INSIDE VTE added to patient safety challenges 8 Senate bill would make MU program friendlier 17 ACP Congress educating providers for 30 years 18 AMA fails to end recertification 26
AUGUST/SEPTEMBER 2016 Vol. 9 No. 5 VEINTHERAPYNEWS.COM
An ACP recognized resource for news and information for and about the phlebology community
MEDCAC Panel covers lower extremity venous disease By Larry Storer On July 20, the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) met in Baltimore to hear and examine the scientific evidence regarding the benefit and risk of existing lower extremity chronic venous disease treatments that aim to improve health outcomes for seniors. Chartered under the auspices of the Centers for Medicare & Medicaid Services (CMS),
See related article, page 12 MEDCAC is trying to identify evidence gaps that exist related to lower extremity chronic venous disease in the Medicare population. MEDCAC supplements CMS internal expertise by allowing an unbiased and current deliberation of “state of the art” technology and science. MEDCAC panels do not make
coverage determinations, but CMS can benefit from their advice. Clinical outcomes of interest to the Medicare program included: reduction in pain; reduction in edema; improvement in functional capacity; improvement in quality of life; avoidance of acute and chronic venous thromboembolism; avoidance of chronic thromboembolic pulmonary hypertension; avoidance of initial venous skin ulceration and recurrent ulceration; improvement in wound healing; reduction in all-cause mortality; and
avoidance of repeat interventions and harms from the interventions. By voting on specific questions, and through discussions, MEDCAC panel members will advise CMS about the extent to which it may wish to use existing evidence as the basis for any future determinations about Medicare
MEDCAC continued on page 33
Varithena earns FDA approval for 30-day post-activation shelf life
Michelle Huie, CEO and founder of VIM & VIGR, shares her experiences building a successful business in the compression hosiery market, noting ways to help physicians grow their practice. See her story in The Practice section on page 24.
The U.S. Food and Drug Administration has approved an extension of the postactivation shelf life of Varithena (polidocanol injectable foam) 7 days to 30 days. “This approval provides physicians with greater flexibility,” said John Sylvester, corporate development officer for BTG, the specialist healthcare company that manufacturers the prescription medication Varithena. “It highlights our continued work to provide a non-thermal chemical ablation solution that best fits practices’ needs.” Brian Ferris, MD and chief of surgery at Overlake Hospital Medical Center, said Varithena has become an important part of his practice. “Varithena is important in particular for patients with tortuous or difficult to treat veins, or for patients who do not want to undergo thermal ablation,” Dr. Ferris said. “With the FDA’s approval of a longer shelf life – once I have activated the canister – I have more flexibility in scheduling patients. This will help ensure that more patients who can benefit from Varithena will get the treatment.” The update enhances the ease of scheduling for a comprehensive, above and below the knee solution for great saphenous vein system incompetence and for veins that other
procedures cannot reach effectively. Physicians can adapt the Varithena procedure to the unique demands of their practice both in terms of timing of procedures, and the wide range of vein sizes and shapes they can treat, including tortuous veins and visible varicosities. Varithena’s UDSS formulation with Uniform Density, Size and Stability results in a long dwell time and thorough cohesion with the vein wall. It addresses underlying venous incompetence, improves vein appearance and shows significant improvements with an established safety profile. Tumescent anesthesia is avoided, and a cohesive, lownitrogen microfoam allows for consistent performance.
ABOUT VARITHENA Varithena is a microfoam made from polidocanol that is used to treat varicose veins caused by problems with the great saphenous vein (GSV) and other related veins in the leg’s GSV system. Varithena helps improve the symptoms of heaviness, achiness, swelling, throbbing, itching (HASTI symptoms) related to or caused by varicose veins, and the appearance of varicose veins. VARITHENA continued on page 25
VEIN THERAPY NEWS 13552 Highway 183 N, Suite A, Austin, Texas 78750 CHANGE SERVICE REQUESTED
PRSRT STD US POSTAGE PAID SAN ANTONIO, TX PERMIT#244
Call for a
“The lastt thing I wanted wass to purchase anotther endovenouss lasserr....” http://totalveinpharmacy.com
“Butt afterr comparing g the e resullts off the e TVS S 1470 0 and d talking g to o myy patients patients, I could d nott help p butt buy y it.” - Kenneth Jesser, MD Vein Specialists Institute Palm Desert, CA
Lowestt supply y costt perr procedure in the industry!
http://totalvein.com
®
888-868-8346
NEWS
Volume 9, Number 5
Disclaimer and Liability Statement The information contained in this publication, including text, graphics and images, is for informational purposes only, and is not intended to be a substitute for professional medical advice. Publications & Communications LP (PCI), Publications and Communications LP, and Vein Therapy News, via its Editors, Publisher, Editorial Board members, or staff, accept no responsibility for any injury or damage to persons or property occasioned through the implementation of any ideas or use of any product described herein. In consideration that great care is taken by the Publisher, Editors, staff, and Editorial Board to ensure all information is accurate, we recommend each reader seek independent verification of all product or drug usage, surgical techniques and clinical processes prior to their use or implementation. The opinions expressed in this publication and all related marketing or sales material of this publication are those of the authors and are not attributable to the publication, Publisher, Editor, staff, Editorial Board, advertisers, or sponsors. References made in articles may indicate uses of medical equipment or medical procedures, or of drugs at dosages, for periods of time, and in combinations not included in the current prescribing information. Inclusion of advertising material in this publication, or in reproduction of articles and pages, or in supplemental materials, does not constitute any representation or guarantee by Publications & Communications LP (PCI), Publications and Communications LP, and Vein Therapy News, via its Editors, Publisher, Editorial Board members, or staff, of the quality of such products, or of the claims made by the manufacturers. Trademarks are used in an editorial fashion with no intent to infringe. Reproduction in whole or in part of this publication is strictly prohibited.
Reader Services SUBSCRIPTIONS To subscribe or to purchase back issues of the magazine, please call 800-678-9724 ext. 344 or e-mail Beth Chorba at bethc@pcinews.com. For more information, please visit veintherapynews.com and click on the Subscribe link. ADVERTISING INFORMATION If you are interested in advertising in Vein Therapy News magazine, online or in our Marketplace, please contact our account executive: Gary Pittman, Jr., 512-637-0373, garypjr@pcinews.com. EDITORIAL SUBMISSIONS Doctors, nurses, clinics, managers, vendors, patients, professors and others are encouraged to submit abstracts, white papers, writings, and ideas for editorial consideration. If you have a paper or story idea to submit, please e-mail larrys@pcinews.com UPCOMING EVENTS AND PRESS RELEASES Vein Therapy News would like to hear about your organization’s upcoming event, product launch, or announcement. Please e-mail press releases or event listings at least two months in advance to larrys@pcinews.com.
Editor Larry Storer lstorer@hot.rr.com 254-399-6484
Art Director Lisa Gouveia lisag@pcinews.com
Advertising Executive Gary Pittman, Jr. 512-637-0373 garypjr@pcinews.com
Accounting Beth Chorba bethc@pcinews.com
Web and Network Manager Joel Nosal joeln@pcinews.com
President Gary L. Pittman garyp@pcinews.com Publications & Communications, LP 13552 Highway 183 N, Suite A Austin, TX 78750 512-250-9023 • 512-331-3950 fax Vein Therapy News is published bimonthly by Publications & Communications, LP, Gary L. Pittman, President, 13552 Highway 183 N., Suite A, Austin, TX 78750 512-250-9023. Subscriptions are available for $45 per year. Payment must accompany orders. Copyright 2016 by Publications & Communications, LP. All rights reserved. Reproduction in any form without written consent from the publisher is strictly prohibited. Postmaster: Send changes to Vein Therapy News Circulation Department, 13552 Highway 183 N., Suite A, Austin, TX 78750. ADVERTISING
512-637-0373
CIRCULATION
512-637-0344
EDITORIAL
254-399-6484
VEIN THERAPY NEWS AUGUST/SEPTEMBER 2016
1
MEDCAC evaluates lower extremity venous disease
The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) met in Baltimore July 20 to hear and examine the scientific evidence regarding the benefit and risk of existing lower extremity chronic venous disease treatments that aim to improve health outcomes for seniors.
1
FDA extends Varithena shelf life
The U.S. Food and Drug Administration has approved an extension of the post-activation shelf life of Varithena (polidocanol injectable foam) 1% from 7 days to 30 days.
THE PRACTICE 24 How to stand out Michelle Huie, who has built a successful business in the field of compression stockings, offers ideas to physicians about how to compete with other clinics for patients.
25 Engaging senior patients In 2013, one in every seven Americans was over the age of 65. The Department of Health and Human Services predicts this figure will nearly double by 2060, bringing the senior population to approximately 98.2 million. An expert explains what seniors actually want to see in their health results.
SECOND LOOK 25 Providing OON services Dr. Deborah Manjoney recently found herself in a position of preparing to do independent contract negotiations with insurers. This is not a trip you want to take without a map.
30 Varithena an important option Patients suffering from symptomatic varicose veins caused by great saphenous vein or small saphenous vein incompetence frequently undergo multiple procedures with a combination of treatment modalities: endovenous thermal ablation, phlebectomy and sclerotherapy. Each of these established therapies has strengths and drawbacks. But Varithena offers another important option.
34 Treating RLS without drugs Restless leg syndrome has been treated in the past with addictive drugs or homopathic products. But Medi USA is offering an FDA approved Class 1 exempt medical device called the restiffic foot wrap that offers evidence of superior results of RLS. It is clinically proven to provide to reduce RLS symptoms.
DEPARTMENTS The VTN Report ACP UPDATE The Practice Second Look Product News
4 18 20 28 38
3
NEWS THE
VTNREPORT ESSENTIAL MEDICAL GETS FDA OK FOR VASCULAR CLOSURE TRIAL
DOJ BUSTS MEDICARE FRAUD TOTALING $900 MILLION, ARREST 301
Medical device company Essential Medical has received FDA approval to conduct a clinical trial to study the safety and efficacy of vascular access closures done using its device branded MANTA. The Malvern, Penn.-based company will study how well MANTA closes femoral arterial access sites in patients undergoing procedures, it said in early July. The device is designed to reduce drawbacks like extended procedure time and higher costs. “I’m very excited to be a part of the MANTA vascular closure trial as I believe it will deliver fewer complications and faster overall procedure times based on the EU data,” said Zvonimir Krajcer, MD and co-principal investigator on the trial. “For the first time with MANTA, we will have the opportunity to use a reliable and simple vascular closure device for large bore sheaths. This device will in a safer way advance the treatment of many patients with aortic aneurysmal and valvular heart disease.” These types of procedures are the fastest growing segment of the cardiovascular market. This submarket alone is expected to exceed $600 million with the next five years, according to an Essential spokesman.
The U.S. Department of Justice has completed its “largest takedown ever” of suspected Medicare fraudsters, worth about $900 million and involving 301 defendants. That easily surpasses last year’s previous record of 243 defendants charged with defrauding Medicare out of a total of $712 million, DOJ said in June. About half the cases in this year’s takedown are related to home health fraud, while another 25 percent involve pharmacy claims. About a third of the defendants came from South Florida. As if to reinforce the idea that Medicare fraud is the unofficial state sport of Florida, federal officials also charged two Jacksonville brothers with conspiracy to defraud the Defense Department’s Tricare program. Details you can’t make up: “During the Simsirs’ arrests, federal agents seized about $344,000 in cash, seven firearms, including an AR-15 semiautomatic rifle, a Lamborghini and a Porsche. Agents later seized $2 million from them.
ICD-10 CODING ACCURACY IMPROVING SLOWLY
University of Missouri Health Care is offering staff members who recruit RNs to its neurosciences, internal medicine and psychiatric ICUs a $10,000 bonus. And those same staff members are also eligible to win an all-expenses paid trip for four to Hawaii. The recruitment strategy shows that in a competitive market where demand is high and supply is low, hospitals will pull out the stops to get qualified nurses to work for their organizations. The idea behind the incentive plan is to convey to its existing staff and new hires the respect and value the health system has for its employees. And perhaps by giving the bonus to employees, rather than the new hires, it will prevent job hopping to the next hospital.
Coding accuracy under ICD-10 is gradually improving, according to a post at ICD10Monitor, but it’s not yet at the same level that was achieved under ICD-9. Looking at coding by 50 organizations, Eileen Tkacik, director of operations and information technology at Aviance Suite Inc., says inpatient accuracy increased to 84.9 percent in the second quarter of 2016, up from the 83.1 percent in Q1. Ambulatory coding accuracy rose to 82.7 percent, from 80.8 percent, and emergency services coding wen from 85.6 percent to 88.9 percent. A survey released by the American Health Information Management Association Foundation earlier this month found that the switch to ICD-10 caused only a “dip” in coding accuracy and a slight decrease in productivity. Tkacik adds that the upward trend in coding accuracy is expected to continue to increase, but there are some areas where it remains low. Those include external causes of morbidity, symptoms; signs & abnormal findings; injury, poisoning and other external; among a couple others. “As coders grow and mature in their knowledge and experience with ICD-10, we expect a continual improvement in coding accuracy in these problem areas,” the report adds.
ANGIODYNAMICS REPORTS 4Q, ANNUAL RESULTS Riding its peripheral vascular segment’s 10 percent year-over-year sales growth, AngioDynamics reported its fourth quarter and full year financial results the 2016 fiscal year ended May 31, 2016. Net sales for the fiscal fourth quarter were $93.4 million, an increase of 3 percent compared with $90.9 million a year ago. On a constant currency basis, sales were also up 3 percent compared to the fourth quarter last year. “The peripheral vascular business growth was driven by the successful launch of Asclera, as well as opportunities created by the recent Cook Medical recall,” said new President and CEO Jim Clemmer. “We also drove strong free cash flow generation during the quarter of $18.1 million, which was primarily attributable to improved inventory management.” “Our fourth quarter results reflect a solid quarter of revenue and adjusted EPS growth driven primarily by outperformance in our Peripheral Vascular business, which saw a 10% increase over the prior year period.” The company recorded a net loss of $44.0 million, or $1.21 on a per share basis, driven by a one-time long-term deferred tax asset write down as well as an inventory write-off related to a change in direction to the Celerity product line. In the fourth quarter of fiscal 2015, the company recorded a net loss of $0.8 million, or $0.02 per share. For the 12 months, net sales were $353.7 million compared to the $357.0 million reported a year ago. The company recorded a loss of $44.5 million, or $1.23 per share, compared to a net loss of $3.3 million, or $0.09 per share, reported a year ago. Excluding the items shown in the attached quarterly non-GAAP reconciliation table, adjusted net income was $21.2 million, or $0.58 per share, compared to adjusted net income of $21.2 million, or $0.58 per share, a year ago. Adjusted EBITDA, excluding the items shown in the attached reconciliation table, was $53.2 million, or $1.46 per share, compared to $56.7 million, or $1.56 per share, in the year ago period.
4
HOSPITAL PUTS NURSES ON RECRUITMENT TRAIL TO HIRE NEW NURSES, EARN BONUSES
INTEGRATED DERMATOLOGY GROUP CONTINUES NATIONWIDE EXPANSION Integrated Dermatology Group (IDG), a national dermatology practice, has expanded its presence in Louisiana with the acquisition of the practice of Dr. Robert Benson, formerly known as Benson Dermatology. Dr. Benson will retain the role of medical director in the practice now known as Integrated Dermatology of Ponchatoula LLC with locations in Covington and Ponchatoula, La. For more than 30 years, Dr. Benson has been performing general dermatology and advanced cosmetic procedures in the United States and abroad. Dr. Benson was among the first physicians in the United States to perform traditional liposuction, Smartlipo laser liposculpture, laser resurfacing, fat transfer procedures and facial-sculpting injectable treatments. “By partnering with IDG, the dermatologist can focus on providing high-quality patient care while IDG manages the infrastructure and back-office operations of the practice, ensuring best clinical practices, outcomes and long-term profitability,” Jeff Queen, president of Integrated Dermatology Group, said. IDG has been pursuing a systematic expansion. The Louisiana purchase announcement comes on the heels of a recent announcement of its partnership in Calumet City, Ill. (Integrated Dermatology of Calumet City, LLC).
McKESSON TO SPIN OUT IT OPS Healthcare giant McKesson plans to spin out much of its IT operations – including PACS – into a separate company with some $3.4 billion in annual sales. In a pair of June 28 announcements, McKesson said it will create a new standalone healthcare IT company in partnership with Change Healthcare Holdings, the revenue cycle management firm formerly known as Emdeon. The new entity will have estimated annual revenues of $3.4 billion, with McKesson owning 70 percent of the firm and Change Healthcare shareholders owning the remainder. The new firm will combine all of Change’s operations with most of McKesson’s Technology Solutions division, which includes its Imaging and Workflow Solutions unit. That offers enterprise PACS software as well as image management applications for radiology and cardiology. Other operations in the division include Health Solutions, Business Performance Services, and Connected Care and Analytics units. VT N
AUGUST/SEPTEMBER 2016 VEIN THERAPY NEWS
Not actual patients.
Offer a comprehensive GSV system solution for above and below the knee.
The essential NTNT choice.
Varithena® (polidocanol injectable foam) 1% reaches veins that others can’t—treating a wide range of sizes and any vein shape including tortuous and varicosities above and below the knee. Varithena’s UDSS formulation—uniform density, size and stability—results in a long dwell time and thorough cohesion with the vein wall. Most importantly it addresses underlying venous incompetence, improves vein appearance and shows significant PRO improvements with an established safety profile.
www.varithena.com
For more information on treatment, visit 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®.
© 2016 Biocompatibles, Inc., a BTG International group company. All rights reserved. Varithena is a trademark of Provensis Ltd, a BTG International group company. BTG and the BTG roundel logo are registered trademarks of BTG International Ltd. NA-VAR-2016-0786
NEWS 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).
6
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
AUGUST/SEPTEMBER 2016 VEIN THERAPY NEWS
NEWS AMA passes new ethical practice guidelines for telemedicine use New ethical guidance adopted at the American Medical Association’s (AMA) Annual Meeting in June will help physicians understand how their fundamental responsibilities may play out differently when patient interactions occur through telemedicine compared to traditional patient interactions at a medical office or hospital. The new ethical guidance on telehealth and telemedicine was developed over the past three years by the AMA’s Council on Ethics and Judicial Affairs, and adopted by a vote of physicians from every corner of the country. The development of the new guidelines coincides with innovations in technology that are changing the ways in which people live their lives, including reshaping the ways they engage with medicine. “Telehealth and telemedicine are another stage in the ongoing evolution of new models for the delivery of care and patient-physician interactions,” AMA Board Member Jack Resneck, MD, said. “The new AMA ethical guidance notes that while new technologies and new models of care will continue to emerge, physicians’ fundamental ethical responsibilities do not change.” In any model for care, patients need to be able to trust that physicians will place patient welfare above other interests, provide competent care, provide the information patients need to make well-considered decisions about care, respect patient privacy and confidentiality, and take steps needed to ensure continuity of care. The evolution of telehealth and telemedicine capabilities offers increasingly sophisticated ways to conduct patient evaluations as technologies for obtaining patient information remotely continue to evolve and improve. The AMA guidelines permit physicians using telehealth and telemedicine technology to exercise discretion in conducting a diagnostic evaluation and prescribing therapy, within certain safeguards. “Physicians who provide clinical services through telemedicine must recognize the limitation of the relevant technologies and take appropriate steps to overcome those limitations,” Dr. Resneck said. “What matters is that physicians have access to the relevant information they need to make well-grounded recommendations for each patient.” Active engagement should support ongoing refinement of telemedicine technologies and relevant standards, while also promoting initiatives that will help make needed technology more readily available to all patients who want to use telemedicine services. VT N
Compression Styles for Every y Lifestyle SURGEONS S SURGEONS’ URGEONS’ CHOICE CHOICE Medical Compression Hosiery
Pantyhose, Thigh Highs and Knee Highs for the budget-minded patient. p
14 95*
$ Support thigh h highs in 3 lengths (Short, Regula ar, Long) for all 6 sizes.
®
Semi-Sheer Stockings
18 ways to get an optimal fit!
19 95*
$
Everyday knee highs.
9 95*
$ ®
Training g and recovery knee high g socks.
http://totalvein.com ®
888 868 8346 888-868-8346
VEIN THERAPY NEWS AUGUST/SEPTEMBER 2016
95 16 95*
$
*Best case pricing.
7
NEWS VTE added to list of new patient safety challenges The Patient Safety Movement Foundation announced three new patient safety challenges at its Midyear Planning Meeting co-convened with Inova in mid-June, with Venous Thromboembolism (VTE) at the top of the list. The 2016 Midyear Planning Meeting in Irvine, Calif., brought together more than 100 medical experts, administrators, patient advocates and government officials from around the world for presentations and discussions on critical topics in patient safety. The meeting concluded with a discussion and vote to select the new challenges where patient death can be easily prevented if proper protocols are followed during patient care. Attendees nominated 15 new challenges. They voted to include the following three challenges as the next most pressing issues in patient safety: VTE, mental health and pediatric adverse drug events.
VENOUS THROMBOEMBOLISM Joe Kiani, founder and chairman of the Patient Safety Movement Foundation, said venous thromboembolism, consisting of deep vein thrombosis (blood clot formation in a deep vein) and pulmonary embolism (a blood clot that travels to the lungs), is one of the most common preventable cause of hospitalrelated death. “It is estimated that more than 50,000 patient deaths in the United States are attributed to VTE,” Kiani said. “For example, when a blood clot travels to the lungs, patients have 30 percent to 60 percent chance of dying from it.”
MENTAL HEALTH Approximately 61.5 million Americans experience a mental illness in any given year. Outcomes of mental health care provided in hospitals lag behind outcomes achieved in large trials of evidence-based treatments. Recipients of mental health treatment are more vulnerable to unintended harm and less likely to advocate for themselves. Kiani said areas of potential harm include misdiagnosis, insufficient treatment, adverse drug reactions, harm resulting from seclusion and restraint, and incidence of suicide. Between 1970 and 2000, the number of public psychiatric hospital beds dropped from 207 beds per 100,000 people to just 21 (Agency for Healthcare Research and Quality). A 2010 survey of 603 hospital emergency department administrators by the Schumacher Group found that 56 percent of emergency departments (ED) are “often unable” to
8
transfer behavioral patients to inpatient facilities in a timely manner.
PEDIATRIC ADVERSE DRUG EVENTS The Patient Safety Movement already has an Actionable Patient Safety Solutions (APSS), but it was determined that pediatric and neonatal adverse drug events needs to be a separate focus. Adverse drug reactions (ADR) in children can have a significantly more severe effect when compared to adults. ADRs can lead to prolonged hospitalization, permanent disability or death. The error rates are highest in the neonatal intensive care unit. Children are usually less able to physiologically tolerate a medication error due to still developing renal, immune and hepatic functions. Children cannot communicate effectively to clinicians regarding any adverse effects that medication may be causing. Kiani said common errors include improper dosing, omission errors, unauthorized/wrong drug, prescribing errors, wrong administration technique, incorrect preparation, wrong dosage form, and wrong route. Additionally, many health care settings are primarily built around the needs of adults and lack trained staff oriented to pediatric care. The three new challenges will be added to the current list of 12 challenges and Actionable Patient Safety Solutions, and addressed at the Patient Safety Movement’s 5th Annual World Patient Safety, Science and Technology Summit in February 2017. VT N READ MORE: patientsafetymovement.org
Intact Vascular launches trial of Tack system Intact Vascular has launched the Tack Optimized Balloon Angioplasty III clinical trial investigating its Tack endovascular system along with Medtronic‘s Admiral drug-coated angioplasty balloon for treating peripheral arterial disease (P.A.D.). The Tack endovascular system is designed to repair dissections that occur as a complication of balloon angioplasty. The system allows operating physicians to repair dissections with only a small amount of foreign material in the artery. “The Tack endovascular system is the ideal adjunct to drug-coated balloon angioplasty. It allows physicians to treat arterial damage in a highly targeted way and address their goals of reducing stress and irritation on the artery,” Clinical Affars Vice President Marc Penna said. “We have a robust clinical development portfolio that is designed to demonstrate the power of this technology combination on the endovascular treatment of P.A.D.”
Enrollment for the trial has opened, and the first patient in the trial has been treated by Klaus Brechtel, MD, at Berlin’s FranziskusHospital. “One of our key goals when using drug coated balloons to perform peripheral angioplasty is to minimize inflammation of the treated artery and leave little foreign material behind,” Dr. Brechtel said. “The Tack system is designed to allow us to repair arterial damage after angioplasty while minimizing vessel irritation and leaving far less metal behind than we would with the traditional stenting approach. “The Toba III trial will provide us with valuable information about the combination of two very promising technologies designed to treat PAD. We are thrilled to be the first center to begin enrollment in this important study,” Brechtel said in prepared remarks. The multi-site Toba III trial is slated to enroll 200 patients with P.A.D., including a subgroup of patients with long arterial lesions, a company spokesman said. In September, Intact Vascular announced it won FDA Investigative Device Exemption for the Toba II trial of its Tack endovascular system for patients with peripheral arterial disease undergoing percutaneous angioplasty. Currently running, the Toba II study is exploring the combination of the Tack system along with C.R. Bard‘s Lutonix DCB in patients with superficial femoral and popliteal artery disease. The company has plans to conduct a trial to investigate the performance of the tack system following balloon angioplasty in patients with arterial disease below the knee. VT N READ MORE: IntactVascular.com
J&J trolling for deals of any size Johnson & Johnson will consider deals of any size and for any of its three main businesses, chief financial officer Dominic Caruso said, though when it comes to pharmaceuticals the company is more interested in less-risky licensing agreements. “We’re equally interested in all three of our businesses,” Caruso said.. “We’re agnostic whether it’s big or small.” That excludes a mega-merger with another drugmaker, he said. J&J is focused on finding value, he said, which means different things for each line of business. In the consumer unit, for example, there is relatively lower risk from a regulatory or market perspective than in other lines of business, making it potentially easier to make a purchase that can generate a worthwhile return. “We do look at areas where we might not be in the market today, where we might add a whole other therapeutic focus.” VT N
Robot, come home: Nyet! Nyet! Nyet! This has nothing to do with veins… or medicine…or anything important. In fact, it’s just weird. A Russian robot capable of thinking for itself is set to be scrapped after it escaped from a hightech lab for a second time. The Promobot IR77 has been fitted with artificial intelligence, meaning that it learns from its experiences and its surroundings, although the programmers had not expected it to yearn for freedom. They say that despite reprogramming it twice, the robot continues to attempt to escape and they are now considering scrapping it. The other robots that have been created from the same series are well-behaved, and are perfectly happy to stay home. But Promobot IR77 made international headlines in June when it escaped, but it ran out of battery power in the middle of a street in the city of Perm in central Russia’s Perm Krai region after just 45 minutes of roaming free. The expert said that they had programmed the robot to try and avoid obstacles, and it had not been intended that it would look for ways to leave the research center or the country. In its first escape, it had been wandering around outside the lab in a yard when it escaped through a gate that had not been shut properly. It must not take long working with Russian programmers to want to run away. VT N
This is making the rounds on social media:
Photos: Flickr user Matt Wade, Facebook user Morgan Bladen
AUGUST/SEPTEMBER 2016 VEIN THERAPY NEWS
ASK FOR THE EVIDENCE The newest addition to our solid body of evidence. VeClose TM
24-month results for the VenaSeal Closure System
VenaSeal Follow-up
1 Year
™
System
™
ClosureFast
ClosureFast™ Catheter
Catheter Long-term Study
Closure Rate
Closure Rate
Closure Rate
96.8%1
95.9%2
96.3%3
94.3%
94.0%
94.5%3
3 Years
Follow-up in progress
Follow-up in progress
92.6%3
5 Years
Follow-up in progress
Follow-up in progress
91.9%3
2 Years
VenaSeal
™
2
2
Closure System
VeClose randomized level 1 evidence with quality of life subset eSCOPE multicenter single arm study Feasibility single-center study
™
ClosureFast
RFA Procedure
Randomized multicenter post market evidence5 Several single and multicenter studies including 5 year follow-up Eight years of published clinical evidence6
References: 1. Morrison, N. Use of Cyanoacrylate adhesive for Treatment of Incompetent Great Saphenous Veins: 12-month Results of the VeClose Trial, European Venous Forum, 2015. 2. Internal data RQ ƬOH 3. Proebstle T, Alm J, Gockeritz O, et al. Three year European follow-up endovenous radiofrequency thermal ablation of the great saphenous vein with or without treatment of calf varicosities. J Vasc Surg. 2011;54(1)146-52. 4. Proebstle et al. Five-year results from the prospective European multicentre cohort study on radiofrequency segmental thermal ablation for incompetent great saphenous veins. BJS. 2015;102 212-218 5. L. H. Rasmussen, M. Lawaetz, L. Bjoern, B. Vennits, A. Blemings and B. Eklof, Randomized Clinical Trial Comparing Endovenous Laser Ablation, Radiofrequency Ablation, Foam Sclerotherapy and Surgical Stripping for Great Saphenous Varicose Veins. British Journal of Surgery Society Ltd., Wiley Online Library, www.bjs.co.uk, March 15, 2011. 6. Proebstle et al. Treatment of the incompetent great saphenous vein by endovenous radiofrequency powered segmental thermal ablation: First clinical experience. J Vasc Surg 2008;47:151-6. ClosureFast long-term data is shown for perspective only and not a head-to-head comparison with the VeClose trial.
DC00046054 © 2016 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together VEIN THERAPY NEWS AUGUST/SEPTEMBER are trademarks of Medtronic. All other brands are trademarks of a Medtronic2016 company.
9
NEWS An ‘A’ can make all the difference in HIPAA breach By Frank Sivilli Receiving HIPAA breach notification letters in the mail has become a disappointingly commonplace occurrence for many Americans over the past few years. In a single breach alone in February 2015, as many as 80 million individuals had their protected health information (PHI) breached by Anthem. HIPAA regulation mandates that breaches be reported to affected patients informing them of the full extent of the information that was exposed.
So when patients of the Buffalo, N.Y., Medical Group received letters informing them that their PHI had been breached, they were rightfully concerned. The letter detailed a convoluted set of interactions, wherein a former nurse allegedly disclosed the PHI of a number of patients to her boyfriend. In August of 2015, though, the nurse and her boyfriend “had a big breakup and he sent a tell-all letter‌ detailing these HIPPA [sic]violations. When the Buffalo Medical Group was reached for comment about the content of the letter, however, they said that it was not official, and that the alleged HIPAA violations were entirely unfounded. The Buffalo Medical Group immediately launched an investigation into the source of the letter, and found that it hadn’t originated
from their offices or from any of their employees. The Group released a statement saying that: “The letter was fabricated and widely distributed for the sole purpose of harassing the individuals named in the letter, and that the motives of the author are wholly unrelated to the professional conduct of the Buffalo Medical Group or its employees. We are working with our advisors to take appropriate legal action against the responsible party.� No word yet as to why the letter was sent to these few patients. But this case raises the important question of the legitimacy of the breach notification process. False claims that PHI has been breached can be damaging to the organizational reputation of the practices
they impersonate, and can pose dangers to the integrity of targeted patients’ privacy. Even though the fraudulent letter wasn’t being used to scam patients, similar schemes have circulated widely for years and have been used to harvest data, amounting to identity theft and significant financial or personal stress. The Department of Health and Human Services’ Office for Civil Rights hasn’t released any guidance about the nature of fraudulent breach notification, but one thing is clear: if you receive a letter and see HIPAA spelled “HIPPA,� you’d be wise to give it a second glance. VT N Frank Sivilli is the editorial director of Blog HIPAA and content and marketing manager at the Compliancy Group.
Intended Use/Indications: The VenaSeal closure system (VenaSeal™ V\VWHP LV LQGLFDWHG IRU XVH LQ WKH SHUPDQHQW FORVXUH RI ORZHU H[WUHPLW\ VXSHUƏFLDO WUXQFDO YHLQV VXFK DV WKH JUHDW VDSKHQRXV YHLQ *69 WKURXJK HQGRYDVFXODU HPEROL]DWLRQ ZLWK FRDSWDWLRQ 7KH 9HQD6HDO V\VWHP LV LQWHQGHG IRU XVH LQ DGXOWV ZLWK FOLQLFDOO\ V\PSWRPDWLF YHQRXV UHƎX[ DV GLDJQRVHG E\ duplex ultrasound (DUS). Contraindications: Separate use of the individual components of the VenaSeal closure system is contraindicated. These components must be used as a system. The use of the VenaSeal system is contraindicated when any of the following conditions exist: previous hypersensitivity reactions to the VenaSeal™ DGKHVLYH RU F\DQRDFU\ODWHV DFXWH VXSHUƏFLDO thrombophlebitis, thrombophlebitis migrans, acute sepsis exists. 3RWHQWLDO $GYHUVH (ƪHFWV RI WKH 'HYLFH RQ +HDOWK %HORZ LV D OLVW RI WKH SRWHQWLDO DGYHUVH HƪHFWV H J FRPSOLFDWLRQV DVVRFLDWHG ZLWK WKH XVH RI WKH 9HQD6HDO V\VWHP 7KH DGYHUVH events associated with the device are similar to those with traditional endovenous thermal ablation procedures. In addition, there are several risks unique to the VenaSeal system due to its material and product design as an implant. These potential adverse events include, but are not limited to, allergic reactions to cyanoacrylates, such as hives, asthma, hay fever DQG DQDSK\ODFWLF VKRFN DUWHULRYHQRXV ƏVWXOD EOHHGLQJ IURP WKH VLWH RI DFFHVV GHHS YHLQ WKURPERVLV '97 HGHPD LQ WKH WUHDWHG OHJ HPEROL]DWLRQ LQFOXGLQJ SXOPRQDU\ HPEROLVP 3( KHPDWRPD K\SHUSLJPHQWDWLRQ LQIHFWLRQ DW WKH DFFHVV VLWH QRQ VSHFLƏF PLOG LQƎDPPDWLRQ RI WKH FXWDQHRXV DQG VXEFXWDQHRXV WLVVXH SDLQ SDUHVWKHVLD SKOHELWLV VXSHUƏFLDO thrombophlebitis, urticaria or ulceration may occur at the site of injection, vascular rupture and perforation, visible scarring. Warning, precautions, and instructions for use can be found in the product labeling. For VenaSeal, this labeling can be found at http://useifu.venaseal.com.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. DC00037656
Aortic | Peripheral | endoVenous 3033 Campus Drive, N550 Plymouth, MN 55441 USA
Orders Toll free: +1.800.962.9888 Fax: +1.800.734.1324
24-hour Technical Support Toll free: +1.800.328.2518
endoVenous Customer Service Toll free: +1.800.842.6410
CardioVascular LifeLine Customer Support Tel: +1.763.526.7890 Toll free: +1.877.526.7890
medtronic.com/endovenous www.medtronic.com/endovenous
10
AUGUST/SEPTEMBER 2016 VEIN THERAPY NEWS
Taking ClariVein to new lengths
®
Now introducing our 85cm device
http://www.clarivein.com
Vascular Insights ® LLC 1 Pine Hill Drive Two Batterymarch Park Suite 100 Quincy, MA 02169
®
www.ClariVein.com www.ClariVein.com
+1-203-446-5711
Indication For Use: ClariVein® IC is intended for infusion of physician-specified agents into the peripheral vasculature. Rx Only. 510(k) Cleared by the Food and Drug Administration for commercialization in the USA. Contraindications: The ClariVein® IC infusion catheter is contraindicated for use in the coronary and cerebral vasculature, in the pulmonary vasculature, in diseased and artherosclerotic arteries; for infusion of blood or blood products; and for patients contraindicated for endovascular procedures. Labeling: Refer to product labeling provided with each product for Description, Directions for Use, Warnings, Precautions, and Potential Complications/Adverse Effects. Read and understand all labeling prior to use. Failure to do so may result in injury and/or device failure. The ClariVein® IC catheter is a single use, disposable device. Note: This material is provided for general informational purposes only and is not intended or recommended as a substitute for professional medical advice. This information is for use only in countries with applicable health authority product registrations. Contact your local representative for product availability in a specific country. M-077 (R1)
NEWS
MEDCAC FRAMEWORK Topic: Lower Extremity Chronic Venous Disease The July 20 Medicare Evidence See related article, Development & Coverage Advisory Committee (MEDCAC) meeting was to pages 1, 33, & 37. examine the scientific evidence underpinning the benefit and risk of existing lower extremity chronic venous disease interventions that aim to improve health outcomes in the Medicare population. This meeting was also to identify evidence gaps that exist related to lower extremity chronic venous disease. Lower extremity chronic venous disease is distinct from lower extremity peripheral artery disease as it is characterized by a different pathophysiology, epidemiology, set of clinical manifestations and outcomes. Lower extremity chronic venous disease includes heterogeneous disorders that encompasses a variety of primary etiologies. Nevertheless, common to most of these venous conditions is a permanent alteration in venous structure and function, which leads to altered venous hemodynamics. Causes of altered venous blood flow include venous dilation and venous valvular reflux (venous valvular incompetence or “chronic venous insufficiency”) or venous obstruction (from prior venous thrombosis or mechanical compression). Patients with any of these venous structural alterations may be asymptomatic or symptomatic, suffering from mild pain to severe discomfort, with or without edema. Chronic venous disease can lead to major decrements in quality of life, and be associated with quality-of-life altering physical stigmata, including telangiectasias and varicose veins. Venous obstruction, venous insufficiency, and post-thrombotic syndrome patients may suffer from significant dependent edema and loss of ambulatory function. When venous insufficiency is associated with untreated (sustained) venous hypertension, the skin may be permanently damaged with initial and recurrent skin ulceration. Existing therapies to improve outcomes for individuals with lower extremity chronic venous disease are grouped into four main categories: medical therapy, lifestyle interventions (including exercise, smoking cessation and weight reduction), mechanical compression therapies (support garments, bandaging and pneumatic compressive devices) and invasive procedures (endovascular techniques including venous angioplasty, stenting and ablation; and surgical interventions, including venous thrombectomy, venous bypass, venous ligation, and venous excision). Clinical outcomes of interest to the Medicare program include: reduction in pain; reduction in edema; improvement in functional capacity; improvement in quality of life; avoidance of Table 1. Definitions of Terms Term
Definition
Venous obstruction
Defined as partial or complete blockage of venous flow in any venous segment; can result from internal blockage (e.g., thrombosis) or external compression of the vein
Venous reflux
Used to describe any retrograde venous flow in any venous segment; typically classified as (a) primary/idiopathic, (b) secondary (typically due to trauma, thrombosis, or mechanical/chemical/ thermal etiologies), or (c) congenital
Venous thrombosis
Defined as the formation of a blood clot in any segment of the venous system; typically classified as deep or superficial
Chronic venous insufficiency or incompetence (CVI)
Post-thrombotic syndrome
12
Reserved for advanced venous disease, indicated by C3-C6 on the CEAP classification, and defined as morphological abnormalities of the venous system that lead to symptoms/signs (specifically, moderate-severe LE edema, skin changes, and/or venous ulcers) Describes chronic venous symptoms and/or signs that occur as a result of DVT and its sequelae
acute and chronic venous thromboembolism; avoidance of chronic thromboembolic pulmonary hypertension; avoidance of initial venous skin ulceration and recurrent ulceration; improvement in wound healing; reduction in all-cause mortality; and avoidance of repeat interventions and harms from the interventions.
VOTING QUESTIONS These are the five questions that the MEDCAC panel asked the presenters to answer and the instructions they were asked to follow. For each voting question, please use the following scale identifying your level of confidence - with a score of 1 being low or no confidence and 5 representing high confidence. 1 — Low Confidence 1.
2
— 3 — Intermediate
4
—
5 High Confidence
For adults with varicose veins and/or other clinical symptoms or signs of chronic venous insufficiency, how confident are you that there is sufficient evidence for an intervention that improves: a. Immediate/near-term health outcomes in patients presenting with symptoms? In patients presenting without symptoms but with physical signs? b. Long-term health outcomes in patients presenting with symptoms? In patients presenting without symptoms but with signs?
DISCUSSION: • If intermediate confidence (≥ 2.5), please identify the specific intervention(s) that are associated with evidence-based clinical benefit and identify the associated beneficial outcome(s). • Considering the heterogeneity of the Medicare population, discuss for which subgroups of the Medicare population the evidence demonstrates likely benefit or which subgroups are not likely to benefit from intervention. 2. For adults with chronic venous thrombosis and venous obstruction (including individuals with post-thrombotic syndrome), how confident are you that there is sufficient evidence for an intervention that improves: a. Immediate/near-term health outcomes in patients presenting with symptoms? In patients presenting without symptoms but with signs? b. Long-term health outcomes in patients presenting with symptoms? In patients presenting without symptoms but with signs?
DISCUSSION: • If intermediate confidence (≥ 2.5), please identify the specific intervention(s) that are associated with evidence-based clinical benefit and identify the associated beneficial outcome(s). • Considering the heterogeneity of the Medicare population, discuss for which subgroups of the Medicare population the evidence demonstrates likely benefit or which subgroups are not likely to benefit from intervention. a. Immediate/near-term health outcomes? b. Long-term health outcomes?
ADDITIONAL DISCUSSION TOPICS 3. Discuss important venous disease evidence gaps that have not been previously or sufficiently addressed. 4. Discuss any current venous disease treatment disparities and how they may affect the health outcomes of Medicare beneficiaries. 5. Discuss any mechanisms that might be supported by CMS that would more quickly generate an improved evidence base that would underpin improved care for the Medicare population affected by lower extremity chronic venous diseases. VT N
AUGUST/SEPTEMBER 2016 VEIN THERAPY NEWS
THEPRACTICE
Revolutionary drug-free therapy for Restless Legs Syndrome • Clinically proven and cleared by the FDA • Published in the Journal of the American Osteopathic Association* • Drug-free treatment with lower risk of negative side effects and zero risk of addiction clinical@restiffic.com Request more info at clinical@restiffic.com KWWS ZZZ UHVWLIÀF FRP www.restiffic.com
VEIN THERAPY NEWS AUGUST/SEPTEMBER 2016
*Kuhn PJ, Olson DJ, Sullivan JP. Targeted Pressure on Abductor Hallucis and Flexor Hallucis Brevis Muscles to Manage Moderate to Severe Primary Restless Legs Syndrome. J Am Osteopath Assoc 2016;116(7):440-450. doi: 10.7556/jaoa.2016.088.
13
NEWS Slavitt says payment burden should be on technology, not docs In a speech that centered on the changes the healthcare industry faces through MACRA’s Quality Payment Program, Andy Slavitt emphasized the need for health IT vendors to do more. In his comments at the American Medical Association’s Annual Meeting, the acting administrator for the Centers for Medicare & Medicaid Services said that one of the keys to fixing a very fragmented healthcare system is making “healthcare technology a tool, not an industry.” He also said that it’s time to “ask a lot more” of vendors, especially when it comes to interoperability. The industry, he said, must put “more pressure on technology vendors and less burden on physicians, so physicians can do simple things like track referrals when a patient sees another specialist or visits a hospital.” Slavitt also mentioned Meaningful Use, acknowledging that the burden should not fall on the shoulders of the user, but on the technology. “Today’s data silos are more a function of business practices than technology capability and we cannot tolerate it any longer,” he said. The first year of the Quality Payment Program will hit bumps as new policies run into the realities of everyday medicine, Slavitt said. “Systems will need to adapt to your needs. Long-time frustration won’t disappear right away. I’m asking for your ongoing collaboration over the next several years, so that we can implement, receive feedback, iterate and progress.” VT N
Teledermatology boosts access to care for Medicaid By offering virtual dermatology and Medicaid coverage, the number of patients who saw a dermatologist nearly doubled, according to a new RAND Corp. study, illustrating how virtual care can increase patient access to specialists. A Veterans Affairs clinic in Spokane, Washington, has also reported a similar increase in cases with the introduction of teledermatology. For the study, published in JAMA Dermatology, researchers examined more than 380,000 members of Health Plan of San Joaquin, a MediCal-managed plan in California’s Central Valley, including about 108,000 who were newly enrolled under provisions of the Affordable Care Act. The region has only about one-third the national
14
Google adding symptom searcher to mobile app After years of serving as the starting point for so many health-related searches, Google has finally done the inevitable: introduced a symptom searcher, at least to its mobile app. With help from Harvard Medical School and Mayo Clinic, the symptom-search function promises to be more accurate and useful than Dr. Google of the past. The Internet giant said that it made the move after determining that fully 1 percent of all searches worldwide are symptom related. Google knew that it wasn’t delivering the best results. “After 20 minutes digging through health forums, chances are you’re overwhelmed by all the complicated medical terms and breaking out in a sweat — whether that’s related to the headache or the overdose of info is unclear!” Product Manager Veronica Pinchin wrote on the official Google blog. The updated Google search app for both Android and Apple iOS will match searches of symptoms against a medical database. The results will pop up as “digital cards,”
average number of dermatologists, according to an announcement. Originally, some primary care physicians who referred patients to teledermatology provided background about patients and took digital images of skin problems, which were uploaded to a secure website. They then received a consult report within a few days. Over time, however, patients were referred to two brick-and-mortar clinics to have photographs taken and to be interviewed by a teledermatology nurse. The remote dermatologist then reviewed the history and images, with the diagnosis and treatment relayed to both the patient and referring primary care provider. If necessary, an in-person follow-up visit was scheduled with the dermatologist. The authors found about half the plan’s members who saw a dermatologist did so virtually; however, 75 percent of the new Medicaid enrollees were treated via telemedicine. The teledermatology patients were more likely to be male, under 17, nonwhite and without comorbid conditions. They were most often seen for issues such as warts or acne. In-person visits tended to be for more complex cases such as psoriasis and skin cancers. VT N
For more industry news and features, please visit us online at VEINTHERAPYNEWS.com
according to the Wall Street Journal, and users can swipe through to find more information about possible medical conditions. Pinchin explained: So starting in the coming days, when you ask Google about symptoms like “headache on one side,” we’ll show you a list of related conditions (“headache,” “migraine,” “tension headache,” “cluster
headache,” “sinusitis,” and “common cold”). For individual symptoms like “headache,” we’ll also give you an overview description along with information on self-treatment options and what might warrant a doctor’s visit. By doing this, our goal is to help you to navigate and explore health conditions related to your symptoms, and quickly get to the point where you can do more in-depth research on the web or talk to a health professional. Still, Google included a disclaimer: “That said, symptom search (like all medical information on Google) is intended for informational purposes only, and you should always consult a doctor for medical advice.” While sites like WebMD have had symptom checkers for years, Google seems to be the default search place for everything online. The company is simply trying to make the search engine “a helpful place to start,” Pinchin said. VT N
Nitinol stent yields favorable femoropopliteal 1-year outcome In patients with severe atherosclerotic disease of the superficial femoral and popliteal arteries, an interwoven nitinol stent yielded a primary patency rate of 78.9 percent and clinically driven target lesion revascularization rate of 87.6 percent at 1 year. Researchers for a retrospective, singlecenter study evaluated 111 consecutive limbs of 97 patients (mean age, 75 years; 68 men) with symptomatic femoropopliteal disease. All patients underwent treatment with an interwoven nitinol stent (Supera, Abbott Vascular) between June 2012 and October 2014. Reasons for intervention included claudication (Rutherford category 1-3) in 56 percent of the patients, critical limb ischemia with rest pain (Rutherford category 4) in 19 percent and tissue loss (Rutherford category 5/6) in 25 percent. More than 50 percent of the lesions were left-sided, and 14 patients were treated bilaterally. The primary endpoint was the absence of binary restenosis. This was conservatively defined as freedom from more than 50 percent restenosis based on a peak systolic velocity ratio greater than two by duplex ultrasound. TLR was defined as procedures performed for more than 50 percent diameter stenosis within 5 mm of the target lesion detected by duplex and arteriography after known recurrence of peripheral artery disease symptoms. Any amputation above the ankle was classified as major amputation.
In total, 146 stents (1.32 stents per limb; length, 40-600 mm) were placed successfully without technical failure. The mean stented artery length was 175.5 ± 130.5 mm. Ninetyone patients completed clinical follow-up, and duplex ultrasound assessment was conducted in 100 limbs. Follow-up occurred at a mean of 6.92 ± 6.43 months (range, 0.2-27.7). Reintervention was conducted in all patients with recurring symptoms and evident in-stent restenosis. At 6 months, the Kaplan-Meier method estimated a 95 percent rate of freedom from TLR; and at 12 months, this rate was 87.6 percent. The rate of primary patency was 87.1 percent at 6 months and 78.9 percent at 12 months. Compared with longer stented arterial segments (> 120 mm), shorter segments (20-120 mm) had better 12-month primary patency (93.3 percent vs. 66.3 percent; P = .016). Compared with stenoses, complete occlusions had worse patency at 6 months (84 percent vs. 93.1 percent; P < .0001). Occlusion or loss of patency occurred in 13 stents. Of these, failure was attributable to stent intussusception in four limbs, compromised inflow or outflow in two limbs, gross oversizing in one, and thrombophilia in one. The mechanism of occlusion could not be identified in five stents. VT N
AUGUST/SEPTEMBER 2016 VEIN THERAPY NEWS
THEPRACTICE
Vascular Reporting Made Simple.
Call today to schedule an online demo!
866-209-3393 x3 Core Sound Imaging, Inc. info@corestudycast.com 866.209.3393 www.corestudycast.com VEIN THERAPY NEWS AUGUST/SEPTEMBER 2016 www.corestudycast.com
15
NEWS
IBM creates Watson-based imaging collaborative Miami Health System; University of Vermont Health Network; and teleradiology provider vRad. “With the ability to draw insights from massive volumes of integrated structured and unstructured data sources, cognitive computing could transform how clinicians diagnose, treat and monitor patients,” Anne Le Grand, IBM’s vice president of imaging for Watson Health, said in the announcement. “Through IBM’s medical imaging collaborative, Watson may create opportunities for clinicians to extract greater insights and value from imaging data while better managing costs.” Some of the program’s initial efforts will include training Watson on cardiovascular disease, eye health and other conditions using information from the collaborative members. IBM also recently teamed up with the American Diabetes Association to create a personalized app that gets smarter over time and works with Watson Care Manager. The entities also are developing a diabetes-focused app development challenge for tools that tap the association’s deep data and IBM Watson’s cognitive insights. VT N READ MORE: www-03.ibm.com/press/us/en/ pressrelease/49985.wss
IBM has formed a Watson Health medical imaging collaborative alongside more than 15 health systems, academic centers, imaging technology companies and ambulatory radiology providers. “Imaging is one of the things that spans across many different areas,” said Anne Le Grand, IBM Watson Health’s vice president of imaging. “The real aim is to bring cognitive imaging into clinical practice. Imaging is vast and costly,” and so much value remains inaccessible. Through the venture, announced by IBM in June, organizations will “put Watson to work to extract insights from previously ‘invisible’ unstructured imaging data and combine that with a broad variety of data from other sources.” That, IBM notes, will help physicians in personalizing care decisions for patients, as well as grow the care knowledge base for future patients. The initial partners include: Agfa HealthCare; Anne Arundel Medical Center, Annapolis, Maryland; Miami-based Baptist Health South Florida; Eastern Virginia Medical School in Norfolk; Hologic, Inc., ophthalmology health IT company IFA Systems and its Inoveon subsidiary; Radiology Associates of South Florida; Sentara Healthcare in Norfolk, Virginia; physician management group Sheridan Healthcare; optical equipment-maker Topcon; UC San Diego Health; University of
HHS clarifies guidance in release of patient info At the beginning of the year, the Department of Health and Human Services issued a public guidance reminding the healthcare industry that HIPAA gives patients the right to access their own health records. Now, HHS, via the Office of the National Coordinator for Health Information Technology, is trying to make the guidance easier to implement. ONC and the HHS Office for Civil Rights, which enforces HIPAA, has released three videos and an infographic informing consumers of their rights. “The videos highlight the basics for individuals to get access to their electronic health information and direct it where they wish, including to third-party applications,” ONC Chief Privacy Officer Lucia Savage said in a statement. On the final day of its annual meeting in Washington, ONC also debuted the “Patient Engagement Playbook,” an online resource to help hospitals and medical practices better engage patients through health IT. “The Playbook provides clinicians with the resources they need to get the most out of their health IT and help patients put their electronic information to work to better manage their health,” ONC Chief Medical Officer Dr. Tom Mason said. Sherilyn Pruitt, director of ONC’s Office of Programs, said will update the document based on response from the public. “We hope that stakeholders – including patients, patient advocates, providers and others – share their input, feedback and additional use cases that could be added to the Playbook in the future,” Pruitt said. The videos are 3-5 minutes each, will be available for healthcare providers to show on monitors in waiting rooms, on tablets for patient registration and on their websites. VT N For the Playbook, see www.healthit.gov/playbook/pe/ For the videos and infographic, see www.healthit.gov/access
16
OCR releases ransomware, HIPAA guidance If a healthcare organization’s computers are infected with ransomware, the government considers it a data breach unless there’s a “low probability” information has been compromised, according to much-anticipated guidance on ransomware and HIPAA from the Health and Human Services Department’s Office for Civil Rights. “The guidance makes clear that a ransomware attack usually results in a ‘breach’ of healthcare information under the HIPAA Breach Notification Rule,” OCR Director Jocelyn Samuels said. If a breach is presumed to have occurred, the guidance says, then the organization must comply with breach notification provisions, which include notifying the effected patients, the secretary of HHS and the news media. A majority of hospitals in the United States have been the target of a ransomware attack or could potentially become a victim, FierceHealthIT reported. In February, Hollywood Presbyterian Medical Center chose to pay ransomware hackers $17,000 after an attack disabled its networks. In March, a
ransomware attack paralyzed MedStar Health’s computer systems. The HHS guidance “reinforces” the ways HIPAA compliance helps prevent and detect security threats, such as requiring entities to conduct risk analysis, implement procedures to safeguard against malicious software, train employees to detect malicious software and limit access to protected health information to only those who need it to perform their jobs. It also defines ransomware and outlines signs of such an intrusion, how to mitigate risk and the importance of backing up data. “Organizations need to take steps to safeguard their data from ransomware attacks,” Samuels said. “HIPAA covered entities and business associates are required to develop and implement security incident procedures and response and reporting processes that are reasonable and appropriate to respond to malware and other security incidents.” VT N READ MORE: guidance on ransomware and HIPAA from the Health and Human Services Department’s Office for Civil Rights
$750,000 HIPAA fine shows need for BA Raleigh Orthopaedic Clinic, P.A., of North Carolina has agreed to pay $750,000 to settle charges that it potentially violated the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule by handing over protected health information (PHI) for approximately 17,300 patients to a potential business partner without first executing a business associate agreement. HIPAA covered entities cannot disclose PHI to unauthorized persons, and the lack of a business associate agreement left this sensitive health information without safeguards and vulnerable to misuse or improper disclosure. Raleigh Orthopaedic is a provider group practice that operates clinics and an orthopaedic surgery center in the Raleigh, N.C. area.
OCR initiated its investigation of Raleigh Orthopaedic following receipt of a breach report on April 30, 2013. OCR’s investigation indicated that Raleigh Orthopaedic released the x-ray films and related protected health information of 17,300 patients to an entity that promised to transfer the images to electronic media in exchange for harvesting the silver from the x-ray films. Raleigh Orthopedic failed to execute a business associate agreement with this entity prior to turning over the x-rays (and PHI). “HIPAA’s obligation on covered entities to obtain business associate agreements is more than a mere check-the-box paperwork exercise,” said Jocelyn Samuels, director of the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR). VT N
AUGUST/SEPTEMBER 2016 VEIN THERAPY NEWS
NEWS xAmplifier tagline maps marketing success for clinics Learn. Improve. Act. Amplify. xAmplifier is a cloud-based application that optimizes customer experience, consultation conversions, marketing automation and reputation management. “Customer experience is the ultimate differentiator,” xAmplifier Founder James Kropp explained. “The most successful companies in the world excel because of word of mouth buzz and referrals. We noticed that there were individual customer experience companies and individual reputation companies but no one bridged the gap.
“We pride ourselves in unleashing happy customers for our clients and that is where the company names derives…..we amplify a practice’s xfactors.” xAmplifier’s tagline, “Learn. Improve. Act. Amplify.” is a standard that they utilize to help client’s perform at the highest levels possible. They are put into action in the following ways: 1. Learn: xAmplifier conducts digital surveys that measures the client’s satisfaction levels with service, staff, atmosphere, etc. 2. Improve: With these measures, x Amplifier delivers graphical representation that depicts to the client areas of strengths and weakness operationally and where the best performance opportunities exist. 3. Act: xAmplifier provides real time alerts that allow client personnel to
engage their customers and nurture relationships. xAmplifier’s analytic capabilities allow clients totarget new customers through its marketing automation solutions. 4. Amplify: Through the management of your digital footprint and social referrals, xAmplifier will distribute positive reviews to help your online reputation, increase referrals and digitally reach out to customers who are most likely to desire practices services. “We help clients to see how their customers view them, we give clients tools to improve the relationship, we unleash positive sentiment to the online world, and lastly, we use our role as an industry aggregator to understand the best ways to communicate with existing and potential new customers.”
Online reputation is one of the most important deciding factors for consumers today and consumers state that doctors represent the business group whose reputation matters the most (BrightLocal Consumer Survey 2015, tied with restaurants) Consider these additional BrightLocal study facts and you know that reputation is important: 92 percent of consumers read online reviews, and 68 percent say that positive reviews make them trust a business more Authenticity of reviews is the most important factor for consumers to trust reviews. Kropp said at xAmplifier that they believe that it is for reasons like these that they shine.
XAMPLIFIER continued on page 25
BE BOLD BE HEALTHY STEP INTO
MICROFIBER SHADES A new graduated compression product series refreshed throughout the year! Now with NEW HEATHERED SHADES!
For more information: http://www.sigvaris.com
sigvarisusa.com | 800.322.7744 SIGVARIS is a registered trademark of SIGVARIS AG, CH-9014 St.Gallen/Switzerland, in many countries worldwide. © Copyright 2016 SIGVARIS, Inc.
VEIN THERAPY NEWS AUGUST/SEPTEMBER 2016
NAVY HEATHER (23)
GRAPHITE HEATHER (27)
GRAPHITE STRIPE (17)
DARK NAVY STRIPE (13)*
ONYX STRIPE (19)*
PINK STRIPE (15)*
Available in15–20 & 20–30mmHg*
17
ACPUPDATE The ACP Annual Congress – educating providers for 30 years This year marks the 30th anniversary of the ACP Annual Congress. Starting with just 100 participants and 28 faculty, the Annual Congress has grown to more than 1,000 attendees, more than 100 faculty and nearly 80 exhibitors, covering the breadth of deep and superficial venous and lymphatic care. meeting is unique and provides physicians and allied health providers opportunities that Each year, the American College of they can’t get at any other single meeting.” Phlebology (ACP) Annual Congress continues A new all-day lymphedema and wound to grow in scope and numbers, making it care track has been added to the Pre-Congress the largest and most comprehensive meeting program (Thursday, Nov. 3), along with dedicated to venous and lymphatic care in tracks for ultrasound and basic & advanced the U.S. This year, the ACP is preparing for phlebology. Specific workshops are offered, yet another exceptional event with the 2016 as well, for IVC filter placement, iliac venous ACP Annual Congress this Nov. 3-6 at the stenting, IVUS, embolization, live ultrasound Anaheim Marriott in Anaheim, Calif. scanning and compression. Under the direction of co-chairs Carl In addition to the scientific sessions, a Black, MD, and Kathleen Gibson, MD, the separate Practice Management symposia will 2016 scientific program will continue to set be available on Sunday. Practice management the pace for vein care with innovative and sessions were developed to help practitioners engaging content presented by respected manage coding and insurance challenges, faculty from around the world. registry participation, and how to market “The committee built a program this year their practice through traditional and digital that carries on the tradition of the very first vehicles. Annual Congress – to provide attendees with Although the curriculum will be the tools they need to improve the standard of challenging, the three-day event will take care in their practices,” Dr. Gibson said. place just steps from the “Happiest Place on The 2016 Annual Congress program Earth™” in Anaheim, a relaxing atmosphere highlights include: luminary lectures from for networking and engaging with colleagues. leaders in Vascular Surgery, Interventional Social activities are planned throughout Radiology, and Vascular Medicine; in-depth the Congress, including a Fun Run, Silent sessions on lipedema, thrombophilia, and Auction, the “flashback” After-Party and the unusual vascular disorders; debates with ACP Foundation’s 10th Annual Golf Outing. international experts on venous stenting, 30 years on and the field of vein care perforator vein treatment and best treatment continues to grow, with the ACP Annual choices for incompetent GSV; hands-on Congress as a driving force, addressing and small group lectures on non-thermal educational needs at all levels of skill. Join the ablation, sclerotherapy, and anticoagulation; ACP Nov. 3-6 in Anaheim for this essential and concurrent symposia for Ultrasound and event. allied health. For more information about the Dr. Black explained that the content and Congress and to register, please see interactivity are what have set the ACP Annual www.acpcongress.org. VT N Congress apart for three decades. “This
Downtown Anaheim
Plenty of palm trees and sun
By Michael Armitage Michael Armitage is director of marketing and communications for the American College of Phlebology. He can be contacted at marmitage@acpmail.org .
2016
30TH ANNUAL CONGRESS
Anaheim Marriott
18
AUGUST/SEPTEMBER 2016 VEIN THERAPY NEWS
SECONDLOOK
2016
30TH ANNUAL CONGRESS
30 years
Vein Care in the Spotlight November 3-6, 2016
of leadership
Anaheim Marriott
in vein care
Join your colleagues at the American College of Phlebology’s 30th Annual Congress for the largest and most comprehensive meeting in the U.S. dedicated to venous and lymphatic disease. The scientific program brings together a multi-disciplinary group of experts, addressing the full spectrum of deep and superficial vein care.
The 30th Annual Congress will provide practitioners with: + Opportunities to improve patient care at all levels of skill from basic through advanced + Presentations and exhibitors of the latest research, technology and trends in the field of vein care + Hands-on workshops and demonstrations with renowned experts from around the world
For additional details and and registration information, please visit:
http://www.acpcongress.org
acpcongress.org
advancing vein care
www.phlebology.org | 510.346.6800 http://www.phlebology.org
VEIN THERAPY NEWS AUGUST/SEPTEMBER 2016
19
THEPRACTICE With the vein industry becoming more competitive than ever, clinics are finding it important to invest money in marketing programs that provide the maximum ROI and profit.
VeinTreatmentForum New patient generation leads to improved practice performance VeinTreatmentForum (VTF) is a business that it’s CEO James Kropp says thrives at providing its clients with targeted, qualified patient consultations. “We consider ourselves successful when new patients say “Wow” and when practices realize an extremely profitable marketing resource,” Kropp said. Unlike other marketing companies that accept fees but have trouble quantifying results, VTF deliverables new customers directly to the practice door on a pay-forperformance basis. As a result, Kropp said VTF is uniquely positioned to measure program return on investment and discern program success immediately. “When clients are realizing tremendous results, VTF can just turn up more volume. If there are glitches in the process, VTF can diagnose the problem and prescribe solutions to create better performing marketing programs. “Our company prides itself on our data and analytics capabilities, but we also embrace what is happening on a local, operational basis. “We marry the 35,000-foot Big Picture with how the rubber meets the road,” Kropp said. Founded over a decade ago (parent company Sf), VTF has proven itself to be one, if not the best at producing valuable consultations in the medical industry.
Early on, VTF produced leads for clients but quickly discovered that there was even more value in managing leads through a 24/7 call center option and overlaying world class CRM technologies that can optimize performance. For clients, that means they can receive a turnkey consultation engine that offers a real time feedback loop for optimizing patient demographics, lead sources and scheduling protocols. The result is happy patients and happy practices. “Customer experience is critical for us,” Kropp said. “We believe that potential patients need to encounter a seamless process and we become thrilled when we introduce them to exceptional practice. “One challenge for VTF arises when clinics receive substantial lead volume that produces outstanding immediate returns for some locations whereas others struggle with consultation attendance rates or consultation conversion rates.” To solve funnel metric problems, VTF uses its proprietary CRM capabilities to analyze each location’s performance on an individual basis and pinpoint where underperforming clinics may be getting impacted. VTF is able to analyze bookout time, attendance rates and cancellation rates real time and in one recent
evaluation discovered underperforming locations were being impacted by: 1. A consultation bookout time that exceeded 30 days. 2. Some busy locations were cancelling new consultations to increase treatment capacity. 3. Leads that were from more than 20 minutes away, thereby causing patients to cancel or no show to appointments. Based on this insight, VTF was able to work with clients to: • open up more consultation capacity on the client side; and • focus on more targeted lead generation at VTF. Since being optimized, these locations have seen cancellation rates plummet, their attendance rate go up by 23 percent and their conversion rates increase by 18 percent. “We believe in empathy and strive to put ourselves in both the shoes of the patient and the practice,” Kropp said. “Through mutual understanding, we are better position to provide great results. The improved business performance is a scorecard that represents how we were able to better meet the needs of patients and clients. VT N
ABOUT THE FOUNDER Strategic marketing executive James Kropp is dedicated to developing and leveraging customer relationships through digital marketing, social media, customer experience measurement, and customized one-to-one customer communication protocols. He is an active alumnus of The Wharton School where he received his MBA and Rensselaer Polytechnic Institute where he received his B.S. in Electrical Engineering. Kropp is founder and chief executive officer of VeinTreatmentForum and xAmplifier.
20
AUGUST/SEPTEMBER 2016 VEIN THERAPY NEWS
THEPRACTICE
LET US DELIVER TARGETED QUALIFIED CONSULTATIONS TO YOUR DOOR
Pre-Show Promotion: Join our Program Before the ACP Show and receive 5 free consultations.
sales@signatureforum.com
sales@signatureforum.com
www.veintreatmentforum.com
veintreatmentforum.com
Contact our Sales Department Today at (708) 542-2092 or (888) 517-4187.
VEIN THERAPY NEWS AUGUST/SEPTEMBER 2016
21
THEPRACTICE
Making patient engagement work for seniors than twice as likely to complete Health Risk Assessment Surveys as those 40 and under. Can we be leveraging these surveys differently then and asking other questions about health habits that might better inform care? For example, what if we asked questions about their living situation such as “Do you have mobility challenges” or “Do you find it challenging to live independently?” This type of information could help population health managers caring for seniors get a level deeper to better inform and direct live (in-person or virtually!) consultations, maximizing the clinician and consumer’s time together.
By Andrea Powers French author Jules Renard once said, “It is not how old you are, but how you are old.” For the U.S., this couldn’t be more true as one in every seven Americans was over the age of 65 in 2013, according to the U.S. Census Bureau. The Department of Health and Human Services predicts this figure will nearly double by 2060, bringing the senior population to approximately 98.2 million. How the healthcare industry cares for and engages these individuals will be critical as the nation moves to a more value-based care model that also holds everyone more accountable for positive results. But what do seniors actually want to see in their health results? Harris Poll and Welltok recently conducted a survey of seniors who were at least 65 to examine just exactly what seniors want with their health and the role technology plays in their health. Survey highlights show that seniors are not only hungry for more information on Medicare (40 percent want to learn more) but 39 percent are interested in better understanding their benefits. 62 percent also wanted to feel good with less pain and 39 percent wanted to live independently. So how can the healthcare industry help the senior population get the right information at the right time to support a healthier and more independent life? Here are some ways to start. 1. Collect, predict and honor communication preferences As people age, it is normal to experience changes in vision, hearing and mobility, but this does not have to impact a senior’s participation in staying healthy. One of the first steps in engaging people is to understand their preferred channel of communication – both offline and online. Consumers no longer just appreciate their preferences being heard, they expect it. Yet, in the healthcare world we tend to assume we know what people want and need. For an aging population faced with health challenges, it is more important than ever to identify the best communications channel to meet them where they are. Having conducted millions of communications with senior populations, we have learned a lot. For example, senior men need multiple communications compared to senior woman, and are less likely to take immediate action. Seniors are more likely to authenticate voice calls, but don’t write off technology. Text is one of the fastest growing communications channels – men over 65 were statistically more likely to enroll in a diabetes text messaging than men under 55.
22
2. Leverage technology Seniors are a tech savvy generation! More than 80 percent of seniors say technology is part of their daily life, and 56 percent say they would use a health program accessible on a mobile device or computer if it was recommended by a doctor or caregiver, according to the Welltok survey. Additionally, a 2014 Pew survey found that 82 percent of seniors reported that owning a smartphone was “freeing.” With the willingness to both access health programs via a mobile device and general desire and feelings of empowerment with the ownership of a device, it’s clear that the mobile health landscape is ripe for disruption. Another Pew report found six out of 10 seniors search health topics online. I learned this lesson personally as a nurse health coach several years ago when I assumed an 82-year-old man would prefer some brochures to read on his condition. He quickly put me in my place and said, “Actually, dear, if you can give me some reliable websites, I like to do my own research.” I didn’t make that assumption again, for the record.
3. Organize the chaos Two of the most common New Year’s Resolutions are “get organized” and “get healthy.” It’s no different for seniors – exercise, good nutrition, regular health screenings, getting vaccines, having enough sleep and participating in social activities are just a few ways to promote healthy aging. And there are a lot of resources available from AARP, Medicare, retail pharmacy programs, but it is a lot to manage and navigate. Seniors need help organizing everything they need to accomplish their goals in one place. This population requires a consumer-designed platform offering a single channel for presenting benefit, health-related and other resources to support them. 4. Personalize Healthcare is deeply personal and there is no “one size fits all,” especially when it comes to seniors who may be treating several complex conditions at once. In order to engage the senior population, the material has to be relevant to them and their situation. The more we can understand any consumer’s goals and needs, the better we can help to provide them with the resources they need to achieve them. Our data shows that seniors are more
5. Incentivize Of seniors with room for improvement in their health status, 38 percent in the Harris Poll and Welltok survey indicated that external motivators, such as gift cards and other financial rewards in the form of vouchers, would incentivize them to engage in healthier behaviors. The potential for even modest incentives to increase program uptake among inactive older adults is great. Vouchers can take all sorts of shapes and forms as well: while cash is the most preferred option for many, supermarket vouchers are a close alternative. Tapping into intrinsic motivators is critically important too – seniors enjoy gamification and being competitive, that doesn’t go away with age! They are also equally motivated by personal goals such as playing with grandchildren, looking and feeling good, and maintaining their independence (or not being a burden on family). The senior population is a group that has always been deeply involved and interested in their healthcare, especially as their health inevitably declines. Yet, it’s traditionally been delivered in a care setting rather than part of their everyday lives. With seniors’ appetite for technology and information, there’s a real opportunity to ensure they have access to the right resources and program, via the right medium and at the right time. And who among us doesn’t want to feel empowered and engaged, to make sure we define how we want to be old, when the time comes. VT N Andrea Powers is the director of Healthcare Solutions at Silverlink, a Welltok company, and former Registered Nurse Professional Development Specialist.
AUGUST/SEPTEMBER 2016 VEIN THERAPY NEWS
http://www.crystalcleardm.com
THEPRACTICE
Tips for keeping up with the competition By Michelle Huie If you own your own practice, you have to play the role of both healthcare provider and business owner. After spending more than a decade studying your field, you no doubt have the ability to provide excellent healthcare to your patients; but how do you oversee that along with managing your staff and growing your practice? It can be incredibly challenging to educate people about the benefits your clinic can provide them while also setting yourself apart from your competitors. There are a few key ways to differentiate your business beyond resorting to flashy ads and temporary growth tactics. Just take it from me as CEO and founder of VIM & VIGR, offering stylish compression legwear for everyday use is a way to stand out. In just two and a half years, VIM & VIGR has doubled year over year growth without taking in any outside funding and is slated to sell 120,000 pairs of socks in 2016 alone. Here’s how I pulled my business from the bootstraps to selling in more than 550 retailers across the nation.
FIND YOUR STORY You cannot expect your customers to choose you above the competition if they don’t
“know” you. Take some time and think about your clinic: What is your story? What made you get in the industry? Why did you branch out and start your own clinic? What are your clinic’s values and is that well communicated throughout your clinic and staff? You have a story, and many underestimate the value in that. When I first started VIM & VIGR, I was passionate about making my story known. I joined the compression industry after my physical therapist told me to wear compression socks to help alleviate some of the symptoms of having a job that requires long hours of sitting. In searching for socks, I found that the compression industry swayed toward either athletic gear or socks geared around medical use and was unable to find any type of compression legwear that I could seamlessly incorporate into my daily lifestyle. I had discovered a real hole in the industry, and I became fervent about building a solution to fill that void. I created VIM & VIGR and started sharing my story and experience. My story and experience resonated with many people and I try to share it in every medium possible. However, it’s important to make sure to tell a consistent story on all mediums, such as your website, any videos or podcasts. Don’t be afraid to share that story as often as possible – studies have shown that
people need to be exposed to a message at least seven times before they actually absorb and commit that information to memory. Find your story and you’ll find a lot of outside support as well.
ADD A PERSONAL TOUCH You can order your morning coffee from an app, buy your wardrobe online and meet your future significant other with the swipe of a finger. Technology is great for saving us time, but does not always facilitate that personal touch or connection. Don’t believe me? Who was the last person to snail-mail you a handwritten card? You likely remember this person over the last e-thank you note that was cleared from your inbox. To stand out amongst your peers, bring back the “person” to your brand personality. At VIM & VIGR, we often surprise random customers with hand written notes or draw personal sketches on the outside of the shipment boxes by one of our in-house sketch artists. Some may think this is time consuming, but we’ve built such strong relationships with our customers and we want them to know that we appreciate their business. It brightens our people’s day when they receive a personalized package, so we will continue to prioritize these fun ways to surprise our customers.
24
Many of us are busy individuals, so we can appreciate a brand that takes the time to go the extra mile. Perhaps this is sending patients a hand-written note for their birthday. Or finding creative and meaningful ways to support your patients in their pre- and postop experiences. Many of my own customers have shared that they received their first VIM & VIGR socks in a post-op care package from their vein clinic – they tell me this in surprise, as it is a gift that is very appreciated because varicose vein removal is often not covered by insurance and most patients must pay out of pocket for their procedures. VIM & VIGR compression socks help their legs in the recovery process, and a small gesture like providing post-op stylish compression socks could leave a lasting impression. I find that, especially when it comes to the medical field and one’s well-being, we are conditioned to expect a one-size-fits-all solution for our health issues, similar to how the compression industry previously offered no diversity in styles. So when you do come across a doctor who remembers you enjoy running, or can recall the names of your children, it truly leaves a lasting impression. Even the smallest gesture like this can have a profound effect when it is done thoughtfully. Don’t be afraid to personalize your approach to business.
AUGUST/SEPTEMBER 2016 VEIN THERAPY NEWS
SECONDLOOK GET SOCIAL If you are not online and active on social media, you are doing yourself a disservice because it is almost certain that one (if not all) of your competitors are. Consumers search online for companies and customer reviews before purchasing a new brand of shampoo, and they are certainly Googling your clinic before agreeing to any sort of surgical procedure. Whether you’ve created your company profiles or not, public websites like Google Reviews or Yelp! allow users to write reviews on your clinic without your “approval.” When you understand that the conversations about your business are already occurring online, it makes it easier to accept that it’s best to join the dialog and build relationships with your customer base. Social media is a great way to connect with your current and potential clients in an organic way that doesn’t come across as a sales tactic. Be engaging. Ask questions, and interact with and not at your followers and you will be leaps and bounds past many brands in the social stratosphere.
For example, our VIM & VIGR socks are great for pregnant mothers to help them manage symptoms like swollen feet. Our social team makes it a point to search relevant hashtags concerning this audience, like #PregnancyProblems, and engages directly with these women because they are precisely the people who need VIM & VIGR’s help. We offer them advice and talk to them about our products as a way to alleviate their
symptoms. These conversations are met with thanks and excitement because we took the time to listen to what they had to say and helped them find a solution. As a vein clinic, you can search hashtags relevant to your business such as #SpiderVeins or #VaricoseVeins; do the research, but your audiences are likely already using social media to express themselves and make their voices heard. If you can find a genuine way to help others on their journey, that is how you build true brand advocates. Generating conversations online will certainly boost the search engine optimization (SEO) value of your website as well, but there are even more ways to promote your brand in creative ways to make your clinic stand out from the competition. Create a great “refera-friend” program or an engaging monthly newsletter.
You can also try to build partnerships or contests with other like-minded brands or retailers in your town. The important thing is that you are finding ways to reach your audiences and are able to share the “big picture:” you are a clinic that helps your patients be the best version of themselves. That alone is a very powerful thing. VT N Working in the biotechnology and pharmaceutical industry for more than 14 years, Michelle Huie has dedicated her adult life to introducing innovative technology and products to people who need them most. In 2013, Huie founded VIM & VIGR: a high-quality compression legwear line with stylish designs to be worn all day. Today, she leads the VIM & VIGR team as they set out to bring the benefits of their products to people everywhere. To contact VIM & VIGR, email info@vimvigr.com.
COMPRESSION LEGWEAR
Care in engaging patients is key to a good experience Patient engagement programs deliver a better experience and may drive revenues, but some professionals have found that changing how they interact with patients may have the biggest impact, according to an article in Healthcare Finance News. Maureen Harding, RN, is leading efforts at Barnabas Health System in New Jersey, and she told Healthcare Finance that one of the system’s major goals is to help patients better trust their providers. “One of things that we do to help with improving the patient experience is to really coach our employees to engage with the patient, and make sure they’re connecting with them on a personal level,” Harding said.
VARITHENA continued from page 1
Varithena should not be prescribed to patients who are allergic to polidocanol or who have clots in blood vessels or lungs. Physicians need to know if a patient has arterial disease; reduced mobility; has had major surgery in the past three months; has recently had a long hospital stay; or is pregnant or has recently been pregnant. The most common side effects seen with V of Varithena (polidocanol injectable foam) 1% are leg pain or discomfort, injection site bruising or pain, and potentially serious blood clots in the leg veins. VT N
Greeting patients with a smile and trying not to overwhelm them with too much information are potential techniques to consider. Harding said that what is a seemingly small measure has made a significant difference in how patients perceive their experiences with the health system. She said they began with having nurses practice the approach before extending it to everyone employed by the system, even those in the corporate suite. Barnabas employees are trained in mock scenarios, Harding said nurses are recorded as if they are treating a patient and the footage is then reviewed by other staff members. VT N
READ MORE: www.varithena. com or www.btgplc.com
XAMPLIFIER
THE VIM & VIGR DIFFERENCE We have 4 Fabulous Fabric Collections. Something for every season!
continued from page 17
“By helping to ensure high standards of customer experience at the practice, we are able to use our tools and insights to record real customer sentiment from truly happy customers and distribute that sentiment online. “It is why we only like to work with reputable, quality practices,” Kropp said. VT N
VEIN THERAPY NEWS AUGUST/SEPTEMBER 2016
Listed with the Food and Drug Administration (FDA) COTTON
WOOL
NYLON
MOISTURE-WICK NYLON
Partnership with Vascular Surgeons & Vein Clinics
Please contact us at info@vimvigr.com to learn more about our wholesale and referral programs.
mailto:info@vimvigr.com
Visit our booth at ACP!
#vimvigr
25
THEPRACTICE
AMA fails to end ‘recertification treadmill’ At the annual meeting of the American Medical Association (AMA) June 21, leaders tried to gut or suppress a resolution calling for an end to costly, onerous recertification examinations, but delegates forced consideration on the floor of the House of Delegates, where the resolution passed, reports the Association of American Physicians and Surgeons (AAPS). In mid-June, the AMA released a position statement against the American Board of Medical Specialties (ABMS). In their position statement, they called for an immediate end to Maintenance of Certification (MOC) and state that there is no proven benefit over traditional continuing medical education (CME). “The public needs to understand what this is about,” said AAPS executive director Jane Orient, MD. “What if you got a time-limited college degree, and 10 years later had to do more homework and pass an expensive and difficult final exam? If you missed a few too many questions, your degree would expire. Then you might suddenly lose your job, and a lot of potential employers would refuse to pay for your work.” Older doctors who successfully went through advanced specialty training got board certified for life, she explained. But doctors who finished training in the late 1980s or later only got time-limited certification. They are on a Maintenance of Certification treadmill for the rest of their lives. This is claimed to be “voluntary,” but those who decline to participate,
or who fail a high-stakes exam may lose hospital privileges or insurance panel membership. Their hospitalized patients lose their trusted doctor, and patients can’t get insurance coverage for that doctor’s care. “There is no evidence that re-certified doctors are any better than ‘grandfathered’ doctors, or those who didn’t make it over their specialty board’s hurdles,” Dr. Orient said. “But the process generates huge revenues for the testing industry, and assures that doctors are forced to study the treatments that elite ‘guidelines’ committees want them to use.” The AMA’s Reference Committee attempted to weaken the proposed Resolution, but the one that ultimately passed after strong advocacy by many delegates, especially the Florida and Pennsylvania state medical associations, reads: “RESOLVED, That our American Medical Association call for the immediate end of any mandatory, secured recertifying examination by the American Board of Medical Specialties (ABMS) or other certifying organizations as part of the recertification process for all those specialties that still require a secure, high-stakes recertification examination.” The ABMS immediately fired back, claiming that continuing medical education is not enough. The AMA’s official rejection of the proprietary recertification process “erodes the public’s trust,” said an ABMS memorandum urging reconsideration of the new AMA policy.
Surgery that’s just a click away Zwivel is an online platform that offers an easier and more efficient way to connect doctors with new patients seeking plastic surgery. It allows patients to check out doctors’ credentials, send photos or videos of themselves to preferred doctors, and get those doctors to answer questions about cosmetic procedures and prices. The entire process is completely private and secure, HIPAAcompliant, and one-to-one between each patient and each doctor. Plastic Surgeon Gary Breslow, MD, and his longtime friend, Craig Abramowitz, interviewed for an article in the New York Times said they created Zwivel with the idea that if patients had a faster and easier way to see doctors’ credentials and get doctors to answer questions about surgical procedures and prices in advance, they would be better informed and more likely to sign up when they went for the in-office consultation.
HOW ZWIVEL WORKS Zwivel goes further than “find a doctor” search platforms or telemedicine sites like HealthTap, in which doctors give patients medical advice through online chats. Just as Match. com allows strangers to scroll through and evaluate potential dates, Zwivel allows patients and doctors to size up each other and ask questions before committing to surgery. Dr. Breslow stresses, however, that Zwivel is only a preconsultation tool and does not replace the full, in-office consultation. “Of course you need to see the patient,” he said. “Zwivel is like Match.com. You still have to go on the date; you just want to know if the date is worth going out on.” There are now about 1,400 doctors and more than 28,000 patients registered on Zwivel, up from 800 doctors and 6,100 patients at the end of its first year in 2015, said Scott Kera, chief operating officer at Zwivel. As more new patients discover the site, the company sees significant growth potential.
26
Neil Zemmel, MD and a plastic surgeon in Richmond, Va., says that Zwivel has been an invaluable tool. According to Dr. Zemmel, more than 80 percent of his patients who come through Zwivel for a formal consultation wind up getting a cosmetic procedure, compared with 40 to 50 percent for other patients.
USERS PRAISE ZWIVEL Susan Delaney, 49, of Haskell, N.J., had been looking for a doctor periodically for about two years for a tummy-tuck procedure before she came across Zwivel in 2016 through a link on a doctor’s website. Getting pricing ahead of the formal consultation was particularly helpful. “The first thing you need to know is if you can afford it so that you’re not wasting your time and the doctor’s time,” she said. Amber Ingerman, 29, who lives in Fort Worth, Texas, found her plastic surgeon through Zwivel. “I was feeling frustrated,” Ms. Ingerman said. “I had wanted the surgery for about 10 years, but I didn’t want just anyone touching me.” Then, in early 2016, she connected with Rod Rohrich, MD and a prominent plastic surgeon in Dallas who was on Zwivel. She immediately booked a formal consultation with him, and had the surgery a month later. She was so impressed with her experience with Zwivel that she is already considering another procedure with Dr. Rohrich, this time, rhinoplasty. She has even introduced her mother, Angel, to the site. “As people find out they can do these consults online to find out prices and doctors’ experience,” she said. “I think Zwivel will completely take over cosmetic surgery and how you shop for it.” VT N READ MORE: Zwivel.com
“It erodes the bottom line of the self-appointed elites,” Dr. Orient said, “but for doctors who prefer to dedicate their time and energy to their patients, it is incredibly good news.”
WHY CME & NOT MOC? Linda Girgis, MD, explained why the CME is more desirable than the MOC. “There are many CME activities available that are evidencebased. MOC is not and the leaders of the medical boards reject any questioning on showing statistics that show they have any use. They cannot provide any that show MOC activities improve patient care or doctors knowledge. They do not even attempt to answer but block these questions from view,” she said. “Doctors have areas that they specialize in, even within their own specialties. A doctor can choose CME activities that are relevant to the medical areas that they deal with every day. This will improve their skills and knowledge base and directly be beneficial to patient care. MOC does not give you so many options and often force outdated and irrelevant information on doctors. This is a waste of time and doctors need to take time away from patients to study this useless data. “CME is needed for life-long learning. Medicine changes rapidly and doctors need to stay abreast of the changing medical landscape. CME is kept current; MOC is not,” Dr. Girgis said. “There are multitudes of sources available for free or inexpensive CME. MOC is costly and over-priced.” VT N
AMA to Congress: Lift ban on CDC gun study Moved to action by the mass shooting in Orlando, Fla., that claimed 49 lives, the AMA House of Delegates voted overwhelmingly to urge Congress to lift its ban on gun violence research by the Centers for Disease Control and Prevention (CDC). A Republican-controlled Congress voted in 1996 to forbid CDC studies that would advocate or promote gun control. A proposal to overturn the ban died in a House subcommittee in July 2015. A resolution to declare gun violence a public health crisis and lobby for lifting the research ban was introduced at the annual AMA meeting shortly after the Orlando massacre in the early morning hours of June 12. The AMA has characterized gun violence as a public health threat before, but the stance on CDC research is new. The AMA joins other medical societies such as the American Academy of Family Physicians, the American College of Physicians, and the American Academy of Pediatrics in opposing the Congressional ban. “We...have a disease on our shore,” American Academy of Family Physicians President Wanda Filer, MD, told fellow delegates. “It’s called gun violence. We need to know more about it.” The resolution encountered only a smattering of opposition. Kilby Osborn, a medical student alternate delegate and an ex-Marine from Indiana, said that what happened in Orlando was less about gun violence and more about “a terrorist attack by an individual who hates our way of life.” Osborn said the sponsors of the AMA measure “are taking what happened and using it for political advantage.” VT N
AUGUST/SEPTEMBER 2016 VEIN THERAPY NEWS
THEPRACTICE HIPAA audits are on the way HIPAA audits are coming, and there are steps providers can take to make sure they are ready to go in the event they are “the lucky winners,” Rebecca Williams, RN, partner and chair for the Health IT & HIPAA Practice group at Davis Wright Tremain LLP, said during the 24th National HIPAA Summit. The Department of Health and Human Services Office for Civil Rights is looking for a diverse pool of covered entities and business associates for the audits, meaning any organization can be impacted, Williams said. OCR Director Jocelyn Samuels said Monday that the effort will comprise more than 200 desk and onsite audits.
Currently, OCR is sending out emails to providers to verify contact information; organizations should make sure they have received the email – including checking spam folders – and that the right people will be in contact with OCR throughout the process, Williams said.
Steps organizations should take to prepare for and address a possible audit, according to Williams, include: • Respond to the request: “If you ignore this letter, OCR can still find you, they know where you live,” she quipped. • Have an audit response team ready to go now. • Read the request carefully: Check if it’s a privacy or security request, calendar the timing and know whether it’s an onsite or desk audit. • Get all data for the audit response in on time: OCR may not assess data that comes in late, Williams said. • Make sure data is current and on target: Don’t submit extraneous information.
• Recognize that the audits will be conducted digitally through a secure portal, and make sure your organization’s information can all be submitted electronically. • Know your business associates: “You will be asked to identify your business associates. “I know OCR says, and I recommend, have lists and contact information for BAs. Do that now,” Williams said. • Update your risk analysis: “If you have not done one since 2003, it’s time for a new risk analysis. If your risk analysis does not have ransomware addressed, it should,” she said. This is like an “open book test” according to OCR, Williams said. “All the questions are there [protocols] all the answers are there [regulations]. Prepare for this now.” VT N
www.precisionpractice.com apulliam@precisionpractice.com VEIN THERAPY NEWS AUGUST/SEPTEMBER 2016
27
SECONDLOOK
Guidelines for providing out-of-network services By Deborah Manjoney, MD I recently have found myself in a position of preparing to do independent contract negotiations with insurers. For the last several years, I had relied on a contracting committee of our Accountable Care Organization (ACO) to perform this duty. The ACO has mandated that all members must use the same Electronic Health Record system to meet their integration of care model, and I would no longer be given an exception waiver for being a solo practice. I had to transition to EPIC, or be out of the ACO as of Dec. 31, 2016. EPIC is an expensive, redundant and timeconsuming system that cannot fully accommodate my officebased surgery and aesthetic practice, and I do not wish to share my business information with the ACO, so I am opting out. There are many insurance providers offering services in my state, Wisconsin, so I have decided to attempt to contract with only the largest volume agencies, and be Out-of-Network (OON) for the rest. Wisconsinites are not accustomed to paying for medical benefits, so I was not brave enough to forgo all contracts. Negotiating contracts and preparing to be OON both involve considerable administrative time and effort. Negotiating is complex, and is the most challenging task for a solo practice in the era of employed physicians. Many insurance companies will not even talk with small independent practices; if they are willing to offer a contract, they will say take it or leave it. So regarding many insurance companies, it may not be your choice to be OON. How can you survive this environment? I will attempt to offer some of what we have learned concerning being an OON provider in modern times. Since the advent of the Affordable Care Act, many insurance plans offered through employer group plans, or to individuals, have excessively high deductibles and co-insurance for OON provider services. Many of the features are veiled within the plans, as secondary networks for a plan appear to offer in-network benefits, but in reality do not. Additionally, some of the OON plans cover only catastrophic events, not elective procedures. Many patients are often shocked by these realities, and are understandably reluctant to proceed with OON services. For the OON plans that truly do offer coverage, deductibles may be $5,000-$10,000, with some even as high as $25,000. This is accompanied by co-insurance, that portion of the fee that the patient pays out-of-pocket, of 40-50 percent, vs 20 percent for an In-Network (IN) provider. In other words, the difference between going to an IN or an OON provider is the amount of cost the patient must share. The final patient fee is also dependent on the eligible expense defined by the carrier. The plan will not automatically base the payment on 50 percent of the bill charged, but may base it on 110 percent of Medicare rate, billed charges, or fee schedule developed by the carrier. For the provider, participation in network contracts results in increased volume and more prompt payments but at a highly discounted rate. A non-participating provider can see fewer of the insurer’s patients with increased inspection of claims
28
and delayed payments. With proper advance preparations and a reputation that may attract patients to choose the provider, however, the OON physician can secure favorable remuneration for services rendered. In some states, it is mandated that the OON provider discloses his non-participation up front to the patient in specific and explicit terms prior to the service. You must become familiar with state requirements. Disclosure should include: • We are out of network. • If you choose to come here your cost share is higher • Your deductible is higher • Your percentage of the cost of the visit is… • Your expected costs are… If you still wish to provide OON care, it is essential to obtain certain documentation prior to treatment. A patient should sign a form assigning benefits to allow you to file claims and appeal denials. Under federal ERISA law, only beneficiaries have rights unless there is an Assignment of Benefits document. Many insurance companies also require their own HIPAA authorization to be signed by the patient to allow you to submit claims. Obtaining this authorization prior to service is often critical and should be done upfront. Specific plan documents are needed to see what the real plan allowable is. This should be obtained from the patient’s employer, and the patient must sign an authorization to allow you to access the plan. You must search the wording to determine rates for OON allowable amounts, and refer to the glossary for clarification of terms. Many health plans have altered their payment rates to reflect 110 percent of Centers for Medicare and Medicaid Services (CMS) for the same service rather than the Usual and Customary formula. But you should not accept that Medicare rate without checking the actual verbiage of the plan. Medicare rates are NOT the Usual and Customary Rate Once a service is performed, differences exist regarding method of payment. OON claims are frequently paid to the patient, not the provider. The provider must then try to recoup the payment from the patient. Providing OON subscribers with an instruction sheet of what to do when they receive the insurance check may alleviate many delays of payment. Our instructions will tell specifics about endorsing the check over to the practice and sending it in the attached envelope within 10 days of receipt of check or be liable for the entire bill. The practice must follow-up on claims, the earlier the better. Most states and plans have rules regarding timeliness of payment, often 30 days from receipt of claim. Appeals need to be sent at 35 days to combat low payment or non-payment of benefits. The plan’s benefits determination reasoning must be provided within 60 days of appeal. Appeals must include medical records documenting the medical necessity of the procedure, and should request plan documents citing the explanation of denial. Having had access ahead of time to the employer plan makes a first appeal much more likely to be favorably resolved. Balance billing the patient is required, even for OON providers. You may not have a contract with the insurance
company, but the patient does, and it is his responsibility to pay the co-insurance. You cannot waive the balance or it is considered insurance fraud. Before sending out the statement to the patient, however, a letter explaining balance billing is very helpful. You must bill, even if you do not collect. You may then choose to write off a portion of the bill, with application perhaps of a “Financial Hardship Policy” for consistency.
IN SUMMARY To summarize, navigating through the process of providing service and getting paid as an OON practitioner begins with preparation of material and documentation of receipt of information from the patient. • Provide disclosure of OON status and obtain signature from the patient acknowledging that information (Check to see what your state requires!)1 • Obtain an Assignment of Benefits document • Obtain a release from patient to get plan documents • Collect payment based on a written estimate of cost prior to the procedure. Be clear that the written estimate will be adjusted after the appeals process, if necessary. • Provide a Balance Billing Policy in writing • Consider a Financial Hardship Policy which is reasonable, and can be applied to relieve some of the excessive patient burden for cost sharing. VT N Deborah Manjoney, MD, FACS, RPVI, opened the Wisconsin Vein Center and MediSpa in 2002, and in 2004 she left her 18-year practice in cardiovascular and thoracic surgery to devote herself to fulltime practice of phlebology. She was one of the first in the area to add the “medispa” concept to her practice.
CLARIFICATION 1
Illinois, for example, has more stringent specific wording which must be supplied to the patient: “WARNING, LIMITED BENEFITS WILL BE PAID WHEN NONPARTICIPATING PROVIDERS ARE USED. You should be aware that when you elect to utilize the services of a nonparticipating provider for a covered service in non-emergency situations, benefit payments to such non-participating provider are not based upon the amount billed. The basis of your benefit payment will be determined according to your policy’s fee schedule, usual and customary charge (which is determined by comparing charges for similar services adjusted to the geographical area where the services are performed), or other method as defined by the policy. YOU CAN EXPECT TO PAY MORE THAN THE COINSURANCE AMOUNT DEFINED IN THE POLICY AFTER THE PLAN HAS PAID ITS REQUIRED PORTION. Non-participating providers may bill members for any amount up to the billed charge after the plan has paid its portion of the bill. Participating providers have agreed to accept discounted payments for services with no additional billing to the member other than co-insurance and deductible amounts.”
AUGUST/SEPTEMBER 2016 VEIN THERAPY NEWS
SECONDLOOK http://totalvein.com
EVERYDAY LOW PRICES from
®
MicroMAX™ PACK
Virtual reality is newest tool to alleviate pain Virtual reality (VR) could soon be the future of pain control as the technology becomes cheaper and more easily accessible. At Cedars-Sinai Medical Center and Children’s Hospital Los Angeles, VR tools are playing a role in studies using games to help patients to alleviate pain. The two health systems are using AppliedVR, a startup that has a library of virtual-reality content for pain management, according to an article from Technology Review. So far, the company has created three different virtual-reality pain applications, as well as one for reducing anxiety, according to Matthew Stoud, AppliedVR CEO. He says it’s using some third-party content, too. Headsets running AppliedVR’s platform are being used in hospitals, doctors’ offices and clinics for things like drawing blood and administering epidurals, as well as for pain management after operations. One game used by Cedars-Sinai, Bear Blast, requires that players throw balls at cartoon bears. That program is being used in a study by the health center with on 60 patients participating who have myriad medical conditions, including abdominal pain and chest pains. Cedars has seen positive results from the study so far, according to Brennan Spiegel, Spiegel directs health services research at the facility, said that about 20 minutes of playing brought pain levels down by 24 percent. “That’s a pretty dramatic reduction for an acute pain,” he added. “It’s not too different from what we see from giving narcotics.” In addition to the steps Cedars is taking with VR, Tufts Medical Center has been using the tools for more than a year to help ease patient anxiety. VR helps its patients who are scheduled for surgery feel more comfortable with the facility before they go in for the procedure. This year, the first cancer surgery was streamed live using virtual reality. VT N READ MORE: technologyreview. com/s/601911/better-than-opioidsvirtual-reality-could-be-your-nextpainkiller/
Great for phlebectomy, bec o y, Laser ase & RF procedures ocedures
ONLY
2995 ea
$
':24'55 ™ TUMESCENT SYRINGE DELIVERY KIT
ONLY
ULTRASOUND PROBE PROB COVERS 48” length 48
5 95 ea
$
ONLY ON N
3 95 ea
$
TVS ':24'55 ™ PUMP TUBING Universal Fit
ONLY
$
595 ea
HYDROPHILIC COATED NITINOL GLIDEWIRES ONLY
$
29
COMPARE AT
$
95
60 00
REPEL H2O™ LIMB PROTECTOR Post-Surgical Showering Made Simple!
ONLY
3 95 ea
$
Over 300 products to choose from!
888-868-8346
Best case pricing applies. See 2016 Product Catalog for details.
VEIN THERAPY NEWS AUGUST/SEPTEMBER 2016
29
SECONDLOOK Varithena is uniquely suited to treat varicose veins not amenable to catheter-based ablation. The minimally invasive procedure is also more patient-friendly than endovenous thermal technologies.
VARICOSE VEIN TREATMENT OPTION Varithena polidocanol endovenous microfoam ablation By Michael Shao, MD Patients suffering from symptomatic varicose veins caused by great saphenous vein (GSV) or small saphenous vein (SSV) incompetence frequently undergo multiple procedures with a combination of treatment modalities: endovenous thermal ablation, phlebectomy and sclerotherapy. Each of these established therapies has strengths and drawbacks. Thermal ablation techniques yield high medium-term closure rates. Laser ablation has a closure rate of 94 percent after 3 years,1 and radiofrequency (RF) ablation has a vein occlusion rate of 92.6 percent after 3 years.2 However, thermal ablation modalities require tumescent anesthesia to prevent thermal damage to adjacent structures. Even with tumescent anesthesia, thermal ablation of the GSV below mid-calf carries a risk of saphenous nerve paresthesia, and thermal ablation of the SSV vein below mid-calf risks sural nerve paresthesia. In addition, tortuous venous anatomy in refluxing accessory veins or tributaries is often not amenable to catheter-based ablation due to the inability to advance the catheter within tortuous segments. Surgical phlebectomy has been traditionally used to treat tortuous superficial venous segments inaccessible to catheter ablation. However, phlebectomy involves multiple small incisions, can be time-consuming, and often results in significant post-procedure bruising and pain. Physiciancompounded foam sclerotherapy is convenient and inexpensive, but carries a risk of neurologic events and has an inferior vein closure rate of only 77 percent after 3 years,3 and, therefore, generally felt to be less effective in closing large diameter veins long-term. Over the past year, I have incorporated polidocanol endovenous microfoam (Varithena; BTG International Group), a novel chemical ablation agent, to the armamentarium to treat symptomatic chronic venous insufficiency caused by reflux of the GSV, SSV, accessory saphenous veins, and large refluxing tributaries or varicose clusters. Varithena is indicated for the treatment of incompetent GSVs, accessory saphenous veins, and visible varicosities of the GSV system above and below the knee. I typically use Varithena to treat large (diameter of 3 mm or greater) tortuous accessory saphenous veins, saphenous tributaries, or tortuous networks of neovascularization in patients who have previously undergone endovenous thermal ablation or phlebectomy to treat truncal venous incompetence. Varithena improves the physical symptoms of superficial venous insufficiency as well as the appearance of visible varicosities.
LESS DISCOMFORT AND SUPERIOR VEIN OCCLUSION RATES For treating visible varicosities, Varithena may be a more elegant solution than conventional phlebectomy. Patients generally prefer the minimally invasive approach of Varithena,
30
which typically only requires injection at one to three sites via a 23-gauge butterfly needle or 21-gauge micropuncture needle, compared with the small but numerous incisions required for phlebectomy. The procedure time for Varithena is generally 5 to 10 minutes compared with 30 to 60 minutes for phlebectomy of a similar area. From a clinical standpoint, patients generally seem to experience less post-procedural pain and bruising with Varithena compared with thermal ablation and phlebectomy. Most patients are treated with 5 to 15 mL of foam. Once activated, a canister of Varithena will produce at minimum 45 mL of usable foam and may generate up to 90 mL of total foam to allow for some waste during syringe transfer. Of note, the FDA recently extended the post-activation shelf life of the canister from 7 days to 30 days, which should facilitate ease of scheduling patients. Varithena is also particularly well-suited to treat the patients with venous stasis ulcers that I see in our Wound Care Center. Often duplex ultrasound will identify refluxing tributaries directly feeding the ulcer bed that can be targeted directly by Varithena injection. The microbubbles in Varithena have uniform density, size, and stability (median bubble diameter of approximately 100 µm and no bubbles >500 µm). They have been shown to break down more slowly in vitro, compared with the larger bubbles generated by the Tessari method. This allows extended contact with the venous endothelium and, therefore, more effective closure of larger incompetent veins or extensive venous networks, compared with physician-compounded foam sclerotherapy. In addition, Varithena contains only trace amounts of nitrogen (<0.8 percent), greatly reducing the risk of gas embolic adverse events, such as stroke, seizures and transient ischemic attack, which have been reported with physician-compounded foam produced with room air.4, 5, 6, 7, 8, 9 For treating isolated refluxing tributaries smaller than 3-mm in diameter, however, there is still a role for conventional foam sclerotherapy; physician-compounded foam is less expensive and easily closes smaller-diameter vessels. The immediate duplex response rate of PEM in the VANISH-2 trial was 86.2 percent,10 suggesting that, compared with conventional physician-compounded foam sclerotherapy, PEM will likely yield superior closure rates in larger (>3 mm) veins. Medium- and long-term data, however, are not yet available. Although there are no randomized head-to-head trials comparing PEM to thermal ablation modalities with regard to medium-term closure rates, the immediate duplex response rate of PEM are comparable to those of laser and RF ablation. It is important to note that the precise definition of “vein closure rate” or “vein occlusion rate” often varies from one study to another in the literature. In a recent review of 17 clinical studies with five-year follow-up data for duplex response and Qualify of Life measures, Huang and Gloviczki
reported the GSV occlusion rate on duplex ultrasound ranged from 62 percent to 92 percent for endovenous thermal ablation, from 41 percent to 58 percent for ultrasound-guided non-proprietary foam sclerotherapy, and from 54 percent to 85 percent for surgery.11 Comparing “closure rates” across studies can be misleading because some of these studies defined successful “closure” of the target vein to be sonographic evidence of segmental occlusion at a single site, even if other segments were still patent. When comparing “closure rate” amongst the different modalities, it is important to compare apples to apples. Perhaps the most stringent definition of radiographic success would be “duplex response rate” cited in Vasquez, Gasparis et al. 2016, defined as “complete elimination of reflux through the SFJ and/or complete occlusion of the target vein(s).” This study demonstrated a successful duplex response was achieved in 79 percent of patients receiving thermal ablation only and in 87 percent of patients who received Varithena and thermal ablation.
SAFETY AND EFFICACY IN TRIALS In two randomized, placebo-controlled trials, Varithena demonstrated clinically meaningful benefit in treating the symptoms and appearance of varicose veins. In the VANISH-2 trial (Polidocanol Endovenous Microfoam Versus Vehicle for the Treatment of Saphenofemoral Junction Incompetence), 232 patients with a broad spectrum of vein disease and with GSV diameters ranging from 3.1 to 19.4 mm were randomly assigned PEM in concentrations of 0.5 percent or 1.0 percent, or placebo.12 At 8 weeks, patients treated with PEM had a greater improvement in symptoms as measured by the Varicose Vein Symptoms Questionnaire (VVSymQ) score compared with placebo; −6.01 (0.5 percent concentration) and –5.06 (1.0 percent concentration) versus –2.00 for placebo. Sixty percent of those who received PEM had an adverse event (AE), mostly mild or moderate, compared with 39 percent of the placebo group. The most common AEs in the PEM group were retained coagulum, leg pain, and superficial thrombophlebitis, most of which resolved without sequelae. No pulmonary emboli were detected and no clinically important neurologic or visual AEs were reported. A follow-up study found that VANISH-2 trial participants treated with Varithena had consistent and durable improvement in symptoms after treatment.13 After one year, 85 percent of treated patients had a total VVSymQ score of 3 or less compared with 64 percent at week 8. At 12 months, there were no new venous thrombus adverse events (VTAEs), and in patients who previously had a VTAE, none had a recurrence of thrombus or evidence of post-thrombotic syndrome. No study participant had a serious AE related to PEM. A second phase III randomized, placebo-controlled trial found that a single administration of 15 mL of Varithena is safe
AUGUST/SEPTEMBER 2016 VEIN THERAPY NEWS
SECONDLOOK and effective in patients with moderate to very severe symptoms of superficial venous incompetence and visible varicosities of the GSV system.14 A total of 279 patients were randomly assigned to five groups: PEM 0.125 percent (sub-therapeutic control), PEM 0.5 percent, PEM 1 percent, PEM 2 percent, or placebo. At week 8, VVSymQ scores for all therapeutic dose concentrations of PEM were significantly superior to placebo. Only 6 percent of the placebo group reported meaningful improvement in symptoms compared with 81 percent of patients treated with 0.5 percent and 2 percent PEM and 63 percent of patients treated with 1 percent PEM. The mean change in VVSymQ score from baseline to week 8 was 2.13 for the placebo group and 5.44 for the PEM group. Slightly more than half of all study participants had at least one AE; half of the AEs were related to treatment. In the 174 PEM-treated patients with AEs, 42 percent were mild, 18 percent were moderate, and 4 percent were severe. More than 90 percent of the AEs resolved without sequelae. The most common AEs in PEM-treated patients were superficial thrombophlebitis, pain in the extremity and injection site hematoma. No PEs or serious AEs were reported. Venous thrombus AEs in a non-target vein occurred in 27 patients treated with PEM. Fifteen were classified as a common femoral vein thrombus extension (analogous to endovenous heat-induced thrombosis (eHIT) from endovenous thermal ablation); 5 as proximal (popliteal vein or above) deep vein thrombosis (DVT); 4 as distal DVT; and 3 as isolated gastrocnemius and soleal vein thrombosis. No patients experienced a thrombus in more than one location. Most (88 percent) thrombi were asymptomatic, and all resolved within 100 days. In pooled data of 1,333 patients in 12 clinical trials treated with PEM, venous thrombus adverse events occurred at the following rates: common femoral vein thrombus extension (2.9 percent); proximal DVT (1.7 percent); distal DVT (1.1 percent); and isolated gastrocnemius and soleal vein thrombosis (1.4 percent). Although Varithena can be used to treat straight GSVs, I still prefer catheter-based ablation to treat truncal incompetence. However, if the patient’s reflux is mainly distal and below the knee, even if the refluxing segment can be accessed by catheter, Varithena may be the better option to avoid the risk of saphenous nerve or sural nerve paresthesia, which are known complications of thermal ablation below mid-calf.
Before 1
After 1
Before 2
After 2
In February 2016, the patient had Varithena injection to treat the superficial varicose veins of the right medial thigh and anterior lower leg. We used venous duplex to map the refluxing tributaries at the time of the procedure. Under ultrasound guidance, we injected PEM using a 23-gauge butterfly needle at 3 sites: distal anterior ankle, distal medial calf, and proximal medial calf. Ultrasound was used to visualize the foam traveling proximally and filling venous tributaries up to the mid-medial thigh. The following week, we injected 5 mL of Varithena in the patient’s GSV varicosities in the left medial calf. Following each procedure, the patient underwent routine venous duplex at 48 hours to confirm successful closure of the treated veins and absence of DVT. At her office follow-up visit 5 weeks later, she reported “100 percent improvement” in her previous leg symptoms and was quite pleased with the results. The patient did develop firm palpable cords in the right medial thigh, right pretibial area and left anterior ankle area, consistent with superficial
thrombophlebitis. She reported that the phlebitis symptoms were mild and were progressively resolving. In our own experience with approximately 50 Varithena procedures, superficial thrombophlebitis seems to occur slightly more frequently than with RF ablation, but it is self-limiting and generally just a minor nuisance. If phlebitis occurs, we advise our patients to treat their symptoms with a nonsteroidal anti-inflammatory drug, such as ibuprofen or meloxicam. In summary, catheter-based modalities used to treat superficial chronic venous insufficiency have excellent medium-term closure rates and continue to be the mainstream techniques appropriate for many patients. Nevertheless, there is a definite role for Varithena in treating tortuous accessory veins, tortuous saphenous tributaries, or neovascularization not amenable to catheter-based ablation. Varithena also offers a distinct advantage in treating distal reflux below mid-calf to obviate the risks of thermal injury resulting in nerve paresthesia. As greater numbers of patients are treated with Varithena and as medium-term outcomes data mature, I believe that the use of this modality and
Case Study left leg after treatment
Case Study right leg right after treatment
CASE STUDY A 74-year-old female patient had been bothered by varicose veins since her first pregnancy in 1963. A few years later, she had surgical vein stripping in the right leg. At her initial office visit with me in October 2015, she complained of bilateral lower leg pain, aching, fatigue, and leg heaviness. These symptoms were exacerbated by prolonged standing and improved with leg elevation. The patient had large tortuous, visible, bulging varicose veins in both legs. Venous duplex in the office did not visualize the right GSV and SSV, consistent with her prior history of vein stripping in these areas. Duplex did demonstrate significant diffuse reflux in the very tortuous visible superficial varicose veins in the right leg, extending from the mid-medial thigh down to the medial calf and anterior lower leg. On the left leg, there was truncal reflux in the GSV from proximal calf to mid-calf, but the vein was very tortuous, precluding catheter ablation. There was no reflux in the left SSV. The patient’s reflux time ranged from 2912 milliseconds to 4101 milliseconds. The refluxing vein diameters ranged from 2.4 mm to 4.5 mm. A trial of conservative therapy with 20-30 mmHg thigh-high compression stockings resulted in minor partial improvement.
VEIN THERAPY NEWS AUGUST/SEPTEMBER 2016
31
SECONDLOOK other non-thermal technologies will grow rapidly and serve as an important adjunct to catheter-based modalities in our arsenal to treat venous disease. VT N Dr. Shao is a board-certified vascular surgeon at Swedish Covenant Hospital. He completed a general surgery residency and vascular surgery fellowship at University of Chicago. Dr. Shao maintains a full-time practice treating both arterial and venous disease using open, endovascular, and hybrid approaches. The endovenous treatments he offers includes RF ablation, laser ablation, sclerotherapy, Varithena chemical ablation, ClariVein mechanical chemical ablation, and VenaSeal.
RESOURCES 1
Van den Bos et al. J Vasc Surg. 2009;49(1):230. 2Proebstle et al. J Vasc Surg. 2011;54(1):146-52. 3Van den Bos et al. J Vasc Surg. 2009;49(1):230. 4Forlee M et al. Journal of Vascular Surgery. 2006;43[1]:162–4. 5Hanisch F et al. Eur J Med Res. 2004;9[5]:282–4. 6Morrison N et al. Journal of Vascular Surgery. 2006;44[1]:224–5. 7Engelberger RP et al. Vasa. 2016;45[3]:255-8. 8Kim M et al. J Am Osteopath Assoc. 2016;116[5]:320-3. 9Malvehy MA and Asbjornsen C. Phlebology. 2016 Jan 28 [Epub ahead of print]. 10 Todd III KL and Wright DI. Phlebology. 2014; 29[9]:608-18. 11 Huang Y and Gloviczki P. Phlebology. 2016;31[1 Suppl]:88-98. 12 Todd KL, 3rd, and Wright DI. Phlebology. 2014; 29[9]:608-18. 13Todd KL, 3rd, and Wright DI. J of Vasc Surg. 2015;3[3]:258-64.e1. 14 King JT et al. Eur J. Vasc Endovasc Surg. 2015;50:7
Global ultrasound growing at 5.8% The global ultrasound devices market is set to expand at a compound annual growth rate of 5.8 percent from 2015 to 2023 to reach $11 billion, according to a new report from Transparency Market Research. Growth in the size of the global geriatric population will drive the market, with people older than 65 representing 20 percent of the population by 2030. VT N
32
AUGUST/SEPTEMBER 2016 VEIN THERAPY NEWS
SECONDLOOK MEDCAC continued from page 1
coverage for interventions related to lower extremity peripheral venous disease.
ACP PRESENTATION As part of a coalition of organizations dedicated to evidence-based care of venous disease, the American College of Phlebology (ACP) submitted a joint presentation at the MEDCAC meeting on treatment strategies for patients with lower extremity chronic venous disease. “This meeting could have a significant effect on our members, the specialty and patients who suffer from chronic venous disease,” coalition chair Neil Khilnani, MD, FACPh, said. “As an advocate for the specialty, the ACP and its coalition partners ensured the voice of
the venous community was heard by CMS,” Dr. Khilnani said. The MEDCAC reviews and evaluates medical literature, reviews technology assessments, public testimony and examines data and information on the benefits, harms, and appropriateness of medical items and services that are covered under Medicare or that may be eligible for coverage under Medicare. The MEDCAC judges the strength of the available evidence and makes recommendations to CMS based on that evidence. CMS selects up to 100 experts in clinical and administrative medicine, biologic and physical sciences, public health administration, patient advocacy, health care data and information management and analysis, health care economics, and medical ethics to serve on the MEDCAC. No more than 15 members with expert knowledge specific to lower extremity chronic
venous disease were allowed to serve on the panel for this MEDCAC meeting. CMS may recruit non-MEDCAC members who have relevant expertise to provide additional input to panel members and invite experts such as ACP to make formal presentations to the MEDCAC. The panel meets in a public forum approximately four to eight times over the life of the committee to review medical evidence for the topic under deliberation, listen to public testimony, and provide advice about the quality of the evidence. The ACP presented as part of a larger group of coalition member organizations, including the Society for Interventional Radiology (SIR), American College of Cardiology (ACC), American College of Radiology (ACR), American Heart Association (AHA), Society for Cardiovascular Angiography and Interventions (SCAI), Society for Vascular Medicine (SVM), Alliance of Wound Care
Stakeholders, and VIVA Physicians (Vascular Interventional Advances). While not a part of the coalition, the Society for Vascular Surgery (SVS) and the American Venous Forum (AVF) also participated at MEDCAC independently. The presentations addressed a defined set of published CMS questions focusing on “the scientific evidence underpinning the benefit and risk of existing lower extremity venous disease interventions that aim to improve health outcomes in the Medicare population.” MEDCAC’s request covered multiple topic areas: the burden of venous disease on the patient, evidence supporting intervention for venous reflux across the spectrum of venous disease, and evidence supporting intervention
MEDCAC continued on page 37
Your Best Protection Against Penalties All physicians who applied for incentive money using VeinDraw have received full payments.
VeinDraw Works For Phlebologists • • • • •
Organization Efficiency Ease of Use Excellent Customer Service and Support Complete EHR Certified for Stage 2 Meaningful Use in 2014
VeinDraw
™
EMR
software built exclusively for Phlebologists
To see how VeinDraw can work for you, schedule a live demo by calling www.veindraw.com 877.990.VEIN or visit oVr website athttp://www.veindraw.com www.VeinDraw.com This VeinDraw EMR is 2014 Edition compliant and has attained Complete Ambulatory EHR Certification from the ICSA Labs ONV Health IT Certification (ONC-HIT) Program. It has been certified by an ONC-ACB in accordance with the applicable certification criteria adopted by the Secretary of Health and Human Services. This certification does not represent an endorsement by the U.S. Department of Health and Human Services. Certificate number: 140319R00. Certified on November 3rd, 2014.
VEIN THERAPY NEWS AUGUST/SEPTEMBER 2016
33
SECONDLOOK
restiffic foot wrap Medical device outperforms drugs for calming restless legs By Larry Storer Restless leg syndrome (RLS), also known as Willis-Ekbom Disease, is a neurological disorder that causes unpleasant sensations and a need or urge to move the legs. The sensations are often described as burning, creeping, tugging or feeling like insects are crawling inside the legs. The symptoms commonly develop when a person is at rest and tries to relax or go to sleep. RLS stops people from sleeping, which can lead to depression and a poor quality of life.
CURRENT TREATMENTS
Patients may wear the foot wraps at any time when they are not putting any pressure on their feet; that is when they are sleeping, reclining or sitting
The restiffic foot wrap is composed of two primary parts: the Flexor-T pad (left) and the outer wrap. The Flexor-T pad exerts a relaxing pressure on targeted muscles in the foot while the outer wrap holds the pressure pad in place, and allows for the application of adjustable pressure specific to a patient’s needs.
Pharmaceuticals are a common treatment method for RLS. Dopamine agonists, dopaminergic agents, opiates, central nervous system depressants, and anticonvulsants are different families of frequently prescribed drugs to manage RLS symptoms. These pharmaceuticals are often accompanied by long lists of negative side effects, including nausea, vomiting, hallucinations, daytime sleepiness, addiction and more. The cost of these medications can vary significantly, as they may or may not be covered by insurance plans. They can easily cost more than $1,500 a year, and costs can increase year to year as many patients need to increase their dosage of medication. With pharmaceuticals, there is the risk of augmentation. Augmentation occurs when a dopaminergic agent or other pharmaceutical relieves symptoms at night, but eventually symptoms begin to develop earlier in the day and spread from the legs to the rest of the body, such as to the arms and trunk. Homeopathic or herbal remedies are another form of treatment for RLS. These remedies are available without prescription and can be purchased over the counter or on the Internet. These are generally not FDAapproved and their claims of success are difficult to verify. As with pharmaceuticals, homeopathic remedies may be accompanied by negative side effects. Costs easily exceed $500 a year. Lifestyle choices, such as limiting alcohol, nicotine, and caffeine may be recommended for treating RLS. Maintaining a healthy diet and ensuring that that your diet has adequate levels of iron may also be suggested. Presently,
there is no single lifestyle choice that has been shown to markedly reduce symptoms of RLS. But Medi USA is offering an FDA approved Class 1 (low risk) exempt medical device called the restiffic foot wrap that offers evidence of superior results of RLS for a one-time cost of $350. It is clinically proven to provide to reduce RLS symptoms.
WHAT IS RESTIFFIC? Restiffic is a foot wrap for the treatment of primary RLS. It is a non-invasive device that has been cleared by the FDA for prescription use. The restiffic foot wrap is composed of two primary parts: the Flexor-T pad and the outer wrap. The Flexor-T pad exerts a relaxing pressure on targeted muscles in the foot while the outer wrap holds the pressure pad in place, and allows for the application of adjustable pressure specific to a patient’s needs. By applying pressure to targeted muscles in the foot, restiffic relaxes the muscles to lessen the symptoms of RLS. It is a lightweight and compact size that won’t interfere with sleep and relaxation. The restiffic foot wrap promotes a gentle, relaxing pressure on specific targeted muscles in the foot – the abductor hallucis and the flexor hallucis brevis, which reduces the uncontrollable impulses to move the legs, and allows the patient to relax and enjoy uninterrupted sleep. Patients may wear the foot wraps at any time when they are not putting any pressure on their feet; that is when they are sleeping, reclining or sitting. The restiffic foot wraps do not interfere with any medication the patient may be taking. The foot wrap is not recommended for individuals who have neuropathy, poor circulation, peripheral vascular disease, varicose veins, deep vein thrombosis, a history of blood clots, or foot and/or leg swelling. An innovative drug-free treatment option with zero risk of addiction, restiffic is a breakthrough in the treatment of RLS. Because it is a drug-free treatment, it provides lower risk of negative side effects. Clinicians can order restiffic prescription pads for patients by email at scripts@mediusa.com. Patients may email completed prescriptions to rx@restiffic.com or fax to 800-660-2429. VT N
READ MORE ABOUT RESTIFFIC 6HH ZZZ UHVWLI²F FRP or call 855.700.6875. The restiffic foot wrap is so light that it doesn’t interfere with sleeping at night.
34
AUGUST/SEPTEMBER 2016 VEIN THERAPY NEWS
SECONDLOOK
restiffic clinical trial proves gentle pressure on abductor hallucis, flexor hallucis brevis superior treatment for RLS Patients who wore restiffic experienced a 69 percent reduction in the severity of their RLS symptoms, and restiffic was found to be 40 percent more effective than the leading pharmaceutical treatment for RLS. The successful results of the restiffic clinical trial were published in the Journal of the American Osteopathic Association in July 2016, in the article “Targeted Pressure on Abductor Hallucis and Flexor Hallucis Brevis Muscles to Manage Moderate to Severe Primary Restless Legs Syndrome” by Phyllis J. Kuhn, MS, PhD; Daniel J. Olson, DPM; John P. Sullivan, MD.
The complete trial results are available at: http://jaoa.org/ article.aspx?article id=2531565#128968474 INTRODUCTION Restless legs syndrome (RLS) is a neurological disorder that causes unpleasant sensations and a need or urge to move the legs. The sensations are often described as burning, creeping, tugging, or feeling like insects are crawling inside the legs. The symptoms commonly develop when a person is at rest and tries to relax or go to sleep. Until now, potent drugs including opioids, central nervous system depressants and dopamine agonist have been used to ease symptoms, but each of these is accompanied by several negative side effects. Examples include dizziness, nausea, vomiting and the risk of addiction. However, restiffic is a drug-free solution to RLS. It is a revolutionary foot wrap consisting of a compressive pad and a hook and loop
system, designed to exert a gentle, relaxing pressure on the abductor hallucis and flexor hallucis brevis muscles in the foot. This pressure reduces the symptoms of RLS.
METHOD A clinical trial was administered to test the efficacy and safety of restiffic. The Principal Investigator of the clinical trial was Daniel J. Olson, DPM; Sub-Investigators were John P. Sullivan, MD and Frederick J. Tomassi, DPM. It was a single arm, open label clinical trial with a repeated measures design. The study population consisted of 30 otherwise healthy adults, mean age 51.5 years (range 30 to 75 years), diagnosed with moderate to severe primary RLS. Efficacy was measured using the International RLS Study Group (IRLSS) Rating Scale, with scores ranging from 0 to 30 (30 being the most severe), and the physiciangenerated Clinical Global Impression (CGI) Scale, measuring severity, improvement and Efficacy Index (EI). Safety was assessed by recording adverse events, analyzing the severity, and the relationship to the restiffic device. During the study, patients recorded their RLS symptoms over eight weeks. After one week of observation without treatment, patients were given a restiffic device for Weeks 2 through 4. The device was removed for Week 5, and returned to the patients for Weeks 6 through 8.
RESULTS In Week 1, all patients exhibited severe symptoms of RLS, with an average patient IRLSS score of 25.05 (“severe”). When patients began wearing the device, many experienced relief after just 24 hours of
VEIN THERAPY NEWS AUGUST/SEPTEMBER 2016
therapy (Day 8), with the mean IRLSS score decreasing from 25.05 to 16.94 (“moderate”) in just one day. Patients’ RLS symptoms decreased significantly and continually over the course of the next three weeks, with an average IRLSS scores at the end of Week 4 of 10.88 (“mild”). When the device was removed for Week 5, patients once again experienced severe RLS symptoms, though not as high as initially seen in Week 1. In Weeks 6 through 8, patients again showed significant and continued decreases in their RLS symptoms while wearing the restiffic device. Over the course of the trial, patients exhibited an average 69 percent reduction in the severity of their symptoms, with the average patient IRLSS score at the end of the trial being 7.83, for an overall reduction of 17.22 points. This represents an improvement from “severe” to “mild” symptoms.
CONCLUSION Targeted pressure on the abductor hallucis and the flexor hallucis brevis muscles with the RLS device was almost twice as effective as historic placebo medication and 1.4 times as
effective as ropinirole in lowering IRLSSG scores, with none of the adverse effects associated with current medications for RLS. Based on the study results and the low-risk nature of the device, restiffic was cleared by the FDA for prescription use to support positive RLS diagnosis. VT N
KEY STATISTICS FROM TRIAL • 97 percent of patients experienced a decrease in the severity of their RLS symptoms. • Patients exhibited 69 percent reduction in the severity of symptoms after six weeks of using restiffic. • restiffic was shown to be 40 percent more effective than the leading drug treatment for RLS. • Physicians reported observing no side effects in 93 percent of patients. • Only nine Adverse Events definitely related to restiffic occurred in seven patients. These included pain, tingling and irritability. All nine Adverse Events were relieved by loosening the device’s straps.
FDA finally OKs absorbable stent The FDA has just approved Abbott’s Absorb bioresorbable stent, ABSORB, for the treatment of coronary artery disease. It is the first approved fully dissolving heart stent. While it is novel, the device isn’t exactly a new product, having been approved in the EU six years ago, is available in more than 100 countries, and has gone through years of study. In coronary artery disease, cholesterol deposits collect along the inner walls of the arteries, which lowers the blood supply to the heart. It is traditionally treated by the insertion of a permanent metallic stent to help prop the artery open, but metal stents come with a number of disadvantages. For example, their permanence means that artery motion is limited for the rest of a patient’s life, and that there is a risk of scar tissue forming within the stent itself, causing the artery to narrow again. Like metal stents, ABSORB treats coronary artery disease by supporting the inner wall of a narrowed artery. It elutes the drug everolimus, which reduces inflammation and the formation of scar tissue and also promotes healing. It is made from a polymer similar to materials used in other absorbable devices, such as sutures. “No metal means the treated artery can pulse and flex naturally as demands on the heart change with everyday activities. No metal may also reduce the potential of future blockages that occur with permanent metallic stents, and allows easier access to other treatment
ABSORB fully resorbable stent in its deployed state
options should they prove necessary in the patient’s future,” said Gregg Stone, MD and director of cardiovascular research and education at Columbia University Medical Centers’ Center for Interventional Vascular Therapy. He is also chairman of the ABSORB clinical trial program. According to Abbott, the stent reabsorbs completely within three years of implantation, once it’s done helping the artery heal. The stent breaks down over time into water and carbon dioxide, leaving behind only four “very small” platinum markers embedded in the artery walls to indicate where the implant was placed. The ABSORB stent is an alternative treatment for patients who are eligible for angioplasty--treatment with a permanent metal stent but who would prefer an absorbable device. VT N READ MORE: abbott.com/ newsroom/news/absorb-stenthits-the-united-states.html
35
CALL FOR ABSTRACTS AVF American Venous Forum
29th Annual Meeting February 14-17, 2017 Hilton New Orleans Riverside New Orleans, Louisiana
Abstract Submission Deadline September 21, 2016 Visit veinforum.org for more info! www.veinforum.org
SECONDLOOK MEDCAC continued from page 33
Add more...
in patients with previous DVT and remaining obstruction. In addition, venous treatment disparities and Medicare beneficiaries, evidence gaps in venous disease, and improving the evidence base and delivering improved care.
accuracy efficiency mobility comfort
SOCIETY FOR VASCULAR SURGERY & AMERICAN VENOUS FORUM The Society for Vascular Surgery and the American Venous Forum also made presentations. According to Lowell Kabnick, MD and president of the AVF and a member of the SVS, the presentations will address a defined set of published CMS questions focusing on “the scientific evidence underpinning the benefit and risk of existing lower extremity venous disease interventions that aim to improve health outcomes in the Medicare population.� Peter Gloviczki, MD and a past president of both SVS and AVF, said it is important that Medicare reimburses for medically indicated interventions that are effective in decreasing disability from chronic venous disease. “But it is equally important that physicians perform these interventions for the appropriate indications,� Dr. Gloviczki said. “The MEDCAC meeting was aimed to accomplish both.� New SVS President Ron Fairman, MD, said that as on previous occasions, the SVS and the AVF welcomed this opportunity to collaborate and provide information for MEDCAC review. “We were privileged to be part of the dialogue and to be recognized for the expertise that the AVF and the SVS provide,� Dr. Fairman said. “We also welcomed the opportunity to collaborate with coalitions presenting at MEDCAC and support our common vision for delivering the highest quality evidence-based care to patients.�
...to your venous reflux studies The VenaPulseŽ Hands-Free Augmentation Device ‡ 'RFXPHQW IURP SHUIRUDWRUV WR VDSKHQR IHPRUDO MXQFWLRQ ZLWK standardized augmentations* ‡ Save time RQ HDFK YHQRXV UHÀX[ H[DPLQDWLRQ ‡ (DVLO\ carry the device IURP URRP WR URRP ‡ Avoid injury ZLWK HUJRQRPLF GHVLJQ ³3URVSHFWLYH FRPSDULVRQ RI WKH SQHXPDWLF FX௺ DQG PDQXDO FRPSUHVVLRQ PHWKRGV LQ GLDJQRVLQJ ORZHU H[WUHPLW\ YHQRXV UHÀX[´ 6 . .DNNRV HW DO 9DVF (QGRYDVF 6XUJHU\ 9RO 1R SS
Mention This Ad and Get Information About the Free Trial Program for Your Facility:
SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS James C. Blankenship, MD, MHCM, FSCAI and 2015-2016 SCAI president, said the organization views MEDCAC as an excellent opportunity to demonstrate the value of early diagnosis and appropriate treatment to save limbs and lives. “Our priority is to work with our partners and with CMS to arrive at policies that are in the best interest of our patients.�
MEDCAC
www.ACIMedical.com/VenaPulse 7ROO )UHH www.ACIMedical.com/VenaPulse $&,0HGLFDO FRP 9HQD3XOVH
Proudly made in the USA L 5.72 Rev. 001, 11/09/15
Attention Independent DME Dealers Call ACI Medical for the opportunity to carry the VenaPulseÂŽ device! Flexible options available (888) 453-4356
continued on page 38
VEIN THERAPY NEWS AUGUST/SEPTEMBER 2016
37
PRODUCTNEWS R&M adds global P.A.D. 2016 market report to offerings The “Global Peripheral Artery Disease Market Report: 2016 Edition” report has been added to the Research and Markets database. The global peripheral artery disease market has seen a persistent growth in the last few years, owing to increased healthcare expenditures across the globe. In recent years, introduction of drug-coated balloons as a peripheral artery device has significantly altered the entire market, slowly becoming the most preferred treatment option. The global peripheral artery disease market, bolstered by rising healthcare expenditures has seen a persistent growth in the last few years. The report provides an overview of the entire global peripheral artery disease market including the devices market and the atherectomy market. Certain key trends such as increased used of drug-coated balloons and favorable reimbursements have also been discussed. Growth drivers including rising aging population, obesity and healthcare expenditures find mention in the report along with the challenges and limitations including under penetrated treatment market for P.A.D. The report has forecasted future trend in the global P.A.D. market by combining SPSS Inc.’s data integration and analysis capabilities. Regression models have been created by employing various significant variables that
MEDCAC continued from page 37
He identified expert panelists who spoke for SCAI and other societies at MEDCAC meeting as SCAI presidentelect Ken Rosenfield, MD, MHCDS, MSCAI; Gerald Brode, who presented the patient perspective; and Joshua Beckman, MD, who spoke on underdiagnosis and under-treatment of peripheral artery disease (P.A.D.). Also, John R Bartholomew, MD, and Robert Lookstein, who spoke on asymptomatic patients with P.A.D.; Michael R. Jaff, DO, FSCAI, and Herb Aronow, MD, FSCAI, who covered intermittent claudication patients: Mehdi H. Shishehbor, DO, MPH, PhD, FSCAI, who spoke for critical limb ischemia patients; Sanjay Misra, MD, who presented evidence gaps in treatment decision-making; and James B. Froehlich, MD, MPH, who covered P.A.D. treatment disparities and the effect on outcomes of Medicare beneficiaries. VTN
38
have an effect on the market. Before deploying the regression model, the relationship between several independent or predictor variables and the dependent variable was analyzed using standard SPSS output, including charts, tables and tests. The key topics covered include global and regional P.A.D. markets; the peripheral atherectomy market; market dynamics and outlooks; and company profiles and the competitive landscape. Companies detailed in the report include Boston Scientific Corp., Cardiovascular Systems Inc., Medtronic plc and Spectranetics Corp. VT N READ MORE: researchandmarkets.com / r e s e a r c h / 774 l m h /gl o b a l _ peripheral
FUJIFILM unveils clinical ultra high frequency US FUJIFILM VisualSonics has won FDA clearance to introduce the world’s first clinical ultra high frequency ultrasound system – the Vevo MD. The compatible transducers operate at frequencies up to 70 MHz, providing imaging details down to 30 micrometers. Typical ultrasounds go up to about 15 MHz, but while imaging resolution is significantly improved by the Vevo MD, the depth of penetration is only a few centimeters. That’s why the system is expected to be used for imaging nerves, vasculature just below the skin, the skin itself and potentially during surgeries to spot objects of interest and to avoid unnecessary damage. It may also find uses in neonatology and pediatrics where the small penetration depth is not as much of an issue, while smaller anatomy requires a higher imaging resolution. The Vevo MD received European regulatory approval back in January. Potential vascular applications include • arteries and veins in pediatric and neonatal patients • measurement of Intima-Media Thickness (IMT) for research and assessment of cardiovascular health • assessment of vein wall morphology for cannulation readiness in AV fistula patients • assessment of peripheral vessels in diabetes and other circulatory conditions • visualization of flow patterns in in atherosclerotic or abnormal vessels Potential dermatology applications include: skin layers, melanoma, lipomas, hair follicles (hair loss), foreign body identification and lumps and bumps. VT N READ MORE: visualsonics.com
New endoscopic ablation system gets FDA OK CardioFocus has received FDA premarket approval for its HeartLight endoscopic ablation system, designed to treat drug refractory recurrent symptomatic paroxysmal atrial fibrillation (AF). It is expected to be released in the U.S. on a limited basis in July. The HeartLight system allows electrophysiologists to control the delivery of laser energy through direct visual guidance to isolate pulmonary veins with high procedural flexibility, according to Mass Device. The device comes with a compliant balloon to accommodate diverse pulmonary venous anatomies. The approval is based on data from a 353-patient, multi-center pivotal clinical study. It met the safety and efficacy endpoints and reported freedom from paroxysmal AF at 12 months post-procedure. Subjects in the pivotal study of the HeartLight device were randomly assigned to treatment with either the laser balloon or standard radiofrequency ablation. A company release stated: Novel medical devices have a challenging path to approval and are evaluated through intensive comparison with control arm devices that are inherently more familiar to the study investigators. The short learning curve of the new HeartLight System will enable even new users to quickly and efficiently deliver durable therapy to their patients, the company spokesman stated. The company is focusing on customers that have a larger volume of patients with atrial fibrillation, will commit to the device’s treatment approach and “get up the learning curve very quickly,” said CardioFocus Chairman Paul LaViolette. VT N READ MORE: cardiofocus.com/
R&M report details P.A.D./PVD disease Research and Markets has announced the addition of the “Peripheral Arterial Disease (PAD)/ Peripheral Vascular Disease (PVD) – Pipeline Review, H1 2016” report to its offering. This report provides comprehensive information on the therapeutic development for peripheral arterial disease / peripheral vascular disease, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for P.A.D/ and special features on late-stage and discontinued projects.
The report enhances decision-making capabilities and helps to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. VT N READ MORE: www.researchandmarkets.com/ research/sl3zwq/peripheral
MediPoint peripheral vascular analysis, report offered Research and Markets has announced the addition of the “MediPoint: Peripheral Vascular Interventions - Global Analysis and Market Forecasts” report to its offering. The peripheral vascular interventions market is a dynamic, billion-dollar market with solid growth potential through 2022. The rising prevalence of peripheral artery disease (P.A.D.) combined with the increasing endovascular procedure rate will ensure that the market will continue to expand in the coming years. Recent technological advancements within this space, including drug-eluting stents and balloons, bioabsorbable stents (BAS), and polytetraf luoroethylene (PTFE)-covered stents have the potential to revolutionize the future of PAD treatment, as these devices provide improved solutions for complex pathologies. The technologies covered in this report include lower extremity stents, percutaneous transluminal angioplasty (PTA) balloons, PTA drug-eluting balloons (DEB), carotid stents, and renal stents. This report focuses on the global peripheral vascular interventions market in North America (Canada, Mexico, United States), Europe (France, Germany, Italy, Spain, Russia, UK), Asia-Pacific (APAC) (Australia, China, India, Japan, South Korea), and South America (Brazil). This report provides insight into the competitive landscape, the marketed and pipeline products, the current and emerging players, and market analysis of each segment. The report identifies the unmet needs in the market while providing an understanding of physicians’ perceptions and decision-making processes in using and evaluating the adoption of different technologies. VT N READ MORE: www.researchandmarkets.com/ research/b8zzzl/medipoint
PRODUCT NEWS Product News is a free section for information regarding new products or enhancements in older products. Please email information, with or without a photo, (high resolution) to: lstorer@hot.rr.com
AUGUST/SEPTEMBER 2016 VEIN THERAPY NEWS
NEWS
In association with International Vein Congress, Vein Global is a year-round source forr venous education where users can watch high-quality y case videos of GHHS DQG VXSHU¿FLDO YHQRXV disease treatmentt featuring H[SHUWV LQ WKH ¿HOG. www.veinglobal.com
veinglobal.com
EDITORIAL BOARD • Jose I. Almeida, MD, FACS, RPVI, RVT • Lowell S. Kabnick, MD, RPhS, FACS
• Edward G. Mackay, MD, FACS, RPVI, RVT • Julian J. Javier, MD, FACC, FSCAI
VIDEO CONTENT INCLUDES EDUCATION: Abstract • Procedure Videos • Case Studies • Slide Presentations RESEARCH: Video Interviews • Literature • Premarket Testing • Regulatory and Finance PRACTICE: ([SHUW 2SLQLRQ RQ 3DWLHQW &DUH 2I¿FH 0DQDJHPHQW 3UR¿OHV RI ,QGXVWU\ 3DUWQHUs
Email us at info@veinglobal.com to receive our newsletter and updates regarding our latest videos. http://www.ivcmiami.com Miami, FL | April 20-22, 2017 VEIN THERAPY NEWS AUGUST/SEPTEMBER 2016
39 VeinGlobal LLC | 127 Main Street North | Woodbury, CT 06798
http://totalvein.com http://totalveinpharmacy.com
ÂŽ
http://totalvein.pharmacy.com totalveinpharmacy.com
888-868-8346
855-332-2855
Lasers, Laserr Fibers, Access Devices,, Proced dure Packs,, Comp pression Hosie ery and Compounded Medications