January/February 2013 by HMP Communications, LLC

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Today’s

Contemporary Approaches to Wound Clinic Management

DEFINING

Quality In

Wound Care: How will we get there?

Also in This Issue: Use of Amniotic Allografts Business Briefs Facility in Focus

SAWCSPRING January/February 2013 www.todayswoundclinic.com

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Today’s

Volume 7, Number 1, Januray/February 2013 • www.todayswoundclinic.com

Table of Contents • Feature Articles 13

Proving Your Quality of Care Compliance: A Case Study When officials at a national wound center and hyperbaric management company wanted to develop a treatment algorithm for wound care, they consulted with a thought leader in the wound industry who encouraged them to “keep it simple.” M. Darlene Carey, MBA

Measuring Quality In Wound Care The wound care industry needs a collaborative approach to the development and testing of quality measures in order to not be left behind during the transition to a value-based health system. Caroline Fife, MD, FAAFP, CWS

Dehydrated Human Amniotic Tissue Improves Healing Time, Cost of Care Human amniotic membrane allografts have been used in surgical procedures for more than 100 years. Known to decrease inflammation, reduce scar tissue formation, and support soft tissue regeneration, these allografts also have been proven to reduce wound-closure time, overall cost to treat wounds, and scarring. Don Fetterolf, MD & Rachel Savage

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

Volume 7, Number 1, Januray/February 2013 • www.todayswoundclinic.com

Managing Editor Joe Darrah jdarrah@hmpcommunications.com

Table of Contents 4

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

Web Editor Samantha Alleman salleman@hmpcommunications.com

From the Editor

Business Staff

Dot Weir, RN, CWON, CWS

Departments

Executive Vice President Peter Norris pnorris@hmpcommunications.com

VP/Group publisher Jeremy Bowden jbowden@hmpcommunications.com

Business Briefs I ntegrating New/Updated Codes Into Your Business for 2013

Publisher Kristen J. Membrino kmembrino@hmpcommunications.com

Kathleen D. Schaum, MS

Sales Associate Brian Hill bhill@hmpcommunications.com

Clinician’s Report Cellular & Bioengineered Alternative Tissue

Classified Sales Associate Jenn Ratcliffe jratcliffe@hmpcommunications.com

26 Facility in Focus Washington (PA) Health System Wound & Skin Healing Center

HMP Communications, LLC PRESIDENT BIll Norton

TWC News Update

Controller Meredith Cymbor-Jones

ConvaTec opens wound clinic in India

Vice President, Special Projects Jeff Hall

30 Ask The Board Kathleen D. Schaum, MS

Marketing Manager Stephanie Manzo Creative Director Vic Geanopulos vgeanopulos@hmpcommunications.com

32 Advertiser’s Index

TWC Online

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

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Online Exclusive:

How Are EHRs Impacting Quality Measures?

Stage II of meaningful use will require implementation of clinical decision-support rules relevant to one’s specialty, along with the ability to track compliance.

Senior Production Manager Andrea Steiger asteiger@hmpcommunications.com Production/ Circulation Director Kathy Murphy kmurphy@hmpcommunications.com Audience Development Manager Bill Malriat MEETING PLANNER Cynthia Noonan MEETING PLANNER Trisha Keppler

Reader Picks:

Top online visits from Nov. 30-Jan. 31: 1) The Importance of Compression in the Outpatient Wound Center 2) Efficacious Treatment of Diabetic Foot Ulceration with Total Contact Casting 3) Skin & Wound Management Under the Wraps

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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Art Director Bernadette Zeminski bzeminski@hmpcommunications.com

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HMP Communications Holdings, LLC Chief Executive Officer Jeff Hennessy Chief Financial Officer Dan Rice Senior Vice President Anthony Mancini Director of e-Media and Technology Tim Shaw Senior Director of Marketing Corey Krejcik Sr. Manager, IT Ken Roberts

2/7/13 2:00 PM

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fromtheeditor

’m a wound care nurse in a well-run, successful wound center. I’m currently working clinically on a part-time basis, but spend a lot of time traveling to various types of speaking and contractual work. One of my recurring themes for lectures in 2012 (mostly to nurses and physical therapists) dealt with changing the healing trajectory for chronic wound patients — my agenda typically being to remind everyone that we are all critical “influencers” of how care is provided, even if we’re not the ones writing orders. Dot Weir In my travels,I meet so many folks from wound centers who Co-Editor of TWC work together for the common good of the patient. Every so often, however, I’m saddened to hear someone describe a fellow staff member who doesn’t perform certain functions, such as wrapping, casting, negative pressure, tissue or cell therapies, etc.What can we do about this? In her article “Proving Your Quality of Care Compliance: A Case Study,” M. Darlene Carey, MBA, shows us how enforcing compliance with data entry and documentation (of what is and is not conducted) at the point of care can improve quality in the wound care clinic.

Focus On Quality Quality in healthcare, particularly wound care, continues to be a bigger, developing issue. It’s not just about what the US government will monitor and the financial incentives it will put into place — it’s a concept that must be central to what wound care providers do every day — for the good of our patients, for the good of wound care itself, and for the image that we want our fellow practitioners and referral sources within our own communities to have of us and the care we provide. In our first “Facility in Focus” article in this issue, managing editor Joe Darrah profiles a wound clinic based in Washington, PA, that has committed itself to quality care. The staff hopes to serve as a reference to those looking to begin a new center or seeking any advice related to quality assurance and the development of patient “relationships.” Additionally, there are many new and exciting technologies that are currently (or soon will be available) that will enhance healing and improve the quality of life for wound patients. Point-of-care protease testing for example, though not available in the US yet, will help us to determine the environment that we are getting ready to place that cell therapy into and impact decision making related to the timing of that. Whether that testing will be covered and paid for is also yet to be determined, but may be an expense that we would gladly take on for the greater benefit of success with another therapy. Another example is the mechanical negative pressure wound therapy device that we have been using for a couple of years for limited patient types now has coding, coverage, and reimbursement. For most, utilizing the device in the wound clinic is a “break even” proposition, though it will replace the need for other dressings that are not reimbursed and can be used in conjunction with same-day debridement, compression, and casting. From that standpoint, it may actually save or improve reimbursement. From a quality-of-life standpoint, however, the ability to work and go through normal daily activities with the device hidden away and out of view has been a huge improvement for so many. If we’re going to continue to improve the state of wound care, we need to be thinking about the development of our quality measures and how the continuous furthering of technology enables us to provide higher standards of care. My fellow co-editor Caroline Fife, MD, FAAFP, CWS, takes another look at the industry’s need for measurable quality standards in her article “Measuring Quality in Wound Care.” We welcome and appreciate your thoughts on this evolving subject. n

Today’s

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

Editorial Board Members Andrew J. Applewhite, MD, CWS, UHM Leah Amir, MS, MHA Desmond Bell, DPM, CWS Trisha Carlson, MSN, MBA-HCM, RN, CWCN Donna J. Cartwright, MPA, RHA, CCS, RAC, FAHIMA Moira Hayes, MHA, RRT, CHT Cathy Thomas Hess, BSN, RN, CWOCN

Harriet Jones, MD, BSN, FAPWCA Robert S. Kirsner, MD, PhD Trisha Markowitz, MSN, MBA-HCM, RN, CWCN, DAPWCA Pamela Scarborough, PT, DPT, MS, CDE, CWS Susie Seaman, NP, MSN, CWOCN Tere Sigler, PT, CWS, CLT-LANA Pamela G. Unger, PT, CWS, FCCWS Randall Wolcott, MD, CWS

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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.

Dot Weir, RN, CWON, CWS, co-editor of Today’s Wound Clinic

January/February 2013 Today’s Wound Clinic®

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2/7/13 1:09 PM

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businessbriefs Integrating New/Updated Codes Into Your Business for 2013 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 author do not represent, guarantee, or warranty that coding, coverage, and payment information is error-free and/or that payment will be received.The ultimate responsibility for information accuracy lies with the reader.

ospital-based outpatient wound care departments (HOPDs) and qualified healthcare professionals should not celebrate the New Year until they have updated their charge sheets as well as their Charge Description Master and billing software. As you begin providing wound care in 2013, carefully monitor your itemized statements and remittance reports to be sure coding changes are processing correctly in your

system. What follows is a review of some major coding changes that took effect on Jan. 1: Healthcare Common Procedure Coding System (HCPCS) Codes The Centers for Medicare & Medicaid Services (CMS) has awarded three new “Q” codes: • Q4134 hMatrix,® per sq cm • Q4135 MEDISKIN,TM per sq cm • Q4136 E-Z DERM,TM per sq cm When using these products in wound care practice, be sure these new codes have been added to your coding and billing system. CMS has also created two new “G” codes to report the application of negative pressure wound therapy (NPWT [eg, vacuum-assisted drainage collection]). When using these products in wound

TABLE 1. New NPWT Codes for Mechanically Powered Devices New HCPCS Code

Descriptor

G0456

Negative Pressure Wound Therapy (eg, vacuum-assisted drainage collection) using a mechanically powered device (not durable medical equipment), including provision of cartridge and dressing(s), topical application(s), wound assessment, and instructions for ongoing care, per session; total wound(s) surface area less than or equal to 50 sq cm.

G0457

TABLE 3. Impairment Limitation Restrictions

Modifier

Impairment Limitation Restriction

0% impaired, limited, or restricted

At least 1%; but less than 20% impaired, limited, or restricted

At least 20%; but less than 40% impaired, limited, or restricted

At least 40%; but less than 60% impaired, limited, or restricted

At least 60%; but less than 80% impaired, limited, or restricted

At least 80%; but less than 100% impaired, limited, or restricted

100% impaired, limited, or restricted

care practice, be sure the codes shown in Table 1 below have been added to your coding and billing system. CMS has also created 42 new non-payable Always Therapy “G” codes that will provide information about the beneficiary’s functional status: 1) at the outset of the therapy episode of care; 2) at specified points during treatment; and 3) at the time of discharge. If therapists provide services in your wound care practice, be sure that the codes shown in Table 2 on page 8 have been added to your coding and billing system.

New Severity/Complexity Modifiers There are seven newly created severity/ complexity modifiers from CMS to reflect the beneficiary’s percentage of functional impairment as determined by the therapist, physician, or non-physician practitioner furnishing the therapy services. One of the seven modifiers must be reported with each non-payable “G” code described above. Be sure that all therapy stakeholders know how to use the new severity/complexity modifiers itemized in Table 3 at left.

Updated HCPCS Codes CMS has also changed some cellular and/or tissue-derived products for wounds from“C”codes to“Q”codes:EpiFix,® Grafix® Core, and Grafix Prime. One product, Endoform Thermal Template,TM has gone from a“C”code to a collagen dressing code. When these products are used in wound care, be sure the codes shown in Table 4 on page 8 are corrected in all coding and billing systems.

HCPCS Code Descriptor Changes Several new products have been assigned to existing HCPCS codes (DermaSpan,TM InteguPly,TM Matrix TM HD, TranZgraft,®

January/February 2013 Today’s Wound Clinic®

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www.todayswoundclinic.com

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Potential Payment May Now Be Available for Every Application As of January 1, 2012, the Centers for Medicare and Medicaid Services (CMS) is eliminating the physician 90-day global surgical period for skin and dermal substitute procedures. For more information, please visit the News page on the Healthpoint Biotherapeutics website at www.healthpointbio.com/news.

Call our Reimbursement Navigation Hotline at 1-877-805-5005 for more information.

ÂŠ2012 Healthpoint Biotherapeutics Healthpoint is a registered trademark of Healthpoint, Ltd. TM1302-0112

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businessbriefs TABLE 4.

TABLE 2. New Always Therapy “G” Codes

PRODUCT

OLD CODE

2013 CODE(s)

Endoform Thermal Template

C9367

A6021, A6022

EpiFix

C9366

Q4131

Grafix Core

C9368

Q4132

Grafix Prime

C9369

Q4133

Physical Therapy/Occupational Therapy G-Code Sets

Speech-Language Pathology G-Code Sets

Mobility: G8978 Mobility: walking and moving around functional limitation, current status, at therapy episode onset and at reporting intervals

Swallowing: G8996 Swallowing functional limitation, current status at time of initial therapy treatment/episode onset, and at reporting intervals

G8979 Mobility: walking and moving around functional limitation, projected goal status, at therapy episode outset, at reporting intervals, and at discharge or to end reporting

G8997 Swallowing functional limitation, projected goal status, at initial therapy treatment/outset, and at discharge from therapy

G8980 Mobility: walking and moving around functional limitation, discharge status, at discharge from therapy or to end reporting

G8998 Swallowing functional limitation, discharge status, at discharge from therapy/end of reporting on limitation

Changing & Maintaining Body Position: G8981 Changing and maintaining body position functional limitation, current status, at therapy episode onset, and at reporting intervals

Motor Speech: G8999 Motor speech functional limitation, current status at time of initial therapy treatment/episode onset, and at reporting intervals

TABLE 5. HCPCS Code

Old Descriptor

2013 Descriptor

G8982 Changing and maintaining body position functional limitation, projected goal status, at therapy episode outset, at reporting intervals, and at discharge or to end reporting

G9186 Motor speech functional limitation, projected goal status at initial therapy treatment/outset, and at discharge from therapy

Q4119

MatriStem Wound Matrix, per sq cm

G8983 Changing and maintaining body position functional limitation, discharge status, at discharge from therapy or to end reporting

G9158 Motor speech functional limitation, discharge status, at discharge from therapy/end of reporting on limitation

MatriStem Wound Matrix PSMX, RS, or PSM, per sq cm

Q4126

Carrying, Moving & Handling Objects: G8984 Carrying, moving and handling objects functional limitation, current status, at therapy episode onset and at reporting intervals

Spoken Language Comprehension: G9159 Spoken language comprehension functional limitation, current status at time of initial therapy treatment/episode outset, and at reporting intervals

MemoDerm,TM per sq cm

MemoDerm, DermaSpan, TranZgraft, or InteguPly, per sq cm

G8985 Carrying, moving and handling objects functional limitation, projected goal status, at therapy episode outset, at reporting intervals, and at discharge or to end reporting

G9160 Spoken language comprehension functional limitation, projected goal status, at initial therapy treatment/outset, and at discharge from therapy

Q4128

FlexHD® or Allopatch HD,TM per sq cm

G8986 Carrying, moving and handling objects functional limitation, discharge status, at discharge from therapy or to end reporting

G9161 Spoken language comprehension functional limitation, discharge status, at discharge from therapy/end of reporting on limitation

FlexHD, Allopatch HD, or Matrix HD, per sq cm

Grafix Prime

C9369

Q4133

Other PT/OT Primary: G8990 Other physical or occupational primary functional limitations, current status, at therapy episode onset and at reporting intervals

Attention: G9165 Attention functional limitation, current status at time of initial therapy treatment/episode outset, and at reporting intervals

G8991 Other physical or occupational primary functional limitations, projected goal status, at therapy episode outset, at reporting intervals, and at discharge or to end reporting

G9166 Attention functional limitation, projected goal status, at initial therapy treatment/outset, and at discharge from therapy

G8992 Other physical or occupational primary functional limitations, at discharge from therapy or to end reporting

G9167 Attention functional limitation, discharge status, at discharge from therapy/end of reporting on limitation

Other PT/OT Subsequent:

Memory:

G8993 Other physical or occupational subsequent functional limitation, current status, at therapy episode onset and at reporting intervals

G9168 Memory functional limitation, current status at time of initial therapy treatment/episode outset and reporting intervals

G8994 Other physical or occupational subsequent functional limitation, projected goal status, at therapy episode outset, at reporting intervals, and at discharge or to end reporting G8995 Other physical or occupational subsequent functional limitation, at discharge from therapy or to end reporting

G9169 Memory functional limitation, projected goal status, at initial therapy treatment/outset and at discharge from therapy G9170 Memory functional limitation, discharge status, at discharge from therapy/end of reporting on limitation

Voice: G9171 Voice functional limitation, current status at time of initial therapy treatment/episode outset, and at reporting intervals G9172 Voice functional limitation, projected goal status, at initial therapy treatment/outset, and at discharge from therapy G9173 Voice functional limitation, discharge status, at discharge from therapy/end of reporting on limitation Other Speech Language Pathology: G9174 Other speech language pathology functional limitation, current status at time of initial therapy treatment/episode outset, and at reporting intervals G9175 Other speech language pathology functional limitation, projected goal status, at initial therapy treatment/outset, and at discharge from therapy G9176 Other speech language pathology functional limitation, discharge status, at discharge from therapy/end of reporting on limitation

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This has necessitated a change to the HCPCS code description. When these products are used in wound care, be sure the codes shown in Table 5 above have been added to all billing and coding systems and that the descriptors have been appropriately modified. CAUTION: Remember, the existence of a code does not guarantee coverage by various payers. All wound care stakeholders should: 1) review pertinent Local Coverage Determinations of the Medicare contractor that processes their claims and 2) verify the insurance benefits (and obtain prior authorization, if required) for patients insured by private payers, Medicare Advantage, Medicaid, etc.Also, the existence of a code does not guarantee payment. Next month we will discuss the 2013 changes in Medicare payment for HOPDs and physicians. n Kathleen D. Schaum is director of medical products reimbursement for Healthpoint Biotherapeutics and president/founder of Kathleen D. Schaum & Associates Inc., LakeWorth, FL. www.todayswoundclinic.com

2/7/13 3:36 PM

businessbriefs

Measuring

Quality In Wound Care

The wound care field must adapt to incentivize and reward quality over quantity. Caroline E. Fife, MD, FAAFP, CWS

Editor’s Note: This article serves as a follow-up to Dr. Fife’s article: “The Changing Face of Wound Care: Measuring Quality” published in October 2012. Dr. Fife shares an affiliation with Intellicure Inc. and US Wound Registry.

ealthcare reform has major implications for the wound care industry. Transitioning to a value-driven payment model that focuses on better care at lower cost necessitates reconsideration of physician and hospital financial incentives. As a way to improve patient care, measure the benefits of specific interventions, and incentivize clinicians for providing them, there is a national initiative to develop and report specific clinical “quality measures.” Previously, I explained the various incentives (and penalties) that apply and detailed those measures relevant to wound care physicians under the Physician Quality Reporting System (PQRS) — formerly the Physician Quality Reporting Initiative (PQRI).1 Wound care clinicians are glad to have some measures to report, even if it is not clear how well these particular measures will improve the outcomes of patients living with chronic wounds. We are going to need more quality measures in wound care, particularly measures that can be reported directly from electronic health records (EHRs) since the Cen-

ter for Medicare and Medicaid Services (CMS) intend for all data to be reported this way — meaning wound care practitioners must decide what constitutes quality care and how it is to be measured … before it’s decided for us.

How Quality Data Gets Reported

More than 40 years ago, the late Avedis Donabedian proposed models for measuring almost every aspect of quality in healthcare. Widely regarded as the first to formally study healthcare quality, Donabedian defined an “outcome” as a change in an individual as a result of the care received. Patient outcomes can be characterized by clinical endpoints (eg, amputation), functional status (eg, ambulation), or general well-being (eg, pain). It is also possible to measure the appropriateness of clinical interventions that are known to improve a desired outcome (eg, diabetic-foot offloading). Although CMS prefers outcome measures to “process” measures, assessing compliance with clinical practice guidelines such as offloading may be easier to de-

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termine than a more subjective clinical endpoint such as “wound healing.” Most medical societies, ie the American Medical Association’s Physician Consortium for Performance Improvement® and the National Quality Forum (NQF), have spent years developing quality measures for the majority of specialties and major disease states. One of the nation’s first quality incentive programs, the PQRS (also known as pay for performance) began in 2007. Since the use of EHRs was not widespread at the time, reporting was facilitated via qualified patient registries that reviewed data via claim forms before transmitting it to CMS on behalf of eligible providers. The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 mandated the adoption of certified EHRs, changing the dynamics of the reporting process. HITECH also made stimulus money available to clinicians who demonstrated the “Meaningful Use” of their EHRs through a number of metrics including participation in quality reporting.

Today’s Wound Clinic® January/February 2013

2/7/13 2:31 PM

qualitymeasures Online Exclusive: How Are EHRs Impacting Quality Measures? Stage II of meaningful use incentives will require implementation of clinical decision-support rules relevant to one’s specialty, along with the ability to track compliance. Read more at www.todayswoundclinic.com. To make electronic data-sharing possible, all certified EHRs must use Health Level 7 Clinical Document Architecture, which consists of a mandatory “textural” component (to ensure human interpretation of the document) and “structured” components for software processing, which allows data to be shared. In order for eligible providers to obtain their HITECHadoption bonus money, they must meet certain program requirements that are still being developed by CMS. Under stage II of Meaningful Use (beginning in 2014), providers must share data with a public health agency or a specialty registry by transmitting “directly from an EHR.” Accomplishing this will require transfer of structured data (not “free-text typing” or dictated notes). Medicare is also driving the PQRS program toward transmission of quality data directly from EHR to CMS via “e-Measures.” The clinician will transmit clinical performance data to CMS, and CMS will calculate the “pass” or “fail” rate of the quality measure to determine subsequent bonus (or penalty) payments. So, while EHRs may change the method of reporting, the real question remains: What, exactly, are we going to report in order to demonstrate wound care quality?

A Real Example in Wound Care

As executive director of the US Wound Registry (USWR), a nonprofit organization that has been a CMS-approved patient data registry since the PQRS launched, I have been involved in performance reporting for four years. Registry responsibilities include: validating eligible providers (EPs), collecting medical data needed for EP reporting measures, acquiring attestation from EPs (permission from the clinician to report data to CMS), calculating measures (including de-identifying data), and transmitting secure data to CMS. PQRS data submission is a daunting task, particularly since

some measures are highly complex to calculate. Initially, there were no PQRS measures directly relevant to wound care physicians, but by 2009 one of the 153 measures pertained to wound care specifically — “percentage of patients over age 18 with a diagnosis of venous ulcer who were prescribed compression therapy within the 12-month reporting period.” To receive bonus pay, clinicians had to successfully report at least three measures. Specialists like cardiologists and oncologists didn’t have much difficulty because their medical societies worked hard to create several relevant quality measures. Unfortunately, wound care providers had to report at least two other measures that were not directly relevant to their practice (eg, inquiring about tobacco use or body mass index screening). In 2009, the bonus for reporting was an additional 2% of a provider’s total annual Medicare billing. After the USWR submitted the physician’s PQRS report to CMS, CMS went through its own validation process before mailing a check to the provider. From 2008-10, the USWR offered free reporting services to clinicians using the Intellicure EHR. Remember, PQRS was really a “pay for reporting” program because it was not necessary for clinicians to actually pass measures.They simply had to successfully report them. Furthermore, while most US clinicians had at least some additional documentation burden to participate in PQRS, wound care doctors for whom we reported did no additional work to report measures because the necessary documentation was incorporated into their EHR and the data was abstracted directly from the EHR. However, an estimated 20% of clinicians eligible to report through the USWR refused to participate. When we later inquired as to their reasons, common themes were: 1) not wanting the government to “watch their practice,” 2) lack of knowledge regarding

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pay for performance, 3) inability to get the paperwork faxed on time, and 4) an employment situation whereby another entity would get the bonus money, thus removing all incentive to report. In 2013, the bonus has been reduced to only 0.5% of total Medicare billing as the PQRS program transitions into its penalty phase. Come 2015, physicians will lose 1% of Medicare revenue for not reporting, increasing to a 2% reduction in 2016 and a 3% reduction for non-reporters in 2017. If the “carrot” of a 2% bonus failed to entice some wound care clinicians to report in 2009, will these penalties be enough to spark them, or is the crux of the problem the quality measures themselves?

Quality Reporting Concerns

It may be worth going through the details of how the venous ulcer measure is reported as an example of what can go wrong in quality reporting. The venous ulcer measure had excellent, well-written supporting materials detailing the evidence base for compression in the healing of venous ulcers and clearly defining “adequate” compression (eg, multilayer bandages, Unna’s boot, 30 mmHg stockings, etc.). However, the “measure” itself (the rules that determine how information is reported) allows any type of compression to pass (eg, T.E.D. hose, AceTM bandages), and the compression only has to be prescribed once in a 12-month period. While wound care clinicians realize how faulty this is as a measure of “quality care,” when the measure was created it was not yet feasible to specify the specific type of compression and/or track the frequency of its provision since most clinicians were still using paper charts. To report the venous ulcer measure in 2009, the USWR began by identifying patients insured by Medicare Part B and who were billed for an evaluation and management service between Jan. 1 and Dec. 31 (a patient’s age had to be older than 18). Data were

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qualitymeasures next queried for ICD-9 diagnosis codes indicating venous disease. Here, we encountered another problem with the venous ulcer measure design. The measure as written omitted the “454.x” diagnosis codes (one of the most commonly used for venous stasis ulcers), potentially excluding the majority of patients in a practice from reporting. However, CMS allowed registries the leeway to identify the target diagnosis even if the code specifications in a measure were flawed. Thus, despite the flaw in the way the measure was written, all venous ulcer ICD-9 diagnoses were identifiable by the USWR, and the above formula provided the “denominator” of the measure. The “numerator” was determined as follows: During the year in question, was compression therapy prescribed at least once? If so, the clinician “passed” the measure. The PQRS reporting process acknowledges that a justifiable reason might exist for not performing a therapeutic intervention. There may have been a medical reason for not providing compression (eg, concern over arterial status), the patient may have refused compression, or there might have been a “system’s reason” (eg, certain supplies were unavailable). If a justification was provided, the measure passed. If no compression was prescribed at any visit during the one-year period without a documented reason for omission, the measure failed. In 2009 (and in all subsequent years) all wound care physicians reporting PQRS data through the USWR passed the venous ulcer measure. In other words, every wound care clinician practiced “quality venous care” if the definition of “quality” is “to provide any type of wrap once.

Does A Measure “Gap” Exist?

At the USWR, we wanted to determine the passing rate of a venous ulcer measure had it been better designed to assess real quality. After calculating the measure as written, we used the same data to calculate the pass rate of the same physicians on the same patients. Had the measure been written as we thought it should be — ie, we ran queries to determine whether the patient had been pro-

vided adequate compression (such as multilayer bandages, Unna’s boots, 30 mmHg stockings, etc.) at each visit. Evaluating clinical performance in this manner, we found that patients living with venous ulcers were discharged from outpatient wound centers in adequate compression only 17% of the time.2 So, (even when allowing for appropriate justifications for not providing compression at any given visit), if we created a venous quality measure defined as adequate compression at each visit, the measure would be much harder to pass given current practice behavior. However, while few might achieve 100% compliance, the “passing score” for the measure is 80%. There are positives and negatives to this from a “measure development” standpoint. If a measure is designed in such a way that it fails to measure quality in any real sense (like the current venous measure), then it is a failure because it doesn’t measure whether appropriate care was ever provided. However, if a measure is designed in such a way that it is either too difficult to report or too difficult to pass, it becomes unusable and thus fails for a different set of reasons.

How Would Wound Care Measures Be Developed?

The current venous ulcer measure is going to be “retired” after 2013 since no measure sponsor has indicated a willingness to provide the mandatory testing. So, as of 2014 there will be no measure of quality in the treatment of a venous ulcer unless the wound care industry decides to create and test a new one. Proposed measures must undergo rigorous evaluation. The NQF provides detailed information on the measures’ testing process and several conditions must be met before NQF will grant consideration. If all conditions for consideration are met, candidate measures are evaluated for their suitability based on four sets of standardized criteria (in the following progressive order): importance to measure and report, scientific acceptability of measure properties, usability, and feasibility (www. qualityforum.org/docs/measure_evaluation_criteria.aspx).

January/February 2013 Today’s Wound Clinic®

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Here’s the most frustrating part: The NQF only considers measures submitted in response to one of their “calls” for measures. We have spent three years looking for an NQF category that could logically have wound care measures placed within it, but have been turned down each time. The testing process can take more than a year and is evolving because it was previously necessary to ensure that measures could be reported equally well via paper forms or via a registry. With the advent of electronic reporting, new types of measures are feasible. If a replacement venous ulcer measure were developed, it would first need to go through the above NQF process. If approved, it would then begin the process of becoming an electronic measure. The process of “e-Measure” development is, in essence, the creation of the specifications of the computer query that enables the transmission of clinical data directly from the physician’s EHR to CMS. This is an expensive development process that requires its own rigorous testing, and specialty societies spend large amounts of financial and personal resources to shepherd measures through the endorsement process. It is not clear where financial resources would come from in the wound care industry. What is at stake is not the loss of 3% of Medicare billing for each practitioner under PQRS for “non-reporters.” The Affordable Care Act mandates that in 2015, a substantial portion of a hospital’s revenue be linked to the reporting of quality measures. The wound care industry needs a collaborative approach to the development of and testing of quality measures so that it will not be left behind in the transition to a value-based healthcare system. n Caroline E. Fife is co-editor of TWC. References 1. Fife CE. The changing face of wound care: measuring quality. Today’s Wound Clinic. 2012;8:10-14. 2. Fife CE, Carter MJ, Walker D. Why is it so hard to do the right thing in wound care? Wound Rep Reg. 2010;18:154–158.

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businessbriefs

Proving Your Quality of Care Compliance:

A Case Study

As more wound care providers progress towards Meaningful Use, validating quality is as important as providing it. M. Darlene Carey, MBA

he fact that the healthcare system is on the verge of a complete overhaul is not a newsflash. For more than a decade, measurement of physician performance (ie, offering incentives to improve care) has been the focus of many governmental, professional, and private groups. However, questions remain unanswered as to what should be measured, how things should be measured, and how to get the requisite “buy-in” from physicians and other wound care providers. A recent editorial in JAMA discusses these challenges and emphasizes some important things to remember about measuring performance: 1) Select measures that physicians can definitively impact. (Many times, healthcare systems choose measures that an individual doctor can’t affect.) 2) Make “doing the right thing1” feasible. (Your information technology [IT] system must ensure that document can be eas-

ily supported.) 3) Consider measures that will be important to the patients and their care. (Having a specific lab value as a goal may not be the best reflection of good care.2) When officials at Precision Health Care, a national wound center and hyperbaric management company based in Boca Raton, FL, wanted to develop a treatment algorithm for wound care, they consulted with a thought leader in the wound industry who encouraged them to “keep it simple” because many organized wound centers “miss the boat” on wound care basics – such as offloading diabetic and pressure ulcers, placing venous stasis ulcers into compression, and screening the vascular status of all patients with lower extremity ulcers. One analysis of electronic health record (EHR) data from wound centers found that only 17% of patients living with venous leg ulcers received compression.1 Why is this? It’s either due

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to doctors not knowing how to provide the service, or they forget to do so consistently, or they do not document when they provided such services.

Merging EHR With Best Practices

Instead of attempting to devise a complicated, multi-page algorithm for wound assessment and management, Precision officials decided to adopt a basic clinical practice guideline (CPG) that focused on vascular screening and compression for venous ulcers, vascular screening and offloading for diabetic ulcers, and nutritional screening and pressure reduction for pressure ulcers. (It was also decided to always assess hemoglobin A1c in diabetics and conduct biopsies on nonhealing wounds.) It seemed like an easy-enough plan. Clinicians were educated on the CPGs and the importance of adhering to them to improve patient care and healing rates. The decision was also

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qualitymeasures figure 1

figure 2

Figures 1 and 2 represent data from the featured facility before and after implementing the best-practice initiative. From Jan. 1, 2012 to March 30, 2012, 34 diabetic foot ulcers (DFUs) were seen. Vascular screening was performed in 22 of 34 (64%) and adequate offloading in 4 of 34 (11.7%). After the initiative, including weekly quality reviews, data from 10/16/12-1/16/12 were evaluated. A total of 26 DFUs, of which 24 underwent vascular screening (92.3%) and 18 of 26 underwent adequate offloading (69.2%), were seen. Over the same time periods, the data on venous stasis ulcers were as follows: 23 of 43 underwent vascular screening initially (53.4%) and 12 of 43 were prescribed adequate compression (27.9%). In the follow-up time frame, 65 of 84 venous ulcers underwent vascular screening (77.3%) and 65 of 84 were prescribed adequate compression (79.7%). While some of the improvement represented better documentation of care, these dramatic performance improvements give us confidence that we are providing more consistent quality patient care.

did the CPG documentation not reveal 100% compliance with measures? Upon further examination, clinicians were found to occasionally document CPG compliance in the incorrect area of the EHR (while manually reviewing the records, reviewers gave credit for those measures). As the JAMA article states, the IT system has to “make it easy to do the right thing.” The EHR we employed had been designed with special “macros” (computer instructions that represent a sequence of operations) that made documenting compliance with the CPGs as easy as “clicking on the box.” It was not necessary for clinicians to type anything into a “field.” “Structured language programming” within the EHR could credit the clinician with having implemented the CPG because the EHR could interpret the use of the macro. However, the automated compliance checks built into the computer could not interpret what the clinician “typed in the box.” Human reviewers manually counted and gave credit for these typewritten en-

tries. Patient outcomes were good because clinicians were, indeed, following appropriate practices. However, clinicians were doing a poor job using the EHR designed to help them document their care. Once this issue was addressed, compliance with documentation improved significantly and matched the data seen in patient outcomes. So, it was demonstrated how well physicians were actually doing with CPG adherence.

January/February 2013 Today’s Wound Clinic®

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made to monitor compliance quarterly and review findings with one’s peers. The results were not considered “stellar” after the first quarter of assessment, as the average rate of compliance for any one measure was less than 50%. However, the problem was not a lack of buy-in from the providers, but a much more manageable issue — the CPGs had not yet become “routine” in their minds. To alleviate this concern, reminders to adhere to guidelines were strategically placed throughout patientcare areas and compliance evaluations began to take place on a monthly basis. As a result, CPG documentation showed improvement after one month’s time. But when that success was shortlived (at the end of the second quarter, documented compliance was actually below the first quarter), new measures were needed.

Failure to Act or to Document?

Healing rates remained in the 90thpercentile range, so clinicians were doing the appropriate things. Why, then,

13_18_TWC_Jan_Feb_EHR.indd 14

Tying Care Quality to Compensation

According to JAMA, the US healthcare system should reinforce the tendency for physicians to act as “knights who are motivated by professional values,” rather than as pawns who passively respond to their circumstances.2 The way physicians are rewarded should reinforce their intrinsic motivation to pursue excellence. There may be no better argument for developing better wound care quality measures. For several years, the only measure relevant to wound care was the Physician Quality Report-

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SAWCSPRING 速

The official meeting site of the Association for the Advancement of Wound Care

AAWC

May 1-5, 2013 Colorado Convention Center Denver, Colorado www.sawcspring.com

Check us out on:

SAWCSpring2013_2pageAd_TWC.indd 2

9/24/12 10:53 AM

Where Wound Clinic Professionals Go For Answers The Symposium on Advanced Wound Care Spring and Wound Healing Society (SAWC Offering up to 30.5 credit ho Spring/WHS) meeting is the urs for wound ca re premier multidisciplinary wound clinicians! care program and is the largest annual gathering of wound care clinicians in the United States. More than 2,000 physicians, podiatrists, nurses, therapists, and researchers are expected to attend the 2013 SAWC Spring/WHS meeting. No other wound care conference offers the level of education, the number of quality sessions, and world-renowned educators each year that clinicians at wound care centers have come to expect at SAWC Spring/WHS. Key Sessions For Clinicians At Wound Care Clinics • Demystifying the Use of Compression • How to Address Complications of Diabetic Foot Ulcers • Assessing the Latest Evidence on HBOT • Wound Care in Special Populations: From Our Smallest to the Largest • Healthcare Reform: What it Means for You • MicroRNA in Wound Repair and Regeneration: A New Paradigm • Telemedicine: What is its Role in Wound Care? • Managing Complex Wounds in the Acute Setting • Strategies For Healing In Palliative Wound Care • Making Wound Centers Run Smoother – A Panel Discussion Learning Objectives • Identify common wound-related skin conditions and their management. • Discuss advances in wound-related physiology, pathology, epidemiology, prevention, assessment, and management. • Evaluate the effects of research on the future of patient care. • Translate scientific data and emerging research knowledge to clinical practice. • Implement the latest best-practice strategies to prevent and manage pressure ulcers. • Explore the wide range of treatment modalities for wound care, including new and emerging therapies. • List the medical and surgical treatment of wounds • Provide optimal healthcare delivery through improved understanding of sites of service and payment schema. • Review current evidence- and consensus-based guidelines and describe how guidelines can be developed into practical algorithms that are used in everyday wound care.

To register for SAWC Spring/WHS in Denver, visit www.sawcspring.com

Intended Learners This conference is designed for physicians, nurses, physical therapists, researchers, podiatrists, and dietitians involved in wound healing or wound care issues. Accreditation Information This activity has been planned and implemented by North American Center for Continuing Medical Education, LLC (NACCME) and the Wound Healing Society (WHS) for the advancement of patient care. North American Center for Continuing Medical Education, LLC (NACCME) is accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team. Physicians: NACCME designates this live activity for a maximum of 30.50 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. 6.25 AMA PRA Category 1 Credits™ for WHS Day 1 4 AMA PRA Category 1 Credits™ for the pre-conference 17.25 AMA PRA Category 1 Credits™ for the main conference 3 AMA PRA Category 1 Credits™ for the post-conference Nurses: This continuing nursing education activity awards 6.25 contact hours for WHS Day 1, 4.0 contact hours for the pre-conference, 17.25 contact hours for the main conference, and 3.0 contact hours for the post-conference. Provider approved by the California Board of Registered Nursing, Provider Number 13255 for 6.25 contact hours for WHS Day 1, 4.0 contact hours for the pre-conference, 17.25 contact hours for the main conference, and 3.0 contact hours for the post-conference. Podiatrists: North American Center for Continuing Medical Education, LLC (NACCME) is approved by the Council on Podiatric Medical Education as a sponsor of continuing education in podiatric medicine. This program is approved for 6.25 contact hours for WHS Day 1, 4 contact hours for the pre-conference, 17.25 contact hours for the main conference, and 3 contact hours for the post-conference. Dietitians: North American Center for Continuing Medical Education, LLC (NACCME) is a Continuing Professional Education (CPE) Accredited Provider with the Commission on Dietetic Registration (CDR). Registered dietitians (RDs) and dietetic technicians, registered (DTRs) will receive 6.25 continuing professional units for WHS Day 1, 4 continuing professional education units for the pre-conference, 17.25 continuing professional education units for the main conference, and 3 continuing professional education units for the post-conference for completion of this program. CDR Accredited Provider #HM001 Level 3 Synthesis Level Physical Therapists: North American Center for Continuing Medical Education, LLC (NACCME) will apply for pre-approval accreditation in California, Florida, Louisiana, Ohio, and Texas, which require pre-approval. If you practice in another state, please consult its PT board. Note: The following sessions are non-accredited: WHS Session F: Concurrent Mini-Symposia WHS Session G: Organogenesis talks WHS Session H: Animal Model Roundtable Requirements for Credit: To be eligible for documentation of credit for each session attended, participants must participate in the full activity and complete the online general survey and the online evaluation form for each session by June 5, 2013. Complete the forms at http://www.myexpocredits.com/naccme . After completing the forms, participants may immediately print documentation of credit. Copyright ® 2012 by North American Center for Continuing Medical Education, LLC. All rights reserved. No part of this accredited continuing education activity may be reproduced or transmitted in any form or by any means, electronic or mechanical, without first obtaining permission from North American Center for Continuing Medical Education. ADA Statement: North American Center for Continuing Medical Education complies with the legal requirements of the Americans with Disabilities Act and the rules and regulations thereof. If any participant in this educational activity is in need of accommodations, please call 609-371-1137.

Robert Kirsner, MD, PhD

Dot Weir, RN, CWON, CWS

Cancellation Policy: Please note the cutoff date for cancellation is March 19, 2013. All cancellations must be received in writing and postmarked by that date. Full registration (less a $75 processing fee) will be refunded only to cancellations received in writing before the above date. No refunds will be issued after March 19, 2013 — without exception. Registrations are transferable at any time.

Vice Chairman and Stiefel Laboratories Professor Department of Dermatology and Cutaneous Surgery University of Miami Miller School of Medicine Miami, FL

Osceola Regional Medical Center Kissimmee, FL

For registration or general information, call 800-854-8869.

SAWC Chairpersons

SAWCSpring2013_2pageAd_TWC.indd 3

*Information contained herein is subject to change without notice.

9/24/12 10:53 AM

qualitymeasures ing System (PQRS), which tallied the percentage of venous ulcers prescribed any type of compression. However, as more wound care physicians become employed by healthcare systems and management companies, employers want to devise compensation packages that include wound care quality measures. Without sound measures from Medicare, these companies have to create their own quality standards to assess and incentivize physician performance. Dedicated clinicians are rarely motivated to do what’s appropriate for patients solely by money, but tying compensation to quality measures does help keep the importance of documenting quality of care a priority. When officials at Precision decided to track the assessment of vascular status and the implementation of compression, an interesting challenge was noted: Only part of the challenge was documenting what was done (eg, venous ulcer compression). The bigger challenge turned out to be documenting what was not done. For example, a physician may not place the patient in compression due to inadequate vascular supply, but forget to document that he or she did not provide compression for a medical reason. Most PQRS quality measures allow a clinician to specify the reason that a quality measure was not performed (eg, patient factors, system factors, or medical reasons). It is important to ensure that the EHR makes it easy for the physician to document both what was done and what was not done, as well as why. However, the reality is that tying performance to physician salaries is the final part of the equation. Quality measures must be directly relevant to patient care (evidence based) within the control of the physician to implement and must be easy to document in the EHR (both what was done and not done). Only then can one expect that quality measures will link to patient outcomes and that compliance with them can be tied to physician payment. But how do we continue to pursue excellence in the long term? The breakthrough at Precision came when point-of-care (POC) charting

was implemented. The Health Information Technology for Economic and Clinical Health Act of 2009, which is driving the adoption of EHRs, presupposes that clinicians conduct POC charting (completed in the room with the patient). No longer can clinicians frequent the “dictation closet” or chart at the end of the day. Only with POC charting are all of the advantages of EHR adoption achieved (ie, warnings about drug interactions). Since EHR uses structured language to help document compliance with CPGs, humans aren’t needed to review the charts. Weekly or daily reports can then be generated in order to provide more feedback, so there’s no lag time in identifying “lost opportunities” for improvement. All new patient consultations are now reviewed. Any patients living with venous, diabetic, or pressure ulcers (or other chronic leg ulcers) who do not have documentation of CPG implementation are brought to the clinician’s attention the following day. In addition, a report analyzing all new admits for that week is generated to ensure CPGs are being incorporated into the patient’s treatment plan. What gets measured gets managed. Since the EHR can automate these reports, it is not labor intensive and the results are easily extractable. This has truly harnessed the EHR to work with staff in this endeavor.

Lessons Learned

clinician accountability. Without true POC charting (regardless of whether electronic or paper), clinicians can’t appropriately practice and document the care each patient deserves. Continued accountability for clinicians to document all considered decisions in the care of their patients will also align best practices in wound care. Another lesson learned: Feedback must be given frequently, even daily.

Further Improvements

The next step at Precision will be to utilize EHR technology to share reminders with clinicians at the time they’re conducting their charting. Reminders will be provided before the user “signs off ” the program (ie, “You’ve noted a venous ulcer as the problem. Did you consider compression therapy?”) Clinicians must embrace accountability and allow technology to assist them to do what’s needed. Continual measurement of compliance to the CPGs will keep this goal a priority and allow “proven outcomes” as the move to accountable care organizations (ACOs) occurs. According to another recent JAMA article: “Three features of EHRs are critical to enable ACOs to succeed: interoperability . . . automated real-time quality measurement, and smarter analytic capacities.3” Patient quality of care and reimbursement for that care will depend on this proof of quality being provided. n M. Darlene Carey is director of operations of Precision Health Care, Boca Raton, FL. She utilizes metric management to enhance performance and embraces workflow improvement to remove obstacles to success.

Much was learned from the experience of linking the CPG implementation process to the EHR. The concept of utilizing national CPGs for ulcer care did not receive any objections by clinicians. By using macros in the form of pre-programmed menus in the EHR, clinicians could more easily comply with CPGs. However, the process had to be tweaked to further improve the flow and remove obstacles. Through consistent feedback, officials learned that the clinicians could modify old habits and adapt behaviors. Obstacles for success in this endeavor included POC documentation and

References 1. Fife CE, Carter MJ, Walker D. Why is it so hard to do the right thing in wound care? Wound Rep Reg. 2010;18:154–158. 2. Cassel C, Jain S. Assessing individual physician performance, does measurement suppress motivation? JAMA. 2012;307(24):2595-2597. 3. Bitton A, Flier L, Jha A. Health information technology reform in the era of care delivery reform, to what end? JAMA. 12;307(24): 2593-2594.

January/February 2013 Today’s Wound Clinic®

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businessbriefs

Dehydrated Human Amniotic Tissue Improves Healing Time, Cost of Care Don Fetterolf, MD & Rachel Savage

uman amniotic membrane allografts have been used in surgical procedures for more than 100 years. Known to decrease inflammation, reduce scar tissue formation, and support soft tissue regeneration, dehydrated human amniotic membrane allografts also have been proven to reduce wound-closure time, overall cost to treat wounds, and scarring. Clinicians who have gone through basic training for chronic wound management are all taught that lower extremity compression is the “gold standard” for management of ulcers caused by chronic venous insufficiency, as long as there is no co-existing arterial disease significant enough to prevent the use of compression therapy.

Role of Amniotic Membrane

Human amniotic membrane is nonimmunogenic, non-vascular tissue comprising the innermost layer of the placenta (the amnion and the chorion). Composed of a single layer of epithelial cells, a basement membrane, and an avascular connective tissue matrix, amniotic membrane contains extracellular matrix (including collagen and laminins), cellsignaling proteins (such as cytokines), and growth factors that are essential to the healing process. Amniotic membrane layers also consist of epithelium cells (lining of hollow organs and glands that protect or enclose); a thick, compact layer (composed of reticular fibers); and a fibroblast layer. The membrane also contains cell-anchoring collagen types IV, V, and VII — structural proteins that are essential for wound healing. In vitro testing confirms presence of essential soft tissue growth factors and cytokines in human amniotic membrane

allografts. Growth factors bind to the extracellular matrix and are released into surrounding tissue, providing a continual release of growth factors during the tissue regeneration process. Unlike many of the xenografts and composite dermal substitutes on the market today, dehydrated human amniotic membrane allografts may be used in a wide variety of applications that can reduce the need to carry products in inventory. Wound healing applications for dehydrated amniotic membrane include acute and chronic full- and partial-thickness wounds such as diabetic foot ulcers, venous leg ulcers, arterial ulcers, pressure ulcers, post-surgical or post traumatic wounds, wound dehiscence, burn injuries, acute suture line repairs, and subcutaneous wound tunnel repair. With a variety of sizes available, the waste typically realized with other grafts is reduced significantly. Many diabetic foot ulcers may be less than 4 sq cm, so sizing options are important.

Improving Healing Time

In 2007, Surgical Biologics (Kennesaw, GA) developed the PURION® process for the use of dehydrated amniotic membrane as an allograft. First utilized in ophthalmic surgery (there have been more than 45,000 implants to date without any adverse events associated with dehydrated amniotic membrane), amniotic membrane has been utilized more recently as a potent facilitator of wound healing in various fields, including lower extremity ulcers, ophthalmological surgery, burns, gynecologic surgery, orthopedics, and a variety of other applications.1-7 The process works by safely and gently separating the placental tissues. The vari-

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ous layers of the amniotic membrane are cleaned and reassembled with minimal manipulation of the tissue to maintain the structure. The tissue is then dehydrated to preserve the elements that are key to healing, with no chemicals being utilized. Dehydrated human amniotic membrane has a shelf life of five years and may be micronized to create a powder configuration to be used as topical powder or injectable solution. The final product may be stored at room temperature and is regulated by the FDA under section 361 of the Public Health Service Act as Human Cells, Tissues, & Cellular and Tissue Products. Placentas are recovered only by scheduled Caesarean section procedures, and each donation is subject to FDA compliant screening criteria and blood testing. Among other benefits, the PURION process allows tissue to be dehydrated and sterilized, producing an easy-to-use graft. To date, 100,000 allografts have been distributed for human implantation in various surgical applications, and a number of recent studies have demonstrated the clinical cost effectiveness of using dehydrated human amniotic membrane allografts. One prospective, stratified, randomized, comparative, parallel group, single-center clinical trial compared the proportion of diabetic foot ulcers completely healed by use of dehydrated amniotic membrane graft (EpiFix,® MiMedx Group Inc., Kennesaw, GA) every other week, plus standard of care (SOC) versus a SOC protocol of advanced wound care dressings in patients living with a nonhealing diabetic foot ulcer with adequate arterial perfusion. Following surgical debridement, all patients underwent weekly dressing chang-

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amnioticallografts Clinical Use of EpiFix® — Pasquale Cancelliere, DPM

es and the graft was applied under a non-adherent dressing. In the EpiFix group, 92 percent of patients healed completely in 6 weeks compared to 8% of the SOC group.8

Scar Tissue Reduction Preoperative Observation: 34-year-old insulin independent diabetic. Total surface area of the wound = 18.76 cm.2 Wound extended to the muscles, but no bone exposed.

Patient Management: After initial debridement, a negative pressure wound closure system was applied to serve as an active drainage system. Patient was placed on gentamycin IV for 14 days. After 10 days, wound debrided again and no nidus or active infection found. After two days, EpiFix Amniotic Membrane Allograft placed on wound using sterile technique. Graft not secured with sutures or staples, and Adaptic® and wet gauze applied with a bolster suture. Graft remained intact for seven days before dressings removed. Wound appeared to reduce greatly by 30% and redressed with sterile wet-to-moist gauze dressings. At day 14, wound reduced by another 15%. A second graft reapplied.

Patient Outcome: At day 28 the wound is extremely superficial and essentially healed with two pinpoint areas that went on to heal successfully. At three months, patient remains fully healed, walking in a custom-molded shoe.

Dehydrated human amniotic membrane allografts help reduce scarring, as demonstrated in a retrospective study9 that reviewed the use of amnion-based allograft membrane to prevent postoperative scarring between the tendon, peritendonous structures, and overlying skin. Patients were evaluated at an average of 1.7 years post-surgery. Of 14 patients, 86 percent were clear of scarring around the surgery site and 93 percent were scar tissue-free at the tendon-repair site. Of the patients with signs of scar tissue, the effects were reported as “mild” or “moderate.” The findings were statistically significant with p=0.012.

Cost Effectiveness

Abrams, et al, tracked 20 patients who failed to have at least 50% closure within four weeks and treated the group with an evidence-based approach and dehydrated human amniotic membrane allograft in lieu of previously used skin substitute. Patients were assigned based on risk into high-risk and low-risk categories. Patients were cared for based on traditional wound care principles including debridement, offloading, infection control, and maintenance of a moist wound environment. Those considered low risk — defined as those with a new ulcer, no infection, palpable pulse, ankle brachial index (ABI) >0.8, and having received advanced therapies after four weeks if wounds did not decrease in size by 50% (but with wounds failing to close by 50% in four weeks) — and patients considered moderate-to-high risk — defined as those with documented renal disease, previous history of ulcer or amputation, elevated HgbA1c, ulcer duration of >30 days, ABI <0.8, and no local signs of infection — were

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treated with dehydrated human amniotic membrane allografts. By using the PURION-processed dehydrated human amniotic membrane allograft, the clinic realized a 42% reduction in cost, 50% reduction in time to closure, and all patients achieved full closure.10 n Rachel Savage is director of marketing with MiMedx Group Inc., Kennesaw, GA. Don Fetterolf, MD, is chief medical officer of MiMedx. References 1. Niknejad H, Peirovi H, Jorjani M, Ahmadiani A, Ghanavi J, Seifalian AM. Properties of the amniotic membrane for potential use in tissue engineering. Eur Cell Mater. 2008;15:88-99. 2. Rahman I, Said DG, Maharajan VS, Dua HS. Amniotic membrane in ophthalmology: indications and limitations. Eye. 2009; (23)10:1954–1961. 3. Baradaran-Rafii A, Aghayan H, Arjmand B, Javadi M. Amniotic membrane transplantation. Iran J Ophthalmic Res. 2007;(2)1.58-75. 4. John T. Human amniotic membrane transplantation: past, present, and future. Ophthal Clin N Am. 2003;16:43-65. 5. Adly OA, Moghazy AM, Abbas AH, Ellabban AM, Ali OS, Mohamed BA. Assessment of amniotic and polyurethane membrane dressings in the treatment of burns. Burns.2010;36(5):703-10. 6. Huiren Tao, Hongbin Fan. Implantation of amniotic membrane to reduce postlaminectomy epidural adhesions. Eur Spine J.2009;18(8):1202-12. 7. Arora R, Mehta D, Jain V. Amniotic membrane transplantation in acute chemical burns. Eye (Lond). 2005;(19)3:273-8. 8. Zelen C, Seren, T, Fetterolf D. Human Amniotic Membrane in the treatment of non-healing diabetic foot ulcers: a randomized controlled trial. Poster presentation, Clinical Symposium o-n Advances in Skin and Wound Care, 2012 9. Jay R, Landsman A. A retrospective study of a novel allograft membrane to prevent post-operative adhesions in the repair of peroneal and posterior tibial tendons. Poster presentation, Desert Foot, 2012. 10. Abrams M. Our experience utilizing advanced wound therapy combined with an evidence-based approach to threatening wounds reduces amputations in the caribbean healthcare system. Poster presentation, Desert Foot, 2012. www.todayswoundclinic.com

2/7/13 1:46 PM

The New Foundation for Tissue Regeneration

Epi

AMNIOTIC MEMBRANE ALLOGRAFT

Simple. Effective.

An Amniotic Membrane Allograft for Chronic and Acute Wound Care • Delivers Essential Wound Healing Growth Factors

Ordering Information Customer Service: 866.477.4219 customerservice@mimedx.com

• Enhances Healing • Reduces Inflammation and Scar Tissue Formation • Stores at Room Temperature for up to 5 Years • Available in Multiple Sizes www.mimedx.com

EpiFix® and PurionSM are trademarks of Surgical Biologics. EpiFix® is processed by Surgical Biologics, a MiMedx Group Company. ©2012 MiMedx Group, Inc. All rights reserved. 60 Chastain Center Blvd., Suite 60, Kennesaw, GA 30144, USA

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EP106.004

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clinician’sreport ACell® Inc.

Cellular & Bioengineered Alternative Tissue

OASIS Wound Matrix and OASIS Ultra Tri-Layer Matrix promote wound closure by facilitating the body’s own tissue repair mechanisms. These products help organize and regulate multiple processes, including maintaining moisture balance and reducing elevated levels of matrix metalloproteinase activity.

FOUNDED: 2002 Product: MatriStem® FOUNDED: 2009 Product Description: MatriStem products maintain and CONTACT: www.oasiswoundmatrix.com; support a constructive healing environment. MatriStem is comprised of urinary bladder matrix, known to promote the formation of site-specific tissue where scarring usually results.

FDA Regulatory Classification: Dressing, Wound, Colla-

gen/Mesh, Surgical.

What sets product apart? It contains basement membrane and numerous collagens, provides a scaffold for natural remodeling, and complements standard of care.

chris.caggiano@healthpoint.com; 800-441-8227. n

MiMedx® FOUNDED: 2008 Product: E piFix® FOUNDED: 2011 Product Description: EpiFix is an amniotic membrane allograft for chronic and acute wound healing. It delivers essen-

How does product improve patient care? MatriStem is tial wound healing growth factors, enhances healing, reduces appropriate for acute wounds, chronic wounds, and various surgical procedures to promote constructively remodeled, sitespecific tissue.

CONTACT: www.acell.com; info@acell.com, 800-826-2926. n

Healthpoint® Biotherapeutics FOUNDED: 1992 Product: O ASIS® Wound Matrix and OASIS Ultra Tri-Layer Matrix

Product Description: OASIS Wound Matrix and OASIS Ultra Tri-Layer Matrix are naturally derived structures that support the body’s own healing process. Both products are intact matrices naturally derived from porcine small intestinal submucosa (SIS) indicated for the management of wounds.

FDA Regulatory Classification: 510(k) Medical Device. What sets product apart? SIS technology provides a natural structure to help the body replace and repair damaged tissue. OASIS Wound Matrix is comprised of porcine-derived, acellular SIS to form a matrix-based product compatible with human tissue. OASIS Wound Matrix is a complex scaffold that provides an optimal environment for restoration of tissue structure and function. OASIS Ultra Tri-Layer Matrix is also a natural extracellular matrix derived from porcine SIS. This unique, tri-layer design incorporates three layers of natural tissue into the wound to help promote an environment conducive to healing. How does product improve patient care? OASIS Wound Matrix and OASIS Ultra Tri-Layer Matrix are natural, threedimensional, intact SIS matrix structures that provide a natural environment for host cells and support their normal function, allowing them to repopulate and revascularize the wound.

inflammation, and reduces scar tissue formation. It is available in multiple sizes. EpiFix, which can also be used for burn, oral, and cosmetic wounds, is processed through the proprietary PURION® Process that combines cleaning, dehydration, and sterilization to produce a safe, sterilized tissue allowing for storage at room temperature.

FDA Regulatory Classification: Human Cells, Tissues, & Cellular and Tissue Product.

What sets product apart? EpiFix is composed of multiple layers, including a single layer of epithelial cells, a basement membrane, and an avascular connective tissue matrix. The PURION Process is a patent-pending process that safely and gently separates placental tissues, cleans, and reassembles various layers before dehydrating the tissue in a way that preserves the key elements associated with healing. The sterilized tissue is packaged and stored at room temperature and has a 5-year shelf life, which negates the need for extra freezers, thawing, etc., required by other dermal substitutes.The tissue may be delivered in a dried sheet configuration using an on-lay surgical or clinical technique. Dehydrated amnion/chorion membrane allograft can also be micronized to create a powder configuration that can be administered as a topical powder or can be mixed with a saline to create an injectable solution. These options allow clinicians to select the appropriate configuration based on the patient’s wound type.With a variety of sizes available, the waste typically realized with other grafts is reduced significantly. How does product improve patient care? EpiFix has unique properties that reduce scar tissue formation, reduce inflammation, and support soft tissue regeneration.The potential medical uses of the tissue are broad, as it can be utilized in procedures where reduction in scar tissue or regeneration of a soft tissue is beneficial.

CONTACT: www.mimedx.com; customerservice@

22 Januray/February 2013 Today’s Wound Clinic

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mimedx.com; 866-477-4219. n www.todayswoundclinic.com

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Expect More With Acell_MatriStem_0213.indd 2 TWC-ACell General Journal Ad-Full-Page.indd 1

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clinician’sreport Organogenesis Inc.

Product Description: TheraSkin is an at-ready extracellular FOUNDED: 1985 matrix to jumpstart healing on any wound, head to toe. Product: Apligraf® FDA Regulatory Classification: Human Cells, Tissues, & FOUNDED: 1998 Cellular and Tissue-based Product. Product Description: Apligraf contains two cell types derived from neonatal foreskin (living human keratinocytes and What sets product apart?: TheraSkin is human skin, cryofibroblasts embedded in a type 1 collagen matrix).

FDA Regulatory Classification: Class III Medical Device. What sets product apart? Apligraf is the only bioengineered, bilayered, living-cell-based product with FDA approval for the treatment of both diabetic foot ulcers and venous leg ulcers.

preserved such that 98% of the dermis and epidermis cells are living at application. TheraSkin has a fully functioning extra cellular matrix with the appropriate types and ratios of collagen and a full complement of growth factors and cytokines to support healing from the very moment of application.

How does product improve patient care?: TheraSkin How does product improve patient care? Apligraf has closes a high percentage of wounds that have not responded

been shown to heal more wounds faster than conventional therapy alone.

to alternative therapies, providing the patient the best chance of healing cost effectively.

CONTACT: www.organogenesis.com; 888-432-5232. n

CONTACT: www.solublesystems.com; 877-222-2681. n

Osiris Therapeutics Inc.

Shire Regenerative Medicine

FOUNDED: 1992 FOUNDED: 2011 Product: Grafix® Product: Dermagraft® Product Description: Grafix is a cellular, three-dimensional Founded: FDA pre-market approval in 2001 matrix derived from placental membrane. It’s designed for direct Product Description: Dermagraft is a cryopreserved human application to acute and chronic wounds, including diabetic foot ulcers, venous leg ulcers, pressure ulcers, and burns. Flexible, conforming, and immune neutral, this cellular repair matrix provides endogenous viable mesenchymal stem cells (MSCs) and growth factors to the wound site while the matrix protects the area from inflammation, scarring, and infection.

FDA Regulatory Classification: Human Cells, Tissues, & Cellular and Tissue-based Product.

What sets product apart?: The combination of living cells that are beneficial for wound healing, particularly mesenchymal stem cells, along with functional growth factors and matrix to provide the optimal environment. Grafix is the only wound care product containing MSCs available today.

How does product improve patient care?: The presence of MSCs in normal skin and their critical role in wound healing, particularly anti-inflammatory properties of MSCs, suggest that the application of products containing MSCs is a promising solution for treatment of chronic wounds. A pilot evaluation of Grafix for treatment of recalcitrant chronic wounds showed >70% probability of wound closure at week 12.

CONTACT: www.osiris.com; osiris@osiris.com; 443-545-1800. n

Soluble Systems, LLC FOUNDED: 2007 Product: T heraSkin® Real Skin Wound Therapy with Living Cells Founded: 2011 24

fibroblast-derived dermal substitute indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients who have adequate blood supply to the involved foot. 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.

FDA Regulatory Classification: Class III Medical Device. What sets product apart?: Dermagraft is composed of living human fibroblasts, an extracellular matrix, and a bioabsorbable polyglactin mesh scaffold. This cryopreserved, three-dimensional, human dermal substitute can be applied weekly for up to eight applications within a 12-week period. How does product improve patient care?: In the phase III pivotal trial, Dermagraft added to conventional therapy resulted in significantly more patients with DFUs greater than six weeks (plantar surface, including heal, forefoot, and toes) achieving complete wound closure by 12 weeks vs. conventional therapy alone (64% relative increase; 30% vs. 18%, P=0.023). CONTACT: www.dermagraft.com; dermagraft@ shire.com; 858-754-3700. n

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www.todayswoundclinic.com

2/7/13 1:38 PM

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

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

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

WCB2013 WOUND CLINIC BUSINESS

WCB2013 Dates/Locations

Note: Dates and locations subject to change.

Friday, May 17

Friday, June 7

Friday, September 20

Friday, October 4

Hilton Philadelphia Airport

Wyndham Lisle-Chicago Hotel

Crowne Plaza Houston Near Reliant Medical

Embassy Suites St. Louis-Downtown

Philadelphia, PA

Chicago, IL

Houston, TX

St. Louis, MO

Friday, May 31

Friday, June 14

Thursday, September 26

Friday, October 18

Sheraton Birmingham Hotel

Doubletree Orlando Downtown

Bally’s Las Vegas

The Westin Gaslamp Quarter San Diego

Birmingham, AL

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Orlando, FL

Las Vegas, NV

San Diego, CA

2/6/13 3:09 PM

facilityinfocus Providing Wound Care in ‘Steeler Country’

An aggressive treatment approach at Washington Health System Wound & Skin Healing Center mimics the lifestyle of the local patient population.

By Joe Darrah

James Marks, DPM, FACFAS, FAPWCA

ashington, PA — Life within the industrialized Pittsburgh Metro region operates under a long-held code, an understanding among residents that has transcended generations. “In this area, we’re known as the ‘Steelers’ because we work hard and play hard — that’s the attitude of individuals around here, and they have a lot of pride in what they do,” said James Marks, DPM, FACFAS, FAPWCA, medical director at Washington Health System Wound & Skin Healing Center. It’s an attitude that goes far beyond the clichéd, stereotypical image of the steel mill worker who grew up among his hardhat-wearing brethren — the local steel industry’s collapse occurred more than 30 years ago. However, a gritty work ethic remains a sense of identity among those who live and work here. And while the reputation may be admirable, it’s not one that lends to great healthcare habits. According to the CDC, each of the three neighboring counties that comprise the clinic’s coverage area (Fayette, Greene, and Washington) was associated with some unappealing health statistics as recently as 2008, when Fayette County was linked to the highest rate of diabetes (10.7 percent) in the state and was among 19 counties (including Washington) to have

at least 30 percent of residents categorized as “obese.” Additionally, Greene County was determined to have the “least active” inhabitants while all three counties were found to have at least 10 percent of those ages 20 and older to be living with diabetes. Whether these disparities are a result of too much hard-nosed work and play interfering with time to exercise, visit one’s physician regularly, or eat healthy is up to conjecture — what’s not is the increasing rate that wound care has been needed, including for work-related injuries. (See sidebar on page 27.) “Because of the Marcellus Shale in this region,” explained Marks, referring to a massive unit of sedimentary rock that has been found throughout parts of eastern North America that serves as a natural gas reserve, “we have a huge influx of people coming here to work and to tap into the natural resource.” The trickle-down effect at the clinic, which was founded six years ago by hospital officials in response to what had already been a growing number of patients who lacked an accessible, dedicated wound facility, has been an ever-increasing patient population. In 2012, the clinic’s patient volume grew by 70 percent (or roughly 23% annually) since its doors opened in 2007.The increased caseload is exactly what hospital administration and clinic staff envisioned as they developed a protocol for providing care through a nursing-focused system that stresses relationship-building. “We make a concentrated effort to build relationships with everyone involved so that the patient knows we’re committed to them and that caregivers, whether they be a family member or local skilled-nursing facility, visiting nurse agency, or personal care home, understand that we’re a resource and that we’ll

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provide the best care for their patients,” Marks said.

A Caring Commitment

These relationships are forged immediately. When patients arrive at the facility, they are briefed by their nurse and physician on the state of their existing wounds as well as their overall health in relation to wound care, their prognosis and expected course of treatment, their timeframe for wound healing, and their responsibilities as a patient to promote wound closure and prevention. “The key is to ‘frontload’ the patient with information from the start of the relationship,” Marks said. “They need to know what to expect. Their time is important, and they need to know that we’re giving them 100 percent of our focus when they’re with us.” In keeping with the theme of the community, the majority of the clinic’s patients are the working type who depend on providers to keep them healthy enough to not just earn a living but to fund their healthcare. This is where the role of education comes squarely into play, Marks said. “These are tough economic times, and unfortunately we see patients who are skipping medications because they can’t afford their copays, or they’re cutting their dosage in half,” he added. As such, overall compliance remains a major concern with patients, who are brought to task by clinic staff just as much as they are kept informed, beginning at the first point of care. “Our patients are normally here because they have complex problems with multiple comorbidities,” said clinic manager Rita Palaisa, BSN, RN, CWOCN. “Many of them have been living with their wounds a long time, and our re-

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facilityinfocus sponsibility is to figure out why their wounds have not progressed toward healing. Regardless of what the barrier is, the best way around it is through the development of relationships.” Which means establishing trust and honesty, she said. For those patients with their hearts set on getting healthy and salvaging limbs because they want to live a normal life and not lose their job, their commitment to care must be assured. “We had a patient recently who we really didn’t want ambulating, but he told us he had to work or he would lose his job, his insurance, and his house,” Palaisa related. “So, we got him back to work, but we made it clear to him that he had to monitor his care and communicate with us regarding any changes.We have to trust that our patients are going to keep in communication with us — and we achieve that by educating them and their caregivers.”

A Sound System

Also central to the clinic’s protocol and structure is the support of the ancillary hospital departments. “Prior to us, we had a lot of family physicians and surgeons in the region who were performing wound care without the benefit of being coordinated within one health system,” said Palaisa, a former home health nurse who earned her certification in 2001 and was hired by Washington Health System specifically to help launch the clinic with former medical director Brent Angott, DO. Marks, a longtime area resident who, as he puts it, “planted his roots” after conducting his residency in Pittsburgh in 1978, joined the health system in 2009 when outpatient podiatry services were expanded. (The wound center shares a facility with the podiatric practice as an extension of hospital services.) “We have a great relationship with the hospital staff,” Marks said. “They do an excellent job of triaging patients and identifying those who have chronic wounds and referring them to the wound center. And that’s important, because unfortunately, in healthcare there can be a ‘gap’ between providers, which can be detrimental to the patient.” Still, Marks, Palaisa, and their staff embrace the center’s independence. “There’s a huge advantage to that because it gives us an availability to move in a particular direction faster,” Marks said. “The hospital administration continues to understand that this is a community service and they’ve continued to support us. Because of their leadership, they understand the ‘halo effect’ to wound care for ancillary services that can be provided and the success you can have.” The facility also boasts a patient-friendly atmosphere that can accommodate many. With today’s healthcare climate, Marks is especially proud of the clinic being adequately equipped to care for those patients “with size.” When the facility was scouted, specific attention was made to the capacity of patient rooms, hallways, and even waiting rooms and restrooms so that necessary equipment, chairs, chambers, and beds could be housed. “Our patients don’t have to feel ‘embarrassed’ when they come in here,” Marks said. “We’re accessible to them.You need to dedicate the space that a wound clinic needs.”

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Wound Care Patient Profile A traumatic wound teaches one patient the value of his health. By Joe Darrah Washington, PA — Growing up on a farm in Waynesburg, PA, Jerry Gooden, 69, was born into an environment predicated on manual labor and “pushing through” its associated aches and pains. He’s broken bones, sprained joints, Jerry Gooden and, in the not too distant future, will undergo his second hip replacement due to arthritis. “Pain is a part of life where I come from,” said Gooden, who now resides in Washington, PA. “It’s just in my nature to keep going.” But life for Gooden and his wife Kathy came to a screeching halt this past Thanksgiving, when he woke up to a massive hematoma the day after dropping a piece of heavy work equipment on his right leg. A bone-deep flesh wound near his shin eventually developed and required surgery and negative pressure wound therapy (NPWT) to initiate closure. “I knew that there was no ‘walking this off,’” Gooden told Today’s Wound Clinic during a recent visit to the Wound & Skin Healing Center at Washington Health System. Having just undergone a dressing change, cleansing, assessment, and reapplication of his NPWT dressing, Gooden reflected on his condition and experience — which included multiple trips to a hospital outside Washington’s system — and came closer to resulting in an amputation than he’d care to remember.

Not Your Average Bruise It was near noon on a cold, late-November day in West Virginia, where Gooden, the owner of a warehousing/trucking company, had driven five hours to unload more than 1,000 pounds of bulk rubber that his company had purchased overseas. Needing to remove 10 pieces (roughly 125 pounds each) of freight from a delivery truck and stack them in order to be brought back to Pennsylvania, Gooden and a partner were two pieces shy of finishing when a unit slipped from Gooden’s hands and slid down his leg with all its weight before he was able to secure his grip. “It didn’t hurt much at all,” he said, “so we finished the job and we left.” Too busy and not concerned enough to fully investigate the injury, Gooden said he noticed some minor scratching on his lower leg and that his leg was “weeping,” likely a sign that a break in the skin had occurred and that serous fluid began to drain, according to Rita Palaisa, BSN, RN, CWOCN, manager of the clinic where Gooden would eventually be referred nearly a week later. “But during the drive home I could feel my leg swelling to the point that my pants became too tight,” he said. “So, I pulled over to call my wife and let her know ‘I think I’m in trouble.” Still, what would happen over the course of the next 12-14 hours was unimaginable to both Gooden and his wife,

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facilityinfocus “First” In The Region

At Washington’s wound clinic, which became one of the first in the tri-county region to offer hyperbaric therapy in 2009, the dedication may be most evident among the depth of its staff, which consists of more than 20 members, including physicians, respiratory therapists, medical assistants, and wound care-credentialed nurses who represent a philosophy shift that has also proven beneficial. “We take more of a ‘primary nursing’ focus to our care now, where each patient is assigned one nurse who guides him or her through their care,” Palaisa said. “Patients develop different relationships with nurses than with other providers. The development of trust really comes into play.” That trust is also reflected in the relationships nurses have with physicians, said Marks, adding the exposure patients have with doctors is also substantial.“Our nurses are our ‘worker bees,’ and there’s that earned respect between physician and nurses, but my partners and I are also aware that you need to have that eyeball-to-eyeball contact with our patients,” he said. “You can’t build relationships by standing at the door, talking down to everyone.” Palaisa and Marks say the impact the staff has on patients is documented in patient satisfaction surveys that have been tracked since the facility opened. “The amputation rate for our hospital has decreased since we’ve opened our wound center, and the positive responses we’ve gotten from our patients have improved as well,” Palaisa said. “Everyone on this team, from the front office staff to those who discharge, we’re all operating with the same goal — establishing the relationship with that patient.” They both stand by the center’s impact on its patients even when the most optimal of outcomes do not occur. “You don’t ‘win’ with every patient,” Marks said. “But, when you build up that trust and confidence in patients by holding their hand and telling them you haven’t forgotten about them as they transition to, say, hospice care, they know that you’re trying to do everything you can to make them comfortable. And when you have those patients who were given no hope before they came to see you from their providers, and I’m talking about real hope — that’s a very powerful pill. And when we’re successful, there’s a lot of hugs and a lot of tears.” n Joe Darrah is managing editor of Today’s Wound Clinic. Online Exclusive: Meet the Wound Care Team The Washington Health System Skin and Wound Healing Center has more than 20 healthcare staff. Meet them online and view a photo slideshow at www.todayswoundclinic.com 28

Wound Care Patient Profile (continued) even though Kathy pleaded with him to go to the hospital because he had developed a large, dark bruise spanning most of his leg by the time he returned home. “It was enormous,” said Kathy, who has accompanied her husband during the duration of his care, which has required three weekly wound clinic visits post-surgery and is expected to continue through February. “It was like a brush burn that overreacted.” After a sleepless night, Gooden decided to go to an emergency room when the pain, the bruising, and the swelling had intensified.

Hopeless Feeling X-rays taken revealed no breaks, so Gooden was given an antibiotic ointment, was discharged, and was told to return if the condition, diagnosed as a hematoma, continued to decline. Relieved to have no broken bones, he couldn’t help but wonder why more hadn’t been done for him given that just about every nurse and physician on staff was brought in to “get a look” at his injury. Two days later, they were back in the hospital because “a black hole” had begun to form on his lower leg and the overall appearance had continued to look yet worse. IV antibiotics were administered and an ultrasound was ordered, and again Gooden was discharged, this time with oral antibiotics and directions to schedule a follow-up with his primary physician. By now, real fear had set in. “I was legitimately scared when they told me at the hospital they were checking me for blood clots, because that could mean, stroke, death, whatever — especially at my age,” Gooden said. When he couldn’t get a same-day appointment with his doctor, the couple drove to the office and was immediately referred to the wound clinic for a consult the next morning. A partial debridement was performed by Brandon E. Crim, DPM, and Gooden was placed in light compression for an anticipated one-week return. But when Gooden said the pain had become unbearable after two days, Crim performed surgery, which included debridement and full evacuation of the hematoma.

Recovery Road Due to his daily prescription of the blood-thinning Coumadin, it’s been determined the hematoma coupled with extensive pooling of blood beneath the skin caused significant swelling and skin breakdown. Originally measured at 148.5 sq cm, after six weeks of NPWT therapy the wound had reduced to 13.1 sq cm. “Now we’re getting to the point where we will use an advanced biological tissue substitute to get full closure,” said James Marks, DPM, FACFAS, FAPWCA, clinic medical director. “His wound, had it continued to progress and gotten an aggressive infection in the soft tissue or possibly the bone ... he could have been looking at an amputation.” A self-proclaimed procrastinator who doesn’t see the doctor until it’s “past time,” Gooden admits he probably endangered his health by not going to a hospital sooner. However, he insists that had his course not led him to Washington, he might have had a worse outcome altogether. “The way they care about you here is just amazing,” he said. “I know it sounds cliché, but it’s hard to describe what something is like when it’s better than you could have ever imagined. I haven’t even missed a day’s work, though I’m only on desk duty now. It’s been remarkable.” n

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TWCnewsupdate ConvaTec Expands, Opens India Facility Officials at ConvaTec, a New Jersey-based developer of ostomy care and advanced wound care technologies, have partnered with Narayana Hrudayalaya Hospital in India to launch an advanced wound clinic and limb-salvage center. According to a ConvaTec press statement, the company will market and distribute a variety of medical products to hospitals and other healthcare providers — including advanced wound dressings and products for those with an ostomy following surgery for colorectal cancer or inflammatory bowel disease. With four focus areas (ostomy care, wound therapeutics, continence and critical care, and infusion devices), ConvaTec provides manufacturing on nearly every continent and owns a production network of 12 plants in nine countries. ConvaTec’s India office in Bangalore was inaugurated by Ken Berger, CEO, in December. The company has also set up a warehouse at Nelamangala on the outskirts of Bangalore, and expects to expand across the country, officials said. “We are excited to begin our operations in India,” Berger said. “With a fast-moving economy, India is on the cusp of exciting times, and ConvaTec is committed to growth and a long-term presence in the country. “We view this as an important first step in building a strong presence in an important growth market for ConvaTec,” Berger added. n

asktheboard Kathleen D. Schaum, MS

In this exclusive column,Today’s Wound Clinic offers our readers the chance to ask industry-related questions to our expert editorial board members.This month’s question comes from Fort Worth,TX.

Q: “I’ve researched Local Coverage Determinations (LCDs) trying to find the maximum number of units billable for the selective debridement add-on 97598 and have not been able to find any specifics as to how many units are billable for this Current Procedural Terminology (CPT®) code. Where will I find this information?”

A: By Kathleen D. Schaum, MS “The information you’re seeking is not typically found in LCDs. You should look for your answer in the Centers for Medicare & Medicaid Services’ (CMS) Medically Unlikely Edits (MUEs): www.cms.gov/Medicare/Coding/NationalCorrectCodInitEd/MUE.html. Under “Related Links” you’ll find two sets of MUEs: one for practitioner services and one for facility outpatient services. MUEs are the maximum units of service that CMS would expect a qualified healthcare professional to report under most circumstances for a single beneficiary on a single date of service. Please remember four important facts when reviewing MUEs: 30

Memphis Hyperbarics Earns UHMS Accreditation Regional Medical Center at Memphis (TN) has earned full accreditation from the Undersea and Hyperbaric Medical Society (UHMS) for its wound care center’s hyperbaric facility. The three-year accreditation comes following a survey by a UHMS team comprised of a physician, nurse, and technician that examined 25 different areas of the hyperbaric program, including compliance with state and local facility codes, adequacy of the chamber and equipment, staff training, patient safety, and quality of care. “The accreditation is something we have worked very hard for, and we are excited to finally announce our achievement and what it means for the quality of care our patients receive,” said Bud Rannou, hyperbaric facility technician and manager of the wound center. Future plans for the facility include upgrades to equipment, modernizing controls, training additional nurses for hyperbaric certification,improving patient experience within the chamber (which can accommodate up to 12 patients at a time), and increasing flow in the wound center, a regional referral center for wound care and hyperbaric oxygen therapy. Regional Medical Center is the 145th US facility to receive this distinction and is the only hyperbaric chamber in the area to be accredited by the UHMS, according to officials. n 1) Select the appropriate set of MUEs based on whether you are a practitioner or a facility outpatient service. 2) Not all Healthcare Common Procedure Coding System and CPT codes have an MUE. 3) CMS publishes most MUE values on its website. Other MUE values are confidential and are for CMS and CMS contractor use only. NOTE: The code you referenced does not appear to have a published MUE. However, if you have received denials for multiple units of this add-on code performed during the same visit, you will have a good idea of the confidential MUE value for that particular code. 4) CMS updates MUEs on a quarterly basis. NOTE: Assign someone to review the additions, deletions, and revisions to MUEs at the beginning of each quarter (visit www. cms.gov/Medicare/Coding/NationalCorrectCodInitEd/ Version_Update_Changes.html). To obtain current coding, payment, and coverage information for qualified wound care professionals and hospitalbased outpatient wound care departments, please consider attending a 2013 Wound Clinic Business seminar (www. woundclinicbusiness.com).” Kathleen D. Schaum can be reached for questions and consultations by calling 561-964-2470 or at kathleendschaum@bellsouth.net. For a full disclaimer related to the information in this column, please refer to Business Briefs on page 6. n

January/February 2013 Today’s Wound Clinic®

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www.todayswoundclinic.com

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Wound Certification Prep Course ™

Prepare For National Wound Care Board Certification Examinations To Advance Your Career.

Select from three different locations in 2013 Denver, CO

April 30 – May 1, 2013 Colorado Convention Center

$520*

Las Vegas, NV

September 25 – 26, 2013 Bally’s Las Vegas

$520*

Faculty

Newark, NJ

October 26 – 27, 2013 Renaissance Newark Airport Hotel

$520 Greg Patterson, MD, FACS, CWS Medical Director General and Vascular Surgery, Bariatric and Metabolic Surgery Archbold Center for Wound Management and Hyperbaric Medicine Thomasville, GA

* $400 – Special Pricing for Attendees to either SAWC Spring (Denver) or SAWC Fall (Las Vegas) * This registration fee is in addition to the normal SAWC Spring or Fall pricing.

AAWC 25% discount

Learning Objectives Pamela Scarborough, PT, DPT, MS, CDE, CWS Director of Public Policy and Education American Medical Technologies Irvine, CA

Dot Weir, RN, CWON, CWS Osceola Regional Medical Center Kissimmee, FL

Intended Learners

Course curricula designed for MD/DOs, DPMs, PTs, NP/PAs, RNs, and other healthcare professionals interested in updating their wound care knowledge.

• Outline the etiology of chronic wounds and extrinsic factors, which contribute to and affect wound healing outcomes. •D escribe the phases of wound healing and the associated microenvironment, cellular components and their functions in wound healing. • I dentify the anatomy of the skin and other important structures. • A ssess research and evidence related to wound management. •D escribe specific diagnostic tests, examination tests, lab tests and measures related to wound assessment and management. • I dentify the components of wound assessment and documentation. • I dentify methods for recognizing soft tissue and bone infections, bioburden management and treatment of local and systemic infections. •D iscuss nutritional factors and the underlying deficiencies that impact wound healing. •R elate the psychosocial and cognitive aspects to patient outcomes in wound repair. •D escribe specific treatment interventions for chronic wounds including debridement, topical therapies, biophysical technologies and the use of HBO therapy. Co-located with, and held before, the 2013 Symposium on Advanced Wound Care conferences (SAWC Spring in Denver and SAWC Fall in Las Vegas), and a third standalone meeting in Newark, NJ.

SAWCSPRING

SAWC FALL

Register online at www.woundprepcourse.com or by calling 800-237-7285, ext. 233. – ACCREDITATION INFORMATION In support of improving patient care, North American Center for Continuing Medical Education, LLC (NACCME) is accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for CANCELLATION POLICY Pharmacy Education (ACPE), and the American Please note the cut-off date for cancellation is 30 days prior to each course date. All cancellations must Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team. be received in writing and postmarked by that date. Full registration (less a $75 processing fee) will be PHYSICIANS: NACCME designates this live activity for refunded only to cancellations received in writing a maximum of 17.0 AMA PRA Category 1 Credit(s)™. before the above date. No refunds will be issued Physicians should claim only the credit commensurate within 30 days prior to each course date – without exception. Registrations are transferable at any time. with the extent of their participation in the activity. Sponsored by North American Center for Continuing Medical Education, LLC

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NURSES: This continuing nursing education activity awards 17.0 contact hours.

For questions regarding this educational activity, please call 609-371-1137.

Provider approved by the California Board of Registered Nursing, Provider Number 13255 for 17.0 contact hours.

PHYSICAL THERAPISTS: PARKS Institute will apply for pre-approval accreditation in Texas, Nevada, and New Jersey which require preapproval. If you practice in another state, please consult its PT board.

PODIATRISTS: North American Center for Continuing Medical Education, LLC (NACCME), is approved by the Council on Podiatric Medical Education as a sponsor of continuing education in podiatric medicine. This program is approved for 17.0 contact hours.

HARDWARE/SOFTWARE REQUIREMENTS: All educational activities are accessible via a PC (Windows 2000/XP/Vista/7) or Mac (Mac OS 10.x or later) computer with current versions of the following browsers: Internet

Explorer, Mozilla Firefox, Google Chrome or Safari. Windows Media Player or compatible alternative, sound card, and speakers are required for streamed audio. The latest version of the Adobe Flash Player is suggested (please download here) for video programs. A PDF reader is required for print publications. Please direct technical questions to webmaster@ naccme.com. REQUIREMENTS FOR CREDIT: To be eligible for documentation of credit, participants must participate in the full activity and complete the evaluation form.

Copyright @ 2013 by North American Center for Continuing Medical Education, LLC. All rights reserved. No part of this accredited continuing education activity may be reproduced or transmitted in any form or by any means, electronic or mechanical, without first obtaining permission from North American Center for Continuing Medical Education. ADA STATEMENT: North American Center for Continuing Medical Education complies with the legal requirements of the Americans with Disabilities Act and the rules and regulations thereof. If any participant in this educational activity is in need of accommodations, please call 609-371-1137.

1/9/13 4:18 PM

Apligraf® Essential Prescribing Information Numbers in parentheses ( ) refer to sections in the main part of the product labeling. Device Description: Apligraf is supplied as a living, bi-layered skin substitute manufactured from cells processed under aseptic conditions using neonatal foreskin-derived keratinocytes and fibroblasts with bovine Type I collagen. (1) Intended Use/Indications: Apligraf is indicated for use with standard therapeutic compression in the treatment of uninfected partial and/or full-thickness skin loss ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy. (2) Apligraf is indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness foot ulcers of neuropathic etiology of at least three weeks duration, which have not adequately responded to conventional ulcer therapy and extend through the dermis but without tendon, muscle, capsule or bone exposure. (2) Contraindications: Apligraf is contraindicated for use on clinically infected wounds and in patients with known allergies to bovine collagen or hypersensitivity to the components of the shipping medium. (3, 4, 5, 8) Warnings and Precautions: If the expiration date or product pH (6.8-7.7) is not within the acceptable range DO NOT OPEN AND DO NOT USE the product. A clinical determination of wound infection should be made based on all of the signs and symptoms of infection. (4, 5) Adverse Events: All reported adverse events, which occurred at an incidence of greater than 1% in the clinical studies are listed in Table 1, Table 2 and Table 3. These tables list adverse events both attributed and not attributed to treatment. (6) Maintaining Device Effectiveness: Apligraf has been processed under aseptic conditions and should be handled observing sterile technique. It should be kept in its tray on the medium in the sealed bag under controlled temperature 68°F-73°F (20°C-23°C) until ready for use. Apligraf should be placed on the wound bed within 15 minutes of opening the package. Handling before application to the wound site should be minimal. If there is any question that Apligraf may be contaminated or compromised, it should not be used. Apligraf should not be used beyond the listed expiration date. (9) Use in Specific Populations: The safety and effectiveness of Apligraf have not been established in pregnant women, acute wounds, burns and ulcers caused by pressure. Patient Counseling Information: VLU patients should be counseled regarding the importance of complying with compression therapy or other treatment, which may be prescribed in conjunction with Apligraf. DFU patients should be counseled that Apligraf is used in combination with good ulcer care including a non-weight bearing regimen and optimal metabolic control and nutrition. Once an ulcer has healed, ulcer prevention practices should be implemented including regular visits to appropriate medical providers. Treatment of Diabetes: Apligraf does not address the underlying pathophysiology of neuropathic diabetic foot ulcers. Management of the patient’s diabetes should be according to standard medical practice. How Supplied: Apligraf is supplied sealed in a heavy gauge polyethylene bag with a 10% CO2/air atmosphere and agarose nutrient medium. Each Apligraf is supplied ready for use and intended for application on a single patient. To maintain cell viability, Apligraf should be kept in the sealed bag at 68°F-73°F (20°C-23°C) until use. Apligraf is supplied as a circular disk approximately 75 mm in diameter and 0.75 mm thick. (8) Patent Number: 5,536,656 Manufactured and distributed by: Organogenesis Inc. Canton, MA 02021 REV: December 2010 300-111-8 References: 1. Veves A, Falanga V, Armstrong DG, Sabolinski ML; Apligraf Diabetic Foot Ulcer Study. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. Diabetes Care. 2001;24(2):290-295. 2. Data on file, Organogenesis Inc. 3. Apligraf® [package insert]. Canton, MA: Organogenesis Inc; 2010.

Advertiser’s Index ACell Inc. ................................................................................................................................................... 23 BSN Medical................................................................................................................................................. 5 Derma Sciences.................................................................................................................................. Cover 2 Healthpoint Biotherapeutics......................................................................................................................... 7 Medela.......................................................................................................................................................... 3 MiMedx Group ........................................................................................................................................... 21 MTI ............................................................................................................................................................ 11

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Net Health Systems............................................................................................................................ Cover 3 Organogenesis Inc. ...................................................................................................................... 32, Cover 4 Sechrist Industries Inc. .............................................................................................................................. 29 Shire Regenerative Medicine...................................................................................................................... 15

January/February Today’s Wound Clinic®

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www.todayswoundclinic.com

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dard

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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.1-16 • 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.17 For more information or questions on reimbursement: call 800.445.7627 or visit www.dermasciences.com

Quicker application. Greater comfort.

1. Armstrong DG, et al. Off-loading the diabetic foot wound. Diabetes Care 24:1019-1022, 2001 2. American Diabetes Association: Consensus Development Conference on Diabetic Foot Wound Care. Diabetes Care 22:1354–1360, 1999 3. 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 4. Helm PA, Walker SC, Pulliam G: Total contact casting in diabetic patients with neuropathic foot ulcerations. Arch Phys Med Rehabil 65:691– 693, 1984 5. Baker RE: Total contact casting. J Am Podiatr Med Assoc 85:172–176, 1995 6. Sinacore DR, Mueller MJ, Diamond JE: Diabetic plantar ulcers treated by total contact casting. Phys Ther 67:1543–1547,1987 7. 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 8. 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 9. 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 10. Liang PW, Cogley DI, Klenerman L: Neuropathic ulcers treated by total contact casts. J Bone Joint Surg 74B:133–136, 1991 11. 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 12. 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 13. 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 14. 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 15. 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 16. 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. 17. 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. © 2012 Derma Sciences, Inc. All rights reserved.

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New Ideas For Your Paper Take control of your documentation. The freedom to create personalized and rolespecific workflows are integrated into the WoundExpert software. You now have the power to craft a charting process that works the way you do. Faster loading time, fewer clicks, and reduced scrolling make charting quick, simple, and smart.

To learn more visit www.WoundExpert.com or call 800-411-6281

ÂŠ 2012 Net Health Systems, Inc. WoundExpert is a Registered Trademark of Net Health Systems, Inc.

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WoundExpert.com 800-411-6281 11/28/12 10:29 AM 12/6/12 6:06 PM

After 4 weeks of failed conventional therapy— Rethink the Wound. Think Apligraf®.

Healing Wounds. Healing Lives. Act now for fast and complete healing of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs).1-3 • Choose the ONLY bioengineered, bilayered, living cell–based product3 • Apligraf is the ONLY treatment indicated for both DFUs and VLUs3 • FDA approval for DFUs as early as 3 weeks3 • FDA approval for VLUs as early as 4 weeks3 • Frequent reassessment and reapplication of Apligraf as needed can signiﬁcantly improve the speed of healing and incidence of complete wound closure in DFUs and VLUs1-3

For information on support programs and tools available from Organogenesis Inc., call 1.888.HEAL.2.DAY (1.888.432.5232—Option 3) Please see accompanying essential prescribing information, or visit www.Apligraf.com for complete prescribing information

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