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Table of Contents 4

Developing and Revising Venous Classifications for SVP and CEAP

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Venous & Lymphatic Medicine Subspecialty Task Force

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Conflict of Interest Task Force

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Venous Ulcer Taskforce: A Multi-Society effort to serve the neediest vein patients

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Phlebectomy task force: Harnessing data to advocate for access to care (by ensuring sustainable payment)

Developing and Revising Venous Classifications for SVP and CEAP

By Kathleen Gibson, MD, FACS, FAVLS

Over the past couple of decades, those of us committed to the treatment of venous disease have recognized that importance of consistently and uniformly classifying our patients results in significant advances in how we conduct research and how we educate each other on venous disease. The CEAP classification system is currently in its 4th revision and is utilized in describing our patients in almost all research and publications. However, when we consider the venous system located in the pelvic region, we have found that CEAP is not an effective tool to describe the patient’s disease appropriately.

Dr. Kathleen Gibson

To better describe patients with pelvic venous disease, an international team led by Mark Meissner, MD, FAVLS, and the American Vein & Lymphatic Society (AVLS) developed a new classification tool, SVP – Symptoms, Varices & Pathophysiology of Pelvic Venous Disease. This new tool was described in the recent publication of the JVS-VL. (read the article) Now that we have a validated tool for classifying all patients with pelvic venous disease, the question has arisen as to how can we ensure that we are all trained on the proper use of the new SVP tool?

Well, thanks to a grant from the Foundation for Venous & Lymphatic Disease made possible by a generous gift from Medtronic, the AVLS is excited to develop an educational workbook that guides learners through a series of pelvic venous disease cases and trains each user to apply the appropriate SVP classification properly. Furthermore, the AVLS led by Kathleen Gibson, MD, FAVLS, has in development a mobile application for both android and IOS devices that quickly helps you correctly specify the SVP designation. The mobile application is expected for global release in early June 2021, followed by the SVP digital workbook in September.

But let’s not stop there! The AVLS and the American Venous Forum (AVF) have reached an agreement to take the digital workbook concept and develop a second workbook focused on training us on the appropriate use of the CEAP classification tool. The CEAP system has been in use for a couple of decades and just underwent its 4th revision in 2020. We have also recognized that while we are all reasonably adept at the C-Clinical designation of CEAP, we are not all as well versed in the E, A, & P. As such, a second team led by Fedor Lurie, MD, and Marc Passman, MD, will develop a CEAP workbook in parallel to the SVP workbook with an expected release date this summer.

Both workbooks will be available at the AVLS online store. Those interested in learning more about pelvic venous disease and how to appropriately classify our patients will be on the lookout over the summer to release these exciting new tools.

Plan to be part of the AVLS Annual Congress this October in Denver, CO (visit website), where you will be able to interact with your peers for a more in-depth understanding of the classification system and the supporting educational tools.

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Venous & Lymphatic Medicine Subspecialty Task Force

by Mark Meissner, MD, FAVLS, DABVLM

Dr. Mark Meissner

The American Vein & Lymphatic Society (AVLS) has long recognized the importance of developing Venous and Lymphatic Medicine as a medical sub-specialty. This significant patient population has been underserved by 20 years of technological advancement. Few training opportunities encompass the breadth of cognitive and procedural skills required of the venous specialist. With the goals of improving standards for patient care and eventual subspecialty recognition, the American College of Phlebology (now the AVLS) developed the American Board of Venous and Lymphatic Medicine (ABVLM) now an independent certification entity, in 2007. The ABVLM has accomplished a great deal in the last 14 years, including developing the core content for venous and lymphatic medicine; establishing program requirements for training programs; defining milestones in a trainee’s education; establishing fellowship programs in Venous and Lymphatic Medicine; and developing a rigorous, psychometrically validated certification examination with ongoing maintenance of certification. There are currently 884 diplomates of the American Board of Venous and Lymphatic Medicine and 5 fellowship programs training as many as 8 fellows per year.

knowledge and skills, the ABMS developed a Focused Practice Designation (FPD) pathway in 2017. Focused practice designations are developed under the supervision of individual specialty boards and require that the physician retain active board certification in that specialty.

Focused practice designations generally require documentation of clinical practice experience as well as an examination. (board-certificationrequirements) Thirteen FPDs are currently offered by 9 ABMS boards. Although the FPD process may provide a valuable experiencebased pathway for recognizing venous and lymphatic medicine, it has the disadvantage of residing under an individual medical board and being available only to diplomates of that board.

The AVLS strongly believes that venous and lymphatic medicine is a truly multidisciplinary specialty that benefits from cross-disciplinary skills found beyond the scope of any single specialty board. A specialist in venous and lymphatic medicine must have knowledge and experience in diagnostic and interventional ultrasound, venous thromboembolism, lymphatic disease, wound care, sclerotherapy, superficial venous disease, deep venous disease, and pelvic venous disorders, the entirety of which a single specialty rarely encompasses.

The pathway to the development of an American Board of Medical Specialties (ABMS) subspecialty is primarily a formal training-based pathway, generally requiring the existence of 20 to 40 training programs before consideration of an application. However, recognizing that medical practice evolves and that experience also has a role in developing specialized

A Focused Practice Designation in venous disease has been recently proposed to the American Board of Surgery. Both the AVLS and ABVLM view this as a valuable opportunity to establish a dialog with the ABMS regarding recognition of venous and lymphatic disease as a multidisciplinary subspecialty.

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• Demonstrate your support for recognizing venous and lymphatic medicine as a distinct area of medical practice by becoming a diplomate of the ABVLM.

The AVLS has established a task force to advance this issue with goals including increasing awareness of venous and lymphatic medicine among the member boards of the ABMS and exploring options for eventual ABMS recognition of the specialty, whether through an FPD or a true subspecialty process. The task force is led by Dr. Jeff Schoonover, with members from most specialties represented by the AVLS, including general surgery, vascular surgery, vascular medicine, cardiology, internal medicine, family medicine, emergency medicine, gynecology, and dermatology.

• Promote the AVLS position that venous and lymphatic medicine is a multidisciplinary specialty involving knowledge and skills that come from diverse areas of medicine and are not confined to any single currently existing medical specialty. Patients are best served by a specialist who can incorporate the knowledge and skills of diverse specialty backgrounds into their practice.

This opportunity is significant for our specialty and should not be ignored. Not only would a recognized multidisciplinary process promote uniform, high-quality care for our patients, but it would also help avoid the specialtybased credentialing restrictions occasionally put in place to exclude otherwise qualified practitioners. Optimally, such a process would recognize and accept the high-quality work already done by the ABVLM.

AVLS SUBSPECIALTY TASK FORCE SPECIALTY

The ABMS is most responsive to diplomates of its member boards, and the pathway toward recognition of venous and lymphatic medicine will require the efforts of our members to educate their respective boards regarding the importance of multidisciplinary recognition.

Steps that you can take as an individual member include, • Get involved in the dialog and volunteer to represent your specialty by contacting Robert White (rwhite@myavls.org) for more information.

• Coordinate efforts with your specialty representatives on the AVLS Subspecialty Task Force. They can provide further information about how to contact and discuss these issues with your respective medical board. Approaching each board in a structured manner will be key in educating the boards regarding the multidisciplinary nature of venous and lymphatic medicine.

• Maintain certification with your primary ABMS specialty designation.

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TASK FORCE REPRESENTATIVES

Dermatology

Vineet Mishra, MD Margaret Mann, MD

Emergency Medicine

Marlin Schul, MD • Satish Vayavegula, MD

Family Medicine

Jeff Schoonover, MD Lisa Amatangelo, MD

Interventional Radiology

Robert Worthington Kirsch, MD Ron Winokur, MD

Internal Medicine

John Fish, MD Marcus Stanbro, DO

Surgery

John Blebea, MD • Stephen Daugherty, MD • Zoe Deol, MD • Nick Morrison, MD • Peter Pappas, MD

Obstetrics & Gynecology

Theresa Soto, MD

AVLS / ABVLM Leadership

Tony Comerota, MD Terri Carmen, MD Neil Khilnani, MD Mark Meissner, MD Julianne Stoughton, MD

CONFLICT OF INTEREST Task Force

by Mark Meissner, MD, FAVLS, DABVLM

W

hile many of the American Vein & Lymphatic Society’s initiatives are driven by our longrange strategic plan of advocacy, research, and education, others are more short-term and are undertaken at the request of our members. Such initiatives encourage direct participation in society activities, with recent examples including the phlebectomy coding and the venous ulcer task forces. One additional task force was created in 2020 to review the Disclosure Policies of the AVLS. The COI (Conflict of Interest) Task Force was developed to review the current disclosure policies of the AVLS and how potential conflicts of interest are handled.

We recognize that many of our members and leadership have developed various relationships with commercial entities over the years ranging from consultation to advisory, research, and various levels of employment and financial interest. While we recognize that these relationships are significant to advancing the field in general, these relationships also present the potential to develop into a conflict of interest when working and volunteering for the Society. Furthermore, we recognize and appreciate the participation of our commercial partners in achieving our mutual goals of improving patient access to appropriate care through educational activities such as our Annual Congress. Concerns by our members over perceived conflicts of interest in the field over the past several years led to the development of this task force to take a fresh look at our policies and procedures for our leadership, committee service, and educational activities.

Participating in the task force are Cindy Asbjornsen, John Blebea, Steve Elias, K. Francis Lee, Chris Pittman, Jeff Schoonover, and Mark Meissner - Chair with staff support from Dean Bender, Executive Director, Joyce King, Director of Continuing Education and John Mangold, Managing Director of FVLD & Corporate Relations. Following various research and several deliberations, the task force made the following policy recommendations that the AVLS Board of Directors approved on May 10, 2021.

LEADERSHIP RECOMMENDATIONS • Board members are required to disclose all financial relationships of any amount that they have had with any commercial interests over the previous 24 months.

• Board members will recuse themselves from any discussions of or voting on matters regarding entities with whom they have a conflict of interest.

• Board members are asked not to speak on behalf of any entity, product, or service at events tied to the AVLS Annual Congress, including events such as industry-sponsored satellite symposia and receptions.

• Board members are encouraged to consider donating income derived from industry relationships to the Foundation for Venous & Lymphatic Disease.

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COMMITTEE SERVICE • Committee volunteers are required to disclose all financial relationships of any amount that they have had with any commercial interests over the previous 24 months.

• Committee volunteers will recuse themselves from any discussions of or voting on matters regarding entities with whom they have a conflict of interest.

EDUCATIONAL PARTICIPATION The AVLS is an accredited body of the ACCME and, as such, adheres to all requirements related to disclosures and conflict resolution as prescribed (standards resources). A few key highlights are; • All Organizers, faculty, and speakers at any AVLS Educational event eligible for continuing education credits are required to disclose all financial relationships of any amount that they have had with any commercial interests over the previous 24 months.

• All disclosures are subject to verification by the AVLS. An AVLS peer review committee will review any potential conflicts of interest that arise from a disclosure and resolve the conflict prior to the educational event. While a speaker’s disclosures are required to be presented at an educational event, it is essential to understand that any disclosures that could be a conflict of interest for the presenter have been resolved before being permitted to present.

These measures will hopefully eliminate even the appearance of conflicts of interest among members of the Board of Directors, Committee Volunteers, and our Distinguished Educational Faculty and provide an example of the pathway by which the Society can address member issues.

If you have a concern or particular interest, all members are encouraged to contact the Board of Directors to discuss how it can be best addressed.

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Venous Ulcer Taskforce: A Multi-Society effort to serve the neediest vein patients Dr. Marlin W. Schul

Marlin W. Schul, MD, RVT, FAVLS, DABVLM

• The NEJM EVRA Trial showed how important early intervention was in healing venous ulcers.

As vein care clinicians, we know that venous ulceration presents not only a clinical challenge but also an excellent opportunity to help those patients most in need. The landmark New England Journal of Medicine study, Early Endovenous Ablation in Venous Ulceration, or the EVRA trial, gave real-world evidence on early intervention and time to healing.

• New LCDs for Novitas and First Coast allow prompt treatment for venous patients who would likely NOT benefit from a period of conservative care.

• Improving Wisely identified a global gap in care, suggesting that less than 1% of VLU patients acquire surgical intervention of ANY type.

Despite Level I evidence, many barriers continue to exist, delaying referral for vascular evaluation in those most in need of vein care. A group of physicians representing several disciplines came together in 2020 to launch a project to brainstorm how we might collectively change the narrative and move the needle to ensure those with a leg ulcer receive a prompt referral and diagnostic vascular assessment of the limb(s).

• We all identify that the IW findings were not in error. We see patients in wound centers for years before they get a vascular referral.

• It is widely recognized that those treating venous ulcers in a wound center may not recognize venous leg ulcers, and often those that do recognize venous leg ulcers do not know to whom to refer their patients.

In sum, the task force’s charge is to support patient access to needed venous care by creating and disseminating evidence-based protocols for venous ulcers and diagnostic assessment of suspected venous ulceration.

Particular emphasis is placed on reaching and educating providers who might not be vascular or venous specialists on how they need to work up suspected ulcer patients.

• The AVLS Registry and private data from the wound care community could be leveraged to give insight into key clinical questions.

• Current Multi-Society Composition of the Ulcer Taskforce. » Marlin Schul- AVLS co-chair » Harold Welch- AVF co-chair

WHY NOW? HOW DID WE ARRIVE AT THE POINT?

» Joe Raffetto-AVLS » Eri Fukaya- SVM

Several factors served as motivation for the task force. Namely,

» Leigh Ann O’Banion- AVF, SVS

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» William Marston- AVF

• Vein Intervention - timing, mixed deep and superficial, proximal obstruction

» William Ennis- AWCA, Healogics Medical director

• Wound care principles - debridement, cleansing, infection mgmt,

» Michael Vasquez- AVF

• Reduction of edema - compression review, all options, pumps, etc.

» Samih Bittar- SVM » Mark Meissner- AVLS President

» Nontypical features with or without venous/arterial findings - biopsy.

CURRENTLY, THE TASK FORCE IS FOCUSING ON A FEW KEY PATHWAYS

» Benchmarks in wound healing.

• 40% less within three weeks

• VLU Algorithm: Expanding on some textbook materials already in use, the task force is developing a flow chart algorithm for care of VLU patients providing visual cues, H&P features, and the understanding that formal vascular evaluation is imperative early in the process. The task force is working on this collaboratively with hopes we’ll have something to share in the coming months.

• Adjunctive considerations • Indications for biologics • Indications for iliac stents » Registry Project: Given the hurdles we have identified and made widely evident in the literature, we have realized we have nearly two thousand patients with leg ulcers. This population will be studied from the AVLS PRO Registry to determine the characteristics of leg ulcer subjects attending vein centers.

Post-thrombotic, isolated SVI, mixed deep and superficial reflux, lymphedema wounds, etc. The end product here is a better characterization of all presenting with wounds to clinics participating in the registry.

• Up to Date: The task force has connected with the vascular surgeon who curates the venous ulcer section of Up to Date, the country’s leading database of care guidelines. Eri Fukaya is leading this effort with Hal Welch, Sam Bittar, and Leigh Ann O’Banion writing various content pieces that will be submitted to Up to Date for the dedicated Venous Leg Ulcer section. The sections below parallel the algorithm above, yet will be different channels to promote this message:

• Long-term Project: The task force has opened the door to a longer-term project targeting the economic impact of deferred ulcer care and its impact on beneficiaries and costs to society. At this time, efforts are being taken to build bridges among multiple resources to try and accurately tackle this complex problem.

» Definition of a venous leg ulcer » History & Physical Exam features. » Images of findings including different ulcer types » Pulses/ABI » Diagnostic Ultrasonography • Deep & superficial systems • Arterial system • Importance of proper positioning for accuracy of diagnosis

The task force represents an excellent multi-societal collaborative effort, focused on expanding awareness of venous leg ulcer pathology while meeting the collective needs of patients throughout the United States. This year should see substantive written guidance, as well as input to evidence-based protocols. Stay tuned for future updates.

» Ulcer Management 10

PHLEBECTOMY TASK FORCE: Harnessing data to advocate for access to care (by ensuring sustainable payment) John Blebea, MD, MBA, FACS Kenneth Harper, MD, FACS, RPVI, RPhS

Dr. John Blebea

Dr. Kenneth Harper

As AVLS members are too well aware, officebased payment for many of the core vein procedures that we can offer our symptomatic patients has been in steady decline for over a decade. As part of the Medicare Part B Physician Fee Schedule, when the ResourceBased Relative Value System was introduced almost 30 years ago, Medicare payment rates set the bar for payment in the United States.

Over the past 18 months, a group of AVLS members has been working to infuse payment methodology with clinical and data-driven insights. The work has not been simple and has much to accomplish, but the effort stands so far as a work-in-progress on harnessing data to support appropriate payment changes.

phlebectomies to assess their responses regarding the two CPT codes describing the procedure. These survey results were collated and summarized, and a multi-specialty group of physician volunteers presented the data to the RBRVS Update Committee or RUC Panel. Since 1992, the RUC is the venue where specialties present their data and share their expertise about what RVUs they recommend to each CPT typically performed by that specialty. The two codes surveyed for ambulatory phlebectomy Çare 37765 (10-20 incisions) and 37766 (more than 20 incisions). There is no code for less than ten incisions.

As a result of the April 2018 RUC meeting, CMS agreed with the RUC recommendations.

Payment for the two phlebectomy codes (37765 & 37766) was adjusted for 2020 and dropped by about 31% effective January 1, 2020. The global period for both codes has also been reduced from 90 days to 10 days.

SETTING THE SCENE In early 2018, specialty societies (e.g., AVLS, Vascular Surgery, Interventional Radiology) surveyed physicians who frequently perform

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This payment drop was substantial, and while no AVLS member was pleased with this, a deeper question of working to ensure that patients had sustainable access to office-based phlebectomy care took center stage. To explore how the AVLS could support a better payment outcome, AVLS President Dr. Marlin Schul and Presidentelect Dr. Mark Meissner charged a member task force to conduct an in-depth analysis and recommend an advocacy strategy that might hold the promise of both more clinical granularity and improved payment. Drs. John Blebea and Ken Harper were asked to co-chair the new task force.

“At the beginning of the process, I was well aware that the challenge before us was both a clinical matter, but also had to be seen in the context of the rather complex coding and payment system that we have here in the United States,” noted Dr. Blebea.

WHERE ARE WE TODAY? Early on, the task force’s work was energized by members who felt strongly that the deep cuts were a direct threat to patient care by potentially restricting access. The task force held several virtual calls in 2020. The task force members agree that the current coding paradigm based on the number of phlebectomy sites is unwieldy and does not lend itself to the clinical granularity required. However, the challenge is to develop a new framework that will hopefully more accurately reflect the clinical

work involved, but this is by no means certain.

Defining a new coding paradigm is under active discussion, but the consensus is that a coding paradigm based on treatment zones will offer more granularity and describe the actual work better than the current “number of stabs” approach.

HARNESSING DATA & NEXT STEPS In early 2021, Drs. Blebea and Harper began to coordinate with the AVLS PRO Registry Committee to see if there is data to inform our next steps. A registry research proposal has been developed to track cases and provide greater detail about patient characteristics and treatment zones. “We know that we cannot just rely on our own anecdotal opinion,” noted task force co-Chair Dr. Ken Harper. “Our strategy must have evidence behind it if we are to go forward and convince the national authorities that a new coding framework is required.” Any AVLS member who performs phlebectomy should work to get their data into the Registry platform. We will analyze the data submitted to the Registry and see if this can provide substantive direction going forward. In addition, work is underway to develop a mobile app for physicians to track phlebectomy procedures and report that data to the AVLS. The task force’s work is a multi-year effort, but the task force is committed to getting the best outcome for AVLS members and patients.

TASK FORCE MEMBERS John Blebea, MD, MBA, FACS Ken Harper, MD, FACS, RPhS James Albert, MD, RPVI, FAVLS Marlin Schul, MD, MBA, RVT, FAVLS, DABLVM Francis Lee, MD Robert Merchant, MD, FACS, FAVLS Mark Meissner, MD, FAVLS Dan Monahan, MD, FACS Stephen Daugherty, MD, FACS, FAVLS, RVT, RPhS

Chris Pittman, MD, FAVLS, FACR Nick Morrison, MD, FACS, FAVLS, RPhS Steve Elias, MD, FACS, FAVLS, DABVLM Paul McNeil, MD Michael Manning, MD Duane Randall, MD Satish Vayuvegula, MD, MS, FAVLS Michael Graves, MD Mark Iafrati, MD

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AVLS 35th Annual Congress October 7-10, 2021 Denver, CO & At Home www.avlscongress.org

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