myAVLS Magazine, Issue 2 - Oct. 2020

Treat Incompetent Perforator Veins with Precision

AngioDynamics 400 micron Perforator & Accessory Vein Ablation Kit (PVAK): Cleared for use with perforator veins.

ANGIODYNAMICS HAS THE PERFECT SOLUTION Venous disease is the most common cause of leg ulceration. Early endovenous ablation of superficial venous reflux has been shown to result in faster healing of venous leg ulcers1.

You can treat Incompetent Perforator Veins (IPVs) with precision, thanks to the 400 micron Perforator & Accessory Vein Ablation Kit from AngioDynamics.

LEARN MORE: 1-800-772-6446 • go.angiodynamics.com/400MicronPVAK 1Gohel, M., Heatley, F., Liu, X., Bradbury, A., Bulbulia, R., Cullum, N., Epstein, D., Nyamekye, I., Poskitt, K., Renton, S., Warwick, J. and Davies, A. (2018). A Randomized Trial of Early Endovenous Ablation in Venous Ulceration. New England Journal of Medicine, 378(22), pp.2105-2114.

RISK INFORMATION Indications for Use: The VenaCure EVLT 400 μm Perforator and Accessory Vein Ablation Kit is intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities.The VenaCure EVLT 400 μm Perforator and Accessory Vein Ablation Kit is indicated for treatment of incompetence and reflux of superficial veins in the lower extremity, and for treatment of incompetent (i.e. refluxing) perforator veins (IPVs).

Contraindications: Contraindications include but are not limited to the following, Patients with thrombus in the vein segment to be treated. Patients with an aneurysmal section in the vein segment to be treated. Patients with peripheral arterial disease as determined by an Ankle-Brachial Index < 0.9. Patients with an inability to ambulate. Patients with deep vein thrombosis (DVT). Patients who are pregnant or breast feeding. Patients in general poor health. Other contraindications may be raised by the individual physician at the time of treatment.Extremely tortuous vein segments may require treatment by alternative techniques (phlebectomy, sclerotherapy).Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. AngioDynamics, the AngioDynamics logo, and the VenaCure PVAK logo are all trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate, or a subsidiary. © 2020 AngioDynamics, Inc. US/VI/AD/382 Rev 01 09/2020

Table of Contents LETTER FROM THE PRESIDENT.................................................................................................................................................... 4 AN UNUSUAL DAY IN THE NEIGHBORHOOD........................................................................................................................... 7 PROPOSED CHANGES TO IAC VEIN CENTER STANDARDS.............................................................................................. 9 VISION FOR THE FUTURE FROM THE NEW AVLS PRESIDENT....................................................................................... 12 PRO 2.0 VENOUS REGISTRY: SO, WHATâ&#x20AC;&#x2122;S IN IT FOR ME?.................................................................................................14 VIRTUAL, IN-PERSON, AVLS PREPARES FOR 2021.............................................................................................................. 17 PROGRESSING VENOUS, LYMPHATIC MEDICINE THROUGH CERTIFICATION.........................................................18 ABVLM CLASS OF 2019....................................................................................................................................................................19 AVLS ULTRASONOGRAPHY SECTION CREATES PROTOCOLS, DEVELOPS DISTANCE LEARNING...............23 WHO ARE AVLS MEMBERS?..........................................................................................................................................................24 THE FINANCIAL IMPACT OF COVID-19 ON VENOUS, LYMPHATIC MEDICINE..........................................................28 SERVING AVLS MEMBERS: ADVOCACY .................................................................................................................................33 SUPPORT THE FOUNDATION FOR VENOUS & LYMPHATIC DISEASE.........................................................................39 FVLD SUNRISE YOGA.......................................................................................................................................................................39 6TH FUN RUN & WALK ...................................................................................................................................................................39 AVLS RESEARCH: PHASE II OF IMPROVING WISELY POISED TO COMMENCE ..................................................... 40 COMPARING 2017 TO 2019 CLAIMS 2021 AVLS BOARD OF DIRECTORS............................................................................................................................................45 YOUR AVLS STAFF........................................................................................................................................................................... 46

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Letter from the President

By Dr. Marlin Schul, AVLS President 2019-2020

It has been an honor and privilege to serve the Society over the past two years. In my wildest dreams, I could not have imagined the organization I have known for 16 years to have evolved into such an active society. In no particular order, I will share some highlights of the AVLS and where we are going as we transition executive leadership. I am grateful for my time leading this Society. I look forward to maintaining my involvement in various committees and as Chairman of the Foundation for Venous & Lymphatic Disease.

I’ll spell out details in the areas below, but THIS SOCIETY IS RELEVANT due to our commitment to advocacy and research.

• myAVLS Community (MAC) Became Reality – Members connecting with members is always a goal. How can we build more awareness of the process and share interesting cases?

How can members learn more about a specific condition or educational offering?

The MAC allows providers to post videos, ask other members about compelling cases, and get real-time feedback. Although in its infancy, we anticipate Ultrasound Sections, Lymphedema Sections, Advocacy Sections, etc. The board’s vision of finding more ways to connect members through the myAVLS Community is accomplishing its intent, and I encourage you to become engaged and share any feedback you may have.

MEMBER SERVICES • Name Change to Fit the Scope of Practice and Description of our Membership – We have learned that swollen legs do not always have a reflux cause of the problem.

Early data from the AVLS PRO Venous Registry estimates that no less than 3% of all visits have a lymphatic component as their primary problem. More and more providers have incorporated services for the lymphedema in their practices. In fact, of the American Vein & Lymphatic Society (AVLS) educational offerings, those involving lymphedema are consistently the most popular sessions.

• AVLS moved Annual Congress from November – The AVLS meeting calendar shifted to early or mid-October as the target dates for the foreseeable future. This timing offers better access for our members, avoiding the time crunch in November, increasing the accessibility for our members to our annual Congress, and navigating the Thanksgiving holiday during a traditionally busy time of the year.

• A True Shift in Mission Has Taken Flight, Built on Pillars of Advocacy, Research, and Education – As Mark Meissner said at the time, “We have always delivered on education, and expansion to the other areas adds value if we can do it right.” Indeed, advocacy is vital to every specialty, and the approach is not as easy as saying “we are advocates.”

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ADVOCACY

with medical directors of government and commercial payers have enhanced access to care in nearly every market. The payers care about data. Leveraging the Improving Wisely data by Medicare Contractor (MAC) and multiple recent manuscripts that run parallel regarding utilization trends opened the door to the more reasonable policy than we have seen in years.

• The Advocacy Department quickly develops structure and takes wins! Indeed, with a full-time director in Robert White, and decades of experience in the Healthcare Policy Committee (HCP) with Dr. Stephen Daugherty as chair, the AVLS has become relevant to patients, providers, other specialty societies, industry, and payers.

• Ambulatory Phlebectomy Task Force was developed – The 30% drop and repricing of CPT37765 & 37766 caused a ripple in our Society and would have been worse had YOUR Society not taken action to support practice expense. This task force, led by Drs. John Blebea and Ken Harper, is actively identifying opportunities that could lead to reclassifying phlebectomy codes by region(s).

• AVLS has an active Healthcare Advocacy Advisory Committee (HAC) led by Dr. Chris Pittman, that battles many issues each year focused on patient access to care, appropriate reimbursement, and standards of care, e.g., preventing abuses. »» HAC Chair – Chris Pittman, MD (AVLS AMA Delegate & CAC Member FCSO) »» Vice-Chair – Vineet Mishra, MD (AVLS AMA Alternate Delegate)

• Our Society is increasingly being looked to for leadership in advocacy and asked by carriers for guidance on policy. There are many wins you will hear about, and the wins will keep on stacking as long as we maintain the focus on patients and access to care for those in need.

»» John Blebea, MD (AVLS RUC Advisor) »» Trip Todd, MD (AVLS RUC Alternative Advisor) »» Satish Vayuvegula, MD (AVLS CPT Advisor) »» Michael Graves, MD (AVLS CPT Alternate Advisor & CAC Member NOVITAS)

RESEARCH • AVLS PRO Venous Registry transitions from PRO 1.0 to PRO 2.0 The AVLS has the largest vein registry hosting quality of life outcomes for superficial venous disease than any other database at this time. Utilization standards found in Crawford, Baber, and the Improving Wisely project have a high correlation with the data in AVLS PRO. Over the past two years, we have been transitioning to the PRO 2.0 platform to aid in data extraction and to expand the registry to include deep and pelvic venous disease in addition to the superficial disease of PRO 1.0, and to allow providers more robust comparisons of their performance with the aggregate.

»» Stephen Daughtery, MD (AVLS HPC Chair & CAC Member Palmetto) »» Ken Nguyen, MD (AVLS Rep. to IAC Vein Center Board) »» Carl Fastabend, MD (AVLS Rep. to IAC Vein Center Board) »» Another (20) volunteer members of this committee offer thorough coverage of our national policy issues.

• The efforts of the advocacy committees have arguably led to greater access to care versus where we were two years ago. We identified through the 21st Century Cares Act that Medicare Contractors had an obligation to meet with societies when a coverage or policy issue was a concern. Through the course of multiple face-to-face meetings

• The Improving Wisely Project provided data that could be broken down by Medicare 5

Contractor (MAC) and shared with medical directors about their respective regions.

This activity demonstrated an opportunity for MACs to rein in policy where needed and enhance access to care and treatment options elsewhere. The second iteration of the Improving Wisely project is forthcoming with the leadership of Dr. Margaret Mann.

Stay tuned as we see if trends have changed over the past two years.

Society has many additional modules under development, offering even more options for our members.

• 2020 Annual Congress is 100% Virtual! – COVID-19 has changed everyone’s usual way of doing things. The same is true as there is no face-to-face meeting in Washington, DC. What has changed is the content delivery, where we’ll have both livestreamed opportunities and additional access to recorded versions through the end of the year. A total of 80.75 hours of CME are possible, and the “Live & Interactive” portion we have come to expect in our Annual Congress will continue to be a significant part of the livestreamed sessions.

• AVLS PRO Registry Writing Groups are working in parallel One recent and critical manuscript regarding the Anterior Accessory Great Saphenous Vein (AAGSV) manuscript has helped change policy to covering treatment for this anatomy. It came solely based on data from the registry. There are many more projects coming as we have writing groups seek to address well established and new treatments and respective outcomes using the registry alone.

• AVLS wins the host role for the 2023 World UIP Meeting in Miami Beach, Florida! – Looking ahead, your Society has committed to hosting the 2023 International meeting, along with our continental partners in North America (Canadian Society of Phlebology, American Venous Forum, and the Mexican Academy of Phlebology & Lymphology). The UIP meeting has traditionally been a wellattended scientific meeting, and Miami is accessible to everyone. Place this on your schedule!

• Guidelines Efforts are continuing – Dr. Mark Meissner has led multiple multisocietal efforts, including the C2 disease guidelines, chronic venous obstruction, lymphedema, and pelvic vein reflux, and the Society has begun a new effort targeting lymphedema. A landmark article will soon be published as the guide to classifying pelvic vein incompetence.

This Society relies upon its members for sustainability, and we take that very seriously.

The executive leadership, volunteer advisory committees, and HQ Staff consistently look for ways to build value in membership to the AVLS. No matter where you look, the Society has delivered in every pillar despite COVID-19 challenges. We cannot do these activities without members and feedback to guide our actions.

EDUCATION • Sclerotherapy Immersive Course (Virtual Reality) – Using a virtual reality headset, participants feel like they are in the room as Dr. Margaret Mann demonstrates her technique for small vein sclerotherapy. The course extensively covers large and small vein sclerotherapy.

The AVLS education portal will share VR headsets and ship the devices and content directly to the address provided. Reviews of this program have been a hit, confirming that this type of education done at the student’s time is truly cutting edge. YOUR

In closing, I am pleased to report that YOUR executive leadership and HQ staff are primed to take the Society to greater heights over the coming years. I encourage you to get involved!

Find a place to serve as our committees’ work can accomplish so much to advance our mission and to improve the future of our field, our practice, and, most importantly, our patients!

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An Unusual Day in the Neighborhood.

By Dean Bender, AVLS Executive Director

2020. Where do we begin when we stop to reflect on the past year’s trials and accomplishments of the American Vein & Lymphatic Society? Perhaps we start with the November 2019 release of “A Beautiful Day in the Neighborhood” and borrow a phrase from the late Fred Rogers, “Can you say PANDEMIC?” Who would have ever guessed coming out of our Annual Congress in Phoenix, AZ last November that we would now be seven months into a global pandemic that has reshaped how we live our lives and how we interact with each other daily? Perhaps today’s word in a Beautiful Day would be, “Can you say ZOOM?” Dean Bender

membership as we are still not out of the woods.

Fortunately, throughout this past year, as many were seeing cutbacks, the Society’s membership experienced slight growth at 1%. It is critical that the membership base remains strong and committed for the Society to be able to provide the support and resources for our members.

Throughout the MyAVLS magazine, you will read about the various accomplishments of the Society’s various committees. I would like to highlight a few of the most significant here related to each of our core pillars, Advocacy, Research, and Education.

Following 18 months of intense work led by Dr. Marlin Schul, President AVLS, the Advocacy Committee saw the release of new LCDs from First Coast and Novitas that, if approved, will significantly improve access to quality care for our patients with chronic venous disease.

Needless to say, the past year for the AVLS has been one of our busiest and most productive years as a Society and, without a doubt, one of our most challenging.

Starting with our greatest asset, our members, the Society rallied together in late March and undertook the task of supporting each other with the development of a COVID-19 resource library (www.myavls.org/covid19). Our “A Part|Together” campaign provided members with the information they needed to know specific to the needs of a practitioner in venous & lymphatic disease. In addition to a series of articles ranging from telemedicine and practice guidelines to PPE and financial support, the Society hosted a series of webinars bringing legal and business experts directly to the membership to help guide us all through this storm. While we are still trying to push through to the other side of this pandemic, the Society continues to maintain the resource library and bring current and relevant information to our

In research, the Operations Committee led by Dr. Joe Jenkins completed the development of the PRO Venous Registry 2.0. The more modern platform expands the breadth of our research capability beyond superficial venous disease into deep and pelvic disease and more in-depth research into lymphedema and compression therapy. New writing groups led by Dr. Marlin Schul will undertake a variety of research projects for the Society utilizing the data from the PRO 2.0 Registry.

And in education, the Society, through a grant from the Foundation for Venous & Lymphatic Disease, launched its first Immersive education course utilizing virtual reality technology. The Immersive Sclerotherapy Course: VR 360, 7

chaired by Dr. Margaret Mann, launched in May. Participants have been impressed by the “near live” environment, which transports learners directly into the lecture hall and the procedure room to experience actual patient procedures. The unique nature of virtual reality is that it permits the student to determine where their attention is placed during the course and is not limited by the focus of the cameraman as experienced in a traditional 2-dimensional video program. The Society has now begun production of additional educational modules to encompass many phlebological procedures.

Most significantly, an international project initiated by the late Dr. Mel Rosenblatt and Drs. Mark Meissner and Neil Khilnani to develop a classification tool for pelvic venous disease, SymptomsVarices-Pathophysiology (SVP), is being introduced at the 2020 Annual Congress. The SVP classification tool will enhance our ability to study and understand patients across the world that suffer from pelvicrelated venous disease.

I have mentioned only a few of the Society’s major accomplishments to advance the specialty for our membership, the field in general, and our patients this past year during a global pandemic.

We encourage you to stay abreast of the Society’s work through our weekly

topical newsletters, our new website www.myavls.org, and the recently launched MAC (myAVLS Community) digital community, where you can interact with other members on a variety of topics and issues daily. These are great ways to remain in touch with your fellow members and to engage in the various opportunities to volunteer and make a difference for the specialty.

I also hope that you will take the opportunity to get to know the various staff people employed by the AVLS that bring a variety of backgrounds and expertise to the Society and are dedicated to supporting the membership in achieving the mission and goals of the Society. They adapted and performed well during the pandemic, learning how to work remotely for a few months and continue to function as a team, while taking on the additional support our membership required through the early stages of the pandemic on top of the normal daily activities of supporting the AVLS. While they know I am proud of how they have performed through this all, I want you to know you have a great team at your disposal, and I hope you will take an opportunity to reach out to them and share your appreciation as well.

Here we are in October 2020, getting ready to start our 34th Annual Congress, where for the first time in our history, we will not be meeting in person.

Yet Dr. Margaret Mann and 8

her program committee have put together a stellar program with over 300 presentations by more than 150 individuals covering all aspects of venous and lymphatic disease. With the technology engaged for the 34th AVLS Virtual Annual Congress, we are now able to provide over 80 hours of CME credit from a single event!

Although we are not together in-person, we have added several opportunities for you to gather digitally with your colleagues. We hope you will find these events engaging and entertaining opportunities to support the fundraising efforts of the Foundation for Venous & Lymphatic Disease. Without the support of the FVLD, many of the Society’s successes would not have been possible. We hope you will participate in the various activities and consider donating to the Foundation.

While it is important to reflect on the struggles and accomplishments of the past year, I am looking forward to when we can gather again in Denver, CO, October 7-10, 2021, to celebrate all that we have accomplished over this next year. The AVLS neighborhood is full of terrific people dedicated to making a difference in our specialty. No matter the challenges we face, please know that you are not alone, and tomorrow will once again be “A Beautiful Day in the Neighborhood.”

I look forward to seeing you there!

Proposed Changes to IAC Vein Center Standards

By Khanh Q. Nguyen, DO, RPVI, IAC Board of Directors

T

he Intersocietal Accreditation Commission (IAC) provides accreditation programs for vein treatment and management. The IAC programs for accreditation are dedicated to ensuring quality patient care and promoting health care and all support one common mission:Â Improving health care through accreditationÂŽ.

At the most recent IAC board meeting, members discussed two significant changes to the current standards. These changes are currently in a comment period and will likely go into effect by the Fall of 2020. The first major change deals with providing guidance for Advanced Practice Providers (APPs) in accredited Vein Centers. The second change pertains to adding an additional pathway for qualification for the Medical Director and/or Medical Staff.

Under the revised Vein Center Standards, APPs may perform the following superficial vein skills: patient evaluation and management, visual sclerotherapy, ambulatory phlebectomy, and saphenous vein ablation under the personal supervision of a qualified medical staff member. Personal supervision is defined as the Physician is in attendance and in the room during the procedure. An APP may also perform certain skills with direct or general supervision within the vein center after qualifying in at least one of three pathways summarized in the Table below. Direct supervision is defined as the Physician must be present in the office suite, immediately available, and general supervision is defined as Physician presence is not required during the procedure but should be available by phone.

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New providers without prior skill-specific experience

Provider with skill-specific experience in a facility other than the applicant facility

Provider with skill-specific experience in the applicant facility

Evaluation and Management of Venous Disease

A minimum of 100* patients evaluated over the previous three years under personal supervision1 of a qualified medical staff member. At least 30* cases must include personal observation of that patientâ&#x20AC;&#x2122;s diagnostic venous ultrasound examination(s).

A minimum of 25* patients evaluated over the previous three years under personal supervision1 of a qualified medical staff member.

A minimum of 25* patients evaluated over the previous three years under personal1, direct2, or general supervision3 of a qualified medical staff member.

Visual Sclerotherapy w

A minimum of 50* cases over the previous three years under personal supervision1 of a qualified medical staff member.

A minimum of 10* cases over the previous three years under personal supervision1 of a qualified medical staff member.

A minimum of 10* cases over the previous three years under personal1, direct2, or general supervision3 of a qualified medical staff member.

Ambulatory Phlebectomy

A minimum of 50* cases over the previous three years under personal supervision1 of a qualified medical staff member.

A minimum of 10* cases over the previous three years under personal supervision1 of a qualified medical staff member.

A minimum of 10* cases over the previous three years under personal1 or direct supervision2 of a qualified medical staff member.

A minimum of 50* cases over the previous three years under personal supervision1 of a qualified medical staff member.

A minimum of 50* cases over the previous three years under personal1 or direct supervision2 of a qualified medical staff member.

A minimum of 10* cases over the previous three years under personal supervision1 of a qualified medical staff member.

A minimum of 10* cases over the previous three years under personal1, direct2, or general supervision3 of a qualified medical staff member.

Skill

A minimum of 150* cases over the previous three years under personal supervision1 of a qualified medical staff member.

Ultrasoundguided Foam Sclerotherapy

Wound Care

OR A minimum of 50* cases over the previous three years under personal supervision1 of a qualified medical staff member if the APP holds an appropriate credential in vascular testing (RVT, RVS, RT(VS), RPhS).

A minimum of 20* cases over the previous three years under personal supervision1 of a qualified medical staff member.

In addition, APPs now have guidance and requirements for qualification, similar to Medical Staff.

All APPs are required to have a minimum of 30 hours of venous specific CME within the last three years. They must also have current Basic Life Support certification, and if performing procedures with moderate/IV sedation, Advanced Cardiac Life Support certification is required (even if another provider participating in moderate/IV sedation cases already possesses such certification).

With regards to Medical Director and Medical Staff qualifications, applicants can now qualify with certification by the American Board of Venous and Lymphatic Medicine. Previously, the only pathways available were either by documentation of experience or by formal training (Residency in a vascular specialty or Fellowship).

The full current and proposed Vein Center Standards can be found at https://www.intersocietal.org/ vein/main/newsroom.htm. Comments are accepted until August 15, 2020.

Khanh Q. Nguyen, DO, RPVI Dr. Nguyen is the Chief Medical Officer for the Center for Vein Restoration and serves on the IAC Vein Center Board of Directors as a representative of the American Vein & Lymphatic Society (AVLS). Dr. Nguyen holds active certifications by the American Board of Osteopathic Emergency Physicians, the American Board of Venous and Lymphatic Medicine, and is a Registered Physician in Vascular Interpretation.

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Saphenous Vein Ablation Ambulatory Phlebectomy / Powered Phlebectomy

Sclerotherapy Non-Operative Management of Chronic Venous Insufficiency with Ulceration

The Intersocietal Accreditation Commission (IAC) accredits vein centers that provide venous evaluation and management and/or treatment procedures.

By participating in the accreditation process, vein centers assess every aspect of their daily operation and its impact on the quality of health care provided to patients. IAC Vein Center accreditation provides participating facilities with a foundation to create and achieve realistic quality care goals and an opportunity for marketing their accreditation status to referring physicians as well as current and potential patients.

While the accreditation process is still voluntary for most, some insurers across the nation have begun to implement policies that require IAC Vein Center accreditation as a condition for reimbursement.

Learn more or get started today at intersocietal.org/vein-accreditation.

Vision for the Future from New AVLS President

By Dr. Mark Meissner, AVLS President 2021-2022

As October approaches, those of us in the venous community look forward to the AVLS Annual Congress and the accompanying transition in leadership of our Society. It is truly a privilege to assume the role of AVLS President from Dr. Marlin Schul. The American Vein & Lymphatic Society is very special in this regard.

Election to leadership in our Society implies not only previous history of service to the Society but also anticipation that our leaders will continue to contribute to the advancement of venous disease in general and the AVLS specifically. This model differs from other specialty societies, where leadership is often an honorary position based mainly on past achievements. Not so in the AVLS, where virtually every member can aspire to become a member of the board of directors and leadership is based more on an interest in advancing the cause of venous disease than on past academic achievements.

The AVLS is also unique in that both the membership and board of directors come from a spectrum of specialties and a variety of practice backgrounds, including small private practices, large group practices, and academic practices. Our differences make our Society both unique and effective - we can share knowledge and learn across disciplines, perform research across multiple specialties, and direct our advocacy efforts towards issues identified by busy practitioners committed to solving the underlying problems. The Society has made a concerted effort to maintain a balanced board that reflects the diversity of membership.

A final unique aspect of the AVLS is the duration of commitment by the Societyâ&#x20AC;&#x2122;s leadership. Rather than the one-year terms of office in many societies, most board members serve for several years before nomination to the executive committee, and the President has usually served on the executive committee for six years before beginning their 12

two-year term. Rather than having an agenda that may change year to year, the continuity of leadership in the AVLS assures that things that are working well continue to do so and that both new and existing initiatives are carried forward to their completion.

It is with these fundamentals in mind that I assume the role of AVLS President, not only with the privilege of assuring the organization’s forward progress but also with a degree of trepidation. The bar for leadership in the Society has been set very high not only by the organization’s previous leaders but also by our members who enthusiastically participate in the Society’s efforts. While the AVLS (formerly the American College of Phlebology) has always been the leader in venous education, the past several presidents have grown the research and advocacy efforts of the AVLS to an equally high level. Dr. Marlin Schul’s contribution to this newsletter outlines many of these achievements, and Marlin deserves generous recognition for the Society’s many accomplishments over the past two years.

My goals for the Society over the next two years are to continue to support the outstanding progress made in advocacy and research through the Health Policy Committee and PRO registry, respectively. The registry has matured to the point where we can investigate the outcomes of our care in a meaningful fashion. As an example, under the direction of Dr. Fedor Lurie and Dr. Marlin Schul, the PRO registry is being used in a pilot project by the Intersocietal Accreditation Commission (IAC) to evaluate the value of vein center accreditation.

With maturing data, we can look forward to an increasing number of studies to provide evidence for the work that we do.

The Research Committee will also continue to work on evidence-based guidelines for the care of patients with venous disorders.

In conjunction with the Society for Vascular Surgery and the American Venous Forum, updated guidelines for the management of superficial venous disease are well underway and are currently at the meta-analysis stage.

The critical questions regarding pelvic and iliac venous disease have also been developed, and the evidence synthesis with subsequent metaanalysis will begin this year.

Education has always been at the forefront of the efforts of the AVLS. Although we won’t have the benefit of the personal relationships at the annual congress, Margaret Mann and the program committee have put together an outstanding program for our first virtual meeting. I fully expect the educational value of this year’s conference to meet or exceed that of previous AVLS congresses.

The AVLS will also continue to have a prominent role in the International Working Group on Pelvic Venous Disorders. Publication of the “SVP” classification system for pelvic venous disorders is anticipated this fall, and several members of our organization are involved in the development of a patient-reported outcome instrument under the direction of Neil Khilnani.

The strength of the AVLS lies in the diversity of its membership. We are in an excellent position with an enthusiastic board of directors that represent the breadth of our specialty. Over the next two years, I would like to encourage further growth, particularly from areas that may be currently under-represented, such as vascular medicine and lymphedema specialists.

I would also ask for the participation of all of our current members – in the registry, research projects, advocacy, and our educational efforts. If something interests you, please ask to participate. This is your Society and, in the end, it is the contributions of our members that are responsible for most of the Society’s achievements.

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PRO 2.0 VENOUS REGISTRY:

SO, WHAT’S IN IT FOR ME?

By Dr. Joseph Jenkins, Chair of the PRO Registry Operations Committee

T

he PRO 2.0 Venous Registry is collecting data. The Research Committee has created writing groups. The initial questions concerning venous disease and its different treatments have been posed. The data analysis is beginning. The registry has the potential of gaining an entirely new understanding of venous reflux disease to include the patient’s standpoint. This is secondary to the patientreported outcome (PRO) component. Members of the American Vein & Lymphatic Society may question why they should be part of the registry.

As one ponders joining, the following question comes to mind. So, what’s in it for me?

Let’s see if I can provide an answer.

PRO 2.0 Venous Registry has expanded on the original registry. The original PRO 1.0 registry focused on superficial venous disease. PRO 2.0 has a newly developed component that deals with deep and pelvic vein disease and treatment.

Thus, we should be able to provide answers to questions that arise within the area

of deep vein therapy. The compression therapy module underwent an extensive redesign. Compression therapy is a non-invasive treatment for venous disease. Compression is just not something that is a requirement of medical necessity from health insurance companies. When dealing with venous ulcerations, compression is a vital component of treatment.

Data analysis of the registry’s compression therapy aspect should allow for a better understanding of non-invasive treatments when faced with venous reflux disease.

The number of patient encounters within the registry is mine blowing. With over 100 current providers uploading data, the number of patients undergoing a given treatment is in the thousands. The power of such numbers allows for analysis that will establish standards of care. The potential is for AVLS to develop guidelines concerning vein care.

With guidelines and standards of care, venous disease specific quality measures are created.

The quality measures can then 14

be used to provide CMS with information that fulfills the MIPS/MACRA requirement.

No longer will a vein practice struggle with finding quality measures that have nothing to do with vein practice to prevent penalties. The registry should provide the means to have numerous vein specific quality measures. Thus, a provider involved mainly in caring for patients with venous disease should give the required CMS documentation for MIPS reporting via the registry of only vein-specific quality measures.

With guidelines and standards of care comes advocacy. The AVLS will work with private insurance companies to defend the vein care that practices are trying to provide. The patientreported outcomes concerning treatment will give a new perspective on the various vein treatments. The labeling of vein treatments as experimental will hopefully be a thing of the past. The analysis of the data should provide the answers to private payers’ questions. Thus, a provider will treat in a way they feel is most appropriate

for a given patient, significantly minimizing the possibility of health insurance denial.

breakdown of veins treated, and more. However, the dashboardâ&#x20AC;&#x2122;s most significant power will be for users to compare their practice to the aggregate of all providers in the database. One will now have a way to see how their practice compares with others, whether it is similar to the median, undertreating, or overtreating patients.

The following are examples of a few of the dashboards that have been created. There are more currently in development.

Finally, there is the ability for an individual provider to the registry to have access to dashboards when logged into the registry. The dashboards will provide an individual with the ability to look at their own data and understand their practice makeup. PRO Registry users will see the age distribution of the patients, gender,

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So, what is in it for me? I would have to say plenty. One just has to take a look at the potential offerings the registry provides to the world of vein care to see the benefit. The dashboardsâ&#x20AC;&#x2122; potential comparison offerings will provide a level of help not seen within the field of Phlebology previously. The registry benefit for all does

not just happen. It requires a commitment from AVLS staff and volunteers. There is a great deal of work still to complete. Please consider volunteering in a position with one of the research writing groups. As the data is analyzed, then the standards of care and guidelines need to be developed, volunteer for a

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position with the Guidelines Committee. There is also a need for quality measure development. Please consider becoming involved with that aspect. As one becomes involved in the various components to the PRO 2.0 Registry, you will see the further benefit of this work on the individual provider.

Virtual, In-Person, AVLS prepares for 2021

By Dr. Robert Worthington-Kirsch, AVLS 2021 Congress Chair

GAYLORD ROCKIES RESORT & CONVENTION CENTER

Greetings, fellow AVLS members! I hope everyone is safe and healthy in the new reality we have been facing for several months. As I sit down to write this in the middle of August 2020, we are in the short period between finalizing the schedule for sessions and speakers for the October 2020 meeting (“Cast Your Vote!”) and gearing up to create the slide decks to use when speaking at the conference.

chatting with friends about our experiences, and getting a pearl from one of our industry partners at lunch or one of my colleagues at the end of the day over a Manhattan.

AVLS 2020 is going to be an exciting and new thing – all virtual and completely available.

Although our faculty will present live over four days with many periods of simultaneous sessions, anyone who desires can watch what they do not see live at a later date for the same CME credit, allowing us to offer 80 hours of credit.

First – the tagline – everyone wants to know the meeting theme. Given that we have a robust Registry 2.0, and the first data from the AVLS PRO will be presented, the 2021 meeting theme is “Show Me the Data!”

We are turning an important corner in venous and lymphatic medicine and will have a strong evidence basis to validate what we do for our patients and to direct us into ways that we can do better for them.

The virtual meeting has advantages – you do not have to be conflicted when you want to hear two topics or two speakers presenting simultaneously. Attend one live and the other at a later time.

But – we will miss the personal interaction of a live in-person meeting. I know that I often get much out of a connection in the hallways – meeting new people,

As AVLS 2020 develops a life of its own and rolls on towards October, it is also time to start planning the 2021 meeting.

AVLS will be in Denver, CO, at the Gaylord Rockies Resort and Convention Center for a hybrid meeting on October 7-10, 2021.

The AVLS 35th Annual Congress will be a mature hybrid meeting restoring the live in-person interactions that we miss. But there will be a virtual overlay on every session. If you cannot make it to Denver, attend virtually. If you have scheduling conflicts over multiple items of

17

interest, attend asynchronously.

If a speaker cannot come in person, they will present over the web alongside the inperson speakers. Similar to this year, attendees will be able to earn CME for every session by watching recordings of sessions in addition to the live experience.

We are going to focus on the data. What does it tell us about how we are doing in caring for patients? What are the areas we need to work on? How can we tweak our protocols? Maybe even get a first glimpse of the Grail – what is the “right” level of treatment?

And we are going to focus on how to use that data beyond our practices. How do we present our needs to our industry partners? How do we present our case to regulators?

How do we show the value of our services to the patient and to the payers who control the purse strings?

AVLS 2021 will be an excellent time for us to learn and grow in our practices and for our specialty. I look forward to seeing everyone, whether physically or virtually, in Denver.

Progressing Venous, Lymphatic Medicine through CERTIFICATION

By Dr. Neil Khilnani, ABVLM President

The American Board of Venous and Lymphatic Medicine (ABVLM) is a multi-disciplinary Board with a tripartite mission. The first is to create benchmarks for cognitive knowledge, experience, and continuous learning in venous and lymphatic diseases to allow practicing physicians to demonstrate their expertise. The second is to improve the level of graduate medical education in all relevant disciplines to ensure these venous specialists are properly and thoroughly prepared to provide safe and effective care. As part of this mission, the Board supports the creation of Venous and Lymphatic Fellowships programs. Ultimately, the Board seeks formal recognition of Venous and Lymphatic Medicine as a subspecialty of various primary disciplines that are engaged in the care of these patients.

In the last year, we have continued to make strides related to these missions.

ABVLM CERTIFICATION: The number of diplomates having achieved certification now exceeds 850 • We anticipate having more than 1,000 diplomates in the next 3-4 years • Congratulations to the Class of 2019

ONGOING LEARN ASSESSMENT: The Ongoing Learning Assessment (OLA) program has been a tremendous success. Nearly all of our Diplomates regularly participate in the monthly OLA program, which is required to maintain certification. The consensus amongst users is the quality of the questions and the educational content provided to support the

correct response are at an extremely high level.

On a personal note, I find ABVLM program questions educational and challenging, much more so than those I complete for my primary specialty MOC. For someone who has unending amounts of work, I look forward to completing my ABVLM OLA each month as I learn something from nearly every item.

IAC-VEIN CENTER RECOGNITION OF ABVLM CERTIFICATION: The Intersocietal Accreditation Commission Vein Center Board recently approved a pathway for physicians to demonstrate knowledge and experience to qualify as a medical director or medical staff physician of an accredited Vein Center using their ABVLM certification. The final standards will be published in the next few weeks with the details related to this.

GRADUATE MEDICAL EDUCATION: There are now five ABVLM-accredited Fellowship Programs, incorporating ten fellowship slots. The newest fellowship will be at the Massachusetts General Hospital. The program is co-hosted through the Vascular Surgery and Interventional Radiology Departments at Harvard Medical School with Dr. Julianne Stoughton as the Program Director. Previously approved VLM Fellowships exist, in alphabetical order, at the Centers for Vein Restoration (Dr. Peter Pappas, Program Director), Jobst Vascular Institute (Dr. John Fish III, Program Director), Center for Venous and Lymphatic Medicine at Prisma Health (Dr. Marcus Stanbro, Program Director) and Stony Brook University, (Dr. Antonios Gasparis, Program 18

Join the over 850 physicians who have already invested in their vein specialty certification

REVISED APPLICATION & EXAM DATES

Why Become Certified in Venous & Lymphatic Medicine?

The benefits of ABVLM certification advance your career by helping you to: ELEVATE PROMOTE DEMONSTR ATE FULFILL SUPPORT

• • • • • • • • •

Elevates core knowledge in venous and lymphatic medicine (VLM) Promotes professional standards in VLM Demonstrates commitment to quality care of the VLM patient Ongoing, real-time, continuing education with an online MOC module Listed on the ABVLM “Find a Physician” website* Highlighted on the AVLS “Find a Provider” webpage as a Diplomate of the ABVLM* Fulfills a key AVLS requirement to obtain AVLS Fellow Status Supports venous credentialing in hospital or practice settings Demonstrates physician commitment to the field, which is critical to specialty recognition

*A single new patient will likely cover the cost of certification

REVISED 2021 ABVLM Exam Schedule Annual Application Period November 1, 2020 to February 28, 2021 Exam Administration at PearsonVUE August 1, 2021 through September 15, 2021 Eligibility criteria for U.S. and Canadian physicians, and online application info, are at www.ABVLM.org. Passing the exam earns a 877-699-4114 info@ABVLM.org www.ABVLM.org 10-year certification. $500 Discount Code: AVLS20

Patients trust certified education and experience

Director). Interested fellow-candidates are encouraged to contact the program directors about their training programs. Programs are listed on the ABVLM website (www.ABVLM.org).

Anyone interest in developing a training program at their site should contact me to discuss what is involved and/or review the VLM Fellowship program documents also on the website.

ABVLM FELLOW RECRUITMENT: The Fellow Recruitment Task Force, led by Dr. Vineet Mishra, launched a June 2020 webinar-style presentation (including Q&A) targeting medical students, residents, fellows, and newer physicians.

• There were over 60 physicians, and trainees who attended the webinar pulled together on short notice.

• Of those interested in applying for a VLM Fellowship, a third of them are interested in attending one next year.

• More such webinars are planned for the future

ABVLM CLASS OF 2019 »» Ajay N. Amarnani, MD »» Sahar Amery, MD »» Thomas K. Barlow, DO »» Alexander C. Batchev, DO »» David R. Buckwalter, MD »» Nelson Chavarria, MD »» Richard Dubois, MD »» Mark S. Elliott, MD »» Abdul Ezeldin, MD »» Kevin Fradkin, MD

ABVLM CERTIFYING EXAM: The ABVLM will broaden the exam period and move the Certification Exam Dates beginning in 2021.

• The exam will move from 2 weeks in April, to 6 weeks in August/September • This move will accommodate fellows graduating from residencies and VLM Fellowships giving them the opportunity to sit for the exam soon after training • This move also anticipates potential COVID-restrictions continuing into early 2021

»» Aditya Gupta, MD »» Ahmed A. Habib, MD »» H. Andrew Hansen, II, MD »» Kyle A. Herron MD »» Adam Isadore, MD »» Harold Jaimes, MD »» Anil Kumar, MD »» Blazej Lojewski, MD »» Sarah P. Lucas, MD »» Gordon D. Lutchman MD

ABVLM REACTS TO COVID-19:

• Full refunds were made available to physicians working on the Certification Process and scheduled to take the cognitive knowledge examination in 2020. Only two of the more than 50 physicians fully withdrew from the process.

• Shifted 2020 exam schedule from 2 weeks in April to 3 months (June-August) 2020 to avoid the peak of viral transmission and allow the testing centers to implement higher standards of medical safety.

The Board members of the ABVLM will be virtually attending the AVLS meeting this October. The staff will also be in the virtual Exhibit Hall. We would be delighted to speak with anyone regarding questions about the Board’s activities as well as specific advice for those physicians considering certification in VLM. 20

»» Mark Macumber, MD »» Ron Mark, MD »» Puneet Mishra, MD »» Elie Moussallem, MD »» Raguveer Murthy, MD »» Caroline Novak, MD »» Joseph Okolo, MD »» Golta Rasouli, MD »» Juan Carlos Rozo MD »» William B. Schoenfeld, MD »» Mike G. Sebastian, MD »» Douglas A. Ward, MD »» Suman M. Wasan, MD »» Yang Xia, MD

TH

ANNIVERSARY

Don't settle¹ - use FDA-Approved Asclera to treat uncomplicated spider and reticular veins in the lower extremities.

Clinical Results with Asclera ® UNCOMPLICATED SPIDER VEIN TREATMENT* (<1MM) PATIENT TREATED WITH 0.5% ASCLERA

BEFORE

AFTER

RESULTS AT 18 WEEKS AFTER LAST TREATMENT UNCOMPLICATED RETICULAR VEIN TREATMENT* (1 TO 3 MM) PATIENT TREATED WITH 1% ASCLERA

BEFORE

AFTER

TREATMENT SUCCESS: 95% of patients treated with Asclera showed good improvement or complete treatment success as rated by physicians.² PATIENT SATISFACTION: 87% of patients were satisfied or very satisfied with their Asclera treatments at 12 weeks.²

95% TREATMENT SUCCESS

87%

PATIENT SATISFACTION

RESULTS AT 18 WEEKS AFTER LAST TREATMENT *INDIVIDUAL RESULTS MAY VARY INDICATION: Asclera® (polidocanol) Injection is a prescription medicine that is used in a procedure called sclerotherapy to remove unwanted veins on your legs.

It is administered by a healthcare provider to treat two types of veins: · Uncomplicated spider veins (very small varicose veins ≤ 1 mm in diameter) · Uncomplicated small varicose veins (1 to 3 mm in diameter) known as reticular veins Asclera® has not been studied in varicose veins more than 3 mm in diameter.

IMPORTANT SAFETY INFORMATION FOR PATIENTS: For intravenous use only.

CONTRAINDICATIONS: Asclera® (polidocanol) Injection is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute vein and blood clotting diseases.

WARNINGS AND PRECAUTIONS: Anaphylaxis: Severe allergic reactions have been reported following polidocanol use, including anaphylactic reactions, some of them fatal.

Severe reactions are most frequent with use of larger volumes (> 3 mL). The dose of polidocanol should be the smallest dose that is effective. Please notify your healthcare provider if you have a known history of severe allergies or allergy to polidocanol.

Venous Thrombosis and Pulmonary Embolism: Asclera can cause venous thrombosis and subsequent pulmonary embolism or other thrombotic events.

Your physician should follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization or pregnancy are at increased risk for developing thrombosis.

Arterial Embolism: Stroke, transient ischemic attack, myocardial infarction, and impaired cardiac function have been reported in close temporal relationship with polidocanol administration. These events may be caused by air embolism when using the product foamed with room air (high nitrogen concentration) or thromboembolism. The safety and efficacy of polidocanol foamed with room air has not been established and its use should be avoided.

Accidental injection into an artery can cause severe necrosis, ischemia or gangrene.

Care should be taken in intravenous needle placement and the smallest effective volume at each injection site should be used. If injection of polidocanol into an artery occurs, consult a vascular surgeon immediately.

bandage, and walk for 15- 20 minutes. Your healthcare provider will provide monitoring during this period to treat any possible anaphylactic or allergic reactions.

Maintain compression for 2 to 3 days after treatment of spider veins and for 5 to 7 days for reticular veins, or as directed by your Healthcare Provider. For extensive varicosities, longer compression treatment with compression bandages or a gradient compression stocking of a higher compression class is recommended.

Post-treatment compression is necessary to reduce the risk of deep vein thrombosis.

ADVERSE REACTIONS: In clinical studies, the following adverse reactions were observed after using Asclera® and were more common with Asclera® than placebo: injection site hematoma, injection site irritation, injection site discoloration, injection site pain, injection site itching, injection site warmth, neovascularization, injection site clotting.

You are encouraged to report any suspected adverse events. To report SUSPECTED ADVERSE REACTIONS, contact your Healthcare Provider, Merz North America at 1-866-862-1211, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

After the injection session is completed, apply compression with a stocking or

¹Mann MS, Munavalli, GS, Amatangelo LS, Morrison NS. Improper potency and impurities in compounded polidocanol. JDD. 2019;18(11):= 1124–1127. ²Rabe E, Schliephake D, Otto J, Breu F, Pannier F. Sclerotherapy of telangiectases and reticular veins: a double-blind, randomized, comparative clinical trial of polidocanol, sodium tetradecyl sulphate and isotonic saline (EASI study). Phlebology. Jun 2010; 25(3): 124-131.

Distributed by Merz North America, Inc. Copyright © 2020 Merz North America, Inc. All rights reserved. Asclera® is a registered trademark of Chemische Fabrik Kreussler & Co., GmbH. The Merz Aesthetics® logo is a registered trademark of Merz Pharma GmbH & Co. KGaA. ML02848-02

Please see the Brief Summary of Asclera Prescribing Information on the next page.

Asclera (polidocanol) Injection, for intravenous use Initial U.S. Approval: 2010 BRIEF SUMMARY For Full Prescribing Information please visit Asclera.com.

INDICATIONS AND USAGE Asclera® (polidocanol) is indicated to sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Asclera has not been studied in varicose veins more than 3 mm in diameter.

DOSAGE FORMS AND STRENGTHS Asclera is available as a 0.5% and 1% solution in 2 mL glass ampules.

CONTRAINDICATIONS Asclera is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute thromboembolic diseases.

WARNINGS AND PRECAUTIONS Anaphylaxis Severe allergic reactions have been reported following polidocanol use, including anaphylactic reactions, some of them fatal. Severe reactions are more frequent with use of larger volumes (> 3 mL). The dose of polidocanol should therefore be minimized. Be prepared to treat anaphylaxis appropriately. Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, care should be taken in intravenous needle placement and the smallest effective volume at each injection site should be used. After the injection session is completed, apply compression with a stocking or bandage, and have the patient walk for 15-20 minutes. Keep the patient under supervision during this period to treat any anaphylactic or allergic reaction.

Venous Thrombosis and Pulmonary Embolism Asclera can cause venous thrombosis and subsequent pulmonary embolism or other thrombotic events. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization or pregnancy are at increased risk for developing thrombosis.

Arterial Embolism Stroke, transient ischemic attack, myocardial infarction, and impaired cardiac function have been reported in close temporal relationship with polidocanol administration. These events may be caused by air embolism when using the product foamed with room air (high nitrogen concentration) or thromboembolism. The safety and efficacy of polidocanol foamed with room air has not been established and its use should be avoided.

Tissue Ischemia and Necrosis Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Care should be taken in intravenous needle placement and the smallest effective volume at each injection site should be used. After the injection session is completed, apply compression with a stocking or bandage and have patients walk for 15-20 minutes. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately.

ADVERSE REACTIONS Clinical Study Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In 5 controlled randomized clinical trials, Asclera has been administered to 401 patients with small or very small varicose veins (reticular and spider veins) and compared with another sclerosing agent and with placebo. Patients were 18 to 70 years old.

The patient population was predominately female and consisted of Caucasian and Asian patients.

Table 1 shows adverse events more common with Asclera or sodium tetradecyl sulfate (STS) 1% than with placebo by at least 3% in the placebo- controlled EASI study (see Clinical Studies [14]). All of these were injection site reactions and most were mild.

Table 1: Adverse Reactions in EASI-study Injection site haematoma Injection site irritation Injection site discoloration Injection site pain Injection site pruritus Injection site warmth Neovascularisation Injection site thrombosis

ASCLERA (180 patients) 42% 41% 38% 24% 19% 16% 8% 6%

STS 1% (105 patients) 65% 73% 74% 31% 27% 21% 20% 1%

Placebo (53 patients) 19% 30% 4% 9% 4% 6% 4% 0%

Ultrasound examinations at one week (±3 days) and 12 weeks (±2 weeks) after treatment did not reveal deep vein thrombosis in any treatment group.

Post-marketing Safety Experience The following adverse reactions have been reported during use of polidocanol in world-wide experience; in some of these cases these adverse events have been serious or troublesome. Because these reactions are reported voluntarily from a population of uncertain size and without a control group, it is not possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Immune system disorders: Anaphylactic shock, angioedema, urticaria generalized, asthma Nervous system disorders: Cerebrovascular accident, migraine, paresthesia (local), loss of consciousness, confusional state, dizziness Cardiac disorders: Cardiac arrest, palpitations Vascular disorders: Deep vein thrombosis, pulmonary embolism, syncope vasovagal, circulatory collapse, vasculitis Respiratory, thoracic and mediastinal disorders: Dyspnea Skin and subcutaneous tissue disorders: Skin hyperpigmentation, dermatitis allergic, hypertrichosis (in the area of sclerotherapy) General disorders and injection site conditions: Injection site necrosis, pyrexia, hot flush Injury, poisoning and procedural complications: Nerve injury DRUG INTERACTIONS No drug-drug interactions have been studied with Asclera.

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. Polidocanol has been shown to have an embryocidal effect in rabbits when given in doses approximately equal (on the basis of body surface area) to the human dose. This effect may have been secondary to maternal toxicity.

There are no adequate and well-controlled studies in pregnant women. Asclera should not be used during pregnancy.

Animal Studies Developmental reproductive toxicity testing was performed in rats and rabbits with intravenous administration. Polidocanol induced maternal and fetal toxicity in rabbits, including reduced mean fetal weight and reduced fetal survival, when administered during gestation days 6-20 at doses of 4 and 10 mg/kg, but it did not cause skeletal or visceral abnormalities. No adverse maternal or fetal effects were observed in rabbits at a dose of 2 mg/kg. No evidence of teratogenicity or fetal toxicity was observed in rats dosed during gestation days 6-17 with doses up to 10 mg/kg. Polidocanol did not affect the ability of rats to deliver and rear pups when administered intermittently by intravenous injection from gestation day 17 to post-partum day 21 at doses up to 10 mg/kg.

Human Studies There are no adequate and well-controlled studies on the use of Asclera in pregnant women.

Labor and Delivery The effects of Asclera on labor and delivery in pregnant women are unknown.

Nursing Mothers It is not known whether polidocanol is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, avoid administering to a nursing woman.

Pediatric Use The safety and effectiveness of Asclera in pediatric patients have not been established.

Geriatric Use Clinical studies of Asclera did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

OVERDOSAGE Overdose may result in a higher incidence of localized reactions such as necrosis.

PATIENT COUNSELING INFORMATION Advise the patient to wear compression stockings or support hose on the treated legs continuously for 2 to 3 days and for 2 to 3 weeks during the daytime. Compression stockings or support hose should be thigh or knee high depending upon the area treated in order to provide adequate coverage. Advise the patient to walk for 15 to 20 minutes immediately after the procedure and daily for the next few days. For two to three days following treatment, advise the patient to avoid heavy exercise, sunbathing, long plane flights, and hot baths or sauna.

Copyright © 2020 Merz North America, Inc. All rights reserved. Asclera is a registered trademark of Chemische Fabrik Kreussler & Co. GmbH, 65203 Wiesbaden, GERMANY

AVLS Ultrasonography Section creates protocols, develops distance learning.

The AVLS ultrasound section:

Linda Antonucci RPhS, RVT, RDCS Board Member

Sara Skjonsberg BS, RVT, RPhS Section chair

Donna Kelly

Marresa Houle BS, RPhS, RVT,

RVT, RPhS, RDMS Program Chair

RDMS Program Chair

Jessica Farris

MHS, RVT, RPhS Alternate Program Chair

Mariah Elliott,

BS, RVT, RPhS Online Community Manager

During the past year, the ultrasound section has been working towards a goal of creating a community of like-minded people interested in learning about venous ultrasound and an arena to answer questions and inspire new developments in our field.

We established standardized protocols for pelvic venous and lower extremity venous ultrasound evaluation (pre, during, and post-treatment), examination worksheets, and a letter advocating for sonographer ergonomics during standing reflux evaluations. We also initiated an infographic for the RPhS credential to convey the importance of the certification for our specialty and to gain further recognition of our specialized skills.

One of our most significant challenges this year has been the continuation of superior venous education during a global pandemic. The all-virtual online RPhS review course was the first successful distance-learning course for our section. It included an interactive mock examination and live Q and A session with discussion from our speakers. For the 2020 Annual Congress, the ultrasound section created a dynamic program, including live scanning and didactic lectures.

We hope to develop our online community through the “MAC” (myAVLS community) so that we can share with you all the hard work we do on your behalf. Our future aims are to focus on standardization and high-quality venous scanning (including the pelvis to get a complete picture of the venous system), to provide resources for sonographers, to advocate for education and ergonomics, and to challenge more sonographers to obtain the RPhS credential. We also want to create an inclusive community that everyone feels they can be a part of and contribute to its growth. Together we are stronger.

THE BENEFITS OF ABVLM CERTIFICATION ADVANCE YOUR CAREER BY HELPING YOU TO: • Elevates core knowledge in venous and lymphatic medicine (VLM) ELEVATE • Promotes professional standards in VLM • Demonstrates commitment to quality care of the VLM patient PROMOTE • Ongoing, real-time, continuing education with an online MOC module • Listed on the ABVLM “Find a Physician” website* DEMONSTRATE • Highlitghted on the AVLS “Find a Provider” webpage as a Diplomate of the ABVLM FULFILL • Fulfills a key AVLS requirement to obtain AVLS Fellow Status • Supports venous credentialing in hospital or practice settings SUPPORT • Demonstrates physician commitment to the field, whis is critical to specialty recognition

23

Who Are AVLS Members?

By Brian Jones, AVLS Membership Manager

As we look back upon the past year, we feel a sense of immense gratification and enthusiasm.

Despite the yearâ&#x20AC;&#x2122;s challenges, COVID-19 in particular, our association maintained its sound structure and organization. Our membership, as well as our leadership, is a diverse group. We are proud to be represented by members in more than 40 countries, with professionals of many different races, ethnicities, ages, and gender. Our membership is comprised of a multidisciplinary group of more than 20 medical specialties, including physicians, nurses, sonographers, therapists, and allied health professionals.

also allowing groups within AVLS, such as committees, task forces, and specialty sections, the opportunity to communicate with each other.

Even in a year that presented obstacles beyond our control, we persevered by launching many exciting new programs and platforms to benefit our members. AVLS introduced a series of free webinars in April to assist during the COVID-19 pandemic. Topics included best practices for employers, telemedicine, dealing with financial turmoil, marketing strategies, virtual practices, and more. Each webinar hosted an average of more than 100 registrants.

To build relationships with organizations as well as individuals, AVLS began offering institutions the opportunity to join as an Organizational Member. Through this new category, organizations can have their physicians and allied health staff join as a group at a discounted rate and receive complimentary live and online educational credits. AVLS has already recruited its first Organizational Member, Indiana Vein Specialists, a practice that has provided memberships for ten allied health professionals and two physician members.

AVLS introduced its first virtual reality educational offering in May, Immersive Sclerotherapy: VR 360. Through this course, our members obtained CME credit in the comfort of their own homes. By the end of our fiscal year, we had 25 registrants, from whom we have received overwhelmingly positive feedback.

To further engage our members and provide a vital networking outlet, we unveiled the myAVLS Community (MAC). The MAC serves as a messaging board for AVLS members.

Through this platform, members have shared ideas, opinions, and insight. This community has increased member engagement while

AVLS partnered with Vitadox.com to help our members reach new patients for vascular and lymphatic system-related symptoms, conditions, and treatment options. This platform enables members to showcase expertise, highlight medical services, and share success stories while establishing credibility, improving online reputation, attracting new patients, and booking appointments.

The AVLSâ&#x20AC;&#x2122;s PRO Venous Registry now has more than 21,000 patient records, mostly comprised of 8 months of CVR data. Work is currently being done with VCA, which will add several years of data to the Registry. Over the past several months, the Operations committee made significant changes to the Registry by implementing a Conservative Therapy table, which will capture compression data from all providers. We made additional modifications, including the newly revised CEAP scoring, a more comprehensive list of vein anatomy,

24

anticoagulation therapies, and treatment zones for Pelvic Venous Embolization.

high-quality care is not defined by narrow specialty.

As a professional society devoted to clinical care of a specific medical condition, the AVLS is unique among medical specialties.

Our Advocacy effort focused on serving the professional interests of our members, with an additional emphasis on ensuring patient access to needed care. Our recent Advocacy work includes detailed engagement with carriers, including Medicare Administrative Contractors, to expand patient access to needed care and to ensure that physicians have reimbursement coverage for the latest vein therapeutic interventions. AVLS works to ensure that our members are not denied privileges to care for patients based on their primary board certification, frequently educating payers that

We are pleased to celebrate the progress of the last year but recognize the challenges of the year ahead. This yearâ&#x20AC;&#x2122;s Annual Congress (Oct. 15-18) will be 100% virtual and will be our first foray onto our web-based platform. Our webinar offerings will be expanded in 2021 to include additional educational topics and member engagement programs. Our virtual offerings will continue beyond Annual Congress with new virtual reality courses and online education courses.

Thank you to the AVLS team, leadership, and members for your dedication to this organization and your efforts in advancing our mission.

Members by Category International Physician; 10%

Allied Health; 22%

Other; 8%

Physician; 60%

25

Members by Primary Specialty Not listed 15%

Cardiology/Radiology 21%

Dermatology 5%

Vascular Surgery 23%

Family/Gen Practice 8%

Other 13%

General Surgery 15%

Members by Gender [CATEGORY NAME] <1% Female 31%

Male 69%

26

Members by Age Average age = 54 Median age = 54

350

324

300 250

226

202

200 150 90

100

57

50 0

11 30 and under

31-40

41-50

51-60

61-70

71 and over

61% of membership represented

Members by Years Active Average member = 9 years 20+ years

94

10-19 years

550

5-9 years

367

2-4 years

228

0-1 year

223 0

100

200

300

27

400

500

600

The Financial Impact of COVID-19 on Venous, Lymphatic Medicine

By Dr. Michael Di Iorio, FVLD Board of Directors

Medical practices of all sizes and specialties across the country have and will continue to be financially impacted by the COVID-19 pandemic.

To better understand the direct and indirect financial impact the COVID-19 pandemic has had on vein practices in the United States, the American Vein & Lymphatic Society conducted the Financial Impact of the COVID-19 Pandemic on Vein Practices survey. The survey was anonymous, and all United States-based AVLS members were invited to participate. A total of 93 members completed the survey, which was open from July 17 to July 31, 2020. As the impact of COVID-19 will likely be felt for some time, a second survey will be conducted six months following the initial survey to gauge the long term effects the pandemic has had on practices.

The vast majority of survey participants reported a 25% or greater decrease in practice revenue as a result of the COVID-19 pandemic, with 35% reporting a 25-50% decrease, 33% reporting a 5175% decrease, and 21% reporting a greater than 75% decrease. Patient volume similarly decreased with 40% reporting a 25-50% decrease in patient volume and 45% reporting a greater than 50%

decrease. When participants responded with their anticipated decrease in practice revenue for the next six months, 49% expect a 25-50% decrease, and 27% predict a 50% or greater decrease. Similar projections were reported for patient volume over the next six months.

The financial burden the pandemic has brought to bear on vein practices is not only attributable to reduced patient volume and loss of revenue but also the added expenses practices have incurred to operate safely during these times. Many of these expenses are more than standard day-day operational costs. They include but are not limited to an increased usage of cleaning supplies, personal protective equipment, telemedicine platforms, equipment to enable employees to work from home, cost of COVID-19 related employee leave, and many more. Due to high demand, some practices are seeing a premium added to certain supplies and equipment. Others must go outside of their usual supply chain to obtain the essential supplies and equipment they need, which often comes with added cost. More than half of all practices reported a greater than 10% increase in expenses as a result of the pandemic, with 34% of practices reporting a 10-25% increase, 12% reporting a 26-50% increase, and 5% reporting greater than 50% increase in added expenses.

With decreased revenue and added expenses, many practices participated in one or more government aid programs. The most common being the Small Business Association Paycheck Protection Program (78% reported participating), a potentially forgivable loan designed to support and incentivize small businesses to keep their employees on their payroll. Other programs reported included the Economic Injury Disaster Loan (EIDL), SBA Express Bridge Loan, Medicare Accelerated and Advance Payment Program, and the CARES Act Provider Relief Fund. Many of the survey participants took part in more than one of these programs.

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This pandemic has resulted in an unprecedented rise in unemployment as businesses across the country have been forced to temporality close, scale back service, layoff or furlough employees, or in some cases, permanently close their doors. Like other small businesses, vein practices were not spared. A total of 57 (61%) survey participants reported having to close temporarily and 60% having to reduce hours. Approximately 50% of participants reported having to temporarily layoff/ furlough employees, and 11% reported having to do the same with physicians. Unfortunately, not all of these changes were temporary, as 15% of practices reported permanent employee layoffs and 3% reported physician layoffs.

Approximately 12% of practices reported employee pay cuts, and 56% reported physician pay cuts. Other actions include delayed hiring of new staff (48%) and postponement of planned practice expansion (40%) in response to the pandemic.

open, and the percentage of time dedicated to the treatment of venous and lymphatic disease.

Practice types were defined as hospital-owned/ affiliated, solo practice, owner/partner of a multiphysician practice, and employed physician of a non-hospital affiliated practice. Respondents represented all practices settings with the largest number of responses from physicians in solo practice (67%). The majority of participants (75%) reported being in practice for greater than ten years, and only six responses came from practices that had been in business for less than two years before the pandemic hit. A total of 71 (76%) participants identified their practice as devoted more than 75% to the treatment of venous and lymphatic disease. Practices from 33 states, including the District of Columbia, were represented in the survey responses. In terms of practice size, 61% of responses were from practices having less than ten employees, 20% from practices with 10-20 employees, and 18% with more than 20 employees.

At the end of the survey, participants submitted their number one concern regarding the COVID-19 pandemic moving forward. A total of 79 participants answered this question. While there isnâ&#x20AC;&#x2122;t enough room to include all of the responses, the consensus was keeping patients and staff safe and the financial uncertainty of the future. Many participants also expressed concern over the possibility of another mandated closure and whether patients will seek out treatment during the pandemic.

The financial toll of the COVID-19 pandemic on physician practices of all specialties will likely be felt for months and maybe years to come, and the long-term impact may be greater than what we have had to endure so far. There will be a follow-up survey in six months to assess better the long-term financial implications of the pandemic on vein practices. I would encourage all AVLS members to participate, even if you did not participate in the initial survey. The results of the follow-up survey, as well as a more detailed review of the current survey results, will be made available to all AVLS members. Once again, the AVLS would like to express our gratitude to all those who participated in this critical survey.

As the effects of the pandemic and the local and state responses have varied, the survey asked in which state a respondentâ&#x20AC;&#x2122;s practice was located.

Additional questions included practice setting, practice size, how long the practice has been

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Questions 6

What is your best estimate of the negative financial impact on your practice's revenue since the beginning of the COVID-19 pandemic?

40.00% 35.00% 30.00% 25.00% 20.00% 15.00% 10.00% 5.00% 0.00%

Responses

No impact

Less than 25% decrease

25 ‐ 50% decrease

51 ‐ 75% decrease

Greater than 75% decrease

Question 7

What is your best estimate of the negative impact on overall patient volume since the beginning of the COVID-19 pandemic, including the impact of any closure of your practice?

50.00% 40.00% 30.00% 20.00% 10.00% 0.00%

Responses No impact estimated

Less than 25% 25 ‐ 50% decrease in decrease in patient patient volume volume

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51 ‐ 75% Greater than decrease in 75% decrease patient in patient volume volume

Question 8

Do you anticipate a decrease in revenue over the next six months related to the COVID-19 pandemic?

60.00% 50.00% 40.00% 30.00% Responses

20.00% 10.00% 0.00%

No impact expected

Less than 25% 25 ‐ 50% decrease in decrease in revenue revenue

51 ‐ 75% Greater than decrease in 75% decrease revenue in revenue

Question 9

Do you anticipate a decrease in patient volume over the next six months related to the COVID-19 pandemic?

60.00% 50.00% 40.00% 30.00% 20.00%

Responses

10.00% 0.00%

No impact expected

Less than 25% 25 ‐ 50% decrease in decrease in patient patient volume volume

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51 ‐ 75% Greater than decrease in 75% decrease patient in patient volume volume

Question12

Question 13

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Dr. Chris Pittman and Dr. Vineet Mishra representing the AVLS at the American Medical Association

Serving AVLS Members: ADVOCACY

By Dr. Stephen Daugherty, Chair of the Healthcare Policy and Advocacy Committee

T

he American Vein & Lymphatic Society (AVLS) was organized and functioned as an educational organization from its inception.

Historically, the AVLS tackled advocacy issues in a limited way, but in 2017, this changed, and the Society formed a board-level committee to address advocacy issues formally. In 2018, the Board renamed the standing committee to the Healthcare Policy and Advocacy Committee (HPAC). A subcommittee, the Healthcare Advocacy Committee (HAC), was formed to expand participation by committed members.

The Society also hired Robert White as the Director of Advocacy, bringing experienced full-time staff support to assist us in our mission to advocate for our patients and our membership. We sought and

OUR 3 CORE OBJECTIVES OF ADVOCACY: AVLS PATIENT ACCESS FAIR REIMBURSEMENT & COVERAGE FROM PAYERS SUPPORT RESEARCH & GUIDELINEST

received financial support from the Foundation for Venous & Lymphatic Disease, which is necessary to support staff and fund travel expenses for participation in important meetings with payors and governmental and regulatory agencies. The HPAC is a subset of the AVLS Board of Directors who set policy and report to the entire Board. The HAC works to implement this policy through members committed to at least three years on the committee for the sake of continuity. The HAC, including the members of the HPAC, meets by conference calls at least monthly for review and input from membership as teams work on specific assigned projects. Beginning at the Annual Congress in November 2019, the HAC holds monthly conference calls with the leadership of the American Venous Forum (AVF) in a very successful effort to align our advocacy efforts and to expand our joint influence outside of our societies. AVF and AVLS members often share common interests, and there is a cross-section of individuals who are members of both organizations.

The HAC includes our representatives who serve multiple-year terms to whom we refer as â&#x20AC;&#x153;Senatorsâ&#x20AC;? because of the importance of the service and the value of building long-term relationships within the other organizations.

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THESE POSITIONS INCLUDE: American Medical Association House of Delegates • Chris Pittman, MD • Vineet Mishra, MD, Alternate American Medical Association CPT Editorial Panel Advisor • Satish Vayavegula, MD • Michael Graves, MD, Alternate American Medical Association Resource-Based Relative Value Update Committee (RUC) • John Blebea, MD • Kenneth “Trip” Todd, MD, Alternate Medicare Carrier Advisory Committee • Chris Pittman, MD—First Coast Services • Stephen Daugherty, MD—Palmetto • Michael Graves, MD—Novitas Intersocietal Accreditation Commission—Vein Center Division, Board of Directors • Khanh Nguyen, DO • Carl Fastabend, MD

AVLS ADVOCACY INSIDER (MONTHLY) We began publishing electronically to membership the Advocacy Insider during the past year to provide a timely review of new topics of interest to our members. While not comprehensive, the intent is to make members aware of issues that we think are vital for them to know. Additionally, the newsletter provides contact information for our members to learn more and get involved.

THE AMERICAN MEDICAL ASSOCIATION The AVLS is the only organization devoted to the care of venous disorders represented at the AMA House of Delegates (HOD), the AMA CPT Editorial Panel (CPT Panel), and the ResourceBased Relative Value Update Committee (RUC).

Each of our AVLS “Senators” serves multipleyear terms in their roles that require several days out of their practices at least 2-3 times per year.

The AMA HOD is the AMA policy-making body where decisions are made that affect medicine.

We engage in relationships that may influence our effectiveness in our other AMA endeavors.

The AMA CPT Editorial Panel writes and revises descriptions of medical services under the close supervision of CMS. A code and an accurate, detailed description of the service are essential for correct payment for the professional services and supplies necessary to perform each specific service. The RUC assigns value to the physician work and other expenses, including supplies required to perform the procedures described for each CPT code under CMS supervision with CMS veto power. An accurate description of the service from the CPT Panel and accurate assessment of the physician work and practice expenses from the RUC is key to appropriate and fair payment for old and new technologies.

We are working to build our influence at the CPT Panel and the RUC.

INTERSOCIETAL ACCREDITATION COMMISSION—VEIN CENTER DIVISION (IAC-VC) The IAC-VC was formed in 2012 as an initiative from the AVLS as concern mounted about low-quality and possibly unsafe practices in vein clinics. The AVLS has two representatives on the IAC-VC Board of Directors. Several other members of the AVLS BOD also serve on the IAC—VC Division BOD representing other societies. The IAC—VC Division has engaged in efforts to convince payors to require IAC— VC Division accreditation as a condition for payment for vein treatment. This is controversial and is not generally supported by the AVLS Board of Directors.

The IAC—VC Division recently published for comment revisions to its standards, which accept certification by the ABVLM as one of the key pathways to membership for the medical staff of an accredited vein center. This revision 34

is a huge win for the ABVLM and the AVLS as it recognizes the value of ABVLM certification.

The other revisions center around expanding privileges of mid-level providers in a vein center based on physician supervision levels. The details of the proposed standards are available at www.intersocietal.org.

OUTPATIENT ENDOVASCULAR INTERVENTIONAL SOCIETY (OEIS)

• Four-year phase-in of office-based supply costs determined by a private contractor with obvious gross errors • Recently announced targeting of the thermal ablation codes for Recovery Audit Contractors (RACs)

KEY HPAC ACTIONS AND ISSUES DURING THE PAST YEAR • AVLS leadership has engaged with Novitas Solutions for the past two years, the Medicare Administrative Contractor (MAC) for Part B Medicare for 11 states, Washington, DC, and adjacent counties in Virginia and Maryland, and the Indian Health Service regarding medical policy issues for treatment of chronic venous insufficiency. Novitas and First Coast Services Options (FCSO) recently published nearly identical draft Local Coverage Determinations (LCDs) for treatment of chronic venous insufficiency, which incorporates a large portion of the recommendations from our team of subject matter experts led by President Marlin Schul.

Public comments (including joint comments

by AVLS, AVF, and SCAI) currently are under consideration, and we expect a final LCD from each MAC soon. The draft policies would cover all of the accepted new vein technologies. Mandatory conservative trials, which are not supported by the medical literature, would no longer be required.

The OEIS is a multispecialty society focusing upon office-based interventional practices.

While much of the clinical work for members is arterial, there is substantial venous care provided in their facilities. The OEIS is developing accreditation for office-based interventional laboratories. The AVLS is participating in this project as some of our members seek an alternative to IAC—VC Division accreditation.

This accreditation would allow a facility that does both venous and arterial procedures to seek a single accreditation.

CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS) CMS views the patient as the consumer, the providers as accountable entities, that payment should be for outcomes, and that prevention of illness and complications is essential. CMS policy announcements come almost daily, but some of the more important activities and policies that we continue to monitor for action as appropriate include:

• The AVLS has been engaged as far back as 2015 with MACs regarding venous stenting policy, and we stopped a poorly written draft LCD with one of the MACs in 2016 and 2017.

The AVLS (now AVLS) and the AVF and OEIS actively engaged Novitas Solutions in 2018 as it developed a new LCD regarding venous stenting. Novitas and FCSO recently published nearly identical draft LCDs for venous stenting, which we believe are appropriate. The AVLS and AVF submitted joint comments supporting the draft LCDs, and we await the final publication of the LCDs.

• Merit-based incentive payments (MIPs) • Alternative payment models (APMs) • Physician-Focused Payment Model Technical Advisory Committee (PTAC) • Revision of Evaluation and Management codes • Annual July draft of physician fee schedule regulations and valuations • Annual November final physician fee schedule regulations and valuations 35

• Palmetto GBA, the MAC for 8 Southeastern states, retired its LCD for treatment of varicose veins in March 2020, we believe, due to the extensive problems with the policy, many of which we pointed out during public comments. Palmetto plans to develop a new LCD, which we think is likely to be similar to the Novitas/FCSO policy as CMS exerts pressure for uniformity of LCDs.

to 10 days and upon a downward revision of physician intraprocedural time by the RUC. CMS pressures the RUC to use the 25th percentile of physician time reported in the RUC survey of physicians who perform the procedures. Many of us believe that the physician intraprocedural time used for the valuation does not match reality. The task force is evaluating several options, but this will be a multi-year process due to the lengthy and rigid process at the CPT Editorial Panel and the RUC. Had the AVLS not participated in the RUC process, the reduction would have been greater since we identified supplies that were not included or undervalued in the initial proposal.

• The Society of Diagnostic Medical Sonographers (SDMS) published a draft set of guidelines for the disinfection of ultrasound transducers in 2018. The AVLS and AVF jointly commented because the proposal would require High-Level Disinfection (HLD) in addition to transducer cleaning, sterile gel, and sterile transducer sleeve for procedures such as ultrasoundguided foam sclerotherapy (UGFS) or ultrasound-guided vascular access. This guideline is contrary to the American Institute of Ultrasound in Medicine (AIUM) guidelines, which would require LowLevel Disinfection (LLD) plus sterile gel and transducer sleeve. The AVLS and AVF commented in support of the AIUM guidelines. We commented again in October 2019 and April 2020 on a new draft proposal, which still contained the problematic language. Finally, on July 1, 2020, the SDMS published its final policy, which accepts procedures such as UGFS and vascular access as semi-critical procedures for which LLD is acceptable as long as the transducer does not become contaminated.

We identified during our diligence that there is a widespread need for clinicians’ education regarding disinfection protocols, and Education Committee will address this.

• CPT codes that reflect the actual work and practice expenses for UGFS are needed. The AVLS continues a lengthy effort to meet the literature requirements and other issues necessary to submit a successful application to the CPT Editorial Panel to create new CPT codes. We await the publication of a critical report showing safety and effectiveness in a US-based population and a review paper with the latest evidence and expert opinion regarding foam sclerotherapy. Because of the CPT/RUC process schedule, the soonest that a successful application will provide useful CPT codes would be January 2023.

• Last year, Humana notified some of our general surgeon members that they would not pay them for interpretation or performance of vascular ultrasound studies.

Our examination of the process revealed that radiologists, cardiologists, vascular surgeons, and multiple other unspecified specialty physicians would be paid. The Humana contractor would not accept the RPhS, RVS, RVT, or RPVI credentials but would accept hospital privileges to read vascular ultrasound as a criterion for physician payment. We pointed out the obvious problems with this policy to Humana and have received no response. Still, we have not received any other complaints from

• A task force co-chaired by Dr. John Blebea and Dr. Ken Harper is examining problems with the two phlebectomy codes, 37765 and 37766, for which Medicare allowable payment dropped about 31% in January 2020. The reduction is based primarily upon reducing the global period from 90 days

36

• The CMS Part B physician fee schedule was published in draft form in August and will be finalized in November. An 11% reduction in the Medicare Conversion factor from $36.09 to $32.26 is proposed to fund increased valuations for Evaluation and Management services. The effect of this is a reduction in valuations for procedures since Congressionally-mandated “budget neutrality” requires these payment adjustments to be revenue-neutral. The AVLS and many other medical societies are encouraging Congress to intervene to avoid such a severe payment reduction, especially as many medical practices are stressed in the COVID-19 economic environment.

our members about adverse actions from Humana. We are engaged with other payors over their limited understanding of the value of the recognized vascular ultrasound credentials. The RPhS credential was developed at the request of and with medical expert participation by AVLS members and first offered in 2010 as the only credential targeted for venous practice. We encourage our members to earn this credential.

• Total Health, a large payor in Michigan, issued guidance that only interventional radiologists, vascular surgeons, and interventional cardiologists may be paid for vein procedures. We have commented to Total Health that initial specialty designation is much less important than a commitment to venous medicine, including certification by the ABVLM. We have involved the American College of Surgeons in this as it affects qualified general surgeons. This remains an important problem.

• CMS proposes reducing the payment in 2021 and further in 2022 for venous thermal ablation procedures based upon CMS’ repricing of the radiofrequency catheters and LASER fibers used for these procedures.

We believe that many small practices cannot purchase the devices for the amount which CMS believes to be market rates, and we are seeking invoices to show this point.

• An application was submitted this year for definition of ICD codes for lipedema with support from the AVLS. • The FDA recently published for comment a notice regarding the 503B Bulk Drug program, which excludes polidocanol from the list of drugs that may be produced in bulk in 503B compounding pharmacies.

This notice does not affect individual patient prescriptions, which may be filled at compounding pharmacies. Drs. Robert Worthington-Kirsch and Khanh Nguyen are reviewing how this may affect AVLS members and patient care to inform leadership. Comments are due to the FDA

by September 29.

• CMS has proposed a new rule which would make ground-breaking new technologies available to Medicare patients for four years after FDA approval of the device or drug.

This rule would affect some technologies approved by the FDA in 2019 and 2020 and the future. The key issue will be what qualifies a new product for this new policy.

• The AVLS sponsored various videoconference sessions this year to assist practices to cope with COVID-related issues—infection control, legal, human resources, and financial.

THE FUTURE The HPAC and HAC will continue working on the active issues referenced above and adding to the list as new issues develop. We hope to increase comments to payors regarding medical policy problems and issues regarding access to care, such as refusal by payors to cover care based solely upon the primary physician specialty. Acceptance of the certification of the ABVLM by payors is a crucial issue. Finally, we are exploring how venous and lymphatic practices may function in “fee-for-value” models, which soon will become more common.

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HPAC MEMBERS

HAC MEMBERS

Stephen Daugherty, Chairman

Chris Pittman, Chairman

Chris Pittman, Vice-Chairman

Vineet Mishra, Vice-Chairman

Marlin Schul, President

Marlin Schul

Steve Elias

Stephen Daugherty

John Blebea

Steve Elias

Vineet Mishra

John Blebea Mark Meissner Satish Vayavegula Khahn “Ken” Nguyen Margaret Mann Lornell Hansen Robert Worthington-Kirsch Peter Pappas Zoe Deol James Albert Michael Graves Francis Lee Thomas Wright James St. George Carl Fastabend Robert Tahara Theresa Soto Ken Harper Michael Di Iorio Dan Monahan, Past-chairman, AVF Health Policy Committee Mark Iafrati, Chairman, AVF Health Policy Committee Bruce Hoyle Kenneth “Tripp” Todd Ali Wazni

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SUPPORT THE FOUNDATION FOR VENOUS & LYMPHATIC DISEASE

Join us at www.myavls.org/fun-run

6TH ANNUAL FUN RUN & WALK  FOR MEL

The 2020 Fun Run and Walk is currently taking place virtually. Every year Annual Congress attendees come together to run, walk, and support advocacy, research, and education for venous and lymphatic disease.

This year we are remembering Dr. Mel Rosenblatt and his contributions to the Foundation and to the field of venous and lymphatic medicine. As your run or walk around your community invite your friends, family, and peers to join and consider rounding up your registration as a donation to the Foundation “For Mel.”

FVLD SUNRISE YOGA OCTOBER 15 AT 9 AM EDT

We are excited to have Susie Schul, a certified Baptiste yoga instructor and Foundation volunteer, leading us in an All Levels yoga class on Thursday morning before Annual Congress.

Her class is for everyone even if touching your toes seems like a pipe dream. All you need is a computer, a web cam, and a soft stable service, preferably a yoga mat, but a beach towel also works! Susie will lead us through a variety of poses and stretches through a Zoom coaching and guiding along the way. Afterwards with loosened muscles, flowing blood and relaxed mind, we will be ready for all the sessions of Annual Congress!

All proceeds of the Sunrise Yoga class go to support the Foundation for Venous & Lymphatic Disease. Add Sunrise Yoga to your Annual Congress registration!

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Margaret Mann, MD

AVLS Research: Phase II of Improving Wisely poised to commence comparing 2017 to 2019 claims

In January of 2019, the AVLS mailed confidential data reports on vein ablations and peerbenchmarking data to over 2,500 providers across the country. A summary of Phase I national data was also published as a research paper (LINK) in the Journal of Vascular Surgery: Venous and Lymphatic Disorders. Now that 2019 Medicare claims data is complete, Phase II will examine claims data to assess if any change in vein ablations occurred between 2017 and 2019, in other words, after providers received their data report. The AVLS office will again mail out individual data reports to NPIs who were part of the Phase I data analysis. Physicians will receive their reports in early 2021 once the Phase II reports are compiled.

In 2018, the AVLS commenced a landmark quality initiative in partnership with the Improving Wisely Collaborative at Johns Hopkins University and the Robert Wood Johnson Foundation. Harnessing the power of comparison feedback and peer education to inspire physician behavior changes is at the core of the Improving Wisely Program. The Improving Wisely program is based on the concept that transparency through peer comparison reduces unnecessary variations, leading to improved patient safety and quality of care while also reducing costs. It works on the premise that we are acting in our patients’ best interests and strive to provide quality care.

“Similar collaborations with other societies have demonstrated the value of informing physicians of their practice utilization of specific resources and those of the national average,” noted AVLS

Key Findings from Phase I/2017 claims: Among 2462 physicians who performed endovenous thermal ablation procedures in 102,145 patients with chronic venous insufficiency, the mean physician ablation rate was 1.9 ± 0.8 ablations per patient annually. After adjusting for patient level variables, outlier physicians (n = 106; ablation rate ≥2 standard deviations above the mean) tended to be of a nonvascular surgery specialty, have fewer years in practice, and have a higher overall venous ablation practice volume. project Chair Margaret Mann, MD, FAAD, FAVLS. Over time, providers who receive notifications begin to modify their practices and curb possible waste due to benchmarking their data to national averages. Studies have also shown increased participation in continuing medical education opportunities.

All providers who performed ten or more venous ablations in 2017 received by mail a confidential report from the AVLS. The Improving Wisely project calculated these reports from 2017 Medicare Part B Claims. Also provided were the national averages for this metric to allow the provider to compare their utilization rates with all providers in the Medicare program.

“Seeing where you are in comparison to your peers is a metric that many physicians find very informative, and heretofore had no idea of that metric,” added Dr. Mann.

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2021

EDUCATIONAL CALENDAR SCLEROTHERAPY COURSE

DEEP VENOUS DISEASE

ULTRASONOGRAPHY HANDS-ON WORKSHOP

NON-THERMAL SYMPOSIUM

PHLEBOLOGY REVIEW COURSE

35TH ANNUAL CONGRESS

Chicago, IL April 16, 2021

Providence, RI August 14, 2021

Chicago, IL April 17, 2021

Chicago, IL April 17-18, 2021

Providence, RI August 15, 2021

Denver, CO October 7-10, 2021

SCLEROTHERAPY COURSE Providence, RI August 13, 2021

Register at www.myavls.org/courses Earn CME any time, any place in the Online Education Center www.education.phlebology.org

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C O R P O R AT E Thank you to our

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INDIVIDUAL New Horizon Donors! forMel CHAIRMAN James D. Albert Dean Bender Felicite Daftuar Terri Harper Sanjiv Lakhanpal Brad Moseley Diana L. Neuhardt Mel Rosenblatt DIAMOND Scot J. Dube Gordon Gibbs Eric Heil James Heinz* Joseph T. Jenkins Chris Pittman A. J. Riviezzo Marlin W. Schul RUBY Tyler Palmer Jeffery P. Schoonover Satish Vayuvegula ESMERALD Glenn Anderson Carl Black Paul H. Cheatum Michael Di Iorio Liza Eden Giammaria Steve M. Elias Joseph A. Zygmunt, Jr.

GOLD Cynthia B. Asbjornsen Joseph Ty Bell Catherine Burdge Yung-Wei Chi Alan P. Crowther Stephen F. Daugherty Mark D. Forrestal Kathleen Gibson Margaret Mann Vineet Mishra Kenneth L. Todd, III Robert Worthington-Kirsch* SILVER Thomas Alosco Jeff Braxton Anthony Comerota Zoe Deol David Draughn Sergio Gianesini Michael Graves Evan Harris Lowell Kabnick Neil M. Khilnani Terrance Krysinski Daniel Monahan Nick Morrison Betty Sanchez Saundra S. Spruiell Julianne Stoughton Dominic Tolitano Satish Vayuvegula Darren Wennen Thomas F. Wright 43

DONOR Michael Aikens Lisa Amatangelo Luis Barajas John Blebea Michael Cornwell Stephanie Dentoni Lance Dillon Suzie Ehmann Chris Freed Mark Joseph Garcia Amanda Godwin Aditya Gupta Todd Hansen Mohamed Hassan Marresa Houle Fernando Illescas Laura Kelsey Seema Kumar Duc Le Thomas Leaton William Marston Mark Meissner Khanh Nguyen Michelle Nguyen Bonnie Pauza-Miller Chris Pittman Neal Reynolds Anuj Shah LouAnn Smith Lawrence Starin Sonja Stiller-Martin Sean Stewart Ronald Winokur Steven Zimmet

2021 AVLS Mark Meissner, MD, FAVLS, DABVLM President

Stephen Daugherty, MD, FACS, RVT, RPhS, DABLVM Treasurer

Kathleen Gibson, MD, FACS, FAVLS President-Elect

Linda Antonucci, RPhS RVT, RDCS Director

Steve Elias, MD, FACS, FAVLS Director

John Blebea, MD, MDA, FACS Director

Sergio Gianesini, MD, PhD Director

Margaret Mann, MD, FAAD, FAVLS Director

Ken Harper, MD, FACS, RPhS Director

Vineet Mishra, MD, FAAD, FAVLS Director

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Board of Directors Marlin Schul, MD, MBA, RVT, FAVLS, DABVLM Past President

Satish Vayuvegula, MD, MS, FAVLS Secretary

Steven Dean, DO, FSVM, RPVI Director

Zoe Deol, MD, FACS Director

Raghu Kolluri, MD, MS, RVT Director

Chris Pittman, MD, FAVLS, FACR Director

Ron Winokur, MD, FSIR, RPVI Director

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Your AVLS Staff

Dean Bender

Executive Director dbender@myavls.org

Robert White

Director of Healthcare Policy & Advocacy rwhite@myavls.org

Brian Jones

Membership Manager bjones@myavls.org

John Mangold

Jen Banys

Managing Director of Sales & FVLD jmangold@myavls.org

Director of Continuing Medical Education jbanys@myavls.org

Amanda Godwin

Amy Pfaffenbach

Director of Marketing & Communications agodwin@myavls.org

Director of Meetings & Events apfaffenbach@myavls.org

Efrain Ibarra

Anna VanDeKerchove

Staff Accountant eibarra@myavls.org

Membership Coordinator avandekerchove@myavls.org

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Betty Sanchez-Azadeh Director of Finance bsanchez@myavls.org

Mike Thompson

Director of Research & Membership mthompson@myavls.org

Sarah Sabet

Marketing Coordinator ssabet@myavls.org

HOW ACCESS TO THE VIRTUAL ANNUAL CONGRESS

1 2

Go to www.avlscongress.org and click “Access” in the menu.

Login with the access key that you received by email.

If you cannot find your access key click “Forgot Access Key?” to have it resent to you.

Watching Sessions Once logged into the Virtual Congress, either:

Click the icon for the livestream channel that you want to watch.

WASHINGTON LIVESTREAM 1

LINCOLN

JEFFERSON

LIVESTREAM 2

LIVESTREAM 3

MLK JR.

LIVESTREAM 4

Navigate to the session in the agenda and click the “Livestream” or “Watch” button to watch the livestream or the recording of the session.

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