October 2013

TODAY’S

®

Contemporary Approaches to Wound Clinic Management

COMMUNITY-ACQUIRED

MRSA WOUND CLINIC

IN THE

ARE YOU PREVENTING INFECTION OR FOSTERING IT?

ALSO IN THIS ISSUE: Treating PJI ICD-10 Prep Tool Business Briefs SAWCSPRING Ocotber 2013 www.todayswoundclinic.com

00_TWC_Oct_CVR.indd 1

the symposium on advanced wound care

www.sawcspring.com

10/18/13 12:41 PM

TODAY’S

®

Volume 7, Number 8, October 2013 • www.todayswoundclinic.com

Table of Contents • Feature Articles 9

14

Community-Acquired MRSA in the Wound Clinic

Wound Management Centers & Prosthetic Joint Infections: The Unlikeliest of Allies, or a Relationship Long Overdue?

CA-MRSA has become a global concern and is particularly prevalent in the US. It’s also more likely to affect outpatient healthcare settings such as wound clinics.This places responsibility on today’s wound care providers to not just efficiently treat CAMRSA but to ensure that their facilities are not contributing to the spread by practicing appropriate infection prevention and educating their patients on how to best eliminate colonization.

It is estimated that by the year 2030, nearly 4 million artificial replacement of hip and knee joints will be performed annually.

Despite low risks involved, there are concerns of unexpected complications, namely infection. Wound management centers have an opportunity to emerge as a potential solution for optimizing outcomes in these patients.

Julia Ernst, MS & Joe Darrah

Harriet Jones, MD, BSN, FAPWCA

30

19

100

75 53.9% 50

25

46.2%

14.4% 2.9%

0

Streamlined Irregular

1.9%

Confusing Effective

Non Existent

7.7% In Need of Change

Preparing Your Documentation for ICD-10-CM: The Countdown is On!

Reader Survey Results: Working With Wound Care Interventionists

Implementation of ICD-10-CM is just 1 year away. In an effort to assist our readers as they transition from ICD-9-CM, Today’s Wound Clinic will feature an assortment of ICD-10-CM documentation tools on particular disease states or conditions to help improve one’s documentation habits. Be sure to study our first keepsake on infectious diseases in this issue.

We’ve received your feedback from our recent survey on referring to wound care interventionists. See the findings in this issue.

Donna Cartwright, MPA, RHIA, CCS, RAC, FAHIMA 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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10/18/13 3:05 PM

EDITORIAL STAFF

TODAY’S

CLINICAL EDITORS AND FOUNDING BOARD Caroline E. Fife, MD, FAAFP, CWS Dot Weir, RN, CWON, CWS

®

FOUNDING EDITORIAL BOARD Kathleen Schaum, MS Christopher Morrison, MD Val Sullivan, PT, MS, CWS

Volume 7, Number 8, October 2013 • www.todayswoundclinic.com

MANAGING EDITOR Joe Darrah jdarrah@hmpcommunications.com

Table of Contents

WEB EDITOR Samantha Alleman salleman@hmpcommunications.com

Departments 4

6

22

BUSINESS STAFF

From the Editor Business Briefs

PUBLISHER Kristen J. Membrino kmembrino@hmpcommunications.com

Facility in Focus

SALES ASSOCIATE Brian Hill bhill@hmpcommunications.com

Virtua Berlin & Washington Township, NJ

Industry Insider

29

TWC News Update

32

VP/GROUP PUBLISHER Jeremy Bowden jbowden@hmpcommunications.com

&M Codes With Procedures & NCCI Edits E Dominated Discussions at SAWC Kathleen D. Schaum, MS

27

EXECUTIVE VICE PRESIDENT Peter Norris pnorris@hmpcommunications.com

Caroline Fife, MD, FAAFP, CWS

CLASSIFIED SALES ASSOCIATE Michael Deleo mdeleo@hmpcommunications.com

An Inside Look at Novadaq Technologies Inc.

HMP COMMUNICATIONS, LLC

J oslin Diabetes Center, Johnson & Johnson form diabetes treatment partnership; Devon Medical announces global NPWT availability

Advertiser’s Index

PRESIDENT BIll Norton VICE PRESIDENT, SPECIAL PROJECTS Jeff Hall CREATIVE DIRECTOR Vic Geanopulos vgeanopulos@hmpcommunications.com

TWC Online

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

www.todayswoundclinic.com

Follow us on Twitter: @TWCjournal

ART DIRECTOR Karen Copestakes kcopestakes@hmpcommunications.com

www.twcjournal.wordpress.com

Online Exclusives: Reader Survey: Working With Wound Care Interventionists

Get the full results of our recent reader survey on wound care interventionist referrals at www.todayswoundclinic.com

Photo Slideshow: Facility in Focus – Virtua

Get a firsthand look at our visit with clinicians and patients at Virtua Berlin and Washington Township, NJ.Visit www.todayswoundclinic.com

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

HMP COMMUNICATIONS HOLDINGS, LLC

Clarification

The evidence and information obtained for the article “Benefits of Negative Pressure Therapy Applications in Newborns” in the August 2013 issue of TWC were obtained by author Carol Price, MSN, RN, CWS, DAPWCA, while she was on staff at Presbyterian/St. Luke’s Medical Center, Denver, CO. 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

an HMP Communications Holdings Company

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™

CHAIRMAN & CHIEF EXECUTIVE OFFICER Jeff Hennessy CHIEF FINANCIAL OFFICER Dan Rice SENIOR VICE PRESIDENT Anthony Mancini CONTROLLER Meredith Cymbor-Jones DIRECTOR OF E-MEDIA AND TECHNOLOGY Tim Shaw SENIOR DIRECTOR OF MARKETING Corey Krejcik SR. MANAGER, IT Ken Roberts

10/18/13 3:05 PM

fromtheeditor

TODAY’S

®

EDITORIAL BOARD

T

he hospital’s infection control committee (ICC) had determined that our wound center served as a “ground zero” for an outbreak of a relatively new problem — methicillin-resistant Staphylococcus aureus (MRSA). It was the mid-1990s and the ICC had just finished investigating a high percentage of wound center patients who had received the diagnosis. When we were visited by ICC members as part of their review, I was reminded of the story related to the 1854 cholera outbreak caused by contaminated Caroline Fife Co-Editor of TWC public water in London’s once squalid Soho District.

According to reports, physician John Snow disclosed the source of the outbreak, which killed hundreds of people, as a public water pump on Broad Street. (Remember that this was even before the “germ theory” was proven.) Snow stopped the deaths in London by removing the handle to the water pump so no one could use it.

I was a bit worried the ICC had a similar fix in mind for the wound center when it cultured every piece of equipment as well as the nares of every wound center employee and physician. In the meantime, I asserted that all the patients living with a MRSA infection had been discharged from our hospital with that diagnosis and were referred to the wound center for their outpatient follow up. After some weeks of head scratching (and negative cultures), the ICC came to the conclusion that the wound center was following a lot of patients who had become colonized with MRSA during their inpatient stay. (It wasn’t long before we began to see MRSA infections that were “community acquired.”) When we first began to treat MRSA patients, the hospital insisted we don gowns and masks and perform a “terminal clean” of the exam room. As the percentage of patients with this diagnosis grew, those practices were unsustainable. Eventually, we treated patients with MRSA using the same “universal precautions” we employed with every patient. Just what is the best practice for managing MRSA patients (or the possibility of them) in the outpatient wound clinic, and how much of a concern should MRSA be for wound care providers? There may not be one single answer to these questions, but authors Julia Ernst and Joe Darrah will share some thoughts that experts have shared with them in this issue.

Practice Doesn’t Always Make Perfect Many standards for “best practices” have changed over the years. A few years ago, one of my patients who had undergone a below-the-knee amputation crafted his own prosthetic out of poly(vinyl chloride), aka PVC pipe after he had been unable to obtain one from his insurer. Fellow TWC board member Harriet Jones, MD, BSN, FAPWCA, also provides in this issue of the journal considerations for best practices in prosthetics. With this month’s TWC we are also excited to introduce the new column, “Preparing for ICD-10-CM,” written by Donna J. Cartwright, MPA, RHIA, CCS, RAC, FAHIMA, another fellow board member. Implementation of ICD-10-CM is just a year away, and TWC is doing what it can to prepare readers with this exclusive content.

When you think about it, TWC might be the most vital piece of equipment in your wound center! n

FOUNDING EDITORIAL BOARD MEMBERS CO-EDITOR OF TODAY’S WOUND CLINIC Caroline Fife, MD, FAAFP, CWS CO-EDITOR OF TODAY’S WOUND CLINIC Dot Weir, RN, CWON, CWS Christopher A. Morrison, MD, FACHM, FCCWS Valerie Sullivan, PT, MS, CWS Kathleen D. Schaum, MS

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

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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.

Caroline Fife, MD, FAAFP, CWS

4

October 2013 Today’s Wound Clinic®

XX_TWC_Oct_Editor.indd 4

www.todayswoundclinic.com

10/18/13 1:17 PM

businessbriefs

E&M Codes With Procedures & NCCI Edits Dominated Discussions at SAWC 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 accuracy of the information. However, HMP Communications and the authors do not represent, guarantee, or warranty that coding, coverage, and payment information is error-free and/or that payment will be received.

The responsibility for verifying coding, coverage, and payment information accuracy lies with the reader.

A

s I write this column, I’m on a flight returning home to Lake Worth, FL, after four unbelievable days of learning and sharing information at the 2013 Symposium on Advanced Wound Care (SAWC) Fall conference, as well as a recent Wound Clinic Business (WCB) seminar in Las Vegas.The WCB event marked the first time it occurred the day prior to SAWC and attendees were very appreciative of the opportunity to maximize these programs back-to-back. In addition to serving as faculty for WCB, I was honored to participate in the wound clinic track for the SAWC meeting. As you might have guessed if you read the session schedule in advance, my assigned topic was “Getting Paid: Reimbursement Pearls.”

Personally, I also had the opportunity to attend most of the high-level SAWC presentations and to have one-on-one discussions with several hundred wound care professionals. Of all the lectures I presented and all the conversations I had over the weekend in general, the most talked about reimbursement issues pertained to evaluation and management (E&M) services with procedures and the National Correct Coding Initiative (NCCI) edits.

At first, I could not understand why these would be such “hot topics” for discussion and debate because they aren’t new to the wound care industry. But I had an “ah ha” moment when several wound care professionals and hospital outpatient 6

October 2013 Today’s Wound Clinic®

XX-XX_TWC_Oct_Business.indd 6

wound care department (HOPD) program directors declared that they do not like the E&M coding rules and NCCI edits, and that they “keep trying to find ways around them.” In that moment I realized that many practitioners would benefit from a reminder of these coding rules, which, I realize are not popular, but must be complied with because nearly every auditing body is targeting E&M. To begin, consider some comments I’ve heard (paraphrased) that are representative of the confusion that reigns: ➢ “ I want to be paid separately for debridement and multilayer high-compression bandaging on the same wound on the same day, so I report different diagnosis codes for each procedure.” ➢ “ We need to get paid for total contact casting and application of cellular and/ or tissue-based products (CTPs [old term skin substitute]) for wounds. How can we get around the NCCI edits?” ➢ “ Our wound clinic bills for a clinic visit at every patient encounter, even when the physician performs procedures, because we always assess the wound.” ➢ “ As a physician, I built my business plan around billing an E&M code at every patient encounter, even when I debride the wounds. I will not make as much money if I stop billing the E&M code.”

If billing clinic visits and E&M codes at each patient encounter represents practice patterns in your wound clinic business, take a moment to understand that the American Medical Association, the Centers for Medicare & Medicaid Services (CMS),the Medicare Administrative Contractors (MACs), the various auditing contractors, and, most recently, the NCCI edits have gone to great extents to educate all qualified healthcare professionals (QHPs) and healthcare facilities about the appropriate use of E&M/clinicvisit codes.The bottom line is that we should

not report an E&M service/clinic visit on the same day as another procedure (particularly surgical procedures or within the surgical global period) unless: 1. The patient presents with a significant, separately identifiable problem.

NOTE: Ask yourself if the service was completely unrelated to the procedure.

2. The visit is for an unrelated problem during a postoperative period.

CAUTION: Medicare considers treatment of a complication that doesn’t require a return to the operating room to be included in the global surgical period.

3. The visit results in the decision for surgery and is not a preoperative visit.

As of July 1, 2013, NCCI edits further clarified coding rules by bundling E&M codes into thousands of surgical and medical procedure codes.The E&M codes that have been bundled are some of the highest volume codes used by wound care professionals and/ or HOPDs.When reviewing NCCI edits for common wound care procedures, look for these newly bundled codes in Column 2: 99211-99215 Office/outpatient visit established 99221-99223 Initial hospital care 99231-99233 Subsequent hospital care 99234-99236 Observation/hospital same date 99238-99239 Hospital discharge day 99241-99245 Office consultation 99251-99255 Inpatient consultation 99304-99306 Initial nursing facility care 99307-99310 Nursing facility care subsequent 99315-99316 Nursing facility discharge day 99334-99337 Domicile/rest home visit established patient 99347-99350 Home visit established patient 99374-99375 Home healthcare supervision. www.todayswoundclinic.com

10/18/13 9:20 AM

businessbriefs If you’re curious as to which wound care-related procedure codes are in Column 1 of the NCCI edits, the following (along with some of the E&M codes listed above) are the wound care-related services that are impacted by the new NCCI edits: 10060-10180 Incision and drainage 11000-11044 Debridement 11100-11311 Biopsy 11400-11471 Lesion excision, benign 11600-11646 Lesion excision, malignant 11720-11721 Debridement of nails 12001-12021 Repair, simple 12031-12057 Repair, intermediate 13100-13160 Repair, complex 14000-14350 Adjacent tissue transfer 15002-15278 Skin replacement surgery 15570-15776 Flaps and grafts.

The Current Procedural Terminology® manual surgery guidelines are the basis for these new NCCI edit bundles.

These guidelines state that the surgical package includes “one related E&M encounter on the date immediately prior to or on the date of procedure (including history and physical).”

The new NCCI edits uphold this coding directive and enforce that wound care professionals and facilities should not routinely report an E&M service with a surgical procedure on the same date of service or within the global surgical period. All new NCCI edits have a modifier indicator of “1.”

Therefore, wound care professionals and facilities can report the bundled codes together by adding an appropriate modifier to the E&M code in Column 2. However, the medical record must have adequate documentation to support the use of one of these modifiers: 24 Unrelated evaluation and management service by the same physician or other qualified healthcare professional during a postoperative period.

TABLE 1. Example of Wound-Related NCCI Edits Effective July 1, 2013 *Providers Should Review NCCI Edits at the Beginning of Each Calendar Quarter Column 1

Column 2

Effective Date

Deletion Date * = No Data

Modifier 0 = not allowed 1 = allowed 9 = not applicable

Author’s Comment

G0456

11000

20130701

*

1

New edit 7/1/13: Debridement of infected skin is bundled into negative pressure wound therapy (NPWT)/not durable medical equipment (DME), unless performed on different anatomical locations.

G0456

11720

20130701

*

1

New edit 7/1/13: Debridement of nails is bundled into NPWT/not DME, unless performed on different anatomical locations.

G0456

11721

20130701

*

1

Same as above.

11042

29445

19990401

*

1

Effective 4/1/1999: Application of total contact cast (TCC) bundled into debridement of subcutaneous tissue, unless performed on different anatomical locations.

11042

29580

19990701

*

1

Effective 7/1/1999: Unna’s boot bundled into debridement of subcutaneous tissue, unless performed on different anatomical locations.

11042

29581

20100101

*

1

Effective 1/1/10: Application of multilayer compression system bundled into debridement of subcutaneous tissue, unless performed on different anatomical locations.

11042

29582

20120101

*

1

Same as above.

11042

97597

20050101

*

1

Effective 1/1/05: Selective debridement bundled into debridement of subcutaneous tissue, unless performed on different anatomical locations.

11042

97598

20050101

*

1

Same as above.

11042

97602

20060401

*

1

Effective 4/1/06: Non-selective debridement bundled into debridement of subcutaneous tissue, unless performed on different anatomical locations.

11042

97605

20060401

20060401

9

Effective 4/1/06: Edit of NPWT and debridement of subcutaneous tissue was deleted.

11042

97606

20060401

20060401

9

Same as above.

11042

99211

20130701

*

1

New edit 7/1/13: Established clinic visit/office visit bundled into debridement of subcutaneous tissue.

11042

99212

20130701

*

1

Same as above.

11042

99213

20130701

*

1

Same as above.

11042

99214

20130701

*

1

Same as above.

11042

99215

20130701

*

1

Same as above.

15271

G0456

20130701

*

1

New edit 7/1/13: NPWT/not DME bundled into application of cellular and/or tissue-based products (CTPs [old term skin substitute]), unless performed on different anatomical locations.

15271

G0457

20130701

*

1

Same as above.

15271

11000

20120101

*

1

Effective 1/1/12: Debridement of infected skin bundled into application of CTPs, unless performed on different anatomic locations.

15271

11042

20120101

*

1

Same as above.

15271

29445

20120101

*

1

Effective 1/1/12: Application of TCC bundled in application of CTPs, unless performed on different anatomic locations.

15271

29580

20120101

*

1

Effective 1/1/12: Unna’s boot bundled in application of CTPs, unless performed on different anatomic locations.

15271

29581

20120101

*

1

Effective 1/1/12: Application of multilayer compression bandage bundled into application of CTPs, unless performed on different anatomic locations.

15271

29582

20120101

*

1

Same as above.

15271

29583

20120101

*

1

Same as above.

Table continued on next page

www.todayswoundclinic.com

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Today’s Wound Clinic® October 2013

7

10/18/13 9:20 AM

businessbriefs Table continued from previous page

TABLE 1. Example of Wound-Related NCCI Edits Effective July 1, 2013 *Providers Should Review NCCI Edits at the Beginning of Each Calendar Quarter Column 1

Column 2

Effective Date

Deletion Date * = No Data

Modifier 0 = not allowed 1 = allowed 9 = not applicable

Author’s Comment

15271

29584

20120101

*

1

Same as above.

15271

97597

20120101

*

1

Effective 1/1/12: Selective debridement bundled into application of CTPs, unless performed on different anatomic locations.

15271

97598

20120101

*

1

Same as above.

15271

97602

20120101

*

1

Effective 1/1/12: Non-selective debridement bundled into application of CTPs, unless performed on different anatomic locations.

15271

97605

20120101

*

1

Effective 1/1/12: NPWT bundled into application of CTPs, unless performed on different anatomic locations.

15271

97606

20120101

*

1

Same as above.

15271

99211

20130701

*

1

New edit 7/1/13: Established clinic visit/office visit was bundled into application of CTPs.

15271

99212

20130701

*

1

Same as above.

15271

99213

20130701

*

1

Same as above.

15271

99214

20130701

*

1

Same as above.

15271

99215

20130701

*

1

Same as above.

29581

99211

20130701

*

1

Effective 7/1/13: Established clinic visit/office visit was bundled into application of multilayer compression system.

29581

99212

20130701

*

1

Same as above.

29581

99213

20130701

*

1

Same as above.

29581

99214

20130701

*

1

Same as above.

29581

99215

20130701

*

1

Same as above.

97597

G0456

20130701

*

1

Effective 7/1/13: NPWT/not DME is bundled into selective debridement, unless performed on different anatomical locations.

97597

G0457

20130701

*

1

Same as above.

97597

29445

20110101

*

1

1/1/11: Application of TCC is bundled into selective debridement, unless performed on different anatomical locations.

97597

29580

20080401

*

1

4/1/08: Unna’s boot bundled into selective debridement, unless performed on different anatomical locations.

97597

29581

20100101

*

1

1/1/10: Application of multilayer compression bundled into selective debridement, unless performed on different anatomical locations.

97597

29582

20120101

*

1

Same as above.

97597

29584

20120101

*

1

Same as above.

97597

97602

20060401

*

0

4/1/06: Non-selective debridement bundled into selective debridement: no exceptions.

97597

97605

20060401

*

1

4/1/06: NPWT bundled into selective debridement, unless performed on different anatomical locations.

97597

97606

20060401

*

1

Same as above.

97605

G0456

20130701

*

0

New edit 7/1/13: NPWT/not DME bundled into NPWT; no exceptions.

97605

G0457

20130701

*

0

Same as above.

99213

G0245

20090101

*

1

Effective 1/1/09: NPWT/not DME bundled into established clinic visit/office visit.

99213

G0246

20090101

*

1

Same as above.

NOTE: E&M service must be for a medical reason unrelated to the original procedure.

25 S

ignificant, separately identifiable evaluation and management service by the same physician or other qualified healthcare professional on the same day of another service or procedure.

NOTE:The medical record must contain medically necessary history, exam, and medical decision-making.

57 D ecision for surgery NOTE: The medical record should show the same diagnosis code for the E&M service and the major surgery with a 90-day global period.

See Table 1 for a representative sample 8

October 2013 Today’s Wound Clinic®

XX-XX_TWC_Oct_Business.indd 8

of wound care-related services and procedures that appear in Column 1 and Column 2 of the NCCI edits. Notice that the NCCI edits bundle many services/ procedures for which wound care professionals and HOPDs wish they could receive separate payment (www.cms. gov/medicare/coding/nationalcorrectcodInited/ncci-coding-edits.html).

One last issue to remember regarding use of codes together: Many MACs have restricted coverage of 2 procedure codes on the same visit, even though the NCCI edits do not specify the code pairs as bundled. A good example of this is the use of 15002-15005 surgical preparation or creation of recipient site in conjunction with

the 15271-15278 application of CTPs for wounds.To identify such coverage restrictions,QHPs and HOPDs should carefully read the Local Coverage Determinations (LCDs) that pertain to the services, procedures, and products that are part of their business. LCDs can be found on the individual MAC’s website or on the CMS coverage database: www.cms.gov/ medicare-coverage-database/overviewand-quick-search.aspx. n Kathleen D. Schaum is president and founder of Kathleen D. Schaum & Associates Inc., LakeWorth, FL. She may be reached for questions and consultations at 561-9642470 or kathleendschaum@bellsouth.net. www.todayswoundclinic.com

10/18/13 9:20 AM

COMMUNITY-ACQUIRED

MRSA

IN THE

Are you preventing infection or fostering it?

WOUND CLINIC

Julia Ernst, MS & Joe Darrah

D

espite its global impact, community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) remains at its most prevalent here in the US.1 And within the US, it may just be that our outpatient wound care clinics have yet to actually feel the full force of the deadly bacteria. Yes, the worst may be yet to come.

“The most common presentation of CA-MRSA is skin and soft-tissue infections (SSTIs), and as a result, wound care clinics are likely to see an increase in the number and the complexity of wound infections,” said Buddy Creech, MD, MPH, assistant professor of pediatric infectious diseases at Vanderbilt University, Nashville, TN. As Creech explains, boils and skin abscesses are not necessarily the type of symptoms that keep healthcare providers tossing and turning all night; but they are, by volume, the most problematic, especially when considering the presence of CA-MRSA. “In the last year or two, the rates for CA-MRSA seem to have plateaued, but staph is a master adapter,” Creech said. “Every few years staph appears in a slightly different version — neonatal sepsis in the 1960s, menstrual-associated toxic shock syndrome in women during the ’70s and ’80s, hospital infections in the ’80s and ’90s, and now CA-MRSA. Therefore, we always have to be diligent to recognize staph’s many different ‘colors.’”

It’s tough to predict just how prevalent CA-MRSA will become in the wound clinic and other healthcare settings as time passes. Still, there are a few certainties that

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wound care providers can take heed of when it comes to effective treatment and best practice toward prevention.

MRSA’s Recent Emergence One common theory, particularly among the general public and the media, pertaining to the overuse of antibiotics as a cause to MRSA overall is only accurate to a point, explains Robert L. Buka, MD, JD, section chief in the department of dermatology at Mount Sinai School of Medicine, founder and medical director of Bobby Buka MD Dermatology, New York.

“The critics who talk about the overuse when it comes to someone who comes in for the ‘sniffles’ and sore throat when the primary care provider prescribes, say, Augmentin, that kind of inappropriate use of antibiotics for viral issues can rapidly lead to bacterial resistance,” he said.

“But the guilty parties are not those who are reaching for antibiotics in the presence of clear [SSTIs].”

In 2008, Talan and colleagues found that about 83% of patients who presented to the emergency department with purulent SSTIs had abscesses, compared to about 79% of admissions for the same complaint in 2004.2 Another study found that severe skin infections are the seventh most common reason for hospital admissions among children, whereas in 2000, they ranked 13th.3 Cellulitis, folliculitis/ furunculosis, and impetigo have also been identified as cutaneous presentations of CA-MRSA4 (see Figures 1 and 2).

“CA-MRSA infections typically begin as skin infections, with patients presenting with single or multiple forms of erythematous pustular skin lesions, commonly pro-

Figure 1. MRSA ulcerative lesion. Photo courtesy of Noel Manyindo, MD/CDC website

Figure 2. MRSA cutaneous abscess. Photo courtesy of Noel Manyindo, MD/CDC website.

gressing to skin abscesses that are usually painful, swollen, draining [pus], and causing fever,”explained Noel Manyindo,MD, MBA,of the Department of Global Health & Population at Harvard School of Public Health. “Central ulceration is sometimes present. Misdiagnosis as folliculitis or insect bite is not uncommon.”

The emergence of CA-MRSA as a more significant problem than healthcare-acquired (HA-MRSA) has occurred in conjunction with the prevalence of cutaneous symptoms over more severe MRSA complications like bone infections and pneumonia. A significant majority of MRSA-related SSTIs are caused by the community-acquired strain compared to the hospital-acquired strain Today’s Wound Clinic® October 2013

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infectionprevention MRSA Scare Hits NFL Franchise A third player for the National Football League’s (NFL) Tampa Bay Buccaneers was recently diagnosed with community-acquired MRSA while one of the other two affected players has contacted a second case of the infection.

According to reports from the NFL, the team flew in an infectious disease expert to answer questions that players had and a recent home game was only green-lighted after a facility cleaning and inspection.

“We have been involved in an ongoing review of the MRSA incidents in Tampa Bay initiated by the concerns we had about the manner in which team officials responded to these cases,” said DeMaurice Smith, executive director of the NFL Players Association, in a prepared statement. He also stressed the need for a league-wide, comprehensive and standardized infectious disease protocol as well as improved accountability measures on health and safety issues by the NFL over the clubs.

Prior to the most recent news of infection, the team had hired a company to sanitize its headquarters and training facility over the summer, on two separate occasions.

— Joe Darrah

(75% versus 37%, respectively).5 This statistic, from 2003, coincides with the time period that CA-MRSA started to appear.

“The emergence of CA-MRSA was really in the first half of the last decade, between about 2000 and 2004,” said Patrick S. Romano, MD, professor of medicine and pediatrics at University of California, Davis School of Medicine. “It was only episodically reported in series before 2000, and then, in larger series starting in 2004, it was apparent that it had become a prominent pathogen, at least for [SSTIs] presenting to emergency departments.”

With these shifts in MRSA subtype and symptomatology, a new patient population has emerged that is atypical of the standard MRSA patient. Once again, the healthcare community, particularly settings like outpatient wound clinics, are thrust under the microscope as carrier suspects.

“Doctors and nurses and respiratory technicians go home at the end of the day, and, unless everybody’s washing 100 percent of the time, they’re going home to kids who have underdeveloped immune systems and diabetic parents who don’t have fully immune-competent immune systems,” Buka said. “MRSA has always had the potential to affect healthy people, [but] those are examples of how CA-MRSA got a foothold in the com10

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munity. Once it gains that foothold in non-hospitalized patients, we start to see the infection in certain categories of people — boarding schools and dormitory students and people living in close quarters in the community setting and metropolitan areas (see sidebar above and on page 13). We’re seeing this expanding bubble get larger and larger.”

The emergence of CA-MRSA in these healthy individuals is indicative of the impact that this new strain is having on people who would not generally be perceived as susceptible to MRSA. “You have to look no further than those who we would say are some of the healthiest people in our society — young athletes and the military who are on active deployment,” Creech added.“Those are the people that we typically think of as being in very good medical shape and very good physical shape,and they are two groups that have been disproportionately affected by CA-MRSA.”

Burden on Wound Clinics As outpatient wound clinics continue to be more susceptible to exposure to patients living with CA-MRSA, they’re also more at risk for being facilitators for its spread in and of themselves.This places a responsibility on wound care clinics as

a frontline care planning source to not just detect CA-MRSA more quickly, but to treat and provide education related to infection prevention and spread of the bacteria more effectively.

On the basic level, this can be accomplished through non-strenuous means in the clinic such as practicing strict hand hygiene, cleaning equipment before and after patient encounters, and wearing gowns and/or gloves as appropriate when in contact with a patient infected with MRSA or other resistant organisms. However, from a more sophisticated clinical standpoint, the challenge of treating and stalemating CA-MRSA is much greater and troubling, according to Buka.

“We’re probably overdue for a revision of that algorithm of what to do on that first presentation because MRSA is so prevalent,” said Buka, adding that he, too, is seeing an increase in MRSA, as approximately 50 % of his cultures now reveal MRSA compared to about 20 % over the last year. “And I’m talking predominately about community-acquired MRSA.I think a lot of it is handled by primary care physicians who are following the literature as it’s currently posed,which will tell you to start with something like Keflex as the baseline for [SSTI], and we just miss coverage of MRSA — which enables it to spread during that missed period or be partially treated and spread to other contacts.”

Buka was quick to note that he’s not referring to negligence among providers here. “It’s not that primary providers are doing anything ‘wrong,’ it’s that the literature needs revision because what we end up doing is treating half of our infections with something that doesn’t target the bug we’re trying to kill for the first two weeks, and that enables the vector to spread,” he continued.“Making things like doxycycline a first-line agent is something that bears consideration.”

Until then, wound clinics might be best suited to focus on what they can have their patients do when at home to assist in the fight against infection spread, and that amounts to a systematic plan to thwart colonization.

“I don’t think there’s a single patient in my practice who hasn’t ping-ponged his or her MRSA through the rest of www.todayswoundclinic.com

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infectionprevention the family,” Buka said.“Any person who’s not treated for colonization will give it to another member in their household within three months.”

His recommendations include soaking with a half cup of bleach in a full bathtub for 10 minutes once per week — “that brings bacterial counts down on the skin” — and mupirocin for the nose, peri-anal, axilla, groin area, 3 times per day for 5 days —“in an effort to decrease MRSA in these warm, dark, moist places where we know the bacteria lives.”

This is not intended to be considered a “cure,” however.

“I still see some of these same patients come back once every two or three years, as opposed to once every couple months, if they’re following the regimen,” Buka related.“I would love to have better direction from our infectious disease colleagues as to how to best eliminate MRSA from those areas for good. There are a number of opinions out there, and mixed literature, but there’s no standard of care.”

Defining Current Treatment At its core, MRSA, in any form, is a staph infection, which is not a significant challenge clinically; but resistance to the beta-lactam class of antibiotics — the penicillin and cephalosporin antibiotics — is what makes treatment so difficult.

Currently, several strategies are utilized to combat CA-MRSA:antibiotics,incision and drainage (I&D), and prevention of recurrence. In January 2011, the Infectious Diseases Society of America (IDSA) issued an updated version of its clinical guidelines for treating MRSA infections.These guidelines recommend a variety of antibiotics for CA-MRSA: clindamycin (Cleocin), doxycycline (Adoxa, others), tigecycline (Tygacil), trimethoprim-sulfamethoxazole (Bactrim, trimethoprim-sulfamethoxazole) and vancomycin (Vancocin).6 Clindamycin. This lincomycin antibiotic is approved by the US Food and Drug Administration (FDA) for treating serious infections caused by S. aureus.6 It is widely used in the treatment of SSTIs and has been effective against CA-MRSA in children.6,7 Some research has suggested the drug works by inhibiting the toxin production that may play a role in MRSA pathogenicity.8 There are side effects aswww.todayswoundclinic.com

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Inappropriate Antibiotic Use Still High Researchers are reporting that antibiotics are still being drastically overprescribed for sore throat and bronchitis despite ongoing speculation that they not be.

According to a report by MedPage Today, analysis of two national ambulatory care databases suggests doctors order antibiotics for about 60% of patients who complain of a sore throat, said Jeffrey Linder, MD, of Brigham and Women’s Hospital in Boston. Meanwhile, only about one sore throat in 10 is caused by a pathogen — group A streptococcus — that responds to antimicrobial agents.

When it comes to bronchitis, some 73% of complaints result in an antibiotic prescription, but the condition never responds to the drugs, Linder said. Some of the research has been presented in JAMA Internal Medicine. The data came just weeks after the CDC warned of antibiotic resistance caused by inappropriate use of drugs.

— Joe Darrah

sociated and some resistance to the drug in recent years has raised questions.4,6 In addition to a resistance that seems, to a degree, regional, clindamycin resistance is also particularly increased in cystic fibrosis patients, making the drug a poor choice for these individuals.4 Side effects of clindamycin are primarily gastrointestinal problems.6 Doxycycline. Of the tetracyclines available for CA-MRSA, doxycycline is preferred, as it has been shown to have adequate coverage against MRSA and better anti-streptococcal activity.4 Doxycycline is FDA-approved for the treatment of SSTIs due to S. aureus, although not specifically for S. aureus infections caused

by MRSA. Data on such use are limited.6 Recently,there have been concerns about resistance.It appears that CA-MRSA may have inducible resistance to doxycycline through the tetracycline resistance gene tet(K).4 Doxycycline is not suggested for use in children younger than 9 because of adverse effects, including discoloration of teeth and inhibition of bone growth.4 Other side effects to doxycycline include gastrointestinal intolerance, photosensitivity, drug hypersensitivity, and skin pigmentation.4 Tigecycline. This glycylcycline, a derivative of the tetracyclines, is FDAapproved for adults with SSTIs and intra-abdominal infections.6 Because it has demonstrated a large volume of distribution and high concentration in tissues and

low concentrations in serum, as well as bacteriostatic activity against MRSA, it is not recommended for the treatment of patients with bacteremia.6 Trimethoprim-sulfamethoxazole.

Known by the brand name Bactrim and abbreviated as TMP-SMX, this drug is “a valuable antibiotic of choice for CA-MRSA.”4 While the drug is not FDA-approved for the treatment of any staphylococcal infections, 95%-100% of MRSA strains have been demonstrated as susceptible in vitro, and it has become a strong option for outpatient treatment.6 In addition, antibiotic resistance to TMPSMX has not been identified as a significant problem in facilities where the treatment is used routinely.8 Vancomycin. A 15-year study of the changing epidemiology of MRSA revealed that all CA-MRSA isolates in the series were susceptible to vancomycin.9 Another study states the drug “is reserved for treatment of infections caused by multi-resistant MRSA strains and for patients with severe systemic infections.”5 It is safe and effective for both children and adults.6 ISDA guidelines state vancomycin has been “the mainstay of parenteral therapy for MRSA infections,” though it is noted that efficacy has come into question in recent years, particularly because of its slow bactericidal activity, the emergence of resistant strains, and possible “MIC creep” among susceptible strains.6 Today’s Wound Clinic® October 2013

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infectionprevention Researchers Link MRSA & Antibiotic Resistance University of Notre Dame researchers have published results that reportedly show how methicillin-resistant Staphylococcus aureus (MRSA) regulates the critical crosslinking of its cell wall in the face of beta-lactam antibiotics.

According to the researchers, including collaborators based in Spain, the findings, published in Proceedings of the National Academy of Sciences, reveal the mechanistic basis for how the bacterium became such a difficult pathogen over the previous 50 years. Modern strains have become broadly resistant to antibiotics, including beta-lactam antibiotics, such as penicillins. In the report, researchers disclose the discovery of an allosteric domain in the X-ray structure of the penicillin binding protein 2a of MRSA, the enzyme that carries out the crosslinking reaction.

Researchers at the Spanish Research Council document that an allosteric trigger by a fragment of the cell wall at a distance of 60 Ångstroms (6 nanometers) activates a set of conformational changes that culminates in the opening of the active site from a closed conformation, enabling catalysis for the physiological role of the enzyme. They also document that the new beta-lactam antibiotic ceftaroline, recently approved by the FDA, is able to bind to the allosteric domain and trigger the same allosteric opening of the active site. This subversion of the allosteric control allows another molecule of ceftaroline to access the active site, which inhibits the function of the enzyme, leading to cell death by MRSA. This mechanism of action for the antibiotic is unprecedented and offers important insights for design of future drugs to combat MRSA, according to the researchers.

— Joe Darrah

Mupirocin. Recommended, specifically,for nasal decolonization,given twice per day for 5-10 days.7 Additionally, chlorhexidine is an agent used by surgeons before a procedure for hand washing, explains Romano, but it is also available in a weaker concentration that can be used for bathing. Some evidence supports the use of chlorhexidine baths for the prevention of recurrent CAMRSA infections.7 These baths work by bringing the bacterial counts on the skin down, according to Buka.

Preventing Recurrence Getting rid of MRSA “is the easier part,” explains Buka.“Preventing it from becoming recurrent can be more challenging.”

Creech agrees. “The combination of virulent organism and draining pus [in the wound clinic] is one that makes infection control a nightmare,” he said.

“Wound care clinics should be particularly astute at ensuring that infectious or12

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ganisms from one patient are not spread to another patient.”

A study in Clinical Infectious Diseases from December 2011 compared decolonization of the CA-MRSA-infected individual alone to decolonization of the entire household.The results showed that while household decolonization was not more effective than individual decolonization for eradication of CAMRSA, decolonization of every individual in the household did decrease recurrent SSTIs.10 Among 126 of 147 total cases completing the 12-month follow up,“S. aureus was eradicated from 54% of the index group versus 66% of the household group (P = .28). Over 12 months, recurrent SSTI was reported in 72% of cases in the index group and 52% in the household group (P = .02). SSTI incidence in household contacts was significantly lower in the household versus index group during the first 6 months; this trend continued at 12 months.”10

Figure 3. A healing wound after I&D without antibiotics. Photo courtesy of Guy Pupp, DPM, FACFAS, and Carmen R. April, DPM.

Figure 4. Heel ulceration in a 62-year-old man after I&D. Photo courtesy of Guy Pupp, DPM, FACFAS, and Carmen R. April, DPM.

Proper hygiene is the key to controlling CA-MRSA from the onset. Strategies for halting the spread of the disease can lessen the impact once an individual becomes ill, and there are effective treatment options but efforts are still needed.

“Given that there’s this uncertainty about whether prevention works, our strategy still relies, principally, on early detection of infections and proper treatment when infections arise,” Romano said.“That’s still going to be the primary focus, but that may change as we get more evidence about prevention.”

CA-MRSA is“the most common infection in the United States right now,”Creech stressed. “What we desperately need is a proactive way to prevent it, because those who have been practicing for a long time will tell you that, about every 10-15 years, there’s another wave of a new sort of version of staph infections.What we really need is a vaccine, and there are finally [a few] candidates that are in the pipeline so that, within the next decade, we may see a vaccine that, especially in those who are the highest risk, could prevent the disease from the get-go.”

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infectionprevention “The outlook, I think, depends upon how rapidly these bacteria adjust to the agents we now have for MRSA,” he said.

“And that’s happening with some of the new antibiotics, like lincomycin, which we use in acute cases where we find a Bactrimdoxycycline-clindamycin resistance.That’s happening, which is frightening, but it’s happening on a very small scale, currently.”

Romano concurs.“I think that our data and others suggests that we’ve probably reached a new equilibrium in terms of the prevalence of the organism in the community and the incidence of associated infections,” he said. “This is not something that’s rising exponentially, it’s not a true epidemic at this point; so we’re at a new equilibrium and it’s changed how we practice medicine, in that you have to use antibiotics that are active against most strains of CA-MRSA, and we have to have a little more readiness with the knife, so to speak, to drain these abscesses before they get too large.”

I&D procedures (see Figures 3 and 4 on page 12) can be done alone or in combination with antibiotics — the choice of one or both should be made on a case-by-case basis.

“A decade ago, two decades ago, the standard of care for these types of boils was to lance it at the doctor’s office or the emergency room and, as long as the draining procedure went well,you probably didn’t even need antibiotics,” Creech said.

“By getting the pus out, you’re also getting the bacteria out.When CA-MRSA came around, people were a little bit nervous to do that, just because we didn’t have proof that it would work; but over time people have felt more comfortable in just draining it and not putting the patient on antibiotics.”

Evaluation of each patient for specific symptoms is the key to determining if and when antibiotics are needed in addition to I&D, according to Romano.

“It’s differentiating whether it’s just cellulitis without a collection of pus, or is there an abscess,” he said. “I think it’s generally accepted that, if there’s an abscess or a collection of pus, that pus needs to be drained. It’s draining the pus, but usually the abscess is surrounded by some cellulitis, some soft tissue infection, and so then the patient usually has to be treated with antibiotics. There are some www.todayswoundclinic.com

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Community MRSA Incidence Rising Among Kids More children are being affected by cases of community-acquired methicillinresistant Staphylococcus aureus (MRSA) infections, according to the CDC. Recent statistics showed a modeled yearly increase of 10.2%, from 1.1 to 1.7 infections per 100,000 from 2005-10. During the same period, healthcareassociated and hospital-onset MRSA infection rates in children have remained the same while they’ve decreased in adults.

“Current prevention strategies for community-associated MRSA focus on education and behavior change aimed at improving hygiene, and it is unknown whether these strategies are effective or have been widely adopted,” researchers said. “Additionally, some interventions recommended for adults may not be recommended in children because of the lack of data about risks versus benefits for young children.”

— Joe Darrah

patients who present only with cellulitis without abscess. One of the features of this organism is that it tends to be more likely to form abscesses than the other pathogens that cause cellulitis.”

A literature review of CA-MRSA in the US from 2011 cites “incision and drainage of purulence and application of heat as the most effective treatment of abscesses regardless of the infecting organism … Antibiotic management of CA-MRSA is different from infections caused by HA-MRSA; therefore, it is important to differentiate the organism through culture and susceptibility confirmation to determine whether CA-MRSA is susceptible to less costly antimicrobials and leave more expensive antibiotics as last resorts.”11 n Joe Darrah is managing editor of TWC. Julia Ernst is a contributing writer.

References 1. Diekema DJ, Pfaller MA, Schmitz FJ, Smayevsky J, Bell J, Jones RN, et al. Survey of infections due to Staphylococcus species: frequency of occurrence and antimicrobial susceptibility of isolates collected in the United States, Canada, Latin America, Europe, and the Western Pacific region for the SENTRY Antimicrobial Surveillance Program, 19971999. Clin Infect Dis. 2001; 32 Suppl 2:S114.

2. Talan DA, Krishnadasan A, Gorwitz RJ, Fosheim GE, Limbago B, Albrecht V, et al.

Comparison of Staphylococcus aureus from skin and soft-tissue infections in US emergency department patients, 2004 and 2008.

Clin Infect Dis. 2011; doi: 10.1093/cid/cir308.

3. Skin & Aging. Increase in skin and soft tissue

infections seen among children. Available at: http://skinandaging.com/content/increaseskin-and-soft-tissue-infections-seen-amongchildren. Accessibility verified February 2, 2012.

4. Hansra NK, Shinkai K. Cutaneous community-acquired and hospital-acquired methicillin-resistant Staphylococcus aureus. Dermatol Ther. 2011; 24: 263-272.

5. Halem M, Trent J, Green J, Kerdel F. Community-acquired methicillin resistant Staphylococcus aureus skin infection. Sem in Cutan Med and Surg. 2006; 25(2): 68-71.

6. Liu C, Bayer A, Cosgrove SE, Daum RS, Fridkin SK, Gorwitz RJ, et al. Clinical practice guidelines by the Infectious Diseases Society of America for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Prac Guide. 2011; doi: 10.1093/cid/ciq146 7. The Reporter,Vanderbilt University Medical Center’s Weekly Newspaper. Study shows popular MRSA drug may not be best option. Accessed at: www.mc.vanderbilt.edu/ reporter/index.html?ID=11193. Accessibility verified February 6, 2012.

8. Management of Methicillin-resistant Staphylococcus aureus (MRSA) infections.

Federal Bureau of Prisons, Clinical Practice Guidelines. April 2011.

9. Crum NF, Lee RU, Thorton SA, Stine OC, Wallace MR, Barrozo C, et al. Fifteen-year study of the changing epidemiology of methicillin-resistant Staphylococcus aureus.

Amer Jour Med. 2006; 119: 943-951.

10. Fritzl SA, Hogan PG, Hayek G, Eisenstein KA, Rodriguez M, Epplin EK, et al. Household versus individual approaches to eradication of community-acquired Staphylococcus aureus in children: A randomized trial. Clin Infect Dis. 2011; doi: 10.1093/cid/cir919.

11. Barnes BE & Sampson DA.A literature review on community-acquired methicillin-resistant Staphylococcus aureus in the United States: Clinical information for primary care nurse practitioners.

Jour Amer Acad Nurse Pract. 2011; 23: 23-32.

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WOUND MANAGEMENT CENTERS & PROSTHETIC JOINT INFECTIONS: The Unlikeliest of Allies, or a Relationship Long Overdue?

With guidelines for preventing and treating prosthetic joint infections firmly in place, wound care providers can better care for their patients.

Harriet Jones, MD, BSN, FAPWCA

M

odern day joint-replacement surgery was first performed in the US in the 1970s. Fast forward to 2009, and approximately 1 million primary total hip arthroplasties (THAs) and total knee arthroplasties (TKAs) had been performed in this country (332,000 and 719,000 respectively), according to the 2010 National Hospital Discharge Survey.

Considered a relatively low-risk surgical procedure today, artificial replace-

ment of hip and knee joints are used to increase mobility and eliminate chronic pain caused by arthritic or severely injured joints. It is estimated that by the year 2030, these numbers will increase to almost 4 million per annum, according to the Infectious Diseases Society of America (IDSA).

Despite the low risk involved, there are a variety of reasons why these surgeries can result in unexpected complications. One major concern remains infection. With

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respect to primary (first time) prosthetic joint (hip or knee) replacements, there is a 1-2% risk of deep infection occurring within the joint and contaminating the arthroplasty components over the lifetime of the prosthetic. That may not seem like many, but that figure translates to 10,00020,000 patients. Of all total hip and total knee revisions that are conducted, 15-25% are needed as a result of infection while 7% of the revisions needed for reasons other than infection will go on to become www.todayswoundclinic.com

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infectionprevention infected.With the changes thus far realized with the implementation of healthcare reform, particularly facility non-payment of certain readmissions, wound management centers have an opportunity to emerge as a potential solution for optimizing outcomes in patients presenting with possible prosthetic joint infection (PJI). Likewise, hospital systems may avoid potential financial hardships due to delayed recognition and treatment of PJIs.

PJI IN THE WOUND CLINIC

Chances are that most wound care providers have evaluated patients presenting to the wound clinic with what could be PJI of the hip or knee. A typical patient could be a 70-year-old female just a few months removed from undergoing TKA or THA with a chief complaint of “drainage” along the incision scar line. The vast majority of the patients (men and women) treated by this author have not experienced true PJI. Rather, they had what turned out to be an obscured fistula within the scar tracking only into the subcutaneous space. More easily treated in the clinic setting, these kinds of wounds usually heal well before deeper compartments become compromised.

Alternatively, this scenario can unfold differently. For instance: Patient presents to the wound clinic and receives an unrevealing assessment of the surgical site and is referred to the surgeon who also doesn’t appreciate the fistula. Because the patient is otherwise considered to have a low probability of having PJI, no further workup is pursued and the patient is prescribed empiric oral systemic antibiotics.

One problem with this scenario is that the patient may have PJI and not necessarily look much different from those without PJI — each likely will experience vague, protean symptoms such as persistent stiffness, soreness, and/or erythema that may persist longer than 1 week. Additionally, it is not at all uncommon for patients to develop PJIs, yet present to the healthcare system weeks (or even years) after the prosthesis was implanted. However, the astute clinician should carefully assess the patient for symptoms and physical findings that could place one in a higher-

FINALLY: PJI GUIDELINES BENEFIT PATIENTS & PROVIDERS Having completed my degree for a bachelor of science in nursing in 1985, I entered the world of healthcare as a surgical nurse in the operating suite of an orthopedic surgical and rehabilitation specialty hospital. My interest in bone and joint infections was about to begin. By 1991 I had transitioned to an adult orthopedic inpatient unit at a university hospital. During those years I became very familiar, albeit in a different way than I am now, with patients living with postoperative hip and knee prosthetic joint complications. What I recall most clearly from those days is my concern for those who were about to be discharged from the hospital once they had undergone the formal intraoperative washout and placement of a central line (or not) for completion of 6-8 weeks of systemic intravenous antibiotics (usually vancomycin and gentamicin). Since those days, the incidence of infections involving prosthetic hips and knees has decreased because of improved standards of care and streamlined processes. However, only in the last few years has there been a consensus for what constitutes a prosthetic joint infection (PJI). Moreover, there isn’t a standardized approach regarding treatment of PJI other than the guidelines reviewed in this article. Because patients who develop these infections have multiple, unique variables to be considered in developing a long-term plan of care, these guidelines may be all that is needed. Advanced multidisciplinary wound management centers are in a unique position to be the place from which the initial patient assessment, diagnostic investigations, and communications with appropriate colleagues should begin.

— Harriet Jones, MD, BSN, FAPWCA

risk category for having a PJI. The patient’s surgeon should then immediately be notified of the situation so that a more direct and specific care plan can be initiated. If morbidity and mortality associated with any PJI or subsequent revision or staged procedure is to be minimized, establishing and delivering a patient-specific plan of care is imperative.

Within the last five years, there have been several well-written guidelines published that discuss diagnosing and treating hip and knee PJI. Although they do represent different schools of thought, they share one basic recommendation — collaboration among all involved medical and surgical specialists.

As a wound-management provider, becoming familiar with the latest guidelines for diagnosing and managing PJI will not only expedite proper patient care, it will also secure your practice’s position as a proactive member of the local healthcare community.

REVIEW OF PJI GUIDELINES

In response to the CDC surveillance authority and the orthopedic commu-

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nity’s collective frustration regarding the lack of a standard definition for PJI, the Musculoskeletal Infection Society (MSIS) convened a 21-member workgroup in 2011 to propose the following as criteria for defining PJI: 1. A sinus tract communicating with the prostheses; or 2. A pathogen isolated by culture from 2 separate tissue or fluid samples obtained from the affected prosthetic joint; or 3. Of the following 6 criteria, 4 exist (although fewer than 4 may not be exclusive): a. Elevated serum erythrocyte sedimentation rate (ESR) or serum C-reactive protein concentration (CRP); b. Elevated synovial white blood cell (WBC) count; c. Elevated synovial neutrophil percentage; d. Presence of purulence in the affected joint; e. Isolation of a microorganism in 1 culture of periprosthetic tissue or fluid Today’s Wound Clinic® October 2013

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infectionprevention TABLE Probability of Infections

Elevations of ESR/CRP

Planned Reoperation Status

Recommended Test

Higher

+/+ or +/-

Planned or not planned

Aspiration

Lower

+/+ or +/-

Planned

Aspiration or frozen section

Lower

+/+

Not planned

Aspiration

Lower

+/-

Not planned

* Referral to original document

Higher or Lower

-

Planned or not planned

No further testing

-

Adapted from AAOS: The Diagnosis of Periprosthetic Joint Infections of the Hip and Knee. 2010.

(3-5 samples should be submitted for aerobic and anaerobic environments); f. Greater than 5 neutrophils per high-power field in 5 high-power fields observed from histologic analysis of periprosthetic tissue at 400-times magnification.

Caveats in the MSIS definition of PJI include: Isolation of a single low-virulence pathogen in the absence of other criteria is not believed to represent a definite infection and histopathology examination of the periprosthetic tissues for the presence of WBCs by a specially trained musculoskeletal pathologist.

In 2012, IDSA published “Diagnosis and Management of Prosthetic Joint Infection: Clinical Practice Guidelines by the Infectious Diseases Society of America.”1 The American Academy of Orthopedic Surgeons’ (AAOS) most recent guideline “The Diagnosis of Periprosthetic Joint Infections of the Hip and Knee” was published in June 2010.2 Each guideline set is based on a panel consensus opinion from exhaustive reviews of published clinical and basic science research. Expert opinion was referenced in areas lacking sufficient published data. It should also be noted that the differences between these two guidelines are based on each panel’s area of expertise. The AAOS and IDSA are in general agreement that supports obtaining an initial complete blood count with differential; CRP, ESR, and plain radiograph when patients present with a possible PJI. Additionally, each group supports obtaining initial cultures after patients have been taken off antibiotics and are clinically stable for at least 2 weeks. The IDSA supports collecting aerobic and anaerobic blood cultures if fever is present; if there is acute onset of

symptoms; or if the patient is living with a condition, suspected condition, concomitant infection, or pathogen (highly virulent) that would make the presence of a bloodstream infection more likely, as well as obtaining a diagnostic arthrocentesis on all patients with a suspected acute PJI. Unless the diagnosis is evident clinically, surgery is planned and antimicrobials can be safely withheld prior to surgery. Performing crystal analysis on synovial fluid aspirate if indicated clinically and sending intraoperative histopathological synovial and periprosthetic tissues for examination are also recommended by the IDSA. The AAOS supports joint aspirations of patients being evaluated for periprosthetic knee infections who have abnormal ESR and/or CRP results. However, a selective approach based on probability of having a periprosthetic infection is utilized for guiding the decision of aspiration and culture for prosthetic hip evaluation.

AAOS authors (see Table above) recommend repeat hip aspiration when there is a discrepancy between the probability of the periprosthetic joint infection and the initial aspiration culture.

Also, in the absence of reliable evidence, the AAOS workgroup recommends re-evaluating patients who would be considered “lower probability” and who have normal ESR and CRP values and in whom no re-operation is planned every 3 months. In patients undergoing re-operation but in whom the diagnosis of PJI has not been established or excluded, AAOS recommends use of a frozen section of periimplant tissues as an additional means to determine whether the patient has a PJI as other reasons for implant failure should be assessed.

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Finally, there is agreement from all workgroups that current research gaps still include epidemiology, diagnostics, management, and prevention of PJIs. The current system of healthcare delivery and management of care for patients undergoing evaluation and treatment of PJI, with or without surgical revisions, can be unnecessarily burdensome for all involved parties. For surgeons, these situations may require more time in the exam room trying to determine exactly what is going on in an otherwise healthy postoperative patient, or, more importantly, exposing the patient to an otherwise unnecessary surgical re-exploration of the affected joint. Hospital systems realize unnecessary risks when patients are unnecessarily readmitted, particularly if the patient undergoes any evaluation under anesthesia. However, the most important burden is endured by patients who find themselves in the crosshairs of all those tasked with managing their care. By becoming familiar with available association guidelines, surgical and medical expert recommendations, and becoming more proactive in the integration of these methods into daily practice, wound care providers can help improve outcomes and lessen morbidity and mortality for at-risk patients who are undergoing evaluation of possible THA and TKA revision and/or exploration surgeries. n For a listing of references and resources used for this article, visit www.todayswoundclinic. com/references.

Harriet Jones is on staff at the University of Mississippi Medical Center and TWC editorial board member. www.todayswoundclinic.com

10/18/13 9:18 AM

Preparing Your Documentation

for ICD-10-CM: THE COUNTDOWN IS ON! As wound care providers inch closer to the ICD-10-CM implementation deadline, TWC offers an exclusive new series of documentation tools.

Here’s a primer.

Donna Cartwright, MPA, RHIA, CCS, RAC, FAHIMA

T

he arrival of ICD-10-CM is on the horizon, and it will soon be essential for all wound care practitioners to refine their documentation skills in preparation for the new coding format.To that end, there’s a lot of education to consider prior to the implementation deadline of Oct. 1, 2014. In an effort to assist our readers as they transition from ICD-9-CM, Today’s Wound Clinic will feature an assortment of ICD-10-CM documentation tools on particular disease states or conditions that have been developed to help improve one’s documentation habits, which will be vital to the success of wound clinics in the ICD-10-CM environment. The tools may also contain information on coding guidelines where appropriate. (Our first tool on Infectious Disease appears in this issue on page 20.) Do not delay in absorbing the materials that will be published over the course of the next year, as there will be an assortment and wealth of information to process as wound care providers move closer to the launch of ICD-10-CM. New topics will be covered in successive issues of TWC, and each topic will feature documentation tools designed as keepsakes that can be promoted/circulated to fellow staff members and colleagues.

Topics have been selected by the author as key terms for review that may or may not be high-volume diagnoses in one’s respective facility, but are universal in nature.

NOTE: All efforts put into improving one’s documentation will assist the wound care center to have very granular, detailed coding under ICD-10-CM. The better the documentation and specificity of one’s codes, the better the subsequent data will be. In addition, these diagnosis codes are also used to document medical necessity for proper payments in the wound center. The data will assist with research, qualityimprovement reporting, identifying trends and patterns in patient populations, and volume statistics.

UTILIZING DOCUMENTATION TOOLS

!

Editor’s Note: 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. Providers, suppliers, and manufacturers are responsible for case-bycase assessment, documentation, and justification of medical necessity. The author does 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 verifying coding, coverage, and payment information accuracy lies with the reader.

For each documentation tool provided, the reader will need to conduct the following process for implementation: 1. Formulate a multidisciplinary team to review record documentation.

2. Run a diagnosis report to find records containing the particular documentation topic. (You may need to consult your coders/billers to assist in running the reports.)

3. Take a random sampling of the charts identified.

4. Audit the records selected for comprehensive documentation utilizing the new key terms provided in the documentation tool.

5. Identify any trends or patterns during the review (ie, all practitioners documenting incorrectly, identify most commonly used phrases for that particular diagnosis, etc.)

6. Utilize the services of a physician champion for one’s wound care program and prepare an in-service education program for practitioners who document in the outpatient record. (The documentation tool will serve as a guide of topics to cover with practitioners.)

7. Approximately 1 month after the in-service program, audit current records to see if the new documentation key terms have been retained by the learners.

8. Repeat in-services for those who are still having difficulty with the documentation key terms.

9. Celebrate successful changes in documentation habits and communicate them to the team and management (eg, expectation: 100% compliance with documentation requirements).

Refer to this introductory article in order to effectively follow the steps toward documentation change. n Donna Cartwright is senior director of strategic reimbursement for Integra LifeSciences Corp., Plainsboro, NJ. She’s approved as a certified trainer on ICD-10-CM by the American Health Information Management Association and has been designated as a fellow of the American Health Information Management Association. She is also member of the Association for the Advancement of Wound Care and was named Woman of the Year in Healthcare 2012-13 by the National Association of Professional Women. She may be reached at 609-936-2265 or donna.cartwright@integralife.com.

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® Today’s Today’s Wound Wound Clinic Clinic® October October 2013 2013

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ICD-10-CM ICD-10-CM DIAGNOSIS CODING DOCUMENTATION TIPS FOR WOUND CARE INFECTIOUS DISEASES (A00-B99)

A

s the implementation deadline for ICD-10-CM nears, TWC offers readers an exclusive collection of tip sheets to assist in identifying pertinent documentation improvement topics in wound care. Readers should refer to the tools provided to better understand the terminologies associated with the new coding system. The first installment covers topics related to infectious disease. For additional information on how to utilize these documentation guidelines, refer to the introductory article “Preparing Your Documentation for ICD-10-CM” available in the October 2013 issue of TWC and online in the “Supplements and Special Projects” section at www.todayswoundclinic.com. n TABLE. ICD-10-CM Diagnosis Coding Documentation Tips for Wound Care Infectious Diseases (A00-B99) Topic

ICD-10-CM Code Ranges

Documentation Tips/Guidelines Code only confirmed cases.

HIV HIV Asymptomatic

Z21-HIV currently asymptomatic

AIDS

B20-AIDS

Confirmation does not require positive serology or culture for HIV-only; requires physician statement.

NOTE: Inpatient hospital guidelines are different.

Known HIV or HIV-positive should be clearly documented.

If patient admitted for HIV-related disease or AIDS, first-listed diagnosis is B20, then the additional codes for the related conditions.

Bacterial/Viral Infections

B95.0-B96.89

May be used as an additional code to specify infectious organism if not already included in the disease code, ie, Acute Bronchitis due to Strep.

Used for infections for diseases classified elsewhere.

Document specific organism in the medical record if known.

Examples: Streptococcus, Staphylococcus, Enterococcus.

Infections Resistant to Antibiotics

Z16-Resistance to antimicrobial drug

Specify which antibiotic the organism is resistant to in the medical record.

MRSA Conditions

Usually appears as a combination code that has the disease and causal organism together.

Example: Pneumonia due to MRSA is code J15.212.

Do not use additional code for resistance to Penicillin, Z16.11.

If a current infection does not have a combination code for MRSA, use a code to identify the condition and use B95.62 for MRSA organism.

MRSA Carrier/Colonization

Z22.322 Carrier or suspected carrier of MRSA

MRSA Susceptible/Colonization

Z22.321 Carrier or suspected carrier of methicillin susceptible

Document carrier or susceptibility to MRSA.

Z22.321 MRSA susceptible with colonization Osteomyelitis, Acute

M86.00-M86.29

Document whether acute hematogenous, other acute osteomyelitis, or subacute. Document left or right and specific site as applicable.

Osteomyelitis, Chronic

M86.30-M86.9

Document whether chronic multifocal, chronic with draining sinus, other chronic hematogenous, or other chronic. Document left, right, and specific site as applicable.

Asceptic Necrosis

M87.00-M90.59

Specify in documentation whether due to drugs, trauma, idiopathic, asceptic necrosis, or secondary osteonecrosis. Specify exact anatomic site as well as laterality (left or right).

Carbuncle/Furuncle

L02.02-L02.93

Specify carbuncle/furuncle and provide exact site location.

Cellulitis/Abscess/Onchyia/ Paronychia

L02.02-L03.91

Document specific body part, cellulitis, abscess, lymphangitis as appropriate. Document right or left as appropriate.

Cellulitis

!

RESOURCE: 2014 ICD-10-CM Official Guidelines for Coding and Reporting 2014 - National Center for Health Statistics. Accessed online at www.cdc.gov/nchs/icd/icd10cm.htm.

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www.todayswoundclinic.com

10/18/13 2:35 PM

facilityinfocus Conforming to a High Standard of Healing Wounds at Virtua One of South Jersey’s preeminent healthcare systems continues to grow its wound clinic services through a multifaceted approach to care.

By Joe Darrah

Virtua Berlin (NJ)

B

erlin, NJ — The necrotic, gangrenous wound literally only scratched the surface of the limb- and life-threatening situation.

The patient, 65-year-old June Flinn of Blackwood, NJ, was septic with a white blood cell count nearing 20,000 and experiencing diabetic ketoacidosis with her blood sugar level pushing 400 when she arrived to the emergency department (ED) at Virtua Berlin on a chilly winter morning last February. Sent to the ED by her podiatrist during an appointment she had made due to a “spot” she had noticed on her foot weeks earlier, Flinn would require emergency surgery to debride and evacuate an abscess that had led to a bacterial infection and cellulitis reaching up to her thigh.

“And it was continuing to move,” said Christopher LaRosa, DPM, medical director of the Wound Healing Center at

Photo courtesy of the facility.

Virtua Berlin, who would have her in the operating room to perform surgery by noon that day. “The wound was just three-by-three centimeters, but we were dealing with an aggressive form of bacteria and necrotizing infection causing an immense amount of soft tissue destruction,” he continued. “Had her initial podiatry appointment been scheduled for a few hours later, she probably wouldn’t have survived, so immediate surgical intervention was paramount for limb salvage.”

As harrowing a scenario as it might have been in the moment, the experience provides a rather routine account as to why LaRosa and a few colleagues had lobbied for a wound care-devoted center to be established at one of South Jersey’s largest hospital networks.

“She presented to us as a newly onset diabetic who didn’t even know she was living with the disease until

she got to the hospital,” explained LaRosa, who, along with fellow physician Paul Quintavalle, DPM, and Kathleen Judge, ACNS-C, NEA-BC, CWOCN, MSN, commissioned Virtua administration in 2001 about the prospects and the need for a specialized center for their community. “We were beginning to realize that many of our inpatients didn’t have the resources when they became outpatients to have their wounds cared for in a comprehensive center,” said LaRosa, a member of Virtua’s staff since completing his residency in foot and ankle surgery at the network’s Voorhees campus in 1998 who had similarly begun to notice an increasing number of patients facing the same challenges through his private practice in Gibbsboro, NJ, which he still operates. “And it always seemed to come back to that lack of disease awareness among our patients.”

Going unaware of one’s comorbid diabetes and other conditions not only defined the existence of many wounds for patients, it further complicated their chances for healing. Unsurprisingly, these individuals often lacked the education needed to manage their diseases and further increased their risk of developing chronic wounds after discharge.

An opportunity to meet the needs of the community was there for the taking.

“It would have been difficult and challenging for any provider to continue the kind of care required for these patients in the office setting,” LaRosa said. “Plus, I was having to provide a lot of wound care in the inpatient setting and we didn’t always have the resources to make available to those patients.”

They do now.

Continued on page 24

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facilityinfocus Serving Up Specialties at Virtua Washington Township When the opportunity for a new multidiscipline wound program in South Jersey arose, Virtua went all in.

Washington Township, NJ — Jack Bondi, DPM, DABPS, had become beyond frustrated with having to refer people “across the river” for their wound care. After 15 years of running his own podiatry practice in South Jersey, he was seeking a means to keep his patients within the local community throughout the continuum of care. So when he learned that Virtua, for which he also worked in the inpatient setting, was constructing a multidisciplinary healthcare facility on its Washington Township campus, he didn’t blink before communicating his desire to make a wound care clinic part of the plans.

“I was seeing too many patients in this region who were dealing with wounds that weren’t being treated in a consolidated facility — we weren’t seeing that multidisciplinary approach that these patients needed,” said Bondi, who today serves as medical director of the Wound Healing Center at Washington Township in addition to his private practice located just a few miles away.

Surely the opportunity to refer patients to Virtua’s Berlin clinic had been an option for several years, but the commute to neighboring Philadelphia was sometimes more convenient for his patient population and, more often than not, out-of-network referrals were the reality.

“I was having to farm patients out to multiple specialty providers, and I think if you look at the statistics in general, a good number of people do that for their medical care,” Bondi continued. “But with Virtua I saw an opportunity to develop a ‘one-stop shop,’ so to speak, for those patients who would come to us for their healthcare needs but then fall through the cracks when it came to wound care. I think that’s where Virtua saw the need and that was the genesis of how we began here.”

And what’s been created is a multidiscipline center that offers specialty-trained wound care nurses, radiology, and physical therapy (PT) as well as onsite certified experts in nutritional counseling, diabetes education (CDE), and lymphedema care.

In particular, the availability of experts in lymphedema was seen as a priority that’s not widely available.

“We really wanted to be able to address that here because there was a huge need in this region and there was nobody around here who was doing lower extremity therapy, probably because it’s time-consuming and there’s extra training and certification within physical therapy involved,” said Bondi. “It’s not easy work.”

Located one floor below the wound clinic, Virtua In Motion offers not only PT and lymphedema therapy but occupational therapy, oncology rehab, and aquatic therapy, among other services.

“We found the need for a mutual collaboration with the wound care staff because PTs in their natural element do see wound care patients and there’s overlapping care that will take place related to their wounds,” said Keith Abruzzese, PT, program manager. “There’s also a lot that we can do for wound patients here and focus on their true functionality. They could have dysfunction in gait and balance, for instance with a lower extremity wound, and require treatment for that, which can also be addressed by the wound care physician or nurse in conjunction with PT.” When it comes to diabetes and nutritional counseling, each patient referred to the clinic is given a comprehensive assessment by a CDE (Virtua employs 20 throughout the network) to determine interventional need.

“The protocol for all of our patients, even when they’re in the acute care setting, is to meet with a CDE or certified dietician to follow very closely their sugars and nutrition,” said Kathleen Judge, ACNS-C, NEA-BC, CWOCN, MSN, wound clinic director. “We conduct nutritional screenings for every patient. We’ll evaluate blood chemistry panels and prealbumin levels, we’ll talk about their eating habits at home and in social settings, and we encourage ankle-brachial index testing — particularly for compression. At least 95 percent of our patients will need to see a CDE. Getting them to actually go can be another story, but it’s our job to help them understand the relationship between wound healing and proper nutrition and diabetes control.”

Likewise, the comprehensive screenings are conducted not just for the purposes of benchmarking, which the facility has many types established, but to help patients understand that appropriate healthcare is not static.

“You can’t practice in healthcare, and especially wound care, anecdotally,” Bondi said. “This is the era of evidence-based medicine, and we’ve developed a multidiscipline approach through our screening process and algorithms that reflects that.”

— Joe Darrah www.todayswoundclinic.com

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Today’s Wound Clinic® October 2013

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facilityinfocus

The Virtua Crew: From left are Kiersten Cesa, registrar; Christopher LaRosa, DPM, CWS; Kathleen Judge, ACNS-C, NEA-BC, CWOCN, MSN; Joe Heggan, EMT, HT; Toni Johnston, LPN, CHT; Renee Sooy, RN; Zack Frazier, LPN; Linda Edminster, RN, WCC; and Pam Donegan, LPN, WCC. Photo credit - Kathy McLaughlin Continued from page 22

COMPREHENSIVE RESOURCES

From the availability of certified diabetes educators and dieticians to wound care-certified nurses and physicians, Virtua’s wound care service features a multidisciplinary staff including vascular, plastics, and infectious disease specialists. Services have since expanded to include an independent satellite clinic that launched three years ago on its Washington Township campus. In 2012, more than 6,500 patients, many of them like Flinn who were previously undiagnosed diabetic, were treated within the two clinics, which often serve as referral sites for one another. Where Berlin is equipped to provide HBOT and an ostomy clinic (see sidebar on page 25), Washington Township offers onsite physical therapists, lymphedema experts, and a certified diabetes educator [CDE] (see sidebar on page 23).

“We are really one entity — we consider ourselves a combined wound care program,” said Jack Bondi, DPM, DABPS, medical director at Virtua Wound Healing Center Washington Township. “We have standardized protocol that we follow and joint goals that we aim to meet, 24

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such as quality control, that are required by the facility, but we try to make the program as homogenous as we can.”

In many respects, the patients dictate the collegial relationship among the centers based on their circumstantial similarities.

“Many of them just don’t know they’re living with diabetes due to their neuropathy, and they just don’t feel the pain that should facilitate them in going to the doctor or the hospital,” LaRosa said. “It’s not until they feel so ill and so lethargic that it actually motivates them to be seen by someone.”

Enter Flinn, who said she didn’t feel well for months leading up to her surgery, but did not have a designated family physician. A mother of two grown children who had long become accustomed to juggling a busy home and work schedule as a full-time homemaker and chiropractor’s assistant, Flinn said feeling sick and exhausted simply had become tolerable.

“I would just go home from work, cook dinner, lay down all night, and start all over again the next day,” she said. “In October I had seen a little

sore on the bottom of my foot, near my toes, that I put a Band-Aid on and thought was healed. We went on vacation in November and I didn’t think anything of it, but apparently it never went away.”

While walking downtown in Philadelphia one afternoon the following February with her husband George, Flinn felt pain in her foot, developed a fever by the time they returned home that evening, and remained bedridden throughout the weekend. The following day she saw the podiatrist and her life forever changed.

Though, her recollection of the day’s events are still fuzzy at best.

“I don’t remember much,” Flinn told Today’s Wound Clinic during a recent visit to the wound center. “By the time I got to the hospital I wasn’t coherent.

When I saw my husband and children later that evening it was all very overwhelming. And when I saw my foot for the first time after surgery, I really didn’t realize what I was looking at. I thought the exposed tendons were something they forgot to take out during surgery.

But I soon began to realize how bad things really were.” www.todayswoundclinic.com

10/18/13 1:04 PM

facilityinfocus She only sacrificed a toe during the procedure, but things would become more complicated when Flinn would be unable to tolerate hyperbaric oxygen therapy (HBOT). Her unique situation is what Virtua clinicians say characterizes their typical individualized approach to care.

HEALING WOUNDS WITH PERSONALIZED TREATMENTS

Following surgery, Flinn was transferred to the hospital’s med/surg unit before ultimately being housed in longterm subacute rehabilitation, where she remained for five weeks while requiring weekly visits to the Berlin clinic for wound assessment and re-dressings.

Three months post-surgery, she’s undergone five additional debridements and has received three applications of bi-layered skin substitute. She’s also required the services of visiting nurses, which is also coordinated through Virtua’s comprehensive care plan, and now is seen in the clinic weekly as an outpatient.

“She’s been through a long haul,” said Judge, director of the wound programs at Berlin and Washington Township. “Her wound was very challenging to conduct negative pressure therapy because of its location under the foot and around the dorsal area, so it was very critical for her to have access to our specialty-trained wound care nurses for her dressings.”

However, Flinn’s care plan could not include HBOT due to her claustrophobia, something she has struggled with for some time.

“I can handle being in an elevator, but being in [the chamber] was just too much,” she said.“Even though I was told about the benefits, I was too scared.”

Not an uncommon fear among their patients, claustrophobia is something the staff at Virtua doesn’t take lightly, LaRosa said, acknowledging that in Flinn’s case the risk of amputation was such a consideration that they even broached the possibility of treatment in a multiplace chamber for space considerations.

“And there’s still some patients who just can’t do it,” he said. “We’ll engage family members into that conversation and if there’s any stalling or regression of healing, then we’d have to look at that www.todayswoundclinic.com

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The Clinic Within the Clinic Not all wound care patients experience the same maladies.

For those living with ostomies, Virtua offers additional support.

Living with a chronic wound is challenging enough, regardless of etiology.

However, those who live with wound ostomies often have additional stressors related to overall quality of life, according to the United Ostomy Associations of America Inc. At Virtua Berlin, a monthly ostomy clinic is offered for patients who’ve undergone urostomy, colostomy, or ileostomy to meet with wound ostomy-certified nurses for ongoing evaluation, care management, and emotional support.

“We’ve had it in place three years now, and each year we continue to grow,” said Kathleen Judge, ACNS-C, NEA-BC, CWOCN, MSN, wound clinic director. “It’s a much needed service in the community.”

Officials at Virtua acknowledged a need for the clinic due to more patients expressing feelings of embarrassment and fear that their ostomies may cause an uncomfortable or even emergent situation away from home.

“Patients were telling us that they hadn’t really left their homes in months or years because they couldn’t go more than a few hours without their ostomy leaking, and that they’d become isolated and depressed,” Judge said. “And it’s often something as simple as finding the right sized appliance to work for them or getting the wounds underneath the appliance to heal. They often only need one visit, and it can change their lives.

They just need that education.”

— Joe Darrah

Foot First: Jack Bondi, DPM, DABPS, treats patient Harry Hofflinger at Virtua Washington Township.

as a major necessity for limb salvage; but it’s the patient’s right to choose the type of care they want.”

However, Flinn would see enough progress that HBOT has been justifiably avoided.

“Her wounds have been healing quite progressively with the comprehensive plan of care we’ve put into place and she hasn’t stalled at all,” LaRosa said, attributing the success in large part due to the individualized education she’s received, Today’s Wound Clinic® October 2013

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facilityinfocus An Unexpected Route of Infection One MRSA patient experiences a surprising set of wound circumstances.

Harry Hofflinger had lived with diabetes for nearly 60 years before his first chronic wound developed, when a nail that he stepped on went through his shoe and punctured his foot. A small wound had formed and effectively treated by his primary provider, but months later while riding his exercise bike (a part of his daily activities to aid blood flow to his legs), Hofflinger complained of more pain in the foot and swelling in his leg. The following morning at the breakfast table with his wife Pat, the pain had intensified and his sock felt wet. A callus had formed on the bottom of his foot, just below the big toe, and had burst. An infection had begun to spread by the time he went back to the doctor. It was later revealed that the nail had remained in his shoe the entire time. At its worst, the wound had grown to 2.8 cm x 1.8 cm x 0.2 cm.

“He had developed a foot ulcer with cellulitis, a neuropathic ulceration that had grown out MRSA,” said Jack Bondi, DPM, DABPS, to whom he was referred at the Wound Healing Center at Washington Township by his primary provider.

Having received his sixth application of human fibroblast-derived dermal substitute, Hofflinger, 66, of Westfield, NJ, has had to scale back his exercise regime and use a wheelchair to assist healing, but is expected to be back in his boat fishing, his true hobby, in a matter of weeks.

“We’re seeing tremendous incremental closing, peripheral re-epithelialization of the wound,” Bondi said during a recent visit to the facility by Today’s Wound Clinic. “We’ve taught him the key is offloading because it’s neuropathic-based, and in a couple weeks he’ll be healed. But given the situation he was in he could have lost his leg with this.”

— Joe Darrah an aggressive treatment protocol, and a change to her dietary habits.

“My lifestyle now is totally different,” said Flinn. “I’m eating three meals per day — no sugar at all. Before, I was always eating cupcakes, ice cream, and candy. I was picking at snacks all day. They really taught me how to be healthy here.”

On the opposite end of the diabetes spectrum is Robert Way, 69, of Tabernacle, NJ, a patient who first arrived to the Washington Township clinic last October for recurring sores between the toes of his right foot. Diagnosed with diabetes as a child,Way has managed his health

most of his life — in a manner of speaking. A longtime consumer of red meat, he experienced a major heart attack in 2005 and went otherwise unaware of the effects of diabetes on his cardiovascular health for many years. Referred to the Berlin center for vascular care due to a lack of blood flow to the affected foot, Way would undergo debridement and bypass surgery. However, the wound would develop gangrene after hospital discharge and two toes had to be amputated. A subsequent stay in Virtua’s Berlin long-term care facility allowed him to easily coordinate the more than 50 hyperbaric treatments he’s required.

At the time of TWC’s visit to the Washington Township campus, Way and his wife Alberta had been counseled by the CDE and negative pressure therapy had been initiated in the clinic and in his home. Had he not been referred to the clinic, he likely would have needed a second lower extremity amputation (he lost his left leg after developing a heel ulcer in 2007).

“All the red flags went up for him when he came in, but he’s very committed to staying healthy and that’s when you tend to see a difference with patients,” Judge said. “Not every patient can get through the extent of hyperbaric therapy he’s had, but the wound has made significant progress and we’re continuing to granulate healthy tissue and advanced wound care until we get it to close. It’s really been a collaborative effort with this wound.”

It’s collaboration predicated on building relationships with appropriate staff members at the onset of care.

“During the initial phone screening for each patient, they’re scheduled with either a podiatric physician or a vascular physician depending on the locality of the wound,” Bondi explained.

“We strive to keep continuity of care, so when patients return for each follow up they’re going to be assigned to the same physician and, for the most part, the same nurse. From a practical standpoint, that’s what’s best for benchmarking the progress of each wound and helping patients form a relationship with our staff.”

This approach has not just led to improved healing rates, it’s also turned patients’ wound care experience into an uplifting event, Judge added.

“Their treatments actually become something they look forward to because many of these patients have become accustomed to not seeing a lot of success with their wounds. It’s just a very positive interaction for everybody.” n Joe Darrah is managing editor of Today’s Wound Clinic.

PHOTO SLIDESHOW: VIRTUA WOUND HEALING CENTERS For a comprehensive selection of patient photos and other images collected during TWC’s visit to Virtua, go to www.todayswoundclinic.com.

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industryinsider An Inside Look at Novadaq Technologies Inc.

T

oday’s Wound Clinic speaks with Arun Menawat, PhD, MBA, president and chief executive officer.

Arun Menawat, PhD, MBA, president and chief executive officer

Today’s Wound Clinic (TWC): How long have you been in wound care, and how did you enter this area of healthcare?

Arun Menawat (AM): Novadaq entered into wound care based on common elements between optimal wound healing and optimal outcomes of complex surgeries, which were the first applications for our core SPY ® Imaging. It was also beneficial that many of the surgeons who have used SPY in other applications, such as plastic reconstruction and cardiovascular surgeries, recommended and encouraged Novadaq to develop a system for wound care. Many of these same surgeons are part of the team caring for patients with chronic, nonhealing wounds. SPY Imaging for wound care, which is marketed under the brand name LUNA, ™ enables visualization of physiologic blood flow in vessels and tissue perfusion.

Adequate blood supply to tissue is critical to healing and, therefore, the ability to distinguish between wellperfused and poorly perfused tissue allows wound care specialists to make treatment decisions that can impact healing and assist patients in returning to activities of daily living. www.todayswoundclinic.com

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TWC: What’s your day-to-day role?

AM: Our vision is clear; we are about providing clinically relevant imaging to wound care specialists and various surgical specialties. Most importantly, I ensure that we have the resources to achieve this goal and deliver on the promises of value we provide to each of our stakeholders.

As the healthcare market evolves, I assure that we as a company also continue to evolve and grow. For example, in 2005,

“I cannot imagine anything more rewarding than to have the knowledge that through the use of our products, physicians and hospitals provide the highest quality care.” following our first clearance by the Food and Drug Administration for our SPY Imaging for use in cardiac surgery, our vision was to put imaging in the hands of surgeons performing open surgery procedures in the operating room (OR).Today, our vision goes substantially beyond open surgery, as we now have products that address the needs of clinicians per-

forming a variety of procedures in open surgery and outpatient wound care clinics and laparoscopic and robotic surgical suites. Our value proposition across these broad markets is the same. The use of Novadaq’s imaging technologies leads to improved patient outcomes, reduced rates of complications, and, consequently, lower healthcare costs.

TWC: What do you find most rewarding about providing for your industry?

AM: A surgeon once told me that an average complications rate in certain surgeries is 10 percent, and that he finds that unacceptable. We were discussing life-threatening diseases and surgeries associated with those diseases. I cannot imagine anything more rewarding than to have the knowledge that through the use of our products, physicians and hospitals provide the highest quality care and, as a result, patients benefit in terms of faster recoveries, shorter hospitals stays, fewer clinic visits, and lower rates of readmission and returns to the OR. It is very gratifying to report that more than 75 peer-reviewed publications demonstrate that the use of Novadaq’s imaging technologies leads to fewer postoperative complications, lower hospital costs and, in many cases, life saving.

TWC: How would you describe the overall mission of your company?

AM: Our global mission is to enable the broad community of medical professionals with clinically relevant, innovative imaging solutions to enhance their lives and the lives of their patients while reducing healthcare costs.

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industryinsider TWC: What’s new with your company in 2013?

AM: This year has been a really busy, banner year for us. First, we launched our LUNA fluorescence angiography system at the Diabetic Foot Global Conference in March and quickly followed up with outstanding reception at the Symposium on Advanced Wound Care (SAWC) Spring/WHS. Most recently, we met with more than 125 wound care specialists at the SAWC Fall in LasVegas.

In addition to the launch of LUNA, we fully launched our PINPOINT® endoscopic fluorescence imaging system at the Society of American Gastrointestinal and Endoscopic Surgeons meeting in April and completed a clinical study of its use in 150 patients undergoing high-risk colorectal resection. Final results of the study will be published in the near future.

In September, we completed the acquisition of a scintigraphy imaging system that we will develop for use by surgeons during operations to treat cancer. Identification and removal of tumor margins and cancerous lymph nodes is critical for surgical success. On top of all this, we really pushed our global agenda in 2013 and I am happy to report that we are successfully driving our products into markets outside the US.To support all of this activity, we have continued to grow our direct sales and marketing teams and other internal resources, and have nearly doubled the number of employees we had at this time last year.

TWC: How is your company unique?

AM: We believe we have created a market that we call “imaging for surgeons.” Interestingly, with the introduction of our technology into wound care, we are expanding the market to “point-of-care imaging.” Additionally, our business model of partnering with market-leading companies to drive adoption of our imaging technology in certain specialty markets such as robotics and breast-reconstruction surgery, while building our own commercial infrastructure to serve the wound care and laparoscopic surgery markets, is unique and is the cornerstone of our corporate strategy for growth.

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TWC: Why are you passionate about the work of your company?

AM: I am passionate about the Novadaq team and the medical professionals I work with. Their intelligence and dedication to improving healthcare is so

“We believe we have created a market that we call ‘imaging for surgeons.’”

admirable that it makes it easy to be passionate about spending my day working with them. It is also truly about the patients. I know of few people other than me and my team who will look back one day and know they changed the practice of medicine in a very positive way.

TWC: How is your company approaching challenges in wound care?

AM: Knowing that patients living with chronic wounds experience a long and arduous path toward healing, it is gratifying to hear that by seeing LUNA images, patients are more likely to comply with treatment. In addition, unlike other tests available in wound care that may be impossible to perform in certain populations due to diseases such as atherosclerosis, LUNA is ideal for use in nearly all patients. We are also keenly aware of the financial challenges that often prevent wound care clinics from acquiring new technologies.To help overcome the burden of acquiring LUNA, our team worked with the Centers for Medicare & Medicaid Services to help establish outpatient code and payment for LUNA procedures that were effective at the time of product launch.

TWC: What are your most popular products and/or services?

AM: Today, there are more than 1,000 SPY Imaging — either SPY Elite,® PINPOINT, Firefly (which is our product integrated into the da Vinci robot) or LUNA — installed in US hospitals alone. As papers become published and the benefits message spreads from clinician to clinician, procedural usage of our systems continues to grow. In 2013, we increased our focus on markets outside the US, where the reception for our products has been welcoming.

TWC: How do you ensure proper training on products and services?

AM: We spend ample time and resources providing comprehensive medical team training and educational programs. In today’s environment, and in the best interest of our customers and ourselves, we take special care to ensure our training efforts are measured against our strict code of ethics. On the wound care side of our business, we partner with experienced physicians and wound care professionals to provide peer-to-peer team preceptor training in our centers of excellence. We also employ a team of highly experienced senior registered nurses to support our training and education initiatives. Recently, we have partnered with outside continuing medical education (CME) providers to offer programs that support our customer’s CME requirements.

TWC: What are the future goals for you and your company?

AM: We will continue to drive the development of new and improved products and programs to meet the needs of our customers and their patients.As 2014 approaches, we are focused on initiatives surrounding the electronic medical record.We are also focused on introducing our technologies into woman’s health medicine such as imaging to improve the detection of endometriotic lesions and cancerous tumor margins in lumpectomy breast surgery for cancer. And, certainly not last and definitely not least, we will continue to focus on expanding into other applications that are related to wound care, such as interventional vascular procedures and endovascular surgery. I believe the future is a bright one for Novadaq. n www.todayswoundclinic.com

10/18/13 1:09 PM

TWCnewsupdate Devon Medical Announces Global Availability of NPWT Dressing Officials at Devon Medical Inc., a medical device manufacturer based in King of Prussia, PA, have announced the worldwide availability of the company’s negative pressure wound therapy (NPWT) dressing for treatment of nonhealing wounds on the toes and forefoot.

The dressing kit comprises a spoonshaped nonwoven dressing pad, a transparent polyurethane skin drape, an adhesive polyurethane suction bell with connection tubing, a silicone gel strip pack, and four nonwoven dressings for use between the toes. Caregivers may use antifungal ointment or powder between the toes and petroleum jelly or ointment on the toenails to prevent them from adhering to the skin drape, officials said.

“We expect our new foot dressing to revolutionize the way caregivers succeed in using negative pressure technology in this anatomical area of the body and hope to give more patients access to the wound

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healing benefits that NPWT provides,” said Chip Ross, president of Devon Medical. “Caring for wounds on the toes and areas of the feet with negative pressure has traditionally been very difficult, with the challenges being the formation and keeping of a seal throughout treatment as well as skin maceration.” n

Joslin Diabetes Center, J&J Form Alliance

Joslin Diabetes Center, Boston, MA, has entered into a partnership with Johnson & Johnson, New Brunswick, NJ, and its affiliate Janssen Research & Development LLC, Cranbury Township, NJ, to identify and advance early-stage, novel therapeutic projects with potential for commercialization and product development to treat diabetes. The first joint project selected in the alliance will reportedly focus on identifying exercise-related drug targets for developing new diabetes treatments.

“Joslin is uniquely positioned to translate findings in the laboratory into new approaches for treatment of diabetes, and

our alliance with Johnson & Johnson Innovation and Janssen Research & Development is an excellent example of how we can move our early discoveries to the clinic with our complementary capabilities,” said Nandan Padukone, PhD, MBA, vice president of commercialization and ventures at Joslin. “We will continue to explore other technologies with Johnson & Johnson Innovation and mechanisms such as venture creation to advance them quickly towards drug development.”

The new alliance is based on pioneering studies by Joslin researchers showing that exercise can train multiple tissues in the body that in turn stimulate metabolic improvements in other tissues.

“The concept of tissue-to-tissue communication has been around for a while, but more recently we have realized that ‘trained’ tissues may communicate to beneficially affect other tissues,” said Laurie Goodyear, PhD, co-head of the Integrative Physiology and Metabolism Section at Joslin and senior investigator on this research presented earlier this year at the American Diabetes Association’s 73rd annual Scientific Sessions. n

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READER SURVEY RESULTS: WORKING WITH WOUND CARE INTERVENTIONISTS In our June/July 2013 issue, Today’s Wound Clinic promoted a survey that was sent out to readers via email regarding their referral habits as they relate to wound care interventionists. Here are the results for the nearly 160 participants.

Survey Stat No. 1: Do you work in a wound clinic?

Survey Stat No. 2: As a wound care provider, do you refer patients with suspected severe PAD or peripheral vascular occlusion to an interventionist?

No 7.8%

No 34%

Yes 66%

Survey Stat No. 3: If your answer to question 2 is “no,” to whom would you consider referring a patient with severe PAD or severe vascular occlusion?

Count

30

Response

4

Vascular surgeon.

1

I am a vascular and endovascular surgeon.

1

I work up the patient and operate on them.

1

Vascular surgeon first, then they refer on to interventionalist when needed.

1

Interventional radiologist, cardiovascular surgeon.

1

Interventionalist.

1

To PCP to refer to specialist or testing.

1

We have to request that the referring MD make that referral as we are PTs and have no MD in our office. We do make sure the referral is made when appropriate.

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Yes 92.2%

Survey Stat No. 4: Have you referred such patients to any of these specialists? (Can choose more than one.)

100

98%

75 49%

50

44.1%

25

0

Vascular Surgeon

Interventional Cardiologist

Interventional Radiologist

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infectionprevention Survey Stat No. 5: Have your patient referrals to an interventionist increased over the past 5 years?

Survey Stat No. 6: How would you describe your referral relationship with your selected interventionist? (Can choose more than one.)

100

75

Yes 84.5%

53.9%

No 15.5%

50

46.2%

25

14.4% 2.9%

0

Streamlined Irregular

7.7%

1.9%

Confusing Effective

Non Existent

In Need of Change

ONLINE EXCLUSIVE: WORKING WITH WOUND CARE INTERVENTIONISTS - FULL RESULTS To view the remainder of our survey results, visit our website.

Go to www.todayswoundclinic.com.

Classified

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Advertiser’s Index ABWM Foundation (Prep Course)...........................................................................................29 Derma Sciences (TCC-EZ)............................................................................................. Cover 2 Medela (Invia)............................................................................................................................3 MiMedx (Webinar)...................................................................................................................21 Net Health (WoundExpert)............................................................................................. Cover 3 Organogenesis (Apligraf)......................................................................................... Cover 4, 32 Sechrist Industries (HBOT Chambers)............................................................................... 16-17

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

Please see complete prescribing information at www.Apligraf.com © 2013 Organogenesis Inc. OI-A1112 All rights reserved. Printed in U.S.A. 4/13 Apligraf is a registered trademark of Novartis.

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