadvertently restricting access to investigational procedures.

Supporting Evidence:

• ACC/AHA/Multisociety PAD Guideline: Guidelines define best practices without replacing physician clinical judgment.
• CMS regulations (42 CFR § 405 Subpart B): Allow coverage for Category A Investigational Device Exemption (IDE) studies under approved protocols, even without published literature.

Recommended LCD Language Changes:

We would request Palmetto to revise the limitations section to remove subjective terms and acknowledge CMS IDE coverage. We respectfully submit several examples below where the language may be modified in order to better align with the Guidelines and preserve flexibility for treating clinicians to apply evidence-based clinical judgement. We note that this list is not exhaustive, but is representative of where we have concerns:

1. Under “Endovascular Revascularization for the UE”, A. Asymptomatic, second bullet, we recommend the following revision: However, it may be warranted for certain complex patients, for example, those undergoing coronary artery bypass grafting (CABG), especially when planning on using an internal mammary artery graft, transfemoral aortic valve replacement, mechanical circulatory support, or endovascular aortic aneurysm repair.
   • The 2024 ACC/AHA (Joint Society) Guideline for the Management of Lower Extremity Peripheral Artery Disease states the following: “In patients with asymptomatic PAD, it is reasonable to perform revascularization procedures (endovascular or surgical) to reconstruct diseased arteries if needed for the safety, feasibility, or effectiveness of other procedures (e.g., transfemoral aortic valve replacement, mechanical circulatory support, endovascular aortic aneurysm repair).”
   • We note that, while the 2024 ACC/AHA Guideline is specific to lower extremity PAD, it acknowledges that endovascular (or surgical) revascularization procedures can be appropriate in asymptomatic patients with PAD if needed to facilitate other necessary cardiovascular procedures. In line with this rationale, we believe similar clinical considerations should apply to both upper and lower extremity PAD when ancillary interventions are required to enable or support critical procedures. This ensures consistent, real-world patient access to revascularization across vascular beds when it is needed for the safe delivery of advanced therapies.
2. Under “Endovascular Revascularization for the LE,” we recommend further simplifying the criteria to more closely reflect the 2024 ACC/AHA Guideline. Specifically, the guideline states it is “reasonable” (vs. “only reasonable” as stated in the Draft LCD) to perform revascularization for certain asymptomatic patients when needed to enable other critical procedures. Removing the word “only” will ensure the policy does not unintentionally limit access for complex, rare patient scenarios where revascularization may be appropriate but not explicitly identified.
   • Removing this limitation language will help ensure that patients can access appropriate options for treatment, without unnecessary restrictions.
3. We recommend that the section heading for “B. Claudication” be revised to “B. Chronic symptomatic PAD (including claudication)” and updating the criteria to better align with the 2024 ACC/AHA/Multisociety PAD Guidelines. The guideline explicitly supports individualized decision-making for revascularization in this group, focusing on improvements in symptoms or function rather than rigid thresholds or outdated criteria. Reintervention is dependent on multiple factors, including certain patient characteristics and lesions. The Guidelines endorse individualized decision-making in treating patients with intermittent claudication. We recommend removing numeric thresholds and substituting a standard based on documented functional improvement and symptom relief. Specifically, we propose that the LCD state:

   • Endovascular Revascularization for the LE, Section B

   • Endovascular revascularization for chronic symptomatic PAD (including claudication) is reasonable when the anatomic characteristics of the lesion(s), patient symptoms, and clinical assessment indicate that the intervention is expected to provide meaningful improvement in symptoms or functional status, as determined by the treating clinician. Decisions should be based on the totality of patient-specific factors—including medical history, prior response to therapy, and lesion anatomy—consistent with contemporary clinical guidelines and evidence.

4. We have concerns about the proposed criteria under sections C and D, particularly the use of “salvageable limb” as the key threshold for revascularization in acute limb ischemia. Acute limb ischemia can threaten not only limb viability but also result in permanent nerve or muscle damage, compartment syndrome, infection, and sepsis. Timely intervention is often clinically necessary in ALI cases to minimize long-term disability or reduce mortality risk, not just to avoid amputation. We recommend expanding the LCD criteria to allow physician judgment for revascularization whenever there is a reasonable expectation of protecting tissue, preserving function, or preventing systemic complications—not just for limb salvage. The EUCLID study and other clinical literature document the diverse presentations and complications associated with ALI. We therefore recommend expanding the criteria for ALI to reflect the full range of clinical risks, including compartment syndrome, muscle necrosis, permanent nerve damage, and sepsis. Revascularization in these cases is medically necessary to preserve limb viability and reduce mortality, and coverage should not be limited solely to limb salvage.
5. Under the Limitations for Endovascular Revascularization section, we request that ALI and chronic limb threatening ischemia (CLTI) be excluded from the following requirements:
   • Absence of prior interventional medical therapy to include antiplatelet therapy for IC of the UE or LE claudication including GDMT for a period of 90 days.
   • Previous SET for LE claudication for less than 90 days.
   • Positive response to GDMT and/or SET.

Peripheral artery disease exhibits a wide spectrum of clinical manifestations. Completion of an exercise program for 90 days and a positive response to antiplatelet therapy are likely not appropriate for severe forms of peripheral artery disease which require urgent revascularization. Acute limb ischemia (ALI) and chronic limb threatening ischemia (CLTI) are the most severe forms of peripheral artery disease and both etiologies present as serious diseases which often require urgent revascularization of the affected limb to prevent adverse outcomes such as amputation and mortality. In patients with ALI, it has been reported that the earlier the diagnosis is made and treated, the higher chance of limb salvage. According to Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) Recommendation 30, all patients with suspected ALI should be evaluated immediately by a vascular specialist who should direct immediate decision making and perform revascularization because irreversible nerve and muscle damage may occur within hours. Following clinical evaluation, the patient may be referred for urgent revascularization (6-24 hours; Category I ALI), emergent revascularization (less than 6 hours; Category IIa and IIb ALI), or primary amputation (Category III ALI). For those patients that present with CLTI, it has also been shown that delays to revascularization are associated with worse outcomes such as increased risk of postoperative major amputation and in-hospital death. The one-year amputation and mortality rates for CLTI are 15-20% and 15-40%, respectively, highlighting the severe manifestation of the disease. Indeed, the 2024 AHA/ACC/SVS/SCAI/AMA guidelines state that revascularization is considered the standard treatment for patients with CLTI to minimize tissue loss and preserve a functional limb. Thus, completion of an exercise program for 90 days and a positive response to antiplatelet therapy prior to revascularization are likely unrealistic for patients presenting with ALI or CTLI.

3. Use Inclusive Procedural and Technology Terms. We request that the LCD refer to procedures and technologies using general terminology vs specific modality/brands to ensure beneficiary access and preserve flexibility for future innovation. We recommend that the LCD consistently use general, industry-accepted terminology when referencing procedures and technologies, rather than product-specific names. This approach will help ensure beneficiary access to the full range of clinically appropriate treatments and allow the policy to keep pace with technological advances. For example, specifying “intravascular lithotripsy (IVL)” refers to a broad class of technologies rather than a single product. To support clarity and future innovation, we request the following revisions:

• Under “Endovascular Techniques Indicated for the UE”, revise the second bullet to:
  • Angioplasty/stenting— Traditional percutaneous transluminal angioplasty (PTA) and intravascular lithotripsy (IVL) with or without stenting may be reasonable and safe in patients with appropriate anatomy (short proximal stenosis or occlusion).
  • Add a new fourth bullet: Other endovascular procedures may also be appropriate.

4. Removing national accreditation requirements will prevent unnecessary burdens for office-based surgery centers. We appreciate Palmetto’s inclusion of office-based surgery centers as eligible sites of service for endovascular procedures. However, we recommend removing the requirement for national accreditation, as it adds unnecessary regulatory and financial burden. Office-based centers that meet CMS Conditions for Coverage, state licensure, and professional oversight standards are already held to high safety and quality benchmarks.

Published studies confirm that outcomes in office-based settings are comparable to those in hospital and ambulatory surgical center (ASC) settings, indicating that office-based centers already maintain rigorous and high safety standards to perform endovascular procedures, without the need for duplicative work that mandates additional accreditation. Therefore, we respectfully request that Palmetto remove any language that national accreditation by a specific external body is a coverage requirement for procedures performed in office-based setting.

We appreciate the opportunity to comment and engage in this important process. We urge Palmetto to incorporate these recommended revisions to ensure equitable access, support clinician judgment, and foster innovation in patient care. We look forward to ongoing collaboration to advance Medicare coverage policies that reflect the latest clinical evidence and best meet the needs of beneficiaries with peripheral arterial disease.

References were provided for review.

Thank you for your comments.

1. See Response 1B above.
2. Currently, the LCD has not limited access to patients who require endovascular revascularization and the literature supports the coverage indications and limitations. While we respect physician decision-making in the process, the coverage guidelines of this LCD are based upon published peer-reviewed literature consistent with CMS guidelines for coverage with evidence development published by CMS, in the Medicare Coverage Database (MCD) and under section 1142 of the Act. Furthermore, endovascular procedures with high risk that are not supported by the peer review literature will not be considered for coverage (See MPIM Chapter 13, Section 13.5.3—Evidentiary Content). Patients involved in approved CMS IDE studies would be exempt from this requirement. Finally, the limitations for patients with high risk of percutaneous failure and other conditions should be the standard of care and are supported by literature.
3. See Response 2A above. The examples provide the potential reasons as cited in the peer-reviewed literature and others may be considered on a case-by-case basis for determination.
4. Claudication is consistent with chronic symptomatic PAD and is used in most of the literature and guidelines throughout this LCD. Therefore, changing nomenclature would affect coverage since claudication not responsive to GDMT and SET is required for coverage.
5. We recognize that other factors may be present in ALI and therefore the criteria are covered for ischemic rest pain. If the limb itself is not salvageable, which is a high threshold, then it would not be reasonable and necessary to perform endovascular revascularization (Category III-harm).
6. Those requirements for SET and GDMT are not listed under requirements for ALI or CLTI coverage as this only pertains to section B. Claudication.
7. The use of broad terms for angioplasty, stenting and atherectomy are noted in the LCD. However, when product specific technologies are mentioned, it is because the peer-reviewed literature supports that product’s usage for that purpose. It is not reasonable to assume that all similar devices are equally effective in treatment and therefore, each device should have support in the peer-reviewed literature. See also MCD—Coverage with Evidence Development and MPIM Chapter 13, Section 13.5.3.
8. See Response 1C above.

We appreciate the opportunity to submit comments in response to your draft LCD DL40228 Endovascular Management for Peripheral Arterial Disease of the Upper and Lower Extremities.

We are a leading health technology company focused on improving people's health and well-being through meaningful innovation. Our diagnostic and therapeutic solutions - diagnostic imaging, coronary, peripheral vascular, and cardiac solutions – are used in the diagnosis or treatment of Medicare beneficiaries. We are focused on the development of specialty devices for treating atherosclerotic lesions and thrombus in lower-extremity arteries and veins, and includes Intravascular Ultrasound (IVUS), vessel preparation, mechanical and laser atherectomy, and scoring and drug-coated balloons.

We appreciate the opportunity to submit comments to the Draft LCD. While we are committed to ensuring procedures and services are medically reasonable and necessary coverage, we are concerned that the policy may limit clinically appropriate interventions which has the potential to result in negative outcomes such as progression to critical limb ischemia. We are concerned that the coverage criteria outlined in the LCD do not reflect current guidelines and undermines individualized decision-making of the treating physician. Below are our concerns and recommendations.

Covered Indications:

Endovascular Revascularization for the LE

B. Claudication

All the following criteria must be met for coverage:

• The anatomic characteristics of the lesion(s) permit appropriate intervention at low risk with a high likelihood of initial and long-term success. Success is defined as a more than 50% likelihood of sustained functional improvement, symptom relief, and anatomic patency for at least 2 years.

While the Society for Vascular Surgery (SVS) Committee on LE treatment guidelines for claudication recommends that an intervention should be offered if there is more than a 50% likelihood of sustained functional improvement, symptom relief, and anatomic patency for at least two years, the more recent 2024 AHA/ACC/SVS/SCAI/AMA guidelines endorse individualized decision-making based on the patient’s goals, anatomic findings, perioperative risk, and anticipated benefit. The greater than 50% two-year patency likelihood was, in part, established based on life expectancy specifically for intermittent claudication or CLTI patients with SFA lesions; significant mortality rates observed in a retrospective Medicare cohort analysis of linked registry claims data suggests lack of justification for up front risks (Levin et al., 2023). However, in sum, there is a dearth of long-term survival data available for all peripheral artery disease phenotypes undergoing intervention.

To remove subjectivity and align with the more recent 2024 AHA/ACC/SVS/SCAI/AMA guidelines we request the following edits:

• The anatomic characteristics of the lesion(s) permit appropriate intervention at low risk with a high likelihood of initial and long-term success. [Remove this sentence: Success is defined as a more than 50% likelihood of sustained functional improvement, symptom relief, and anatomic patency for at least 2 years.]

D. Acute Limb Ischemia

• In ALI with a salvageable limb, revascularization (endovascular or surgical, including catheter-directed thrombolysis) is indicated to prevent amputation.

Acute limb ischemia presents a range of risks beyond amputation, including compartment syndrome, muscle necrosis, permanent nerve damage, and sepsis. Revascularization in these cases is medically necessary to preserve limb viability and reduce mortality. We therefore recommend expanding the criteria for ALI to reflect the full range of clinical risks, including compartment syndrome, muscle necrosis, permanent nerve damage, and sepsis. In these cases, revascularization is medically necessary, and coverage should not be limited solely to limb salvage.

We request Palmetto revise the bullet above to reflect other risks beyond amputation by revising to read:

In ALI with a salvageable limb, revascularization (endovascular or surgical, including catheter-directed thrombolysis) is indicated to prevent other comorbidities (e.g. amputation, compartment syndrome, muscle necrosis, permanent nerve damage, and sepsis.)

Endovascular Techniques Indicated for the LE:

Balloon Angioplasty

The Draft LCD defines intravascular lithotripsy (IVL) as: …balloons [that] use acoustic shockwaves to induce fracture in severely calcific plaques, facilitating luminal gain and vessel expansion to prepare the vessel for subsequent intervention.

We believe the use of acoustic shockwave in the sentence above refers to only one specific method of intravascular lithotripsy (IVL). We request Palmetto revise the sentence to remove reference to a specific type of IVL as follows:

Intravascular lithotripsy (IVL) balloons [remove this verbiage: use acoustic shockwaves] to induce fracture in severely calcific plaques, facilitating luminal gain and vessel expansion to prepare the vessel for subsequent intervention.

Limitations for Endovascular Revascularization

We believe the first three bullets of the limitations section which are stated to be reasonable and necessary for endovascular revascularization are overly restrictive.

The following are not considered reasonable and necessary for endovascular revascularization:

• Absence of prior interventional medical therapy to include antiplatelet therapy for IC of the UE or LE claudication including GDMT for a period of 90 days.
• Previous SET for LE claudication for less than 90 days.
• Positive response to GDMT and/or SET.

These restrictions may be reasonable for stable claudication but are clinically inappropriate for patients with ALI and CLTI. Peripheral artery disease exhibits a wide spectrum of clinical manifestations. Completion of an exercise program for 90 days and a positive response to antiplatelet therapy are likely not appropriate for severe forms of peripheral artery disease which require urgent revascularization. ALI and CLTI are the most severe forms of peripheral artery disease and both etiologies present as serious diseases which often require urgent revascularization of the affected limb to prevent adverse outcomes such as amputation and mortality. In patients with ALI, it has been reported that the earlier the diagnosis is made and treated, the higher chance of limb salvage. According to Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) Recommendation 30, all patients with suspected ALI should be evaluated immediately by a vascular specialist who should direct immediate decision making and perform revascularization because irreversible nerve and muscle damage may occur within hours. Following clinical evaluation, the patient may be referred for urgent revascularization (6-24 hours; Category I ALI), emergent revascularization (less than 6 hours; Category IIa and IIb ALI), or primary amputation (Category III ALI). For those patients that present with CLTI, it has also been shown that delays to revascularization are associated with worse outcomes such as increased risk of postoperative major amputation and in-hospital death. The one-year amputation and mortality rates for CLTI are 15-20% and 15-40%, respectively, highlighting the severe manifestation of the disease. Indeed, the 2024 AHA/ACC/SVS/SCAI/AMA guidelines state that revascularization is considered the standard treatment for patients with CLTI to minimize tissue loss and preserve a functional limb. Thus, completion of an exercise program for 90 days and a positive response to antiplatelet therapy prior to revascularization are likely unrealistic for patients presenting with ALI or CTLI.

Intravascular Ultrasound

The Draft LCD references many clinical studies supporting the use of IVUS but has omitted two key randomized controlled trials that were recently published.

Allan et al. aimed to assess whether the addition of IVUS guidance compared with angiography guidance alone reduced the rate of binary restenosis at 12 months in patients treated for Rutherford 3-6 femoropopliteal artery disease. The study was a prospective, investigator-initiated, single-center, randomized controlled trial. One hundred and fifty patients were randomized to IVUS+angiography guidance or angiography guidance alone. Treatment options were at the discretion of the treating surgeon and included plain old balloon angioplasty, drug-coated balloon (DCB), stenting, and/or atherectomy (as an adjunctive vessel preparation technique). Patient and vessel and lesion characteristics were well matched between the two arms. Treatment parameters were similar except that a larger DCB size was noted in the IVUS+angiography group. The authors reported that reference vessel diameter and lesion length were larger when measured by IVUS compared with angiography alone. At 12 months, the rate of freedom from binary restenosis was 72.4% versus 55.4% (P = 0.008) in those who received IVUS+angiography guidance compared with angiography guidance alone. There was no significant difference in clinically driven-target lesion revascularization between the two cohorts (although the study was not powered for this outcome). The authors also reported that there was no difference in major adverse events between the two study arms. In a subgroup analysis of those who were treated with DCB, the rate of binary restenosis was 9.1% in the IVUS+angiography guidance group compared with 37.5% in the control group (P = 0.004). In those treated with plain balloon angioplasty, there was no significant difference in binary restenosis between two cohorts. In this study, Allan et al. also revealed that the treatment plan changed caused by IVUS imaging in 78.9% of cases. The authors concluded that the use of IVUS resulted in a significant reduction in restenosis in those undergoing endovascular intervention and that the primary utility appears to be accurate vessel sizing with the benefit of this being in cases treated with DCB.

A prospective, investigator-initiated, multi-center, randomized study performed by Ko et al. in South Korea aimed to assess whether IVUS guidance compared with angiography guidance alone improved outcomes in patients treated with DCBs for Rutherford 2-5 femoropopliteal artery disease. The study enrolled 243 patients and randomized 122 to IVUS-guided DCB angioplasty (99 completed primary patency evaluation) and 121 to angiography-guided DCB angioplasty (97 completed primary patency evaluation). The mean age was 70 years, 85% were men, and most patients were Rutherford 3. Baseline characteristics were well matched. In the IVUS-guided cohort, the authors found that there were larger pre-balloon diameters and larger pre-dilatation and post-dilatation pressures utilized during the procedure compared with patients who had angiography guidance alone. Adjuvant post-dilatation also occurred more often in the IVUS group. Post-procedural angiography showed that the lesions in the IVUS guidance group had larger minimum lumen diameter and a lower residual diameter stenosis compared with the angiography guidance group. IVUS was associated with improved rates of technical and procedural success as well as higher post-procedural ankle brachial index compared with angiography guidance alone. At 12 months, patients who had received IVUS guidance compared with angiography guidance alone had significantly higher primary patency (83.8% versus 70.1%, P = 0.01), freedom from clinically driven-target lesion revascularization (92.4% versus 83.0%, P = 0.02), and improvements in Rutherford (89.1% versus 76.3%, P = 0.01) and ankle brachial index (82.4% versus 66.9%, P = 0.01). There were no differences in the secondary safety endpoints. The authors concluded that the addition of IVUS significantly improved the 12-month outcomes of DCB endovascular therapy to treat femoropopliteal artery disease and this may be attributed to IVUS-guided optimization of the lesion before and after DCB treatment.

Recommendation: We respectfully request that the following two studies are referenced and discussed in the section titled, “Intravascular Ultrasound.”

Provider Qualifications and Site of Service

The policy only includes three sites of service where treatment is considered reasonable and necessary when often, treatment is also provided in the inpatient setting and should be revised as below:

Endovascular treatment for peripheral vascular disease can be considered reasonable and necessary to be performed in the following settings:

1. Ambulatory surgical center (ASC)
2. Hospital outpatient department
3. Office-based surgery center that meets both national accreditation standards AND any additional state guidelines for office-based surgery
4. In the hospital inpatient department

We appreciate the opportunity to provide input into the draft local coverage decision and respectfully request CMS address stakeholder concerns before finalizing the LCD.

References were provided for review.

Thank you for your comments.

1. See Response 1A above.
2. See Response 4F above.
3. The coverage for ALI allows for endovascular revascularization when the limb is salvageable per the peer reviewed literature. Therefore, it is reasonable when there is concomitant arterial vascular disease that needs to be bypassed, stented or treated with angioplasty alone. The provider should first determine that the limb is salvageable and that there is disease that can be treated or that there is the presence of ischemic rest pain. The other conditions mentioned would be secondary to vessel involvement. However, if there is no disruption to the arterial supply to the limb, then endovascular revascularization would not be considered reasonable and necessary.
4. See Response 2B above.
5. We appreciate the additional studies provided for the use of IVUS. IVUS is already supported by the LCD, when required or medically necessary, and those additional studies will be added to the bibliography.
6. See Response 1B above.

We appreciate the opportunity to offer comments to Palmetto GBA on the Proposed Local Coverage Determination (LCD): Endovascular Management for Peripheral Arterial Disease of the Upper and Lower Extremities (DL40228). The societies signing this letter have collaborated numerous times to develop clinical practice guidelines that describe the Standard of Care (SoC) for the treatment of peripheral artery disease. Every day the members of our societies strive to help patients who struggle with peripheral artery disease to complete normal daily activities without significant leg pain and to help patients with critical limb threatening ischemia (CLTI) keep their legs. Our societies believe that the SoC that provides the best care for patients is achieved when physicians treat their patients in accordance with our clinical practice guidelines.

We commend Palmetto GBA’s commitment to improving patient outcomes and ensuring appropriate use of endovascular therapies. However, several provisions of this proposed LCD diverge from the statutory and regulatory standards set forth under Section 1862(a)(1)(A) of the Social Security Act, which requires that services be “reasonable and necessary” for the diagnosis or treatment of illness or injury. Furthermore, multiple elements are inconsistent with current national clinical practice guidelines and evidence-based practice.

This letter offers recommendations, including specific revisions, clarifications, and suggested language changes to align the LCD with evidence-based practice, preserve physician discretion, and maintain access to high-quality, cost-effective care in outpatient settings.

I. Limitations for Endovascular Revascularization

The proposed LCD lists several exclusions under which endovascular revascularization would be deemed not reasonable and necessary, including lack of 90 days of medical therapy or supervised exercise and performance in non-accredited facilities. We respectfully disagree with these blanket exclusions.

This requirement may be reasonable for stable claudication but is unsafe and clinically inappropriate for patients with CLTI or acute limb ischemia (ALI). Mandating a 90-day waiting period risks irreversible ischemic damage or amputation. The 2024 AHA/ACC PAD guidelines emphasize individualized assessment rather than arbitrary timeframes.

We do note that supervised exercise therapy is dependent on patient accessibility to such programs. In many rural locations this may not be available, or patients may be unable to attend such activities to continue with their job. In such instances, it is appropriate to provide instructions on walking exercise that the patient can comply with at home with the indirectly monitored supervision of their care provider.

Recommendation: We recommend replacing this provision with language that exempts CLTI and ALI and allows physician judgment for severe claudication. Alternatively, we would recommend “structured,” rather than “supervised” exercise therapy. Structured exercise is a recognized and approved CMS quality measure and has been utilized by registries, such as the OEIS National Registry, to report MIPS quality measures.

II. Provider Qualifications and Site of Service

We firmly support appropriate credentialing, facility oversight, and quality assurance, but do not endorse the imposition of mandatory “national accreditation standards” that would create unnecessary and duplicative regulatory and financial burdens for office-based laboratory (OBL) owners. The LCD should instead acknowledge that OBLs operating under existing CMS Conditions for Coverage, state licensure, and professional oversight mechanisms already meet high standards of safety and quality.

Numerous peer-reviewed studies demonstrate that procedures performed in office-based laboratories are equally safe, and in some cases safer, than those performed in hospital outpatient departments (HOPDs) or ambulatory surgical centers (ASCs) when performed by appropriately trained physicians with established safety protocols.

These findings confirm that OBLs already maintain rigorous quality and safety standards through well-established practices in use today—including credentialing, staff training, and emergency protocols—without the need for additional, duplicative, and costly national accreditation mandates.

Recommendation: We recommend that Palmetto GBA recognize and preserve the effectiveness of these existing safety systems and strike any language suggesting that national accreditation by a specific external body is required for reimbursement or coverage.

III. Acute Limb Ischemia

ALI represents a vascular emergency with a 15% thirty-day mortality rate. Limiting revascularization solely to amputation prevention fails to recognize systemic risks such as compartment syndrome, loss of function, and sepsis. Revascularization is medically necessary to preserve limb viability and reduce mortality.

Recommendation: We urge Palmetto GBA to clarify this in the final LCD.

IV. Claudication

The LCD relies on Conte et al. (2015) to require >50% two-year patency likelihood for coverage. This benchmark is outdated. The 2024 AHA/ACC and SVS/SCAI/AHA guidelines favor and explicitly endorse individualized decision-making.

Recommendation: We recommend removing rigid numeric thresholds and substituting a standard based on documented functional improvement and symptom relief.

V. Requests for Clarification and Revision

We respectfully request Palmetto GBA to: 1) remove fixed guideline-directed medical therapy (GDMT) / Supervised Exercise Therapy (SET) timelines for CLTI/ALI; 2) remove accreditation requirements; 3) eliminate surgical preference bias; 4) update citations to 2024 guidelines; and 5) reinforce patient-centered decision-making.

VI. Additional Considerations Relevant to OBLs and Policy Implementation

The LCD references intraoperative imaging modalities including digital subtraction angiography (DSA), intravascular ultrasound (IVUS), and extravascular ultrasound (EVUS) as “reasonable and necessary.” We agree that these may enhance procedural success but strongly caution against interpreting them as mandatory. Mandating such technologies would disproportionately burden smaller OBLs, increasing procedural costs by 20–30% without clear evidence of improved outcomes in all lesion subsets.

Recommendation: We request language clarifying that use of these adjuncts remains at the physician’s discretion.

VII. Conclusion

We appreciate the opportunity to engage constructively with Palmetto GBA on this important policy. The recommendations contained herein align the LCD with the statutory standard of “reasonable and necessary,” current national clinical guidelines, and CMS’s objectives of cost-effective, high-quality care.

We respectfully request that Palmetto GBA incorporate these modifications before finalizing the LCD and consider convening a joint stakeholder working group to ensure continued alignment with evidence-based practices and patient-centered outcomes.

References were provided for review.

Thank you for your comments.

1. See Response 4F. In addition, the guidelines or requirements for SET or GDMT are based upon peer review published literature. The published literature does not differentiate between types of claudication and therefore these requirements will be maintained for this category of coverage.
2. See Response 1C above.
3. See Response 5C above.
4. See Response 1A above.
5. Some of the imaging techniques provided such as IVUS in the LCD may be reasonable and necessary and are at the provider’s discretion to utilize (must have documentation to support that the imaging techniques are reasonable and necessary). The other imaging techniques have options as to what would be appropriate imaging modalities and considered reasonable and necessary.

I am pleased to provide comments on both the proposed Peripheral Arterial Disease of the Upper and Lower Extremities and Proposed Reference Article: Billing and Coding: Endovascular Management for Peripheral Arterial Disease of the Upper and Lower Extremities. We have a track record of developing and commercializing products intended to transform the way that calcified cardiovascular disease is treated, by establishing a new standard of care for endovascular procedures with coronary and peripheral intravascular lithotripsy (IVL). Our differentiated and proprietary approach to calcium modification seeks to minimize trauma within the artery by delivering ultrasonic acoustic pressure waves locally to fracture both intimal and medial calcium in the artery wall, allowing complex lesion modification without creating embolic debris or vessel injury, instead passing through surrounding soft vascular tissue in a safe manner.

We do appreciate the opportunity to provide comments to the proposed documents and respectfully request that Palmetto consider the following two changes to the Proposed LCD DL40228:

I. In the section titled “Endovascular Revascularization for the LE” we would like to include the language sufficient to achieve revascularization in the description of uses for intravascular lithotripsy (IVL):

“Intravascular lithotripsy (IVL) balloons use acoustic shockwaves to induce fracture in severely calcific plaques, facilitating luminal gain and vessel expansion sufficient to achieve revascularization or to prepare the vessel for subsequent intervention. In 1 randomized trial, lithotripsy improved technical success rates from 50 to 66% in moderate and severely calcified femoropopliteal arteries.”

Background

Description of Unmet Need

According to recent data from the World Health Organization, cardiovascular diseases are the leading cause of death worldwide. Further, the presence of vascular calcification is growing: although diabetes and chronic kidney disease, amongst other risk factors, may accelerate deposition of vascular calcium, the principal driver is increasing age; with the changing demographic in the US to an increasingly older population, the incidence of vascular calcification is set to continue to rise. Although accurate estimates are difficult to gauge, moderate or severe coronary artery calcification (CAC) is reported in up to 30% of patients with coronary artery disease presenting for PCI procedures, and calcification is even commoner in peripheral vascular beds, estimated at around 70% in the iliac territory, 40% in the superficial femoral/popliteal artery segment and 60% below the knee. Peripheral IVL, similarly, has enjoyed widespread uptake owing to the challenging nature of patients with lower limb occlusive disease and the high rates of lesion calcification. Many patients requiring revascularization procedures may be considered inoperable due to age, frailty and/or multiple co-morbidities - and are therefore referred for percutaneous approaches in both coronary & endovascular settings. However, the presence of vessel calcification is associated with difficult device delivery, sub-optimal balloon expansion and stent deployment (where required), and prolonged procedures with increased rates of complication.

A number of devices are available for treating vascular calcification, including specialty balloons, atherectomy devices and laser, although access to these tools, requisite training and experience, as well as efficacy and safety metrics may vary with each approach. Expert reviews of available tools in both the coronary and endovascular spaces have noted that: “the key advantages of IVL are: its ease of use compared to atherectomy devices; the ability to maintain multiple guidewires during use; a theoretical ability to create fractures deep in thick calcium; efficacy in larger lumens with 1:1 balloon-to-vessel sizing and no guidewire bias; a potentially lower risk of trauma to the vessel wall and embolization of debris” and that: “the safety and efficacy of IVL for peripheral vascular intervention was assessed in DISRUPT PAD trials (for femoropopliteal and iliac disease) and DISRUPT BTK trials which demonstrated high procedural success, excellent safety profile, and 79% or greater freedom from clinically driven target lesion revascularization at up to 1 year follow-up.”

Description and characteristics of use of device/technology

Intravascular lithotripsy (IVL) is an energy-based therapy, based on technology that has been used for over three decades to treat kidney stones (extracorporeal shockwave lithotripsy). However, IVL catheters are characterized by emitters incorporated into a fluid-filled balloon catheter optimized for treatment of vascular calcium (or, in the case of the Javelin Peripheral IVL catheter, a chamber located immediately proximal to the catheter tip); each Shockwave IVL catheter is designed to treat a specific targeted vessel area, with unique design elements including balloon size, number of emitters, and electrical energy delivery channels to optimize treatment in the targeted vasculature.

IVL does not rely solely on pressure to modify calcific lesions but rather uses the conversion of electrical energy to ultrasonic acoustic pressure waves to fracture calcium deposits and improve vascular compliance: once a calcified arterial lesion is crossed with a guidewire, the chosen IVL catheter is advanced across the lesion and positioned using radiopaque marker bands. In order to effectively modify intimal and medial calcium, the balloon needs to be sized appropriately and inflated appropriately to achieve wall apposition to allow transmission of the acoustic pressure waves to the vessel. The integrated balloon is inflated to only 4 atm using a mixed saline and contrast solution, decreasing the risk of barotrauma, contributing to the demonstrable safety of IVL technologies.

After generator activation, activating the IVL catheter by means of a simple button press passes 3 kV of electrical energy through the connector cable and catheter to the lithotripsy emitters. The electrical pulse vaporizes the fluid within the balloon and creates a rapidly expanding and collapsing vapor bubble, itself producing ultrasonic acoustic pressure waves which travel through the fluid-filled balloon, pass through soft vascular tissue, and selectively impact calcified tissue and create longitudinal, circumferential and transverse fractures in calcified plaque, improving vessel compliance and thereby allowing for optimal vessel expansion. Between cycles of IVL, the balloon is flushed to minimize residual remaining cavitation bubbles and optimize delivery of subsequent IVL therapy.

Once treated with IVL, further treatment, such as stents or balloons (including drug-coated balloons), may be administered based on physician recommendation or preference. While additional definitive treatments are common in coronary arteries, they are less commonly used in the peripheral vasculature.

FDA Approval

IVL for peripheral artery disease received FDA approval through the PMA process in 2016 with the following labeled indication:

“The … IVL System is intended for lithotripsy- enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.”

A further FDA approval was achieved for the novel Javelin Peripheral IVL catheter in 2024, based on the findings of the FORWARD PAD IDE trial. This device is a novel ‘forward’ platform that substitutes a balloon for a fluid-filled chamber located immediately proximal to the catheter tip, providing physicians with an alternative for the treatment of balloon-uncrossable or high-grade occlusive disease.

II. Update the Billing and Coding article to include the 46 new lower extremity endovascular revascularization the CPT and HCPCS codes in the Billing and Coding article to reflect the changes that go into effect January 1, 2026.

In 2024, the AMA CPT Editorial Panel completely revised the lower extremity endovascular revascularization services CPT codes, creating 46 new LER codes, replacing the current 16 LER CPT codes. The 46 new CPT codes are effective January 1, 2026. The draft Billing and Coding article is missing the eight C-Codes for IVL that CMS has maintained for use in the hospital outpatient and ASC settings of care. Table 1 lists the existing C-codes that we request that Palmetto include in the Billing and Coding article to report IVL.

A table listing the 2025 Medicare Hospital Outpatient Coding (C9764-C9767, C9772-C9775) was included for review.

Clinical Data

Shockwave IVL has an extensive and growing body of supporting evidence: as of September 2025, the peer-reviewed literature extends to over 600 publications detailing over 22,000 patient outcomes across all vascular beds.

In addition to the publications referenced in your proposed policy, we would like to submit the following additional key references for your consideration, which will provide clinicians added context and confidence in the extensive data underpinning IVL’s efficacy and safety in peripheral interventions across the full range of vascular territories: References were provided for review.

CONCLUSION AND REQUESTED ACTION

We appreciate the opportunity to provide these comments and stand ready to collaborate on scientifically rigorous and patient-centered LCDs. In this case, we would respectfully and strongly urge Palmetto to amend the proposed LCD to include the modifications suggested, to clarify IVL’s utility and its current CMS status.

Thank you for your comments.

1. A corrected reference for #32 in the bibliography will be added as follows: Tepe G, Brodmann M, Werner M, et al. Intravascular lithotripsy for peripheral artery calcification: 30-Day outcomes from the randomized Disrupt PAD III trial. JACC Cardiovasc Interv. 2021;14(12):1352-1361. The wording of the IVL balloons will not be changed since it was a 30 day study and patients were treated with DCB or stent placement and therefore the IVL balloon lithotripsy wording will remain unchanged.
2. The finalized billing and coding article will contain the new CPT codes.

We appreciate the opportunity to provide comments on the draft Local Coverage Determination (LCD) for Endovascular Management for Peripheral Arterial Disease of the Upper and Lower Extremities (DL40228). We are the world’s leading medical technology company, specializing in implantable and interventional therapies that alleviate pain, restore health and extend life. We are committed to the continual research and development necessary to produce high-quality products and innovative therapies that improve health outcomes for all patients, including Medicare beneficiaries.

We are dedicated to advancing innovation in peripheral vascular disease therapies with the goal of improving outcomes and quality of life for patients with peripheral artery disease (PAD). Our broad portfolio of minimally invasive devices - including drug-coated balloons and atherectomy systems - addresses the complex needs of patients across the PAD spectrum. We share with CMS a common goal: ensuring timely access for Medicare beneficiaries to safe, effective, evidence-based treatments.

We commend Palmetto for recognizing the importance of optimal care for patients with peripheral arterial disease and for the thoughtful approach taken in developing this LCD. We value the importance of establishing evidence-based coverage policies that ensure Medicare beneficiaries have access to proven treatments while maintaining coverage integrity, and support the inclusion of proven, evidence-based technologies as part of this proposed LCD.

In reviewing the draft LCD, we identified opportunities to strengthen alignment with the most current clinical evidence and regulatory guidance. Our comments are offered with a view to ensure that coverage decisions reflect the totality of available evidence and support optimal patient care.

Specifically, we would like to offer input regarding:

• Paclitaxel safety - Updating the LCD to reflect FDA's July 2023 determination based on comprehensive patient-level data which shows no mortality risk
• Device-specific effectiveness - Recognizing proven long-term superiority for specific drug coated balloon devices with robust 5-year RCT evidence
• Additional clinical evidence - Including the most recent, updated systematic reviews and real-world evidence from Medicare beneficiaries (SAFE-PAD analysis of ~170,000 Medicare beneficiaries and comprehensive real-world evidence)
• Coverage criteria clarity - Suggestions for objective terminology that supports appropriate clinical judgment

Our goal is to help ensure that the final LCD reflects current scientific consensus and avoids unintended barriers to patient access to appropriate endovascular procedures.

COMMENT 1: PACLITAXEL SAFETY AND FDA'S 2023 DETERMINATION

Current LCD Language: The draft LCD references early meta-analyses that raised concerns about paclitaxel-coated devices, including statements about dose-dependent effects. (Page 23: "The harm signal was more evident for the high dose [3 to 3.5 microgram/mm2] compared with the low dose [2 microgram/mm2]").

Background of the Paclitaxel Issue and Resolution

We appreciate that Palmetto's draft appropriately acknowledges both the initial safety concerns and subsequent evidence refuting them. We respectfully suggest updating this section to more fully reflect the comprehensive resolution of this controversy and FDA's current regulatory position. The initial 2018 Katsanos meta-analysis raised mortality concerns that prompted immediate regulatory action. However, subsequent patient-level meta-analyses with complete vital status data have definitively resolved these concerns. The 2023 Parikh patient-level meta-analysis (N=2,666 patients, median 4.9-year follow-up) found no excess mortality risk (HR 1.02, 95% CI 0.80-1.30, P=0.87) or amputation risk (HR 0.97, 95% CI 0.65-1.45, P=0.88). Critically, no dose-response relationship was observed when adjusted for lesion length (P=0.45), refuting earlier dose-dependent claims. The SAFE-PAD study of 168,553 Medicare beneficiaries (median 4.3-year follow-up) corroborated these findings with no difference in amputation rates (adjusted HR 0.99, 95% CI 0.97-1.02).

Based on review of all available data, including updated meta-analyses and real-world studies, the U.S. Food and Drug Administration stated in July 2023:

“Based on the FDA's review of the totality of the available data and analyses, we have determined that the data does not support an excess mortality risk for paclitaxel-coated devices.”

The FDA recommends that health care providers discuss the risks and benefits of all available PAD treatment options, including paclitaxel-coated devices, with their patients, and continue routine monitoring of patients treated with these products.

We respectfully suggest updating the LCD’s language to reflect this current FDA position.

Suggested LCD Edits to Reflect Current Evidence

Page 19, Reference 198: Update to cite the 2023 Parikh patient-level meta-analysis rather than the 2018 Katsanos summary-level analysis.

Page 22, FDA Guidance: Update to reflect FDA's current July 2023 position emphasizing no excess mortality risk and recommending discussion of risks and benefits of ALL available PAD treatment options (not paclitaxel-specific).

Page 22, Reference 199: The cited reference does not appear to correspond directly with the statement regarding paclitaxel DCB and DES in this section. We respectfully suggest reviewing this citation and consider replacing it with a source that more specifically supports the associated text.

Page 23, References 225-226 (Katsanos 2020, 2022): Both analyses rely on summary-level data and share the methodological limitations associated with the original 2018 meta-analysis, including incomplete patient follow-up and inconsistent cross-over reporting. Notably, the dose-dependent risk interpretation has been addressed and refuted by subsequent patient-level meta-analyses. Additionally, Reference 226 includes devices that are not FDA-approved for infrapopliteal use in current U.S. clinical practice. We recommend reviewing these references and considering removal or substantial revision of the associated sections to more closely align with current evidence and regulatory context.

Recommended Revision to LCD Language:

We would recommend updating the LCD language on Page 22 to state:

"DCBs and DESs have been increasingly used to treat femoropopliteal disease. DCBs can be used as adjuncts or as an alternative to PBA for the treatment of medium- to long-length lesions. Multiple trials have evaluated the effectiveness of these devices in the superficial femoral artery. While earlier studies had suggested increased mortality risk and possibly an increased risk for amputation using paclitaxel-coated devices in patients with PAD, longer-term data from premarket randomized trials and several subsequent meta-analyses have found that paclitaxel does not pose a risk to long-term survival. Based on the United States Food and Drug Administration's (FDA) review of the totality of the available data and analyses, the FDA determined that the data does not support an excess mortality risk for paclitaxel-coated devices. The FDA has urged health care providers to discuss the risks and benefits of all available PAD treatment options, including paclitaxel-coated devices, with their patients.”

COMMENT 2: EFFECTIVENESS OF DRUG-COATED BALLOONS

Current LCD Language: Page 19 states: "Multiple randomized studies of drug-eluting stent (DES) or drug-coated balloon (DCB) show promising results for decreasing restenosis rates in the femoral-popliteal segment."

Evidence of Proven Long-Term Effectiveness:

We believe that the term 'promising' may not fully capture the strength of the long-term evidence available for drug coated devices. Drug-coated balloons (DCBs) and drug-eluting stents (DESs) have become established therapies in the treatment of femoropopliteal peripheral artery disease (PAD). Substantial evidence from randomized controlled trials and systematic reviews demonstrates that both DCBs and DESs provide durable vessel patency and significantly reduce clinically driven target lesion revascularization compared to conventional angioplasty or bare-metal stents. Long-term studies confirm these benefits, and data show no difference in overall mortality between these therapies and standard alternatives.

Multiple RCTs and systematic reviews have demonstrated statistically significant long-term superiority. Published 5-year pivotal RCT data shows statistically significant clinical superiority of DCB over PTA in (Laird et al., 2019; Krishnan et al., 2024; Sachar et al., 2025) with 5-year freedom from CD-TLR of 74.5% (DCB) vs. 65.3% (PTA), P=0.02 (Larid et al., 2019). Additional publications (Zeller et al., 2022; Ansel et al., 2024) also provide extensive real-world evidence of DCB vs PTA with durable 5-year outcomes in high-risk cohorts, showing high rates of freedom from revascularization, low major amputation rate, and durable outcomes in high-risk subgroups.

Recommended Revision: We would recommend revising the LCD to reflect the above evidence:

Recommended Revision:

“Multiple randomized controlled trials and long-term outcome studies have established the clinical effectiveness of drug-coated balloons (DCBs) and drug-eluting stents (DESs) for reducing restenosis and repeat interventions in femoropopliteal PAD. These therapies are well supported by robust evidence and should be considered proven options—rather than merely promising—for enhancing vessel patency and improving patient outcomes in appropriate patient populations. Device selection should be based on published clinical outcomes, physician judgment, and patient characteristics rather than presuming all devices are equivalent.”

Additional Evidence & References

We noted that the list of references (189–195) does not currently include the most recent published 5-year randomized data for the three DCBs discussed. We would suggest adding the following publications to ensure the references are as comprehensive and up-to-date as possible:

• Laird JA, Schneider PA, Jaff MR, et al. Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions. Circ Cardiovasc Interv. 2019;12(6):e007702.
• Krishnan P, Faries P, Niazi K, et al. Stellarex Drug-Coated Balloon for the Treatment of Peripheral Artery Disease: Five-Year Results from the ILLUMENATE Pivotal Randomized Controlled Trial. Am J Cardiol. 2024;227:83-90.
• Sachar R, Soga Y, Lopez L, et al. Long-term results of the RANGER II SFA randomized trial of the Ranger drug-coated balloon vs standard percutaneous transluminal angioplasty for femoropopliteal artery treatment. Vasc Med. 2025:1358863X251349782.

COMMENT 3: ADDITIONAL EVIDENCE AND POLICY CONSIDERATIONS

A. Atherectomy Evidence - Updated Systematic Review

Current LCD Language: Page 23 states that "current evidence only shows noninferiority of atherectomy as compared with PBA and stenting."

We respectfully note that the most comprehensive systematic review to date (Carr et al., 2025) presents a substantially different evidence profile:

• Scope: 322 articles analyzed including 12 meta-analyses, 19 RCTs, and 96 prospective observational studies
• RCT Findings: Of the 15 published RCTs comparing commercially available atherectomy devices to non-atherectomy controls, 11 (73.3%) demonstrated improved outcomes for atherectomy on at least one key outcome
• Superior outcomes included: Superior technical/procedural success, fewer periprocedural complications, lower dissection rates, reduced bailout stenting, improved patency, and reduced TLR
• Safety Profile: 12-month amputation rate 1.7% (across 71 studies), 12-month mortality 2.8% (across 63 studies), distal embolization 2.2% (across 159 studies)

Real-World Medicare Evidence: Analysis of Medicare claims for femoropopliteal interventions demonstrated significantly lower rates of amputation and surgical reintervention following atherectomy use compared to PTA without atherectomy (Krawisz et al., 2023).

We suggest revising the statement on Page 23 to reflect this comprehensive body of evidence showing favorable safety profiles and superiority on multiple clinically relevant outcomes, rather than characterizing the evidence as showing only noninferiority.

B. Functional and Patient-Centered Outcomes

Current LCD Language: Page 22 states "The clinical significance of reported long-term outcomes using paclitaxel-coated devices remains unclear. Outcomes of reported trials overwhelmingly use lesion-oriented outcome measures, such as TLR or primary restenosis, rather than functional or patient-oriented measures, such as improved walking distance or increased LS rates."

We believe that this statement may benefit from clarification. Clinically driven target lesion revascularization (CD-TLR) is itself a highly patient-centered outcome, as it reflects symptom recurrence severe enough to require reintervention. The definition typically requires return of symptoms or significant decrease in ankle-brachial index compared to post-procedure values. For elderly Medicare beneficiaries with multiple comorbidities, each avoided reintervention reduces medical risk, recovery time, and healthcare costs.

IN.PACT SFA trial data show that both DCB and PTA improve walking ability through 3 years, but the DCB group achieved similar functional outcomes with far fewer repeat procedures, demonstrating a meaningful patient benefit (Schneider et al., 2018).

Quality of Life in CLTI: Subgroup analysis from the IN.PACT Global Study shows that DCB treatment leads to greater improvements in quality of life and walking ability in CLTI patients compared to those with less severe disease, highlighting clinical benefit in high-need populations.

Cost-Effectiveness and Healthcare Resource Utilization: Multiple health economic analyses have demonstrated cost-effectiveness of devices with proven TLR reduction through decreased reintervention rates (Salisbury et al., 2016; Pietzsch et al., 2022; Saratzis et al., 2024).

C. Coverage Criteria Clarity

We appreciate the LCD's thorough coverage criteria and respectfully offer suggestions to enhance clarity:

1. Asymptomatic Patients

While symptomatic presentation is the primary indication for revascularization, the 2024 ACC/AHA/Multisociety PAD Guideline acknowledges that certain clinical scenarios may warrant intervention in asymptomatic patients, such as:

• High-risk anatomical lesions posing future limb ischemia risk
• Preoperative optimization for major lower extremity surgery
• Progressive disease on surveillance imaging, especially in patients with diabetes or renal disease

We respectfully suggest acknowledging these clinically justified exceptions based on individualized physician judgment and guideline recommendations (Gornik et al., 2024).

2. Terminology Clarity

Certain terms in the coverage criteria may benefit from clearer definitions or replacement with objective, guideline-based criteria to ensure consistent application across providers:

• "Irreversible disease" - Consider defining with specific clinical parameters or guideline-based staging
• "High risk for percutaneous failure" - Consider providing objective anatomical or clinical criteria
• ">50% likelihood of sustained benefit" - Consider replacing with guideline-based treatment algorithms or objective outcome predictors

CONCLUSION

We appreciate Palmetto's efforts to establish evidence-based coverage for peripheral artery disease treatments and commend the recognition of PAD as a growing clinical challenge requiring appropriate revascularization options.

We respectfully encourage Palmetto to consider the revisions outlined in this letter to ensure that the final LCD reflects the most current clinical evidence and regulatory guidance. The comprehensive body of evidence demonstrates:

• Safety is Definitively Established: FDA's July 2023 determination based on patient-level meta-analysis (2,666 patients, 4.9-year follow-up) and SAFE-PAD analysis (168,553 Medicare beneficiaries, 4.3-year follow-up) show no excess mortality or amputation risk. The initial mortality signal was explained as differential follow-up bias.
• Long-Term Effectiveness is Proven for Specific Devices: IN.PACT Admiral demonstrates statistically significant 5-year superiority in pivotal RCTs (P=0.02) with durable real-world outcomes through 5 years in complex lesions. Device-specific differences exist; coverage policy should reference device-specific evidence.
• Atherectomy Evidence is Strong: The largest systematic review (322 studies) shows 73.3% of RCTs demonstrated superiority on at least one key outcome with favorable safety profile. Real-world Medicare data shows reduced amputation and reintervention rates.
• Patient-Centered Outcomes are Meaningful: Reduced reintervention rates represent clinically significant benefits for Medicare beneficiaries, avoiding repeated procedures, complications, and healthcare resource utilization while maintaining functional improvement.

We remain available to provide additional clinical, technical, regulatory, or evidentiary information as needed. Thank you for your consideration of these comments, and we look forward to ongoing collaboration to advance coverage policies that reflect the latest clinical evidence and best serve Medicare beneficiaries with peripheral arterial disease.

References were provided for review.

Thank you for your comments

1. The comparison between atherectomy devices and PBA (plain balloon angioplasty) and stenting shows noninferiority based upon the available literature. Policy does not suggest one modality over another modality of treatment and therefore covers the use of devices that are supported by peer reviewed literature based upon reasonable and necessary criteria.
2. The current LCD does allow for the use of DCB if it is reasonable and necessary for the targeted lesion as supported by the literature (see specialty balloons) under coverage guidance. There is also sufficient guidance in the summary of evidence to allow for the use of DCBs as reasonable and necessary.
3. See Response 1E above. See Response 1A above. In addition, the terminology is consistent with other published peer-reviewed literature. The interpretation of the subjective irreversible disease, high risk of percutaneous failure likewise is from the literature and allows medical decision making to be performed by the provider of the service as reasonable and necessary.