The First Five Years

Five years have quickly passed since VEIN Magazine launched into the venous community. In those early days, it was all about educating our audience about joining in the venous revolution. Our concept has stayed the same, although the passage of time has fine-tuned us quite a bit. Much like you, we’ve learned a few things, forgotten a few things and tweaked a few things and now, we are taking a glimpse back at some of those things that stand out. The following section features reprints of ten of our best-read articles from the last five years:

Welcome to the Inaugural issue-of VEIN Magazine Page 57

Incorporating Phlebology into a Vascular Surgery Practice Page 58

The BC/BS Memo that Vein Care Specialists Can’t Ignore Page 62

Waiting and Watching: BC/BS MA Privilaging

ChangesKeep Industry On High Alert Page 67

Challenges and Solutions for Incorporating Phebology

into your Interventional Radiology Practice Page 70

Scerotherapy of Minor Varicosities: A different Story Page 74

Continuing Medical Education through Accreditation Page 78

Venous Disese Coalition - The On Going Challenge to Educate About Venous Disese Page 84

10 Common Medical Practice Security Mistakes Page 88

Leading Medical Societies Team Up to Encourage the Public to Rethink Varicose Veins Page 90

Regardless of if you’re new to VEIN Magazine, or if you’ve been along for the ride since the beginning, we think you’ll glean something from each of our articles and we look forward to bringing you more informative contributions in the years to come.

Welcome to the Inaugural issue-of VEIN

The magazine will present a broad range of topics ranging from interviews with leading phlebologists, industry news, the business of phlebology practice, “hot” topics within the industry, case studies, and a meetings calendar. The creation of VEIN is in response to the tremendous growth and interest in the field.

For many years, physicians didn’t really understand venous insufficiency, most common of venous disorders, and probably didn’t much enjoy applying the limited treatment tools available. Thus it is understandable that venous disorders were considered a “Cinderella” in medicine. Over the last decade a revolution has occurred in the understanding, diagnosis and management of venous insufficiency and other venous disorders. As Dr. Min suggests in his interview, these improvements have been important in stirring the interest and involvement of physicians in the field of phlebology.

The American College of Phlebology (ACP) is by far the largest society in the United States, and one of the largest in the world, devoted to venous disorders. The tremendous growth in membership and the many significant initiatives of the ACP are reflections of the momentum in the field. The ACP’s mission is to improve the standards of practice and patient care of venous conditions. Always an inclusive organization, the ACP has taken a broad approach to the advancement of the field, welcoming physicians from various specialty backgrounds as well as recognizing nurses and ultrasound technology health professionals as valued contributors. In meeting the challenge of educating its diverse membership, the Board commissioned a survey in June of 2005 to identify the most critical priorities. The results focused the Board’s efforts on specialty recognition, board certification, academic fellowship programs, expanded educational meetings and research interests. The American College of Phlebology Foundation, publicly launched at the Annual Congress of the ACP in November 2006, is already underwriting phlebology educational programs and research.

This first issue-of VEIN will provide exciting news about recognition of phlebology in the United States. Other achievements of the ACP include the first-ever 12-month ACP Academic Fellowship in Phlebology, now underway at UCSD under the tutelage of Dr. John Bergan. This Fellowship Program is patterned after an Accreditation Council for Graduate Medical Education (ACGME) post-graduate medical training program. The ACP’s first statement regarding content was recently published in Phlebology. 1 Three new ACP Research Awards were announced in July 200:

• Research-In-Practice Grant ($24,000 for 12 months) for Clinical Phlebologists who wish to initiate a clinical research project of importance to Phlebology.

• Research Trainee Grant ($45,000 for 12 months) for young investigators (in graduate-level medical or research programs) not yet professionally established in the phlebological sciences to gain insight into scientific investigation in the field of Phlebology.

• Junior Faculty Investigator Grant ($ 0,000 for 12 months) for Junior Faculty, typically at institutions of higher learning, with a career interest in Phlebology research to initiate a basic, pre-clinical, or pilot clinical research project of importance to the field of Phlebology.

Board certification, perhaps the most significant and exciting program, will be unveiled very soon. ACP leadership is extremely pleased with the pace, status and anticipated delivery of a comprehensive, high quality, psychometrically valid exam in phlebology by early spring 2008. The exam will be computer-based and delivered at testing centers throughout both the United States and internationally. ACP will have a public announcement with more details soon.

You may call (510-834-6500) or email ([email protected] org) ACP headquarters or check the ACP website (www. phlebology.org) for updates and information on the many educational and research opportunities available through the ACP.

As John Bergan said, “Cinderella has come to the ball.”

By Steven E. Zimmet, M.D., RVT, FACPh

Incorporating Phlebology into a Vascular Surgery Practice

Most young surgeons learn quickly that surgical practice as an attending surgeon is quite different from the practice they were exposed to as residents. While many of us were exposed to many complex arterial reconstructions, very few training programs give much exposure to proper care of wounds. In particular, care for wounds caused by venous insufficiency syndromes are in many cases ignored, as they do not threaten life or limb, as arterial lesions can. A busy clinical practice quickly reinforces that venous pathologies are not only much more prevalent than arterial pathologies, but that they cause a significant decrease in quality of life for our patients. Incorporating a thorough understanding of phlebology into a vascular surgery practice will achieve three major goals:

• To relieve suffering of patients.

• To increase self satisfaction for the surgeon.

• To become a previously unrecognized source of revenue for a practice.

It is estimated that the incidence of venous disorder is perhaps an order of magnitude greater than that of arterial disorder. Varicose veins alone have been estimated to occur in 15-20% of the population depending on gender. Aging of the population and increase in the rate of obesity may only increase this prevalence. “Chronic venous insufficiency syndromes are a major cause of lost time from work and decrease productivity as well as engendering significant amounts of direct and indirect health costs.”

Until recently, there were few good treatments for these problems. Ulcers were treated with application of UNNA boots over several months; congestive symptoms were controlled with long term use of graduated compression stockings; and surgical treatment was limited to the somewhat inelegant technique of vein stripping, which was prone to intermediate and late term failure secondary to recannalization. Within the last five-to-10 years there has been an explosion of interest in phlebology as newer treatments have become more widely accepted. Paving the way for acceptance of these treatments has been the greater comfort all surgeons have experienced with ultrasound technology. Ultrasound has been gradually incorporated into all aspects of surgical practice, from FAST scanning in initial evaluation of trauma patients to office diagnosis of breast lesions to the use of endoscopic ultrasound in examination of the tracheobronchial tree and foregut.

Use of ultrasound technology has been revolutionary in many aspects of vascular surgery, from surveillance of arterial bypasses to localization of vessels to the more recent development of IVUS (intravascular ultrasound).

This overall greater facility with ultrasound gives all surgeons the critical tool needed to introduce phlebology into their practice. A large amount of information can be gleaned quickly with a fairly simple ultrasound survey of the legs as can be performed in the office. Working diagnoses can be confirmed with studies done in accredited vascular labs. The most common problem of varicose veins and chronic venous insufficiency can be diagnosed reliably and treatment performed with ultrasound-guided ablation of refluxing and dilated greater or lesser saphenous vein trunks. Ablations can be performed in an office setting with a variety of radiofrequency or laser techniques. The procedure is performed completely with local anesthesia and has no significant recovery time, as patients are encouraged to walk immediately afterward.

Once refluxing superficial vein systems are closed, extremities are de-pressurized and congestion disappears. We have found that the worst pathologies have the most dramatic improvements. In particular, severe venous stasis ulcerations close in an accelerated manner, and future development of ulceration is effectively pre-empted. Significant decreases in symptoms such as aching and heaviness in the legs can create a positive feedback loop, leading to greater ability to exercise, higher energy levels and overall dramatic improvement in quality of life. Many of our most grateful patients are those who have been treated for venous disorders. It is not uncommon to treat patients who have suffered for many years because of an inability to effectively diagnose and treat these disorders.

Ablation procedures are generally reimbursed well by most insurance, including Medicare. As a practice matures, additional patients are usually encountered who benefit from phlebectomies (direct excision of dilated superficial veins) and/or sclerotherapy (directed injection of superficial veins). Those vascular surgery practices with accredited vascular labs may also capture the reimbursements associated with diagnostic procedures. Most practices find the added revenue and patient referral to be well worth the cost of equipment and the effort to gain expertise. The American College of Phlebology has an excellent website (www.phlebology.org) and hosts a number of educational conferences each year at sites throughout the country, highlighted by the Annual Congress in November. Many vascular surgery practices will find a significant crossover of patients from treatment of venous disorders to arterial disorders and vice-versa, as many patients exhibit dual pathologies.

By Cristobal G. Alvarado, M.D.

The Blue Cross/Blue Shield Memo that Vein Care Specialists Can’t Afford to Ignore

December 15th was a normal day at The Vein & Aesthetic Center of Boston. Doctors Elizabeth Foley

and Judith Hondo bustled from room to room, caring for patients and doing procedures. Their office

staff made sure everything was running smoothly. Little did they know, as they settled into the comfortable, daily groove of a well-established vein care practice, that their thriving business was about to

be threatened—threatened by a memo that slipped into the office like a stealth bomb.

The memo was from Blue Cross Blue Shield of Massachusetts (BCBSMA). Ironically, for the gravity of the news that it contained, it was written with the seemingly casual heading, “F.Y.I.”

For your information: Effective on April 15th, 2009, there will be “new privileging requirements” for the treatment of varicose veins. Specifically, varicosities treated with radio frequency ablation (RFA) and endovenous laser ablation (EVLT). In order to continue to get reimbursed for these procedures, physicians must meet one of the following criteria:

• Board-certified in vascular surgery (VS)

• Board-certified in radiology with interventional training (IR)

• Board-certified in general surgery prior to the establishment of the vascular boards (GS)

In addition, all sites of service must be accredited by the American College of Radiology (ACR) or the Intersocietal Commission for the Accreditation of Vascular Laboratories (ICAVL). Claims for procedures performed at unaccredited sites will be denied, regardless of the performing physician’s privileging status.

BCBSMA: “Quality is the focus of this initiative.”

The memo cites “safety” and “the rapid adoption of these procedures by physicians” as the reason for the new requirements. Dr. Jan Cook, Regional Medical Director for BCBSMA, said, “Over the last five years, an increasing number of people have been receiving this procedure with a wide variety of physicians performing it. We became concerned about the quality of the training. We don’t understand the quality of the training of the physicians that are rendering this service.”

To remedy their lack of understanding, BCBSMA looked to the American Board of Medical Specialties (ABMS) to create new privileging criteria. Says Dr. Cook, “Like other insurers we use the ABMS as our gold standard. In that world, these specialties [VS, IR, GS] are the ones who specialize in venous diseases. We need to ensure that our members have the benefit of seeing professionals who can offer them a wide range of treatment options for symptomatic venous disease.” VEIN asked Dr. Cook if the company consulted with physicians, vein specialists, or either of the two main vein societies in the U.S., the American Venus Forum (AVF) or the American College of Phlebology (ACP). She responded that BCBSMA “consulted with a variety of people in our network.”

In modern vein care, quality not necessarily tied to specialty

The ABMS is of course a good place to find specialties with the skill set to treat venous disease. But by adhering exclusively to the ABMS, BCBSMA has overlooked the “contemporary world” of vein care, where skilled physicians across many specialties have been providing quality care for years—and have been getting reimbursed for it. Doctors Foley and Hondo, from The vein & Aesthetic Center of Boston, are a prime example.

Both board-certified in OB/GYn, Dr. Foley and Dr. Hondo dedicated their practice exclusively to vein treatment in 2002. BCBSMA has been reimbursing them for RFA and evLT since 2004, when the treatments were approved for coverage. in addition to handling thousands of cases and having innumerable hours of experience, both doctors have earned their credentials as registered vascular technicians (RvT) and registered physicians in vascular interpretation (RPvi). Both doctors became board certified Phlebologists in May of 2008, having met the rigorous standards set by the American Board of Phlebology (ABPh). Prior to receiving this memo, the doctors had initiated the process for iCAvL accreditation.

And yet, as of April 15th, after five years of coverage, their practice will be denied payment from BCBSMA, which represents approximately 40% of their patients.

By comparison, an iR, vS or GS who has potentially never performed RFA or evLT will be eligible for reimbursement— provided their site of treatment is ACR or iCAvL accredited. There is no specific requirement for the study or treatment of superficial venous disease in general surgery, vascular surgery, or interventional radiology fellowships.

It is worth mentioning that there is no division between medical specialties on this issue. To the contrary, concerned physicians and societies are uniting en masse to address it. Significantly, one of the doctors heading a special task force on the issue, Dr. Julie Stoughton, is a general surgeon who operates an ACR accredited facility in Massachusetts. Another key committee member, Dr. Robert Min, is a prominent interventional radiologist and past president of the ACP. In addition to the ACP, societies that have pledged their support include the Society of interventional Radiology (SiR), the Society of vascular Surgery (SvS), the American venous Forum (AvF), the Society for vascular Ultrasound, (SvU) and the American Society of Dermatologic Surgery (ASDS).

Quality of care: A defensible argument?

Nobody will argue that the patient comes first: high quality care is—or should be—of paramount importance to physicians and insurers alike. However, looking at the facts, it is difficult to give BCBSMA the benefit of the doubt when they say that patient care is the focus of this initiative.

Dr. Nick Morrison, President of the ACP, calls the BCBSMA reasoning “disingenuous and indefensible… it’s a blatant attempt to restrict access to patients under the guise of providing them with high quality care.”

In addition to missing the mark by excluding many highly skilled vein care specialists from their privileging criteria, technological advancements and low rates of serious complication also argue against their claim that this directive is quality-driven.

EvLT and RFA are minimally invasive, ultrasound-guided procedures most commonly performed on an outpatient basis, using local anesthesia. The most common risk of complication is deep vein thrombosis (DvT). The occurrence of DvT in RFA/evLT treatments is around 1%. in the majority of cases, these procedures have replaced the older practice of vein stripping. vein stripping is commonly performed in operating rooms under general anesthesia. in addition to the higher risks associated with general anesthesia, DvT occurrence in vein stripping is closer to 5%. And in simple terms of patient comfort and recovery, there is no comparison: evLT/RFA patients can usually resume normal activities within hours or days, whereas vein stripping recovery can take weeks, with substantial discomfort.

Varicose veins have been estimated to occur in 15-20% of people. An aging population and enduring obesity epidemic will likely keep those percentages on the rise. it is easy to see how patient access to safe, affordable treatment has driven rapid growth in the field of vein care, particularly over the last five years.

It is also easy to deduce that this phenomenon has caused a rapid and substantial increase in claims to insurance carriers. BCBSMA does not mention this in their memo.

Why all vein specialists should be concerned

The memo that has Massachusetts on edge could be the snowstorm before an avalanche. Asked if this is a matter of national concern, Dr. Morrison of the ACP responded, “for now it’s Massachusetts, but there is a well-founded intuition that if they go ahead with this, similar policies will be adopted nationwide. That would have terrible consequences for patients in terms of accessibility, and for the venous disease industry across the board, from physicians to equipment manufacturers. It is critically important that we stop this or get them to be more reasonable. Everybody except the insurance companies will suffer.”

At the time of this writing, a special ACPappointed committee is attempting to talk with BCBSMA. First and foremost, the committee hopes to delay the implementation of the directive and to open discussions. One critical topic is the importance of continued patient access to treatment. Another is rethinking privileging criteria to include a broader range of specialists. Physicians who can prove their competency should have the opportunity to do so, and to be considered for continued payment privileges.

Dr. Cook of BCBSMA says the insurer is “always open to

talking with network physicians,” and that they are “having ongoing conversations with [the ABPh] and their members on this topic.”

Nonetheless, she said the program is still set to go live on April 15th.

Back at The Vein & Aesthetic Center of Boston, things are on hold. A large investment in new ultrasound equipment has been shelved, and the ICAVL accreditation process has been frozen. Says Dr. Foley, “My initial reaction [to the memo] was that this issue would be easily rectified. I thought we’d just call and explain that they’d forgotten to include phlebology in their privileging criteria. I never thought it would turn into the nightmare it’s become.”

By Sarah Spataro

Watching & Waiting: BCBSMA Privileging Changes Keep Industry on High Alert

Recap

In our spring issue, VEIN broke a story about imminent changes to RFA/EVLT privileging requirements in the Blue Cross/Blue Shield of Massachusetts physicians network. Effective April 15th, all physicians wishing to be reimbursed for these procedures have to be vascular surgeons, interventional radiologists, or general surgeons prior to the establishment of vascular boards.

These changes effectively exclude a large percentage of vein specialists who have been expertly treating superfi cial venous disease for years, but who do not fall within the BCBSMA guidelines.

In addition, all sites of treatment have to be accredited by ICAVL or ACR. But BCBSMA ignored the fact that ICAVL and ACR accredits diagnostic labs, not therapeutic. In a letter to BCBS, the Society for Vascular Ultrasound (SVU) writes:

“There exists, however, an incompatibility with the policy as written: many venous ablations are performed in settings outside the non-invasive vascular laboratory. The referenced accrediting bodies do not offer therapeutic ultrasound facility accreditation; therefore there can never be compliance with the BCBS policy in these settings.”

BCBS maintained the party line that this is a “quality-driven initiative,” and never so much as alluded to a sharp increase in claims that must have coincided, over the last fi ve years, with an explosion of improved ablative technology. But most members of the venous community cried foul, viewing this as a multi-level assault on patient’s access to care, and physician’s access to reimbursement. It is a widely—if not unanimously— held belief that the only benefi ciaries of this policy shift will be the insurance companies themselves. There is also speculation, and trepidation, that Blue Cross will set the precedent for other organizations to follow suit.

A task force, staffed by physicians and industry leaders nationwide, was assembled to address the issue with BCBS.

What’s Happening Now?

As summer settles in all over the country, there is a quiet yet palpable tension around the issue, yet little progress has been made to change or modify the new policy. This is not for lack of effort within the industry; physicians have acted individually and societies, such as the above-referenced SVU, have written respectful but straightforward letters. It is the stalwart resolve of BCBS that has things at a standstill. In a response letter to the SVU, Jan Cook, the BCBS medical director supporting the initiative, wrote:

The [RFA/EVLT] privileging program is a quality initiative