Response to Comments: Treatment of Varicose Veins of the Lower Extremities

Medtronic is 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 to support innovative therapies that improve patients' lives.

Medtronic appreciates the opportunity to comment on the Proposed LCD - Treatment of Varicose Veins of the Lower Extremities (DL39121). We strongly support the development of this LCD and we believe the language in the proposed policy will achieve the goal of providing appropriate access to patients in whom these treatments are medically necessary. As the leading manufacturer of endovenous treatments for chronic venous insufficiency, including ClosureFast™ radiofrequency ablation (RFA) therapy and the VenaSeal™ Closure System, a cyanoacrylate ablation therapy, we would like to provide minor comments to refine and clarify the policy in the final LCD, and to share recent clinical evidence for your consideration to support the current coverage outlined in the proposed LCD.

Medtronic is pleased with the inclusionary language put forth by Palmetto in the proposed LCD to explicitly include coverage for multiple types of noninvasive therapies for treatment of varicose veins, including both thermal ablation therapies and non-thermal ablation therapies such as VenaSeal cyanoacrylate adhesive. We believe this language ensures that all indications for FDA-labeled therapies remain covered in patients for whom varicose vein treatments are indicated.

VenaSeal - background

The VenaSeal Closure System is a type of non-thermal ablation therapy. It is the only non-tumescent, non-thermal, non-sclerosant ablation treatment approved by the FDA for symptomatic venous reflux in the United States.¹ The CPT codes used to describe VenaSeal are found in Table 1. ²

Table 1. CPT® codes and descriptions

CPT Code & Description

36482: Endovenous ablation therapy of incompetent vein, extremity, by transcatheter delivery of a chemical adhesive (eg, cyanoacrylate) remote from the access site, inclusive of all imaging guidance and monitoring, percutaneous; first vein treated

36483: Endovenous ablation therapy of incompetent vein, extremity, by transcatheter delivery of a chemical adhesive (eg, cyanoacrylate) remote from the access site, inclusive of all imaging guidance and monitoring, percutaneous; subsequent vein(s) treated in a single extremity, each through separate access sites

VenaSeal is provided as a sterile, single-patient-use kit comprised of the VenaSeal™ adhesive (cyanoacrylate-based) and the delivery system components. The VenaSeal™ adhesive polymerizes into a solid material upon contact with body fluids or tissue and blocks blood flow, at the site of injection the block occurs immediately following injection, becoming increasingly durable over time as the material becomes fibrotically encapsulated.3 The intended use of the device is consistent with other types of ablation:

• The VenaSeal closure system (VenaSeal system) is indicated for use in the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation. The VenaSeal system is intended for use in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).⁴

The VenaSeal system has treatment differences when compared to thermal ablation modalities. No tumescent anesthesia is required with the use of VenaSeal.4 The VenaSeal system enables distal access to the target vein, allowing for ablation of the entire segment of refluxing vein.5,6 Other thermal ablation treatments may result in thermal nerve injury due to thermal damage to adjacent nerves, with the risk of nerve injury potentially higher with treatment location at or below the calf.6 Post-procedure compression stockings are not required after treatment with VenaSeal, although some patients may benefit from the use of compression stockings.^7,8

Categorization – VenaSeal cyanoacrylate ablation

We suggest a minor language clarification in the cyanoacrylate adhesive section. The proposed LCD categorizes covered invasive procedures by type. Current language to describe VenaSeal in the policy is found below.

• C) Chemical Adhesive (Cyanoacrylate embolization):

• This nonthermal technique uses a glue delivered into the saphenous vein using a catheter for access that induces a foreign body reaction leading to inflammation and fibrotic occlusion of the vessel. It is used for the treatment of incompetent saphenous or ASVs.

We request a modification to this section to clarify that VenaSeal is a type of ablation. This is consistent with the mechanism of action of the therapy and may reduce confusion with the ablation CPT codes used for this treatment, found above in Table 1. Suggested language is as follows:

• C) Chemical Adhesive (Cyanoacrylate fibrotic occlusion / ablation of the vessel):

• This nonthermal ablation technique uses a glue delivered into the saphenous vein using a catheter for access that induces a foreign body reaction leading to inflammation and fibrotic occlusion of the vessel.

Clinical evidence

The proposed LCD summarizes data from the VeClose randomized controlled trial, providing outcomes through 24 months in the summary. The proposed LCD also indicates “longer term data will be collected at 3 and 5 years” for VenaSeal. We are pleased to share the publication for the VeClose study at 36 months and the 60-month publication of a subsequent extension study with a subset of these VeClose patients.

• Current LCD language summarizes the existing evidence from the Gibson 2018 VeClose study.9 Investigators observed these patients to 3 years and subsequently conducted an extension study to follow patients to 5 years.10,11 These studies support the continued noninferiority of VenaSeal to RFA. The 36-month complete closure rate of 94.4% in the VenaSeal group and 91.9% in the RFA group. The 60-month extension study identified the freedom from recanalization rate of 91.4% in the VenaSeal group and 85.2% in the RFA group, with no serious adverse events reported between 36 and 60 months and sustained improvement in quality of life and venous disease symptoms through the study period. These studies demonstrate that VenaSeal is safe and effective, and non-inferior to radiofrequency ablation (RFA) for the closure of target veins up to 5 years.

In addition, we have summarized three additional studies for your consideration as you summarize relevant evidence for the final LCD.

• O’Banion et al (2021) conducted a multi-center retrospective cohort study to compare VenaSeal ablation and radiofrequency thermal ablation for venous ulcer healing in patients with clinical class 6 chronic venous insufficiency.6 100% of patients in both arms achieved wound healing in both groups. Patients treated with VenaSeal ablation therapy had a significantly shorter median time to wound healing compared with patients treated with RF ablation (104 vs. 43 days, p= .001), demonstrating superior time to wound healing in both large and small ulcers. The authors concluded that both VenaSeal and radiofrequency are safe and effective ablation techniques for treating venous ulcers, and that VenaSeal ablation has superior time to wound healing compared with thermal ablation.

• Kiguchi et al (2021) conducted a multi-center retrospective cohort study to explore the need for subsequent perforator vein treatment for patients who received either VenaSeal ablation or radiofrequency thermal ablation for venous ulcer healing in patients with clinical class 6 chronic venous insufficiency.12 The study was looking for a difference in incidence of follow-up procedures based on the initial ablation treatment modality. Results showed patients who needed subsequent RFA procedures to address perforator reflux were more likely to have received an initial treatment of RFA compared with those initially treated with VenaSeal. (49%vs 27%, P = .003). The authors concluded that VenaSeal ablation treatment is associated with fewer subsequent perforator interventions.

• Kolluri et al (2020) performed a literature review and meta-analysis to compare the outcomes of VenaSeal with other modalities to treat chronic venous insufficiency (CVI). A total of 20 randomized controlled trials (RCTs) with 4,570 patients were included in the meta-analysis. After analyzing the data using the Bayesian model, VenaSeal was ranked first for anatomic success followed by RFA, endovenous laser ablation (EVLA), surgery, mechanochemical ablation (MOCA), and sclerotherapy at the 6-month follow-up. In this analysis, the relative treatment effect of VenaSeal Closure System was found to be superior to surgery and other comparators such as EVLA, RFA, MOCA and sclerotherapy with VenaSeal having least probability of side effects amongst all.

Conclusion

Medtronic appreciates the opportunity to suggest language clarification on the current policy and to submit clinical evidence for your consideration. We thank you for the proposed LCD, which we believe will ensure appropriate access to advanced medical technologies in the Medicare population and enable appropriate coverage for this critical therapy.

Thank you for your consideration of these comments regarding varicose vein treatments. Please do not hesitate to reach out with any questions or if we can provide any further information during the coverage revision process.

Thank you for your comments. After further review of the LCD we have revised the verbiage to clarify that Cyanoacrylate is an ablation technique.

I am a vascular surgeon that has been in practice for 6 years. I trained in Detroit, MI for general surgery and then did my fellowship in Michigan and in Phoenix, Arizona at Arizona Heart Hospital. I run a vein clinic in North Carolina and solely treat superficial veins now.

After reviewing the proposed LCD for NC, I would like to make a few suggestions/recommendations, please.

• Conservative therapy, I believe, should be a recommendation but not a requirement prior to treatment. Some patients that benefit from treatment are not able to wear compression due to other medical conditions that they might bedealing with. I believe, that as physicians, we are able to make those decisions regarding whether or not the patient would benefit.

• Liquid/foam sclerotherapy should be able to be utilized for veins from 3 mm-6 mm that are symptomatic. Studies have proven that treatment of these veins is beneficial in patients. Also, symptomatic varicose veins greater than 6 mm, should be allowed to be treated with foam or phlebectomy, as determined by the treating physician.

• At our clinic, we see a large population of patients with wounds. We should be able to treat these patients as deemed necessary to help in healing their wounds.

Thank you for your time reading and considering these recommendations. We are physicians and always want the best for our patients.

Thank you for your comments. We have received multiple comments on the issue of conservative therapy and liquid/foam sclerotherapy. We have taken into consideration and reviewed the comments on conservative therapy and the LCD was revised accordingly. We have received multiple comments on the issue of vein diameter and have taken it into consideration and have revised the LCD accordingly. We have received multiple comments regarding the different types of foam and have revised the LCD to reflect the different types of foam; physician compounded foam (PCF) and non -compounded foam (NCF).

I have reviewed the proposed LCD and would like to present some concerns regarding the LCD. As a practicing vein specialist since 2003 and Diplomate of the American Board of Venous and Lymphatics Medicine, I believe that I can offer some suggestions that will help us improve the treatment of venous disease patients.

My main concern is regarding the requirements for Ultrasound-guided foam sclerotherapy. There is no distinction in your LCD regarding Physician-compounded foam and non-compounded foam (Varithena). I am pleased that your LCD allows the use of foam for the treatment of Axial veins, Accessories, and perforators, but I am concerned about the 6mm or greater requirement. Lowering the size requirement to 4mm or greater will allow more flexible, comprehensive, and effective treatment of venous stasis disease, especially ulcer patient. I have seen many patients with severe venous stasis disease with axial veins that are smaller than 6mm. The use of foam along with Ultrasound guidance allows us to be much more comprehensive in the treatment of varicose vein disease. Although Endovenous thermal ablation (EVTA) has vastly improved the treatment of varicose vein disease. I believe that EVTA be used for the proximal Great Saphenous Vein (GSV) and Small Saphenous Vein (SSV) because of my concern for thermal injury to the Saphenous nerve and Sural nerve. Using physician-compounded foam for these residual veins and accessory veins will allow us to treat vein disease in a more safer, cost-effective, and efficient way to treat vein disease. I believe that non-compounded foam (Varithena) should be allowed for varicosities (including Axial veins) of 4mm or greater and physician-compounded foam be used for ultrasound-guided foam sclerotherapy for varicosities 3mm or greater. Thank you for allowing me to review this LCD and make comments. I hope you will take in consideration my insights.

Thank you for your comments. We have received multiple comments on the issue of vein diameter and have taken it into consideration and have revised the LCD accordingly. We have received multiple comments regarding the different types of foam and have revised the LCD to reflect the different types of foam; physician compounded foam (PCF) and non -compounded foam (NCF).

Thank you for providing the proposed Varicose Vein Policy. It will be nice to have, once again, a single, active Palmetto GBA policy, as currently, it's very confusing and challenging, for both physician and patient, to manage symptomatic chronic venous disease, as each advantage plan now creates their own separate policies.

The proposed policy is very concise with many current standards of care included. There are, however, a few items that are a departure from usual care. Please consider these following comments, suggestions and possible policy modifications:

Conservative Management (Noninvasive procedure)

• "Components of conservative therapy (period of 2-4 weeks) .....

• Why is a trial of conservative therapy even necessary? What is special about 2-4-6-12 weeks? It's arbitrary. Most patients are either treatment candidates or they are not. Patients are given all the treatment options, including conservative therapy. Some patients are not treatment candidates, some want to try conservative therapy and some prefer to proceed straight to definitive treatments. I think conservative therapy SHOULD be discussed and offered as a therapy option, but do not think an arbitrary number of 2-4 weeks should be required for definitive treatment, especially if a patient is a treatment candidate.

• Re: weight reduction - while I agree, that weight reduction, if necessary, should be part of overall health improvement, however: 1) it's not feasible to effect significant weight reduction in a 2-4 week conservative therapy period, 2) many patients don't need weight reduction, and 3) patients with lipedema (10% of the females in the US) are not able to lose the lipedema weight. Perhaps consider removing weight loss from the policy.

A) Sclerotherapy

• It is well accepted that foam sclerotherapy is more effective than a liquid sclerosant in treating varicose veins, because the liquid layers out inside the vein, mixes with the blood and is more rapidly metabolized. Conversely, foam not only displaces the blood, there is less immediate mixing, the foam fills the entire vein cavity, hence a better treatment effect.

• That said, there are some patients, based on underlying medical conditions, where liquid sclerotherapy is preferred.

• It is also well accepted that a varicose vein is > 3mm, and any vein < 3mm is considered "cosmetic." I think all would agree with the policy, that there is no medical indication to treat of vein< 3mm.
• Perhaps, a better consideration, is to allow the treating physician, based on the medical judgement, to decide on liquid vs foam sclerotherapy and to allow treatment of veins 3mm or greater - thus, eliminate the 6mm size cut off.

B) Non-Invasive Venous Studies

• The policy is written as, "It is expected that these studies will be performed by the physician planning to provide the therapy."

• While all physicians treating varicose veins would be able to perform and interpret all non-invasive venous studies (ultrasound evaluations), some physicians may utilize a registered vascular technologist (RVT) to perform the study. Please consider including RVT to this section of the policy.

" ... studies performed by an RVT or the physician planning to provide the therapy."

C) Limitations - 8 Klippel-Trenaunay Syndrome 

• Because some patients with the rare Klippel-Trenaunay Syndrome (KTS) can be treated successfully with varicose vein treatments, please eliminate line #8 and allow the physician to make a judgement on whether the patient with KTS can be treated. 

Please consider these suggestions and modifications in the final, active varicose vein policy.

Thank you for your comments. We have received multiple comments on the issue of conservative therapy .We have taken into consideration and reviewed the comments on conservative therapy and the LCD was revised accordingly. We have received multiple comments regarding the different types of foam and have revised the LCD to reflect the different types of foam; physician compounded foam (PCF) and non -compounded foam (NCF). We have added your comment to include a registered vascular technologist (RVT) to the Non-Invasive Venous Studies. We have removed the limitation for the Klippel Trenaunay Syndrome.

The American Vein and Lymphatic Society (AVLS), the American Venous Forum (AVF), and the Society for Vascular Surgery (SVS) are the principle American medical societies dedicated to the evaluation and management of venous disorders. Our professional combined membership of approximately 8,500 members includes most of the national leaders in research, education, and patient advocacy for venous disorders. We have reviewed the proposed LCD within our leadership and reviewed comments to us from our membership. We offer comments and suggestions for improvement of the proposed LCD to clarify medically appropriate policy with language that we hope will improve patient care and reduce the potential for confusion for physicians now and for auditors in the future.

Comments on the proposed LCD

We wish to bring to your attention two terminology issues. Since a consensus statement was published in 2005 (Cagiatti, et al) the accepted terminology is Great Saphenous Vein, not Greater Saphenous Vein. The accepted term to describe a non-physician ultrasonographer is Vascular Technologist, not Vascular Technician. The term “technologist” implies a higher level of understanding and thought process than does the term “technician”.

We agree that conservative care is an important component of venous management and that it may be the only necessary care for some patients. However, there is no evidence that conservative care prevents the need for the minimally invasive procedures that are considered medically necessary under the terms of the LCD. While we encourage conservative care such as weight reduction, moderate exercise, periodic leg elevation, and compression therapy when appropriate, we believe the language in the LCD should clearly state that these conservative measures are not requirements for coverage and should be individualized to meet the needs of each patient.

Selective use of a trial of compression (elastic or inelastic) may be helpful in discriminating ambiguous lower extremity symptoms but should otherwise not be a requirement prior to treatment. This has been a published evidence-based guideline from the Society for Vascular Surgery and the American Venous Forum since 2011. Compression may be very useful to help manage edema or pain and can be very useful in the post-operative patient and for short and long-term management of venous thrombosis. Graduated compression stockings are one option for compression, but some patients are unable to use compression hose due to anatomic characteristics, arthritis, abdominal obesity, back pain, shoulder pain, neurologic disease such as prior stroke, or general disability. Inelastic compression is a preferred, more effective alternative for some patients and some patients are intolerant of hose due to local pain or central nervous system issues. However, despite the type of compression pursued or the ability of the patient to tolerate the therapy, these conservative treatments do not correct the underlying venous pathology and patients still benefit from correction of their disease, using the various procedures covered in this policy. This is particularly evident in patients with advanced venous disease where early intervention to correct venous reflux results in clear and persistent benefit.

Abdominal obesity and inactivity are major contributing factors in the development of lower extremity edema, leg pain, and progression of venous insufficiency, but the ability to manage these problems is so variable from patient to patient that rigid rules regarding management of these problems as a prerequisite for vein treatment is not reasonable.

Sclerotherapy may be the only necessary treatment for some patients while it is an essential adjunctive treatment for others. Additionally, it is a cost-effective means of dealing with recurrent varicose veins or progression of venous insufficiency as will happen for many patients since venous insufficiency is a chronic, progressive problem with strong genetic determinants and other life-style issues such as obesity, inactivity, prolonged sitting or standing, neuromuscular and musculoskeletal disorders, and pregnancy.

Liquid sclerotherapy is most effective for treatment of very small veins though some use it for veins up to 6 mm in diameter. Foam sclerosants have the advantage of displacing blood from the treated veins so the active drug (usually polidocanol or sodium tetradecyl sulfate) can contact the vein wall undiluted by admixture with blood to achieve a better sclerosing effect than a liquid sclerosant which mixes quickly with blood when injected into larger veins. Additionally, use of the foam technique allows a much smaller volume of sclerosant to fill the target veins than is required with liquid injections. “In common practice, physicians often treat telangiectatic or reticular veins (< or =2 mm in diameter) with liquid sclerosants, reserving foam for the treatment of larger veins.” (Cartee JVSVL 7 2021 and Rabe Phlebology 2014 cited in Cartee). We highly recommend the Cartee article as the most current thorough review of foam sclerotherapy and that you revise your review on page four to reflect the information provided therein regarding liquid and foam sclerotherapy.

Physician compounded foam (PCF) is made immediately prior to injection by agitating a detergent sclerosant (polidocanol or sodium tetradecyl sulfate) with a gas, most commonly room air, though some prefer carbon dioxide, oxygen, or a physiologic mixture of gases. “Non-compounded foam” (NCF) is a proprietary foam which is generated in the office prior to use in a manufactured cannister with a carbon dioxide-oxygen mixture and stabilizing agents for which there are two specific CPT codes (36465 and 36466) limiting use to treatment of truncal veins. These codes include the preoperative mapping and ultrasound guidance for UGFS with NCF. There is no specific CPT code for use of NCF for treatment of varicose veins which makes use of NCF financially unfeasible for treatment of non-truncal varicose veins since the currently available CPT codes 93971, 76942, and 36471 in sum pay less than the cost of the NCF for the drug alone.

Preprocedure mapping with ultrasound and ultrasound guidance for foam sclerotherapy allows more effective treatment of veins beyond those that can be observed in the skin. Preprocedure mapping to determine the target, non-target, and associated perforating and deep veins is essential for safe and effective sclerotherapy of veins in the subcutaneous tissues. Ultrasound-guided sclerotherapy (UGFS) also allows treatment of veins which are too deep or numerous to effectively treat with phlebectomy alone. UGFS may be utilized safely and effectively for treatment of varicose veins, venous malformations, and truncal veins (great saphenous, small saphenous, anterior accessory great saphenous, posterior accessory great saphenous, intersaphenous). (Cartee, et al)

While specific codes (36465, 36466) exist for use of NCF, there is no CPT code which correctly describes the work components of UGFS when using PCF. In the absence of a correct code to describe all of the work involved in UGFS with PCF, CPT 93971 describes preprocedure mapping of the target, non-target, perforator, and adjacent deep veins; CPT 76942 describes ultrasound guidance for placement of a needle into the vein(s); and 36471 describes visually-guided injection of sclerosant into more than one vein.

There is a practical limit in terms of whether to cover sclerotherapy treatment of small abnormal veins. The technical definition of varicose veins historically requires the veins to be over 3 mm in diameter and to be abnormal with dilatation and valve failure. Some veins smaller than 3 mm in diameter may contribute to local pain, edema, or skin changes associated with valve failure, but documentation of medical necessity for treatment of these small veins may be difficult and expert opinion may vary widely between whether treatment is medically necessary or more cosmetic. Many payors have chosen to limit payment for sclerotherapy to symptomatic abnormal veins over 3 mm in diameter which is somewhat arbitrary, but useful administratively. We agree with the 3 mm limitation with the provision that treatment of these small abnormal veins may be medically necessary (and sometimes standard of care) for active or recent spontaneous or traumatic hemorrhage or in the vicinity of active or healed venous ulcers.

The draft policy (page 9) states, “Medicare would not expect to see the following when performing sclerotherapy: More than three sclerotherapy sessions for each leg…”. Our previous questions to Palmetto regarding the time frame (lifetime, annual, episode of care?) for this limitation remain unanswered which is very problematic when we are counselling patients who need more than three treatment sessions per leg. The word “expect” is problematic from the stand-point of post-treatment review. A process and details of documentation must be outlined to allow for additional medically necessary care. A reasonable requirement would be clinical re-evaluation after a defined course of sclerotherapy such as three sessions per leg to determine if the patient still meets medical necessity requirements.

We agree with the proposed language regarding Thermal Ablation techniques except that you have overlooked use of Endovenous LASER Ablation (EVLA) for treatment of incompetent perforating veins which has been FDA-approved since 2018.

We suggest coverage for the following:

1. Symptomatic abnormal veins between 3 and 6 mm in diameter may be treated with liquid or foam sclerotherapy with ultrasound guidance as necessary or phlebectomy.

2. Treatment of telangiectatic and reticular veins less than 3 mm in diameter is not covered except for a. recent spontaneous or traumatic hemorrhage, b. dilated intradermal veins in the elderly judged to be a substantial risk for hemorrhage with minimal trauma, c. near an active or healed ulcer if judged to contribute to local venous hypertension.

3. Symptomatic varicose veins 6 mm or greater in diameter may be treated with foam sclerotherapy or phlebectomy with ultrasound guidance as necessary.

4. Saphenous Veins (Great, Small, Anterior Accessory, Posterior Accessory, and Intersaphenous) may be treated with endovenous thermal ablation (radiofrequency or LASER), chemical adhesive (cyanoacrylate), non-compounded foam (NCF) ablation, mechanochemical ablation (MOCA), or surgical ligation and stripping) with documentation of CEAP Class C2-C6 disease, and reflux over 500 ms in the treated segments.

5. Incompetent perforating veins (IPVs) may be treated with thermal ablation with radiofrequency or LASER or with ultrasound-guided foam sclerotherapy (UGFS) or surgical ligation in the presence of reflux time over 1000 ms in the IPV if the IPV is associated with an active or healed venous ulcer or if the IPV is an important source of reflux into symptomatic refluxing veins or locally symptomatic with pain and tenderness not resolved with treatment of other local refluxing veins. (Note that recent randomized clinical trials have shown that early treatment of venous insufficiency shortens ulcer healing time and that a delay of treatment as suggested in the proposed LCD only delays important care with the morbidity and expense associated with delay.) 

We think it is useful to define criteria which are not specified above but which reflect acceptable symptomatic or clinical criteria for coverage of treatment:

1. Significant pain or other symptoms of venous hypertension such as aching, leg fatigue, or soft tissue tenderness which interfere with activities of daily living (ADLs), or
2. Refractory dependent edema, or
3. Stasis dermatitis (CEAP Class 4 or greater), or
4. Venous leg ulcer, or
5. Spontaneous or traumatic hemorrhage from varicose, reticular, or telangiectatic veins, or
6. Recurrent episodes of superficial thrombophlebitis.

Non-invasive venous DIAGNOSTIC ultrasound examination and occasionally, plethysmography, are essential to evaluate lower extremity symptoms or physical findings such as:

• Pain, tenderness, aching, leg fatigue, restless leg syndrome, edema, symptomatic varicose veins, soft tissue bulges or palpable masses, leg ulcers, dermatitis, suspected superficial or deep vein thrombosis, skin discoloration. 

Preprocedural vein mapping is essential for ultrasound-guided foam sclerotherapy to define the target, non-target, perforating, and adjacent deep veins. This mapping should be performed the day of the UGFS and should be performed by the clinician performing the UGFS or by a vascular technologist who provides the mapping information to the treating clinician. This mapping is best coded with CPT 93971 (limited extremity venous ultrasound). Ultrasound guidance for needle placement for injection of a sclerosant is coded with CPT 76942. Ultrasound mapping and needle guidance associated with thermal ablation techniques, use of Non-Compounded (proprietary) Foam, and MOCA are included in the CPT descriptions and practice expense allocations and are not to be separately billed.

Venous ultrasound exams, CPT 93971 (limited extremity), are indicated as a single study within 7 days of treatment of saphenous or perforator veins to evaluate success of vein ablation and to rule out procedure-related deep vein thrombosis. Venous ultrasound also is indicated to evaluate for new or recurrent symptoms after treatment that might be related to procedure complications or progression of venous disease. There is no agreement regarding the frequency of venous ultrasound exams after treatment otherwise, but it is reasonable to perform a venous diagnostic ultrasound exam after a defined course of treatment (often several treatments) if there are significant residual symptoms or clinical findings suggesting incomplete treatment. (Cartee, et al).

We agree with some of the “Limitations”, but others are not supported by the evidence or by a reasonable standard of care.

1. Intolerance to compression is not a reason to deny otherwise appropriate care as previously discussed,
2. We agree that acute deep vein thrombosis is a contraindication to elective treatment of venous insufficiency, but many patients who have significant residual venous obstructive changes after the acute DVT has resolved may be treated selectively with superficial venous ablative techniques when reflux in those superficial veins is a clinical problem. The language about “obliteration” of the deep venous system should be removed,
3. Venous malformations (VMs) including those associated with Klippel-Trenaunay are commonly and effectively treated with UGFS. Many of these patients have local pain from enlarging venous malformations and the enlarging VMs also may become an important source of venous reflux in the extremity. Many VM patients require periodic retreatment with UGFS as they also do with much more painful alcohol injections or ablative surgery, but UGFS is much less morbid and usually less expensive. Treatment of VMs with UGFS should be covered when local pain or tenderness interfere with QOL or when the VM contributes to symptomatic venous insufficiency,
4. “Advanced generalized systemic disease that limits quality-of-life (QOL) improvements following venous intervention” is vague and subject to misinterpretation by auditors years after the care has been provided. It may be reasonable to require a statement of the objective of treatment in such cases,
5. You require that equipment used for the covered procedures must be FDA-approved for the procedures performed. This is reasonable. It may be worth noting in the LCD that it is recognized that foam sclerotherapy is not FDA-approved even though the liquid component of the foam may be FDA-approved. UGFS has been in use in the United States for more than 20 years and is a standard of care for many venous disorders with an excellent safety profile. There is no financial incentive for a pharmaceutical company to seek FDA-approval which likely would cost more than the potential financial gain from having FDA-approval. Cartee, et al, wrote a thorough review of UGFS which was published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders in July, 2021 which strongly supports the use of UGFS.

[We] have agreed that we should make on additional suggestion to you about treatment of incompetent perforating veins. The SVS/AVF guideline document published in 2011 which is the first reference article listed in the bibliography of our comment letter recommends that incompetent perforating veins should be at least 3.5 mm in diameter for treatment. This figure remains generally accepted 10 years later and it may be helpful in discouraging abusive treatment.

Thank you for your review of our comments and suggestions. If we can be helpful to Palmetto as you finalize the LCD, please do not hesitate to contact us.

1. Gloviczki P, Comerota AJ, Dalsing MC, Eklov BG, Gillespie DL, Gloviczki ML, et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg 2011:53(Suppl 5):2S-48S.
2. Caggiati A, Bergan J, Gloviczki P, Eklof B, Allegra C, Partsch H. Nomenclature of the veins of the lower limb: Extensions, refinements, and clinical application. J Vasc Surg 2005;41:719-24.
3. Cartee T, Wirth P, Greene A, Straight C, Friedmann D, Pittman C, et al. Ultrasound-guided foam sclerotherapy is safe and effective in the management of superficial venous insufficiency of the lower extremity. J Vasc Surg Venous Lymphat Disord 2021;9:1031-40.
4. Welch H, Schul M, Monahan D, Iafrati M. Private payers’ varicose vein policies are inaccurate, disparate, and not evidence based, which mandates a proposal for a reasonable and responsible policy for the treatment of venous disease. J Vasc Surg Venous Lymphat Disord 2021;9:820-32.
5. Rabe E, Breu F, Cavezzi A, Coleridge-Smith P, Frullini A, Gillet J, et al., European guidelines for sclerotherapy in chronic venous disorders. Phlebology 2014:29(6):338-354.
6. Yamaki T, Nozaki M, Sakurai H, Takeuchi M, Soejima K, Kono T. Prospective randomized efficacy of ultrasound-guided foam sclerotherapy compared with ultrasound-guided liquid sclerotherapy in the treatment of symptomatic venous malformations. J Vasc Surg 2008;47:578-84.
7. Ali H, Saleh M, Mohammed W. Efficacy and safety of Duplex-guided polidocanol foam sclerotherapy for venous malformations, Int Angiol 2017;36(3):22-36.
8. Blaise S, Charavin-Cocuzza M, Riom H, Brix M, Seinturier C, Diamand J, et al. Eur J Vasc Endovasc Surg 2011;42(3):412-7.
9. Bergan J, Cheng V. Foam sclerotherapy of venous malformations. Phlebology 2007;22(6):299-302
10. Manjit S. Gohel, M.D., Francine Heatley, B.Sc., Xinxue Liu, Ph.D., Andrew Bradbury, M.D., Richard Bulbulia, M.D., Nicky Cullum, Ph.D., David M. Epstein, Ph.D., Isaac Nyamekye, M.D., Keith R. Poskitt, M.D., Sophie Renton, M.S., Jane Warwick, Ph.D., and Alun H. Davies, D.Sc., A Randomized Trial of Early Endovenous Ablation in Venous Ulceration New England Journal of Medicine, 378;22 nejm.org May 31, 2018

Thank you for your comments. We have received multiple comments on the issue of conservative therapy .We have taken into consideration and reviewed the comments on conservative therapy and the LCD was revised accordingly. We have received multiple comments on the issue of vein diameter and have taken it into consideration and have revised the LCD accordingly. We have received multiple comments regarding the different types of foam and have revised the LCD to reflect the different types of foam; physician compounded foam (PCF) and non -compounded foam (NCF).We have taken into consideration your comment to remove the sentence “Medicare would not expect to see the following when performing sclerotherapy” and have removed the sentence. We have added your comment to include a registered vascular technologist (RVT) to the Non-Invasive Venous Studies. We have removed the limitation for the Klippel Trenaunay Syndrome. We have removed the limitation of the language about “obliteration” of the deep venous system. We have responded to your comment and have added a response to require a statement of the objective of treatment in advanced generalized systemic disease that limits quality -of- life. We have responded to your comment that foam sclerotherapy is not FDA approved but is a standard of care for many venous disorders with an excellent safety profile. We have added your comment that incompetent perforator veins should be at least 3.5 mm in diameter for treatment in the LCD.