April 2014 by HMP Communications, LLC

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TODAY’S

Contemporary Approaches to Wound Clinic Management

2014 UR

O G N I T N E S PRE

TRENDS ISSUE

NEW PRODUCTS & MODALITIES DRESSINGS, NPWT

SPECIALTY WOUND CARE EMRs

ALSO INCLUDED: ICD-10 Update Business Briefs Facility In Focus SAWCSPRING

April 2014 www.todayswoundclinic.com

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the symposium on advanced wound care

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TODAY’S

Volume 8, Number 3, April 2014 • www.todayswoundclinic.com

Table of Contents • Feature Articles 10

Will Simultaneous Irrigation Become New Trend for NPWT?

New & Emerging Concepts in Wound Care Products

A group of researchers at UT Southwestern Medical Center is aiming to establish the effectiveness of simultaneous irrigation with negative pressure to heal wounds and reduce bioburden.

As science advances the approach to and outcomes for nonhealing chronic wounds, it’s incumbent upon clinicians to be knowledgeable of available resources.

Kathryn Davis, PhD

Heather Hettrick, PhD, PT, CWS, CLT, CLWT

Specialty Wound Care EMR: 6 Areas Driving Critical Value & Compliance

Ultimate Standardization of First-Line Wound Dressings to a Single Type

A specialty wound care EMR will capture a granularity of information in a certain workflow that other EMRs simply cannot. This article addresses six key components of

A Texas-based wound clinic achieves significant cost reduction while improving outcomes, personnel productivity, and patient and clinician satisfaction by adopting a new method of standardization. Randall Wolcott, MD & Vicki Fischenich, RN, MSS, GNP-BC, WCC

the specialty wound care EMR that will drive clinical value and compliance in the clinic. Cathy Thomas Hess, BSN, RN, CWOCN

Removing Deterrents Without Adding Potentially Harmful Agents: A New Paradigm for Effective Wound Healing

This article will discuss the methodology and provide a clinical case file behind this new paradigm. Martin Winkler, MD, FACS & Michael E. Steadman 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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ICD-10-CM Diagnosis Coding Documentation Tips For Venous Ulcers In the fifth installment of our special column on ICD-10-CM implementation, we provide tips for the categories 170-174 and 180.00-187.9. Donna J. Cartwright, MPA, RHIA, CCS, RAC, FAHIMA ADVERTISING QUERIES should be addressed to Jeremy Bowden, Publisher, Today’s Wound Clinic®, HMP Communications, 83 General Warren Boulevard, Suite 100, Malvern, PA 19355. Telephone: (800) 237-7285 or (610) 560-4154 Fax: (610) 560-0501. Email: jbowden@hmpcommunications.com DISPLAY AND CLASSIFIED ADVERTISING: HMP Communications, 83 General Warren Boulevard, Suite 100, Malvern, PA 19355, Phone: (800) 237-7285 or (610) 560-0500 x259 CORPORATE OFFICES HMP Communications, LLC 83 General Warren Boulevard Suite 100 Malvern, PA 19355 Phone: (610) 560-0500 or (800) 237-7285 Fax: (610) 560-0502

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EDITORIAL STAFF

TODAY’S

CLINICAL EDITOR AND FOUNDING BOARD MEMBER Caroline E. Fife, MD, FAAFP, CWS

FOUNDING EDITORIAL BOARD Kathleen Schaum, MS Christopher Morrison, MD Valerie Sullivan, PT, MS, CWS Dot Weir, RN, CWON, CWS

Volume 8, Number 3, April 2014 • www.todayswoundclinic.com

MANAGING EDITOR Joe Darrah jdarrah@hmpcommunications.com

Table of Contents

WEB EDITOR Samantha Alleman salleman@hmpcommunications.com

BUSINESS STAFF

Departments

EXECUTIVE VICE PRESIDENT Peter Norris pnorris@hmpcommunications.com

From the Editor

Caroline E. Fife, MD, FAAFP, CWS

Business Briefs

VP/GROUP PUBLISHER Jeremy Bowden jbowden@hmpcommunications.com PUBLISHER Kristen J. Membrino kmembrino@hmpcommunications.com

CTPs: From Coding & Payment Changes (Then) to Coverage Changes (Now) Kathleen D. Schaum, MS

SALES ASSOCIATE Brian Hill bhill@hmpcommunications.com

Facility in Focus

Maximizing Collaboration to Develop Wound Care Service Line at Excela Health Joe Darrah

TWC News Update

CLASSIFIED SALES ASSOCIATE Michael Deleo mdeleo@hmpcommunications.com

HMP COMMUNICATIONS, LLC PRESIDENT Bill Norton VICE PRESIDENT, SPECIAL PROJECTS Jeff Hall

ICD-10-CM implementation delayed

CREATIVE DIRECTOR Vic Geanopulos vgeanopulos@hmpcommunications.com ART DIRECTOR Karen Copestakes kcopestakes@hmpcommunications.com PRODUCTION MANAGER Elizabeth Vasil evasil@hmpcommunications.com

TWC Online

Find us on Facebook @ www.facebook.com/todayswoundclinic

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PRODUCTION/ CIRCULATION DIRECTOR Kathy Murphy kmurphy@hmpcommunications.com AUDIENCE DEVELOPMENT MANAGER Bill Malriat MEETING PLANNER Cynthia Noonan MEETING PLANNER Trisha Keppler

Online Exclusive:

Healthcare Reform Reader Report The results of our Reader Report on the state of wound clinic practice under the new reform are in! To see the full findings, visit www.todayswoundclinic.com. Thanks to all our readers who participated!

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, Malvern, PA 19355 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. , LLC

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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

4/8/14 2:25 PM

S:7.625 in

Where Sophistication and Simplicity Are One

S:10.5 in

One matrix for the advanced management of challenging wounds Recent reimbursement changes applicable to OASIS® Matrix and other cellular- and tissue-based products could impact you in 2014. Watch the Smith & Nephew Webinar on the 2014 Medicare Final Rules (OPPS, MPFS) at http://www.woundsresearch.com/2014reimbursement to learn more. INTENDED USE: OASIS® Matrix is indicated for the management of wounds including: partial- and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), draining wounds, surgical wounds (donor sites/grafts, post-Mohs’ surgery, post-laser surgery, podiatric, wound dehiscence). This device is not indicated for use in third-degree burns. CONTRAINDICATION: This device is derived from a porcine source and should not be used in patients with known sensitivity to porcine material. PRECAUTION: OASIS® Matrix should not be applied until excessive exudate, bleeding, acute swelling, and infection are controlled. POTENTIAL COMPLICATIONS: The following complications are possible. If any of these conditions occurs, the device should be removed: infection, chronic inflammation (initial application of wound dressings may be associated with transient, mild, localized inflammation), allergic reaction, excessive redness, pain, swelling, or blistering.

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fromtheeditor

TODAY’S

EDITORIAL BOARD

y father used to joke that his definition of “mixed emotions” was seeing your motherin-law drive off a cliff in your new car. I had mixed emotions on March 31, when the US Senate approved a bill to delay national adoption of ICD10-CM diagnosis codes by one year, but put only a temporary patch on the Medicare physician payment crisis. As a Today’s Wound Clinic subscriber, you have been collecting the excellent series of ICD-10 tools by my fellow board member Donna J. Cartwright that are helping to prepare you for the transition from Caroline Fife Editor of TWC ICD-9 and the addition of more than 70,000 new diagnosis codes. The earliest that ICD-10 will now be implemented is Oct. 1, 2015. Millions of dollars have been invested by electronic medical record companies, hospital systems, billing companies, and physician practices preparing for implementation. However, despite huge investments, everyone in the healthcare industry was not ready for this change to occur this year. Many had voiced concerns that the Centers for Medicare & Medicaid Services (CMS) had not performed the necessary testing of new codes within its system.The very public problems with the Obamacare website also had not engendered confidence that Medicare was prepared for another huge information technology (IT) rollout. The American Medical Association (AMA) has already voiced approval of the delay, but implementing ICD-10 has been yet another frustrating, confusing change to a system still in upheaval over the Affordable Care Act. One concern has been how Medicare Administrative Contractors (MACs) will implement coverage policies specified by diagnosis code. Presumably, MACs have to issue revised local coverage determinations (LCDs) for advanced therapeutics such as cellular and/or tissue based products for wounds and hyperbaric oxygen therapy to incorporate hundreds of new covered diagnosis codes. That is the only way providers will know with certainty which diagnosis codes are covered for a particular advanced therapy. Concern had also been raised as to the timing of new LCDs in relation to the ICD-10 rollout. Expect to see continued big changes with LCDs and advanced therapeutics. Although CMS has estimated the delay of ICD-10 will cost the healthcare industry more than $1 billion, the news brought a sigh of relief to many physicians faced with the cost of upgrading their office IT in the face of a 24% pay cut. The “Protecting Access to Medicare Act of 2014” is actually the 17th time Congress has patched physician payments in the Sustainable Growth Rate (SGR). Enacted by the Balanced Budget Act of 1997, the SGR is a method used by CMS to control spending on physician services.The goal is to ensure the annual increase in expenses per Medicare beneficiary does not exceed the growth in gross domestic product. Each year, CMS sends a report to the Medicare Payment Advisory Commission, which advises Congress on the previous year’s expenditures. If those expenditures exceed the target, the report provides a conversion factor that will decrease payments for the following year in order to match the target SGR. However, this decrease in Medicare’s Physician Fee Schedule (PFS) can be suspended or adjusted by Congress, often referred to as “the doc fix.” Congress has implemented a temporary fix each year for the past 17 years. Without the patch passed by Congress March 31, physician payments would have been cut by 24% April 1.The problem is that the legislation only freezes Medicare physiContinued on page 37

April 2014 Today’s Wound Clinic®

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FOUNDING EDITORIAL BOARD MEMBER & EDITOR OF TODAY’S WOUND CLINIC Caroline Fife, MD, FAAFP, CWS FOUNDING EDITORIAL BOARD MEMBERS Dot Weir, RN, CWON, CWS Christopher A. Morrison, MD, FACHM, FCCWS Valerie Sullivan, PT, MS, CWS Kathleen D. Schaum, MS EDITORIAL BOARD MEMBERS Leah Amir, MS, MHA Desmond Bell, DPM, CWS Donna J. Cartwright, MPA, RHIA, CCS, RAC, FAHIMA Moira Hayes, MHA, RRT, CHT Cathy Thomas Hess, BSN, RN, CWOCN Harriet Jones, MD, BSN, FAPWCA 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 EMERITUS EDITORIAL BOARD MEMBERS Andrew J. Applewhite, MD, CWS, UHM Robert S. Kirsner, MD, PhD

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83 General Warren Boulevard, Suite 100, Malvern, PA 19355 © 2013, HMP Communications, LLC. All rights reserved. Reproduction in whole or in part prohibited. Opinions expressed by authors, contributors, and advertisers are their own and not necessarily those of HMP Communications, LLC, the editorial staff, or any member of the editorial advisory board. HMP Communications, LLC is not responsible for accuracy of dosages given in articles printed herein. The appearance of advertisements in this journal is not a warranty, endorsement or approval of the products or services advertised or of their effectiveness, quality or safety. HMP Communications, LLC disclaims responsibility for any injury to persons or property resulting from any ideas or products referred to in the articles or advertisements. Content may not be reproduced in any form without written permission. Reprints of articles are available. Contact HMP Communications, LLC for information.HMP Communications, LLC (HMP) is the authoritative source for comprehensive information and education serving healthcare professionals. HMP’s products include peer-reviewed and non-peer-reviewed medical journals, national trade shows and conferences, online programs and customized clinical programs. HMP is wholly owned subsidiary of HMP Communications Holdings LLC. Discover more about HMP’s products and services at www.hmpcommunications.com.

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4/8/14 2:39 PM

WHEN THERE’S A NEED FOR EPIDERMIS PRESS START

The CelluTome™ System is an innovative epidermal harvesting device which can be easily integrated into your everyday practice

To learn more, visit www.cellutome.com or call 1-800-275-4524

NOTE: Specific indications, contraindications, warnings, precautions and safety information exist for KCI products and therapies. Please consult a physician and product instructions for use prior to application. Rx only. ©2013 KCI Licensing, Inc. All rights reserved. All trademarks designated herein are proprietary to KCI Licensing, Inc., its affiliates and/or licensors. DSL#13-0548.OWM (Rev. 10/13)

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10/3/13 10:32 AM

businessbriefs CTPs: From Coding & Payment Changes (Then) To Coverage Changes (Now) 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 shall be received. The ultimate responsibility for verifying coding, coverage, and payment information accuracy lies with the reader.

any qualified healthcare professionals (QHPs) who manage patients living with chronic wounds and many manufacturers of products such as cellular and/or tissuebased products for wounds (CTPs) [old term “skin substitutes”] often proclaim an unrealized hope that CTPs “have a code and a Medicare payment rate.” But remember, a product requires three things before it will be reimbursed by any payer, including Medicare: relevant codes, adequate payment rate, and coverage. For the past few months this column has discussed the 2014 code changes and Medicare payment changes for hospital-based outpatient wound care departments (HOPDs). Believe it or not, Medicare Administrative Contractors (MACs) have begun to make coverage changes for CTPs. Some of these changes have caught the industry by surprise. Let’s discuss some of the coverage changes occurring now. Prior to 2014, when new CTPs were launched into the marketplace, I maintained a color-coded map of the US representing each brand of CTP: - Red indicated states where the MAC did not cover the CTP; 6

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- Green indicated states where the MAC covered the CTP per a published local coverage determination (LCD); and - Yellow indicated states where the MAC did not publish an LCD and covered CTPs based on medical necessity.

reconstruction and/or replacements (eg, tendon and/or ligament augmentation/ repair, breast reconstruction, abdominal hernia repair), burns, skin cancer, or pressure ulcers that were covered based on medical necessity. NOTE: Read your specific LCD for the exact details.

Upon any product launch, the US map is overwhelmingly red. If a product has published randomized clinical trials, the MAC(s) typically provide coverage, which turns those states on the map green. Because an LCD is not required for the MACs to provide coverage for any service, product, or procedure, not all MACs write an LCD pertaining to CTPs. In fact, prior to 2014:

The goal of every CTP manufacturer is to obtain positive or neutral Medicare coverage throughout the US. This means that my brand-specific coverage maps should ideally display mostly green states and a few yellow states, but no red states. However, during the first few months of 2014, the MACs have given the wound care industry a few coverage surprises, which have rendered my color-coded map project nearly impossible. Let’s look at a few of the coverage surprises:

• One MAC (Palmetto GBA) chose not to write an LCD pertaining to CTPs. • Another MAC (Highmark, now Novitas Solutions Inc.) chose to write an LCD only about the CTPs the MAC wished to control. All other CTPs were covered based on medical necessity. • Several MACs (Cahaba GBA LLC; CGS Administrators LLC; Noridian Healthcare Solutions LLC) changed the titles of their LCDs to only pertain to the use of CTPs on lower extremities. All other wound types were covered based on medical necessity. • Other MACs (Cahaba GBA, CGS Administrators, and Novitas) identified covered indications for some wound types. In addition, those MACs stated their LCDs did not apply to treatment of wound types such as acute wounds, acute postoperative wounds, deep tissue

Noridian (JF) posted this notice Feb. 21: “Effective March 1, 2014, the LCDs L24273 and L24409 will be retired. Data analysis and recent Centers for Medicare and Medicaid Services (CMS) changes to reimbursement have been reviewed and Noridian feels these two LCDs, while still fundamentally sound, are no longer currently related to billing and coding. Noridian has determined that a portion of this LCD as it regards non-coverage of dressings remains pertinent and will be continued. This non-coverage will be transferred to the non-covered services LCDs L24473 (Part B) and L27445 (Part A). As this transference does not restrict coverage, no formal comment period is required. The only change in coverage reflects www.todayswoundclinic.com

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businessbriefs Noridian’s decision to provide coverage for Q4131 EpiFix,® per sq cm, beginning March 1, 2014. Noridian will allow coverage of the bioengineered products only in accordance with the respective FDA approved indications.We will continue to monitor utilization trends and, when deemed appropriate, require providers to submit their clinical notes to substantiate claims. Current wound care of diabetic foot ulcers and venous stasis ulcers continues to evolve. The main premise of any such care is the optimal provision of excellent wound care and the assurance of proper arterial circulation to the affected area. These items shall be clearly documented in the clinical records.We fully expect wound care medical professionals to adhere to the best evidence-based clinical standards as they continue to provide care to the Medicare beneficiaries.” For the first time, Noridian (JF) referred providers to its non-covered services LCD to see the list of noncovered products. (See Table at the end of article.) Therefore, I was able to color my brand-specific US map red for these non-covered products. Then I did something new: I changed the covered products from green to yellow because they went from positive coverage in the LCD to coverage based on medical necessity. On Feb. 22, Novitas released a future effective LCD 27547 “Wound Care and Cellular and/or Tissue-Based Products for Wounds” that was scheduled to become active March 27. This was the first time that a MAC attempted to combine coverage for the CTPs in an LCD with other wound care services and procedures. In addition, Novitas did not include a list of covered ICD-9-CM codes for any of the covered wound care products, services, or procedures. Shortly before this combined wound care LCD was scheduled for release, Novitas placed LCD 27547 “on hold” and reverted to the LCDs (L32622 and L27549) that were in effect Jan. 1, 2014.The Table reflects these LCDs. To provide readers with a

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preview of Novitas’ intentions, following are the CTP-related excerpts from the LCD that was placed “on hold”: CTPs for Wounds: “The provisions (products and procedures) of this LCD apply to payment for CTPs and the physician services reported for wound preparation and material application to chronic wounds. This LCD does not address human skin autografts, cadaveric human skin allografts, or porcine dermal xenografts, as specified by the Food and Drug Administration (FDA). Additionally, the provisions of this LCD do not apply to treatment of acute and acute postoperative wounds, deep tissue reconstruction and/or replacement (eg, tendon and/or ligament augmentation/repair, breast reconstruction, abdominal hernia repair), or burns. The following general indications and limitations to Medicare coverage and payment apply to all CTPs and physician services related to CTP application: Indications: Any CTP may be considered reasonable and necessary if it is provided in accordance with the materials labeled ‘indication provided in accordance with the manufacturer’s package insert instruction/guidelines under the 361 HCT/P provisions (21 CFR 1271) or FDA-approved/cleared package label with respect to application requirements, frequency, etc., either of which is uncontested by the FDA.’” Surgical Wound Preparation (Current Procedural Terminology [CPT] codes 15002, 15003, 15004, and 15005): “CPT codes 15002, 15003, 15004, and 15005 are used to report excision of nonviable tissue in preparation of a clean and viable wound surface for initial skin graft, flap, negative pressure wound therapy, or substitute graft application. Medicare does not expect to be billed for CPT codes 15002, 15003, 15004, and 15005 in conjunction with routine, simple, and/or repeat application of skin substitutes/replacements. Wound cleansing and removal of exudates, existing skin replacement graft material,

and/or nominal amounts of devitalized tissue are included with the skin replacement application procedure. Medicare expects separate reporting of surgical debridement with application of skin replacements only when gross contamination requiring extended cleansing and removal of appreciable amounts of devitalized tissue are performed and documented. Medicare expects that most repeat applications of skin replacement materials will not require separate debridement procedures.” CTP Application Procedures (CPT codes 15271, 15272, 15273, 15274, 15275, 15276, 15277, and 15278): “American Medical Association CPT 2012 and CPT Changes:An Insider’sView 2012 contain vastly different descriptions of these CPT codes and their related preamble information. Providers are strongly encouraged to review and understand this information prior to the use of these codes. These application codes are not to be reported for application of non-graft wound dressings (eg, gel, ointment, foam, liquid) or injected skin substitutes. The CPT procedure codes listed in this policy describe and are to be used to report topical application of skin replacement or graft using CTPs. Do not report any CPT procedure code listed in this policy when using a CTP as an implanted or prosthetic material, or otherwise used not as an application to skin and surrounding tissues (eg, material used for non-skin applications such as tendon augmentation, breast reconstruction, ventral and incisional hernia repair, etc.). See CPT for coding instructions regarding non-topical use of skin and tissue replacement materials.” “As published in CMS Institute of Medicine 100-08, Section 13.5.1: In order to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under Section 1862(a)

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businessbriefs (1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is: • Safe and effective. • Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after Sept. 19, 2000, that meet the requirements of the clinical trial’s national coverage determinations are considered reasonable and necessary). • Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is: a) Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member. b) Furnished in a setting appropriate to the patient’s medical needs and condition. c) Ordered and furnished by qualified personnel. d) One that meets, but does not exceed, the patient’s medical needs. e) At least as beneficial as an existing and available medically appropriate alternative. Post-payment medical review will be conducted as the primary method for ensuring that the above criteria are satisfied, by also using the FDA labels as more specific technical guidance.” For the first time, Novitas’ future effective LCD listed all CTPs that were assigned a “Q” code as covered based on medical necessity.Therefore, I colorcoded my CTP maps yellow for each product in each state in the two Novitas jurisdictions. When the LCD was placed “on hold,” changes to colorcoded maps were needed to reflect the Jan.1 status. Although I was surprised by the Noridian LCD and the future effective (now “on hold”) Novitas’ LCDs, First Coast Service Options Inc. surprised me the most when it retired its Part A LCD but maintained its Part B LCD. CAUTION: Do not confuse Part A and Part B Medicare pay-

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ment with Part A and Part B LCDs. Part A LCDs pertain to all providers (eg, acute care hospitals, HOPDs, and hospital-owned ambulatory surgical centers [ASCs]) that use the hospital claim form CMS-1450s. Part B LCDs pertain to all QHPs who use the 1500 claim form. The retirement of the Part A LCD means HOPDs and ASCs will be covered based on medical necessity for any of the products with “Q” codes. The Part B LCD only provides coverage to five products (see Table), but does not mention the procedure codes for the application of CTPs. Therefore, QHPs have clear guidance for which products are covered in their offices, but do not have clear guidance about which products they can apply in facilities such as HOPDs and ASCs. The lack of direction in the Part B LCD causes QHPs to believe they may be covered based on medical necessity for CTPs applied in facilities. CAUTION: If QHPs want clarity about coverage for their work of applying CTPs in facilities, they should contact the medical director of First Coast. Following is the notice that First Coast released about the Part A and Part B LCDs: “Effective Jan. 1, 2014, CMS implemented an Outpatient Prospective Payment System (OPPS) change request edit (CR 8572) that requires hospitals to report all high-cost skin substitute products in combination with one of the skin application procedures described by CPT codes 1527115278 and to report all low-cost skin substitute products in combination with one of the skin application procedures described by Healthcare Common Procedure Coding System codes C5271-C5278. All pass-through skin substitute products are to be reported in combination with one of the skin application procedures described by CPT codes 15271-15278. Based on this change in payment methodology in OPPS, the varied application of these products in the hospital setting, and the additional controls in the hospital setting, the MAC J9 retired the Part

A skin substitutes LCD. Currently, the MAC J9 is silent on coverage for skin substitute services in the hospital setting, given there is no LCD or NCD in play. If a claim is audited, any service/ procedure utilizing these products in an episode of care would have to meet the Medicare reasonable and necessary (R&N) threshold of coverage as documented in the patient’s medical record, assuming all other requirements of the Medicare program are met. The Part B LCD remains in effect and has limited coverage to the following four products: Apligraf,® Dermagraft,® Integra Dermal Regeneration Template,® and OASIS® Wound Matrix and OASIS Ultra Tri-Layer Matrix, with the R&N criteria as outlined in the indications and limitations section of the LCD. To review the products that remain non-covered, as medical necessity for these products has not been established, please refer to the Part B LCD skin substitutes L29279 (Florida) and L29393 (Puerto Rico/US Virgin Islands).” By now you can probably imagine that I have given up on updating my color-coded maps for each brand of CTP. First Coast’s separation of Part A and Part B coverage made this project much too difficult to maintain.Therefore, I’ve created the Table below to track CTP Medicare coverage. An “X” in the Table indicates the LCD specifically covers the product. An “MN” means the product may be covered based on medical necessity. A blank box signifies the product is not covered per that MAC’s LCD. REMEMBER: The Table is correct as of press time for Today’s Wound Clinic. Because the MACs can revise their LCDs at any time, be sure to assign someone in your practice to research your MAC’s LCDs and share changes on a monthly basis.Hopefully the Table will help you get started with this very important CTP coverage vigilance. n Kathleen D. Schaum is president and founder of Kathleen D. Schaum & Associates Inc., Lake Worth, FL. She may be reached for questions and consultations at 561-9642470 or kathleendschaum@bellsouth.net.

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businessbriefs TABLE. Medicare Coverage for (CTPs) Effective March 2014

Cahaba GBA LLC

CGS Administrators LLC

First Coast Service Options Inc.

Part A

National Government Services Inc.

Part B

Noridian Healthcare Solutions LLC

Novitas Solutions Inc.

Palmetto GBA

Wisconsin Physicians Services Insurance Corporation

Q4100

SKIN SUBSTITUTE NOT OTHERWISE SPECIFIED

Q4101

APLIGRAF, PER SQ CM

Q4102

OASIS WOUND MATRIX, PER SQ CM

Q4104

INTEGRA BILAYER MATRIX WOUND DRESSING (BMWD), PER SQ CM

Q4105

INTEGRA DERMAL REGENERATION TEMPLATE (DRT), PER SQ CM

Q4106

DERMAGRAFT, PER SQ CM

Q4107

GRAFTJACKET, PER SQ CM

Q4108

INTEGRA MATRIX, PER SQ CM

Q4110

PRIMATRIX, PER SQ CM

Q4111

GAMMAGRAFT, PER SQ CM

Q4115

ALLOSKIN, PER SQ CM

Q4116

ALLODERM, PER SQ CM

Q4117

HYALOMATRIX, PER SQ CM

Q4119

MN X

MATRISTEM WOUND MATRIX, PSMX, RS, OR PSM, PER SQ CM

Q4120

MATRISTEM BURN MATRIX, PER SQ CM

Q4121

THERASKIN, PER SQ CM

Q4122

DERMACELL, PER SQ CM

Q4123

ALLOSKIN RT, PER SQ CM

Q4124

OASIS ULTRA TRI-LAYER MATRIX, PER SQ CM

Q4125

ARTHROFLEX, PER SQ CM

Q4126

MEMODERM, DERMASPAN, TRANZGRAFT OR INTEGUPLY, PER SQ CM

Q4127

TALYMED, PER SQ CM

Q4128

FLEX HD, ALLOPATCH HD, OR MATRIX HD, PER SQ CM

Q4129

UNITE BIOMATRIX, PER SQ CM

Q4131

EPIFIX, PER SQ CM

Q4132

GRAFIX CORE, PER SQ CM

Q4133

GRAFIX PRIME, PER SQ CM

Q4134

HMATRIX, PER SQ CM

Q4135

MEDISKIN, PER SQ CM

Q4136

EZ-DERM, PER SQ CM

Q4137

AMNIOEXCEL OR BIODEXCEL, PER SQ CM

Q4138

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Today’s Wound Clinic® April 2014

4/8/14 2:35 PM

WILL SIMULTANEOUS IRRIGATION BECOME

NEW

REND FOR NPWT?

A group of researchers at UT Southwestern Medical Center is aiming to establish the effectiveness of simultaneous irrigation with negative pressure to heal wounds and reduce bioburden. Kathryn Davis, PhD

ecades prior to the first negative pressure wound therapy (NPWT) device being cleared by the US Food and Drug Administration in 1997, Pal Svedman, PhD, MD, reported the use of simultaneous irrigation in conjunction with NPWT to treat infected wounds. The process of irrigating a wound consists of delivering a topical solution to the wound bed to cleanse and eliminate infectious materials. The use of simultaneous irrigation allows continuous wound irrigation without sacrificing negative pressure therapy. Although the most recent advancements in NPWT have shown profound healing effects for chronic wounds in particular, there have been no controlled, preclinical, or clinical studies that have evaluated the effectiveness of NPWT with and without irrigation, or that have compared the efficacy of different irrigation solutions. To close this gap, a team of academic researchers at the University of Texas (UT) Southwestern Medical Center in Dallas set out to investigate a new wound therapy system that couples NPWT with simultaneous irrigation therapy while maintaining constant negative pressure. The study aimed to determine the effectiveness of simultaneous irrigation therapy to heal wounds and reduce bioburden. The study results represent the first set of randomized, controlled data confirming the effectiveness of simultaneous irrigation. This article offers a review of the study.

ENHANCING HEALING, REDUCING BIOBURDEN

For this study, the research team (which, besides the author, included Jenny Barker, PhD; Paul Kim, DPM; Lawrence Lavery, DPM, MPH; and Jessica Bills, BS) used a porcine model where full-thickness excisional wounds were placed on the dorsum of six pigs. (See Figure 1.) Each site was inoculated with 500 colony-forming units (see Figure 2) of Pseudomonas aeruginosa and left to establish for three days prior to the initiation of therapy. Therapy was applied for 21 days and consisted of (see Figure 3) either NPWT, NPWT with simultaneous irrigation therapy using normal saline or polyhexanide biguanide (Prontosan,® B. Braun) at low or high flow rates, or control (no NPWT). NPWT was administered using the Quantum™ NPWT system (Innovative Therapies Inc.) at -125 mmHg of pressure. (See Figure 4.) The data from this study demonstrate two significant findings: 1) NPWT with all irrigation conditions improved wound healing rates over control-treated wounds by at least 20% and 2) NPWT with simultaneous irrigation with saline or Prontosan further reduced bioburden over the control and NPWT-treated wounds. However, flow rate did not affect these outcomes. Together, these data show that NPWT with simultaneous irrigation therapy with either normal saline or an antiseptic, such as Prontosan, has a positive effect on bioburden in a porcine model.

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Figure 1. Dorsum of pig with dressings in place. Photo reused with author permission.

CLINICAL IMPACT

When embarking on new research to explore unchartered territory, it’s important to start at the “ground level” with controlled, preclinical work. For wound care research, the ground level typically starts at the porcine level. Although the next step for our research team has been to apply the same methodology to an ongoing clinical trial, the porcine results helped us to better define the parameters of that trial currently underway at UT Southwestern. In this study, the porcine wound model used represents acute wounds in healthy young animals, the healing of which differs from the complex chronic wounds

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woundcaretrends in humans with multiple comorbidities that are typically seen in the outpatient clinic setting. Pigs are also highly resistant to infection, suggesting the data presented may understate the potential effects that could be observed in chronic wound patients. Ultimately, the results will likely translate clinically to improved wound healing outcomes in humans and more efficient care.

Figure 2. Each site was inoculated with 500 CFUs of Pseudomonas aeruginosa. Image copyright of the author.

IMPROVED ECONOMICS

Wound care is very cost intensive and providers in all care settings are looking for technology advancements that offer improved economics alongside effective clinical outcomes. There are a number of cost drivers for treating wound care pa-

Figure 3. Therapy applied for 21 days and consisted of either NPWT, NPWT with simultaneous irrigation using normal saline, or polyhexanide biguanide at low or high flow rates, or control (no NPWT). Image copyright of the author.

tients, with the two most common being infection and hospitalization. Reducing wound bioburden can help improve healing time, which can lead to shorter hospital stays and lower the overall cost of care. This study

has shown, for the first time, that simultaneous irrigation reduces bioburden, which has been demonstrated clinically to result in faster healing time. Another profound finding from an economic standpoint is that saline was found to be just as effective as the more expensive antimicrobial 4. NPWT was administered using Quantum NPWT system at -125 mmHg of Prontosan at reduc- Figure pressure. Image copyright of the author. ing bioburden. Unlike antimicrobial irrigant solutions, saline doesn’t have to be ability for providers.” administered through a pharmacy, thus In addition to these economic benefits, eliminating more total care costs. Fur- Lavery said there are other ease-of-use ther, saline administered at low or high attributes that will translate to the wound flow rates demonstrated similar efficacy care clinic as well. “A defining attribute to reduce bioburden without significant- of the Quantum device allows for unly affecting the outcome, suggesting that interrupted therapy as the same device irrigation solution can be just as effective can be used in a variety of care settings, when administered at a lower flow rate, including at the clinic and home,” he reducing the labor involved in adminis- said. “Because there’s no need to switch tering therapy. In addition, the applica- devices when being discharged from the tion of simultaneous irrigation using this hospital, patients have to deal with less particular device requires minimal acces- paperwork and can count on continuity sory modifications over negative pressure of care. The device may be particularly therapy alone. appealing for wound care clinic patients, Dr. Lavery, a professor of plastic sur- as it is also the lightest NPWT device on gery at UT Southwestern and study the market (15 oz without carrying case) co-author, states, “Our work further es- and is easy to use.” tablishes the effectiveness of NPWT and coupling NPWT with simultaneous irri- NPWT’S FUTURE gation converts the system into a dynamIn the wake of sweeping healthcare ic drug-delivery system.This will save the changes, one key new reality for wound legs of many of my patients with diabetes care providers is providing “more with and foot wounds.” less.” Studies like this are critical in showing how a device, technique, or TRANSLATING RESULTS TO CLINIC approach is equivalent or superior to This study is the first to demonstrate today’s standard, as more decisions will the benefits of simultaneous irrigation be based on the full cost of care delivalong with negative pressure treatment. ery. Because outcomes will be so vital to “The device also provides a new cost- making healthcare decisions, the study’s efficient purchase model in which hos- authors predict simultaneous irrigation pitals, wound clinics, and long-term care with NPWT will become the standard facilities pay only for therapy hours used,” of care in drug delivery to accelerate Lavery said.“This is a stark contrast to the healing of the wound bed. n current industry standard rental model Kathryn Davis is on staff at UT Southwestern and may provide more financial predict- Medical Center.

April 2014 Today’s Wound Clinic®

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NEW & EMERGING CONCEPTS IN IN WOUND WOUNDCARE CAREDRESSINGS PRODUCTS As science advances the approach to and outcomes for nonhealing chronic wounds, it’s incumbent upon clinicians to be knowledgeable of available resources. Heather Hettrick, PhD, PT, CWS, CLT, CLWT

ound care products and applications continue to evolve. This can be challenging for both the seasoned clinician as well as those new to the field of wound management. Keeping current with trends and scientific literature can also be a difficult task due to increased demands for productivity while having less access to resources and time. This article will provide an overview of some new and emerging products available for wound management. A comprehensive review is beyond the scope of this article; however, unique products and features will be discussed to provide insight into emerging options available to manage complex wounds. For the purposes of this review, we will focus on some of the new and emerging dressing and topical technologies such as mircocurrent, exudate transfer, bacterial binding, protease modulation, amniotic membranes, cellular and tissue-based products (CTPs), and emerging interventions under development.

A BRIEF HISTORY ON DRESSINGS

Historically, the first wound treatments were described more than five millennia ago. Although the science behind some of the interventions was not thoroughly understood, practitioners of the time utilized various natural products to manage “diseased” wounds (infection), to cleanse wounds, and to prevent inflammation. Figs containing papain helped to debride wounds; wine, 14

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vinegar, and water were used to cleanse wounds; and dry powders containing metals (mercury, zinc, silver, and copper) were used to reduce and prevent inflammation. The Egyptians may have been the first to employ the principles of moist wound healing through linens soaked in grease, honey, oil, and lint.1 Today, we have evidence and science to support our wound interventions, yet we continue to use derivations of the treatments utilized thousands of years ago, such as plant-based products, metals, and honey. Overall, the woundologist must consider the five main goals of topical care: optimization of the wound environment, wound stabilization, activation of the wound environment to hasten healing, bioburden control, and quality-of-life improvement. With more than 4,000 products available on the market and more becoming available, it is important to separate them into categories. General dressing categories are a great starting point, such as hydrocolloids, hydrogels, collagens, foams, etc. Increasingly, more products are combining characteristics of these general categories to create products with unique wound healing characteristics (ie, silver-impregnated alginates provide antimicrobial coverage while absorbing and managing exudate). Such combination dressings, however, still fall under the main dressing categories. They are categorized according to whichever prod-

uct they primarily consist of. Antimicrobial dressings are a category in and of themselves, given the various components and ingredients used to provide either broad-spectrum coverage or targeted functionality.

A NEW APPROACH TO E-STIM

In 1982, Barker and colleagues concluded that human skin has a sodiumdependent battery that may drive epidermal healing.2 From this, Robinson in 1985 altered the orientation and galvanotaxis of epithelial and fibroblast cells using electrical fields.3 Vanable (1989) determined the highest electrical potential occurs in the first 0.5mm of skin bordering a wound and that there is negligible current in dry wounds.4 In 1991, Neher and Sakman received the noble prize for detecting subtle electrical currents in cell membranes throughout human body.5 Electrical stimulation (ES) has been a mainstay biophysical agent with strong evidence to support its use during clinical wound management. Traditional ES can be time-intensive to achieve desired results. Treatments can last more than an hour and are often recommended 3-5 times per week. Because of this, Vomaris Wound Care Inc. has created a new spin on ES through the creation of a bioelectric dressing. This single-layer dressing consists of a polyester fabric containing elemental zinc and silver microcells ranging between 1 mm and 2 mm in diameter. www.todayswoundclinic.com

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woundcaretrends The Procellera® dressing requires no external power source, as the microcells are activated in the presence of conductive fluid (either wound exudate or exogenously applied normal saline). Once activated, it generates an electrical potential of 0.6-0.7 V, resulting in a sustained micro-current similar to that of skin injury.This provides continuous broad-spectrum antimicrobial activity that’s effective against bacteria, fungus, yeast, mold, and is indicated for use in diabetic foot ulcers, abrasions and skin tears, full-thickness wounds, skin eruptions, burns, traumatic wounds, surgical sites, and venous leg ulcers. Procellera can be used in combination with hyperbaric oxygen, compression therapy, negative pressure wound therapy, and CTPs. Many chronic wounds tend to be further complicated by moderate to copious amounts of exudate. It is well known that chronic wound fluid often contains senescent cells, matrix metalloproteinase, and other substances that can further delay or hinder wound closure. Some newer products on the market have been designed to specifically manage wound exudate through unique and specific methods. Such products either focus on the concept of exudate transfer whereas others target and bind bacteria.

ADDITIONAL DRESSING INTERVENTIONS

SteadMed Medical LLC has created a hydroconductive wound dressing (Drawtex®) using a proprietary LevaFiber technology. A combination of two types of absorbent cross-action structures draws exudate away from wound surface and holds and transfers the exudate vertically and horizontally. Drawtex can absorb 500% of its own weight, keeping the wound base and periwound area free from excess moisture. Another unique product has the ability to bind bacteria. Cutimed® Sorbact® dressings by BSN Medical (Charlotte, NC) employs DACC antimicrobial technology (diakyl-carbamoyl-chlowww.todayswoundclinic.com

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ride), which creates a hydrophobic interaction where the dressing fibers bind the microbes to the dressing, render them inactive, and remove them whole. DACC does not contain chemical, pharmacological, or antimicrobial agents; therefore, there is no concern for bacterial resistance or sensitivity. Similarly, another product combines both exudate transfer and bacterial binding characteristics. KendallTM AMD Antimicrobial Dressings (Mansfield, MA) contain polyhexamethylene biguanide (PHMB) that effectively wicks wound fluid while employing bactericidal effects. Through its bacteria-killing polymer, it attacks bacteria on and within the dressing to effectively manage various wound pathogens and resistant organisms. The wound literature continues to uncover the mysteries of the wound bed at the macrocellular and microcellular level. One area that has gained significant attention centers on proteases. Proteases have various roles in wound healing, such as growth factor activation, remodeling of the extra cellular matrix, and controlling the migration and activation of fibroblasts. However, in some nonhealing chronic wounds, protease activity remains at an elevated level that impairs wound healing and can lead to chronic inflammation. Smith & Nephew has recently introduced Cadesorb, which has been specifically designed to control the pH of its local environment. In addition to the benefits of pH control and protease modulation, this topical product promotes slough removal and absorbs wound exudate. This white, starchbased sterile ointment controls local wound pH and thereby modulates protease activity. Studies have shown that chronic wounds have a typical pH value of around 7–8. There is evidence to suggest that a slightly acidic environment may promote healing of open wounds. Ex vivo studies have shown that treating wound fluid with Cadesorb lowers this pH value to around 5, allowing protease activity levels to return to those of a healing wound. By

controlling pH levels and modulating protease activity, in addition to managing slough and exudate, Cadesorb may help correct or restore the natural balance in chronic wounds to stimulate healing. Emerging technologies hold promise for accelerated and targeted healing. Stem cells and gene therapy will be at the forefront of wound healing over the next decade. In addition, DNAguided personalized medicine will enhance wound healing trajectory as it is specifically targeted to the wound bed. Wound care practitioners are on the cusp of having bedside diagnostics to determine the specifics of wound bioburden, methods to detect subdermal tissue changes, and personalized medicine directed at the wound for a particular patient. Today, we have various new regenerative biomaterials made from amniotic membrane as well as CTPs. Amniotic membrane (AM) is a unique material that is composed of structural extracellular matrix (ECM) containing collagen types I, III, IV, V, and VII. Further, it contains specialized proteins, fibronectin, laminins, proteoglycans, and glycosaminoglycans — all essential components for successful wound closure. In addition, AM contains essential active healing growth factors such as epidermal growth factor, transforming growth factor beta, fibroblast growth factor, and plateletderived growth factor. For wound management, two companies manufacture AM products for clinical use; Liventa Bioscience produces AmnioClearTM and MiMedx produces EpiFix.® AmnioClear is derived from human allograft membrane and comes in two forms: a patch of amnion or the entire amniochorionic membrane in particulate form to mix with patient blood, forming a liquid wound covering. AmnioClear is processed by the musculoskeletal transplant foundation that disinfects and dehydrates the amnion and chorion. This does not undergo terminal sterilization. According to the manufacturer, it is indicated for inpatient burn interToday’s Wound Clinic® April 2014

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woundcaretrends vention, chronic ulcers, and as a postoperative covering. It is a good alternative to synthetic films and bovine collagen. Its potential benefits include that it is immune privileged, non-immunogenic, and provides endogenous collagen matrix with growth factors and antimicrobial peptides. AmnioClear is easy to handle, can be cut to size/shape, and is conformable; it is hydrophilic, stays in place, and has the ability to be stored. EpiFix is available as an allograft or in micronized form, which is a dry powder that can be mixed with saline to form an injectable. EpiFix is dehydrated and sterilized via the PURION® Process and can be stored at room temperature for up to five years. The allograft is available in four sizes and is composed of epithelial cells, basement membrane, and avascular connective tissue matrix. EpiFix is a biologically active matrix containing growth factors. The manufacturer states it is indicated for acute and chronic partial- and full-thickness ulcers. Additional potential benefits may include enhanced healing, reduction of inflammation, and scar tissue formation, and it contains growth factors essential for wound healing.

MORE ON CTPs

CTPs continue to evolve and make a significant positive impact on healing outcomes. CTPs can be classified as acellular or cellular. Acellular products do not contain cells and consist of a matrix that functions by binding to the host, allowing matrix-cell interactions. Porous in nature, the matrix allows host cells to infiltrate. Today, a matrix can contain virus vectors, or plasmids, which can transcribe and translate the in-built DNA, leading to secretion of specific growth factors.6-9 These growth factors carry out specific functions by stimulating host cells to enhance wound healing. In specific conditions, it is even possible to manufacture matrices containing plasmids that can release hormones. The matrix contains ECM-proteins such as colla16

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gen, hyaluronic acid, and fibronectin, thus ensuring biocompatibility. Examples of these products include: e-Matrix™ (Syneron Inc.), OASIS® (Smith & Nephew), Integra® (Integra LifeSciences), Permacol® (Covidien), Matriderm®* (Dr. Suwelack Skin & Health Care AG), and EZDerm® (Brennen Medical).10 Please refer to individual manufacturer guidelines for use. Cellular products, conversely, do contain living cells, most often fibroblasts and keratinocytes embedded in a collagen or polyglactin scaffold that forms an epidermal skin layer.7 Autologous cells are used in these products to minimize the risk of rejection. Autologous keratinocytes are derived from progenitor cells from dermal sheets in the outer root surrounding hair follicles,10 or from epithelial cells obtained via biopsy of the recipient’s skin. A permanent autologous epidermal skin graft, which functions as a reliable barrier and promotes the formation of granulation tissue, is applied. Examples of tissue-engineered epidermal substitutes are: Epicel® (Sanofi), Laserskin®* (Fidia Advanced Biopolymers), Myskin®* (Celltran Ltd.), and EpiDex™* (Modex Therapeutics).11 Two of the most widely studied and utilized include Apligraf (Organogenesis) and Dermagraft (Shire Regenerative Medicine). Apligraf is a livingcell-based, bilayered skin substitute derived from bovine type 1 collagen and human fibroblasts and keratinocytes derived from neonatal foreskins. It is approved by the US Food and Drug Administration (FDA) for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness ulcers secondary to venous insufficiency of greater than one-month duration that have not adequately responded to conventional therapy. Dermagraft is a cryopreserved human fibroblast-derived dermal substitute. The fibroblasts are obtained from neonatal foreskin. Dermagraft is FDAapproved for use in the treatment of full-thickness diabetic foot ulcers that

are greater than six weeks in duration that extend through the dermis, but without muscle, tendon, joint capsule, or bone exposure. It should be used in combination with standard wound care protocols and in patients with adequate blood supply to the involved foot/extremity. The benefit of such products is their regenerative healing capabilities. These products stimulate, improve, and modulate wound healing by stimulating the patient’s own cells to regenerate tissue. In addition, they deliver cytokines and growth factors while maintaining a moist wound bed. For additional product information and guidelines for use, refer to the manufacturers.

CONCLUSION

As stated by many, wound management is an art as much as it is a science. As science continues to rapidly grow and provide unique and novel dressings, topicals, and devices for wound management, it is incumbent upon the wound care practitioner to apply the art and customization of these resources for patient-centered care. Dressing selection can be challenging and overwhelming given the number of options available. One must consider the components of wound bed preparation, the clinical presentation of wound and patient, the prognosis, and goals of care in addition to the realities and constraints of medicine today. Staying abreast of the literature, attending conferences, and seeking advice from known wound experts; following manufacturer recommendations; and justifying product utilization through outcomes are methods to help all providers succeed. n These products are not available for use in the US as of Today’s Wound Clinic press time. *

Heather Hettrick is associate professor in the department of physical therapy at Nova Southeastern University, Fort Lauderdale, FL.

References available online at www.todayswoundclinic.com www.todayswoundclinic.com

4/7/14 1:51 PM

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SPECIALTY WOUND CARE EMR: 6 AREAS DRIVING CRITICAL VALUE & COMPLIANCE Cathy Thomas Hess, BSN, RN, CWOCN

s a healthcare business entity, the outpatient wound clinic operates for a patient population living with complex chronic conditions unlike any other throughout the care continuum.Associated morbidity, decreased quality of life, and, in some cases, mortality are among the many reasons significant interest has been focused on the prevention and treatment of chronic wounds. Care planning requires a multifaceted approach by specialists managing the care and integrating proven clinical practice guidelines. As a wound care provider, the very root of proving one is working within the guidelines of the clinic is found within the data captured using the specialty electronic medical record (EMR). A specialty wound care EMR will capture a granularity of information in a certain workflow that other EMRs simply cannot. This becomes high-value information that proves worth and compliance within the wound clinic. Furthermore, hospitals seek to open outpatient specialty clinics focused on wound care to support patients living with chronic wounds and to provide a setting that can manage recurring visits. This places a great responsibility on the wound clinic to have competent staff and processes in place to support documentation, patient safety, revenue cycle management, regulations, compliance, clinical therapies and workflows, operational leadership, clinical quality measures (focusing on Meaningful Use and Physician Quality Reporting System [PQRS]), reporting, and data analytics (See Figure 1). To ensure financial success within the clinic, process efficiencies must be in place to manage volume, support outcomes, and drive data/reporting. Utilizing a comprehensive, interoperable specialty EMR, supporting these process efficiencies, is key

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for the department’s success.1 “Numerous documentation elements are captured for specialty care, which are not always available in standard EMR solutions. Some specialty documentation forms can be template driven, but others require complex algorithms to reflect the steps that specialty clinicians take in their clinical encounters. The views, protocols and order sets are another aspect requiring special design and consideration. It is critical that the specialty content and workflow be analyzed correctly in order to effectively achieve user adoption.”2 This article will address six key components of the specialty wound care EMR that will drive clinical value and compliance in the clinic.

1) INTEROPERABILITY Interoperability is critical to receiving and collecting data. According to www. HealthIT.gov, “A complex healthcare system requires diverse EMR products. One size does not fit all. To realize their full potential, EMR products must be able to share information seamlessly. An interoperable health information technology (IT) environment makes this possible. EMR interoperability enables better workflows and reduced ambiguity, and allows data transfer among EMR systems and healthcare stakeholders. Ultimately, an interoperable environment improves the delivery of healthcare by making the “right” data available at the “right” time to the “right” people. In creating an interoperable health IT environment, standards are particularly critical in four areas of EMR technology: • How applications interact with users (such as e-prescribing); • How systems communicate with each other (such as messaging standards); • How information is processed and

managed (such as health information exchange); and • How consumer devices integrate with other systems and applications (such as tablet personal computers).”3 Integrating interoperability within the clinic is critical for capturing and sending codified data, decreasing duplicative work, and improving patient safety.

2) PATIENT SAFETY Implementing specialty wound care EMRs with guided workflows also assists the clinic in improving patient safety, among other initiatives. Customizing the specialty EMR with clinical practice guidelines, payment, and clinical regulations (eg, Centers for Medicare & Medicaid Services [CMS], Joint Commission) provides a platform for multidisciplinary communication. Implementation of the guidelines, evidence-based clinician instructions, predefined order sets, medication management through the use of Computerized Physician Order Entry, regulations, and product formularies further supports patient safety and objectives that are necessary to provide quality clinical care.

3) REVENUE CYCLE MANAGEMENT, REGULATIONS, & COMPLIANCE The documentation process begins at the time the patient’s appointment is scheduled within the specialty outpatient clinic. The workflow encounter may include verification of: • front-end collections; • coverage prior to the patient visit; • insurance information; • patient demographics; and • reason for visit. Each of these measures has additional action steps that can be built into a work-

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flow to ensure complaint documentation and billing. Additionally, demographic and payer information is gathered, medical necessity and coverage is confirmed, and all information is entered into the documentation system. Revenue cycle processes that include patient registration, compliant billing, and denial management complement the documentation process for a fiscally successful wound clinic.These processes are also governed by policy. Medicare is required by the Social Security Act to ensure payment is made only for those medical services that are reasonable and necessary. Policies specify the circumstances under which Medicare covers specific services. Further, most payers have implemented medical necessity guidelines for wound care services. At the heart of the specialty wound care clinic is compliance. Compliance provides oversight for clinical, operation, and financial standards. Staying abreast of coding regulations and government changes is critical to maintain a compliant clinic. Managing compliance standards through a specialty wound care EMR ensures complete, compliant documentation.

4) CLINICAL QUALITY MEASURES (CQMs) As we continue to leverage resources for “meaningful documentation,” we also need to take a closer look at another important tool — clinical quality measures (CQMs) — and their impact on the wound care business. CQMs assist providers in measuring and tracking the quality of healthcare services provided within the healthcare system. CQMs are set in place to ensure the safety and efficacy of care delivered and to measure aspects of patient care including: • health outcomes; • clinical processes; • patient safety; • efficient use of healthcare resources; • care coordination; • patient engagements; • population and public health; and • adherence to clinical guidelines. In the past, quality measures were obtained from claims processing. Now, the focus for quality measures has transitioned to be collated and reported by the provider through EMRs.Through various measures, CMS has aligned quality-reporting pro20

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6 Critically Interconnected Elements Driving Value & Compliance

grams, including the EHR Incentive Program (Meaningful Use) and PQRS. Monitoring, measuring and reporting CQMs on a regular basis assists the health care system in delivering care that’s effective, safe, efficient, patient-centered, equitable, and timely. Collecting this level of documentation for CMS from a specialty outpatient wound clinic ultimately allows CMS to review reported quality metrics, thereby improving quality of life for patients living with chronic wounds.

5) MEANINGFUL USE & PQRS FOR WOUND CARE CMS has led the charge to implement clinical quality measures within its programs, including Meaningful Use and PQRS. Through the transmission of data, clinical quality measures assist CMS in understanding the care provided to the patient/beneficiary and, ultimately, the data collected will improve quality care for the patient population. To successfully implement and achieve both mandates, the wound care community needs to embrace three key building blocks: • Workflow – optimize clinical, operational, and financial processes to fully leverage technology. • Certified Specialty Wound Care EMR and Reporting Suite – discrete data fields focused on specific wound care elements and medical necessity requirements that support documentation standards, enhance outcomes, and optimize reimbursement.4 • Meaningful Data Reports – develop core reports to manage the clinic; generate

quality reports and utilize data to improve patient and facility outcomes; attest to Meaningful Use and report for PQRS.

6) DATA & REPORTING Capturing discrete, or structured, data provides the information necessary to meet Meaningful Use and PQRS while ensuring the integrity of healthcare data, decision-making, and quality patient care. A compliant specialty wound care EMR standardized to capture the work and assessment data using discrete data fields is critical to complying with regulations and reportable data. Integrating evidence-based guidelines and templates, standardized dropdown lists, and reference tables can assure quality data is captured and reported to support a meaningful platform.And, to make the clinical data meaningful and rich in information, data must be captured in a codified way. “Specialty areas have sophisticated reporting needs that are different. In many implementations the focus is on the clinical workflow and process for capturing data, and the requirements for data analytics are not considered.The EMR can bring great value to the clinicians in monitoring their practice, reviewing quality measures, understanding opportunities for improvements, and supporting their research objectives.”1 n References available online at www.todayswoundclinic.com

Cathy Thomas Hess is a TWC board member and vice president, chief clinical officer of Net Health, Pittsburgh, PA. www.todayswoundclinic.com

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SNaP® Wound Care System Negative pressure therapy that won’t slow patients down. Now Reimbursed in Wound Care Centers To learn more about the SNaP Wound Care System, contact us at: 1.877.774.7228 or visit www.spiracur.com ®

ULTIMATE STANDARDIZATION OF FIRST-LINE WOUND DRESSINGS TO A SINGLE TYPE A Texas-based wound clinic achieves significant cost reduction while improving outcomes, personnel productivity, and patient and clinician satisfaction by adopting a new method of standardization. Randall Wolcott, MD & Vicki Fischenich RN, MSS, GNP-BC, WCC

aintaining a varied inventory of dressings in the outpatient wound clinic is expensive and time-consuming. In keeping with the discovery that wound healing must take place in a moist environment,1 wet-to-dry gauze has been gradually replaced by numerous specialty wound care dressings — including alginates, hydrofibers, foams, collagens, hydrocolloids, hydrogels, films, membranes, sachets, gels, powders, combinations, and negative pressure wound therapy — all of which are designed to address various healing stages and wound types. Today, well-trained clinicians make dressing decisions based on regular assessments of the wound and patient’s needs. Because current wound care training dictates that a change in wound characteristics typically necessitates a switch to a new dressing, clinicians must have a detailed understanding of wound products, cost-effective treatment modalities, and the principles of optimal wound interventions. Given that hundreds of wound care dressings and devices have been developed or become obsolete as the science of wound care has progressed, even the most motivated, welleducated caregivers cannot keep up with the available options easily. The sheer number of new, advanced dressings has driven up both inventory costs and the usage of adjunctive products such as gels, pastes, and wound contact layers — increasing inventory that is only partially used. As a result, overhead costs of logistics and inventory management are driven ever upward and overall operational efficiency of wound clinics is reduced.

EMPHASIS ON QUALITY Two main goals of an outpatient wound clinic are helping to ensure excellent patient outcomes and minimizing the risk of complications, both of which highlight

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the importance of functional quality of the dressing placed on the wound. In addition, newly imposed limits on reimbursement, as well as lifetime limits of wound care delivery per wound, also emphasize the importance of quality in wound care treatment and quicker healing. However, due to the relatively high expenditures on wound care products, as a percentage of overall expenses, the overriding goal within wound clinics often is to reduce initial product expenses. Unfortunately, the primary focus on sticker price can lead to sacrifices in quality and patient satisfaction, and an increased overall cost of wound care. This article will discuss the methodology and findings of a retrospective, observational study conducted at an outpatient wound clinic to determine the economic and clinical outcomes of standardization to a single type of advanced self-adaptive wound dressing as the first-line modality for most wounds.

POSITIVE EFFECTS OF STANDARDIZATION Considering the widening range of wound care modalities, the concept of standardizing to a single type of dressing may seem counterintuitive. However, the investigators postulate that standardization to a self-adaptive category of wound dressings that are effectively utilized through all wound healing stages could save overall wound clinic costs, simplify care, improve clinical outcomes, and increase patient and caregiver satisfaction. When quality becomes a primary focus in any setting, quality tends to increase and costs fall over time, according Dr. W. Edwards Deming, a well-known author and business consultant who established successful quality business improvements during the 20th century. However, when people and organizations focus primarily

on costs, costs tend to rise and quality declines over time.2 Many of Deming’s basic tenets of good management remain applicable to managing a successful wound care clinic today. In an effort to curb costs and enhance healing rates, one recent study describes a process of standardization undergone by a hospital to limit vendors and eliminate the use of multiple similar products being used to perform similar clinical functions.3 A thorough standardization of wound care products led to a reduction in the number of vendors from nine to three, as well as a significant annual reduction in supply expenses.

INTRODUCTION OF SELF-ADAPTIVE WOUND CARE TECHNOLOGY

New self-adaptive wound care technology is based on the science of dynamic wound dressing materials with variable on-demand functionality. Composed of “smart” synthetic polymers, the Self-Adaptive Wound Dressings (SAWD, OSNovative Systems Inc.) are produced as sterile, super-absorptive, and simultaneously hydrating, multilayered, pliable sheets with a breathable backing film impermeable to fluids and microorganisms. The dressing material is engineered to change its properties according to underlying wound and periwound tissue conditions. What sets SAWDs apart is their capability to accommodate the full spectrum of wound conditions, from dry to heavily draining, and from the simplest to the most complex. SAWDs are designed to dynamically balance the moist wound microenvironment, such that hydration or absorption is provided depending on the evolving needs of the wound bed, wound edge, and periwound skin independently. That is, non-draining areas of the wound stay

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woundcaretrends properly hydrated through automatic regulation of moisture losses. At the same time, fluid from draining areas containing exudate, liquefied slough, and microorganisms is absorbed and locked inside the dressing material — protecting periwound skin from maceration.

USING SELF-ADAPTIVE DRESSING VS. DIFFERENT DRESSING TYPES

The ideal, effective wound dressing should effectively remove barriers to wound healing, including exudate, inflammatory mediators (cytokines, proteases), non-vital tissue, and infectious microorganisms. As well, the dressing should maintain an optimal moist wound healing microenvironment for each part of the wound bed and wound edge while supporting autolytic debridement. Additional attributes and capabilities include protection of the periwound skin; a microbial and fluid strikethrough barrier; painless, non-traumatic dressing changes; and a dynamic and adequate response to changing wound conditions and wound edge moving due to re-epithelialization while the dressing is worn. SAWD is the first wound dressing category that facilitates all of these basic principles of wound healing throughout all healing stages. These dressings were ideal for an experiment in standardization because, unlike all current compositional advanced wound dressing types (eg, foams, alginates, hydrocolloids, hydrogels, etc.) that are applicable only to specific wounds or a narrow range of wound conditions, SAWDs are applicable to any wound, from those highly exuding to those nonexuding, in any healing stage.

STUDY PARAMETERS

An initial 30-day supply of SAWDs (sizes 2 in x 2 in; 4 in x 4 in; and 6 in x 6 in) was ordered for the clinic by the supply manager directly from the manufacturer based on historical quantities of consumed dressing supplies. The entire wound care staff was then informed of the plan to convert to a single dressing type during a formal meeting. An inservice for all staff was also conducted to detail the application of

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SAWD and to answer questions. During a three-month period (Dec. 5, 2012 to Mar. 8, 2013), indicated patients treated at the outpatient wound clinic received SAWD as the first-line dressing. Patients were excluded from use of SAWD if they had just received a one-month supply of a different dressing from the clinic; once these supplies were consumed, patients then received SAWD. There were no other exclusion criteria. Dressing changes took place once weekly (at a minimum). Dressings were changed more often initially (2-3 times per week) in cases of slough, high bioburden, and excessive drainage, with the timing between changes gradually increased until a goal of once-weekly changes was achieved. Patient demographics, the number of patient visits, and wound type were all recorded at each clinic visit. At the end of the study period, records of dressing-related expenditures were extracted from supply invoices by the month for the previous six months. Dressing expenditures and stock keeping units (SKUs) number during the preceding three-month period (September 2012 to November 2012) were used as a baseline for economic comparison. In addition, a caregiver satisfaction survey was issued to each caregiver at the clinic who treated patients during the study period. Its results were then recorded and tabulated.

SUMMARY OF RESULTS

Patient/Clinical Outcomes. SAWDs were used on 547 patients (250 female; 297 male) with 1,168 chronic and acute wounds during 2,583 clinic visits. Wound etiologies and occurrence frequency are shown in Figure 1. Based on questionnaire responses, average patient and caregiver satisfaction were higher with SAWD compared to prior dressings, due to consistently faster wound improvements, decreased dressing change frequency, reduced pain and odor, painless dressing changes, superior drainage management, and prevention of skin maceration. Standardization to the first-line usage

of SAWD improved the consistency of care for the same wounds and patients. This consistency of care is known to lead to better outcomes and reduce errors in documentation. Additionally, some products were observed to work well with, and even synergistically enhance the results of, self-adaptive technology, such as compounding gels prepared per patientspecific DNA culture analysis. Workflow Improvement. Standardization to the first-line usage of SAWD increased overall caregiver satisfaction by dramatically simplifying care protocol and decision-making; eliminating the need for medical order changes during the course of treatment; and minimizing dressing-related retraining time, mistakes, and documentation; as well as reducing nursing workload while improving nurse productivity. The reduction in dressing change frequency during the study period also allowed staff to devote more time to other patient care responsibilities and documentation while allowing clinicians to see more new patients. Similarly, the materials manager experienced drastic time-savings in terms of inventory management during the study period as compared to prior inventory management methods. Product and Supplier Variety Reduction. Standardization to SAWD replaced the use of primary foam; alginate; hydrofiber; hydroconductive, super-absorbent collagen; hydrocolloid; hydrogel; and combination dressings including silver-containing products, wound contact non-adhering layers, skin preps and moisture barriers; and noticeably decreased the amount and variety of products entering treatment rooms. During the study, inventory of primary wound dressings was greatly reduced, with inventory utilization close to 100%. The variety of primary wound dressings and number of managed SKUs in everyday inventory was reduced by more than 60%, as shown in Figure 2. The number of primary dressing supplies was reduced by 70%, with potential for future reduction (Figure 3). Both primary wound dressing SKU and supplier number reduction resulted

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woundcaretrends in an ultimate standardization of wound dressing supply: One primary dressing type from one supplier represented 84% of the total dressing supply with an obvious potential of further increase to more than 90%, as shown in Figure 4. Cost Reduction and Financial Results. SAWDs are in the midrange of current advanced wound dressing prices. They are generally more expensive than simple foam dressings, but significantly less costly than advanced foam dressings and silver-containing, collagen, hydroconductive, and other products. The moderate price of SAWDs and their nearly 100% utilization led to reduction of total monthly spending on primary wound dressings upwards of 30% during the standardization study at the clinic compared to baseline spending before the study (Figure 5). This spending reduction is estimated to provide the clinic with more than $40,000

Figure 1. Wound etiologies during study.

Figure 4. Primary wound dressing

supply standardization after adoption of SAWD. 24

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annual savings on primary dressings. Additional cost savings come from the elimination of many adjunctive products and the simplification of training, documentation, and inventory management. Quantification of these factors and expected financial gains due to higher personnel productivity were not the subject of this study.

ADDITIONAL BENEFITS

Cost Saving to Referring Long-Term Acute Care (LTAC) Facility. A referring LTAC facility that standardized to SAWD during the same study timeframe also benefited from significant cost savings. Patient outcomes met or exceeded facility expectations during this time. The managing pharmacist Dr. Abdel Bendamkila reported a reduction in topical pharmaceutical wound care product expenditures from an average of $5,900 per month to $1,900 per month (Figure 6). These

Figure 2. Reduction of primary

dressing SKUs in inventory with adoption of SAWD.

Figure 5. Reduction of monthly expenses on primary dressings after adoption of SAWD.

cost savings were due to a reduction in dressing change frequency from daily to 1-2 times weekly, as well as considerably reduced consumption of topical ointments, particularly autolytic debridement agents. n Randall Wolcott serves on the TWC editorial board and founder of Southwest Regional Wound Care Center, Lubbock,TX. Vicki Fischenich is clinical specialist at OSNovative Systems Inc., Santa Clara, CA. References 1. Hinman CD, Maibach H. Effect of air exposure and occlusion on experimental human skin wounds. Nature. 1963;200:377–378. 2. Halwes T. Revealing Examples: Deming’s Quality Management Training. Accessed online at www.dharma-haven.org/five-havens/deming. htm 3. McNees P, Kueven JA. The bottom line on wound care standardization. Healthcare Financial Management. 2011;65(3):704, 76.

Figure 3. Reduction of primary dressing suppliers with adoption of SAWD.

Figure 6. Reduction of referring LTAC monthly spending on adjunctive topical ointments after adoption of SAWD.

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These three mechanisms of action draw exudate, slough, wound debris, bacteria and deleterious cytokines into the dressing for optimal wound bed preparation.1

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REMOVING DETERRENTS WITHOUT ADDING POTENTIALLY HARMFUL AGENTS:

A NEW PARADIGM FOR EFFECTIVE WOUND HEALING Martin Winkler, MD, FACS & Michael E. Steadman

urgical incisions and traumatic lacerations are closed through wound approximation. Chronic wounds and large-surface burn wounds cannot be closed by primary intention. Many advanced wound dressings, skin substitutes, and peptide growth factors have been used with varying success to assist wound healing by secondary intention. Tertiary closure by pedicled or free flaps, or by split-thickness skin grafts, fulfills the “gold standard” for wound closure (ie, closure with autologous skin).To accomplish the goal of increasing function while decreasing the rate of disabilities and hospital stays,1 many different medicants, drugs, and dressings have been introduced into today’s market and onto wounds. However, not all of these products have been innocuous to wound tissue. The Hippocratic injunction to “not harm the patient” is enunciated by Thomas Sydenham in the Latin expression, “primum non nocere.”2 Based on these principles, a new paradigm for effective wound healing is presented by simplifying the overall approach to wound care. This new paradigm is designed around meticulous wound bed preparation to allow the wound to proceed to endogenous healing or to set the stage for successful wound closure with autologous tissue.3 This approach is accomplished by removing deterrents to normal healing without adding any agents that might interrupt the normal cellular or humoral processes of the wound healing scheme.

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This article will discuss the methodology and provide a clinical case file behind this new paradigm.

WOUND BED PREPARATION

Three products in particular have been added to the wound clinician’s armamentarium to accomplish this mode to healing. Following debridement of all necrotic and nonviable tissue, the wound can be cleansed with Vashe® Wound Therapy (SteadMed Medical LLC), a solution of hypochlorous acid (the body’s natural material for eliminating invading pathogens via the oxidative burst within neutrophils.)4 Vashe cleanses the wound by soaking and further debrides the wound by wiping the excess Vashe from the wound. Application of Drawtex® Hydroconductive Dressing (SteadMed Medical LLC) can then be used to draw off any remaining debris, slough, bacteria, and deleterious cytokines.5 Drawtex functions by a unique combination of three physical actions: capillary action, hydroconductive action, and electrostatic action.6,7 This approach does not introduce any substances into the wound that may have a degree of cytotoxicity, such as silver or antimicrobials. Using the combination of Vashe and Drawtex, wound bed preparation is optimized for those wounds healing by secondary intention. For wounds that are not proceeding rapidly to closure, an Xpansion® Micro-autografting Kit (SteadMed Medical LLC) can be used to allow a method of grafting epidermis and

dermis to the wound as an outpatient procedure without using an operating theater and with a minimal donor site. This technique allows a small splitthickness autograft to be expanded up to 100 times in order to minimize the donor site.8 These microautografts allow the wound to be closed with autologous epidermis and dermis.

PATIENT CASE FILE

A clinical example of using the three products described in this novel paradigm occurred with a 77-year-old female who presented to the wound clinic nearly four weeks after dropping a frozen turkey onto her leg while removing it from the freezer. A large pretibial hematoma with necrotic overlying skin resulted and complicating factors included the patient being a “very heavy” smoker living with venous insufficiency in the injured leg.The area of injury was cleansed and soaked with Vashe to soften the eschar to facilitate debridement (Figure 1). Following removal of the eschar, the area was treated with Drawtex dressings changed weekly (Figure 2). Seven days after the Vashe cleansing and Drawtex dressing, the wound was beginning to granulate satisfactorily with little nonviable tissue remaining (Figure 3). At each weekly clinic visit, the wound was soaked with Vashe and wiped free of debris. After three weeks, wound bed preparation was considered adequate for wound closure. Using Xpansion, a small split-thickness skin graft was obtained under local anesthesia

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woundcaretrends in an outpatient wound clinic and the minced graft was applied to the wound (Figure 4). One week after grafting, the minced graft segments were beginning to spread in the wound (Figure 5). By two weeks, the grafts had almost closed the wound (Figure 6).Total closure was achieved three weeks after grafting and six weeks after the beginning of treatment (Figure 7). To maintain compression to the wounded leg, EdemaWear® (Compression Dynamics LLC) compression stockinette was used over the specific wound dressings throughout the treatment course. The three products discussed in this paradigm and used in the clinical case are synergistic and designed to aid the wound in healing without outside interference and without doing any extra undue harm to the healing tissues. n

Martin Winkler is a vascular surgeon and associate professor of surgery, department of surgery at Creighton University, Omaha, NE. Michael Steadman is president and chief executive officer of SteadMed Medical LLC, Fort Worth,TX.

burns with a hydroconductive wound dressing: clinical and mechanistic effects. Surg Sci. 2013; 4: 268-272. 7. McGuire J, Sadoughi N: Hydroconductive wound dressings. Podiatry Management. 2013; August 145150. 8. Hackl F, et al: Epidermal regeneration by micrograft transplantation with immediate 100-fold expansion. Plast Reconstr Surg. 2012; 129: 443e-452e.

References 1. Tobin GR. Closure of contaminated wounds: biologic and technical considerations. Surg Clin N Amer. 1984;64:639. 2. Smith CM. Origin and uses of primum non nocere – above all, do no harm! J Clin Pharmacol. 2005;45 (4):371-377. 3. Robson MC. Advancing the science of wound bed preparation for chronic wounds. Ostomy Wound Manage. 2012;58 (11):10-12. 4. Liden BA. Hypochlorous acid: its multiple uses in wound care. Ostomy Wound Manage. 2013;59(9):1012. 5. Robson MC (Ed). Innovations for wound bed preparation: The role of drawtex hydroconductive dressings. Wounds. 2012; 24(9 Suppl):1-27. 6. Smith DJ, Karnoski RA, Patel A, Cruse CW, Brown KS, Robson MC: The treatment of partial-thickness

Figure 1. Use of hypochlorous acid soaks, cleanses, and softens eschar to facilitate debridement of necrotic tissue.

Figure 2. Following debridement, hydroconductive dressing changed weekly to remove remaining debris, slough, bacteria, and excess exudate.

Figure 3. Wound following dressing removal at one week. Remaining nonviable tissue debrided and Drawtex reapplied to complete wound bed preparation.

Figure 4. Three weeks following presentation, wound bed prep is complete and microautografting performed.

Figure 5. At first postgraft dressing change, graft fragments begin to spread onto wound surface.

Figure 6. By two weeks post-graft, fragments are coalescing and most of wound surface is closed.

Figure 7. Three weeks post-graft and six weeks from presentation, wound is successfully closed.

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Today’s Wound Clinic® April 2014

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ICD-10-CM ICD-10-CM DIAGNOSIS CODING DOCUMENTATION TIPS FOR VENOUS ULCERS (CATEGORIES 170-174; 180.00-187.9)

he arrival of ICD-10-CM has been pushed back to at least October 2015, but Today’s Wound Clinic is still helping wound care practitioners get an early start on refining their documentation skills in preparation for the new coding format. In an effort to assist our readers as they continue to transition from ICD-9-CM, we’re offering an assortment of ICD10-CM documentation tools on particular disease states or medical conditions that have been developed to help improve documentation habits, which will be vital to the success of wound clinics in the ICD-10-CM environment. The tools may also contain information on coding guidelines when appropriate. This month’s tool covers the category of venous ulcers. ICD-10-CM Diagnosis Coding Documentation Tips for Venous Ulcers (Categories 170-174; 180.0-187.9) Topic

ICD-10-CM Code Ranges

Documentation Tips/Guidelines

Requirement of a 7th Character for Trauma Codes

I70.201-I70.209: Atherosclerosis of extremities, unspecified

Documentation should include specific site of thigh, calf, ankle, heel, midfoot, and other or unspecified, as well as any laterality. In addition, it is important to specify if the disease is with ulceration or gangrene.

I70.231-I70.25: Atherosclerosis of extremities with ulceration I70.262-I70.269: Atherosclerosis of the extremities with gangrene

Note: If ulcer is present, be sure to document depth and tissue involved with the ulcer. Coders will need to use additional codes to identify the specific ulcers.

I73.00: Without gangrene I73.01: With gangrene

Document with or without gangrene.

I79.1-I79.8: Plus code from diabetes (E08.51-E13.5)

Be sure to document whether angiopathy is due to any underlying disease such as diabetes.

Arterial Embolisms

I74.2: Upper extremity I74.3, I74.4: Lower extremity I74.5: Iliac artery

Specify site of embolism.

Phlebitis/ Thrombophlebitis Lower Extremity Superficial Vessels

I80.00-I80.03: Superficial vessels

Document laterality.

I80.10-I80.299: Deep vessels

Specify femoral, popliteal, tibial, other, unspecified, and laterality.

Varicose Veins Lower Extremity

I83.001-I83.029: With ulcer I82.201-I83.229: With ulcer and inflammation I83.811-I83.999: With other complication

Document thigh, calf, ankle, heel, midfoot, other, unspecified laterality. May use additional code for specific ulcer site.

Postphlebitic Syndrome

I87.011-I87.019: With ulcer I87.031-I87.039: With ulcer and inflammation

Document laterality. (May use additional code for specific ulcer site.)

Chronic Venous Hypertension

I87.311-I87.319: With ulcer I87.331-I87.339: With ulcer and inflammation I87.391-I87.399: With other specified complication

Document laterality. (May use additional code for specific ulcer site.)

Raynaud’s Syndrome Peripheral Angiopathy in Diseases Classified Elsewhere (ie, Diabetes)

Phlebitis/ Thrombophlebitis Lower Extremity Deep Vessels

Document any other complications, such as pain.

National Center for Health Statistics: www.cdc.gov/nchs/icd/icd10cm.htm

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As a reminder, refer to the original ICD-10-CM article in the October 2013 issue of Today’s Wound Clinic for instructions on how to properly use this grid to begin your documentation improvement program. Pointers: Remember to have any operative reports and documentation regarding the circumstances surrounding the injury readily available. Stay tuned for a new ICD10-CM topic next month! n www.todayswoundclinic.com

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facilityinfocus Maximizing Collaboration to Develop Wound Care Service Line at Excela Health By Joe Darrah

Excela Health, Greensburg, PA

reensburg, PA — On a sunsoaked afternoon last summer, Anna K. “Kay” South, FNP-C, MSN, CCRN, received a phone call that would forever change her career. Uncommonly hot that day for the Pittsburgh suburb, the temperature was enough to convince South to retreat into the nearest building to answer her cell as she strolled across the campus at Excela Health. Calm, collected, and, yes, now cool enough to recognize that she had stepped into the entry way to the health system’s Advanced Wound Center, to take the call, South serendipitously remembered hearing that the clinic was in search of a nurse practitioner to augment its daily clini32

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Photo courtesy of the facility.

cal operations. The call all of a sudden didn’t seem so important. In a matter of moments she was off the phone and inquiring about the position, which she assumed would be a perfect fit for her desires as a newly minted NP with a background in critical care and home care to treat a patient population that would benefit greatly from her clinical experience in a setting that would give her the chance to provide hands-on care where positive outcomes are overwhelmingly the expectation. “I figured that my background in the ICU and critical care, where rapid responses were needed for people who were very sick and taking care of the ‘whole person’ was not new to me, that

this could be a good fit,” South explained during a recent visit by Today’s Wound Clinic to the outpatient center, a 5,000-square-foot facility established in 2003. “So, I ducked in, spoke to the receptionist who confirmed that they were looking for an NP, and it all came together.” Today, that theory of togetherness remains as South has comfortably made the transition to her still relatively new position, which has required her to gel with an existing staff of more than 20 professionals that includes a longstanding, six-member panel of specialty physicians and surgeons as well as more than 10 registered nurses. Through the utilization of a case management model of care, she and the staff have also jointly reached some lofty wound healing metrics established as part of the health system’s initiative to expand its wound care services while formulating a service line that revolves around the wound clinic. The validity of the benchmarking success is evident in what the last three years has produced: the most productive clip of healing rates the clinic has ever seen. “We want to have 80 percent of our patients 100 percent healed within 16 weeks — that’s our metric,” said Tom Capco, system director of ambulatory and outpatient services at Excela, a title that includes management of the wound clinic. “Right now we’re running at 82 percent. And with a 16-week timeframe for who we see here and the high population of diabetics that we have living in this region — I think that’s wonderful.” www.todayswoundclinic.com

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facilityinfocus Equally impressive has been the clinic’s method of adapting to a significant level of change across a host of clinical and business perspectives since Capco took over the daily operations of the center in fall 2011. It’s a series of modification that’s been enabled by a dedicated team approach carried out by a determined group effort. “Teamwork makes this place go,” said Scott Jacobson, DO, internal medicine specialist and physician panel member. “Everyone is well respected. Nobody is more important than anyone else. That’s what makes us so successful.”

CHAMPIONS OF CHANGE

It was a completely hypothetical situation that Capco feared as he initially surveyed the landscape of his clinic upon his own transition from an Excela inpatient department (see sidebar on page 37) that served as the impetus for enacting what would soon lead to a widespread remodeling of wound clinic protocol and practice to attempt to meet the quality standards that had been set. The vision: an overcrowded waiting room filled with patients awaiting care by an overwhelmed healthcare staff. “With the number of patients we were seeing and the metrics we had been striving for, it was conceivable to think that if we had a full lounge and the surgeon who was supposed to be in clinic was stuck in the operating room all afternoon, our customers could also be stuck waiting — and that’s not the kind of service we would want to provide,” he said. “You wouldn’t want people leaving because they’re frustrated — that’s not what we’re about. And you certainly don’t want to lose that revenue, so the bottom line is that you have more continuity of care in practice when you have someone in the clinic full time every day.” Enter South, a nurse of nearly 40 years, who in her role serves as the clinic’s sole full-time provider who assists in the care planning coordination of the more than 30 (on average) patients seen in the clinic each day, which has resulted in as many as 100 new admissions in one month’s time over the course of the last three years. Her appointment marked the first time www.todayswoundclinic.com

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Patient Profiles: Jean Graham & David Herold Even though there wasn’t much physical pain to speak of, the mental and emotional anguish had become unbearable for Jean Graham. More than three years had already passed since the 62-year-old Greensburg, PA, resident developed what would become “too many wounds to count” following a breast-reduction procedure in November of 2009. When Graham first noticed an open sore on the stitch line of her left breast the following summer, she assumed it was an irritation caused by her bathing suit. “I didn’t think too much of it initially, but then the opening got bigger and JEAN GRAHAM I didn’t know what to do,” Graham said during a recent interview at Excela Health’s Advanced Wound Healing Center, where she’d eventually be referred. Upon seeing her gynecologist, she was placed on an oral antibiotic that did not improve her condition over a 10-day treatment. In fact, her condition worsened — with more wounds continuing to form around the areola before spreading underneath her breast. She then went back to her plastic surgeon, who suspected an allergy to the sutures used and ordered her various cultures to go along with another oral antibiotic. DAVID HEROLD “And this went on, I hate to say it, for three years,” said Graham, who today is as healthy as she can remember being in a long time. Diagnosed with pyoderma gangrenosum, a rare autoimmune condition with unknown causes that admittedly also baffled the clinic staff for a time, Graham told TWC that her lack of faith in being healed that had been restored when she arrived to the clinic in September 2013 never wavered throughout her four months there because of the staff’s diligence to attempt multiple routes to a resolution while continuing to work to identify her condition. The findings came late one night while Susan Poklembo, BSN, CWCN, wound clinic supervisor, was up late conducting research at home. When she confirmed her suspicions the following morning with clinic medical director David A. Kenney, MD, who had been leading the case with Poklembo, she got to deliver some of the most impactful news she’s ever told a patient. Graham was placed on a high-concentration steroid cream and prednisone. She healed in four weeks. “The staff was really uplifting and always encouraging,” Graham said. “It’s the greatest group of people I’ve ever met. It’s just been absolutely remarkable.” David Herold, 58, recently had a more life-threatening situation develop even if it didn’t appear to be quite as dramatic. The North Huntingdon Township, PA, resident was admitted to the clinic in March 2013 for hyperbaric treatment following a surgical-site infection that developed after having an exostectomy performed on his right foot. Slow to heal, the wound developed into osteomyelitis that he nearly waited too long to address. “They told me that if it had been another day or two, I might not have lived to see 59 because the infection was so deep,” said Herold, who required 30 hyperbaric treatments and IV antibiotics to reach closure. A former plow operator for the Pennsylvania Department of Transportation, Herold had long become accustomed to bunions and bone spurs on his feet. But for reasons he can’t quite account for, he was never one to return to the same podiatrist for foot care. As his sore lingered last winter, he didn’t suspect much of it. He still lives with general neuropathy and poor gait that don’t affect his life much, but he said the education and treatment he got at Excela will remind him of where he needs to go again should he experience any similar complications. “You don’t always feel like you’re constantly being taken care of everywhere you go,” he said. “But I always felt like everyone here was watching out for me. I hope other doctors are referring patients here too. This place saved my life.”— Joe Darrah

since the clinic had been built that the physician panel would not be exclusively relied upon to rotate oversight of the wound patients’ care. “We’ve always had a panel of physicians from a multitude of practices in place, and they’re all vested, loyal providers, but nobody ‘owned’ wounds here, if you will,” Capco explained. “So, to really get better continuity of care, she’s been a great addition to our staff as an expe-

rienced ICU nurse who is also comfortable working with the home care staff to facilitate and expedite orders on anything else that may be needed in the home right away, which can save the patient an additional trip to the clinic or the hospital — a potential barrier that we avoid. And there’s great respect and camaraderie between her and the staff in the clinic. It’s been a smash hit for the nursing staff because they also have that Today’s Wound Clinic® April 2014

4/7/14 3:30 PM

facilityinfocus

Kim Strashensky, RN (left), and Scott Jacobson, DO, meet with 95-year-old patient Olada Petri on her last day in clinic. photo credit - Joe Darrah

direct access to a provider all day long if they have questions or need assistance with our patients.” David A. Kenney, MD, a member of the physician panel who also serves as the clinic’s medical director, agrees, adding that South has just as easily forged a constructive collaborative relationship with the physician group as she has with the nurses. As the medical director, he has a particularly close affiliation with the NP. “By having Kay in the clinic each day, we have a paradigm in place that allows us to see every patient on a weekly basis unless they’re palliative,” he said. “We meet regularly to discuss our patients’ needs and consult one another on our care planning — and it’s just been an extremely productive collaborative between the two of us and the nursing staff as a whole. And that’s one of the keys to our whole system working well.”

ON THE CASE

That system refers to the clinic’s case management approach, in which each patient is provided with a primary physician depending on the specialty required per the wound as well as a consistent RN who remains involved with patients as the physician’s “case manager” throughout the care trajectory in an effort to foster familiarity and supportive relationships for both patient and provider. In this vein, South’s direct coordination with the physicians will often see her rotate in on patient visits when panel members are 34

April 2014 Today’s Wound Clinic®

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in surgery or private practice. Additionally, South’s scope as an NP allows for her to conduct comprehensive assessments of each patient at admission (along with the assistance of an assigned admissions nurse) and to order all needed diagnostics without the presence of a “supervising physician” onsite. At discharge, the patient then receives an assigned exit nurse so that any questions post-care can be streamlined and supported by continuity among South and/ or the physician and the RN. “The case manager model allows us to be very collaborative and allows the nurses and the physicians to communicate with the patients together as we pursue things like vascular intervention, or changing dressings, or ordering specific tests, or getting a nutritional assessment,” said Susan Poklembo, BSN, CWCN, wound clinic supervisor. A member of the clinic staff for 11 years, Poklembo has witnessed the modifications that have occurred at the wound center from a unique vantage point and has realized the rewards of an effective collaboration in care on various fronts. This winter, she and Kenney successfully treated a patient, Jean Graham, who had gone more than three years with an incorrect diagnosis (see sidebar on page 33). Upon the correct diagnosis at Excela, the patient’s recovery actually bested the stringent metrics standards by a few weeks. According to Kenney, while the

experience was quite unique, the rate of satisfaction expressed to him by the vast majority of patients and their families at the clinic remains consistent. “I get a lot of feedback, and what I hear is that people are extremely happy with how things are run here and the quality of care,” he said. “And the reason that we’re able to help them get better in a short period of time is that we work well together as a staff, we communicate with one another, and the understanding of patient care is the fuse for everyone. It’s just a nice setting, and I’m fortunate to be a part of the job that people are doing here.” In spring 2013, Kenney and Poklembo, as his wound care case manager, were honored by the health system with a quarterly Hospital Teamwork Award, which recognizes the collaborative efforts of a physician and an RN based on overall mission-driven values to clinical care. The award is considered just as much a positive reflection on the clinic as a whole as it is the provider pair. “It’s just another way of recognizing the care we’re doing here and at Excela that we all get, because we’re part of the same team,” Capco said.

EMPHASIS ON EXPANSION

The clinic’s reputation within the health system is also solidified in its plans to expand wound care into an additional outpatient clinic this May in Mount Pleasant, PA, along the region’s “Route 119 Corridor” as well as its emergence as a “hub” for what has become and will continue to be an evolving service line of care that includes a diabetes center and will soon envelop sleep services. Currently coordinating sleep care through a vendor-line model that sees Excela already responsible for the capital and three laboratories while an outside party manages scheduling and care services, Capco said he has initiated the transition to centralize everything within the Greensburg location because it makes more sense logistically from a business sense and as a means to help improve on those healing metrics they continue to examine. “It’s simple logic: You need glucose control and optimal oxygen levels to heal www.todayswoundclinic.com

4/7/14 3:30 PM

facilityinfocus

David A. Kenney, MD

photo credit - Joe Darrah

wounds,” he continued. “And some of these patients we’re seeing are dropping down to the 60s in their O2 saturations when you want to be 90s and up. There are cardiac issues that can develop if you have untreated sleep apnea, so we’re

looking at it from the whole continuum of care from a system perspective.” With the expected continued success of healing rates, however, it’s actually plausible that patients will have their particular wounds healed prior to going through the protocol of two sleep studies to properly diagnose those who are referred for sleep services based on their admissions assessment. As such, Capco envisions patients to be more compliant with their sleep health with all services localized in one setting. “When we’re healing wounds in 10 weeks, for patients to get through their studies and have any needed equipment set up at home by our durable medical equipment service — it’s not going to impact the wound they came to us with on that timeline, unless, for instance, you’re talking about a palliative care patient with a coccyx wound,” Capco continued. “But we’re doing what’s right for the patient overall.” The same holds true with diabetes care, which initially ran independently, but is now tied to the clinic through a

process that includes an assessment by a certified diabetes educator (CDE) when appropriate candidates are identified. “If you let a patient who’s living with diabetes leave your building without getting introduced to that CDE, you’re lucky if you have a 25 percent chance of them coming back in to get their education,” Capco said. The nearly finalized expansion has been necessitated by the number of patients currently being seen in Greensburg from as far out as the Westmoreland/Fayette County border, a region south of Pittsburgh that’s especially known for its prevalence of diabetes, many of whom were referred to the clinic through an RN liaison program that brings clinic nurses into private practices and other healthcare settings to educate providers on the services and structure of the clinic (see sidebar on page 40). The new clinic will function with existing staff rotating along with the addition of another NP, will add three exam rooms to Greensburg’s eight, and likewise develop into a hyperbarics center after need is continued on page 40

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TWCnewsupdate The US Senate has pushed the compliance date for ICD10-CM by one year with the passing of legislation aimed at providing a patch for the Sustainable Growth Rate (SGR). This is the 17th consecutive SGR patch passed, with a vote of 64-35, though senators from both sides — namely Sens. Ron Wyden, Mark Warner, and Tom Coburn, MD — were vocal in opposition of the patch and attempted to move the debate to the importance of paying for value rather than volume. It is still unclear how delaying the ICD-10 deadline became part of Section 212 of this latest SGR fix. Provider associations have voiced their lack of support for the delay, citing displeasure with ICD-10 being made part of the SGR repeal and frustration with the task of figuring out where ICD-10 fits into their plans moving forward. Many organizations had already invested significant time, energy, and resources into being ready for Oct. 1, 2014. The bill, “Protecting Access to Medicare Act of 2014 (HR 4302),” was approved by the House of Representatives in late March. n

fromtheeditorcontinued from page 4

cian payments through March 2015 and does not provide a longterm solution (a “permanent doc fix”) to this growing financial crisis within Medicare.The projected cost of SGR repeal legislation is between $140 billion (for SGR repeal alone) and $180 billion (to also extend other expiring provisions and make other desired changes). If Congress were to offset that price tag with commensurate reductions to Medicare spending, most stakehold-

ers would see Medicare payments drop in one form or another. Each year that Congress delays repealing the SGR is another year of avoiding a “day of reckoning” for every other health industry stakeholder. Support had been growing in Congress for a bipartisan “permanent doc fix” that would have involved a complicated system of alternative payment models including quality and incentive programs based in part on (as yet to be determined) quality metrics. Although it did not pass this time, the draft legislation further emphasizes the importance of welldesigned wound care quality measures.The March 31 legislation also increases the Department of Health and Human Services’ (HHS) authority to revalue services reimbursed under the PFS. Congress allows HHS to collect information from eligible professionals (or any other source) on time involved in furnishing services, prices for practice expense, overhead, etc. HHS is then permitted to adjust practice expense relative to values based on this information. Congress also significantly expanded the basis under which individual codes could be subject to review under the “mis-valued code” review process. The criteria for review includes codes that have experienced the fastest growth, have low relative values, are billed multiple times for a single treatment, and account for a majority of spending under the PFS. This entire exercise is focused on giving primary care more money. This process is budget neutral, so if some services get “re-valued” up, others have to be “re-valued” down. The process of valuing physician work (and thus payment for individual physician services), which used to be left almost exclusively in the hands of the AMA, can now be decided almost entirely by HHS. What do you think this will mean for our industry? n

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facilityinfocus Former Respiratory Therapist Reforms Wound Care Clinic Greensburg, PA — Tom Capco has never been afraid to use “buzz” words in his wound clinic, and there are several that he and the staff in the Advanced Wound Center at Excela Health have built into their collective vernacular. One of them is “vulnerability.” Another is “barriers.” “As a business, you have to be able to identify where you may be vulnerable and where there may be barriers,” explained Capco, system director of ambulatory and outpatient services at Excela, which includes the wound clinic. That mentality has not only generated a new vocabulary, it’s led to several new clinical and business-related practices in the clinic, which during his tenure has transitioned from a physician panel-based service to a nursing model of care, merged with the health system’s diabetes center and sleep center, and will soon expand into another outpatient wound center in Mount Pleasant, PA. A former respiratory therapist who made a career change to administration by accepting a management position at Excela in 2011 after more than 20 years in healthcare, Capco has also brought a passion for streamlined service and value-based care into a clinic that TOM CAPCO today heals more patients at a quicker rate than ever before seen in the health system. Though at first glance respiratory therapy and wound care may seem foreign to each other, Capco explains there’s actually a clinical similarity that cannot be denied that aided his change of practice setting. “With hyperbarics in here already, I felt there was at least a ground-level type of involvement clinically that I could have relationships with these providers and patients,” he said. “I understand the physiology of the O2 just as well as our technician, who’s also an RT. I can talk at length clinically about the anatomy of the lung. There certainly was a natural transfer.” Of course, there was a learning curve as well, for which Capco said he placed his trust in clinic medical director David A. Kenney, MD, to provide guidance and/or make the significant clinical decisions that are needed in the center; supervisor Susan Poklembo, BSN, CWCN, to lead the nursing staff; and newly hired Anna K. “Kay” South, FNP-C, MSN, CCRN, to oversee daily primary care. This affords him the opportunity to focus on what he says he knows best: leadership and processes. “People are people, processes are processes, and I think if you have the qualities to engage people to follow you — insight, intuition, energy, and vision — you can make transitions like this,” he said. “I don’t think it matters which arena you’re in clinically. It’s all in the ability to look at processes and know how they work or don’t work.” If the success of his clinic doesn’t speak enough to that, his staff and Excela’s senior administration do. Sherry Gaston, vice president, ambulatory and diagnostic services, credits much of what’s transpiring across the spectrum of the health system’s outpatient platform to Capco’s ingenuity and ability to endear himself to a largely preexisting staff of doctors and nurses while generating enough profit to warrant growth. “You have to focus on helping people the right way, and that will allow the revenue to follow,” Gaston said. “Bringing in the diabetes center to the wound clinic not only helped the clinic, it helped the diabetes center. With everyone’s help we were able to make quality our focal point and let everything else fall in line. And I have to attribute a lot of that to Tom to looking at his original service line and this service line, and how they overlapped.”

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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 that 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

Please see complete prescribing information at www.Apligraf.com

Dermagraft® Essential Prescribing Information 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 that 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 (eg, lotions, ointments, creams, or gels) on an ulcer being treated with Dermagraft as such preparations may cause reduced viability of Dermagraft. Caution: Do not reuse, refreeze, or sterilize the product or its container. Caution: Do not use the product if there is evidence of container damage or if the date and time stamped on the shipping box has expired. Caution: Dermagraft is packaged with a saline-based cryoprotectant that contains 10% DMSO (Dimethylsulfoxide) and bovine serum. Skin and eye contact with this packaging solution should be avoided. Caution: Dermagraft has not been studied in patients receiving greater than 8 device applications. Caution: Dermagraft has not been studied in patients with wounds that extend into the tendon, muscle, joint capsule, or bone. Dermagraft has not been studied in children under the age of 18 years, in pregnant women, in patients with ulcers over a Charcot deformity of the mid-foot, or in patients receiving corticosteroids or immunosuppressive or cytotoxic agents. Caution: To ensure the delivery of metabolically active, living cells to the patient’s wound, do not hold Dermagraft at room temperature for more than 30 minutes. After 30 minutes, the product should be discarded and a new piece thawed and prepared consistent with Preparation for Use instructions. Caution: The persistence of Dermagraft in the wound and the safety of this device in diabetic foot ulcer 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) Maintaining Device Effectiveness: Dermagraft must be stored continuously at -75°C ± 10°C. Dermagraft must be thawed and rinsed according to the Preparation for Use instructions. After the initial 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. Dermagraft is packaged with a saline-based cryoprotectant. This solution is supplemented with 10% DMSO (Dimethylsulfoxide) and bovine serum to facilitate long-term frozen storage of the product. Refer to the step-wise thawing and rinsing procedures to ensure delivery of a metabolically active product to the wound bed. (9) Caution: Federal (U.S.) law restricts this device to sale by, or on the order of, a physician (or properly licensed practitioner). US Patent Number: 4,963,489; 5,266,480; 5,443,950 Manufactured and distributed by: Organogenesis Inc. La Jolla, CA 92037

Please see complete prescribing information at www.Dermagraft.com

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Advertiser’s Index Advanced Tissue (Wound Care Supplies)........................................................................................................... 3 8 Angelini Pharma (BioPad).................................................................................................................................... 13 BSN Medical (Cutimed Siltec)..............................................................................................................................17 Derma Sciences (TCC-EZ)..........................................................................................................................Cover 2 ETC (BARAMED Select Hyperbaric Chamber)............................................................................... .......................35 Innovative Therapies Inc. (Quantum NPWT)........................................................................................................11 KCI (CelluTome)..................................................................................................................................................... 5 MTI (Chairs)......................................................................................................................................................... 31 Net Health (WoundExpert)................................................................................................................................... 19 Organogenesis (Apligraf/Dermagraft)...................................................................................................Cover 4, 39 Progressive Medical Technology (IodoForm BlackGold)..................................................................................... 37 Spiracur (SNaP Wound Care System)................................................................................................................. 21 Sechrist Industries (HBOT Chambers)........................................................................................................Cover 3 Smith & Nephew (OASIS)...................................................................................................................................... 3 SteadMed Medical (Drawtex & Xpansion)..................................................................................................... 25, 28

facilityinfocus Continued from page 35 evaluated.The new facility will also allow for more local referrals to be accommodated in Greensburg. “Once you open that center, you hope it will be a feeder for you for new business, but to backfill the void that will be created by taking people out of this center — and there will be a void — that’s where marketing comes in,” Capco said. “Our marketing team is phenomenal. They’ve done TV commercials, billboards — whatever we need from them. And when I say ‘we have a great team here,’ the senior administration is part of that. We’ve got a great group of people, and I know a lot of clinics and health systems will say that because you have to be if you’re going to provide great wound care, but I’m very proud of the people we have and couldn’t ask for much more.” n Joe Darrah is managing editor of Today’s Wound Clinic.

RN Liaison Initiative Springboards Expansion When the nursing staff at Excela Health’s Advanced Wound Center, Greensburg, PA, was asked for volunteers last year to lead a new initiative to aid in the expansion of its outpatient wound services by providing needed wound care education to area clinicians, Mary Lou Miller, RN, CWCA, didn’t give it a second thought. The opportunity to strengthen the relationship with the existing referral base while recruiting more providers to refer their patients to heal in the clinic was simply too promising to avoid. “I have a passion for our wound center and I love helping people, so I wanted to be able to share that with the community because there’s a big need for wound care and diabetes around here,” said Miller, clinical coordinator of wound care and nurse liaison at Excela. As liaison, Miller is one of two nurses (Ashley Holtzman, RN) who visits private practice and various healthcare and geriatric settings, from skilled-nursing homes to senior centers, to meet with staff and provide information about the clinic and its presence within the community. With a laptop containing HIPAA-compliant photos and health record details for referring providers regarding their patients and marketing-type materials to present to potentially new referring physicians, Miller will spend as many as three days per week on the road when she’s not in clinic. Make no mistake, however: “I’m not a ‘rep.’ I’m going out and giving comprehensive updates to the physicians and surgeons who have already trusted us with their patients, and I’m speaking with others about how dangerous the wounds can be that they’re trying to treat on their own,” Miller said. “They can actually see what we’re doing here.” While she insists the clinic has always made it a priority to keep in regular communication with referring physicians and surgeons through mail and telephone correspondence, this initiative provides the extra step of establishing clinical relationships with providers by sharing an enhanced knowledge about their shared patients. “I think relationships with the PCPs and referral centers can always be strengthened,” Miller said. “Sometimes, they just don’t know that something that seems small could lead to a severe bone infection. And this program allows us to reach all those places where there may be people who need our help.” — Joe Darrah

TWC ONLINE EXCLUSIVE: EXCELA HEALTH PHOTO SLIDESHOW For more photos from our visit to Excela Health, visit WWW.TODAYSWOUNDCLINIC.COM 40

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TCC wound healing rate1, 2

Advancing the Gold Standard of Care to the Next Generation. Total Contact Casting is recognized as the GOLD Standard of Care for off-loading diabetic foot ulcers.1-17

Choice for TCC

• Fast and Effective Healing1 – TCC, 89% healed in 33.5 mean days – Removable Cast/Walker, 65% healed in 50.4 mean days – Half Shoes, 58% healed in 60.1 mean days

• Enforced Patient Compliance

TCC-EZ® offers a one-piece, roll-on, woven design that simplifies the application process while reducing the potential for causing additional tissue damage. The result is now an application process that can be completed in under 10 minutes while providing greater patient comfort.18 For more information or questions on reimbursement: call 800.445.7627 or visit www.tccez.com

Quicker application Greater comfort

1. Armstrong DG, et al. Off-loading the diabetic foot wound. Diabetes Care 24:1019-1022, 2001 2. Bloomgarden ZT: American Diabetes Association 60th Scientific Sessions, 2000. Diabetes Care 24:946-951, 2001. 3. American Diabetes Association: Consensus Development Conference on Diabetic Foot Wound Care. Diabetes Care 22:1354–1360, 1999 4. Coleman W, Brand PW, Birke JA: The total contact cast, a therapy for plantar ulceration on insensitive feet. J Am Podiatr Med Assoc 74:548 –552, 1984 5. Helm PA, Walker SC, Pulliam G: Total contact casting in diabetic patients with neuropathic foot ulcerations. Arch Phys Med Rehabil 65:691– 693, 1984 6. Baker RE: Total contact casting. J Am Podiatr Med Assoc 85:172–176, 1995 7. Sinacore DR, Mueller MJ, Diamond JE: Diabetic plantar ulcers treated by total contact casting. Phys Ther 67:1543–1547,1987 8. Myerson M, Papa J, Eaton K, Wilson K: The total contact cast for management of neuropathic plantar ulceration of the foot. J Bone Joint Surg 74A:261–269, 1992 9. Walker SC, Helm PA, Pulliam G: Chronic diabetic neuropathic foot ulcerations and total contact casting: healing effectiveness and outcome probability (Abstract). Arch Phys Med Rehabil 66:574, 1985 10. Mueller MJ, Diamond JE, Sinacore DR, Delitto A, Blair VPD, Drury DA, Rose SJ: Total contact casting in treatment of diabetic plantar ulcers: controlled clinical trial. Diabetes Care 12:384 –388, 1989 11. Liang PW, Cogley DI, Klenerman L: Neuropathic ulcers treated by total contact casts. J Bone Joint Surg 74B:133–136, 1991 12. Walker SC, Helm PA, Pulliam G: Total contact casting and chronic diabetic neuropathic foot ulcerations: healing rates by wound location. Arch Phys Med Rehabil 68:217–221, 1987 13. Armstrong DG, Lavery LA, Bushman TR: Peak foot pressures influence the healing time of diabetic foot ulcers treated with total contact casts. J Rehabil Res Dev 35: 1–5, 1998 14. Lavery LA, Vela SA, Lavery DC, Quebedeaux TL: Reducing dynamic foot pressures in high-risk diabetic subjects with foot ulcerations: a comparison of treatments. Diabetes Care 19:818–821, 1996 15. Lavery LA, Armstrong DG, Walker SC: Healing rates of diabetic foot ulcers associated with midfoot fracture due to Charcot’s arthropathy. Diabet Med 14:46–49, 1997 16. Lavery LA, Vela SA, Lavery DC, Quebedeaux TL: Total contact casts: pressure reduction at ulcer sites and the effect on the contralateral foot. Arch Phys Med Rehabil 78:1268–1271, 1997 17. Fife CE; Carter MJ, Walker D: Why is it so hard to do the right thing in wound care? Wound Rep Reg 18: 154–158, 2010. 18. Jensen J, Jaakola E, Gillin B, et al: TCC-EZ –Total Contact Casting System Overcoming the Barriers to Utilizing a Proven Gold Standard Treatment. DF Con. 2008. © 2014 Derma Sciences, Inc. All rights reserved.

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For diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs)

Close with the power of living cells

A leader in wound healing, Organogenesis offers the only two cellular technologies with FDA approval for healing chronic wounds: Apligraf and Dermagraft for DFUs1,2 Apligraf for VLUs1 ®

Learn more at Apligraf.com and Dermagraft.com References: 1. Apligraf Package Insert. Canton, MA: Organogenesis Inc., 2010. 2. Dermagraft Directions for Use. Canton, MA: Organogenesis Inc., 2012.

© 2014 Organogenesis Inc. OI-A1153 All rights reserved. Printed in U.S.A. 3/14 Apligraf is a registered trademark of Novartis. Dermagraft is a registered trademark of Organogenesis Inc. Please see complete prescribing information at Apligraf.com and Dermagraft.com.

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