June/July 2013 by HMP Communications, LLC

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Today’s

Contemporary Approaches to Wound Clinic Management

Focus on:

Lower-Limb Preservation Identifying Appropriate Interventionists Utilizing Orthotics & Prosthetics

Also in This Issue: Examining PAD Business Briefs June/July 2013 www.todayswoundclinic.com

SAWC FALL www.sawcfall.com

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Today’s

Volume 7, Number 5, June/July 2013 • www.todayswoundclinic.com

Table of Contents • Feature Articles 10

Identifying Appropriate Interventionists for Lower-Limb Preservation As wound care has evolved, so too have wound care centers. And as the number of wound care centers has increased with demand, so too has those looking to lend their skills to assist in the field. How should providers choose where to allow intervention? Desmond Bell, DPM, CWS & Leah Amir, MS, MHA

Utilizing Orthotic & Prosthetic Intervention in Wound Care Wound care providers should understand the functions of orthotists and prosthetists in order to optimize patient care and produce the most optimal outcomes. Amy Rosetta, CPO, LPO

Peripheral Arterial Disease: Giving Appreciation to an Often-Overlooked Cause of Poor Wound Healing PAD of the lower limbs is an often-overlooked cause of poor wound healing, particularly among the elderly, and affects 1214% of the US population.This article discusses risk factors, prevention, diagnosis, optimal wound care delivery, and alternative diagnoses to be entertained in the event of delayed healing. Michael Cioroiu, MD, FACS, CWS & Jeffrey M. Levine, MD, AGSF

TODAY’S WOUND CLINIC® (ISSN 1938-6311), is published by HMP Communications, 83 General Warren Boulevard, Suite 100, Malvern, PA 19355. TODAY’S WOUND CLINIC® website, www.todayswoundclinic.com, is registered with all major Internet search engines. Full content is available online to TODAY’S WOUND CLINIC print subscribers. Subscriptions: TODAY’S WOUND CLINIC® annual rates for US subscriptions: $99.00 annual; single copies, $39.00. Single or replacement copies of TODAY’S WOUND CLINIC® are subject to availability. To subscribe to TODAY’S WOUND CLINIC®, call (800) 237-7285, ext. 221, write to TODAY’S WOUND CLINIC®, Circulation Department, HMP Communications, 83 General Warren Boulevard, Suite 100, Malvern, PA 19355, or visit us online at www.todayswoundclinic.com. Reprints: Bulk professional-quality reprints (minimum quantity 100) of articles may be purchased. Contact the Managing Editor at (610) 560-0500 for information.

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Editorial Staff

Today’s

Clinical Editors and Founding Board Caroline E. Fife, MD, FAAFP, CWS Dot Weir, RN, CWON, CWS

Founding Editorial Board Kathleen Schaum, MS Christopher Morrison, MD Val Sullivan, PT, MS, CWS

Volume 7, Number 5, June/July 2013 • www.todayswoundclinic.com

Managing Editor Joe Darrah jdarrah@hmpcommunications.com

Table of Contents

Web Editor Samantha Alleman salleman@hmpcommunications.com

Business Staff

Departments 4

Executive Vice President Peter Norris pnorris@hmpcommunications.com VP/Group publisher Jeremy Bowden jbowden@hmpcommunications.com

From the Editor Dot Weir, RN, CWON, CWS

6 Business Briefs Coding, Payment, & Coverage for Fluorescence Vascular Angiography

Sales Associate Brian Hill bhill@hmpcommunications.com

Kathleen D. Schaum, MS

Product Spotlight HMP Communications, LLC

LUNA Fluorescence Angiography System

PRESIDENT BIll Norton

24 TWC News Update

ew Docs Meeting Meaningful Use, Study Shows; MacroCure Names F AAWC Official Lead Clinical Trial Investigator

2013 SAWC Spring/WHS

Ask The Board

Vice President, Special Projects Jeff Hall Marketing Manager Stephanie Manzo

26 Conference Connection

Publisher Kristen J. Membrino kmembrino@hmpcommunications.com

Creative Director Vic Geanopulos vgeanopulos@hmpcommunications.com Art Director Karen Copestakes kcopestakes@hmpcommunications.com

Kathleen D. Schaum, MS

Advertiser’s Index

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TWC Online

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Online Exclusive: Wound Clinic Business Blog

MEETING PLANNER Trisha Keppler

HMP Communications Holdings, LLC Chairman & Chief Executive Officer Jeff Hennessy Chief Financial Officer Dan Rice Senior Vice President Anthony Mancini

83 General Warren Boulevard, Suite 100, ™ , LLC Malvern, PA 19355 an HMP Communications Holdings Company Editorial Correspondence should be addressed to Managing Editor, Today’s Wound Clinic®, HMP Communications, 83 General Warren Boulevard, Suite 100, Malvern, PA 19355. Telephone: (800) 237-7285 or (610) 560-0500 /Fax: (610) 560-0502. Editorial policy: TODAY’S WOUND CLINIC® seeks to provide practical, timely insight into clinical and operational issues inherent to the success of an outpatient wound center. Program Directors, Medical Directors, and Clinical Managers (including Nurse Practitioners and other professional wound care providers across multiple disciplines) will benefit from the interactive nature of feature articles and regular departments that address medical and practice management options and perspectives affecting fiscal and, most importantly, patient outcomes of wound clinics. Articles from knowledgeable, experienced practitioners are invited and will be subject to Editorial Board review.

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Controller Meredith Cymbor-Jones Director of e-Media and Technology Tim Shaw Senior Director of Marketing Corey Krejcik Sr. Manager, IT Ken Roberts

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fromtheeditor

e’re approaching the first official day of summer, but I still haven’t totally distanced myself from the chill of snowy Denver, where many of us recently participated in another magnificent meeting of the Symposium on Advanced Wound Care and the Wound Healing Society. We Dot Weir heard many great comments about the program, the venue, and Co-Editor of TWC the city. I’ve been inundated with phone calls, emails, and text messages from fellow providers, some of whom are calling the event our best ever! It truly was a great program that featured many new and returning speakers and clinicians who are all dedicated to helping their patients heal their wounds and improve their quality of life by, in many instances, preserving limbs.

Saving Limb ‘Salvage’ To that end, with this issue of Today’s Wound Clinic, we too are focused on lower-limb preservation — the goal of all outpatient wound centers. Recognizing the presence of and making the commitment to address the limb-threatening diseases and comorbid conditions that our patients live with is essential to our decision-making as wound care practitioners. Peripheral arterial disease (PAD) of the lower limbs is an often-overlooked cause of poor wound healing (particularly among the elderly) and affects roughly 12-14% of the general population — with increasing risk associated with age. Michael Cioroiu, MD, FACS, CWS, and Jeffrey M. Levine, MD, AGSF, discuss other related risk factors, prevention methods, diagnosis, optimal wound care delivery, and alternative diagnoses to be entertained in the event of delayed healing beginning on page 18. Understanding the differences between those who provide endovascular services is becoming just as important as understanding the disease processes themselves. How should we choose interventionists when referring to cardiologists, radiologists, or vascular surgeons? Unfortunately, differences in quality will arise and people may claim to be “endovascular and limb-salvage specialists” with varying degrees of experience and knowledge. In an effort to guide providers through this maze, TWC editorial board members Desmond Bell, DPM, CWS, and Leah Amir, MS, MHA, have addressed strategies for defining and identifying appropriate endovascular services in your community. Read this piece, which begins on page 10, for vital information that readers need to know.

Proper ‘Heel’ing Helping our patients heal does not fully define the role of the wound care specialist.We need to help them remain healed, and when it comes to offloading or fitting for the right shoe post-transmetatarsal amputation, we should seek the services of a prosthetist or an orthotist. An expert on this topic, Amy Rosetta, CPO, LPO, makes a special contribution as an author to TWC with her article “Utilizing Orthotic & Prosthetic Intervention in Wound Care” beginning on page 14.This feature offers insight that will assist in writing the most appropriate prescription for your next patient, so be sure to check it out. As we gear up for SAWC Fall, our focus on limb preservation will gain a boost from an exciting educational collaboration with the PAD Coalition to co-develop a comprehensive, one-day track on critical limb ischemia (CLI).The PAD Coalition, an alliance of leading health organizations, vascular health professional societies, and government agencies that have united to raise public and health professional awareness about lower-extremity PAD, is a prime ally in the creation of “CLI 2013.” A major focus of the PAD Coalition is to raise awareness of CLI as well as the need for urgent medical care for this condition.Through the newly established partnership, SAWC and the PAD Coalition seek to improve the prevention, early detection, treatment, and rehabilitation of people with or at risk for CLI through continuing medical education beginning at SAWC Fall 2013. n 4

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Today’s

Editorial Board Founding Editorial Board Members Co-Editor of Today’s Wound Clinic Caroline Fife, MD, FAAFP, CWS Co-Editor of Today’s Wound Clinic Dot Weir, RN, CWON, CWS Christopher A. Morrison, MD, FACHM, FCCWS Valerie Sullivan, PT, MS, CWS Kathleen D. Schaum, MS

Editorial Board Members Andrew J. Applewhite, MD, CWS, UHM Leah Amir, MS, MHA Desmond Bell, DPM, CWS Donna J. Cartwright, MPA, RHA, CCS, RAC, FAHIMA Moira Hayes, MHA, RRT, CHT Cathy Thomas Hess, BSN, RN, CWOCN Harriet Jones, MD, BSN, FAPWCA Robert S. Kirsner, MD, PhD Trisha Markowitz, MSN, MBA-HCM, RN, CWCN, DAPWCA Pamela Scarborough, PT, DPT, MS, CDE, CWS Susie Seaman, NP, MSN, CWOCN Tere Sigler, PT, CWS, CLT-LANA Pamela G. Unger, PT, CWS, FCCWS Randall Wolcott, MD, CWS

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businessbriefs

Coding, Payment, & Coverage for Fluorescence Vascular Angiography Kathleen D. Schaum, MS

Information regarding coding, coverage, and payment is provided as a service to our readers. Every effort has been made to ensure the accuracy of the information. However, HMP Communications and the authors do not represent, guarantee, or warranty that the coding, coverage, and payment information is error-free and/or that payment will be received.The ultimate responsibility for verifying coding, coverage, and payment information accuracy lies with the reader.

hile attending the exhibits at the 2013 Symposium on Advanced Wound Care/Wound Healing Society Spring conference, I learned about a fascinating new technology — fluorescence vascular angiography. Currently, numerous approaches are used to determine vascular flow, including the ankle-brachial index test, Doppler measurement, duplex ultrasound scanning, arteriogram, toe systolic pressure index, transcutaneous oxygen measurement, and other more invasive procedures such as computed tomography fluoroscopy. While similar to these procedures, fluorescence vascular angiography provides qualified healthcare professionals (QHPs) with real-time arterial blood flow to an ulcer, capillary perfusion within the tissue in question, and venous outflow (including potential congestion as well as the most current degree of necrosis). This technology allows wound care QHPs to assess macrovascular blood flow and microvascular perfusion in extremities. It is ideal for assessment of both arterial and venous issues, selection for hyperbaric oxygen therapy, interventional surgery, limb salvage, and serial assessment of wound healing and wound care effectiveness. (For more information on this subject, see “Product Spotlight” on page 22.)

It’s probably no surprise that I had many reimbursement questions regarding fluorescence vascular angiography. The manufacturer was kind enough to answer all of my questions. This article shares these reimbursement questions and answers. Q: Hospital-based outpatient wound care departments (HOPDs) will want to know if a code exists for the use of fluorescence vascular angiography in their site of service. Have the Centers for Medicare & Medicaid Services (CMS) established a Healthcare Common Procedure Coding System code for the procedure? A: Yes, in April 2012 CMS established the temporary pass-through code: C9733 Non-ophthalmic fluorescent vascular angiography. Q: Has C9733 been assigned to an ambulatory payment classification (APC) group? A: Yes,C9733 has been assigned to APC group 0397 since April 2012. Therefore, C9733 is separately billable when used in HOPDs. CMS did assign the Q2-status indicator: no separate payment is provided when billed with procedures that are assigned a T-Status indicator, eg, surgical debridement (11042-11047), application of skin substitutes (15271-15278), removal of devitalized tissue (97597-97598), negative pressure wound therapy (97605-97606), and negative pressure, not durable medical equipment (G0456-G0457). Some common wound care services/procedures that do not have a T-status indicator are: application of rigid leg cast (29445), application of paste boot (29580),application of multilayer compression (29581-29584),

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TABLE 1. 2013 Medicare Payment Rates for C9733 National Average Payment Rate

Minimum Unadjusted Co-payment

HOPD

$330.97

$66.20

ASC

packaged

office/outpatient visits (99201-99204, 99211-99214), and hyperbaric oxygen (C1300). See Table I for the 2013 APC payment rates. Q: Some wound care physicians may wish to use this technology in an ambulatory surgery center (ASC). Is this procedure separately payable in ASCs? A: CMS assigned the N1-status indicator to C9733 when performed in an ASC. That status indicator tells wound care QHPs that C9733 is considered a packaged service/item that does not have separate payment when used in the ASC. Q:What Current Procedural Terminology (CPT®) code should QHPs use when they perform this procedure? A: Like other new medical services, no Level I CPT code currently exists that specifically describes the non-ophthalmic fluorescence vascular angiography. Until such time that a specific CPT code is established, CPT coding conventions require that these procedures be reported using an “unlisted procedure” CPT code. Whenever reporting a service using an unlisted CPT code, it is strongly recommended that the freeform field of the CMS 1500 claim form (Field 19,“reserved for local use,” which is 61 characters in length) be www.todayswoundclinic.com

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businessbriefs used to present a crosswalk to another procedure believed to be fairly equivalent and/or comparison to a CPT code for which there is an existing valuation. For example: XXX99 (unlisted code) comparable to XXXXX, payment of $XXX.XX expected. QHPs should consider the following four CPT coding options for fluorescence vascular angiography: OPTION 1: 37799 Unlisted procedure vascular surgery The possible crosswalk is: 75710 Angiography, extremity, unilateral, radiological supervision and interpretation, and 15860 Intravenous injection of agent (eg, fluorescein) to test vascular flow in flap or graft. In this case, the crosswalk in Field 19 of the CMS 1500 claim form might be: 37999 comparable to 75710 and 15860, payment of $XXX.XX expected. OPTION 2: 76499 Unlisted diagnostic radiographic procedure The possible crosswalk is: 75710 Angiography, extremity, unilateral, radiological supervision and interpretation, and 15860 Intravenous injection of agent (eg, fluorescein) to test vascular flow in flap or graft In this case, the crosswalk in Field 19 of the CMS 1500 claim form might be: 76499 comparable to 75710 and 15860, payment of $XXX.XX expected. OPTION 3: 17999 Unlisted procedure, skin, mucous membrane, subcutaneous tissue. OPTION 4: 28899 Unlisted foot or toe procedure. Q: Does Medicare typically cover fluorescence vascular angiography for patients living with chronic wounds, and do any local coverage determinations exist pertaining to this procedure? A: In the absence of a local or national coverage determination, the local Medicare Administrative Contractor (MAC) will determine whether coverage is available for fluorescence vascular angiography on a case-by-case basis. CMS requires all MACs to manu-

TABLE 2. Items to Consider Documenting as Part of Medical Necessity ocument that the patient has critical limb ischemia with tissue loss based on 1. D non-invasive studies and physical examination and that the patient has inoperable disease that cannot be dealt with percutaneously or with additional surgery and why. In addition, document detailed wound care that the patient has had and how it has been unsuccessful.

2. D ocument patient has critical limb ischemia with tissue loss and has no surgical or percutaneous options:

a. Patient has failed prolonged medical therapy and wound care (document both) and is facing amputation.

b. O utline that the level of amputation is difficult to determine because of unreliable ankle-brachial indexes due to calcified non-compressible vessels.

c. Document that a computed tomography scan has been done that demonstrates inoperability. This then leads into why fluorescence vascular angiography should be performed to help delineate the perfusion to the foot or lower extremity to help determine the level of amputation (ie, toe, transmet, bka, aka, etc.)

3. D ocument that without fluorescence vascular angiography, imaging it is likely that the patient will receive a higher level of amputation while the fluorescence vascular angiography procedure would suggest the best level, and therefore save additional procedures should the non-fluorescence vascular angiography directed amputation fail and has to be revised.

ocument that fluorescence vascular angiography was used successfully to as4. D sess perfusion in response to or for selection of therapy (hyperbarics, revascularization, skin graft, other).

ally review all claims submitted with unlisted procedure codes. Therefore, it is recommended that prior to any claim submission that QHPs directly contact their MAC to establish definitive coding direction and intended payment amounts for fluorescence vascular angiography procedures. Failure to do so may result in unnecessary claim rejection and denials. This will require that QHPs write to their respective MAC and express their coding and relative value unit recommendations. Direct physician interaction with MACs is critical to proactively ensure they fully understand the fluorescence vascular angiography procedure. Q: Do private payers cover fluorescence vascular angiography for patients living with chronic wounds? A: Private payer coverage depends on the patient’s insurance plan. Before using fluorescence vascular angiography

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for a particular patient, the QHP should verify the patient’s insurance benefits and obtain written prior authorization, when required. QHPs should keep in mind that prior authorization is never a guarantee of payment.To prior-authorize fluorescence vascular angiography before the procedure is rendered, the following information should be provided to the payer’s prior-authorization department: • Beneficiary name • Beneficiary address • Beneficiary ID number • Date of birth • ICD-9-CM diagnosis code • CPT procedure code • Requesting physician • Requesting physician address • Insurer tax identification or provider name • Facility name • Facility address • Date of service Today’s Wound Clinic® June/July 2013

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businessbriefs Q: What type of documentation is typically required to prove medical necessity for fluorescence vascular angiography? A: All payers will require supporting clinical documentation, which should include: • Detailed patient history with description of patient’s current status, including diagnosis, complaints, and level of impairment. Describe functional impairments, and how the patient’s condition has impacted his/her activities of daily life. • Previous treatment efforts – note procedures, medications, and/ or therapies attempted; include outcome of each treatment. • The medical necessity and rationale for fluorescence vascular angiography, eg, specifics substantiating why this procedure is an appropriate option at this point in the patient’s care, therapeutic goals and anticipated

outcomes, and risk to patient if procedure is not performed. • Description of the procedure. • Clinical benefits of the procedure, eg, how fluorescence vascular angiography will impact physician management of the patient, anticipated improvement in outcomes, etc. • FDA clearance letter for the procedure. • Operative report (if the QHP performed one). • Clinical references supporting the appropriateness and efficacy of the procedure. See Table 2 for items to consider documenting as part of medical necessity. Q: Has Medicare specified diagnosis codes that it deems prove medical necessity? A: No, Medicare has not provided any diagnosis code guidelines.

Q: Are there any National Correct Coding Initiative (NCCI) edits pertaining to C9733? A: As of June 2013, there are no NCCI edits pertaining to C9733. However, remember that the Q2 APC-status indicator prevents payment of C9733 when procedures assigned T-status indicators are performed. Q: I understand that plastic and reconstructive surgeons also use this technology in the operating room (OR). Is there an ICD-9-CM procedure code for the work performed in the OR? A: Yes, in 2007 CMS established ICD9-CM code: 17.71 Non-coronary intra-operative fluorescence vascular angiography. n Kathleen D.Schaum is president and founder of Kathleen D. Schaum & Associates Inc., Lake Worth, FL. She may be reached for questions and consultation by calling 561-964-2470 or emailing kathleendschaum@bellsouth.net.

Wound Care Revenue Cycle Insights: Multiple V iewpoints Don’t miss this entirely new 2013 program that highlights all the changes you must implement.

New Program and Format for 2013

To accommodate the requests from previous years’ attendees and to address the numerous 2013 “hot reimbursement topics,” our faculty has changed the format of Wound Clinic Business 2013. It will be composed of a series of interactive discussions from the viewpoint of the hospital-based outpatient wound care departments (HOPDs), and the qualified wound care professionals who manage wounds in the HOPD and their offices. Who Should Attend? The evaluations from all previous years have one resounding message: “This was the best wound care reimbursement seminar — I only wish people on my team had attended.” Therefore, plan to bring your entire team so that everyone has the benefit of participating in the interactive discussions: medical directors, physicians and podiatrists, non-physician practitioners, HOPD program directors, therapists, coders and billers, office managers, charge description master directors, corporate compliance officers, health information management directors, revenue integrity auditors, hospital executives, and clinical managers. 7:00 a.m. – 7:45 a.m. Registration and Continental Breakfast with Exhibitors 7:45 a.m. – 12:00 p.m. Sessions 12:00 p.m. – 1:00 p.m. Sit-Down Lunch with Exhibitors and Speakers 1:00 p.m. – 4:15 p.m. Sessions 4:15 p.m. – 4:20 p.m. Program Conclusion

Early-bird and group pricing available! Please visit www.woundclinicbusiness.com for complete agenda, registration fees, and additional information.

WCB2013 WOUND CLINIC BUSINESS

WCB2013 Dates/Locations

Note: Dates and locations subject to change.

Friday, September 20

Thursday, September 26

Friday, October 4

Friday, October 18

Crowne Plaza Houston Near Reliant Medical

Bally’s Las Vegas

Embassy Suites St. Louis-Downtown

The Westin Gaslamp Quarter San Diego

Houston, TX 8

Las Vegas, NV

St. Louis, MO

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San Diego, CA

www.todayswoundclinic.com

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Identifying Appropriate InterventionistS For

Lower-Limb Preservation

As wound care has evolved, so too have wound care centers. And as the number of wound care centers has increased with demand, so too has those looking to lend their skills to assist in the field. How should providers choose where to allow intervention? Desmond Bell, DPM, CWS & Leah Amir, MS, MHA

o witness wound care centers evolve into “limb preservation centers” over roughly the past quarter century speaks to the demands of the market as well as the meeting of medical, business, and logical (yet sometimes opportunistic) marketing. The term “limb salvage” has become a common buzzword within the wound care community as the magnitude of the problem surrounding diabetic foot ulcer management has become increasingly apparent. However, not one medical specialty can truly claim ownership of limb salvage expertise over the years. Podiatrists, who focus on the lower extremity, would seem to have the most logical reason to capture the limb salvage market, but the concept of limb salvage has gained rapid acceptance among those in vascular medicine, with the advent of endovascular interventional procedures serving as the catalyst for a greater range of specialists to promote themselves as “limb salvage experts.” Interventional cardiologists, radiologists, and vascular surgeons all recognize the impact of limb preservation, and members within each specialty have marketed their practices as “limb salvage centers.” Can anyone justifiably make these claims? How should wound care providers best determine whom to refer to and when? Definitive answers require practitioners within wound care centers to clearly understand the expertise available to them and to track the clinical success of interventionists they have used or are considering for their patients.

THE ROOTS OF LIMB SALVAGE

Interestingly, limb salvage initially referred to the surgical focus of neoplasm 10

removal that would otherwise be treated by amputation.1 Traditionally an orthopedic specialty, limb salvage focused on both adequate removal of bone tumors followed by bone and soft tissue reconstruction. The Ilizarov techniques utilized in Charcot foot reconstruction have further brought attention to the concept of limb preservation versus amputation, and certainly the acceptance of the concepts of advanced and evidencebased wound care have taken the concept of limb preservation into the medical mainstream. As the population ages and the number of people living with diabetes continues to rise, the need for proficient and efficient wound healing and limb preservation specialists is sure to increase concomitantly. A unique opportunity exists for the multidisciplinary wound care team approach to emerge as the standard model for the delivery of care in limb preservation versus the informal, word-of-mouth network that presently exists. Let’s examine some of the basics, obstacles, and reasons for optimism in the emerging specialty of limb preservation.

EMERGING FROM “SILOS”

It’s becoming cliché to hear the sentiment in wound care that many people are or are not “working in silos.” Although the comparison being made here refers to silos used on farms for storage (each silo on a farm is designated for one specific type of grain), the term has really come into vogue with the emergence of information technology systems and refers to “information silos,” or management systems that are incapable of reciprocal operation with

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other related information systems. Likewise, the term “silo effect” refers to a lack of communication and common goals being shared between departments within a given organization. Focusing on the patient’s need, ensuring quality outcomes, and reducing patient morbidity while operating within a viable fiscal management plan helps to create a shared purpose and vision. While this may sound like an idyllic referral network within one’s practice, it is necessary as the changes resulting from healthcare reform begin to take hold on the practice of medicine. The “silo effect” is a fair assessment of how much of the medical community beyond wound care has long functioned. “Incapable of reciprocal operation with other related specialties” and a “lack of communication and common goals between departments in an organization” could just as easily describe experiences or the dynamic many of us have encountered when trying to engage specialists such as vascular surgeons in our patient care efforts. Knowing, or not knowing, the scope of practice of each other’s specialties is part of the difficulty that exists when seeking to move beyond “silos” and into the dedicated limb preservation team. Finding the appropriate providers who share equally in the motivation to preserve limbs is another challenge. Wound care providers must understand that identifying the correct endovascular specialist for individual patients may determine not only whether a patient could undergo a potentially unnecessary amputation, but may also hold a key as to long-term success and viability of a wound/limb salvage center. www.todayswoundclinic.com

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limbpreservation NEED TO KNOW

Differentiating the differences among endovascular specialists is the first important step in integrating interventionists into the limb preservation team.That said, a brief overview and understanding of peripheral arterial disease (PAD) will enhance the process of wound specialists teaming with interventionists in the fields of radiology, cardiology, and vascular surgery.2 Significant PAD (or the more serious life-and-limb-threatening versions), critical limb ischemia, and acute limb ischemia are often associated with multiple areas of occlusion (multisegmental disease) and presents bilaterally, although one extremity will typically be more symptomatic. Not everyone living with PAD requires intervention. However, the disease state results in atherosclerosis throughout the body and the presence of PAD correlates highly with the presence of coronary arterial and carotid disease. Therefore, screening of these patients is recommended on an annual basis by the American College of Cardiology and the American Heart Association, if the individual is 50 years or older and has a history of diabetes or tobacco use, or if he/she is 70 or older and in otherwise good health. The reasoning here is the increased risk of heart attack and stroke in addition to the complications seen in the lower extremity, such as claudication, rest pain upon elevation of the extremity, ulcer formation, and amputation. Vascular surgeons have long been those specialists who have received the referrals from wound care providers when revascularization of an ischemic limb has been needed. The “toe and flow” model championed by Lee Rogers, DPM, and George Andros, MD, et al, has been cited for its call for podiatrists to work closely with vascular surgeons, and vice versa.3 (For more on PAD, see the article “Peripheral Arterial Disease: Giving Appreciation to an Often-Overlooked Cause of Poor Wound Healing” in this issue.) While this relationship between specialties is an important consideration, the exclusion of cardiologists and radiologists from this model is less of an oversight than an illustration of how quickly the

Bringing the Wound Care Team Together The great news for wound care patients today is there has been a realization among many interventionists who want to work with dedicated wound care practitioners as tantamount to their success as care providers. Making the case for a team approach in medicine, let alone limb preservation, has led to the development of interdisciplinary relationships that may not have previously existed. The obvious benefits are better outcomes for patients in the form of fewer amputations. Consider a situation in which a wound care provider refers a patient who’s living with significant peripheral arterial disease (PAD) to an interventional cardiologist. Upon a complete cardiovascular evaluation of the patient (including an echocardiogram), the cardiologist discovers significant blockage of either coronary vessels or carotid arteries, resulting in an intervention that may have prevented a major event such as heart attack. The interventional cardiologist would also assist in providing the needed intervention to treat the patient’s PAD. It is this balance of medically necessary referrals that can aid the revenue stream to strategically important service lines of an acute care hospital. Referrals between wound care providers and interventionists are mutually beneficial and intuitively yield better care for patients typically living with multiple comorbidities. Finding the best interventionist to enhance the wound care center’s efforts will, in effect, further the progression from wound center to limb salvage center to limb preservation center. The emphasis here remains on the importance of being proactive and taking the holistic approach to the patient and intervening before things turn so bad that “salvaging” is all that can be hoped for. “Salvage” implies a last hope with less than optimal function of the limb. “Limb preservation” implies maintaining hope with a higher level of functioning and independence for the patient. Recognizing your wound care center as a comprehensive limb preservation center should be a goal of providers and administrators alike. — Desmond Bell

emergence of endovascular technology has created a paradigm shift in the way limb preservation is extending beyond the traditional team members. Interventionists refer to vascular surgeons, cardiologists, and radiologists (as well as neurologists and neurosurgeons) who utilize endovascular techniques to restore perfusion to previously occluded arteries. Such techniques are typically minimally invasive and less traumatic than traditional surgical bypass procedures that have (until within the last 10 years) been standard of care for revascularization. Endovascular procedures are usually categorized as atherectomy (physical removal of plaque from arteries either through a cutting or rotating sanding device), stenting (placing of a metal mesh implant designed to keep artery patent), angioplasty (use of a balloon device to physically open a blocked artery), laser, and thrombolysis (when

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a blood clot has formed in an area of plaque or narrowing, a small catheter is placed at the site of the clot and a clotdissolving drug is administered directly to the site. In some cases, thrombolysis is followed by angioplasty and/or stenting to further open the vessel). Deciding which procedure(s) to employ is the decision of the interventionist. Techniques to be used are determined by the location and severity of the occlusion(s). Even the type of blockage can be a factor in that some plaque tends to be more “rubber-like” in texture, while some is far more calcified — more of the consistency of porcelain or cement. As far as vascular tests are concerned, the acuity of the situation will dictate the timing and tests that the interventionist will employ. It would not be appropriate for the wound specialist to order an angiogram or a magnetic resonance angioToday’s Wound Clinic® June/July 2013

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limbpreservation Reader Survey: Working With Wound Care Interventionists The authors and Today’s Wound Clinic would like to know the referral habits of our readers related to wound care interventionists. Look for an exclusive survey through email and we’ll post results in a future issue of the journal!

gram, for example. These tests are the domain of the interventionist. However, the wound care provider should have some familiarity with vascular testing for the sake of knowing which tests to consider and when to order them in order to expedite patient care. The additional ability to perform some cursory arterial tests may further expedite care in situations in which screening, such as an ankle-brachial index, transcutaneous pressure of oxygen, or skin perfusion pressure could validate a clinical concern. One important role the wound care provider plays that is often greatly appreciated by the interventionist is that of “post-procedure advisor.” Within the team approach to limb preservation, the continuum of care model has the wound care provider making timely referrals to the interventionist. After a successful endovascular procedure, the patient continues to be followed by the wound care specialist, who can utilize the same pre-procedure screening tests in the post-procedure setting. This is critical for several reasons. Remember, the typical PAD patient has multisegmental bilateral disease, and, therefore, is always at risk of developing an occlusion at another vessel or within the same vessel. Also, re-occlusion can occur in the same vessel. Diligent monitoring of these patients to the point of erring on the side of caution in communicating any suspicious changes back to the interventionist is always preferred over waiting for obvious ischemic changes to appear. Diligent monitoring of the patient after the intervention is not just sound wound care practice, but is now essential to avoid a 30-day readmission.

DETERMINING BASIS OF EXPERTISE

There are other questions that wound care providers should ask themselves before choosing an interventionist to join 12

in patient care: What special training do interventionists undergo to become proficient in endovascular techniques? Are all interventionists equal in knowledge and scope? How does one determine true aptitude when judging interventionists from a wound care provider’s perspective? Some frank discussion is in order as the rapid evolution of endovascular medicine has facilitated the preservation of many limbs that would have previously been amputated less than a decade ago. Still, this emergence into the mainstream and arguably the new standard of care has created plenty of debate regarding the validity, fiscal responsibility, and examination of who is performing endovascular procedures. Similarities exist between wound care providers and interventionists in that the majority of training that occurs in each field is not typically part of postgraduate training or residency. Much of the clinical experiences obtained by both classes of providers stems from a personal desire or preference to practice in the respective specialty. Interventionists may receive peer-to-peer mentoring in on-site training programs that may be subsidized by industry. At face value, this may seem to hold the potential to create inherent commercial bias, but in reality the demand to train skilled interventionists has outpaced the number of providers. As the number of skilled interventionists continues to grow, the natural progression will see endovascular training become a part of post-graduate medical residencies. Just as wound care providers have varying levels of skill and aptitude, the same must be said of interventionists. One barometer to consider when evaluating an endovascular specialist who focuses on limb preservation is the ability to take his/her skill set to the arteries below the knee. The trifurcation below the popliteal artery is where arteries become less robust and, therefore, are more susceptible to occlusion. Placing a stent or perform-

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ing an angioplasty within the superficial femoral artery is much less technically difficult than performing the same procedure within the anterior tibial, peroneal, or posterior tibial arteries. Truth be told, not every interventionist may have the ability or inclination to perform procedures below the knee. These cases tend to be physically demanding on the interventionist, who must wear a protective lead vest weighing approximately 40 pounds while standing for hours in cases that can often run between 4-6 hours in a cath lab (or often in an angiography suite). Ultimately, the body of work that an interventionist produces over time truly determines whether or not he/she is appropriate for the limb preservation team. The same must be said regarding wound care providers. One thing is certain, however: There is a mutual respect and admiration between members of both groups that comes with repeated success. This is amplified when members work together and communicate with one another as well as with the patient. n Desmond Bell is a board-certified wound specialist (CWS-American Academy of Wound Management, for which he’s a board member) and a fellow of the American College of Certified Wound Specialists. He is founder of the Limb Salvage Institute and Wound Care on Wheels LLC. A frequent lecturer and author on wound care, peripheral arterial disease, and diabetes, Bell was awarded the Frist Humanitarian Award by Specialty Hospital in 2009. He may be reached at drbell@savealegsavealife.org. Leah Amir, MS, MHA, is a healthcare economist with experience bringing together multidisciplinary teams to focus on cost-effective patient management. She is executive director of the Institute for Quality Resource Management, St. Louis, MO. References 1. Gitelis S, Malawer M, McDonald D, Derman G. Principles of limb salvage. Chapman’s Orthopaedic Surgery. 126; 3310. Lippincott Williams and Wilkins. 2001. 2. Thrombolysis in the management of lower limb peripheral arterial occlusion — A consensus document. J Vasc Interv Radiol. 2003; 7:S337–S349. 3. Rogers LC, et al.Toe and flow: Essential components and structure of the amputation prevention team. J Vasc Surg. 2010 Sep;52(3 Suppl):23S-27S. www.todayswoundclinic.com

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Utilizing

Orthotic & Prosthetic Intervention in Wound Care

Wound care providers should understand the functions of orthotists and prosthetists in order to optimize patient care and produce the most optimal outcomes. Amy Rosetta, CPO, LPO

aking a multidisciplinary approach has become the “gold standard” within the medical community, as it has proven to be optimal for patient care. Wound care is no exception, and as the incidence of wounds and diabetes has increased over the years, so too has the need for educational programs and, more recently, an orthotic and prosthetic wound care specialty in order to complement wound care delivery. The evaluation, offloading, and prevention methods established by orthotics and prosthetics have been proven enhancements to all wound care protocols. A multidisciplinary approach to wound care that includes orthotics has also improved outcome measures and decreased healing times for neuropathic patients while improving quality of life for this highrisk population. Orthotic/prosthetic intervention can play an important role in wound care treatment or preventative care. It is important to understand the services that orthotic/prosthetic facilities offer and how to obtain these devices. Many factors including patient need, facility inventory, and insurance coverage

affect the waiting time for a particular device. By understanding the orthotic options and keeping open communication, the patient benefits through quality care and improved quality of life. This article looks at the development of orthotics, the special role it plays in the wound care industry, how wound care providers can best integrate orthotics into daily practice, and pathways to consider to become specialty credentialed (see Table 1).

Roots of Orthotics & Prosthetics

Archaeologists have uncovered evidence of orthotic and prosthetic devices being used on Egyptian mummies and in tombs dating back to 300 B.C.1 The study of orthotics is said to have begun with blacksmiths and armor makers fabricating ambulation devices for injured people through the making of splints and braces. After the Civil War and subsequent wars, injured soldiers served as the stimulus for improved ambulation options, leading to advancements in the study of prosthetics, which have closely been associated with amputation surgery

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performed as a lifesaving measure for military soldiers. Before the Civil War, few artificial limb companies existed. But by the time the aftermath of World War II and polio epidemics of the late 1940s and early 1950s set in, survivors of musculoskeletal and neuromuscular impairments or traumatic war-related amputations further increased the demand for orthotic and prosthetic services. Although orthotics and prosthetics may seem to be worlds apart in that the former involves treating body parts while the latter replaces damaged limbs, a correlation exists between the patient evaluation process, the fabrication process, and the understanding of gait. In 1948, the American Board for Certification in Orthotics, Prosthetics & Pedorthics (ABC) was formed to set minimum standards for practitioner education and experience levels as well as to test clinical knowledge. Today, the field of orthotics and prosthetics is a well-recognized specialty in the medical community. As of 2010, more than 5,600 practitioners had been certified by ABC. www.todayswoundclinic.com

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limbpreservation Comparing Orthotics & Prosthetics

The goal of treatment for any neuropathic or dysvascular patient is to preserve the limb and ambulatory function. The role of the orthotist/prosthetist is to redistribute weight-bearing forces on the neuropathic limb. This role is continuous from ulcer management to accommodation and follow up. Orthotists treat the entire body through externally applied devices designed to support or correct deformities. This can vary from upper-limb to spinal deformities to cranial-remolding bands. Prosthetists treat limb deficiencies by replacing the missing limb with a device or prosthesis. The most common orthotic/prosthetic interventions in wound care include: • Compression therapy: Serves several purposes in the treatment of venous insufficiency by improving circulation and decreasing edema. If a lymphedema specialist is not available, an orthotist can easily measure and fit the patient with compression stockings. Ideally, the patient is treated with wraps until the edema is under control or the venous ulcer has healed enough to prevent reoccurrence. Some facilities may keep stockings on-site; however, there are many different styles and options that patients may choose. Juzo,® Jobst,® and Medi offer some of the more common compression hoses, which should be ordered about two weeks before the patient is ready to begin wearing stockings. The prescription should also detail whether below- or above-the-knee compression is needed and the range of compression desired (low, medium, or high). Open toe/closed toe and designs/colors that will appeal to men and women should also be considered. If the patient is currently wearing professional wraps, a coordination of teams is important to get the optimal fit. For example, when the patient is due for a wrapping change, send him or her to

TABLE 1. Certification Title

Abbreviation

Credentialing Organization

Certified Orthotist

ABC

Certified Prosthetist

ABC

Certified Prosthetist Orthotist

CPO

ABC

Certified Orthotist

BOCO

BOC

Certified Prosthetist

BOCP

BOC

Certified Prosthetist Orthotist

BOCPO

BOC

Certified Pedorthotist

C.Ped

ABC

Certified Pedorthotist

BOCPD

BOC

Certified Orthotic Fitter

CFo

ABC

Certified Orthotic Fitter

BOC COF

BOC

Certified Fitter Therapeutic Shoes

CFts

ABC

Licensed Prosthetist Orthotist

LPO

State regulated

the orthotists, who can remove the wraps and measure the patient before being sent back to the wound care center for new wraps. Once those wraps are worn and ready to be changed, the compression stockings should be ready for the patient to receive. • Wedge shoes or half shoes: Both strive to offload a pressure area on the bottom of the foot. The wedge shoe has full contact with the foot, but reduces load by lessening the amount of sole in contact with the ground. For example, to offload the forefoot, the heel is elevated and angled to prohibit forefoot contact with the ground. Although effective, a problem with this design is the undesirable effect on balance and gait, which may increase the need for an assistive device. The half shoe is a shoe cut in half across the width and is designed to offload a certain area of pressure such as the heel. It does effectively offload

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the affected area, however, it puts tremendous stress at the transition point on the foot when weightbearing. • Postoperative or cast shoes:Very common in the wound care setting. They contain a rigid sole and removable insole that can be cut out under the ulcerated area for relief. As the simple Velcro design allows for bandage volume, it does not offer an intimate fit, so it cannot control foot motion (which may leave the patient at risk for rubbing). These are particularly helpful when the patient is under a continuous-care program where the foot is monitored closely. They are also very easy to adjust or change as the patient changes. Also, the bottom typically is flat and rigid, so patients may have to adjust their gait. • Wound care shoe system: A special style of shoes designed specifically with wound care relief in Today’s Wound Clinic® June /July 2013

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limbpreservation mind, though it’s a more expensive option that is not always covered by insurance. The wound care shoe system is a leather sandal designed to be trimmed away at pressureprone areas such as bunions or the heel. The leather is fully padded to not induce extra pressure. The sole is a rocker bottom, which allows the patient the full gait cycle — unlike the cast shoe. It has four removable insoles that give plenty of room to offload multiple areas. • Prefabricated (CAM walker or CAM boot): Primarily designed for treatment of fractures and sprains, as it is basically a removable cast. Eliminates the motion of the ankle with a rocker bottom for easy ambulation and has become popular due to availability and built-in removable layers for pressure relief along the plantar surface of the foot. The soft padding is removable, making sanitation easy. These boots can also be pneumatic, which gives the patient an optimal total contact fit as to decrease adverse pressures. • Charcot Restraint Orthotic Walker (CROW): Custom-made bivalved ankle foot orthotic, this device is a removable total contact cast that has been proven in treatment of plantar diabetic foot ulcers. This device is plastic and lined with a soft foam padding called plastazote and uses a total contact surface to help distribute pressures evenly up the calf. The insole is a removable custom-molded insert made from different density layers and can be modified to offload an area or areas of concern. The plantar surface has a built-in rocker bottom sole, so the boot replaces the shoe on that extremity.This device is particularly helpful in preventing further breakdown of the Charcot ankle. herapeutic shoes: Designed •T to prevent or decrease the risk of future complications. In a wound 16

care setting, it is important to first treat the patient for the wound until it’s a manageable size and requires limited bandaging before attempting to place the patient in shoes. To be considered as a therapeutic shoe, the shoe must provide extra depth and must have a closure such as laces or Velcro strap. The main difference between regular shoes and therapeutic shoes is the deeper toe box and overall increased depth to allow room for an accommodative insert. The purpose of the shoes is to achieve a proper fit in order to avoid shearing forces caused from movement of the foot inside the shoe or by an improper width, which can apply undesirable pressure along the sides. Shoe modifications can range from adding an elevation to address height discrepancy to a flared wedge to help control ankle motion. A metatarsal bar on the outside of the shoe is a nice modification to help roll over the metatarsal heads, therefore offloading them. In severe cases such as deformity, custom shoes may be needed in which a custom cast is taken, and fabrication is usually 4-6 weeks. • Shoe inserts: Go by many different terms such as “foot orthotics,” “accommodative insoles,” and “arch supports.” The insole is molded to the bottom of the foot, causing the entire sole to participate in the force distribution and resulting in lower pressures. There are many different materials that inserts can be fabricated from, but typically will be a compilation of layers made from different materials with different densities for neuropathic patients. For insensate feet, the arch support should be accommodative, not corrective, as one does not want to create adverse pressures that could lead to breakdown. One of the main purposes and goals with inserts is total contact (similar to the CROW boot).

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Toe fillers and partial feet amputations are addressed based on the level of amputation and need for the patient. A common transmetatarsal amputation for a neuropathic patient would be an insert with a foam block to fill the toe area to fill the shoe.These toe fillers should be carefully fabricated as not to rub on the remaining limb. • Diabetic socks: Have no seams and are made of materials such as cotton to help wick away perspiration. Decrease the risk of rubbing caused by seams and provide a dry environment. They can also come with silver, which has been shown to be antibacterial and an aid to healing.

Obtaining Orthotics

A common misconception is that an orthotic/prosthetic facility is similar to a pharmacy, in that patients arrive with a prescription that is filled while they wait. Many times this is not feasible because patients will need to be seen and evaluated by the practitioner orthotist/prosthetist, who, for the most part, is filling a prescription but has to consider many variables that are different for each patient. For example, if a physician orders “diabetic shoes and inserts,” the patient still needs to be evaluated to determine if the inserts should be customized or off-the-shelf, whether any pressure areas require relief, and what type of material is best suited for the patient. Most facilities prefer appointment scheduling, but sometimes walk-ins are necessary based on logistics or overall need. Once the practitioner has chosen an item for the patient, it is coded through the Healthcare Common Procedure Coding System. The office staff will usually check benefits to determine coverage and patient copay. It is important to note that coverage varies depending on the plan or insurance company. Once coverage is determined, fabrication or ordering of the device can begin. Depending on the device, the patient will be contacted when it is ready for delivery or www.todayswoundclinic.com

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limbpreservation when the wound care professional approves patient fitting.

Patient Communication

Communication is crucial to providing quality patient care, and wound care providers play an important role in discussing the patient’s needs to the orthotic/prosthetic clinic. From this author’s experience, a basic prescription is a good starting point. For example, a patient with an amputated first ray and ulcer under the first metatarsal head could come to the facility with a basic script that reads, “insert to offload 1st methead.” The trained orthotist or pedorthotist will evaluate the patient and the facility will generate a prescription with the detailed coding and descriptions of the services planned to provide to the patient. This may seem tedious to the ordering physician who then has to sign another script, but it is a doublecheck system, a chance to make sure the orthotists/prosthetist is providing something within good scope of practice. If the ordering physician disagrees or has questions, he/she has the opportunity to address the issue before patient delivery. Although Medicare is the only provider that requires these detailed prescriptions, a detailed script with coding is effective protocol to use for all patients because it conveys sound patient care and thorough communication.

Therapeutic Shoe Bill

In 1993, the US Congress introduced the Therapeutic Shoe Bill in an effort to reduce lower-limb amputations and other foot complications related to diabetes. This bill provides coverage for extra-depth shoes and accommodative inserts for patients who live with diabetes. In recent years, this policy has undergone many changes as Medicare tries to eliminate abuse and fraud. This is very important to address since many wound care patients receive Medicare and live with diabetes. Other private insurance companies may or may not provide coverage for therapeutic shoes, but most do

There are many pathways to take in order to become a practitioner in the orthotic and prosthetic field. Typically, an orthotist or prosthetist will receive a baccalaureate in orthotics, prosthetics, or a related field before traversing to a post-baccalaureate certificate program or a master’s program. (Currently, the field is transitioning, replacing certificate programs with master’s programs.) Once formal education is complete, the student then conducts a year’s residency per discipline and must pass a three-part exam per discipline by a certification board in orthotics and prosthetics to gain certification. There is another route through a different credentialing organization (Board of Certification) that exists, which includes some level of higher education, a certain number of years of experience, and an exam. Other careers in the orthotic/prosthetic field include an orthotic/prosthetic assistant, orthotic fitter, pedorthotist, and therapeutic shoe fitter. In the world of wound care, a patient could be treated by any of these personnel and may be under the supervision of a certified orthotist, depending on state regulations. The pedorthotist education levels vary, but specialize in orthotic treatment of foot and ankle conditions, which are most predominate in wound care. Each practitioner is trained to assess and formulate a treatment plan based on the patient’s needs. — Amy Rosetta

not have the stringent requirements of Medicare. Currently, Medicare will allow one pair of approved shoes and three sets of inserts per calendar year. Certain substitutions may occur due to shoe modifications or toe fillers. The shoe provider must be accredited and the individual practitioner must be certified.The wound care physician may order shoes and inserts; however, the diabetes-treating physician must be the one to sign the “statement of certifying physician or certificate of medical necessity.” The supplier providing the shoes must also retain a copy of the physician’s records that document the need for the care provided. This could mean that the patient has to visit his/her primary care physician, in which case it is helpful to provide wound care clinic notes to allow the physician to document ac-

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cordingly. It’s the responsibility of the supplier to obtain all necessary forms before the patient can receive shoes. Although this can create a delay, it also means that all members of the patient’s care team need to work together to provide the patient with the best possible service. Due to these requirements, many orthotic/prosthetic facilities do not provide therapeutic shoes due to labor intensity and low profits. n Amy Rosetta is a certified prosthetist orthotist and licensed prosthetist orthotist on staff at Muilenburg Prosthetics, Houston,TX. Reference 1. Atlas of limb prosthetics: Surgical, prosthetic, and rehabilitation principles. American Academy of Orthopaedic Surgeons. 2nd Edition; 1981. Edited by John H. Bowker and John W. Michael. Mosby Year Book. Today’s Wound Clinic® June /July 2013

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Peripheral

Arterial

Disease:

Giving Appreciation to an OftenOverlooked Cause of Poor Wound Healing Michael Cioroiu, MD, FACS, CWS & Jeffrey M. Levine, MD, AGSF

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limbpreservation

eripheral arterial disease (PAD) of the lower limbs is often neglected when evaluating reasons for poor wound healing, particularly in elderly patients. Affecting roughly 12-14% of the general US population, PAD increases with age and affects up to 20% of patients who are older than 75.1 Risk factors include diabetes mellitus, hypertension, smoking, and hyperlipidemia. PAD can also critically hamper one’s wound healing as well as prevent optimum delivery of systemic antibiotics, which can result in polymicrobial infections and advancement to osteomyelitis. The healing of any wound of the lower extremity, including those from trauma, pressure, or venous stasis, can be adversely affected by poor perfusion associated with atherosclerotic disease. Treatment of any lower extremity wound involves local hygiene, moisturizing cream for dry and flaking skin, removal of slough and necrotic tissue, antimicrobials (if indicated), and judicious choice of advanced dressings. If a wound does not respond to routine measures, alternative diagnoses must be entertained. Diagnostics include basic blood work, biopsy, and consideration of non-invasive vascular studies. This article discusses proper monitoring for PAD and appropriate approaches to treatment.

PAD SURVEILLANCE

The typical symptom of a wound resulting from PAD is extreme pain; however, lack of pain does not rule out arterial disease as a contributor to poor wound healing. When PAD of the lower extremities is present, there are often other manifestations of arterial disease in the history, such as heart attack or stroke. The classic symptom of PAD is intermittent claudication, or muscle cramps, occurring in the legs when walking, usually around the calf. Pain can be mild or severe and usually goes away with rest. Intermittent claudication may be absent in patients with limited mobility. People who walk slowly or are wheelchair-bound due to musculoskeletal disease may not have symptoms of claudication but still 20

have advanced PAD. Pain in the limb while at rest, advanced ulceration, or gangrene is categorized as critical limb ischemia and may lead to limb loss if revascularization is not considered. Diagnosing PAD in a patient with a nonhealing wound is important, as improvements in arterial perfusion promote wound healing. Once diagnosed, treatment can begin with antiplatelet therapy, vasodilators, statins, and lifestyle changes such as weight loss and smoking cessation. Surgical therapies such as endovascular procedures or vascular bypass grafting must also be con-

“The typical symptom of a wound resulting from PAD is extreme pain; however, lack of pain does not rule out arterial disease as a contributor to poor wound healing.” sidered. Many complications related to PAD can be prevented with basic foot care, control of risk factors, timely treatment of ulceration, and interdisciplinary collaboration between nutritionists, nurses, physicians, and other specialists including podiatrists and vascular surgeons. Patients who live with PAD also have increased prevalence of vascular events elsewhere in the body, making control of risk factors a priority. Atherosclerosis is characterized by thickening and loss of elasticity of the arterial walls and affects the abdominal aorta and the small- and medium-size arteries of the lower extremities. Physical signs include diminished or absent popliteal artery, posterior tibial, and dorsal pedis pulses. Other bedside diagnostic signs include delayed capillary refill, coolness, and chronic changes of the skin such as hairlessness, shininess, pallor, and thinning. Decreased sensation associated with peripheral neuropathy is often present, particularly in those living with diabetes. When diag-

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nosing vascular ulcers, it is important that bedside physical diagnostic signs be supplemented by objective measurements obtained by vascular studies.

TESTING FOR PAD

Several non-invasive vascular studies are available, including ankle-brachial index (ABI), duplex ultrasound, and pulse-volume recordings using plethysmography. A plethysmograph is a device that records variations in volume and blood flow through the extremity and translates arterial pulsation in the lower extremity into visible waveforms (pulse volume recordings) using inflated cuffs at various levels of the leg. ABI is a measure of ankle systolic pressure divided by brachial systolic pressure and is considered a standard test for PAD, but loses diagnostic value when arteries have advanced stiffness due to calcification. A normal ratio is 0.9-1.3, and a ratio less than 0.9 indicates a decrease in ankle blood flow relative to the arm. An ABI less than 0.5 indicates severe occlusive disease to the leg; however, this result is less reliable when arteries are stiff, as occurs when calcification is present. It is therefore advisable to supplement ABI with other studies. Pulse volume recording does not examine specific blood vessels but assesses the entire blood flow of the examined limb. The normal pulse volume waveform shows a systolic upstroke with sharp peak, followed by a downstroke with a dicrotic notch. Changes in contour that indicate PAD include diminution of pulse amplitude, blunted amplitude of the waveform, and absence of dicrotic notch. With severe PAD, pulsation is absent and waveforms are flattened. Transcutaneous oxygen pressure is another non-invasive test that can assist with therapeutic decision-making, as an abnormal result suggests the patient may benefit from hyperbaric oxygen therapy. If non-invasive vascular studies suggest that a patient has blockage in the arteries of the lower extremity, chances of wound healing are greatly rewww.todayswoundclinic.com

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limbpreservation duced and revascularization must be considered as an adjunctive therapy. Medical resonance angiography, computerized tomographic angiography, and angiogram are the next steps in determining endovascular intervention or revascularization. The rapid advances in catheter-based technology and percutaneous, minimally invasive vascular procedures have drastically decreased the use of open surgical revascularizations. Endovascular treatment offers the advantage of local anesthesia and return to ambulation on the day of treatment.

PAD TREATMENT APPROACHES

A large variety of minimally invasive endovascular technologies have become the mainstay of PAD treatment today and have largely supplanted open surgical bypass revascularization. Until recently, severe infrainguinal atherosclerosis was too anatomically challenging for minimally invasive treatments,

but it is now assuming a primary role. Endovascular revascularization avoids additional wound healing problems related to vein harvesting and other surgical incisions and promotes shorter hospital stays. These newer technologies include laser atherectomy, balloon angioplasty, cryoplasty, and stenting. Outcomes related to percutaneous endovascular interventions are promising with regard to limb salvage rate and wound healing. Several factors are considered when deciding upon revascularization, including general health of the patient, ambulatory status, and severity of the wound and limb ischemia. The vascular surgeon will also consider anatomic distribution of the disease and history of prior vascular interventions. Techniques for endovascular interventions are evolving rapidly, and outcomes related to particular technologies are still being studied. The elderly population is currently the most rapidly growing

REFRAIN FROM

PAIN

sector of American society. Multiple comorbidities frequently accompany advancing years and wound etiology is often multifactorial. When patients present with nonhealing wounds of the lower extremity, PAD must be considered as a contributing factor. The outpatient wound center should be prepared with access to resources that include vascular testing and consultation from a vascular specialist. (For more information on consultation, see “Identifying Appropriate Interventionists For Lower Limb Preservation” in this issue of Today’s Wound Clinic.) n Michael Cioroiu is a medical director and Jeffrey Levine is a staff physician at the Center for Advanced Wound Care, Beth Israel Medical Center – Petrie Division, NYC. Reference 1. Meijer WT, et al. Peripheral arterial disease in the elderly: The rotterdam study. Arterioscler Thromb Vasc Biol. 1998;18(2):185-92.

Painful dressing changes can occur when the wound bed adheres to the dressing material. Removal not only causes pain, but tears away vital granulation tissue, thus regressing the healing process. Now you can make painful dressing changes a thing of the past, no more need to premedicate patients, or expend tedious efforts to remove a dressing. LipoGel, a proprietary mixture of lipids, forms an easy-release barrier between healing tissues and the dressing materials. And for more difficult wounds, LipoGel® Rx even offers anti-microbial prescription strength formulation.

BMG

BIOFILM MANAGEMENT GROUP 1070 E. Wieland Rd. | Lansing, MI 48906 | 888-906-4440 email: BiofilmMgtGroup@gmail.com

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Today’s Wound Clinic® June /July 2013

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productspotlight What You Need to Know About the LUNA Fluorescence Angiography System Information for this feature was provided by Brian D. Lepow, DPM, AACFAS, associate at Lepow Foot and Ankle Specialists, Houston, TX.

Featured product: LUNA Fluorescence Angiography System.

Date of product launch/release: Pre-launch occurred during fall 2012 with full launch in March 2013 at the Diabetic Foot Global Conference in Los Angeles. In honor of the launch and to highlight the winner of the 2013 Edward J. Olmos Award for Advocacy in Amputation Prevention (Lawrence B. Harkless, DPM), Novadaq presented the College of Podiatric Medicine at Western University Health Sciences (Pomona, CA), where Harkless serves as founding dean and professor of podiatric medicine and surgery, with a LUNA system for use in podiatric medical and surgical training.

Product description: The LUNA Fluorescence Angiography System is the latest member of Novadaq’s SPY Fluorescence Imaging technology family of products. LUNA combines the properties of a fluorescence imaging agent called indocyanine green with unique near-infrared laser, camera technologies, and sophisticated software to produce high-quality angiographic images of blood flow in vessels and tissue perfusion. LUNA does not involve the potential safety hazards associated with ionizing radiation and traditional contrast agents, making it an ideal system for use by wound clinic staff and in patients

NOVADAQ TECHNOLOGIES INC. Toronto, ON Email: customerservice@novadaq.com Phone: 800-230-3352 www.novadaq.com Company profile: Novadaq’s global mission is to enable medical professionals with clinically relevant, innovative fluorescence imaging solutions to enhance the lives of patients and their caregivers while reducing healthcare costs.

whose kidney function may be of concern, such as those living with diabetes. The LUNA system consists of a mobile unit with an articulating arm that facilitates easy movement of the imaging head over the area of interest. Once the

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camera is positioned, the imaging agent (which binds to the proteins in blood and circulates naturally and quickly through the body) is administered and the LUNA system is activated. Moving images of blood flow into and out

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productspotlight of the area of interest are captured by the camera and displayed on flat-screen monitors that are attached to the mobile unit. Images are processed, can be further analyzed using the analysis toolkit software, and are then stored for future reference and comparison. LUNA software enables the automated generation of a procedure report that can be printed and stored in the patient’s record. LUNA also allows for the capture, storage, and printing of still-color photographs with the push of a button. The system also consists of the LUNA convenience Paqs, which include all the disposable products required to perform LUNA studies in the wound care clinic.

Product’s role in the wound care clinic: LUNA allows for visual assessment of blood flow quality to extremities and chronic nonhealing wounds. LUNA images can assist wound care specialists in determining the best care pathways for patients and have been reported in the literature to potentially be predictive of wound healing. The use of LUNA allows specialists to quickly and easily observe real-time, clinically relevant images of inflow and outflow of blood in an area of interest and to make critical decisions that may influence patient outcomes. The result: Patients can be more efficiently directed into the appropriate care pathways to promote healing, which ultimately can also reduce the cost of care. LUNA procedures are reimbursable and allow wound care specialists to assess and document baseline tissue perfusion on admission, define optimal care pathways based on the visual quality of blood flow, and validate and revise treatment strategies by assessing perfusion before and after therapies such as: • vascular intervention • hyperbaric oxygen therapy (HBOT) • tissue debridement • negative pressure wound applications • skin substitutes.

How is the product unique? The LUNA system is unique in that

it provides wound care specialists with a real-time, clinically relevant visual image of tissue perfusion in the extremities and chronic nonhealing wounds. Images can be acquired within approximately 2-3 minutes without causing any patient discomfort or need for sedation. LUNA imaging studies can be performed by existing wound care staff and do not require specialized personnel or additional infrastructure. Multiple imaging studies can be done if necessary during a single patient visit. Images can be stored for future reference and specialized software allows for the comparison of serial images over time, which can be critical in managing patients through certain therapies such as a series of HBOT, for example.

Are there different variations/ models of the product or are any planned? No, and none are planned for the immediate future.

Are there any warranty offers? Yes, LUNA is sold as a “program,” which means customers are eligible to receive additional value beyond what is typical of other device purchases. The LUNA program fee includes clinical education and training support, marketing and reimbursement support, and technical service for the life of the program agreement. So, with the exception of gross negligence, Novadaq covers the cost of all service and maintenance of the system.

Does the product come with any training or educational materials?

Does the product come with any add-on services?

Where is the product available for purchase?

Yes, the LUNA program includes clinical and educational support services that offer trained professionals to be on-site to ensure the system is being used properly by both physicians and support staff. The LUNA program also includes the support of reimbursement experts to help ensure proper billing and coding practices are put in place to maximize reimbursement to the clinic. The Centers for Medicare & Medicaid

The product can be purchased in the US through Novadaq’s direct-selling organization. To contact a local sales professional, call Novadaq customer service at 800-230-3352 or email customerservice@novadaq.com

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Services have effected code C9733 to describe LUNA fluorescence angiography and have established a standard payment for the procedure as of October 2012. In addition, LUNA can assist wound care centers in differentiating themselves from other centers in their regional area. Knowing that marketing budgets are tight for both wound care clinics and hospitals, Novadaq provides turnkey marketing support and materials that are customizable and allows our customers to promote themselves as leaders in the field. Materials include news, broadcast and media releases, newsletter templates, patient education materials, referring-physician campaigns, health fair materials, and more. Novadaq can act like a silent partner or be as active as our customers would like, and we’re often asked to reach out to media and others on their behalf. Customers who have taken advantage of Novadaq’s marketing support have claimed to save thousands of dollars in expenses by not having to develop their own materials.

Yes, in addition to the on-site mentoring program, Novadaq provides reference guides, videos, and other materials that assist wound care specialists and their staffs to properly perform and interpret LUNA images to physician and support staff. We also provide materials to educate patients and referring physicians.

For additional information: Contact a sales representative or customer service associate at 800-230-3352 or customerservice@novadaq.com. n

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TWCnewsupdate MacroCure Names AAWC Official Lead Clinical Trial Investigator Vickie R. Driver, DPM, MS, FACFAS, has been nominated as the lead principal investigator of a Phase III clinical study on chronic lower-extremity ulcers currently being conducted in the US, Canada, and Israel by MacroCure, an international biotechnology company. The trial reportedly includes 400 adult patients who live with chronic ulcers of the lower extremities that are being treated with CureXcell.® The objective of the study is to evaluate the safety and efficacy of CureXcell as an adjunct to wound care, according to MacroCure officials. The trial is being conducted as a randomized, double-blind, parallel group, sham-controlled study. Driver, president-elect of the American Association of Advanced Wound Care (AAWC), also currently serves as chief of podiatric surgery/director of research for limb preservation and wound healing with the VA New England Health Care Division’s department of surgery. Additionally, she is active with the Wound Healing Center of Rhode Island Hospital, a Brown University teaching hospital, and has served as director of clinical research, limb preservation and wound care, and international research fellowship programs at Boston Medical Center. She was also an associate professor of surgery at Boston University School of Medicine. “I am pleased to have been appointed as principal investigator for MacroCure’s Phase III clinical study,” Driver said. “Previous studies of MacroCure’s innovative CureXcell cell therapy treatment have demonstrated positive results,

indicating the tremendous potential it holds for the treatment of hard-to-heal wounds currently effecting millions of people suffering from diabetes mellitus, hypertension, coronary artery disease and other chronic conditions.” “We are excited to have someone with Dr. Driver’s credentials and experience in wound healing leading this next phase of trials exploring CureXcell’s potential for treating patients with hard-to-heal wounds,” said Nissim Mashiach, president and CEO of Macrocure. “The multinational trial currently underway follows our successful treatment of ulcer patients in Israel and will allow us to advance our solution in the global market.” n

California Wound Center Appoints Medical Director Board-certified vascular surgeon Omar Araim, MD, has been named medical director for the Adventist Health Wound Healing Center in Hanford, CA. Araim earned his medical degree at Emory University School of Medicine, followed by general surgery training at Medical College of Virginia Hospitals and vascular surgery training at Yale University’s Vascular Surgery Division and Ann Arbor’s St. Joseph Mercy Hospital. He completed his fellowship training at Cleveland Clinic. The center features a team of board-certified physicians that provides a multidisciplinary approach to chronic wound issues. Physician specialties include general surgery, podiatry, and vascular surgery. The center is also staffed with experienced wound care nurses. n

Few Docs Meeting Meaningful Use, Study Shows While more physicians overall are said to be utilizing electronic health records (EHRs), only a small sampling of them have met Stage I of Meaningful Use, according to a new study. A national survey released in March 2012 showed that 43.5% of physicians reported having a basic EHR (up from 34% in 2011), but only 9.8% said they met criteria for Meaningful Use, according to Mathematica Policy Research, Cambridge, MA. The results followed a 2012 survey from the National Center for Health Statistics that only reported about 25% of physicians had computers in their respective practices that were equipped to meet Stage I Meaningful Use, which earns eligible providers up to $44,000 in extra payments from Medicare and Medicaid. Eligible professionals who don’t meet the requirements are subject to penalties beginning in 2015. The Mathematica study also concludes 9.8% of physicians met the criteria (11.2% among primary care physicians and 24

7.6% among specialists). Among primary care physicians, 40.5% had 8-10 Meaningful Use functions, as did 36.5% of specialists. Among primary care physicians and specialists, 14.6% and 12%, respectively, had 0 functions. According to researchers, more than half of respondents reported they were not planning to participate in the Meaningful Use incentive program (17.7%) or didn’t know if they would participate (36.1%). However, 25% had registered for payments. Researchers received 1,820 responses (60% response rate) to a questionnaire on basic EHR adoption and ability to meet criteria sent to physicians in the American Medical Association’s Physician Masterfile. Among the respondents, 62% were primary care physicians and 56% were specialists. The study authors’ measure of Meaningful Use reportedly included 11 of 15 core requirements for Stage I. n

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conferenceconnection 2013 SAWC Spring/WHS SAWC Honors 2013 Scholarship Recipients Another six healthcare providers were awarded through the Symposium on Advanced Wound Care (SAWC) scholarship program during the 2013 SAWC Spring/Wound Healing Society (WHS) conference held May 1-5 at the Colorado Convention Center in Denver. Launched in April 2012 through the SAWC’s “Gives Back” initiative, the scholarship program celebrates those wound care clinicians as selected by prominent wound care groups such as the Association for the Advancement of Wound Care, the American Podiatric Association, and the American Physical Therapy Association’s Clinical Electrophysiology & Wound Management Section. Recipients for the 2013 SAWC Spring/WHS scholarships (awarded among six specific categories) included: • Susan R. Opalenik, PhD – Wound Healing Research • Devn Frandsen, DO – Wound Healing Fellow • Humberto J.Villalvazo, MD – Wound Care Physician • Jessica Browning, LPN – Wound Care Nursing • Stephanie Woelfel-Dyess, PT, MPT, CWS, FACCWS – Wound Care Therapist • Andrew Belpedio, DPM – Wound Care Podiatrist n

Susan R. Opalenik, PhD

Devn Frandsen, DO

Humberto J. Villalvazo, MD

Jessica Browning, LPN

Stephanie Woelfel-Dyess, PT, MPT, CWS, FACCWS

Andrew Belpedio, DPM

Abstract Winners Selected by Expert Wound Care Panel HMP Communications, LLC, publisher of Today’s Wound Clinic, recently recognized its abstract award winners for the 2013 Symposium on Advanced Wound Care (SAWC) Spring/Wound Healing Society conference held in Denver, CO, May 1-5. More than 350 abstracts were reviewed and blind-scored by a panel of 24 judges, all of whom are experts in wound care, in determining this year’s winners: Highest Scoring Oral Abstracts (first authors listed only): • 1st place –“Inflammation in Diabetic Foot Ulcers,”Nanjin Park, DPM • 2nd place – “Debridement of Venous Leg Ulcers with Low Frequency, High Intensity, Contact Ultrasound: Results of a Randomized Clinical Outcome Trial,” Martin Wendelken, DPM, RN • 3rd place –“Re-amputationAfter Minor FootAmputation in Diabetic Patients: Risk Factors Leading to Limb Loss,” Vincent Nerone, DPM PGY-III Young Investigators: • Nanjin Park, DPM – “Inflammation in Diabetic Foot Ulcers” • Edwin P Monroy, PT, DPT, CLT, SCI/D – “In a Pilot Study of Patients with Spinal Cord Injuries, Far-red Light at 670 Nanometers Accelerated Wound Area Reduction” • Claudia Chavez-Munoz, MD, PhD – “Adipose-derived Stem Cells Transdifferentiate into Stratified Keratinocytelike Cells in the Presence of Ca+ and EGF” Highest Scoring Poster in Category (first authors listed only): • Case Study – “Use of Cyanoacrylate-Based Skin Barrier in Protection of Skin Around Tracheostomy,” Martha Fjelde Ondrejko, BSN, RN, CWOCN • Laboratory Research – “Modular Biocompatible In-vivo Bioreactor forTissue Engineering,” Claudia ChavezMunoz, MD, PhD • Information/Educational Report – “Barriers and Facilitators to Evidence-based Pressure Ulcer Prevention and Treatment for Hospital Inpatients,” Toba Miller, MScN, RN, MHA, GNC(C), CETN(C) • Clinical Research – “An Assessment of Sacral Pressures in Two Seated Positions,” Stephannie Miller, BA

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conferenceconnection SAWC FALL Plans Announced For SAWC Fall 2013

Registration is currently open for the 2013 Symposium on Advanced Wound Care (SAWC Fall) convention to be held in Las Vegas Sept. 27-29 at Bally’s. SAWC Fall 2013 will offer up to 40 new clinical sessions and host a major exhibition of products and services for wound care professionals. SAWC Fall is committed to providing the highest level of clinical education and information to physicians, podiatrists, nurses, physical therapists, and allied health professionals dedicated to the advancement of wound care and healing. For more information, visit www.sawcfall.com.

SAWC Offers Mobile App Attendees of the Symposium on Advanced Wound Care (SAWC) can now stay more easily connected to the conference prior to and while attending the event by downloading the free SAWC Mobile App for mobile phones.The app, which is available now via iTunes, provides access to conference

Dermagraft

Human Fibroblast-Derived Dermal Substitute Essential Prescribing Information

Sept.27-29, 2013

Bally’s Las Vegas Las Vegas, NV

materials and conference-related activities through a simple touch of a smartphone or tablet device. Stay connected after the meeting via Facebook and Twitter, and receive updates on upcoming meetings right to the mobile device. Features include: • Conference schedule • Exhibitor list • Floor plan of sessions • Faculty list • Continuing medical education information • Attendee information • Twitter feeds • Searchable content n

application of Dermagraft, subsequent sharp debridement of the ulcer should continue as necessary. Additional wound preparation should minimize disruption or removal of previously implanted Dermagraft. (13) Patient Counseling Information: After implantation of Dermagraft, patients should be instructed not to disturb the ulcer site for approximately 72 hours (three days). After this time period, the patient, or caregiver, should perform the first dressing change. The frequency of additional dressing changes should be determined by the treating physician. Patients should be given detailed instructions on proper wound care so they can manage dressing changes between visits. Compliance with off weight-bearing instructions should be emphasized. Patients should be advised that they are expected to return for follow-up treatments on a routine basis, until the ulcer heals or until they are discharged from treatment. Patients should be instructed to contact their physician, if at any time they experience pain or discomfort at the ulcer site or if they notice redness, swelling, or discharge around/from the ulcer. (8) How Supplied: Dermagraft is supplied frozen in a clear bag containing one piece of approximately 2 in x 3 in (5 cm x 7.5 cm) for a single-use application. The clear bag is enclosed in a foil pouch and labeled unit carton. Caution: Dermagraft is limited to single-use application. Do not reuse, refreeze, or sterilize the product or its container. Dermagraft is manufactured using sterile components and is grown under aseptic conditions. Prior to release for use, each lot of Dermagraft must pass USP Sterility (14-day), endotoxin, and mycoplasma tests. In addition, each lot meets release specifications for collagen content, DNA, and cell viability.

Numbers in parentheses ( ) refer to sections in the Directions for Use of the product labeling. Device Description: Dermagraft is a cryopreserved human fibroblast-derived dermal substitute. (1) Intended Use/Indications: Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot. (2) Contraindications: • Dermagraft is contraindicated for use in ulcers that have signs of clinical infection or in ulcers with sinus tracts. • Dermagraft is contraindicated in patients with known hypersensitivity to bovine products, as it may contain trace amounts of bovine proteins from the manufacturing medium and storage solution. (3) Warnings: None (4) Precautions: Caution: The product must remain frozen at -75°C ± 10°C continuously until ready for use. Caution: Do not use any topical agents, cytotoxic cleansing solutions, or medications (e.g., lotions, Dermagraft is packaged with a saline-based cryoprotectant. This solution is supplemented with 10% DMSO ointments, creams, or gels) on an ulcer being treated with Dermagraft as such preparations may cause (Dimethylsulfoxide) and bovine serum to facilitate long-term frozen storage of the product. Refer to the reduced viability of Dermagraft. step-wise thawing and rinsing procedures to ensure delivery of a metabolically active product to the wound Caution: Do not reuse, refreeze, or sterilize the product or its container. bed. (9) Caution: Do not use the product if there is evidence of container damage or if the date and time stamped Customer Assistance: For product orders, technical support, product questions, reimbursement on the shipping box has expired. information, or to report any adverse reactions or complications, please call the following number which is Caution: Dermagraft is packaged with a saline-based cryoprotectant that contains 10% DMSO operative 24 hours a day: (Dimethylsulfoxide) and bovine serum. Skin and eye contact with this packaging solution should be avoided. Shire Regenerative Medicine Customer Service Caution: Dermagraft has not been studied in patients receiving greater than 8 device applications. (877) DERMAGRAFT or (877) 337-6247 Caution: Dermagraft has not been studied in patients with wounds that extend into the tendon, muscle, Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician (or properly joint capsule, or bone. Dermagraft has not been studied in children under the age of 18 years, in licensed practitioner). pregnant women, in patients with ulcers over a Charcot deformity of the mid-foot, or in patients receiving Shire Regenerative Medicine, Inc. corticosteroids or immunosuppressive or cytotoxic agents. US PAT Nos. Caution: To ensure the delivery of metabolically active, living cells to the patient’s wound, do not hold 4,963,489; 5,266,480; 5,443,950 Dermagraft at room temperature for more than 30 minutes. After 30 minutes, the product should be ©2012 Shire Regenerative Medicine, Inc. discarded and a new piece thawed and prepared consistent with Preparation for Use instructions. All Rights Reserved Caution: The persistence of Dermagraft in the wound and the safety of this device in diabetic foot ulcer DERMAGRAFT is a registered trademark of Shire Regenerative Medicine, Inc. patients beyond six months has not been evaluated. Testing has not revealed a tumorigenic potential for cells contained in the device. However, the long-term response to these cells is unknown. Caution: Always thaw and rinse product according to the Preparation for Use instructions to ensure the delivery of metabolically active, living cells to the patient’s wound. Caution: Do not use Dermagraft after the expiration date indicated on the labeled unit carton. (5) Adverse Events: In clinical studies conducted to date, the overall incidence of reported adverse events was approximately the same for patients who received Dermagraft compared to those who received the Control treatment. (6) 11095 Torreyana Road Maintaining Device Effectiveness: Dermagraft must be stored continuously at -75°C ± 10°C. San Diego, CA 92121-1104 Dermagraft mustJune/July be thawed and 2013 rinsed according to theWound PreparationClinic for Use instructions. After the initial 28 Today’s www.todayswoundclinic.com

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asktheboard In this exclusive column, TWC offers readers the chance to ask industry-related questions to our expert editorial board members. This month, we received several questions pertaining to the appropriate selection of revenue code(s) for use in hospital-based outpatient wound care (HOPD) departments.

By Kathleen D. Schaum, MS Q: Which revenue code should be used on the HOPD Charge Description Master (CDM)?

A: By Kathleen D. Schaum, MS Confusion apparently reigns in the “revenue code” world. For example, one reader writes: “I am the medical director of a large university HOPD.The CDM director and I are having a disagreement. I believe the HOPD should use revenue code 510. The CDM director believes the HOPD should use revenue code 761. Can you please pick the “winner” of this debate? Sorry to say, but there is no “winner.” Both the medical director and the CDM director are 50% correct and 50% incorrect. Let’s discuss. As you already know, four-digit revenue codes are related to the various ancillary services that are billed by an HOPD. Different revenue codes must be linked to specific Healthcare Common Procedure Coding System (HCPCS) and Current Procedural Terminology® (CPT) codes on your CDM. Some typical Medicare linkages are: • 0510 or 519 Clinic is typically linked to CPT codes 9920199215. Check with the Medicare Administrative Contractor

(MAC) who processes your Medicare claims. • 0 636 Drugs Requiring Detailed Coding is typically linked to separately payable cellular and/or tissue-based products for wounds (outdated term “skin substitutes”) HCPCS codes Q4101 – Q4133. • 0 761 Treatment Room is typically linked to surgical procedures such as 11042-11047. Although this seems simple enough, there is one catch: Not all payers require the same revenue code linkages as does Medicare. In those cases, you must build different revenue codes into your CDM for different payers. For example, some MACs accept revenue code 0510 Clinic, but many other payers do not cover services billed under 510.You should review your major payer contracts and their billing manuals to determine the appropriate revenue codes to link to the HCPCS and CPT codes that represent your HOPD services, procedures, and products. Then, build the payer-specific revenue codes into your CDM for each payer. For an in-depth discussion of HOPD CDMs, attend an all-day 2013 Wound Clinic Business seminar: www. woundclinicbusiness.com. Better yet, bring your entire revenue cycle team and your medical staff to the seminar: It is a great opportunity to learn together! n Kathleen D. Schaum can be reached for questions and consultations by calling 561-964-2470 or at kathleendschaum@bellsouth.net. For a full disclaimer related to the information in this column, please refer to Business Briefs on page 6.

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Advertiser’s Index Biofilm Management Group (LipoGel)................................................................................................................. 21 Derma Sciences (TCC-EZ)..........................................................................................................................Cover 2 Edgepark Medical Supplies (Corporate).............................................................................................................. 2 9 KCI (Graftjacket)..........................................................................................................................................Cover 3 Medela (Invia)......................................................................................................................................................... 3 MTI (Chairs)........................................................................................................................................................... 5 Net Health (WoundExpert)................................................................................................................................... 19 Novadaq (Luna)...................................................................................................................................................... 9 Organogenesis (Apligraf).......................................................................................................................Cover 4, 32 Sechrist Industries (HBOT).................................................................................................................................. 13 Shire Regenerative Medicine (Dermagraft)....................................................................................................27, 28

Apligraf® Essential Prescribing Information Numbers in parentheses ( ) refer to sections in the main part of the product labeling. Device Description: Apligraf is supplied as a living, bi-layered skin substitute manufactured from cells processed under aseptic conditions using neonatal foreskin-derived keratinocytes and fibroblasts with bovine Type I collagen. (1) Intended Use/Indications: Apligraf is indicated for use with standard therapeutic compression in the treatment of uninfected partial and/or full-thickness skin loss ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy. (2) Apligraf is indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness foot ulcers of neuropathic etiology of at least three weeks duration, which have not adequately responded to conventional ulcer therapy and extend through the dermis but without tendon, muscle, capsule or bone exposure. (2) Contraindications: Apligraf is contraindicated for use on clinically infected wounds and in patients with known allergies to bovine collagen or hypersensitivity to the components of the shipping medium. (3, 4, 5, 8) Warnings and Precautions: If the expiration date or product pH (6.8-7.7) is not within the acceptable range DO NOT OPEN AND DO NOT USE the product. A clinical determination of wound infection should be made based on all of the signs and symptoms of infection. (4, 5) Adverse Events: All reported adverse events, which occurred at an incidence of greater than 1% in the clinical studies are listed in Table 1, Table 2 and Table 3. These tables list adverse events both attributed and not attributed to treatment. (6) Maintaining Device Effectiveness: Apligraf has been processed under aseptic conditions and should be handled observing sterile technique. It should be kept in its tray on the medium in the sealed bag under controlled temperature 68°F-73°F (20°C-23°C) until ready for use. Apligraf should be placed on the wound bed within 15 minutes of opening the package. Handling before application to the wound site should be minimal. If there is any question that Apligraf may be contaminated or compromised, it should not be used. Apligraf should not be used beyond the listed expiration date. (9) Use in Specific Populations: The safety and effectiveness of Apligraf have not been established in pregnant women, acute wounds, burns and ulcers caused by pressure. Patient Counseling Information: VLU patients should be counseled regarding the importance of complying with compression therapy or other treatment, which may be prescribed in conjunction with Apligraf. DFU patients should be counseled that Apligraf is used in combination with good ulcer care including a non-weight bearing regimen and optimal metabolic control and nutrition. Once an ulcer has healed, ulcer prevention practices should be implemented including regular visits to appropriate medical providers. Treatment of Diabetes: Apligraf does not address the underlying pathophysiology of neuropathic diabetic foot ulcers. Management of the patient’s diabetes should be according to standard medical practice. How Supplied: Apligraf is supplied sealed in a heavy gauge polyethylene bag with a 10% CO2/air atmosphere and agarose nutrient medium. Each Apligraf is supplied ready for use and intended for application on a single patient. To maintain cell viability, Apligraf should be kept in the sealed bag at 68°F-73°F (20°C-23°C) until use. Apligraf is supplied as a circular disk approximately 75 mm in diameter and 0.75 mm thick. (8) Patent Number: 5,536,656 Manufactured and distributed by: Organogenesis Inc. Canton, MA 02021 REV: December 2010 300-111-8

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