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AUGUST/SEPTEMBER 2015  Vol. 8 No. 5 VEINTHERAPYNEWS.COM

U.S. may pay end-of-life counsel VEINS Conference joins VIVA VenaSeal recall was voluntary Cures Act now in Senate LEVANT2 results published

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An ACP recognized resource for news and information for and about the phlebology community

Another year living under government regulations By Deborah L. Manjoney, MD, FACS, RPVI A year ago, I wrote about the onerous government demands on medical practitioners in regards to HIPAA, Meaningful Use and ICD-10. The financial burden of change, sheer volume of the rules and the changing influences of medical reimbursement have led many solo physicians and physician groups to sell their practices to hospitals or multispecialty groups. The larger organizations have better negotiating powers and trained personnel to implement the requirements.

Many physicians have already regretted their decisions, as they are now employees of corporations. They face productivity quotas, salary reductions, and restrictions on practice visits for the sake of supporting administrative overhead and corporate profit. Sacrifice of independence seems a steep price to pay for many of us “old-timers.” What is the status of these government regulations?

HIPAA HIPAA enforcement and levying of fines has indeed increased in the last year.

To be brief, six resolution agreements were reached between the Office for Civil Rights (OCR) of the Health and Human Services Department (HHS) and violators in 2014. These were based on reported or discovered data breaches. Since 2009, when fines were first levied, more than $25.1 million has been collected. It should be noted that the largest data breach to date, the Anthem breach involving 80 million people, and is prompting legislation to make encryption mandatory. REGULATIONS

medAge

continued on page 16

Dr. Manjoney

Dr. Ellis created medAge health program to complement vein practice By Laura Ellis, MD

Dr. Ellis

As insurance reimbursements continue to decline within most sectors of traditional medicine, many practitioners have branched into complementary areas of integrative practice. Whether it is adding pharmaceuticalgrade dietary supplements to their offerings, or providing an overall expanded holistic approach to care, most physicians on the cutting edge are extending their cash/self-pay patient services. Anti-aging, Functional, and Integrative medicine programs are among those specializations trending most significantly. I founded medAge Comprehensive Health Program in 2011, a comprehensive functional

medicine program, focusing on the prevention, apprehension, and reversal of degenerative and age-related illness. The medAge protocol is built on a holistic foundation with four pillars: • Scientific Stress Management • Custom Nutrition • Optimized Exercise • Bio-identical Hormone Replacement The reasoning behind and importance of these four focus areas of the practice (not necessarily in this order) are:

SCIENTIFIC STRESS MANAGEMENT

“psychophysiological” coherence  within the human body is tantamount to the apex of healthcare. This is because it promotes a high degree of balance, harmony and synchronization within and between cognitive, emotional and physiological processes. This state is associated with highperformance, reduced stress, increased emotional stability and numerous health benefits. Fundamentally it involves purposefully increasing parasympathetic activity dominance in resting state, interrupting lingering and chronic physiological stress

Modern research is confirming that creation and maintenance of a

MEDAGE

continued on page 20

See page 18 for more information

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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.

Volume 8, Number 4

Editor Larry Storer larrys@pcinews.com 254-399-6484

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Advertising Executive Gary Pittman, Jr. 512-637-0373 garypjr@pcinews.com

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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 2015 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

NEWS 1 Looking back with regret This is a one-year follow-up to a sweeping article on the effects of HIPAA, Meaningful Use and ICD-10 to vein practices. Some have sold their practices to hospitals or multispecialty groups because of the sheer volume of the rules and changing influences of medical reimbursements. A year later many doctors regret the decision as they now work for corporations and face productivity quotas, salary reductions and restrictions on patient visits.

10 ICD-10 looking stronger The CMS ICD-10’s development has been the stuff of soap operas. It looked for awhile like ICD-10 would be delayed – again! Maybe canceled for good if the AMA had their say. Then the House sent a veto-proof bill to the Senate and the GOP in the Senate has been looking for the right time to vote. Now the AMA has switched horses and are on board for passage. But with VTN’s long publication date, who knows what will happen by Oct. 1.

THE PRACTICE 12 Are you using “Paid Search”?

Many practices consider a good digital presence if it has a website and an automated response system. But digital marketing has gotten much more complicated. Consider the value of “Paid Search” to your practice.

14 Digitally-enabled patients key

Your practice’s professional image or lack thereof, can make or break you as far as attracting patients. The most skilled physician doesn’t have much of a chance of success if their practice culture has a negative reputation in the community.

ACP UPDATE 18 The 29th Annual ACP Congress

The 2015 ACP Annual Congress has planned its 29th educational meeting Nov. 12-15 at the Hilton Bonnet Creek in Orlando, Fla.

SECOND LOOK 1 Complementing a Vein Practice

As insurance reimbursements continue to decline within most sectors of traditional medicine, many practitioners have branched into complementary areas of integrative practice. Laura Ellis, MD, founded medAge Comprehensive Health Program in 2011, a comprehensive functional medicine program, focusing on the prevention, apprehension, and reversal of degenerative and age-related illness.

23 A Case Study

Manu Aggarwal, MHSA, MD, covers a case of a man with varicose veins who had a complicating hematoma as a result of a fall on the ice. Follow the complications from first visit to the end.

CIRCULATION 512-637-0344 EDITORIAL 254-399-6484

VEIN THERAPY NEWS < AUGUST/SEPTEMBER 2015

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NEWS THE

VTNREPORT FUJIFILM SONOSITE NAMES NEW CHAIRMAN, PRESIDENT, CEO Ultrasound developer Fujifilm SonoSite has appointed a new chairman, as well as a new president and CEO. Effective July 1, Naohiro Fujitani began serving as the company’s chairman. Masayuki Higuchi was named president and CEO, succeeding Fujitani in this position. Both have also been appointed to the company’s board of directors. Fujitani has 40 years of experience at Fujifilm and has held various positions with the firm. Most recently, Higuchi was chief financial officer at Fujifilm SonoSite. Prior to this, he was general manager of corporate planning for Fujifilm in Tokyo.

CMS PROPOSES PHYSICIAN PAY FOR DISCUSSING END OF LIFE The Centers for Medicare & Medicaid Services (CMS) July 9 proposed to pay physicians beginning next year for optional end-of-life discussions with Medicare patients, a subject that helped spark the “death panels” furor during the healthcare reform debate of 2009 and 2010. CMS introduced two CPT billing codes for end-of-life discussions, also called advance-care planning, in its physician fee schedule for 2015, but did not make them payable. CPT code 99497 covers a discussion of advance directives with the patient, a family member, or surrogate up to 30 minutes. The add-code of 99498 covers an additional 30 minutes of discussion. The proposed fee schedule for 2016, released July 9, would activate these two CPT codes for payment, but does not set a rate. The draft regulation notes that making these billing codes active “does not mean that Medicare has made a national coverage determination regarding the service.” When there is no national Medicare policy, the decision to reimburse physicians for an active billing code falls to so-called Medicare administrative contractors (MACs) – typically private health insurers – across the country that process Medicare claims, according to CMS.

AVVI - PRACTICE MANAGEMENT HITS NO. 37 ON COLORADO’S TOP 100 WOMEN-OWNED FIRMS LIST American Vein & Vascular Institute – Practice Management, the management company that oversees the business side of the American Vein & Vascular Institute’s network of vein and arterial disease diagnosis and treatment centers in Colorado and Texas, has received the Number 37 spot on ColoradoBIZ magazine’s 2015 Top 100 Woman-Owned Companies List. This is the second consecutive year that American Vein & Vascular Institute – Practice Management and CEO Erin Gibbs have made the list and at Number 37 of 100 honored companies, they have surpassed the majority of woman-owned companies in Colorado in terms of annual growth and revenue. American Vein & Vascular Institute – Practice Management, owned and managed by Gibbs, functions to serve the American Vein & Vascular Institute’s clinics from a business operational standpoint and specializes in managing business development, HR, finance, marketing, technology, and special projects. The management team develops and executes strategic processes and procedures for the operational success of the business as a whole. For further information about the American Vein & Vascular Institute, contact CEO Erin Gibbs at 719.966.7684 or see avviusa.com.

MEDTRONIC ACQUIRES CARDIOINSIGHT Medtronic has acquired Cleveland -based CardioInsight for $93 million in a debt-free transaction of $75 million in cash plus the retirement of an outstanding $25 million Medtronic loan, less $7 million in CardioInsight cash. Additional terms are not disclosed. CardioInsight’s principal product is the ECVUE system, a non-invasive mapping system for electrical disorders of the heart.

GETTING IT RIGHT: TYPE COMMAND LINGERS FOR CONFUSING PUBLIC DISPLAY A typesetting command in the Business Side of Medicine column (June/July) failed to delete in section two of the “Business Side of Medicine.” While it did not interfere with reading, it may have been confusing. Here’s how the first paragraph of section two should have appeared: Training, education and experience are important qualifications for this position. Pharmaceutical companies and medical device manufacturers spend between $7,500 and $10,000 annually, per sales rep, in sales training expenses in order to train their reps to ask the right questions that meet the needs of their clients in a professional manner. Nothing can replace experience … and yet medical practices try to shortchange this continually.

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But it didn’t stop there. Author David Schmiege was named Featured Contributor for the issue on the VTN website. The headline identified him as Dr. Schmiege. He is not a doctor, but still writes expert, compelling articles on practice management in each issue. VTN regrets any confusion.

ACP TOUTS SCIENTIFIC PROGRAM The American College of Phlebology’s (ACP) 29th Annual Congress will explore the latest techniques and education in the treatment of venous and lymphatic disease. The accessible scientific program addresses the full spectrum of deep and superficial vein care in didactic, interactive, debate and hands-on demonstration sessions, providing practitioners with: Opportunities to improve patient care at all levels of skill from foundational through advanced. Presentations and exhibits of leading research, technology and trends in the field of vein care. Hands-on workshops and demonstrations with renowned experts from all over the world, including topics such as sclerotherapy, compression, non-thermal saphenous vein treatments and superficial venous imaging. To register, see acpcongress.org

ACP OFFERS VEIN-RELATED BOOKS ACP is offering three books that spokesmen say will help improve a vein practice “Fundamentals of Phlebology : Venous Disease for Clinicians” contains contributions from vein experts in a number of specialties. This practical guide provides an understanding of the pathophysiology of venous disease and authoritative information on management, and details current treatment options available to physicians. Members pay $75, while non-members pay $100. “Inside Ultrasound: Vascular Reference Guide” is newly revised and updated, and is a complete guide to vascular disease, noninvasive testing and interpretation. The book would be a resource for students, educators, technologists, sonographers and physicians. Members pay $151.45, while non-members pay $161.45. “Core Curriculum for Phlebology Nurses” is written for nurses by nurses and allied health care professionals. It establishes patient care standards for venous care. Topics range from anatomy and pathophysiology to treatment options and professional practice issues. Members pay $30, while non-members pay $45. To order, see phlebology.org/member-resources/store/

STUDY SHOWS PATIENTS WANT RADIOLOGY REPORT FROM DOC Radiology leaders have been urging their colleagues to come out of the reading room and deal more directly with patients. But it turns out that when it comes to getting the results of their imaging exams, patients want to hear from the doctor who ordered the study, according to research in the Journal of the American College of Radiolgy. “The traditional model is that the referring physician orders the study and delivers the results to the patient, even though the radiologist is the imaging expert,” contributing author Dr. David Naeger of the University of California, San Francisco told medical news service AuntMinnie.com. “Our hypothesis was that if patients were given the option, they would want to receive imaging exam results from the expert, the radiologist. But that was not the case.” Yet Naeger and colleagues did find that patients want to see their images and read their exam reports – which could offer an entrée for radiologists. “Patients desire access to their reports ... and expressed a strong preference to review their images when receiving their imaging results,” the authors wrote. “Given that radiologists are in the best position to accurately review medical images, this could present an opening for [them] to take the lead in relaying results sometime in the future.”

MEDTRONIC ACQUIRES RF SURGICAL Medtronic has acquired Carlsbad, Calif-based RF Surgical Systems for $235million. RF focuses on the detection and prevention of retained surgical items (e.g., sponge, gauze, towel) after surgical procedures. The company’s product, designed as an adjunct to manual counting methods, uses low radio frequency to track and detect items embedded with an radio frequency tag. VT N

AUGUST/SEPTEMBER 2015 < VEIN THERAPY NEWS


NEWS VEINS conference Oct. 31-Nov. 1; joins VIVA Physicians The VEINS (Venous Endovascular INterventional Strategies) conference will be Oct. 31-Nov. 1 at the Wynn Las Vegas in a unique multispecialty environment. This twoday interactive course will offer a comprehensive analysis of the critical issues facing vascular specialists with an interest in acute and chronic venous diseases today. Register at vivaphysicians.org. With pulmonary embolism representing the highest death rate of hospitalized patients and DVT episodes outnumbering heart attacks or strokes in the United States annually, it is now more important than ever to be at the forefront

The Worldwide Leader in Compression Therapy

appropriate physiology and therapeutic options available. • Prepare venous interventionalists in proper understanding of the indications for IVC filter implantation, explanation and complications. of new, state-of-the-art technologies. Get in on the discussion at the VEIVs Conference. Upon completion of The VEINS, the targeted learners should be able to: • Understand the current medical and emerging endovascular therapy for venous thromboembolic disease. • Appreciate the utility and diagnostic abilities of duplex ultrasound, CTV and MRV in diagnosis and management of venous disease. • Appreciate the complexities and variations of venous anatomy and understand

VEINS JOINS VIVA

VIVA Physicians is excited to welcome The VEINS (Venous Endovascular INterventional Strategies) course to VIVA 15. Beginning this year, Dr. Raghu Kolluri joined the VIVA team to produce The VEINs course at VIVA, complete with a multispecialty faculty, hands-on workshops, and intimate breakout discussions. This two-day interactive course, focused on acute and chronic venous diseases, will offer a comprehensive analysis of the critical issues facing vascular specialists today.   With

pulmonary embolism representing the highest death rate of hospitalized patients and DVT episodes outnumbering heart attacks or strokes in the U.S. annually, it is now more important than ever to be at the forefront of new, state-ofthe-art technologies. Continuing the VIVA philosophy, The VEINS includes extended hands-on training with live patients and ample time for discussion allowing vascular specialists to better manage challenging patients. VT N

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NEWS 2015 Vein Forum offers two tracks of venous topics The 2015 Vein Forum: Comprehensive Venous Management for the Practicing Clinician will be Oct. 16-17 at the Hyatt Regency Washington on Capitol Hill. Registration is open at veinforum. org/medical-and-alliedhealth-professionals/ education/the-vein-forum. The program features dual track workshops to tailor each participant’s learning experience. The program will include basic and advanced tracks, with hands-on workshops in each track. The Basic Track will include: • Endovenous Ablation Methods • Hands-on Ultrasound • Wound Care and Compression • Sclerotherapy • Practice Management including financial implications, staffing, IAC accreditation and marketing/social media. The Advanced Track will include: • IVC Filters • Mechanical Thrombolysis/Angioplasty and Stenting/IVUS • Pelvic Venous Embolization and Scelotherapy • Special Sessions, including tough cases and Meet the Experts. CME Credits including Self-Assessment Credits will be provided for this course. VT N

AVVI recognizes employees, clinics, sock productivity American Vein & Vascular Institute (AVVI), a network of vein and arterial disease diagnosis and treatment centers in Colorado and Texas, have announced the recent recipients of its 2014 Employee Excellence Awards. These awards are peer nominated and recognize the outstanding contributions that employees have made over the past year, within the clinical and non-clinical sides of the business. Eight different awards were presented, including three new awards for 2014: Rookie of The Year to recognize an outstanding new individual, Top Sock Award to a clinic that generated the highest number of compression socks sold at its Compression Center, and Top Sock MVP to honor an individual who went above and beyond to generate sales at The Compression Center. Recipients of American Vein & Vascular Institute’s 2014 Employee Excellence Awards include Dr. Thomas E. Eidson for Provider of the Year, Maggie Morales for Rookie of the Year, the company’s Canon City location

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for Clinic of the Year, Ann Allen for Unsung Hero, and Tess Lloyd for Top Sock MVP. Additionally, Angie Higgs received the Founder’s Award, Ashton Gonzales was recognized for Service Excellence, the Vail Valley clinic received the Top Sock Award, and Bryan Huston was bestowed with a special award for his dedication to and embodiment of the company’s unique culture and values. As part of the festivities surrounding the 2014 Employee Awards, Chief Medical Executive Gordon F. Gibbs, MD, and his wife, Chief Executive Officer Erin Gibbs, toured the entire network of AVVI clinics to recognize each clinic and award-winning individual in person. The annual Employee Excellence Awards are meant to further strengthen relationships among clinics and employees. VT N READ MORE: avviusa.com

Registration open for AVF Fellows course in Seattle The American Venous Forum’s Fellows Course in Venous Disease is presented for the benefit of fellows within the specialty of vascular surgery, interventional radiology, vascular medicine and associated programs. The fall course is Dec.4-5 at the University of Washington Medical Center/Renaissance Seattle Hotel in Seattle. Registration is free at veinforum.org/medical-and-allied-healthprofessionals/education/fellows-course-invenous-disease. The course program will cover: • Anatomy and Pathophysiology of Venous Disorders and Non-Invasive Diagnostics • Chronic Venous Insuff iciency (Superficial and Deep) • Pregnancy, Upper Extremity Venous Issues, Acute DVT and Wound Care • Future of Venous Disease • The Business of Venous Disease. The goal of the course is to educate and update the fellows regarding the latest theories and developments in the clinical practice of vein disease management. Fellows will gain an overall understanding of vein disease to allow them to successfully incorporate venous knowledge, skills and techniques into their overall practice as they make the transition from training to the clinical practice. VT N

VenaSeal recall in Europe, Asia was voluntary Because the Covidien VenaSeal Sapheon Closure System was voluntarily recalled in Europe and Asia in April, just before the product was released in the United States, no FDA recall exists in the United States.

A Medtronic spokeswoman said the recall was not triggered by the U.S. Food and Drug Administration or a field complaint as reported previously. The recall was actually initiated by the company, according to Director of Communications for Aortic and Peripheral Vascular Krystin Hayward. “VenaSeal was never launched in the U.S. so currently there is no recall in place in the U.S. “The potential for a sterile breach in the outer pouch material was discovered during standard internal package testing,” she said. In addition to the adhesive, the VenaSeal consists of a dispenser gun and associated catheter, guidewire, dispenser tips, and syringes. Medtronic recalled 1,661 units of the system, a procedural delivery system for an adhesive that treats venous reflux disease by closing the affected veins in the lower leg. “We are working with global-registered customers and global authorities to resolve the issue and the recall is currently ongoing,” she said. Affected customers in European and Asian markets were contacted by letter or email on April 28. The VenaSeal was approved via FDA’s stringent PMA pathway for innovative or high-risk (and hence more profitable) devices. In the approval letter, the FDA said the device is unique because it enables vein closure procedures without the use of heat or injections, which reduces the risk of nerve injury and other side effects. VT N

R&M adds DVT report to lineup Research and Markets has added a report that provides comprehensive information on the therapeutic development for Deep Vein Thrombosis (DVT). R e se a rc h A nd Ma rket s.c om /re se a rc h / nqvdl6/deep_vein is 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. The report also reviews key players involved in the therapeutic development DVT and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-inclass and best-in-class products. VT N READ MORE: researchandmarkets.com / research/nqvdl6/deep_vein

St. Jude trial compares OCT to IVUS, angiography St. Jude Medical Inc. has launched the ILUMIEN III clinical trial, a prospective, international, randomized trial evaluating the clinical benefits of the company’s optical coherence tomography (OCT) guidance during stent implantation. The ILUMIEN III study will compare OCT-guided stent implantation to implantation guided by intravascular ultrasound (IVUS) or angiography alone, diagnostic tools that offer less resolution than OCT during intravascular assessments and percutaneous coronary intervention (PCI). The ILUMIEN III study is the largest multicenter randomized study to date to compare PCI outcomes associated with all three imaging tools. By assessing each diagnostic system head-to-head, the study should offer clear insight into OCT’s ability to influence clinical outcomes. The first patient enrolled within the ILUMIEN III trial was randomized at Columbia University Medical Center and underwent PCI guided by the St. Jude Medical Optis Integrated PCI optimization system. “We are excited about ILUMIEN III because this is the first randomized study of its kind to directly compare patient outcomes associated with guidance by OCT, IVUS or angiography during PCI,” said Dr. Ziad A. Ali, associate director of translational medicine at the Columbia University Medical Center’s Center for Interventional Vascular Therapy and principal investigator of the ILUMIEN III study. During PCI procedures, physicians use diagnostic imaging to make decisions related to stent sizing and to assess how to best keep the artery expanded to restore blood flow to the heart. One key factor in reducing stent failure is increasing the minimal stent area (MSA) and securing appropriate stent expansion during PCI to restore blood flow, a process commonly known as revascularization. Previous research, including findings from the ILUMIEN I and ILUMIEN II studies, has shown that with superior resolution over IVUS and angiography, St. Jude Medical’s OCT imaging technology can influence preand post-PCI decision making, stent sizing and deployment. The ILUMIEN III study is the next step in assessing the benefits of OCT guidance in relation to first generation imaging tools. The ILUMIEN III trial aims to enroll up to 420 patients at up to 35 sites across Europe, the U.S. and Japan. All patients will undergo PCI for stable or unstable angina (chest pain caused by insufficient blood flow to the heart), silent ischemia (restricted blood flow to the

AUGUST/SEPTEMBER 2015 < VEIN THERAPY NEWS


NEWS heart that causes no chest pain), or patients who’ve suffered NSTEMI or STEMI heart attacks due to arterial blockages. Patients will be randomized to undergo PCI with either OCT, angiography or IVUS and the primary endpoint will be the degree of minimum stent area achieved. VT N READ MORE: sjm.com

CMS nominee Slavitt may face an uphill battle Former UnitedHealth Group executive Andy Slavitt, who is also acting administrator for the Centers for Medicare & Medicaid Services (CMS), may face a tough confirmation process due to conflict of interest concerns. First, Slavitt will be tasked with establishing rules for his old boss at UnitedHealth Group, the nation’s largest health insurance company, where he wasa n executive. During his time with UnitedHealth – which reported $122 million in operating revenues in 2013 – he founded Optum, a subsidiary of the insurer that specializes in advanced data. He assumed the role of top executive at Optum for nearly a decade Some believe those ties to the industry make Slavitt’s nomination “highly inappropriate,” Craig Holman, a lobbyist for the consumer advocacy group Public Citizen, told the Daily Caller, adding that it “undermines the president’s own executive order on ethics.” Additionally, Holman says he was worried about an administration decision to issue Slavitt an unusual “ethics waiver” that exempted him from certain ethics rules when he joined CMS last summer as a deputy administrator.  Chairman of the Senate Finance Committee Orrin Hatch (R-Utah) told FierceHealthPayer that he will have tough questions for Slavitt based on his time at UnitedHealth. Ron Wyden (D-Oregon), a ranking member in the same committee,  praised the nomination.  Based on CMS’ critical role in providing Americans with affordable healthcare, he said Slavitt’s confirmation is a perfect fit, as now is the time to work together to ensure Americans get coverage. The American Hospital Association “applauds the nomination of Andy Slavitt to serve as administrator of CMS,” for “he has a deep understanding of the U.S. healthcare system and a commitment to improving patient care.” Slavitt became acting administrator earlier this year after former Administrator Marilyn Tavenner resigned. VT N

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NEWS

House OKs 21st Century Cures Act by wide margin The U.S. House of Representatives approved the 21st Century Cures Act July 10 by a 344-77 margin, and sent it on to the Senate. The bipartisan  legislation is meant to streamline regulatory approval of devices and drugs through the Food and Drug Administration, as well as provide additional research funding for the National Institutes of Health. Some of the highlights of House Resolution 6 before its passage follow, although the final bill may contain lastminute amendments not available at deadline: INNOVATION FUND: For the next five years, NIH would get $1.75 billion and FDA $110 million annually to address “major challenges” in biomedical research that could potentially lead to important breakthroughs. The bill’s authors say the new spending is fully offset with savings realized in other parts of the legislation. NIH REFORMS: In addition to reauthorizing  NIH  operations for the next three fiscal years, the 21st Century Cures Act requires the agency to develop a strategic research plan, become more accountable in its awarding of grants and find ways of lessening the administrative burden on researchers and grantees. The bill also would promote more collaborative research and establish a national pediatric research network under NIH. PRECISION MEDICINE: FDA would have to define and later update as necessary the term “precision medicine or biological product.”  FDA also would have the authority to approve treatments for rare and life-threatening diseases based on data submitted for previously approved products that takes a similar “underlying approach” to fighting the disease. PATIENT ACCESS TO “BREAKTHROUGH” THERAPIES: Congress directs the FDA to continue its policy of fast-tracking  approval of “breakthrough” drugs and therapies, as long as the innovation meets established safety and efficacy standards. PATIENT-CENTERED DRUG DEVELOPMENT: The FDA would have to develop a “structured framework” that would incorporate patient observations and experiences into drug-safety evaluation. MEDICAL DEVICE REGULATION: The bill would authorize a third-party, voluntary quality assessment program for device-makers  to have their quality systems pre-authorized, theoretically speeding up pre-market review.

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FDA also would be more lenient in its review and oversight of low-risk Class I or Class II devices, possibly opening the door to  faster approval of diagnostic medical apps and other mobile devices. Another section is meant to provide more clarity about when smartphones and other wireless platforms would be considered medical devices. INTEROPERABILITY: In light of the Office of the National Coordinator for Health Information Technology finding rampant “information blocking” by certain health IT vendors, the bill gives the Department of Health and Human Services power to hold scofflaws responsible, in the name of creating data interoperability. HOME-BASED CARE: The legislation changes Medicare’s payment system for durable medical equipment to remove  barriers to seniors receiving the same kind of care and access to medical devices in the home as they would in a hospital or skilled nursing facility. While House members were pleased with their bipartisan bill, some patient privacy advocates worry the language in the final HR 6 that could significantly weaken the HIPAA privacy protections for patient data, according to an article at HealthcareInfoSecurity. The draft legislation – designed to accelerate the discovery, development and delivery of new drugs and treatments – would allow protected health information (PHI) to be used for research purposes without patient consent as long as it’s being used by covered entities or their business associates. “Because PHI used for research could involve genetic information, the [research exemption] could potentially provide [use and disclosure] of information on the genetic traits of family members,” privacy attorney David Holtzman told HealthcareInfoSecurity. “Once that data is out, you can’t get it back.” Deborah Peel, MD and founder of the advocacy group Patient Privacy Rights, said it’s an especially bad idea, pointing out that there is “no ‘chain of custody’ for our health data. It’s impossible to know where in the world it is or how it’s being used.” Another provision in the draft bill would give researchers remote access to PHI maintained by a covered entity if “appropriate security and privacy safeguards are maintained by the covered entity and the researcher, and the protected health information is not copied or otherwise retained by the researcher. VT N

ICD-10 deadline looms By the time this magazine is published in August, the implementation deadline for ICD10 is about 60 days away, but lawmakers on Capitol Hill continue to push for transition periods or an outright ban of the code set while surveys reveal that participation in testing still lags. A new House bill would require a new transition period for ICD-10 by mandating dual coding in ICD-9 and ICD-10 for six months. The Code-FLEX Act, introduced by Reps. Marsha Blackburn (R-Tenn.) and Tom Price (R-Ga.), is just the latest move in the battle over the controversial code set. The new bill comes days after the Centers for Medicare & Medicaid Services introduced measures in conjunction with the American Medical Association to ease the transition. Those measures include that Medicare claims, for the first year of ICD-10 use, will not be denied or audited based solely on the specificity of diagnosis codes, as long as the codes on such claims are from the correct family of codes in the new code set. If Medicare contractors cannot process claims due to problems with ICD-10, CMS will authorize advance payments to physicians. In addition to those measures, the  Transitioning Effectively Now Act (ICDTEN Act), proposed by Rep. Diane Black (R-Tenn.), would require end-to-end testing of the transition from ICD-9 to ICD-10 by the Health and Human Services Department, and would provide an 18-month transition period to the new code set. Robert Tennant, of the medical group Management Association, said of the bill by U.S. Reps Blackburn and Price, that it is not a delay, and would allow providers who are ready to start submitting ICD-10 codes on Oct 1. to do so. Despite numerous delays for ICD-10 in the past, members of the House Energy and Commerce Committee’s Subcommittee on Health made clear at a February hearing that they do not want to see the transition delayed yet again. However, in March, 100 physician groups-led by the American Medical Association-expressed concern in a letter to Acting Centers for Medicare & Medicaid Services Administrator Andrew Slavitt about ICD-10 issues such as testing and lack of contingency planning. And in May and June both  Reps. Diane Black (R-Tenn.) and Gary Palmer (R-Ala.) have released separate bills that ask for a grace period for the transition. Rep. Black’s bill would require end-to-end testing of the transition from ICD-9 to ICD-10 by the Health and Human Services Department, and would provide an 18-month transition period to the new code set. Rep. Palmer’s bill would provide  a grace period of two years during which physicians and other providers would not be «penalized for

errors, mistakes and malfunctions relating to the transition.» At the same time, Rep. Ted Poe (R-Texas) takes it even further--his bill wouldn’t simply delay the new code set; it would ban its use outright. The Coalition for ICD-10 asserts that a grace period would compromise the ability of Medicare to monitor quality of care. In addition, Juliet Santos, ICD-10 principal consultant for Leidos Health, wrote in an opinion piece at ICD-10 Monitor that the grace period could be a massive risk when it comes to audits. The Centers for Medicare & Medicaid Services said recently its second round of ICD10 testing, which involved 875 providers, clearinghouses and billing agencies in April, had an 88 percent acceptance rate. However, a new survey from eHealth Initiative released in June found  testing lagging among 271 providers polled. Only 34 percent said they have completed internal testing and just 17 percent have completed external testing. VTN

AMA ON BOARD

The American Medical Association has publicly expressed support for newly announced flexibility in enforcement of the rules regarding the switch to ICD-10. This news was joined with accommodating guidance from Centers for Medicare and Medicaid Services that has the AMA’s blessing. Responding to a request from the AMA, CMS on July 6 announced that it would not penalize providers during the first year of ICD-10 use if their diagnosis codes are not specific enough, as long as the codes come from the proper code “family.” The same policy will apply to coding as it applies to reporting for the  Physician Quality Reporting System, Meaningful Use or CMS value-based payment programs. In addition, CMS said it would establish an ICD-10 Coordination Center and name an ICD-10 ombudsman to answer questions from healthcare providers – particularly small physician practices – about ICD-10 claims submission. “With easy-to-use tools, a new ICD-10 ombudsman, and added flexibility in our claims audit and quality reporting process, CMS is committed to working with the physician community to work through this transition,” acting CMS Administrator Andy Slavitt said in a joint announcement with the AMA. Among the tools Slavitt referenced is Road to 10, a website CMS put up in June to help small practices with the switch. AMA President Dr. Steven J. Slack was pleased. “These provisions are a culmination of vigorous efforts to convince the agency of the need for a transition period to avoid financial disruptions during this time of tremendous change.” he wrote on an AMA blog. “These significant improvements for the impending ICD-10 roll-out are just one way our

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NEWS collective voice is helping improve our practice environment for greater practice stability and ongoing quality care,” Dr. Slack added.

2ND ROUND OF TESTING DONE

Eighty-eight percent of test claims were accepted during the Centers for Medicare & Medicaid’s second round of ICD-10 testing in April, the agency announced in June. That compares with an 81 percent acceptance rate from the first round of testing, which began in January. About 875 providers, clearinghouses and billing agencies participated in the second round of testing. CMS received 23,138 test claims and accepted 20,306, according to statistics unveiled by the agency. It also reported that 2 percent of test claims were rejected due to invalid submission of ICD10 diagnosis or procedure code, and that less than 1 percent were rejected due to invalid submission of ICD-9 code.

Other rejections were not related to ICD-10, according to CMS, and instead included incorrect National Provider Identifiers (NPI), health insurance claim numbers or submitter IDs, or dates of service outside the range valid for testing. In addition to acknowledgement testing, which may be completed at any time, a final end-to-end testing week was held in July, though those who participated in the January and April testing are automatically eligible to participate again in July. In the guidance available to providers, clearinghouses and others, CMS explains that while acknowledgement testing is open to all electronic submitters, end-to-end testing is limited to a smaller sample of submitters who volunteer and are selected to take part.

WHAT HAPPENS AFTER OCT 1?

The Journal of the American Health Information Management Association has published an article about what physicians and

hospitals can expect when the ICD-10 deadline Oct. 1 arrives and what to expect after that. The article explores three stages: Oct 2 to 6 Months A drop in coder productivity is expected across the board, though facilities that have practiced dual coding or engaged in end-to-end testing will be much better off. There’s a big difference between learning a coding system and being able to understand clinical factors of a diagnosis. Pat Maccariella-Hafey, director of education at Health Information Associates, says organizations should focus on making sure coders have a strong understanding of the guidelines of ICD root operations. 1-5 Years Sandra Kersten, a senior consultant for eCatalyst Healthcare Solutions currently assigned as an ICD-10 project manager at a Chicago-area hospital, thinks there will be a permanent reduction in coder productivity, making it a smart move for hospitals to invest in extra coders. This is an opportunity for students

and less-experienced coders, according to the article, because no one will have that much experience with ICD-10. Maccariella-Hafey foresees coders becoming more educated in the clinical aspects of medicine and surgery. And the benefits of more precise, accurate data from ICD-10 are expected to be felt within the overall healthcare system as well, providing a better view of the quality of patient care and patient self-management. 5-10 Years A major expectation about ICD-10 is that it will help stimulate programs like patient-centered medical homes, value-based purchasing, and accountable care organizations by giving the government and care management organizations better data to work with. Everyone stands to benefit from improved data quality, according to Maccariella-Hafey. Researchers and public health-monitoring organizations are expected to be able to compare data apples to apples for global disease monitoring. VT N

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THEPRACTICE

TAKE THE LEAD.

Internet Marketing Strategies for Success PAID SEARCH BEST PRACTICES FOR VEIN INDUSTRY By Gregg Nell It’s been a running theme throughout most of my columns because it’s common amongst our clients – they’re so busy focusing on the practice and patients (and rightly so) that their digital presence often falls by the wayside. This is especially true when it comes to the complex details of digital marketing. Most physicians Gregg Nell understand that it’s important to have a user-friendly website and upto-date online listings. But what about going beyond the basics to actively promote your practice, clinical qualifications, high levels of patient satisfaction and a “Call to Action” to schedule new patients? Enter Paid Search.

WHAT IS PAID SEARCH?

Paid Search goes by several names: Pay-per-click (PPC), costper-click (CPC), search engine marketing (SEM) ... to name a few. In layman terms, Paid Search means advertising within a search engine’s “sponsored listings” (or on a partner site) and paying each time a user clicks on your ad. So if you were to do a Google search for “Vein Clinics in Los Angeles,” you’ll notice the first few results on the top of the page AND the results on the right side of the page are paid for. They display on top of the organic results with yellow labeling that reads “ad”. Google’s goal here is to offer those vein practices a way to advertise (which accounts for roughly 87 percent of Google’s own revenue) that is still helpful to the consumer.

WHAT’S THE BENEFIT?

Search engines use algorithms to determine which websites should show up at the top of the results page organically. They take into consideration website quality, popularity, etc. Paid Search pushes your vein practice to the top of the results page, regardless of whether or not you would get there organically. Of course there are limitations, and you’re competing against other vein practices, but you understand the ultimate goal. Another benefit is the unique way in which Paid Search is budgeted. You set the budget based upon your needs, taking into consideration the average cost-per-click for your keywords. You can set a cap on your daily spend and change it at any time. Then, you only pay when someone clicks. In traditional digital advertising, you pay regardless. And while you can track click-through-rate on a traditional display ad, that’s all you know. In Paid Search, you know that person was actively searching for YOUR clinical services and, to a certain extent, you can gather demographic data on those users.

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HOW DOES IT WORK?

In order to run ads on Google, Bing, Yahoo, etc., you’ll need to create accounts with each of these search engines and master their Paid Search systems – how to book ads, how to pay, how to analyze the results, etc. There are a lot of moving pieces, so most medical practices will work with a practice management or marketing firm that understands the process and can manage the accounts for them. GOALS: Your marketing advisor should start by assessing your goals and establishing reasonable expectations. Are you looking for more free screenings, consultations, laser procedures or cosmetic sclero? Are you promoting your vein practice as a whole, or do you want to focus on a new service, physician? AD GROUP STRUCTURE: This refers to the topics or clinical services that you’re looking to promote. Your campaign might focus on vein care, but your ad group would focus on varicose vein removal. The ad groups should be specific so the keywords and their subsequent bids are narrow. This saves money and ensures you’re getting quality attention to your web site – prospective patients who are looking for that specific treatment. COPY WRITING: Search engines have character limits for the title and body of your ad copy. So you’ve got 95 characters total to grab a user’s attention and get them to act. It’s a good idea to mix and match ad copy and keywords to see what users are more attracted to. Some are looking for clinical experience and training, others prefer to see easy online appointment making. AD EXTENSIONS: This refers to the extra tidbits (in addition to your main headline and body copy) that appear with your ad. Things like address, a link to specific pages of your website, call-to-actions, etc. They also provide a larger amount of real estate when your ad is shown on the results page, so you get more bang for your buck. This is key in an expensive Google category like healthcare, which is right up there with finance and insurance as industries in price and demand.

CONVERSION TRACKING: Even the best Paid Search campaign is useless without reliable conversion tracking. Whether you count this in form fills (inquiries), online appointment settings, or number of inbound phone calls, you must have an accurate way of determining the success of the campaign. Your marketing firm should be able to give you some ideas and set everything up for you. GETTING STARTED: Before you can really dive into a Paid Search campaign, it’s worth doing a brief audit of your current website. Search engines want to know they’re sending users to quality websites, not ones filled with spam and irrelevant information. In many cases, you’ll want to make tiny tweaks (maybe it’s adding keywords to your homepage) before the campaign kicks off. Some vein practices prefer to build a new, separate landing page geared directly toward the topic of the Paid Search ad. For example, an ad about “laser treatment for varicose veins” would direct a prospective patient to a landing page that completely focuses on that. After your website or landing page is ready, talk with your marketing firm about your business goals and strategy. From there, they’ll do some background research on the topic, write the ad copy, implement your conversion tracking, and help you determine what success looks like. With so much competition in the vein industry, it’s more important than ever to get your practice in front of consumers who are actively searching (literally) for the services you offer. Don’t miss out on low hanging fruit, talk with a digital marketing expert about your Paid Search potential. VT N Gregg Nell is the director of digital marketing strategies at Vein Specialists of America. He can be reached at (312) 550-9349 or Gregg.Nell@veinbusiness.com

AUGUST/SEPTEMBER 2015 < VEIN THERAPY NEWS


THEPRACTICE GOP eyes right time to vote on 2.3 percent device tax repeal Efforts to repeal the tax on medical devices that has helped fund the Affordable Care Act faces an uncertain future as it moves through the Senate. Republican senators are now looking at the best time to take a vote on the issue. It’s almost a certainty that President Barack Obama would veto such a repeal, but there are a number of Democrats who also oppose the levy and could cobble together enough votes to override the president. Members of the House of Representatives have already voted in favor of doing away with the 2.3 percent tax on devices by a veto-proof margin of 280-140. The bill is in the Senate where it faces a filibuster unless 60 senators endorse bringing the bill to the floor for debate. More than likely, a repeal of the tax, which is imposed on manufacturers or importers of medical devices, could come in the form of a bargain as part of approving spending bills later this year. Medical device manufacturers have opposed the tax, saying that they could make and sell devices at much cheaper prices without the added cost of the levy. “This is a tax on manufacturing, and I’ve always been in favor of eliminating it,” Sen. Amy Klobuchar, a Minnesota Democrat has said. She is one of five Democrat senators cosponsoring the Senate bill to repeal the tax. Her state has several medical device manufacturing firms, including Medtronic and St. Jude Medical. VT N

VSA gets your vein practice seen online!

Biotronik touts trial results Biotronik’s Pulsar-18 stent for peripheral artery disease (P.A.D.) trial results have been released, showing the device can be used in challenging cases of the condition. The aim of the study was to verify patency results for the Pulsar-18 stent system in routine clinical treatment of long, occlusive femoropopliteal lesions. Twelve months post-implantation, the 36 patients with lesions in their popliteal artery (located near the knee joint) had a primary patency rate of 85.4 percent, meaning the stent was still positioned to support the vessel wall. In addition, 87.5 percent of patients had not received a repeat procedure known as target lesion revascularization. The spokesman says the Pulsar-18 nitinol (a mixture of nickel and titanium) stent is coated with a silicon carbide layer that improves its hemocompatibility and biocompatibility. The company also touts its ease of deliverability using a 4 French sheath. VT N

Web Design & Development | Search Engine Optimization Paid Search Campaigns | Social Media Campaigns Contact us to learn more about our digital marketing solutions! Gregg Nell Director of Digital Marketing gregg.nell@veinbusiness.com gregg.nell@veinbusiness.com Tel (312) 550-9349

VEIN THERAPY NEWS < AUGUST/SEPTEMBER 2015

Vein Specialists of America, Ltd. 900 Oakmont Lane, Suite 100 Westmont, IL 60559 www.veinbusiness.com www.VeinBusiness.com

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Winning Customer Service: Assess — Improve — Maintain By David P. Schmiege

A well-planned customer service initiative, combined with a professional image, not only differentiates your vein practice from your competition, but it sets the tone for the entire patient experience. Due to the increased availability of providers offering treatments for venous disease in most communities across the David Schmiege country, patient satisfaction needs to become a high priority within your practice to fend off competition and retain physician referrals. Patient satisfaction should be the No. 1 goal of every medical practice … which leads to clinical and financial success. Gone are the days when you can ignore your patients and act as though you are doing them a favor by taking care of their medical problems. Patients need to be treated with respect and valued because the majority of consumers now have freedom of choice – they can go to most any provider that they want! To succeed in a competitive environment, you must display the clinical and interpersonal skills necessary to gain consumer and referral physician confidence. A successful practice commits to customer service excellence with every patient interaction in order to differentiate itself from the competition. Professionalism and exceptional customer service starting with the patient’s first interaction with your staff (phone skills, appointment scheduling, patient registration), sets the tone for the entire patient experience, before the patient even arrives for their appointment! Your practice’s professional image or lack thereof, can make or break you as far as attracting patients. The most skilled physician doesn’t have much of a chance of success if their practice culture has a negative reputation in the community. To make matters worse, dissatisfied patients have easy access to the Internet to post negative comments about you, your staff or your practice in general. Negative comments on Facebook or negative tweets can reach hundreds or thousands of existing and prospective patients and have a dramatic effect on your practice’s reputation. It can start a negative slide and have an adverse effect on your practice revenue for years.

IMPROVING YOUR IMAGE

What are some things you can do to improve your professional image? Lead by example with exceptional interpersonal skills with your staff and your patients. Pay attention to how your staff interacts with patients. While everyone has their own specifics of how they like to be treated, the consensus is that all patients want to be treated like they are the most important patient coming to your office that day! Patients like to know that they are appreciated. Does your staff answer the phone, register patients, room patients and overall interact with each and every patient they come in contact with in a friendly and appreciative attitude? Do they treat the practice’s patients like they would their own

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family? Do they demonstrate empathy towards each patient’s situation? Does your staff thoroughly understand venous disease and available treatment options and are they able to convey that information in a consistent manner, just as you would in an initial consultation? Have you ever tested your staff on their knowledge of vein disease and treatment options available? Do your employees stop conversations among themselves to greet and facilitate the patient’s visit? Are your incoming phone lines answered within three rings? Are patient phone calls returned with 1-2 hours? How many days or weeks are your patients waiting for an initial consultation? Be sure your office décor reflects a clean and professional image. If your office is outdated and worn, your patients may not trust that you are keeping pace with current treatment protocols and medical technology. Use your website. Be sure to have an up-to-date website that portrays your professionalism and friendliness toward patients. Use video for provider introductions and patient testimonials. Differentiate your practice from your competition by measuring your image and patient experience with mystery shopping. You’ll learn where you can make improvements that can help you achieve success for years to come! When attempting to measure patient satisfaction, it is helpful to keep in mind that patient satisfaction has some intangible elements. Satisfaction is a clearly subjective perception of the patient who receives a clinical service. The typical patient enters a medical practice with needs, wants and expectations. The extent to which your vein practice fulfills the needs of the patient defines the degree to which the patient will be satisfied. Relative success or failure on these three dimensions dictates the relative satisfaction of the patient. Published in 1982, my favorite business book was written by Thomas Peters and Robert Waterman called “In Search of Excellence.” The book explores the art and science of management used by leading 1980s companies with records of longterm profitability and continuing innovation. The message

was easy to understand … that certain outstanding (“excellent”) companies outperformed, outsold and outproduced their competitors because they had created and nurtured a uniquely positive corporate culture. Within this unique corporate culture employees were more innovative, more productive, and more responsive to their customers. The total effect of all of these superior efforts of employees within these corporate cultures was growth where others contracted, profits where others lost and significant successes where others failed. The lesson learned is simple – stay close to your customers. Not only do successful vein practices listen to their patients, many get their best ideas in process improvement from patients and employees. There are consequences to having dissatisfied patients. If a patient is dissatisfied with the care received at your vein practice and seeks future care somewhere else, their entire network of family and friends may not consider your practice for future services. As patients talk about their bad experiences, even more people may decide to seek treatment elsewhere. Most vein practices cannot replace lost patients fast enough to stem the inevitable tide of negative feedback. Quality perceptions and patient satisfaction are closely tied to the profitability of your vein practice. Low perceived quality in any context leads to decreased return visits and new patient referrals, in much the same way as poor patient satisfaction. Those providers in a vein practice who keep the patient satisfied will see an enhanced image of quality as a direct and immediate consequence. Just as tangible, however, will be the positive financial aspects on increased utilization, market share and profitability. VT N David Schmiege is the president and CEO of Vein Specialists of America. Have an idea for a future article, David can be reached at 630-638-0060 or David.Schmiege@VeinBusiness.com

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THEPRACTICE REGULATIONS

continued from page 1

2015 is predicted to be a much more active year, with the legislated compliance audits poised to start. However, Jocelyn Samuels, director of OCR, says that the new audit program remains “under development.” The OCR hopes to recoup much higher collections once audits start in earnest. Ms. Samuels has also indicated that more guidance will be issued on cloud computing later in the year. Large data breaches certainly have been weighted towards hospitals and corporate entities with large IT departments. If they cannot adequately protect against data breaches, it seems unrealistic to expect small medical practices to implement the level of security needed to prevent theft or hacking. But all practitioners are mandated to perform a risk analysis, have compliance and employee education programs for protected health information (PHI), have technical safeguards in place and take efforts to correct any potential breaches. Violations fall into two major categories, “Reasonable Cause” and “Willful Neglect.” Fines begin at $100 and range to $50,000 per violation or record. If one is found guilty of “Willful Neglect,” criminal charges can also be brought, with sentences of 1 to 5 years, depending on the offense. It’s obvious that physicians are held to a higher standard than the IRS is in protecting personal information.

MEANINGFUL USE

The program that was launched to try to force providers of medical care to institute electronic records has been expensive and fraught with difficulties. Through May of 2015, Medicare incentive payments for Electronic Health Records (EHR) demonstrating Meaningful Use (MU) have totaled $7,319,985,802 to Eligible Professionals (EP) who are physicians. When other professionals are included, and Eligible Hospitals are added, the total payments come to almost $21 billion dollars since the program began in 2011. Although statistics published online by CMS claim that 614,519 physicians have been paid to date, further examination reveals that as of May 2015, only 271,673 unique doctors have received monies after meeting all requirements for Stage 1 MU, and 47,687 unique physicians have attested to Stage 2 of MU, according to the Kaiser Family Foundation (March 2015) report that lists 897,420 professionally active physicians in the United States. Stage 2 continues to be a difficult level to achieve, and new proposed rules published in the Federal Register on April 15 again attempt to make requirements more realistic for both Stage 1 and Stage 2 completion. Specifically, they propose an amendment to the reporting period for 2015 to be any continuous 90-day period rather than the full 12 months originally ruled for users to avoid the Medicare payment adjustments. The full year requirement for returning participants would be in place beginning Jan. 1, 2016. The proposed changes also look to reduce the redundancies and duplications of effort in Stage 2 requirements that had included paper-based action (e.g. Clinical Summary). Most physicians believe that demonstrating data collection for Stage 2 and beyond is not worth the effort at this time. Michelle Homes, MBA, of ECG Management Consultants said she has seen many physicians “de-prioritize” the Meaningful Use program. The dropout rate from MU was 16 percent from 2011 to 2012, and 19 percent from 2012 to 2013. The dropout rate is expected to climb. As maximum incentive for physicians entering the program declines with each year, it is unlikely that there will be a sudden upsurge in newly-entering Stage 1 providers. It is also apparent that regulations cannot keep pace with evolving technology for patient communication. One example is

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patient portals that are required for electronic communication of PHI. Although many early adopters have instituted patient portals on their websites, one group in Laurel, Md., has noted that despite 90 percent registration of patients, only a third of those patients ever use the portals to garner clinical reports. Patients must remember a logon and password to access a portal. Texting messages to patients, not inclusive of any secure information, to have them call to receive results, yields much higher returns. Another of the proposed rules from 2015 Meaningful Use requires vendors of certified EHRs to build application programming interface capabilities so that patients can use thirdparty online tools to access their health records. All maintenance and transmissions of patient information must, of course, follow all HIPAA security rules. It is incumbent on the physician to conduct a security review and risk analysis for each EHR reporting period, and the physician remains responsible for any hacking or theft of information occurring via a Business Associate’s (third-party’s) tools.

ICD-10

Despite some in Congress attempting to delay implementation of ICD-10 again, it will take effect on Oct. 1 of this year. In response to the new ICD-10 ‘go-live’ date established last year, then AMA President-elect Dr. Steven J. Stack stated, “While the AMA appreciates that physicians have additional time to comply with ICD-10, we continue to have fundamental concerns about ICD-10 and its implementation, which will not be resolved by the extra time. The AMA has long considered ICD-10 to be a massive unfunded mandate that comes at a time when physicians are trying to meet several other federal technology requirements and risk penalties if they fail to do so.” The AMA had continued to seek repeal of ICD-10, publishing a 2014 updated report by Nachimson Associates, stating that small practices could expect to pay between $22,560 and $105,506 to comply. The estimates included purchasing of new software to accommodate the new codes, planning, internal and external testing, process updates and training. On July 6, the Centers for Medicare and Medicaid Services (CMS) announced that it would not impose penalties in the first year as long as codes are in the proper code “family.” Acting CMS administrator Andy Slavit stated that CMS would be appointing an ICD-10 ombudsman to respond to

questions from providers about claims submissions within a newly established ICD-10 Coordination Center. In a joint announcement with the AMA, Slavit offered that CMS had also launched a new website, Road to 10, in June to help small practices make the move to the new coding system. He stated that, “CMS is committed to working with the physician community to work through this transition.” Dr. Slack indicated that he felt vindicated by this new response by CMS and endorsed the new plan. CMS has supposedly been engaged in “acknowledgement testing” over the last several months to verify that their systems will accept the new codes. Starting in January of 2016, the plan was to use “end-to-end” testing to review whether physicians are using the appropriate codes and that the remittances match the codes. It is unclear now, with the latest announcement, whether the anticipated delays in payment will occur. The extensive detail of ICD-10 still seems to smack of sociologists’ input rather than that of physicians. In closing, I would like to offer a brief glimpse at a few of the more unusual codes. I credit Keith L. Martin for these, in a piece in Medical Economics on June 16 titled “20 bizarre new ICD-10 codes”. W55.21 – Bitten by a cow W61.33 – Pecked by a chicken Y92.146 – Swimming pool of prison as the place of occurrence of the external cause Y92.241 – Hurt at the library Y 93.D1 - Accident while knitting or crocheting W56.32 – Struck by marine mammals V91.07 – Burn due to water-skis on fire V95.40 – Unspecified spacecraft accident injuring occupant I think that practices limited to venous treatment have a multitude of advantages given the landscape of current and future governmental regulations. 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.

AUGUST/SEPTEMBER 2015 < VEIN THERAPY NEWS


THEPRACTICE Merz’s Radiesse garners FDA OK The U.S. Food and Drug Administration (FDA) has approved the injectable dermal filler Radiesse by Merz North America for hand augmentation to correct volume loss in the dorsum of the hands, the company announced June 4. Earlier this year, as reported by Medscape Medical News, the FDA’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee voted 9 to 4 that the benefits of Radiesse outweigh its risks. A majority of panelists also voted that it is safe and effective. “Radiesse provides an immediate volumizing effect and can help to reduce the prominence of tendons and veins in the hands, delivering smooth, natural-looking results that can last up to 1 year,” the company said. Radiesse is an opaque dermal filler composed of synthetic calcium hydroxylapatite microspheres suspended in a water-based gel carrier. It was first approved in the United States in 2001, and has since had subsequent approvals, including for correction of nasolabial folds in 2006. It has been used off-label for hand augmentation – and is approved in 52 countries for that indication. Data to support the FDA approval for hand augmentation came from a multicenter, randomized controlled study of 114 patients. Most were white women with an average age of 53 years. Eighty-five patients were randomly assigned to immediate treatment, and 29 to delayed treatment and were considered controls. The control group crossed over to treatment at 12 weeks. The effectiveness of Radiesse was measured by the Merz Hand Grading Scale (MHGS) – validated by the company in another study – and the Global Aesthetic Improvement Scale (GAIS), which the patients used to self-assess results. According to the MHGS, 75 percent of Radiesse patients experienced at least a one-point improvement at three months compared with 3 percent of those in the control group. The mean change in the MHGS from baseline was 1.1 point for those given Radiesse compared with 0.1 in the control group. In addition, 98 percent of treated patients reported improvement in the appearance of their hands at three months. Improved aesthetic outcomes as measured on the GAIS after initial and repeat treatments correlating with clinical improvement were demonstrated in this study, with all primary and secondary endpoints being met, the company spokesman said. Most adverse events were injection site reactions such as swelling, redness, pain, and bruising, which were usually mild to moderate, short in duration (lasting about 1 week), and required no treatment. No severe device-related adverse events were reported that required treatment, according to the company. Radiesse is contraindicated for patients with severe allergies. VT N

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ACPUPDATE

2015 ACP Annual Congress: Nov. 12-15 in Orlando By Michael Armitage The 2014 ACP Annual Congress, in Phoenix, Ariz., marked the largest and most successful Annual Congress hosted by the ACP to date. This year, the American College of Phlebology (ACP) is preparing for yet another exceptional educational meeting with the 2015 ACP Annual Congress, Nov. 12-15 at the Hilton Bonnet Creek in Orlando, Fla. This year marks the 29th year the ACP will host what has become the largest and most comprehensive meeting dedicated to venous and lymphatic disorders in the United States. Under the direction of Program Co-Chairs Lisa Pavone, MD, RVT and Melvin Rosenblatt, MD, FACPh, the scientific program will continue to set the pace for vein care with innovative and engaging content presented by respected faculty from around the world. “The 2015 committee is building on last year’s successful approach: Allow for as much interaction with faculty as possible,” explained Dr. Pavone. “Our aim has always been to provide attendees with the tools that they need to improve the standard of care in their practices.” Focusing on that interactivity, program highlights include hands-on workshops in sclerotherapy, compression, non-thermal saphenous vein treatments and superficial venous imaging. In addition, special interest sessions and pre-Congress tracks allow attendees to target their personal educational goals with topics covering basic phlebology, ultrasound, practice management, aesthetics, and advanced phlebology & deep veins. “The ACP Annual Congress stands apart from other venous symposia,” Dr. Rosenblatt said. “We have been careful to craft a program which addresses the wide breadth of topics for all specialties involved in vein care.” In addition to the scientific sessions, the Annual Congress will also present sessions to help practitioners practice ethically, manage insurance challenges, understand the literature in venous disease, and learn about credentialing and accreditation. Although the curriculum will be challenging, the 3-day event will take place in sunny Orlando at the Hilton Bonnet Creek, a relaxing atmosphere for networking and engaging with colleagues. Social activities are planned throughout the Congress, including a Fun Run, Silent Auction, the ACP AfterParty, and the ACP Foundation’s 9th Annual Golf Outing at the prestigious Waldorf Astoria Golf Club. As the field of vein care continues to grow, so too does the need for educational offerings at all levels of skill. Attendees of the 2015 ACP Annual Congress will find sessions to meet their specific needs from basic to advanced. Join the ACP Nov.12-15 in Orlando for this essential educational event. For more information about the Congress and to register, please see acpcongress.org. VT N Michael Armitage is director of marketing and communications for the American College of Phlebology. He may be emailed at marmitage@acpmail.org.

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AUGUST/SEPTEMBER 2015 < VEIN THERAPY NEWS


THEPRACTICE

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SECONDLOOK MEDAGE

continued from page 1

response. The ability to induce this parasympathetic-dominant state, at will, during stressful circumstances, also enables the patient to mitigate the impact of stressful situations as they arise. Thus, the physiological impact of stress is lessened and controlled, at the source. By repeated practice of the foregoing method, the patient becomes more adaptive and resilient to stress triggers, and demonstrates a calmer, more cohesive entrainment between cardiovascular and cerebral systems. This not only produces an appreciable sense of well-being in the patient, but a statistically significant reduction in risk for hypertension, heart disease and CVD.  In a recent three-year analysis of more than 46,000 workers from six major U.S. companies, depression and unmanaged stress emerged as the top two most costly risk factors in terms of medical expenditures –– increasing healthcare costs by 2 to 7 times as much as known cardiovascular physical risk factors such as smoking, obesity and poor exercise habits. [R. Goetzel et al. J Occup Environ Med. 1998; 40(10)] In a study of more than 10,000 government employees, workers who perceived they had little control over circumstances in their jobs, had nearly twice the likelihood of developing coronary heart disease as employees with high perceived job control.  [H. Bosma et al. British Medical Journal. 1997; 314(7080] The medAge stress Management Protocol follows the modality described above, and the patient’s progress is tracked weekly by the medAge practitioner, via a private patient portal in the cloud.

CUSTOM NUTRITION

Breaking out of false paradigms about healthful nutrition presents the biggest struggle for most patients in making positive dietary changes. Decades of repetitive conditioning regarding The Food Pyramid, RDA, DV, and other myopic promulgations about what constitutes a healthy diet, have contributed significantly to current rates of obesity, diabetes, cancer, arthritis and inflammatory conditions of numerous sorts, allergies and food sensitivities, celiac disease, and the overall weakened immunological state of the populace.

Misinformation about healthy/unhealthy fats, while positioned as a boon to those seeking sound cardiovascular health, in actuality has promoted inflammatory conditions by endorsing consumption of denatured, rancid, oxidative stressinducing oils. In the medAge Custom Nutrition protocol, the patient is provided a customized dietary plan that is assembled with the patient’s health goals in mind, and within the boundaries of sound, modern, scientific insights about healthful combinations of food, nutritional vs. caloric values of food, food sensitivities, fat metabolism, and with the relationship between food and inflammation in the body in mind. Through initial micronutrient and food sensitivity testing, the patient is screened for any nutritional deficiencies or negative immunological responses to food, and the results of those tests are then utilized in designing the patient’s dietary program, unique to his or her constitution and need. Patient progress is tracked over time by the medAge director of nutrition, and adjustments are made as needed to ensure nutritional and dietary success in support of optimal health.

OPTIMIZED EXERCISE

If you’ve spent any time in the gym lately, you’ve likely seen someone on a treadmill, blazing at perilous speeds for extended periods, drenched with sweat from head-to-toe, flushed and nearly hyperventilating in the pursuit of a “good aerobic workout.” Perhaps you have even been that person at some point. While there’s no doubt that the endorphin rush of such a workout is quite palpable, an undesirable by-product is that of inducing unnecessary oxidative stress on the body, proinflammatory conditions and long recovery times. Of course, there are competitive sports-related reasons that training at such a level might be justified. But research bears out that a more moderate approach to aerobic and strength training will produce desired long-term health benefits, in a shorter amount of time, with a fraction of exertion expended.  In the medAge Optimized Exercise discipline, patients are not only interviewed to elicit their particular fitness goals, but are tested for oxygen utilization capacity, via V02 Max analysis. The results identify ideal heart-rate training zones for each patient, based on age and other factors that the patient should aim to achieve during exercise. This V02 Max information is combined with ideals expressed by the patient regarding desired fitness targets to arrive at a

custom, optimized workout regimen. This patient-specific regimen, created by the medAge an Exercise Physiologist, includes efficiently designed interval training protocols for sustainable aerobic and strength development that support health and longevity and limit oxidative stress impact on the body.

BIO-IDENTICAL HORMONE REPLACEMENT THERAPY

The importance, safety and effectiveness of Bio-identical Hormone Replacement Therapy (BHRT) have been demonstrated over decades of clinical experience and published data. BHRT confers numerous health benefits without the elevated side effects/risks associated with non bio-identical hormones, which have a different structure and action as compared to those found naturally in the human body. Bio-identical hormones are produced from one of two natural ingredients; Mexican Wild Yam, or soy. They are chemically identical to the structure of the human body’s natural hormones and exert the same positive effects as natural human hormones. Whereas non bio-identical hormones, such as those used in the flawed 2002 Women’s Health Initiative (WHI) trials, are synthetic in the form of conjugated equine estrogen and progestin. Even though the synthetic hormones utilized in the WHI produced desirable effects in treatment of hormonerelated conditions, they also presented increased risk of stroke, heart disease, and breast cancer in the WHI, which halted the study early. Conversely, treatment with BHRT does not present with the same risk levels, yet the associated health benefits of BHRT include: • Reduced osteoporosis • Reduced heart disease • Improved heart pump function   • No increase in prostate or breast cancer risk • Reduced incident of colon cancer • Reduced menopausal symptoms such as night sweats and hot flashes • Better cognition/clearer thinking • Maintenance of muscle mass • Better skin integrity/appearance • Alleviated depression/anxiety • Improved quality of sleep • Improved sexual function/desire • Better exercise strength, performance and recovery The medAge BHRT protocol prescribes only bio-identical hormones, and carefully monitors patients according to proven scientific data. Topical, oral and implantable methods of delivery and dosages are customized for each patient by the medAge Physician after initial blood tests are performed to determine the patient’s hormonal health status.  The patient’s progress is then tracked, and hormone levels are retested at regular intervals. Dosage and methods are adjusted as necessary throughout treatment to accomplish desired hormone balancing and management of health. The medAge Comprehensive Health Program is being systematized for replication and franchise opportunity. VT N Editor’s Note: For more information on the medAge Comprehensive Health Program, and how to establish a medAge practice within your existing clinic, contact Dr. Laura Ellis at: MymedAge.com, or call 828-684-1212. Dr. Laura Ellis is a wellness doctor and vein surgeon.  Her national medAge practice specializes in hormone replacement and anti-aging medicine. She is author of “The Hormone Handbook.” She is host of The Dr. Laura Ellis Show at Sunset Gower Studios in Hollywood and a motorcycle road racer with championship wins.  

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AUGUST/SEPTEMBER 2015 < VEIN THERAPY NEWS


SECONDLOOK Article authors deny low rads cause cancer An article in Technology in Cancer Research and Treatment, the theory that links low levels of radiation to cancer incidence is deeply flawed and cannot be used as a model to predict excess cancer incidence. The article challenges the linear no-threshold (LNT) theory, which holds that there is no threshold of radiation exposure below which radiation is safe to humans, and that the cancer risk of radiation rises in a linear fashion with the level of radiation exposure. The LNT model has formed the basis for most of the efforts to regulate and reduce radiation exposure. Despite the widespread media coverage of studies purporting to show that radiation from x-ray, CT and other medical imaging technologies causes cancer, “no data have ever unequivocally demonstrated the induction of cancer following exposure to low doses and dose rates,” Jeffry Siegel, PhD, from Nuclear Physics Enterprises and Dr. James Welsh from Loyola University Chicago argue in the paper. The authors say that studies that purport to show such a link have enormous flaws, including their universal reliance on an unproven statistical model. In particular, these studies achieve their goal by citing the LNT model, in which the well-established cancerous effects of high radiation doses are extrapolated down to encompass low doses and low dose rates. Siegel and Welsh wrote that although LNT is commonly used, it “is of questionable validity, utility, and applicability for estimation of cancer risks.” Contrary to the LNT model’s predictions, there is compelling evidence that the human body has evolved an ability to repair damage from low-dose radiation exposure (Technol Cancer Res Treat, March 30, 2015). They cite the mutation rate caused by lowdose background radiation in the environment as an example. The mutation rate is actually 2.5 million times lower than the rate of spontaneous mutations in the body. So even if the LNT model were valid, the small increase in genetic mutations caused by low-dose radiation from medical imaging would hardly overwhelm the body’s defenses. Siegel and Welsh also cited two recent studies that showed a possible increased risk of cancer from low-dose radiation in pediatric CT scans, noting that the cancers are likely due to the underlying medical conditions that prompted the scans, rather than the radiation exposure. Many people are focused on the dangers of radiation from medical imaging, but the risks associated with not undergoing a procedure or exploratory surgery are far higher – and generally ignored in the media, they wrote. VT N

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SECONDLOOK

CASE STUDY: Hematoma and varicose veins By Manu Aggarwal, MHSA, MD A 62-year old male presented to the Vein Care Center satellite office in Celina, Ohio, for evaluation of varicose veins. On Feb. 2 of this year, the patient fell on the ice and sustained a significant bruise to his left leg. He was seen in his local emergency room and referred to his orthopedic physician for further evaluation. The hematoma was close to the knee and he was scheduled to have his left knee replaced within a few weeks. He presented to the surgeon on Feb. 20 and was found to have a large hematoma with moderate tenderness and redness. It was decided at that time to perform an incision and drainage to relieve any compromise to the skin and surrounding tissues. A hematoma is an escape of blood outside of the blood vessels. The patient had a subdermal hematoma. Large hematomas can form into hard masses under the surface of the skin due to the limitation of the blood to escape the subcutaneous or intramuscular tissue space. This is due to the fascial planes. This key anatomical feature prevents such injuries from causing massive blood loss. In most cases, the sac of blood or hematoma eventually dissipates. However, as in the case of the patient, they may continue to grow. There are two usual methods that are usually used for evacuating a hematoma: 1. Needle aspiration Though commonly used, this method is no longer recommended by many because of hematoma recurrence. The aspiration is often not adequate and the hematoma requires additional management. 2. Incision and drainage The incision is not made over the hematoma where the skin is thin, tense and shows signs of skin necrosis. The incision should be made at the edge of the hematoma, where the skin appears normal. Also, the incision should follow the lines of tension. The incision must penetrate the entire thickness of the skin at one stroke and at even depth along its entire length. The incision should be made at right angles to the surface of the skin so that the skin edges may meet perpendicularly when healed. The patient underwent the procedure without complications until the tourniquet was released and excessive bleeding was noted due to multiple varicose veins in the area. The wound was then packed with sponges and wrapped tightly with an Esmarch. After 10 minutes, Gelfoam soaked with 10,000cc of thrombin was placed into the wound as well as a second Surgicell Fibrillar. The wound was then closed with vicryl and nylon. An attempt to place a drain was unsuccessful in the operating room due to excess drainage. The patient then presented to us about a month later for evaluation. The wound seen below is the same day as the first visit to our office.

CASE STUDY

A bilateral venous mapping was done at our IAC-accredited office. The patient was found to have venous reflux of the left anterior accessory vein from the saphenofemoral junction to midthigh. The vein measured 6.4mm with 3.34 seconds of reflux.

Ultrasound of AAGSV with compression and reflux time. The disease management team debrided the wound using a No.15 blade and forceps. The eschar was removed into the subcutaneous tissue. Hematoma, Gelfoam and Surgicel was also removed from the wound bed, which was irrigated with 40cc of hydrogen peroxide and 20cc of normal saline. There was 12.6 square cm of tissue debrided, and iodoform gauze was packed into the wound. The following day, a wider excision was done. Bleeding was noted again from the varicosities and controlled with silver nitrate, as seen in the right corner of the wound. Wound cultures were negative, as well as normal white blood count. Iodoform gauze was continued and the patient was

Initially,12.6 square cm of tissue was debrided. A wider excision was done the next day.

Patient presented to us about a month after I&D of the left lateral calf for evaluation with black, necrotic skin and clear drainage. There is erythema and tenderness to palpation. He was referred to wound care for debridement and further treatment.

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Bleeding due to varicose vein(s) was controlled with silver nitrate as seen in right corner.

AUGUST/SEPTEMBER 2015 < VEIN THERAPY NEWS


PRODUCTNEWS Left: A week later, Mesalt was discontinued and silver calcium alginate was started with dressing changes every other day.

Below: Finally, approximately two months later, the patient was healed enough to be discharged.

seen weekly. On the fourth day after the wide excision, Mesalt packing was begun. The patient also began using Tubigrip. In the meantime, his insurance company has denied him coverage for endovenous laser treatment of his AASV and ambulatory phlebectomy, despite peer-to-peer review as well as a written appeal. The patient has therefore decided not to proceed with any treatment. As already well-established in the literature, AAGSV insufficiency is the third most common vein presenting with venous reflux. At the Georgetown Vein Center from December 2006 to June 2008, a total of 313 limbs in 255 patients were found to have superficial venous insufficiency involving the GSV, AAGSV and SSV by venous duplex ultrasound examination. The incidence of isolated AAGSV reflux was 10 percent (31 limbs in 30 patients). The incidence of both AAGSV and GSV reflux was 1.6 percent (5 limbs in 5 patients). Laredo, et. al, did a study that showed that patients with isolated AAGSV insufficiency, 16 limbs in 16 patients (51.6 percent) had recurrent varicose veins and previous GSV treatment of the ipsilateral limb. The AAGSV is present in about 50 percent of patients, giving rise to anterolateral varicose veins, as seen in our patient. However, many insurance companies have denied coverage, claiming treatment of the AAGSV (or any accessory vein), is investigational. In this particular case, this patient’s insurance company thinks his complicated hematoma and subsequent wound care caused by trauma to the varicose veins, is investigational. The patient is scheduled for a knee replacement in the near future, where the varicose veins may bleed again. Our practice always advocates for venous insufficiency be addressed prior to major procedures such as knee and hip replacements to reduced potential issues with bleeding, phlebitis or thrombophlebitis. There are numerous studies that show great efficacy with treatment of the AAGSV. The treatment using endovenous laser treatment improves quality of life as well as pain and discomfort. The policies need to be revised to match the scientific data. VT N

SOURCES

March 2010 Endovascular Today: Endovenous Thermal Ablation of the Anterior Accessory Great Saphenous Vein by James Laredo, MD, PhD; Byung B. Lee, MD, PhD; Richard F. Neville, MD. Dr. Manu B. Aggarwal, MD, is a board certified family physician and medical director specializing in phlebology at the Vein Care Center. Since 2007, the VCC has been an IAC-accredited vascular laboratory. The VCC has been dedicated to venous disease and laser treatments since 2004. It is located in Lima, Ohio, with a satellite office in Celina, Ohio.

VEIN THERAPY NEWS < AUGUST/SEPTEMBER 2015

New England Journal of Medicine publishes Bard’s LEVANT2 results

C.R. Bard Lutonix Drug Coated Balloon The New England Journal of Medicine published a study June 24 that C.R. Bard said showed that its Lutonix drug-coated angioplasty balloon for peripheral artery disease has superior efficacy and equivalent safety to standard angioplasty balloons. Results from the company’s LEVANT 2 study demonstrated superior primary patency for Lutonix 035 Drug Coated Balloon (DCB) PTA Catheter over standard percutaneous transluminal angioplasty (PTA), as well as safety consistent with standard PTA balloons. The Lutonix 035 DCB is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel, and also utilizes standard mechanical dilatation of the vessel to restore blood flow for patients with peripheral arterial disease (P.A.D.) in the femoropopliteal arteries. The Lutonix 035 DCB was the first drug coated balloon approved by the U.S. Food and Drug Administration (FDA) in October 2014. This approval followed a unanimous favorable recommendation from the FDA's Circulatory Systems Devices Advisory Panel, which voted 9 to 0 on each element of safety, efficacy and benefit/risk. The LEVANT 2 pivotal study is a global, prospective, single-blind, randomized, 54-site study (42 sites in the United States and 12 in Europe) that enrolled all patients under one protocol, comparing Lutonix 035 DCB with standard PTA. Kenneth Rosenfield, MD, MHCDS., section head of Vascular Medicine and Intervention in the Division of Cardiology and Fireman Vascular Center at Massachusetts General Hospital, was principal investigator for the study. "LEVANT 2 followed a rigorous blinding protocol, which was designed to reduce bias in the results,” Dr. Rosenfield said. “In addition to superiority in primary patency, the paclitaxel-coated balloon used in the study also demonstrated sustained improvements in Rutherford category from baseline to 12 months, and improved patient-reported walking distance scores." Dr. John A. DeFord, senior vice president of Bard’s Science, Technology & Clinical Affairs division, said the publication of these data in the New England Journal of Medicine reinforces not only the superior results for

Lutonix 035 DCB compared to standard PTA, but also the rigor of the clinical trial. “This should provide additional confidence to clinicians looking to use a drug coated balloon in treating PAD in the femoropopliteal arteries, Dr. DeFord said. According to the American Heart Association, P.A.D. affects nearly 8 million Americans with more than 50 percent of cases involving the SFA and popliteal arteries. Globally nearly 202 million patients suffer from this disease, which if untreated could increase the risk of heart attack or lead to death. Patients with P.A.D. have reduced blood flow to their lower extremities due to narrowed arteries and carry the risk of amputations. Amputations or limb loss can cause huge physical and psychological burdens to patients and significant costs to the healthcare system. VT N READ MORE: crbard.com

Rivanna gets FDA OK to market its handheld imager Rivanna Medical announced in June that it has received FDA 510(k) clearance to market Accuro, a handheld and untethered smart phone-sized device that is designed to guide a clinician using a needle or probe to a target within the human anatomy. The Accuro device is designed to provide 3D navigation to an anatomical target so a clinician may avoid “guessing” where the target is. The initial application of the Accuro device is for spinal anesthesia needle guidance. “Because there are numerous clinical uses for Accuro, we believe it is a disruptive, gamechanging device platform technology,” John A. Williams, president and CEO, said. Based in Charlottesville, Va., Rivanna Medical is a privately held medical technology company that is commercializing its initial product, Accuro, a proprietary and versatile imaging product that is FDA 510(k)-cleared for spinal anesthesia guidance and a variety of additional imaging applications, such as diagnostic imaging of the cardiac and abdominal anatomies. VT N

For more news, please visit us online at VEINTHERAPYNEWS.com

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Call for abstraCts American Venous Forum th

28 annual Meeting february 24-26, 2016 buena Vista Palace Hotel orlando, florida

abstract submission Deadline: september 14, 2015 Visit veinforum.org for more information! AVF-0715-096


PRODUCTNEWS SIGVARIS adds color to sock lines SIGVARIS North America has introduced its newest innovation in compression socks designed for men in their daily life and for use in the gym. For style that’s quick on its feet, men will appreciate this fun new way to incorporate compression socks into their daily routine. A simple change in socks could dramatically help improve overall leg health by increasing circulation to keep legs looking and feeling their best.

MIDTOWN MICROFIBER

SIGVARIS is an innovator when it comes to creating comfortable compression products that are easy to wear every day. When the

Midtown Microfiber line launched in 2014, it was SIGVARIS’ first compression therapy collection designed exclusively for men in three compression levels. Since that time, the line has expanded with additional sizes and color options, including SIGVARIS’ latest innovation, the dark navy stripe. Constructed from a unique, extremely fine synthetic fiber, Midtown Microfiber was designed with all-day comfort in mind. These socks and thigh-highs offer a tailored look that are perfect for work, travel and daily wear. A high-tech thermo-regulating construction provides year-round comfort and breathability. For men who wear graduated compression daily, Midtown Microfiber in the new dark navy stripe is the perfect combination of style, comfort, therapeutic relief and durability.

Midtown Microfiber is available in 15-20mmHg, 20-30mmHg and 30-40mmHg. The line is available in socks, socks with a grip-top (for men with large calf muscles or slim legs), and thigh-highs (featuring a discreet top band that gives the appearance of socks when worn under pants). The line is currently offered in black and tan-khaki. Several styles are also available in a limited-edition steel grey. The dark navy stripe socks are available in the 15-20mmHg and 20-30mmHg compression levels. SIGVARIS graduated compression products are constructed to be tightest at the ankle and decrease in pressure going up the legs, improving circulation and providing relief SIGVARIS

continued on page 26

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PRODUCTNEWS SIGVARIS

continued from page 25

for tired, achy legs. They also help with the treatment and prevention of varicose veins and other venous disorders.

PERFORMANCE SOCKS

Get ready to hit the gym, road or field sporting the newest shades of the SIGVARIS PERFORMANCE SOCKS. Since the socks were first introduced, they have rapidly been gaining attention among active adults, physicians, fitness experts and athletic trainers. Their significant popularity has inspired four new, fun shades including: blue, lime, pink and red. Utilizing innovative textile technology with active people in mind, the SIGVARIS Performance Socks keep feet cool, dry and comfortable during any activity. The builtin Achilles tendon protector helps protect vulnerable ligaments and a cushioned foot bed was designed to keep feet blister free. In addition to the new colors, SIGVARIS Performance Socks are also available in white and black. The SIGVARIS Performance Socks improve circulation and flush out lactic acid by featuring 20-30mmHg of medical-grade

graduated compression from the worldwide leader in graduated compression. Though there are many different athletic compression products on the market, the SIGVARIS Performance Socks are constructed in a unique way. They are designed to be tightest at the ankle and decrease in pressure going up the leg. This construction helps fight the force of gravity and circulate blood back to the heart and lungs more efficiently, thus helping to improve athletic performance. They also help prevent varicose and spider veins. The complete SIGVARIS SPORTS lineup includes the SIGVARIS Athletic Recovery Socks, the SIGVARIS Performance Sleeves, the SIGVARIS Performance Socks and the SIGVARIS Merino Outdoor wool compression socks. VT N READ MORE: sigvarisusa.com

CSI wins FDA ViperWire OK for P.A.D. treatment Cardiovascular Systems reported July 7 that it has received FDA 510(k) clearance for its ViperWire advance  peripheral guide wire with flex tip for use with peripheral orbital

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atherectomy systems, used to treat peripheral artery disease (P.A.D.). The next-generation ViperWire has reduced tip stiffness and comparable torque transfer, as well as improved trackability through the peripheral arteries, a spokesmen at the St. Paul, Minn.-based company said. The new iteration of the device also has a nitinol support coil and a larger proximal core. “We designed the ViperWire advance with flex tip to improve ease-of-use for our peripheral orbital atherectomy systems when treating complex calcified lesions,” CEO David Martin said. “By improving the predictability and deliverability of the guide wire, physicians will now have more confidence in their ability to navigate tortuous peripheral anatomy and address P.A.D. in a traditionally difficult-totreat patient population.” Cardiovascular Systems released the device in August. In April, Cardiovascular Systems won 510(k) clearance from the FDA for a new iteration of its Diamondback 360 peripheral orbital atherectomy device. Last December, Cardiovascular Systems closed enrollment in the Japanese arm of a trial of its coronary atherectomy device, which it hopes to use to back approval bids in both countries. VT N READ MORE: CSI360.com

TransLite expands Veinlite line with Veinlite EMS PRO TransLite LLC, makers of the innovative Veinlite brand vein finders, have added a bold, new entry into their product lineup for 2015. The new Veinlite EMS PRO joins Veinlite’s family of portable vein access products. Veinlite vein finders are already distinguished by their clinically-proven effectiveness at improving IV access success rates over the standard of care. The new Veinlite EMS PRO is designed specifically to meet the needs of Emergency personnel and nurses, where the current Veinlite EMS has been a major success. It’s no surprise that so many of these medical professionals already rely on Veinlite devices for locating and accessing veins in the field. The Veinlite EMS PRO’s new, integrated exam light takes this reliability and utility one step further by providing quick, one-button access to a built-in flashlight mode. Day or night, this aids in initial patient assessment and reduces the amount of gear required to deliver quality care, making it an essential part of any EMS kit. Key features include: Clinically proven for finding and accessing veins. Locks vein in place during needle sticks – prevents vein rolling. Built-in exam light extends versatility.

Among other benefits, the Veinlite EMS PRO also meets INS Guidelines for infection control, a critical consideration when providing healthcare treatment to any patient. This device is suitable for use on adults and children, and its combination of orange and red LED lights provide optimal contrast for both light and dark skin tones. “Veinlite products are trusted by more than 35,000 medical professionals, with a solid reputation built on effectiveness, quality and innovation,” CEO and Inventor Nizar Mullani said. “The Veinlite EMS PRO takes that legacy one step further.” READ MORE: veinlite.com

Hemogrip wins FDA clearance Remedium Technologies has gained FDA 510(k) clearance to market the Hemogrip patch for the treatment of uncontrolled hemorrhage. The patch controls bleeding occurring from the access of veins or arteries during medical treatment, a company spokesmen stated in a press release. The product relies on chitosan, a natural polymer found in the exoskeleton of crustaceans, to generate a mesh capable of coagulating blood. This is the first product from Remedium, but the company has other bleeding control products in the pipeline, including a clear transparent film, hemostatic gauze and a foam that can be sprayed. Based at the University of Maryland, Remedium has received funding from the National Science Foundation, the United States Army Research Lab, the Maryland Industrial Partnerships, the Maryland Biotechnology Center and Tedco. The devicemaker is seeking CE Mark certification as well. VT N

Cynosure SculpSure wins an expanded indication by FDA Cynosure’s SculpSure lipolysis laser treatment has won an expanded FDA indication, the Westford, Mass., devicemaker reported July 8. The product can be used to eliminate fat in the abdomen. SculpSure was previously cleared for lipolysis of the flanks in May. The device works by disrupting subcutaneous fat cells without the need for surgery, with procedure time taking about 25 minutes for an individual area, the company says. In a multicenter clinical trial, 90 percent of patients reported satisfaction with their treatment, the company claims. Overall, patients demonstrated a significant reduction in fat layer thickness during six- and 12-week follow-ups. VT N READ MORE: Cynosure.com

AUGUST/SEPTEMBER 2015 < VEIN THERAPY NEWS


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Vein Therapy News  

August/September 2015

Vein Therapy News  

August/September 2015