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ANNIVERS
DECEMBER 2017/JANUARY 2018 Vol. 10, No. 6 VEINTHERAPYNEWS.COM
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An ACP recognized resource for news and information for and about the phlebology community
Medtronic VenaSeal gets more favorable codes
BTG gets CPT codes for Varithena
By Larry Storer The U.S. Centers for Medicare and Medicaid Services have published the final fee schedule for new Current Procedural Terminology (CPT) Category 1 codes for BTG International’s Varithena® procedures and changed CPT codes for Medtronic’s VenaSeal, effective Jan. 1, 2018. The new codes for Varithena, which close veins through the ultrasound-guided injection of non-compounded
foam scleroscant, allow for automated claims adjudication, substantially simplifying and allowing consistent and predictable reimbursement policies for physicians, Medicare and commercial payers. Also on Jan. 1, Medtronic’s VenaSeal varicose vein closure device will get new CPT codes setting higher billable rates for those procedures, which use cyanoacrylate, a proprietary adhesive, to close an incompetent vein in lower extremities in
people suffering from symptomatic venous reflux or varicose veins. Medtronic has been able to get more favorable rates for its VenaSeal Closure System under the new CPT codes 36482 and 36483 going forward in 2018.
CPT CODES
continued on page 17
WHAT’S UP IN 2018?
Physicians respond to concerns facing them in the new year By Larry Storer When I recently polled a dozen physician leaders by email about what issues were at the top of their list of the most critical issues facing them in 2018, concerns fell into two categories: political and medical. Then, face-to-face conversations with some of the physicians attending the 31st American College of Phlebology in Austin demonstrated how deeply these and other issues affect the way these doctors see the future of venous disorder treatment and medicine in general. Not surprisingly, those issues causing the most angst were political – things that are difficult to impossible to change. These “external” issues are the leading cause of the professional frustration of these doctors as they prepare for another year.
POLITICAL ISSUES
At the top of the list of “political” concerns is reimbursement. Easy enough to understand, right? Because money is not exchanged at the time of service, physicians are challenged because it is reimbursed by a third party, either Medicare/Medicaid or private. The problem comes when the amount reimbursed and
the time that it takes to receive that reimbursement can become a gray area that can squeeze larger practices and mercilessly shut down smaller ones.
“Basically I am feeling the squeeze as reimbursement drops and the costs go up,” said Edward Mackay, MD, RVI, RPVI, who has offices in St. Petersberg and Palm Harbor, Fla. “The margins on some of our main procedures are narrowing. The costs of employees are up, mostly because of health insurance. As this squeeze occurs, the temptation for some doctors to overprescribe procedures rises.” Laura Ellis, MD, with offices in Asheville, N.C., and Laguna Beach, Calif., is concerned about insurance. “In both my North Carolina and California practices we are mindful of various insurance company “Policy Statements” on treatment of varicose veins and venous insufficiency, and changes in these statements. “Extremely problematic right now in North Carolina is the Blue Cross Blue Shield policy change as of Jan. 1, 2017,” she said. “They now allow approval of endovenous ablation of only one vein per leg per lifetime for their policyholders. As you know, we often have to ablate two or even three veins per leg in certain patients,” Dr. Ellis said. “The expense of treating any diseased veins after the one “allowed” becomes the 2018
continued on page 16
AVF plans 30th Annual Meeting By Larry Storer Registration for the 30th Annual Meeting of the American Venous Forum (AVF) Feb. 20-23 in Tucson, Ariz., is underway, and final touches on the program are being made. The site of this year’s event will be the JW Marriott Tucson Starr Pass Resort & Spa in
Tucson. Detailed information and registration is available at veinforum.org AVF President Marc A. Passman, MD, said that while many of the events are traditional favorites of returning members, there will be AVF
continued on page 32
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Volume 10, Number 6
Editor Larry Storer lstorer@hot.rr.com 254-399-6484
NEWS 1 BTG’s Varithena gets CPT codes
Varithena, BTG International’s ultrasound-guided injection
of non-compounded foam scleroscant, has received its own new Current Procedural Terminology (CPT) Category 1 codes
Art Director
beginning Jan. 1. Meanwhile, Medtronic has announced that its
Lisa Gouveia lisag@pcinews.com
VenaSeal Closure System will get favorable new codes allowing
Executive Vice President of Sales and Operations Gary Pittman, Jr. 512-637-0373 garypjr@pcinews.com
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them to charge more for the procedure.
1 AVF plans 30th Annual Meeting
Registration for the 30th Annual Meeting of the American
Venous Forum Feb. 20-23 in Tucson, Ariz., is underway, and final touches on the program are being made. The program will include several 30th anniversary special events.
THE PRACTICE 21 Prioritizing your circulation
More often than not, we care for our health by reacting
to conditions rather than proactively working to prevent them. But if there’s one thing you shouldn’t wait to care for, its proper circulation and the health of your veins.
SECOND LOOK 1 What’s up in 2018?
Doctors respond to a survey as to which issues concern them
the most in the New Year.
22 Closed-loop thrombophlebitis
We all have had patients with large venous aneurysmal
dilatation along the course of axial veins, most often associated with the Great Saphenous Vein (GSV). So, how do we avoid closed-loop thrombophlebitis?
24 LEAN and your vein practice
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VEIN THERAPY NEWS < DECEMBER 2017/JANUARY 2018
3
NEWS THE
VTNREPORT ISET TO MEET FEB. 3-7 IN FLORIDA The multidisciplinary meeting ISET will convene Feb. 3-7 in Hollywood, Fla. For 30 years, ISET has served as the premier arena for endovascular education. Alumni have gone on to transform the fields of interventional radiology, interventional cardiology, vascular surgery, and phlebology. REGISTER NOW: iset.org
TRUMP NOMINATES ALEX AZAR TO HEAD HHS, LOWER DRUG COSTS President Donald Trump has nominated former pharmaceutical company executive Alex Azar II to head the Department of Health and Human Services (HHS) and preside over the execution – either the elimination or implementation – of the Affordable Care Act (ACA). Like Trump, Azar takes a dim view of the law. In television interviews, Azar has called the ACA “a fundamentally broken system” that was “failing completely on its own terms, and nobody impacted it from the outside.” In Azar, Trump also has an experienced HHS hand. Azar served as the department’s general counsel from 2001 to 2005 in the George W. Bush administration, and then as its deputy secretary, the number-two position, from 2005 to 2007. It’s Azar’s last high-profile job as president of Lilly USA, the largest affiliate of drugmaker Eli Lilly, however, that critics of everything Trump does sees the area of attack. The president campaigned on the promise to lower the cost of prescription drugs by having government programs such as Medicare negotiate prices with pharmaceutical companies, which he said in January were “getting away with murder.” If confirmed by the Senate, Azar will be Trump’s lead person in dealing with Big Pharma. The implication being that because Azar worked at Eli Lilly for a decade after his stint at HHS, his agenda is suspect. HHS is now led by Acting Secretary Don Wright, MD, MPH. He took over in September after orthopedic surgeon Tom Price, MD, resigned while facing intense criticism and scrutiny for taking government trips on charter and military aircraft when less expensive commercial flights were available.
COLLEGE OF PHLEBOLOGY’S 2ND INTERNATIONAL VEINS MEETING WILL BE MARCH 14-15 IN LONDON The College of Phlebology’s 2nd International Veins Meeting will be March 14-15 in London. The conference will be hosted by The College of Phlebology, in conjunction with the Leg Ulcer Charity, Lindsay Leg Club Foundation and the Venous Times Newspaper. The aim of the meeting is to bring excellence in phlebology at the forefront of clinical practice. It emphasizes the importance of conducting first-hand research that aims at increasing scientific knowledge that when applied has the objective to improving patient care. Abstract submissions were due by Nov. 10, 2017. Notification of acceptance of the abstract should be received Jan. 23, and the final email presentation is due by Feb. 28. Questions may be emailed to meeting2018@collegeofphlebology.com . There will be a Prize Awards Dinner Thursday, March 15, for the best oral and e-poster presentations.
HURRICANES COST SMITH & NEPHEW $5M; BIGGER STORMS FACING BRITISH COMPANY Smith & Nephew has reported that it took a $5 million hit during the third quarter from the hurricanes that devastated Texas and Puerto Rico and guided toward the low end of its outlook for the rest of the year. The British medical supply giant, which only reports profit numbers at the middle and end of the year, said Q3 sales grew 2.9 percent to $1.15 billion, compared with the same period last year. CEO Olivier Bohuon, who’s slated to step down at the end of the year, declined to comment on rumors about a possible takeover or sale of its divisions, or about the Smith & Nephew stake taken by hedge fund Elliott Management. “We are not thinking about asset disposal at this stage at all,” Bohuon said. “We do not comment on rumor or speculation and we don’t comment on the identity of our investors unless required to do so under disclosure rules.
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MEDICAL DEVICE, INSURANCE INDUSTRIES FIGHT JAN. 1 RETURN OF OBAMACARE MEDICAL DEVICE TAX The medical device and insurance industries are fighting to stop ObamaCare taxes from taking effect now that it’s clear the law will remain on the books next year. Medical device maker AdvaMed and other industry sources say they’re optimistic and that momentum is growing. They point to new legislation released in mid-October to delay the health insurance tax and a letter – with a list of 179 signees from both parties – sent to Speaker Paul Ryan (R-Wis.) in favor of repealing the medical device tax. “The suspension of the medical device tax expires on January 1, 2018, and it is critical to the health and sustainability of this vital American manufacturing industry that this tax is not once again applied to its products,” the lawmakers wrote. But there isn’t much time. Congress passed a bill in December 2015 that delayed both the tax on health insurance and the tax on medical devices for two years, but the pause is set to expire at the end of the year. The taxes were created by President Obama to pay for the Affordable Care Act that became law. “We’re fully activated now,” said AdvaMed’s JC Scott, chief advocacy officer. “We’re engaging with members on both sides of the Capitol, both sides of the aisle regularly on [repealing the medical device tax]. We’ve shared our concerns with the administration.”
UNINSURED RATE CREEPING UP After reaching a historic low late last year, the U.S. uninsured rate has been on the rise amid uncertainty over the future of the Affordable Care Act. The uninsured rate was 12.3 percent in the third quarter of 2017, according to the newly released Gallup-Sharecare Well-Being Index survey. That’s an increase of 1.4 percentage points – representing nearly 3.5 million adults – since the uninsured rate reached an all-time low of 10.9 percent in the third and fourth quarters of 2016. The uninsured rate is now the highest recorded by Gallup since the last quarter of 2014, when it was measured at 12.9 percent. Even so, the current rate is still much lower than 18 percent, the rate measured in the third quarter of 2013 before the ACA’s major provisions were implemented. Lower-income and middle-income adults have seen comparatively larger increases in their uninsured rates since 2016 than their higher-income counterparts, and black and Hispanic adults have since seen higher increases than non-Hispanic whites. The Gallup article said one of the factors that may be driving the increase is uncertainty about the ACA. “Congressional Republicans’ attempts to replace the healthcare law may be causing consumers to question whether the government will enforce the penalty for not having insurance,” it noted. Some insurers’ decision to exit the ACA exchanges may also be playing a role, as the resulting lack of competition in some marketplaces may be driving premiums upward and driving some consumers to forgo insurance, the article said. Indeed, while there are no U.S. counties without an ACA exchange carrier for 2018, many areas are served by just one insurer. Premiums are also expected to rise next year – in part to account for the Trump administration’s decision to end cost-sharing reduction payments – which will hit consumers who don’t qualify for subsidies especially hard. Insurers also have reason to worry that they will see lower sign-up figures than they’ve had in years past during the upcoming open enrollment period for ACA marketplace plans. The open enrollment period will be half as long this year, and the Trump administration has significantly scaled back advertising and outreach efforts.
VIEWRAY RAISES $50M THROUGH STOCK SALE ViewRay, an image-guided radiation therapy developer, raised approximately $50 million through the release and sale of 8.4 million shares of common stock in October. The purchase price for each share was $5.95. Immediately after the closing, one new investor will own 9.9 percent of the company’s outstanding shares. ViewRay plans to use the proceeds for the ongoing commercialization of its MRIdian linear accelerator technology, for research and development related to continued product development activities, and for general corporate purposes, including working capital. VT N
DECEMBER 2017/JANUARY 2018 < VEIN THERAPY NEWS
Some things you shouldn’t do yourself. Compounding your own foam is one of them. Varithena is a modern, safe on-label solution for varicose veins that delivers reliable results for even the most challenging anatomies. Backed by Phase III clinical data and its own CPT codes—there’s really no reason to take the risk. Leave the foam to us.
New CPT codes coming January 1st
To see the Varithena difference visit: LeaveTheFoamToUs.com
www.varithena.com INDICATIONS Varithena® (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Varithena® improves the symptoms of superficial venous incompetence and the appearance of visible varicosities. IMPORTANT SAFETY INFORMATION The use of Varithena® is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease.Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately. Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with underlying arterial disease may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately. Varithena® can cause venous thrombosis. 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. The most common adverse events observed were pain/discomfort in extremity, retained coagulum, injection site hematoma or pain, common femoral vein thrombus extension, superficial thrombophlebitis, and deep vein thrombosis. Physicians administering Varithena® must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease and be trained in the administration of Varithena®. For Full Prescribing Information visit Varithena.com © 2017 Biocompatibles, Inc., a BTG International group company All rights reserved NA-VAR-2017-1193 10/17 Varithena is a registered trademark and Varithena Solutions Center is a trademark of Provensis Ltd, a BTG International group company BTG and the BTG roundel logo are registered trademarks of BTG International Ltd
Varithena® (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013 Brief Summary of Prescribing Information. For complete Prescribing Information, consult official package insert. INDICATIONS AND USAGE Varithena® (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Varithena® improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.
In Varithena®-treated patients, 80% of pain events in the treated extremity resolved within 1 week.
DOSAGE AND ADMINISTRATION Varithena® is intended for intravenous injection using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities.
Proximal symptomatic venous thrombi occurred in <1% of patients treated with Varithena®. Approximately half (49%) of patients with thrombi received treatment with anticoagulants.
Physicians administering Varithena® must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease, and be trained in the administration of Varithena®. CONTRAINDICATIONS The use of Varithena® is contraindicated in patients with: • known allergy to polidocanol [see Warnings and Precautions] • acute thromboembolic disease WARNINGS AND PRECAUTIONS Anaphylaxis Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately. Tissue Ischemia and Necrosis Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with underlying arterial disease, such as marked peripheral arteriosclerosis or thromboangiitis obliterans (Buerger’s Disease) may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately. Venous Thrombosis Varithena® can cause venous thrombosis [see Adverse Reactions]. 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. ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under controlled but widely varying conditions, adverse reaction rates observed in clinical trials of Varithena® cannot be directly compared to rates in the clinical trials of other drugs or procedures and may not reflect the rates observed in practice. A total of 1333 patients in 12 clinical trials were evaluated for safety when treated with Varithena® at dose concentrations of 0.125%, 0.5%, 1.0% or 2.0%, including 437 patients treated with Varithena® in placebo-controlled clinical trials. Adverse reactions occurring in 3% more patients receiving Varithena® 1% than receiving placebo are shown in Table 1. Table 1: Treatment-emergent adverse reactions (3% more on Varithena® 1% than on placebo) through Week 8 (n=588) Adverse Reaction Pain in extremity Infusion site thrombosis b Contusion/injection site hematoma Limb discomfort Tenderness/injection site pain Venous thrombosis limbc Thrombophlebitis superficial Deep vein thrombosis
Placebo (N=151) 14 (9.3) 0 9 (6.0) 5 (3.3) 5 (3.3) 0 2 (1.3) 0
Varithena® 1.0% (N=149) 25 (16.8) 24 (16.1) 23 (15.4) 18 (12.1) 16 (10.7) 12 (8.1) 8 (5.4) 7 (4.7)
Pooleda Varithena® (N=437) 65 (14.9) 46 (10.5) 38 (8.7) 32 (7.3) 30 (6.9) 24 (5.5) 40 (9.2) 10 (2.3)
a Includes Varithena® 0.125%, 0.5%, 1.0%, and 2.0% from the placebo-controlled trials. b Retained coagulum. c Common femoral vein thrombus extension (non-occlusive thrombi starting in the superficial vein and extending into the common femoral vein).
In the 1333 patients treated with Varithena®, the following venous thrombus adverse events occurred: common femoral vein thrombus extension (2.9%), proximal deep vein thrombosis (DVT) (1.7%), distal DVT (1.1%), isolated gastrocnemius and soleal vein thrombosis (1.4%).
Since Varithena® induces thrombosis in the treated superficial veins, D-dimer is commonly elevated post-treatment and is not useful diagnostically to assess patients for venous thrombus following treatment with Varithena®. Neurologic adverse events (cerebrovascular accident, migraines) have been reported in patients following administration of physician compounded foam sclerosants. None of the 1333 patients in the Varithena® trials experienced clinically important neurological or visual adverse events suggestive of cerebral gas embolism. The incidence of neurologic and visual adverse events within 1 day of treatment in the placebo-controlled studies was 2.7% in the pooled Varithena® group and 4.0% in the placebo groups. Skin discoloration adverse events were reported in 1.1% of the pooled Varithena® group and 0.7% of the placebo group in the placebo-controlled studies. DRUG INTERACTIONS No specific drug interaction studies have been performed. There are no known drug interactions with Varithena®. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies of Varithena® in pregnant women. Do not use Varithena® during pregnancy. Labor and Delivery The effects of Varithena® on labor and delivery in pregnant women are unknown. Nursing Mothers It is not known whether polidocanol, the active pharmaceutical ingredient in Varithena®, 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 Varithena® to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Of the 1333 subjects in clinical studies treated with Varithena®, 9.1% (n=121) were ≥65 years of age. No clinically important differences in safety or efficacy were observed between older and younger patients in all studies. OVERDOSAGE There are no known cases of overdosage with Varithena®. In clinical studies, total volumes of up to 60 mL of Varithena® per treatment session have been administered.
Manufactured for Provensis Ltd by: Biocompatibles UK Ltd Chapman House, Weydon Lane, Farnham, UK, GU9 8QL. Distributed by: Biocompatibles, Inc. 115 Hurley Road, Building 3, Oxford, CT 06478 Provensis Ltd, Biocompatibles UK Ltd, and Biocompatibles, Inc. are BTG International group companies Varithena is a registered trademark of Provensis Ltd. BTG and the BTG roundel logo are registered trademarks of BTG International Ltd
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Vascular Insights® , LLC • 1 Pine Hill Drive • Two Batterymarch Park, Suite 100 • Quincy, MA 02169 • USA • +1-203-446-5711 M-101 (R1)
NEWS Six abstracts from IVC will be published in JVS-VL The IVC 2018 abstract deadline is March 1 for the April 19-21 conference in Miami Beach. Six selected abstracts will be published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL), the official journal of the Society For Vascular Surgery and the American Venous Forum. These abstracts will require formal oral presentations, which will be critiqued live by IVC faculty whom are members of the JVSVL editorial board. According to IVC course director Jose I. Almeida, original abstracts not presented elsewhere either before or after IVC presentation are eligible. VT N READ MORE: ivcmiami.com/abstracts.php
“Furthermore, he has a kindness that patients appreciate to help them or a loved one understand their diagnosis and feel comfortable during the treatment and followup process.” Dr. Randono said he is happy to be able to continue to serve patients in Southern Colorado with his skills and years of experience. VT N READ MORE: americanvein.com
AMA report warns insurance markets open to abuse due to payer’s strength Roxwood catheters for peripheral arterial disease and cardiovascular disease
BTG acquires Roxwood Medical
John Joseph Randono, MD
American Vein adds a new physician to its phlebology staff John Joseph Randono, MD, has joined the phlebology staff of American Vein & Vascular Institute, a network of eight vein and arterial diagnosis and treatment centers in Colorado and Texas. Dr. Randono has more than 30 years medical experience, specifically as a cardiac and thoracic vascular surgeon, and as a phlebologist and vein disease specialist. He holds a B.S. from the University of Northern Colorado in Chemistry, and an M.D. from St. Louis University in St. Louis, Mo. He is also a Diplomate of the American Board of Venous and Lymphatic Medicine. “Dr. Randono is an exceptional and highly qualified phlebologist with the special combination of expertise and experience in treating vein disease,” Gordon F. Gibbs, MD and cofounder and owner of American Vein & Vascular Institute, said.
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successfully treat patients with severe arterial blockages.” BTG will pay up to $80 million in cash to acquire Roxwood, comprising $65 million paid on closing and up to an additional $15m should certain future commercial milestones be achieved. The transaction is expected to be accretive to adjusted EPS from the second full year of ownership. VT N READ MORE: btgplc.com
BTG acquired Roxwood Medical in early October, 2017. Roxwood is a provider of advanced cardiovascular specialty catheters used in the treatment of patients with severe coronary and peripheral artery disease (P.A.D.). Roxwood’s anchoring catheters (CenterCross, CenterCross Ultra, MultiCross) and microcatheters (MicroCross) offer options for physicians in the crossing of complex lesions and arterial blockages. By incorporating a self-expanding scaffold that stabilizes the delivery of a guidewire, Roxwood’s catheters provide positioning accuracy and support to facilitate the crossing of blockages, mitigating guidewire buckling and enabling treatments such as angioplasty, stenting or atherectomy. “This bolt-on acquisition continues to build BTG’s strength in the interventional vascular space, further expanding our portfolio of differentiated minimally invasive vascular technologies,” said John Sylvester, BTG’s chief commercial officer. “Roxwood’s products complement our existing business and will be offered through our existing Ekos hospital sales force, providing our customers with options to enable treatment of these patients with complex lesions.” Mehrdad Farhangnia, Roxwood’s CEO, termed this an exciting new chapter for the team at Roxwood and further testament to the utility of the anchoring and microcatheter platforms. “With the expanded commercial and clinical reach of BTG, these minimally invasive tools can help far more clinicians
Health insurance markets across the country are becoming increasingly concentrated, making them ripe for payers to exercise market power in a way that can negatively affect patients and healthcare providers, according to a new American Medical Association (AMA) report. The report, produced by the AMA, found that in 43 percent of metropolitan areas in 2016, a single health insurer had at least a 50 percent share of the market. That was the case in 40 percent of metropolitan areas in 2014. Put another way, the commercial health insurance market became more concentrated from 2014-2016 in 27 states. Overall, 69 percent of metropolitan areas had a significant absence of health insurer competition in 2016 – earning them a “highly concentrated” rating based on federal guidelines used to assess market competition. Anthem, the AMA noted, dominated the rest of the pack by being the largest health insurer by market share in 82 out of 389 metropolitan areas that the trade group examined. Health Care Service Corp. had a market share lead in 42 out of 389 metropolitan areas, while UnitedHealth led in 26 areas. Two separate federal judges, however, have prevented further insurer consolidation by blocking the Aetna-Humana and AnthemCigna mergers – decisions that the AMA cheered. Both Aetna and Anthem ultimately decided to abandon the deals. “Previous versions of the AMA study played a key role in efforts to block the proposed megamergers by helping federal and state antitrust regulators identify markets where those mergers would cause anticompetitive harm,” AMA President David O. Barbe, MD, said in a release. The AMA report urged federal and state regulators to continue to scrutinize insurer consolidation, noting that retrospective studies of past deals have shown that less competition drives premiums upward. Insurers with greater market power also tend to make payments to healthcare providers below competitive levels,
and reduce the quantity of coverage to levels below those produced in a competitive market. But America’s Health Insurance Plans pointed out in a study released last month that provider consolidation – specifically, hospital systems buying smaller physician practices – also contributes to rising costs. Kristine Grow, AHIP’s senior vice president of communications, also offered the following statement: “The role of health insurance providers is to ensure that every consumer they serve receives the greatest value possible – the best possible experience, outcomes and cost,” she said. “As they build their networks, health insurance providers focus on how they can work with doctors, hospitals and health systems to deliver high quality, good health outcomes, and the best use of every dollar that a consumer spends on care. We are focused on a better experience for the patient.” VT N READ MORE: rsna.org/Annual_ Meeting.aspx
Thrombectomy device market to reach $1.45B value by 2022 The global thrombectomy devices market is expected to reach a value of $1.45 billion by 2022, growing at a CAGR of 6.7 percent during the forecast period, according to a new Research and Markets report, “Thrombectomy Devices Market - Global Forecasts to 2022.” The growing target patient population, ongoing technological advancements, favorable medical reimbursements, rising demand for minimally invasive thrombectomy procedures and increasing healthcare expenditure across emerging markets are some key factors propelling the growth of this market. The factors such as increasing number of research activities in the field of thrombectomy and expanding application of ultrasound in vascular treatment are expected to offer renewed growth opportunities for market players during the forecast period. In this report, the market has been segmented on the basis of type, application, end user and region. Based on application, the cardiovascular segment commanded the largest share of the global thrombectomy devices market in 2016. This large market share is mainly attributed to factors such as increasing prevalence of cardiovascular diseases across major markets, procedural benefits offered by mechanical thrombectomy in cardiac surgeries, higher prevalence of thrombotic diseases among geriatric individuals, and growing preference of surgeons for image-guided and minimally invasive cardiac surgeries. VT N
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NEWS ACP 31st Annual Congress – New Horizons: 810+ attend, 350 exhibit at Austin Congress The buzz of energy surrounding the American College of Phlebology’s (ACP) Annual Congress in Austin was undeniable as medical healthcare providers gathered from all over the globe for the four-day event. With more than 810 attendees and more than 350 exhibitors, it was a full house. “The feedback from this year’s attendees of the Annual Congress has been tremendous,” said Dean Bender, executive director of the ACP. “With so much going on in Austin, you couldn’t help but feel the energy and excitement about the future of our field and our society.”
NEW HORIZON
The ACP announced its New Horizon Strategic and Capital Campaign officially on Friday evening during its business meeting. The goal of the campaign is to refocus the mission of the ACP around three foundational tenets of advocacy, research and education. The New Horizon is already off to a great start with more than $3 million raised in support of the ACP and the Foundation. “We ‘ARE’… excited!” Bender said. “From the depth and breadth of our educational program, to engaging social and networking opportunities, to the roll-out of our New Horizon strategic plan and the solidarity of our corporate partners and leadership investing in the future, it all came together in Austin to launch the next phase of our society. “We ARE… Advocacy, Research and Education. So, keep your boots on, step up and get involved, become a member, join a committee, contribute to the Foundation. We ARE you!” Attendees had access to more than 80 faculty members throughout the event and more than 50 sessions from which to choose. Several hands-on sessions, including sclerotherapy, phlebectomy and ultrasound, provided attendees the opportunity to learn new techniques through practicing alongside experienced faculty. As a part of expanding the educational horizon of the ACP, Stanley Rockson, MD, from Stanford Health Care was the keynote speaker during the Friday morning general session. He shared how vein disorders and lymphedema often go hand-inhand, and the importance of understanding both disorders to more comprehensively treat patients. “I am delighted to see this growing partnership of lymphatic practitioners with this American College of Phlebology and the
Several hands-on sessions provided attendees an opportunity to learn new techniques.
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field of venous medicine,” Dr. Rockson said. “We are, in fact, very natural partners.” The Thursday sessions, formerly known as Pre-Congress, were integrated into the balance of the programing this year. The tracks offered were expanded to include a series on advanced phlebology and deep venous interventions, as well as a hands-on track studying pelvic ultrasound and pelvic venous disorders.
GOLF, FUN RUN
It wasn’t all work as attendees also participated in the 11th Annual ACP Foundation (ACPF) Golf Outing and the 3rd Annual ACPF Fun Run. Together they raised more than $70,000 to support the future of vein disease treatment with the ACPF. The 11th Annual ACPF Golf Outing took place at the Falconhead Golf Club in Austin on Wednesday before the
The 11th Annual ACPF Golf Outing drew 70 golfers to the Falconhead Golf Club in Austin, Texas.
official start of the Annual Congress. More than 70 golfers of all skill levels, participated in a best ball format competition with the winning foursome coming in 12 under par. Mulligans were available for a donation. A highlight of the event was Glenn Anderson’s Closest to Pin award with a Hole-in-One. More than 190 people registered for the early morning Fun Run and Walk around Lady Bird Lake in downtown Austin. The route followed the shore of the lake for a beautiful run and a great view up Congress Avenue into downtown Austin as runners and walkers circled back to the finish line.
NEXT UP – NASHVILLE
Plans are already underway for the ACP 32nd Annual Congress in 2018, which will be in Nashville, Tenn., Nov. 8-11. Mark your calendars because you do not want to miss what’s new and what is next for the ACP and the venous and lymphatic community! VT N
More than 350 exhibitors prepare for the doors to open in the exhibit hall in the JW Marriott.
DECEMBER 2017/JANUARY 2018 < VEIN THERAPY NEWS
NEWS CMS releases 2018 Physician Fee Schedule Physicians will receive a small increase in Medicare payments under the 2018 Physician Fee Schedule released in early November. The Centers for Medicare & Medicaid Services issued a final rule Nov. 2 for the 2018 Physician Fee Schedule, which increases payments by 0.41 percent. The new rate, CMS said in a fact sheet, reflects the additional 0.50 percent update established under the Medicare Access and CHIP Reauthorization Act of 2015, reduced by 0.09 percent, due to the misvalued code target recapture amount, required under the Achieving a Better Life Experience Act of 2014. The final conversion factor is $35.99, an increase from $35.89 in 2017. In addition, CMS said in an announcement that beginning in 2018 the agency will update payment for biosimilars, lower-cost alternatives to certain types of drugs known as “biologicals.” This change promotes competition to ensure that millions of patients will have access to new lower cost therapies, the agency said. Furthermore, the agency said it would transform access to Medicare telehealth services by paying for more services and making it easier for providers to bill for these services. Improving access to telehealth services reflects CMS’ work to modernize Medicare payments to promote patient-centered innovations. Perhaps the most controversial change in the Fee Schedule is the agency’s decision to cut 20 percent from payments for certain services to off-campus provider-based hospital departments. These services are no longer paid under the Outpatient Prospective Payment System, and CMS has changed the payment rates for these services from 50 percent of the OPPS payment rate to 40 percent. The agency said it believes that this adjustment will provide a more level playing field for competition between hospitals and physician practices by promoting greater payment alignment. But Blair Childs, senior vice president of public affairs at Premier, an alliance of approximately 3,900 U.S. hospitals and health systems and approximately 150,000 other providers and organizations, said the alliance was disappointed by the action because it fails to reflect the higher costs that these sites incur relative to free-standing physician offices. “This decision will reverse momentum toward providing care across the continuum. At this transitional moment where the industry is moving from fee-for-service to valuebased payment, this decision undermines the movement to provide care outside the walls of the hospital, potentially leading to increased Medicare spending,” Childs said. VT N
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NEWS Vein practice in Houston is now for sale The Cosmetic Vein Centers of Texas PA, the first office based vein center in Houston, is now for sale. As part of the sale, training for all forms of venous interventions is included. Mark F. Skellenger, MD, FACPh, RVPI, RVT, has been treating his patients at this center since 2002, but he is now interested in working part-time for a well-trained associate. Other services offered by the Cosmetic Vein Centers of Texas include laser hair and tattoo removal, skin tightening, Botox and injectables, facial resurfacing, and advanced skin care. Dr. Skellenger can be reached at 281-990-8346 or at drskellenger@ cosmeticvenincenters.com. VT N
American Vein earns challenging IAC accreditation in vascular testing American Vein and Vascular Institute, a network of vein and arterial diagnosis and treatment centers located throughout Colorado and in Arlington, Texas, was recently granted a three-year term of accreditation by the Intersocietal Accreditation Commission (IAC) in Vascular Testing. IAC accreditation is a certification that the facility consistently provides patients with the highest quality care. “Cardiovascular diseases are the number one cause of death in the United States,” Gordon F. Gibbs, MD and cofounder and owner of American Vein & Vascular Institute, said. “On average, one American dies every 39 seconds of cardiovascular disease.” Nearly 800,000 new strokes occur annually, making stroke the third leading cause of death and the leading cause of disability in the United States. The key to decreasing death and disability caused by cardiovascular disorders is early detection through vascular testing procedures. Many factors contribute to an accurate diagnosis based on vascular testing: training and experience of the technologist performing the procedure, the type of equipment used and the quality assessment metrics each facility is required to measure all contribute to a positive patient outcome. Erin Gibbs, cofounder and CEO of American Vein & Vascular Institute, said that IAC accreditation is a “seal of approval” that patients, referring physicians and the community can rely on as an indicator of best healthcare care practices and dedication to continuous improvement. IAC Accreditation indicates that American Vein & Vascular Institute has undergone an
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intensive application and review process and is in compliance with the required standards, according to Javier Calderon, RVT, technical director of American Vein & Vascular Institute. “This process was a great undertaking, and huge accomplishment for our team,” Calderon said. “All of our technologists were under scrutiny from a panel of medical experts who assessed the operational, as well as technical components of our facilities. I’m proud of this team and proud to say we are the largest privately-owned accredited vascular lab in Colorado.” American Vein & Vascular Institute services include diagnostic vein and peripheral arterial disease consultations and treatments, vein disease consultations and treatments, cosmetic treatments for varicose veins and spider veins and compression wear with custom fittings at an onsite retail center. VT N READ MORE: americanvein.com
Chocolate PTA
Medtronic takes Chocolate PTA, project updates to VEITH2017 Medtronic was presenting information on the Chocolate PTA, In Pact Admiral and HawkOne in its booth at VEITH2017 in November in New York. The Chocolate PTA evolved from QT Vascular’s plan to develop a drug-coated version of a PTA called Chocolate Touch, which was the subject of a pivotal trial after winning an investigational device exemption from the FDA last year. Medtronic agreed to acquire an option on the Chocolate PTA non-drug-coated balloon from QT Vascular to treat peripheral vascular disease. For $28 million Medtronic acquired a five-year deal to distribute the device.
MEDTRONIC PROJECTS
Meanwhile in the conference sessions, physician speakers brought attendees up to date on several Medtronic projects. “At this year’s VEITHsymposium, we are thrilled to be able to feature nearly 40 different clinical presentations on our aortic, peripheral, endoVenous, and vascular embolization therapies, six of which are podium-firsts,” said Jason Weidman, senior vice president and president of the Aortic & Peripheral Vascular Division, which is part of the Cardiac and Vascular Group at Medtronic. “The vast amount of data being featured at VEITHsymposium underscores our
commitment to durable, consistent and safe vascular procedures, as well as industryleading clinical rigor and data transparency.” In a first-to-podium presentation at VEITHsymposium, William Jordan, MD, professor of surgery and chief, Division of Vascular Surgery and Endovascular Therapy at Emory University School of Medicine and co-principal investigator of the ANCHOR registry, reported on 12-month results from the ANCHOR Registry evaluating the FDAapproved Endurant II/IIs Stent Graft System in combination with the Heli-FX EndoAnchor System in subjects with abdominal aortic aneurysm (AAA) with aortic necks less than 10mm. Frank R. Arko III, MD chief of Vascular and Endovascular Surgery, professor of cardiovascular surgery, and co-director of the Aortic Institute, presented new 30-day clinical outcomes on the investigational Valiant Navion device, a minimally invasive thoracic endovascular aortic repair (TEVAR) system for patients with descending thoracic AAA disease. VT N
Aziyo Biologics report positive PERFORM results at VEITHsymposium Aziyo Biologics Inc., a fully integrated regenerative medicine company, has announced positive results from PERFORM, a prospective, post-market study conducted in patients undergoing femoral arterial reconstruction using the company’s biologic extracellular matrix (ECM) scaffold. The preliminary results of the PERFORM study were presented at the VEITHsymposium 2017 in November by Joshua D. Adams, MD. Dr. Adams reported that patients undergoing femoral arterial reconstruction with patch angioplasty closure were eligible for the study, and a total of 43 patients were enrolled at three U.S. centers. “To date, there have been no devicerelated adverse events and no instances of patch infection,” he said. Primary patency as determined from duplex imaging was maintained in 97.6 percent of procedures at an average of seven months follow-up. Patient follow-up includes duplex imaging and assessment of adverse events through 4-6 weeks, 6 months and 12 months following endarterectomy. “This preliminary analysis of Aziyo’s biologic ECM for femoral arterial reconstruction demonstrates the product’s safety and efficacy in peripheral vascular reconstruction,” said Dr. Adams, principal investigator and a vascular and endovascular surgeon at Carilion Clinic Vascular and Endovascular Surgery, and previously the Medical University of South Carolina.
Dr. Joshua Adams Dr. Adams explained the process. Aziyo’s biologic extracellular matrix for vascular repair is constructed from a multi-laminate sheet of decellularized, non-crosslinked, lyophilized extracellular matrix (ECM) derived from porcine small intestinal submucosa (SIS). Porcine SIS is a decellularized matrix that serves as a bioscaffold to allow vascular ingrowth from adjacent tissues to deliver progenitor cells and nutrients to the matrix, which then differentiate into tissue-specific cells and structures. The ECM is gradually replaced as the patient’s own cells restore the diseased or damaged site. During repair, the matrix is naturally degraded and resorbed, leaving remodeled functional tissue where damaged or injured tissue would normally be expected. Since 1999, an estimated 2 million patients worldwide have received SIS ECM implants. Once implanted, evidence shows that over time the ECM transforms into vascularized tissue. The extracellular matrix for vascular repair has been implanted in more than 30,000 procedures. “Evidence also supports the antimicrobial properties of ECM, rendering it more resistant to infection than standard prosthetic material. Continued patient follow-up in the study will be important to further understand the longterm effectiveness of this unique biomaterial.” Michelle LeRoux Williams, PhD., chief scientific officer of Aziyo Biologics, said the preliminary data from PERFORM is encouraging. “We believe this biologic ECM scaffold is an important solution for vascular repair as part of a surgeon’s regenerative medicine toolkit.” VT N READ MORE: aziyo.com
Anthem names Gail Boudreaux CEO After nearly five years at the helm, Anthem President and CEO Joseph Swedish stepped down Nov. 20. He was replaced by Gail Boudreaux. Boudreaux served as CEO of UnitedHealthcare from 2011-2014. VT N
DECEMBER 2017/JANUARY 2018 < VEIN THERAPY NEWS
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NEWS Chinese robot, Xiaoyi, passes China’s medical licensing exam
UIP: Reunion of the Union By Kurosh Parsi On behalf of the Australasian College of Phlebology, I would like to invite you to join us in Melbourne, Australia, for an exceptional UIP World Congress of Phlebology. Melbourne, the most livable city in the world, will be your host city in the Australian summer. The meeting is scheduled to run from Feb. 4-8, a week after the Australian Open Tennis competition. The motto of the 18th UIP World Congress is the “Reunion of the Union.” We genuinely wish to bring the Union back together, to elevate its scientific standing, to strengthen phlebology as a specialty and to showcase the full spectrum of this exciting field. Phlebology is a multi-disciplinary field and we will bring together world experts in vascular disease, vascular anomalies and malformations, interventional radiology, lymphology, dermatology, hematology, thrombosis and hemostasis, fluid mechanics and hemodynamics, ultrasound and wound healing.
The program will feature daily multidisciplinary state-of-the-art keynote lectures that focus on new technologies and innovations, international guidelines, debates and consensus meetings. For those seeking practical knowledge, there will be hands-on training sessions, a comprehensive Ultrasound Certification Program, live broadcasts of procedures, daily videos and workshops on a range of topics. The social functions will be spectacular with the Award Ceremony promising to bring the glamour of the Oscars together with the excitement of the Olympics Opening Ceremony! The Gala Dinner will take you back to the 1920s. Make sure you dress for the occasion. Participation at the World Congress offers unequalled opportunities at the largest gathering of the phlebology community on the planet. We sincerely hope you can join us at this exciting congress and look forward to delivering a highly memorable and valuable experience. VT N
Aesthetic vein meetings set The first 2018 Aesthetic Vein Conference, which will be open to only 75 physicians, will be in April at the Hilton Palm Beach Airport in Palm City, Fla.. The second conference will be Oct. 13. Ronald Bush, MD, FACS, is the course director. The content will describe cutaneous venous hypertension from spider veins to ulcers. “Insurance reimbursements are decreasing rapidly and may disappear forever for the treatment of venous disease,” Dr. Bush said. “Eighty percent of all patients, even with varicosities, may be classified as cosmetic in the future. The vast majority of patients that you will see in a venous practice will have spider telangiectasia or veins of the face and hands. “Based on years of clinical experience and research in the dermatopathology lab, I have developed techniques that will improve patient outcome, avoid complications and give you the physician a sound grounding in all aspects of venous disease.’ He said many physicians who treat venous disease have a very limited knowledge of the
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pathophysiology of large and small vessel disease. “Most vein conferences cover the same material year after year with little new information. In order to have a successful vein practice in the future, the physician will have to address all facets of venous disease.” Complete information is available online at aestheticveintraining.com/conferences/ . VT N
SK&A counts docs SK&A has released again its April 2017 market coverage report “Nationwide Physician Specialties by State.” The report lists the top 20 physician specialties, which apparently went down to about a 14,000-physician cutoff. Phlebologists did not make the Physician Specialty table, but it did list 6,827 vascular and interventional radiologists and 7,140 vascular surgeons. It also listed 14,066 dermatologists – many of whom also do veins and plastic surgery, and e 13,881 plastic surgeons. READ MORE: skainfo.com/ reports/
Dr. Kenneth Madsen
American Vein celebrated Pueblo Northside Arterial Clinic milestone American Vein & Vascular Institute, an award-winning network of vein and arterial diagnosis and treatment centers, recently celebrated the one-year anniversary of its Pueblo Northside Arterial Clinic and Kenneth R. Madsen, MD. “Pueblo Northside Arterial Clinic offers the same expertise and high-level of customer service our patients have come to expect from American Vein & Vascular Institute,” Gordon F. Gibbs, MD, cofounder and owner of American Vein & Vascular Institute, said. “We are honored to have Dr. Kenneth Madsen and an expert team of medical professionals at the forefront of patient care for our Pueblo Northside location,” Dr. Gibbs said. Dr. Madsen, a vascular surgeon who is board-certified in general and vascular surgery, has performed more than 400 surgical procedures since the clinic opened a year ago. He received his medical degree with honors from George Washington University School of Medicine and has been in practice for more than 24 years. In addition to Dr. Madsen, the Pueblo Northside Arterial Clinic includes a nurse practitioner, three registered nurses, one registered vascular technician and one medical assistant on staff, with a combined 40 degrees and certifications among this team. The Pueblo Northside Arterial Clinic houses The Arterial Center, a state-of-theart facility for comprehensive diagnostic and vascular care, and is the only office-based lab performing peripheral arterial interventions in Colorado, according to Dr. Gibbs.. American Vein & Vascular Institute services include diagnostic vein and health consultations, vein disease treatments, cosmetic treatments for varicose veins and spider veins, compression wear custom fittings at an onsite retail center, and peripheral arterial disease treatments. VT N READ MORE: americanvein.com
A Chinese medical robot named Xiaoyi achieved a passing score of 456 on China’s medical licensing exam in early November. A passing score is 360 out of 600. But 456 is an impressive result considering the robot scored 100 in its first practice run. Chinese IT company iFlyTek and Tsinghua University in Beijing collaborated on the development of Xiaoyi, which means “little doctor.” It was developed to test if artificial intelligence (AI) can be effective in identifying links between words, sentences, paragraphs and other natural language features to develop a capacity to reason. Its much improved score is certainly a demonstration that Xiaoyi has the capacity not only to reason, but to learn and make judgments by itself. After its first pitiful attempt, Xiaoyi was trained by processing dozens of medical textbooks, 2 million medical records and 400,000 articles. While that was effective enough for it to breeze through the questions that involved memorization and information recall, it didn’t do as well when it came to answering questions about patient cases. An American version of Xiaoyi won’t be replacing any physicians, but the technology could prove useful in correlating symptoms quicker and making clinically useful suggestions. VT N
Microrobot sutures sub-mm vessels in lymphedema surgery At Maastricht UMC+, an academic hospital in The Netherlands, the first surgical procedure using a new microrobot has been successfully performed. The physicians used a system from Microsure, a Dutch firm that spun off from Eindhoven University of Technology and Maastricht UMC+, to suture sub-millimeter vessels in the arm of a patient suffering from lymphedema. The robotic device converts the movement of the surgeon’s hands into precise, but tiny actions of the robot, giving physicians an unprecedented level of dexterity that would be impossible with just bare hands. During the surgery, lymphatic vessels of between .3 and .8 millimeters in diameter were attached to blood vessels, allowing lymphatic fluid to drain from the area, alleviating painful and dangerous swelling.
MICROBOT
continued on page 25
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patient’s responsibility. This can be quite a hardship for patients who already have high premiums and deductibles.” Deborah Manjoney, MD, who practices in Wisconsin, said that certainly reimbursement was at the top of the list, in part because it may affect some physicians’ choice of the “best practice” in treating veins. “Did you know that Medtronic has been able to ‘set’ reimbursement for VenaSeal Closure System at $2,100 from CMS going forward in 2018? They are positioning to have a higher reimbursement than laser and radiofrequency closures. Will that influence physician decision?” James White, MD, FACS, said that the biggest problem he faces in his Tennessee practice now is the major increase in deductible amounts since the Affordable Care Act. “My Medicare population has increased on an annual basis as the private insurance vein procedures have decreased. Also, the complexity of the procedures have increased due to older patients with longstanding venous stasis who present for care in place of young working adults with C3 disease. Patients present with symptomatic varicose veins and C3 disease. “We go through the hoops to get the EVA procedure predetermined. But many times, older patients directly tell me: ‘I cannot afford the deductible and out of pocket fees, so I will not have the procedures completed.’ “Varicose venous stasis is an insidious disease, but not urgent. Each year, benefits decrease and deductibles increase, effectively limiting the number of patients who need treatment to prevent end-stage venous stasis disease.” Just under reimbursement in the list of pressing “political” concerns was ethics. Or, more to the point, a lack of them. Mel Rosenblatt, MD, FACPh, whose surgical practice is in Connecticut, was specific about where he is seeing the most unethical procedures: “Unethical treatment of a normal great saphenous vein.” Another physician with a lot to say about the lack of ethics by some vein doctors is Jose I Almeida, MD, FACS, RVT, whose vein practice is in Florida. “In my home state of Florida, unnecessary laser ablations have risen to especially high levels,” he said. “Patients show up to my office in droves for second opinions after having encountered unnecessary procedures by doctors who run the gamut of backgrounds. “Because doctors are reimbursed on the same fee schedule regardless of their experience, qualifications, knowledge and expertise, some doctors have entered the field with poor training and an even poorer sense of ethics.” “This has inadvertently led to doctors themselves cashing in, favoring volume over value, and offering patients unnecessary treatments and procedures for their own financial gain. “Unscrupulous doctors respond by gaming the system – embellishing records to suggest that the procedure is medically necessary in order to justify insurance coverage.” Dr. Mackay said that competition is up from people who are not well trained. “We have techs doing the procedures for these poorly trained doctors – not PAs, NPs, but RVTs or ultrasound techs. “It’s very hard to compete with practices that essentially treat venous disease as just another profit center with no real interest in the disease.” Manu Aggarwal, MD, MHSA, whose two offices in Ohio have been Intersocietal Accreditation Commission certified since 2007, agrees, but is unsure of how to police physician ranks. “First and foremost in my mind is the negligent and fraudulent care of patients with venous and lymphatic disease,” she said.
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POLITICAL ISSUES 1. Reimbursements a. Medicare b. Private 2. Ethics a. Non-providers proving care b. Credentialing of providers c. Differences of LCDs and ethics d. Misuse of social media 3. Government Regulations and interference a. Over-treatment b. Investigations arising from embolization code for ClariVein 4. Adoption of FDA-approved devices
“How can we police this and utilize our accrediting bodies?” Jeff Miller, MD, who operates his vein treatment centers in five Southeast Michigan locations, said unethical care should be at the top of the list. “The bad players are going to adversely affect those with morals.” Lowell Kabnick, who is an associate professor at NYU and has a practice in New Jersey, said he is concerned about the differences between LCDs and ethics. Another ethical issue facing phlebologists in 2018 was listed by a number of physicians who also selected ethics as a separate item: Non-providers providing care. The late Dr. John Kingsley called them “weekend wonders”: Physicians who take a weekend course and then hold themselves out as a qualified vein specialist. Additionally, new technological developments have made some procedures easy to perform. Add to this a bad economy and doctors with an even worse sense of ethics and these weak practitioners are popping up everywhere. Dr. Almeida said the endovenous revolution began around the year 2000 when venous procedures traditionally done by surgeons in the operating room under general anesthesia, moved to the office under local anesthesia. When catheter-based vein ablation started to take a foothold and really disrupted traditional surgical practice – things went from the hospital to the office. “The problem is that there is little or no oversight in the office – i.e., to perform a procedure in a hospital one needs to get privileges from a credentialing committee. But to do the same procedure in an office, you are your own credentialing committee,” he said. That’s allowing different doctors from all different specialties looking for new sources of revenue to enter the venous space with often no training except for a weekend course. There is no oversight when you are your own credentialing committee. Another problem that physicians see as only getting worse in the future is social media. Doctors from other specialties who have become mentor-taught in a weekend course can look just as qualified as any of these distinguished doctors when they do a little creative writing on their website. “So online, we look the same,” Dr. Almeida said. “Someone like me who is a double-board certified, fellowship-trained vascular surgeon doing venous surgery for 20 years might look the same online as a doctor who started yesterday and embellished their online credentials. To make matters worse, I often see content from my website copied verbatim on someone else’s.” One can now buy Google Adwords and boost search engine optimization (SEO) to come up first in a Google search –
MEDICAL ISSUES 1. Pelvic venous disease 2. Misdiagnosis/complexity of vein problems 3. Men with venous disease 4. More discussion regarding central venous disease a. May-Thurner b. Pelvic venous congestion. 5. Managing increasing overhead a. Cost of finding, training and retaining employees b. Rising cost of health insurance c. Cost of locating and retaining new patients, and marketing d. Rising cost of technology and its short shelf life 6. Discussion on best treatment methods with the large variety of thermal and non-thermal options basically, untrained doctors are “purchasing credibility.” So when a patient looks online for varicose veins or vein doctor or spider veins, the doctors with the highest SEO come up first and then that’s where the patient is naturally going to click and begin their search and often fall into the wrong hands. Government regulations was also mentioned by several physicians as a problem sure to get worse in 2018. “This is becoming unbelievable,” Dr. Almeida said. “I spent six hours last night, and still need another four hours next week of training on a new EMR system at the University of Miami Hospital.” Another aspect of government interference is over-treatment. “This is huge,” Dr. Mackay said. “We are spending time finding out about the last mammogram or checking their blood pressure or smoking history or whether they have their flu shot. It goes on and on. I don’t treat hypertension or order mammograms. They have doctors for that. It’s a waste of time. Let us concentrate on what they are seeing us for.
MEDICAL ISSUES
It was apparent there was generally less frustration when the physicians began to discuss medical issues that they believe they will face in 2018. Finally, something they believed they could do something about. Managing overhead issues was at the top of about four lists: the cost of finding, training and retaining employees; the rising cost of health insurance; the cost of locating and retaining new patients, and marketing; and the rising cost of technology and its short shelf life. The misdiagnosis of complex vein problems was next on the list of medical issues in 2018. Specific references to venous aneurysms, a spectrum of congenital anomalies of the inferior Vena Cava; pelvic congestion and pelvic venous disease; and May-Thurner syndrome, also known as the iliac vein compression syndrome. In various ways, three physicians noted that while venous insufficiency is the most common vascular disorder today, it remains the most prevalent but underdiagnosed and misdiagnosed disorder. Literature estimates that more than 30 million Americans suffer from symptomatic venous insufficiency, but fewer than 2 million actually seek treatment. Venous vascular disease is five times as prevalent as peripheral arterial disease and 2.5 times as 2018
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DECEMBER 2017/JANUARY 2018 < VEIN THERAPY NEWS
NEWS CPT CODES
continued from page 1
BTG’S VARITHENA
Varithena (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein system above and below the knee. It improves the symptoms of superficial venous incompetence and the appearance of visible varicosities. Varithena GM Mike Motion said CPT Codes 36465 and 36466 have been assigned to the Varithena procedures. “CPT Code 36465 is assigned for injection of non-compounded foam sclerosant with ultrasound compression maneuvers to guide dispersion of the injectate, inclusive of all imaging guidance and monitoring the treatment of a single, incompetent extremity vein,” Motion said. “A single incompetent extremity truncal vein; for example, the great saphenous vein (GSV) or an accessory saphenous vein (AGSV).” He said CPT Code 36466 is for the treatment of multiple incompetent truncal veins; for example, the GSV or AGSV in the same leg. “More than 10,000 Varithena procedures have been performed since its U.S. Food and Drug Administration’s approval in November 2013 and its subsequent commercial launch in August of 2014,” Motion said. Through the end of 2017, physicians using Varithena had to bill through the unlisted vascular surgery procedural code 37799 in conjunction with the unspecified drug code J3490, and then spend valuable clinical time jumping through hoops to secure reimbursement. The new codes set reimbursement at $1,624.30 for treatment of a single incompetent extremity vein and $1,697.02 for treatment of multiple incompetent veins in the same leg. “Having a CPT Code is important to physicians because it reduces the number of manual claims; allows automatic and electronic processing of claims, which means faster, easier experience; and potentially decreases time to receive payment.,” Motion said. The new codes treat Varithena as a procedure and a supply, so they will be included in the code and not separately reported. “To be specific: the unspecified J3490 code for the drug is separately reported in 2017 and starting Jan. 1, 2018,” Motion said, “Varithena, as a supply, will be included in the new CPT codes and not separately reported.”
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NEWS
NEWS CPT CODES
continued from page 17
MEDTRONIC’S VENASEAL
Medtronic’s VenaSeal Closure System received a favorable new CPT code as a level 4 vascular procedure as part of the 2018 Medicare Physician Fee Schedule and Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems. Medtronic spokesperson Julia Baron said Medtronic’s new CPT codes – 36482 and 35483 – bring the device closer to positive coverage from public and private insurers in the United States. CPT Code 36482 covers an endovenous thermal chemical adhesive for the first vein with VenaSeal, which is $2,162. Baron said CPT Code 36483 is an add-on code that must be billed in conjunction with 36482 to cover subsequent veins treated in a single extremity, each through separate access sites. Its CMS national average payment is $147. Covered as part of the code is the endovenous ablation therapy of the incompetent vein, extremity, by transcatheter delivery of a chemical adhesive (cyanoacrylate) remote from the access site, inclusive of all imaging guidance and monitoring; percutaneous; first vein treated. “This definitely represents progress for us as we seek positive coverage for VenaSeal,” she said. Earlier this year, Medtronic released three-year outcomes and one-year data that demonstrated long-term clinical benefits and quality of life improvements for patients. The procedure, however, remains under a self-pay model since its FDA clearance and U.S. launch in 2015, according to Sandra Lesenfants, vice president and general manager of Medtronic endoVenous. “Medtronic has been working to pursue payer coverage, and we will continue to provide updates over the next several months as we work with regional Medicare Administrative Contractors (MACs) and private payers to obtain that coverage,” Lesenfants said. “While we cannot discuss market share, we do believe payer coverage will provide additional patient access and ultimately drive additional adoption and growth for VenaSeal,” she said. Medtronic touts VenaSeal as the only nontumescent, non-thermal and non-sclerosant procedure, so it avoids the risk of nerve injury sometimes associated with certain thermalbased treatments of the small saphenous vein presently in use. The VenaSeal closure system is also designed to allow rapid recovery with minimal downtime; people may not even need to use compression stockings after undergoing the procedure. CPT CODES
continued on page 25
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THEPRACTICE
AT-RISK PROVIDERS
APIC survey: 4 in 10 healthcare professionals work while sick Just because your doctor tells you to stay at home when you are sick, don’t count on her or him following the same advice. In fact, chances are your doctor, sitting close to you and breathing in your face, may be ill. Many health professionals aren’t following their own advice, according to a new Association for Professionals in Infection Control and Epidemiology (APIC) study. A survey of more than 1,900 healthcare professionals during the 2014-2015 flu season found that 4 in 10 came to work while experiencing influenza-like illness (ILI), including a combination of fever and cough or sore throat. Of the 414 people who said they came to work with these symptoms, about 40 percent said they worked ill for the median of three days. As in all workplaces, contagious employees risk infecting others when they turn up for work. But with higher concentrations of older patients and individuals with immunosuppression or severe chronic diseases in healthcare facilities, ILI transmission by healthcare professionals presents a grave public health hazard. Sophia Chiu, MD, the study’s lead researcher and a medical officer for the National Institute for Occupational Safety and Health, said the statistics are alarming. “We recommend that healthcare facilities take steps to support and encourage their staff not to work while they are sick. “At least one earlier study has shown that patients who are exposed to a healthcare worker who is sick are five times more likely to get a healthcare-associated infection,” Dr. Chiu said. The survey assessed a variety of health occupations across multiple institutions: physicians; nurse practitioners and physician assistants; nurses; pharmacists; assistants/aides; other clinical healthcare professionals; nonclinical healthcare
professions; and students. Four types of work settings were assessed: Private practices or ambulatory care; hospitals; longterm care facilities; and other clinical settings. Clinicians have reported a number of reasons that they report to work despite being sick, including: • They can still perform their job. • They feel obligated to their co-workers. • They don’t feel sick enough to miss a day of work. • They don’t think they are contagious. • They feel professionally obligated to continue seeing patients. Part-time workers are especially likely to come to work ill because they may not have the sick leave to take time off when they’re sick.
Of those surveyed who felt they were healthy enough to work, 39 percent sought medical treatment for their flu symptoms while at work, as did 54.0 percent of those who did not think they were contagious. The survey found that hospital-based healthcare workers were the most likely to come to work while they are sick. Pharmacists and physicians worked while sick most often, with about 67 percent and about 63 percent, respectively, coming to work will flu symptoms. Remember how your doctor insisted that you take a flu shot? The survey also found that 22.7 percent of respondents did not get the flu shot during that flu season. Linda Greene, RN and president of the APIC, said that providers put potentially-vulnerable patients at risk when they come to work sick, and that healthcare facility leaders should re-examine their sick leave policies to encourage staff to stay home. “Tailored strategies per occupation and health institution, including updating paid sick leave policies, can empower [healthcare professionals] to make healthy choices, not only for themselves but for their coworkers and patients,” Greene said. From 1976-2007, influenza-associated fatalities accounted for up to 16.7 (ranged between 1.4 and 16.7) deaths per 100,000 people in the U.S. Flu-related deaths predominantly impact individuals 65 years and older. Influenza may be transmissible from one day before, and up to seven days after, symptoms onset. VT N READ MORE: apic.org
Companies want to help cut time wasted doing pre-authorizations How much time do you spend each week making prior authorization requests? A survey of 1,000 physicians revealed they made prior authorization requests 37 times per week on average, according to data from the American Medical Association. About one fifth of the survey participants said it takes 20 hours to do these requests each week. The prior authorization process is a frequent, time-consuming process for physicians. It’s no wonder small and large health IT vendors see opportunities to use technology to create a more efficient workflow. It’s also yet another reason one of the best and most recent examples for the opportunity health IT vendors see in this market is the huge acquisition of CoverMyMeds earlier this year. PriorAuthNow closed a $3.6 million round in late August to add to its staff and roll out its prior authorization tool to health systems. Its focus is speeding up the process of connecting hospitals with health insurers to check whether procedures and certain drugs are covered by patients’ insurance plans.
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PriorAuthNow’s product is designed to work within electronic health records, according to a news release. NCT Ventures led the funding round with involvement from Detroit Venture Partners. Another health IT startup with a product that includes prior authorization in its wheelhouse is Klara. The clinical messaging platform, which raised $3 million in seed stage funding last year, is intended to improve
communication between patients, their physicians and insurers. Cofounder and managing director Simon Lorenz, MD, has said it wanted to connect everyone who has a role in taking care of a patient, including primary care physicians, specialists, clinical and office staff, insurance companies, care coordinators and patients. “The better the prior authorization, the more likely prescriptions will be filled,” Dr. Lorenz said. Klara has integrated with health IT vendors, most notably Epic Systems, and is in the process of integrating with others to allow authorized users to read and share clinical notes, schedules and patient-specific information through the platform. ZappRx, which focuses on specialty drugs, is also trying to improve the prior authorization process. Its initial focus is pulmonary arterial hypertension but it also plans to expand into drugs for rheumatology, neurology, oncology and gastroenterology.
CenterX is another business that has prior authorization as part of its product offer but with a medication adherence component. It gives doctors out-of-pocket cost information so patients are armed with accurate information for their prescription therapy plan. It is also designed to work easily with electronic health records by using data from EHRs to alert patients when electronic prior authorization is needed. CenterX also is intended to eliminate prior authorization requests with missing data that are required. Although it’s not prior authorization per se, InteliSys Health wants to make drug prices more transparent so physicians and patients can have meaningful conversations about choosing a medication that is within patients’ budget range. The idea is that if patients know they can afford the drug they will be more likely to pick it up from the pharmacy and that can offer a meaningful way at reducing one of the many reasons for poor medication adherence. VT N
DECEMBER 2017/JANUARY 2018 < VEIN THERAPY NEWS
Importance of prioritizing circulation By Sophie Van Sickle More often than not, we care for our health by reacting to conditions rather than proactively working to prevent them. But if there’s one thing you shouldn’t wait to care for, its proper circulation and the health of your veins. In fact, it’s highly recommended that you make it a priority to care for your veins and circulation for the sake of your overall health. Lack of blood circulation compromises proper blood flow and the release of oxygen and nutrients to the entire body, including vital organs. Poor circulation is often a symptom of a more serious issue, so closely monitoring circulation levels is crucial. Improving blood circulation helps promote cell growth and organ function, including the health of your skin. When your heart is functioning properly, your heart muscles relax, heart rate lowers and your blood pressure flows evenly. Increased blood circulation also helps improve brain function, keeping your mind sharp and focused. The brain’s limbic system controls memory and concentration, so in order for your brain to function at its full capacity, it must be oxygenated at healthy levels. Research suggests that serious health risks, including cognitive impairment, increase without blood pressure control. While this affects individuals of all ages, it is especially prevalent among older patients already susceptible to memory loss. Circulation also plays a large role in the health of your extremities, especially the legs, where blood flow is affected the most by gravity. Because blood must travel uphill, your body has to work harder to return blood to the heart from lower parts of the body. One of the easiest ways to combat this is exercise, even if it’s something as low-impact
as walking. When you walk, the muscles that surround the veins contract and relax, which stimulates blood flow and prevents blood from pooling around the ankles. During times of extended sitting, such as long flights or prolonged work days, try using compression socks to keep freshly oxygenated blood flowing back to your legs. Individuals must be aware of signs that suggest blood circulation is being compromised before the body begins to show more serious effects. When diagnosing for poor circulation, vein therapists look for pain, discomfort or achiness in the legs and feet. Deficiency in circulation causes achiness, muscle weakness and fatigue to the feet and legs, as well as numbness or tingling. Another uncomfortable symptom is for hands and feet to easily grow cold. These signs of poor blood circulation are concerning, but also uncomfortable, and can affect your everyday life. These symptoms occur when muscles do not receive a sufficient amount of blood to properly function. Without sufficient blood levels in the legs and feet, the body loses energy and becomes fatigued. This occurs because your body quickly falls tired when the heart is working harder to keep up blood circulation. Oxygen isn’t accessing the muscles with speed and ease, resulting in fatigued muscles and longer recovery periods. Now that you’re aware of the signs of poor blood circulation, you are empowered with the knowledge to provide yourself with treatment for it to prevent such ailments. If you find yourself suffering from the symptoms of poor circulation, ensure that you’re getting enough exercise. Working out regularly strengthens the heart and increases blood flow throughout the entire body. Hitting the gym doesn’t have to be a dreadful
chore – find a routine that you enjoy doing and you’ll be more likely to keep it up. Whether it be long walks with a friend, a weekly solo hike, morning yoga or playing basketball with a family member – you’re getting up and moving, and your circulatory health will thank you. In addition to regular exercise, massages (particularly in the legs and feet) ease the muscles, improve circulation and provide pain relief. Whether you learn the proper techniques to massage for better circulation or regularly see a professional, this natural remedy soothes aches and stimulates blood flow. Massages for the legs and feet increase blood movement throughout the circulatory system. Essential oils are a great addition to these therapeutic massages. In fact, some specifically function to promote healthier, better performing veins. Another remedy that is often overlooked is compression application. Accessories such as compression socks may be commonplace in phlebology practices and hospitals, but many are unaware of the benefits these socks provide. By utilizing integrally-knit therapeutic pressure, compression socks increase the circulation of freshly oxygenated blood in your legs and work to prevent swelling and discomfort. This compression technology applies pressure that begins at the ankle and eases as you go upwards. VIM & VIGR’s stylish compression legwear is one example of a company that provides these socks to boost blood flow and aid circulation conditions. When worn regularly, these socks prevent ankle swelling and slow the onset of varicose veins and deep vein thrombosis. Contemporary compression wear caters to your health needs – whether you’re being proactive and aiming to prevent circulation problems later in life, or you’re currently experiencing circulation complications and require medical grade, doctor-recommended compression. While blood circulation may not be the first thing that comes to mind when you think of preventative health care, you should ensure it becomes a priority. Strong circulation equates to a strong heart, and a strong heart makes for a healthy body. VT N
THEPRACTICE
http://www.vimvigr.com
Sophie Van Sickle is a marketing associate at VIM & VIGR Compression Legwear in Missoula, Mont. She is a recent graduate of Calvin College.
VEIN THERAPY NEWS < DECEMBER 2017/JANUARY 2018
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THEPRACTICE
Techniques to avoid Closed Loop Thrombophlebitis
By Casi White, RDMS and James E. White, MD We all have had patients with large venous aneurysmal dilatation [s] along the course of axial veins, most often associated with the Great Saphenous Vein (GSV). The usual anatomic presentation is enlargement of the GSV at the saphenous femoral junction (SFJ) with consistent enlargement of the axial vein some distance from the SFJ, with sudden venous aneurysmal dilatation followed by segments of slightly dilated vein followed by another venous aneurysmal dilatation (See Illustration 1). The pathologic etiology of the aneurysmal dilatation is felt to be related to “hold out” competent venous valve[s] attempting to maintain one-way normal venous return flow. Over time, proximal venous reflux causes intraluminal pressures to increase proximal to the lone valve[s] trying to maintain competency. Aneurysmal dilatation proximal to the hold out competent valve[s] results in a large venous pool[s]. Our practice has identified many such venous pools over the years with the largest recorded at 52mm in the mid-thigh associated with gross venous reflux in the GSV. Many of the venous pools are situated within the fascial strands covering the GSV; others may be more superficial. Standard of care has been based on the anatomic presentation of the venous pool. If the pool is very superficial just below the dermis, superficial stab phlebectomy or pin stripping is indicated. If the pool is deep below the fascia associated with the GSV, therapy usually involves thermal venous ablation and conservative observation as the body breaks down the ablated vein and breaks down the venous aneurysm. Early in the history of endovenous laser ablation, phlebologists were taught that endovenous ablation using certain wave lengths of lasers resulted in increased vein wall perforation rates post-endovenous laser ablation. These venous wall perforations were felt to result in increased ecchymosis and increased pain experienced by patients post laser ablation. We have used multiple wavelengths for endovenous laser ablation in our practice – 810nm, 970nm and 1470nm. Since 2002, we have noted a few patients with presentation of acute pain and superficial, segmental erythema of the skin associated with thrombophlebitis. These acute presentations are usually 2-6 weeks post-endovenous laser ablation. We have also reviewed patients with similar findings due to spontaneous thrombophlebitis. Not all patients with superficial thrombosis have acute unrelenting pain. So what is the difference in presentation? I believe that the
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Photograph 1 acute pain is due to thrombosis with pressure expansion of the vein wall termed Acute Closed Loop Thrombophlebitis (ACLT) [Vein Therapy News 2014]. ACLT presentations can occur spontaneously or in association with heatinduced thrombus post-endovenous laser ablation. The signs and symptoms appear to be the same, yet the etiology is varied. Acute Closed Loop Thrombophlebitis has remained constant in our populations for each of the lasers used in the EVA. Ecchymosis and tenderness have been noted to be decreased as expected with different target chromophores for the different laser wavelengths. Yet, patients with ACLT present with specific localized pain associated with localized inflammation and ultrasound evidence of peri-venous inflammation (See Photograph 1). Despite treatment of the entire vein by the same wavelength laser with the same energy in joules and the same pull back exposure; localized segments of the treated vein may progress to have an acute inflammatory reaction resulting in significant localized pain. This similar pattern is noted in some patients who present with spontaneous superficial thrombophlebitis and ACLT. No perforations are associated with spontaneous superficial thrombophlebitis. Not all patients with superficial thrombophlebitis will have acute localized pain. Not all patients post endovenous laser ablation will have acute localized pain. Presenting with similar symptoms, patients with acute thrombophlebitis due to closed loop syndrome have acute pain. I believe that the factors are similar in ACLT and acute thrombosed hemorrhoids. Thrombosis occurs, heat-induced or spontaneous. If the thrombosis is mechanically trapped, increased pressure causes stretch of venous wall and signals from pain receptors within the venous walls leading to significant
pain associated with phlebitis [See Illustration 2]. We have all seen patients with acute pain associated with superficial thrombophlebitis. The standard of care for these patients with acute pain due to superficial thrombophlebitis has included conservative observation, compression stocking support, NSAID medications and local heat. Sequential ultrasound evaluations were recommended to monitor SVT for progression and propagation to formal deep vein thrombosis. Despite conservative measures; many patients would complain bitterly about increasing pain with progression over a few days. With conservative measures, the acute pain would slowly resolve over time. Similar to the course of an acutely thrombosed external hemorrhoid. Taking the concept that ACLT and acute external hemorrhoid vein thrombosis are similar animals, we have been empirically treating the venous pools to avoid development of ACLT. These patients are treated with ultrasoundguided venous enucleation with aneurysmal perforations completed post-ablation. The ultrasound-guided enucleation allows for immediate decompression of venous aneurysm contents. The local perforations allow the residual aneurysm to decompress and decrease the chance of pressure pain due to increase in intraluminal pressures associated with ACLT. With this technique, the venous aneurysms are noted to resolve quickly and allow absorption by the body post ablation.
TECHNIQUE
The large venous pools are delineated and marked in the pre-operative evaluation. Endovenous thermal ablation is completed as per routine with attention to collapse of the aneurysmal wall by tumescence fluids during tumescence infiltration.
Illustration 1
Illustration 2
Illustration 3
Illustration 4 Endovenous thermal ablation is completed with same fiber pull back throughout the axial vein. No increased energy is delivered
DECEMBER 2017/JANUARY 2018 < VEIN THERAPY NEWS
THEPRACTICE to the site of the venous aneurysm. Ablation is completed by laser or radiofrequency. Once ablation has been completed, thrombosis of the axillary vein proximal and distal to the aneurysm is confirmed. Thrombosis of the venous aneurysm is confirmed as well. Approach is then delineated for needle aspiration. The skin is infiltrated with 1 percent Xylocaine with epinephrine wheal for anesthetic effect with a 30-gauge needle. The soft tissues around the thrombosed vein are then infiltrated with 1 percent Xylocaine with epinephrine using ultrasound guidance in addition to the previously infiltrated tumescent fluid. A 15-gauge 1.5-inch or 16-gauge 3-inch needle is used on a 3cc syringe on suction to puncture the aneurysmal vein wall using ultrasound guidance (See Illustration 3). Thrombus is aspirated and the vein wall punctured in multiple places along the venous aneurysm allowing for complete decompression and evacuation of thrombus related to the thermal ablation. This must be completed with a large bore needle (See Illustration 4). Note, multiple punctures must be made in the segment of vein wall, through and through. This must be completed with a larger bore 15-gauge needle to allow for complete decompression and to allow perforation of the venous aneurysm to assist in vein remnant absorption and to avoid a site conducive to the development of ACLT. Then 20-30mmHg compression stockings are placed with simple Kerlix pressure dressings over the residual venous aneurysm at the site of the aspiration. The patient is dismissed to home with similar conservative measures postendovenous thermal ablation: Compression stocking support, NSAID medications and local heat. We add empiric antibiotics for five days post-ablation, Keflex or Septra DS. Patients are warned that drainage may occur at the skin puncture site for a few days, especially with ambulation. Our practice has treated multiple patients with venous aneurysm(s) with this management approach over the last three years. The approach has decreased our ACLT rate by 90 percent with noted rapid involution of the residual venous pool(s) post-endovenous ablation. To date, our practice has not had any problems with vein recanalization post-EVA nor infections post-enucleation perforations to venous pools. Empiric ultrasound-guided venous pool perforations and thrombus aspiration is felt to mechanically decrease the development of acute closed loop thrombophlebitis. It is postulated that in the early post ablation period, thrombosis at the site of the venous
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VEIN THERAPY NEWS < DECEMBER 2017/JANUARY 2018
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SECONDLOOK
LEAN
Cars, Cancer…and Varicose Veins? square approach starting in the upper left quadrant and moving clockwise the owner of the task described:
By James Williams When a prospective patient calls your office to inquiry about vein treatment are you confident in your system as well as your processes? Do you have: • A streamlined process that is consistently repeated by each employee? • A system of metrics that follows the patient from initial call through followup and also identifies best practices? • Sales and educational processes that seamlessly move the patient successfully through the treatment cycle? • An experience that would cause them to say, “Yes, they treated my veins, but let me tell you how they treated me as a person?” • A culture that takes as much pride in employee satisfaction as it does patient satisfaction? If you answered “yes” to all of these questions, congratulations and well done. If not, read on.
BEGINNING OF A REVOLUTION After World War II and throughout the 1950s, the teachings of Taiichi Ohno, W. Edwards Deming and Phillip Crosby throughout Japan led to what is now known as LEAN production and manufacturing. LEAN and the Toyota Production System (TPS) are synonymous. LEAN is defined as all of the tools and concepts, including the philosophical approach derived from TPS, working together to eliminate all waste or non-value-added activities from a process. Waste and nonvalue-added effort that the customer should not, and will not, pay for. Think continuous improvement, zero defects, doing things at the right time, in the correct amount and without error. Think Value Stream or all of the activities that take a defined product or service from its raw beginning (initial inquiring phone call) all the way to its natural end (treatment), in the most efficient and effective way possible.
CANCER CARE AND LEAN Now think about being diagnosed with cancer and calling a center that is promoting breakthrough technology but, because of a myriad of obstacles and disconnects, you have less than a 10 percent chance of receiving treatment AND it will take more than three months before treatment can begin.
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This was the reality my patients faced in 2010 when I led the construction and opening of the nation’s ninth proton therapy cancer treatment center. This was the second of four such centers my company built. Nearly two years after our shovel first hit the ground, we were finally less than a month away from opening. To prepare for the opening of the second facility, I met with the staff of our first center. They presented key policies and procedures that they suggested we adopt, and it was then that I learned of the 10 percent conversion to patients and the three months it took before the care is delivered. Imagine if only 10 percent of the patients you saw received treatment. You wouldn’t accept that, but what would you do? Where would you start? We knew we needed to
but what was more important was to build a “culture of excellence.” This is an overused term that is casually thrown about in healthcare and often without any supportive substance. But it couldn’t just be words for what we were doing. We wanted and needed a culture that would literally be defined by excellence. We wanted 30/30 to be a result of our culture and not an isolated goal.
FROM ‘IS’ TO ‘SHOULD’
Our LEAN and Six Sigma experts helped us define the current or “is” process. We counted forms, words, keystrokes, etc. We simulated every process we could, from initial phone call to consult to pre-procedure testing to treatment.
Ironically, some argue LEAN was introduced to healthcare not by those within the industry but from those in the automobile industry. At that time, the most expensive part of any car made in the U.S. was the healthcare cost of the automotive workers. identify and understand the disconnects and areas of breakdown. But WHERE did we need to start? LEAN management was the answer. We set a 30/30 goal – 30 percent conversion from inquiry to treatment in 30 days or less. We gave ourselves a full year to reach this goal – knowing it would take time and we’d definitely need this level of performance in 12 months when our financial covenants kicked in. We started by challenging and clarifying our goal. Yes, 30/30 is a measurable goal,
We identified hundreds of areas of wasted time and effort and numerous disconnects. And with unbridled creativity, we constructed the future or “should” process. The “should” process required hundreds of fixes. We attacked quick fixes first to satisfy our hunger for results and to build momentum. We phased in longer term fixes, categorized them into logical groups by department and assigned owners. We met weekly to report on progress, identify obstacles and assign additional resources as needed. We used a simple four-
1. what they were to accomplish during the past week; 2. what obstacles if any were encountered; 3. how the obstacle was removed or what assistance is needed and finally 4. by reconciling these three squares when the next week’s assignment was made. Owners came prepared and each person had no more than two minutes to cover their specific four-square. We learned if it took longer than two minutes the owners did not have a firm handle on their project. Once a step was complete, policies and procedures were developed to aid in delivering replicable results at each specific juncture in the process. Metrics were also established to ensure compliance with the policies and procedures and exceptions were highlighted, both good and bad, which drove continuous improvement. The entire patient cycle was illustrated step by step (Value Stream) on a 4-foot-wide roll of paper that reached more than 30 feet in length. Listed under each step was the owner, their job qualifications, the purpose and output of that step, the policy and procedure and performance metric. Beyond its original purpose, we used the Value Stream system as a training and education tool that accelerated the opening of the subsequent centers (our third and fourth). We even used it for patient experience. For example, we identified what we wanted our patients to feel or experience at each major step in the process. This could be clarity and understanding of their condition and treatment options or physical warmth and support, etc. The winning behavior is the action required to create the intended feeling. For example, for clarity and understanding of a patient’s condition and treatment options, the winning behavior was a family versus an individual consultation. Here the patient has the support of their family, who can help raise the questions needed to fully understand the situation. Family could be physically present or attend via phone if necessary. For physical warmth and support, it was as simple as providing a plush robe (that the patient could take home) and an organized choreography of physical support – with the aim of ensuring that when one supporting
LEAN
continued on page 32
DECEMBER 2017/JANUARY 2018 < VEIN THERAPY NEWS
SECONDLOOK MICROBOT
continued from page 14
While this kind of surgery is not a new idea, and a few surgeons around the world are able to perform it without the help of robotics, it remains incredibly difficult. Even the steadiest of hands still tremble a bit and the amount of focus required of the doctor makes this kind of procedure nearly impossible for most surgeons. The system essentially erases the trembling before transferring the hand movement data to the robot, maintaining a steadiness that only a robot can maintain. “Microsure enables us to be very precise in our movements during procedures that need a surgical microscope,” said Shan Shan Qiu Shoa, plastic surgeon at Maastricht UMC+. “Their robot allows us to operate on minuscule lymph vessels and blood vessels
with more ease, while getting better results for these complex and fatiguing interventions. Besides it is very convenient that, within microsurgery, we can operate on vessels of every size with this robot. Most importantly, of course, this is good news for the patients concerned.” VT N CPT CODES
continued from page 19
OTHER CHANGES
In addition, under the Final Rule (CMS1678-FC), which addresses the final changes to the amounts and factors used to determine the payment rates for Medicare services paid under the Hospital Outpatient Prospective Payment System (OPPS) and those paid under the Ambulatory Surgical Centers (ASC) payment system, mechanochemical (ClariVein), and
laser were reassigned from level 2 to Level 3 Vascular Procedures. This reassignment reflects the clinical resources needed to perform these procedures. The CPT coding did not change; however, the comprehensive-ambulatory payment category (C-APC) and reimbursement amounts changed from a Medicare National Average of $2,360 (C-APC 5182) to $2,493 (C-APC 5183). VT N
ElastiMed raises $1M in funding In its second round of funding in October, Israeli medical startup ElastiMed has raised $1 million from a strategic investor, existing investors – The Trendlines Group and Pix Vine Capital – new private investors, and the Israeli Innovation Authority.
ElastiMed, which was founded in 2015, has developed a wearable medical device improving circulation in the legs for the treatment of venous and lymphatic diseases. Omer Zelka, founder and chief executive officer of ElastiMed, said that based on new proprietary technology and utilizing innovative “smart” materials, ElastiMed’s device compresses and massages the legs when stimulated by an electric pulse. ElastiMed’s product rhythmically expands and contracts, mimicking calf muscle contraction for improved circulation, combating venous insufficiency, lymphedema, deep vein thrombosis and various sports injuries. “The smart sock provides patients with a comfortable, easy-to-wear, highly effective, and affordable treatment option to prevent symptoms such as swelling, blood clots, leg ulcers, and sports injuries,” he said. VT N
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VEIN THERAPY NEWS < DECEMBER 2017/JANUARY 2018
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SECONDLOOK
Factors that cause doctors to burn out By Linda Girgis, MD Burnout definition: “physical or mental collapse caused by overwork or stress” Many doctors are always a step away from burnout. Doctors are expected to keep long hours and always be available. Life-saving decisions often need to be made in seconds. And if we fail, people can die. Yet, knowing this, we all chose this profession anyway because we want to make a difference Burnout rates are escalating among physicians, as well as other healthcare workers. In a system that is already stressed by many forces, losing any member of the team can have devastating consequences. Nurses are a prime example of how they are expected to do more and more work with less and less help and resources. Hospitals cut back on their ranks to save money. And patients suffer because of it. Big organizations do not so much care about the health of these nurses who selflessly try to give patients their best. Rather, the bottom line dictates staffing standards. Burnout factors causing the most problem with doctors include:
MINDLESS BUREAUCRACY
We see the patient and discuss their care with them. It is agreed upon the best next course of action. The test gets ordered and then the doctor and his staff gets thrown into prior-authorization purgatory. While the fires are heating up, the patient keeps calling to find out the status on authorization. Yet, no one has an answer to give because the insurance company is reviewing the medical necessity of the test for days. This is enough to drive one patient mad. Imagine doing this same scenario many times a day, day after day. Doctors just want to practice medicine. We don’t want to play insurance company roulette.
NEEDLESS REGULATIONS
Many people see the need for electronic health records and better management of patient data. But then the government stepped in and regulated how we record that data. Seeing a patient is now a data-recording feat that must comply with rules set up by the government which does not understand how these things work. We saw how meaningful use caused havoc on many practices and organizations. Yet, when the government realized they weren’t able to enforce Stage 3 because the technology still was not able to do a key goal of the HITECH Act (i.e. interoperability), they bailed out of the program and revamped it.
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Now we have MIPS/MACRA which increases our data work-load further while threatening our payments at the same time.
UNREALISTIC EXPECTATIONS
Everyone needs a break sometimes. Yet, when I return from an infrequent vacation, there are some patients who rain down their ire on me for being away when they needed me. This despite the fact that we pay another physician to cover the practice when we are away. Patients expect good outcomes with no side effects. It just doesn’t work that way and no matter how much pressure is placed on us, we cannot deliver the impossible. Sometimes bad things happen that are unpreventable.
INCREASING OVERHEAD WITH DWINDLING REIMBURSEMENTS
I haven’t had a raise in reimbursements since I started practicing 17 years ago. Yet, my rent and many other costs rise yearly. Small practices are struggling to stay solvent. Yet, many people still label us as greedy.
INCREASING KNOWLEDGE
Medical knowledge advances at rapid-fire speed. It is the responsibility of doctors to keep abreast of all the latest medical information.
TOP-HEAVY EXECUTIVES
Many healthcare executives are businessmen/women without any medical background. There are more of them than ever before. If you can think of a department to create, you can probably find two or three vice-presidents to be in charge of it. They rule the roost and for the most part, their success is tied to finances. Doctors are expected to make money. Doesn’t matter if you are a skilled doctor or have a good bedside manner, you need to make that cog in the wheel flow quickly and bring in top dollars.
VOICELESSNESS
Most can agree that our healthcare system has grown quite dysfunctional. For years, doctors were prohibited from joining together to fight the injustices in the system that we work in. It is illegal for us to form unions or collectively bargain. For doctors who speak out, they often get labeled as disruptive and their jobs threatened. Additionally, many of the organizations that we trusted to represent our interests failed us. Everyone knows the AMA and think it speaks for doctors; yet, only 18 percent of doctors BURNOUT FACTORS
continued on page 28
MISERY INDEX Firm fights physician burnout to restore the ‘Joy of Medicine’ By Heather Staples Lavoie We can and must do more to stop physician burnout. At Geneia, we believe technology is part of the solution. “Physician Burnout Spikes 25% in Just Four Years” That’s the headline from an article about the Medscape “2017 Physician Lifestyle Survey.” The article reports physician burnout has increased from 40 percent in 2013 to 51 percent today. For health plans, burnout is especially troubling as network physicians are the face of the plan to members. I’ll confess these alarming statistics did not surprise me. Given what physicians are expected to accomplish during each patient visit, I’m amazed the burnout numbers aren’t higher. It’s quite possible my view also may be colored by the number of physicians and healthcare leaders who heralded Geneia’s Physician Misery Index.
GENEIA’S PHYSICIAN MISERY INDEX
Geneia surveyed more than 400 full-time physicians and found widespread physician burnout and a nationwide Physician Misery Index of 3.7 out of 5. The survey also revealed 78 percent of doctors said they frequently feel rushed when seeing patients. It seems to me the heart of the doctor/ patient relationship is rooted in patient visits, and I suspect the solution lies in looking at patient visits in more detail. After all, for most physicians, the ability to create meaningful relationships with their
patients and truly affect health outcomes is why they entered the practice of medicine, and therefore is critical to experiencing joy in their work.
PHYSICIANS, PATIENTS BOTH FEEL RUSHED
According to Medscape’s 2017 Physician Compensation Report, the average patient visit is about 19 minutes. Additional research led by Christine Sinsky, MD, of the American Medical Association found that only 52.9 percent of a visit is dedicated to talking to or examining patients. Yet, there is an ever-expanding list of things to do in 10 minutes or less: • Greet the patient. • Ask the patient why he or she has come into the office. Potentially engage in a dialogue about a chronic or recurring illness. • Examine, assess and diagnose the patient. • Communicate the diagnosis and explain the treatment plan. Ensure the patient understands the diagnosis and next steps. • Answer questions. • Create and maintain a relationship with the patient. At the risk of stating the obvious, that’s a demanding and action-packed 10 minutes, and the physician needs to do this as many as 18 times a day. Every day.
MISERY INDEX
continued on page 28
DECEMBER 2017/JANUARY 2018 < VEIN THERAPY NEWS
SECONDLOOK 2018
continued from page 16
Here’s why the TVS 1470 is Number One...
prevalent as coronary artery disease. And finally, two people thought that more emphasis should be placed on men with venous disease.
AN APPROACH TO PROBLEM RESOLUTION
Dr. Rosenblatt praised a recent Society of Interventional Radiology (SIR) Foundation Research Consensus Panel (RCP) on pelvic venous disease and prioritization of research in this area. The SIR Clinical Research and Registries Division supports one-day RCP meetings twice a year to discuss critical research areas and determine how the priority topic can be further developed. After the SIR Foundation leadership selects a current critical topic in IR, such as pelvic venous disorders, the lead investigator coordinates a panel of multi-disciplinary subject matter experts. Each panelist presents on a specific subtopic and discusses future research needs. Then the RCP panel determines two to three top clinical research priority topics that may be developed into a clinical research trial or research project, and the principal investigator is encouraged to write an article on the research and solution for the organization’s peer-reviewed journal. VT N
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Pharma gifts to docs increase drug sales An analysis of Medicare Part D prescription data encompassing almost 2,900 providers in the D.C. area in 2013 shows gifts of any size can drive higher prescribing rates for highcost and brand-name pharmaceuticals. The study’s results, published in the journal PLOS ONE, found that among the physicians and providers in the study, nearly 40 percent accepted gifts ranging in value from $7 to $200,000 a year. Pharmaceutical companies’ returns on those investments included prescribing rates over twice as high as those providers who did not receive gifts, and a nearly 8 percent bump in brand-name drug prescriptions. No national laws currently prohibit such gifts, according to the announcement. Previous studies have traced the influence of pharmaceutical sales practices across various channels and practice areas. For example, the majority of physicians who post on Twitter have issues with undisclosed financial ties to drugs they mention on the platform. A recent study published in JAMA noted that academic medical centers that restricted marketing by drug company reps saw an increase in generic prescriptions after doing so. VT N
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SECONDLOOK
HIPPOCRATIC OATH 2.0 2,500-year-old oath revised in ‘17 with pledge to physician well-being No one knows if Hippocrates had to deal with physician burnout because he never mentioned it. Physician leaders, meeting at the World Medical Association’s (WMA) annual General Assembly in Chicago in October 2017 approved revisions to the Declaration of Geneva that addresses physicians’ well-being. The Declaration of Geneva, originally adopted by WMA in 1948, serves as a core document of medical ethics and a modern version of the 2,500-year-old Hippocratic Oath. Among the more substantive changes is a clause designed to encourage focus on physicians’ mental state: “I will attend to my own health, well-being, and abilities in order to provide care of the highest standard.” That language came at the urging of a New Zealand physician, Sam Hazledeane, MD, who was in Chicago as the WMA unanimously voted to include his change. “Despite ‘first, do no harm’ being the core principal of our profession, the way we’re being as doctors – in the majority of us – is
actually causing us to harm our patients,” Dr. Hazledeane told Radio New Zealand. While opinions vary among physicians about the Hippocratic Oath’s relevance to modern medical practice, the threat of burnout continues to be a very real concern. Despite that threat, physicians face institutional barriers to addressing mental health concerns, even as the profession produces worryingly high rates of suicide and depression. In addition to the language about physician well-being, the WMA adopted some other notable revisions to its Declaration – starting with a change in terminology: It will not be referred to as an “oath,” but rather as a “pledge.” The WMA and its national member medical associations have strongly reiterated their long-standing opposition to physician assisted suicide and euthanasia on the basis that they constitute the unethical practice of medicine. The WMA cites its Declaration on Euthanasia which states: ‘Euthanasia, that
BURNOUT FACTORS
MISERY INDEX
continued from page 26
remain members because we do not feel they have our interests at heart. Rather, they have joined the political arena and left us to fend for ourselves. Doctors are facing pressures like never before on many fronts. We are working long hours with little time off and more and more is expected from us. We are no longer a respected profession and have little voice left in our sector. No wonder burnout is becoming the norm. VT N Dr. Linda Girais, MD, FAAFP, is a family physician who treats patients in South River, N.J. and its surrounding communities. She holds board certification from the American Board of Family Medicine and is affiliated with both St. Peter’s University Hospital and Raritan Bay Hospital. Dr. Girgis also collaborates closely with several universities and medical schools where she teaches medical students and residents. She is a blogger for several publications and an author of books and articles for many industry publications. You can read her blogs at http:// drlinda-md.com/?author=384
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Is it any wonder physicians are increasingly burned out?
WHAT IF TECHNOLOGY HAD A HEART?
Even before we created the Physician Misery Index, we started asking ourselves, “What if technology had a heart?” In answering that question, we set out to create technology solutions to stop physician burnout and increase the satisfaction of physicians and patients. We have always believed technology and analytics designed with physician input and to fit within the existing workflow can help restore the Joy of Medicine to physician practice. We believe: • Physicians are a highly-valued, limited resource; • The central tenant to design of physician workflows and tasks must be to minimize the overall effort expended by physicians; • To the greatest extent possible, everything that can be done by someone other than a physician, in fact, should; • That other administrative and care team members are perfectly equipped, if given the right information and tools, to identify risk, coordinate care, manage
is the act of deliberately ending the life of a patient, even at the patient’s own request or at the request of close relatives, is unethical’. It also refers to its Statement on Physician Assisted Suicide which declares: ‘Physician assisted suicide, like euthanasia, is unethical and must be condemned by the medical profession. Where the assistance of the physician is intentionally and deliberately directed at enabling an individual to end his or her own life, the physician acts unethically’. And further it quotes its Resolution on Euthanasia, which notes that the practice of euthanasia with physician assistance has been adopted into law in some countries and that ‘The World Medical Association reaffirms its strong belief that euthanasia is in conflict with basic ethical principles of medical practice, and strongly encourages all national medical associations and physicians to refrain from participating in euthanasia, even if national law allows it or decriminalizes it under certain conditions’. Other changes: open care opportunities, close care and coding gaps, motivate and engage patients, and perform recordkeeping to maximize a return on quality, cost and revenue, and • We must reserve physicians’ time for the patient relationship, diagnosis and treatment.
REMOTE MONITORING HELPS STOP BURNOUT
The Geneia @Home remote patient monitoring program, a 24x7x365 solution that helps chronically-ill members as well as their physician and care team better understand, monitor and manage their health, is a perfect example. Nearly all components of the remote patient monitoring program happen outside the doctor’s office and the traditional patient visit, and are managed by a broader care team. At the same time, our 12-month scientific study shows remote patient monitoring works. We were able to slow disease progression, reduce hospitalizations and lower costs. Remote patient monitoring also results in more fruitful office visits for the physician and the patient. Rather than rely on patient recollections, accurate @Home™ program health values are seamlessly integrated into the patient’s health record and are actionable during and between patient visits.
• Language requiring students to respect their teachers will be revised to underscore reciprocal respect between teachers and students. • New language obliges physicians to respect patient autonomy. • Physicians will pledge to share their medical knowledge “for the benefit of their patients and the advancement of healthcare.” VTN
All of us need and want satisfied physicians. That’s why those of us who work at Geneia are so passionate about solutions like the @ Home™ remote patient monitoring program that effectively use technology to improve patient care as well as patient and physician satisfaction. VTN Heather Lavoie is the chief strategy officer for the Geneia Institute. In this role, she has overall accountability for strategy development and execution, supporting the launch and administration of products and services that sit at the intersection of personalized and population health and help healthcare organizations transform the way they deliver care. In addition to leading strategy, Lavoie has accountability for the sales, marketing, legal, human resources and client relations functions. Geneia LLC is an analytic solutions and services company that helps its clients improve outcomes, lower costs and restore the Joy of Medicine to physician practice. To learn more, see Geneia.com.
DECEMBER 2017/JANUARY 2018 < VEIN THERAPY NEWS
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SECONDLOOK
ULTRASOUND TECHNOLOGY
Industry veteran CEO vows physician-concentric sales and support at UMI By Larry Storer United Medical Instruments Inc. (UMI) has more than 35 years of experience providing ultrasound equipment sales and services to more than 3.000 customers in the United States. The San Jose, Calif., based company is a worldwide provider of new and pre-owned ultrasound systems, parts and transducers from manufacturers such as Siemens, Terason, Toshiba, GE, SonoSite and Phillips. Mansoor Ghanavati, CEO and president, spoke about the success of his company in the vascular and venous treatment market while exhibiting at the 31st American Congress of Phlebology in Austin. He has been in the ultrasound industry for more than 35 years, and seen many changes in ultrasound technology and customer needs. “But one aspect of the business that has remained constant for me is being a solution provider for physicians,” he said. “There are a number of excellent ultrasound machines, but there is probably just a few that are right for your practice. So at UMI, we take a physician-concentric approach to every sale.” Ghanavati said it is no secret that ultrasound technology is essential to the treatment of vein disorders. “Ultrasound is used to determine the presence of venous reflux, to screen for venous insufficiency, for follow-up to procedural exams, to conduct a deep venous thrombosis
But one aspect of the business that has remained constant for me is being a solution provider for physicians. exam, and for ultrasound-assisted ablation procedures and ultrasound-assisted sclerotherapy procedures.” But it takes the right ultrasound technology for the specific use in a phlebology or vascular practice. Physicians have to understand the advantages of all the different systems to find the right one for their practice. This, Ghanavati said, is where we can help with our physician-concentric approach to sales. “Our vision is to evolve fully as the premier resource for physicians, providing them compact ultrasound equipment, working within their budget, servicing their systems and transducers if the need ever arises, and offering them ongoing support through online system training or continued education. “We at UMI understand the challenges of private practice physicians, and we are their partner in working through those challenges so they can grow their practice and focus on what they do best while we assist them with what we do best.” One of those challenges is helping the physician select the right ultrasound for his or her practice. Ghanavati said UMI will recommend several machines based on the services and procedures the physician offers, and with features that make treating vascular and venous disease easier and more accurate. Several ultrasounds are designed specifically to do those things required in the practice with easy workflow, and all carry a fiveyear standard warranty.
30
A COMPANY PROFILE MULTI-VENDOR APPROACH Ghanavati said United Medical Instruments is a multivendor ultrasound company, providing choice to its customers based on needs and desires, and with good solutions at every price point. UMI also provides service, transducers and other parts if needed, and upgrade options as desired. Among the units optimized for treatment of vascular and vein problems are:
MYLAB ULTRASOUND
MyLab Alpha Ultrasound with eHD Technology, is focused on real diagnostic value, offering top performance and high dynamics in a compact size and weight. MyLab Gamma Ultrasound is a best in class highly portable system based on Esaote’s operating platform. This lightweight portable system is loaded with productivity features and can be used anywhere at a moment’s notice from point-ofcare to shared services. MyLab One/Touch Ultrasound is a high performance, arm-held ultrasound scanner with a 12-inch screen display ultrasound system that makes it ideal for many fields of application from phlebology to interventional, vascular screening and general practice. Esaote MyLab Six Ultrasound was designed with exclusive ergonomics and ultrasound imaging features to maximize user comfort and diagnostic confidence. It has a 19-inch widescreen LCD with touchscreen technology and easy workflow. MyLab Seven delivers high class performance in a compact size with a wide 16:10 LCD monitor and large-sized high-definition touchscreen. The main philosophy of this ultrasound is “Productivity in Real-time,” which Ghanavati said means a better diagnosis in less time.
TOSHIBA VIAMO ULTRASOUND The Toshiba Viamo Ultrasound carries the advanced imaging technologies from Toshiba’s larger imaging systems, which give the user consistent image quality with less manipulation for greater diagnostic confidence. Features include: • State of the art technology • Intuitive 15-inch LCD touchscreen monitor • High frequency transducers with 5+ selectable frequency ranges for better diagnostic capabilities • Customizable console and touch panel • Up to a five-year warranty available
ACUSON ULTRASOUNDS The ACUSON P500 Ultrasound System, FROSK edition, is an adaptable hand-carried system engineered for point-of-care imaging to better serve a range of environments and patient types. Features include: application-specific imaging presets; internal 180Gb SSD; Quick Boost, which is ready to scan in
less than 30 seconds; and dual system operation devices – a traditional control panel and an infrared touch screen. The Siemens Acuson P300 Ultrasound Machine offers advanced image optimization tools such as panoramic imaging, speckle reduction and spatial compounding, which optimize the imaging data automatically, improve the diagnostic confidence and support efficient clinical workflow. Among its features are a 15-inch XVGA LCD monitor; high frequency imaging up to 18.0 MHz on linear transducers, which provide detailed and precise imaging; and with a wide selection of linear, convex, phased and endocavity probes.
We think supporting the American College of Phlebology through the ACP Foundation is an important part of expanding educational opportunities in venous and lymphatic disease… SONOSITE M-TURBO ULTRASOUND The SonoSite M-Turbo, introduced in 2007, is the premier portable ultrasound system. It offers superior image quality for assessment and treatment monitoring of patients as well as needle visualization software to ensure accuracy of needleguided injections. Features include: • Advanced needle visualization software • Sharp contrast resolution and clear tissue delineation • 16 times the processing power of previous SonoSite generators • Five-year warranty
GIVING BACK WITH ACP FOUNDATION Ghanavati said he was not at the ACP just to introduce his line of computers to existing customers and potentially new customers. “We think supporting the American College of Phlebology through the ACP Foundation is an important part of expanding educational opportunities in venous and lymphatic disease, funding research and promoting patient and professional education,” he said. “It’s through our major corporate contributions to the ACPF that we can help to invest in research and education. And it is with support from donors of the ACP Foundation that ACP is able to fund many of its scholarship, research and training programs.” But he said attending also allows him to visit with his customers who keep coming back when it’s time to upgrade or repair. “I believe that service and support are at the heart of why customers continue to partner with us year after year, and it’s great to see them at the Congress. “For these doctors and new ones to come, we remain committed to helping them select the right ultrasound machine and provide for their continued satisfaction with a 24x7 program we call One Call, a suite of service offerings that take care of any problem immediately with just one call.” VTN
DECEMBER 2017/JANUARY 2018 < VEIN THERAPY NEWS
Mark your Calendars
SECONDLOOK
2018 ACP Educational Schedule Phlebology Review Course
February 9-10
Chicago Marriott Suites O’Hare Rosemont, IL
RPhS Review Course
February 9
Chicago Marriott Suites O’Hare Rosemont, IL
Sclerotherapy Course
March 3
Denver Airport Marriott Gateway Park Aurora, CO
Practice Management Course
March 3
Denver Airport Marriott Gateway Park Aurora, CO
Fundamentals of Compression Therapy
Late April
Charlotte, NC (SAWC)
Sclerotherapy Course
September 8
Sheraton Baltimore Washington Airport Linthicum, MD
Compression Hands-on Workshop
September 8
Sheraton Baltimore Washington Airport Linthicum, MD
ACP 32nd Annual Congress
November 8-11
Gaylord Opryland Hotel Nashville,http://www.acpcongress.org TN
Including track for Lymphedema Therapists
Register Today:
http://www.phlebology.org
www.phlebology.org/2018-edu
VEIN THERAPY NEWS < DECEMBER 2017/JANUARY 2018
advancing vein care
31
SECONDLOOK AVF
continued from page 1
special activities that will honor the 30th anniversary of the AVF. The David S. Sumner Venous Summit Wednesday, Feb. 21, will highlight the 30th anniversary with the topic “AVF 30 Years: Past, Present and Looking to the Future” as a framework for discussion of critical scientific events. In addition, the President’s Session on the final day will include a 30th Anniversary panel discussion. While looking back and projecting forward is important, most of the activities are the medical and scientific events that have become the familiar foundations of the annual meetings. “What highlights this 30th Anniversary Annual Meeting is the unsurpassed scientific program that brings people back year after year,” Dr. Passman said. “They come to learn from the internationally recognized authorities on all aspects of venous and lymphatic disease, diagnosis, pathophysiology and treatment. “Those events that encourage current thinking in effective clinical management of venous and lymphatic disease, and provide valuable insight into the future directions from critical analysis of investigative findings are still the mainstay of the program.” He said the objectives of these comprehensive meetings are to provide attendees with knowledge of current thinking in effective clinical management of venous and lymphatic disease and insight into the future directions from critical analysis of investigative findings.
EXHIBIT HALL
Hundreds of representatives from leading vascular healthcare companies that share the vision of improving patient outcomes and quality of care for individuals with venous THROMBOPHLEBITIS
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pool can cause pain associated with venous wall distention. Multiple empiric perforations and decompression of the venous aneurysm is believed to decrease thrombus burden and allow extrusion of the ultimate residual thrombus decreasing the development of increase intraluminal pressures leading to acute pain associated with acute closed loop thrombophlebitis. We have noted rapid absorption of venous pools in follow up ultrasound studies in our patients treated with the new protocols. VTN James E. White, MD, FACS, who is board certified in general surgery, phlebology and cosmetic surgery, owns Advanced Surgical Concepts, in Chattanooga, Tenn., a
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disease will exhibit the latest products and services. The 30th AVF Annual Meeting is designed to enhance networking with about 50 industry partners and more than 600 expected attendees. The exhibit hall is open every day during the Annual Meeting. In addition, there will be breakfasts, receptions, coffee breaks, lunch and dinner opportunities, and hospitality events that will encourage casual sharing of information and ideas.
THE PROGRAM
There will be six scientific sessions for oral presentations arranged by topic, including deep venous and chronic venous occlusion; superficial venous; venous thromboembolism, imaging and diagnostics, and additional scientific sessions. In addition, there will be a poster presentation session/competition, a half-dozen panel discussions, the Strandness Memorial Lecture, International Symposium, Specialty Symposia, The Villavicencio Symposium, Live Imaging Superficial Venous Symposia, and Symposia on IVC Filter Complications and a debate on whether to take them out or leave them in. The Day of Innovation and Science will mark its third year at the 30th Annual Meeting on Tuesday, Feb. 20. Ever since its inception, the Day of Innovation and Science has been an informative, all-inclusive (non-CME) forum designed to identify current research priorities in the area of venous and lymphatic diseases. This year, the day-long forum will explore “Basic Science and Bioengineer” from an educational viewpoint in the morning and from an industry position in the afternoon. The AVF Day of Innovation and Science was originally designed to bring together all major stakeholders in the field of venous and lymphatic disease including representatives of practice in phlebology and cosmetic surgery. He was graduated Magna Cum Laude from the Medical College of Georgia in 1990. He then completed a General surgery residency at the University of Tennessee, Chattanooga in 1996. He is a Diplomat with the American Board of Phlebology and the American Academy of Cosmetic Surgery. Casi White, RDMS, is the office administrator at Advanced Surgical Concepts. She has degrees in radiologic technology with credentials: RT-Registered Radiologic Technologist, RT-M–Registered in Mammography, RDMS-Registered Diagnostic Medical Sonographer, as well as, CPC-Certified Professional Coder.
industry; government agencies such as NIH, FDA and CMS; private payers; basic scientists; clinical researchers; and practitioners. Through participation in the Day of Innovation and Science, the representatives of these different sectors will address the state of the field, discuss next steps for closing knowledge gaps in the two highlighted areas, discover the role data can play in influencing, positive changes in coverage, and ultimately, identify what is needed to improve medical treatment of patients with venous and lymphatic disease. A new feature this year will be the Early Career Venous Session covering discussions of interest to those beginning their practice. Coding and billing tips; how to approach pelvic disorders; how to set up a successful outpatient vein practice; how to balance venous and arterial work; and how to collaborate with a wound care center. On Wednesday, Feb. 21, the David S. Sumner Venous Summit will frame several discussions within the last 30 years by the past, the present and the future. Those topics will include classification of chronic venous disease, treatment of Iliofemoral DVT, venous leg ulcers, and appropriateness in venous care. Afternoon features include Scientific Session 1: Deep Venous and Chronic Venous Occlusion, and for a variation in thinking, the best paper from the Society of Venous Medicine will present Thrombophilia Topics; and the best paper from the American College of Phlebology on the subject of Management of Middle-size Veins be presented. They will be followed by the International Symposium, which will include Spanish translation and the Villavicencio Symposium, which will highlight important randomized studies in venous and lymphatic disease. Thursday, Feb. 22, will feature scientific LEAN
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hand left the patient, another immediately replaced it. Screening tools were developed to identify candidates that could naturally demonstrate the winning behaviors. The winning behaviors became part of job descriptions. Employee performance was evaluated based on a 50/50 weighting of skills and winning behaviors. Our values were already well-entrenched within our culture, but still took on an entirely new sense of importance and purpose through this process. Quarterly, I was inundated with peer nominations for those who best reflected our values and we celebrated and honored winner throughout the year. The energy was contagious. Over time, we built a true culture of excellence that pervaded our organization from top to bottom and from side to side. We also exceeded our goal – not just in terms
session 2 (Superficial Venous) in the morning and Scientific Session 3 (Venous Thromboemboloism). The D. Eugene Strandness Memorial Lecture will be given by Peter Lawrence, MD. Friday, Feb. 23, will include Scientific Session 4 on Imaging and Diagnostics. The 30th Anniversary Panel is a part of the President’s Session Friday afternoon and will honor the AVF founding members. The Presidential session will highlight many of the accomplishment of the AVF over the past year, culminating in the Presidential Address. The afternoon includes the annual member business meeting, Live Imaging Superficial Venous Symposia and a symposia on IVC Filter Complications and other Tough Problems.
FUNDRAISING Several activities are planned to raise money to support pioneering research, medical education and awareness of venous and lymphatic health during the Annual Meeting. These include the Venous Open Golf Tournament, and the silent auction. The AVF will host the 2018 Venous Open Golf Tournament at 1 p.m. Thursday, Feb. 22, at the Starr Pass Golf Club, on property at the JW Marriott Tucson Starr Pass Resort & Spa.
CONCLUSION Building off the past 30 years, the AVF 2018 Annual Meeting will continue to highlight its dedication to improving the care of patients with venous and lymphatic disease through quality educational programs and innovative research, delivered in the beautiful Tucson setting. VTN
of 30/30 but also in terms of patient and employee satisfaction, employee retention, a robust list of referring MDs, tumor mix complexity, a partnership with a national leading children’s hospital and a culture you could “see, feel and touch” – not my words, but those from a former patient. We had no idea how much we’d learn from this process – both collectively as a team and individually as leaders and managers.
LEAN AND YOUR VEIN PRACTICE LEAN is an effective tool to manage your day-to-day operations by creating best practices and standardization. LEAN can be applied to obvious processes such as billing and collections; however, it can also be applied to less obvious areas such as outstanding LEAN
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DECEMBER 2017/JANUARY 2018 < VEIN THERAPY NEWS
PRODUCTNEWS
Shockwave study yields good result Shockwave Medical, a provider of treatment of calcified cardiovascular disease, has reported positive results from the DISRUPT BTK study, which were presented at the annual Cardiovascular and Interventional Radiological Society of Europe (CIRSE) congress in Copenhagen, Denmark. DISRUPT BTK, a prospective single-arm study, evaluated the use of the Shockwave Medical Lithoplasty System as a treatment for peripheral artery disease (P.A.D.) patients with calcified lesions in arteries below the knee. The study enrolled 20 patients at three sites in Europe and New Zealand. “The results of this study are consistent with findings from previous studies of lithoplasty, showing a low rate of residual stenosis with minimal complications in a predominantly critical limb ischemic patient population,” said Marianne Brodmann, MD, of the Medical University of Graz, Austria. “These results suggest that the lithoplasty treatment has the potential to address challenges that calcified stenosis pose below the knee, where calcium is more prevalent and different than above the knee.” The Peripheral Lithoplasty System is commercially available in both the United States and Europe and is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries. It is not for use in the coronary or cerebral vasculature. The devices used in the DISRUPT BTK study are not available or approved for sale in the United States. VTN READ MORE: shockwavemedical.com
FDA OKs Xavant nerve stimulator Xavant Technology, a company based in Pretoria, South Africa, won FDA clearance for its NMS 460 peripheral nerve stimulation system. The device, distributed in the United States by Bell Medical Inc. in St. Louis, Mo., is used to address chronic intractable pain, post-surgical pain, post-traumatic acute pain, and for pain control arising from rehab routines.
The device delivers a hybrid pulsed radio frequency (PRF) waveform, developed by Xavant, through the skin via an accompanying stylus. The company claims that the resulting electromagnetic effects are similar to the ones that implanted neuro stimulators generate, delivering some of the benefits of such devices without their invasive nature. The device also has a nerve mapping probe that helps to spot damaged nerves, and to assess their state and how they’re responding to treatment. VTN READ MORE: xavant.com/products/nms460
A $10 sensor chip detects the orientation of an ultrasound probe.
Tech converts 2D ultrasound to 3D scanner Portable ultrasound technology is improving and becoming more affordable, allowing it to be used in places previously impossible due to size and cost. Full size ultrasound imagers can do some impressive stuff, such as creating 3D reconstructions obtained from 2D probes. Now researchers at Duke University are introducing cheap and easy to integrate technology that can convert any 2D ultrasound into a 3D imaging system. It works thanks to a $10 sensor chip that detects the orientation of an ultrasound probe. As the probe is used to scan the body, the chip’s readings are combined with the 2D data coming from the probe’s transducer to properly stitch it together, resulting in a volumetric dataset. This data can then be viewed much like MRI and CT scans, letting physicians view 3D models or to virtually slice through the volume. The chip is integrated into a snap-on attachment that can be connected to any ultrasound probe. A computer is used to grab the output video signal of an ultrasound machine and the chip on the ultrasound probe is connected to the same computer. The computer then does the stitching and displays the output on its screen.
VEIN THERAPY NEWS < DECEMBER 2017/JANUARY 2018
Because the technology doesn’t require any particular skills to perform the imaging, the researchers even envision patients themselves scanning a body part that they feel is at pain. The physician would then simply look at the 3D scan to use in the diagnosis. VTN READ MORE: medschool.duke.edu/
Butterfly iQ puts ultrasound on your iPhone for under $2K Butterfly Network, a firm based in Guilford, Conn., won FDA clearance and is introducing its Butterfly iQ portable ultrasound system. It consists of a portable transducer that connects directly to an iPhone, and an iOS app to display the images and to control settings. The device actually works as three different transducers thanks to an ultra-wide band matrix array. This allows a clinician to perform different scans and for the Butterfly iQ to be applicable in different clinical settings. The matrix array of microelectromechanical (MEMS) sensors is directly integrated onto an integrated circuit that contains all the necessary electronics. This tight integration supposedly results in a fast, high-resolution device that can perform tasks that only fullsize ultrasound machines were capable just a few short years ago. The firm compares its technology to how photo camera sensors have been integrated within smartphones, enabling anyone to have high quality photo imaging in their pocket. Perhaps the biggest deal with the Butterfly iQ is that it costs under $2,000. Previous portable, hand-held ultrasounds have often been priced at more than $10,000. VTN READ MORE: butterflynetwork.com/index.html
FDA approves Senhance robotic surgical device The U.S. FDA has cleared the Senhance System, a new robotically-assisted surgical device (RASD) that can help facilitate minimally invasive surgery, developed by Morrisville, N.C.-based TransEnterix Surgical Inc. “Minimally invasive surgery helps reduce pain, scarring, and recovery time after surgery,” says Binita Ashar, MD, director of the division of surgical devices in the FDA’s Center for Devices and Radiological Health. “RASD technology is a specialized innovation in minimally invasive surgery designed to enhance the surgeon’s access and visualization within confined operative sites.”
RASD, or robotic surgery, enables the surgeon to use computer and software technology to control and move surgical instruments through one or more tiny incisions in the patient’s body (laparoscopic surgery) in a variety of procedures. The benefits of RASD technology may include its ability to facilitate minimally invasive surgery and assist with complex tasks in confined areas of the body. Further, the design of the Senhance System allows surgeons to sit at a console unit or cockpit that provides a 3D high-definition view of the surgical field and allows them to control three separate robotic arms remotely. The end of each arm is equipped with surgical instruments that are based on traditional laparoscopic instrument designs. The Senhance System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue. The system is for use on adult patients by trained physicians in an operating room environment. VTN READ MORE: transenterix.com LEAN
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customer care and new patient acquisition, just as it did in our cancer center. I recently returned to work in vein disease after almost 10 years. My first run in this space resulted in the development and sale of the nation’s largest vein disease practice at that time. A lot has changed in 10 years, but there’s a lot that’s remained the same. Of the 30 million people with varicose veins, less than two million seek treatment. When they do seek treatment, they are confronted by providers who all sound alike – no surgery or hospitalization, covered by insurance and back on your feet in the same day. Vein treatment has, in many respects, become a commodity – it is difficult to own a unique selling proposition. Therefore, in order to survive, and thrive, we all need to get LEAN! VTN READ MORE: transenterix.com James R. Williams has more than 30 years of healthcare experience building regional/ national platform companies and successful exit strategies. His primary focus is disruptive spaces including LASIK, varicose vein disease, proton therapy and other Cancer Treatment modalities. As President of Miller Vein, he is leading the development of a strong operational infrastructure combined with rapid growth. Additionally, he is an advisor to numerous healthcare companies and private equity investors.
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PRODUCTNEWS FDA approves New HyperView Imaging system HyperMed Imaging’s new HyperView imaging system is U.S. Food and Drug Administration (FDA)-cleared, and, according to a company press release, represents “a new standard of performance when assessing tissue oxygenation and perfusion in patients with potential circulatory compromise.” The HyperView is a handheld, battery operated, non-invasive and portable diagnostic imaging device that is used to assess tissue oxygenation without contacting the patient and without the need for injectable contrast. According to HyperMed Vice President of Sales Annette Plishka, this new diagnostic imaging device can be used in wound care, vascular intervention and reconstructive surgery.” HyperMed’s U.S. headquarters is in Memphis, Tenn. The system uses proprietary technology to capture color-coded images containing data that provides the clinician critical information such as oxyhemoglobin levels (Oxy), deoxyhemoglobin levels (Deoxy) and oxygen saturation (O2Sat) in superficial
provide clinicians a new class of tool to rapidly assess perfusion and locate ischaemic tissue. “This information helps caregivers better understand potential circulatory compromise and allow more informed treatment of complications of vascular disease and diabetes.” VTN READ MORE: hypermed.com tissue. Such information may assist clinicians when determining if a patient has adequate blood perfusion to heal a wound or maintain healthy tissue. Understanding both arterial and venous sufficiency in the surface tissue may enable clinicians to make more informed decisions regarding when to intervene, President and CEO Mark Darty said. The HyperView system also helps document perfusion levels before and after vascular interventional procedures such as: peripheral bypass, stent placement, or balloon angioplasty. “Early market feedback from customers has confirmed that HyperView is a game changer,” Darty said. “It is a product poised to impact a number of important market segments. The low cost, speed, portability, ease of use and high-quality data and imagery
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TVA Medical gets a CE Mark for endovascular AVF TVA Medical’s everlinQ 4 endovascular arteriovenous fistula (AVF) system has received a CE mark in the European Union. The technology uses a 4F catheter system with enhanced visual indicators to create hemodialysis access using an endovascular technique without open surgery. In a prospective, single-arm, single-center study evaluating the everlinQ 4 endoAVF system, 97 percent of endovascular AVF procedures were successful, and fistula maturation was achieved in 83% of patients. Tobias Steinke, MD and chief of Vascular and Endovascular Surgery of Schön Klinik in Düsseldorf, Germany, performed the first case in Europe using the everlinQ 4 system. “The new system with smaller profile catheters and radiopaque visual indicators was extremely easy to use,” Dr. Steinke said. “This new approach streamlines the procedure for providing patients a functional AV fistula without open surgery.” Adam L. Berman, president and CEO of TVA Medical, said he is pleased to achieve this next regulatory milestone that broadens availability of the everlinQ endoAVF system for patients. “We are now offering the 4F catheter system in Europe, as well as in the everlinQ endoAVF EU Study, which is gathering additional clinical data to support future clinician education, patient access, and reimbursement of the everlinQ endoAVF System.” VTN
Phase I/II SHIELD trial with SB-030 in PVD announced Symic Bio has announced results from the phase I/II SHIELD trial evaluating SB-030, a locally administered therapeutic in patients with peripheral vascular disease undergoing angioplasty. In this first-in-human, prospective, randomized, single-blind controlled study of 67 patients, SB-030 demonstrated a positive safety profile, with no clinically meaningful difference observed in adverse events between treatment and control groups. In addition, treatment with SB-030 demonstrated potential for improvements as compared to control
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across measurements of clinical efficacy in late lumen loss, target lesion revascularization and primary patency rate. Symic Bio CEO Ken Horne said these results support the plan to develop SB-030 as a first-in-class treatment to prevent vein graft failure following peripheral bypass graft surgery. “There are no approved treatments for reducing vein graft failure and patients experience high rates of amputation and mortality. We see potential for SB-030 to have a major impact in this area of vascular disease. We intend to begin a phase III trial of SB-030 in prevention of peripheral vein graft failure in 2018. “The outcomes observed in the SHIELD trial suggest potential for SB-030 to improve vessel healing. Peripheral vein graft procedures are in serious need of innovative approaches to extend long-term patency, and SB-030 provides a technically and biologically attractive solution.” Of the per-protocol patients within the SHIELD trial at 24 weeks following treatment, SB-030 treatment demonstrated potential to improve angiographic measurements of vessel diameter relative to control, referred to as late lumen loss, with a 32 percent mean improvement that did not reach the level of statistical significance (p=0.165). Statistical assessment was affected by a smaller than expected control arm, nonnormal data distribution, and a higher rate of bailout procedures in the control arm. Bailout procedures, typically stents that are placed peri-procedurally due to vasospasm, were required for 38 percent of patients in the control group as compared with 9 percent of patients in the SB-030 treatment group (p=0.006). Non-parametric testing of the distribution of measurements in late lumen loss demonstrated a statistically significant difference between treatment and control groups (p=0.018). SB-030 treatment also reduced the rate of target lesion revascularization (TLR) by 22 percent. In addition, interim results from the extension phase of the study show promising trends for improved primary patency rate at 12 months. Safety assessments were confirmed by an independent medical monitor. SB-030 is in development to improve clinical outcomes following peripheral vein graft procedures. SB-030 is administered locally, acting on the extracellular matrix of exposed connective tissue. In targeting responses mediated by the extracellular matrix, SB-030 aims to reduce neointimal hyperplasia and blood clot formation that leads to vein graft failure. Beyond vein graft failure, SB-030 has potential applications for other types of vascular procedures, including coronary bypass and surgical intervention in late-stage kidney disease. VTN
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DECEMBER 2017/JANUARY 2018 < VEIN THERAPY NEWS
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