January February 2014

Page 1

, LLC

an HMP Communications Holdings Company

TODAY’S

®

Contemporary Approaches to Wound Clinic Management

OPENING YOUR

WOUND CLINIC:

CHAPTER 1

THE OUTPATIENT CENTER DEFINED TRAINING STAFF & MARKETING YOUR SERVICES

ALSO IN THIS ISSUE: Autologous Skin Business Briefs SAWCSPRING January/February 2014 www.todayswoundclinic.com

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the symposium on advanced wound care

www.sawcspring.com

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TODAY’S

®

Volume 8, Number 1, January/February 2014 • www.todayswoundclinic.com

Table of Contents • Feature Articles 9

12

Determining the Validity of Your Outpatient Wound Center

Preparing Your Staff for Wound Clinic Launch: Comprehensive Education & Training

So, you’re planning to open an outpatient wound clinic? Are you sure your clinic meets the appropriate criteria to open its doors? This article will help you assess just how “ready” your facility really is and needs to be.

Effectiveness and competence of the wound clinic are a direct result of the effectiveness and competence of one’s staff. Here’s what needs to be known at Day 1. Valerie Sullivan, PT, MS, CWS

Caroline Fife, MD, FAAFP, CWS & Toni Turner, RCP, CHT, CWS

16

20

Effectively Marketing The Hospital-Based Wound Care Center

Getting Your Wound Clinic Ready for Business: A Comprehensive Checklist

Are you getting the word out on your wound care center appropriately? Doing so could determine the success of your new wound clinic. Christopher A. Morrison, MD, FACHM, FCCWS & Jessica Taft

This comprehensive checklist will assist any wound clinic on the horizon by providing a generalized rundown of items that should be considered from documentation coding to fire codes. Compilation of resources from industry experts

24

28

Achieving Efficient Wound Closure With Autologous Skin

ICD-10-CM Diagnosis Coding Documentation Tips For Current Burns/Corrosions

Recent advancements in a wound care method that has roots running a century deep is proof that pathways to wound closure will continue to evolve. David J. Smith, Jr., MD, FACS

In the third installment of our special column on ICD-10-CM implementation, we provide tips for the category T20-T25, current burns/corrosions. Donna J. 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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EDITORIAL STAFF

TODAY’S

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

®

Volume 8, Number 1, January/February 2014 • www.todayswoundclinic.com

MANAGING EDITOR Joe Darrah jdarrah@hmpcommunications.com

Table of Contents

WEB EDITOR Samantha Alleman salleman@hmpcommunications.com

BUSINESS STAFF

Departments 4

6

30

EXECUTIVE VICE PRESIDENT Peter Norris pnorris@hmpcommunications.com

In Memoriam: Jeffrey Unger Pamela G. Unger, PT, CWS, FCCWS

VP/GROUP PUBLISHER Jeremy Bowden jbowden@hmpcommunications.com

Business Briefs

PUBLISHER Kristen J. Membrino kmembrino@hmpcommunications.com

HOPD Payment Changes Continue in 2014 Kathleen D. Schaum, MS

SALES ASSOCIATE Brian Hill bhill@hmpcommunications.com CLASSIFIED SALES ASSOCIATE Michael Deleo mdeleo@hmpcommunications.com

Facility in Focus

Desert Springs Hospital Medical Center, Las Vegas Joe Darrah

36

TWC News Update

Rural Wound Care Event Coming to Louisiana; Innovative Wound Imaging Debuts in Outpatient Clinics

40

Advertiser’s Index

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

HMP COMMUNICATIONS, LLC PRESIDENT Bill Norton VICE PRESIDENT, SPECIAL PROJECTS Jeff Hall CREATIVE DIRECTOR Vic Geanopulos vgeanopulos@hmpcommunications.com ART DIRECTOR Karen Copestakes kcopestakes@hmpcommunications.com PRODUCTION MANAGER Elizabeth Vasil evasil@hmpcommunications.com

TWC Online

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

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Follow us on Twitter: @TWCjournal

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

Online Exclusive: Facility In Focus Photo Slideshow: Desert Springs Hospital Medical Center Get a look at all the photos we took during our recent visit to the facility in Sin City. Visit the Supplements and Special Projects section at www.todayswoundclinic.com.

HMP COMMUNICATIONS HOLDINGS, LLC CHAIRMAN & CHIEF EXECUTIVE OFFICER Jeff Hennessy CHIEF FINANCIAL OFFICER Dan Rice SENIOR VICE PRESIDENT Anthony Mancini

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

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CONTROLLER Meredith Cymbor-Jones DIRECTOR OF E-MEDIA AND TECHNOLOGY Tim Shaw SENIOR DIRECTOR OF MARKETING Corey Krejcik SR. MANAGER, IT Ken Roberts

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inmemoriam: Jeffrey Unger

J

effrey (Jeff) Unger was born in West Reading, PA, April 19, 1952. He married Pamela Fenstermacher Unger in April of 1977. His sudden and unexpected passing this past fall shocked an entire community. But his fond memories continue to be cherished. If you will indulge me for a few moments. I met Jeff nearly 40 years ago. He was the most understanding Pamela G. Unger, PT, CWS, FCCWS, and Jeffrey Unger individual and had no expectawith grandchildren Madeline Anne (left) and Sophia Jane. tions of our friendship. My primary goal in life at that time was to complete my education and launch my career. He managed to capture my heart and convince me that marriage and children would not dampen my goal to be successful as a physical therapist. This man was as honest and caring as anyone I know. While I’ve always considered myself to be a very strong woman, this man grounded me on a daily basis — he was my rock. We raised two very compassionate and successful children (Stephanie, companion of Carlos Vasquez, and Jeremy, husband of Caitlin) and have two granddaughters (Sophia Jane and Madeline Anne) who were the love of his life. A few of you within my professional family have had the opportunity to meet him. I was happy to share the genuine love we have shared for all these years. Jeff lived in Kutztown, PA, most of his life. While he attended Hiram Scott College in Nebraska and Kutztown University, he chose to forgo his college education and become a professional photographer. Living in a small community, he did all kinds of photography: portraits, weddings, sports, and public relations. He was most proud of his sports photography, having photographed National Football League players Andre Reed, Bruce Harper, Doug Dennison, and John Mobley, all of whom played football at Kutztown University. Secondly was his PR work, having photographed President Clinton, Barbara Bush, both President George H.W. and George W. Bush, Margaret Thatcher, Colin Powell, and Michael Eisner (to name a few). He started each day trying to make someone’s life happier by telling jokes and using humor to draw out that special smile. As his photography business began to transform, he filled his days with handiwork. Not only was he a talented photographer but an excellent carpenter. The past few years he cherished the moments when he could spend hours photographing his granddaughters. Jeff loved life and lived it to the fullest. When he was at home there was always a dog at his side, all of which absolutely needed us to rescue them. At one time we had two Old English sheepdogs and a shepherd mix. His love for dogs led him to research training; he was absolutely brilliant at training family dogs. He had just finished training Ziva, our newest puppy, a Bernese mountain dog, at the time of his death. Jeff took his humor to the golf course and the ski slope, his two favorite pastimes. (This man convinced 16-20 grown men to be judged on their attire each day prior to heading out to golf on their annual golf trip, scoring points daily for awards at weeks end.) He was also known to spread his Christmas cheer to all the town merchants and door-to-door delivery personnel to brighten their day during the hectic holiday season. The happiness and love he shared with others always went to his family first. One last thought, please remember to tell or reach out to those you love frequently. Life is a gift to be lived to the fullest. Jeff and I did live and enjoy life! n Pamela G. Unger, PT, CWS, FCCWS, is a member of the TWC editorial board

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January/February 2014 Today’s Wound Clinic®

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TODAY’S

®

EDITORIAL BOARD FOUNDING EDITORIAL BOARD MEMBER & EDITOR OF TODAY’S WOUND CLINIC Caroline Fife, MD, FAAFP, CWS FOUNDING EDITORIAL BOARD MEMBERS Dot Weir, RN, CWON, CWS Christopher A. Morrison, MD, FACHM, FCCWS Valerie Sullivan, PT, MS, CWS Kathleen D. Schaum, MS EDITORIAL BOARD MEMBERS Leah Amir, MS, MHA Desmond Bell, DPM, CWS Donna J. Cartwright, MPA, RHA, CCS, RAC, FAHIMA Moira Hayes, MHA, RRT, CHT Cathy Thomas Hess, BSN, RN, CWOCN Harriet Jones, MD, BSN, FAPWCA Trisha Markowitz, MSN, MBA-HCM, RN, CWCN, DAPWCA Pamela Scarborough, PT, DPT, MS, CDE, CWS Susie Seaman, NP, MSN, CWOCN Tere Sigler, PT, CWS, CLT-LANA Pamela G. Unger, PT, CWS, FCCWS Randall Wolcott, MD, CWS EMERITUS EDITORIAL BOARD MEMBERS Andrew J. Applewhite, MD, CWS, UHM Robert S. Kirsner, MD, PhD

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

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2/11/14 10:25 AM


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businessbriefs HOPD Payment Changes Continue in 2014 Kathleen D. Schaum, MS

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

O

ur November/December 2013 Business Briefs column introduced hospital-based outpatient wound care departments (HOPDs) to “packaged” Medicare payments. Let’s review a few of the packaged items that we discussed in that column and then discuss some additional packaged items as well as some revised Medicare Ambulatory Payment Classification (APC) payments.

Packaged Add-On Debridement Codes Prior to 2014, add-on codes typically received separate payment based on APC assignment. Because add-on codes represent an extension or continuation of a primary procedure, they are typically supportive, dependent, or adjunctive to a primary surgical procedure. Effective Jan. 1, the Centers for Medicare & Medicaid Services (CMS) announced they are unconditionally packaging all procedures described by add-on codes in the Outpatient Prospective Payment System (OPPS) with the exception of add-on codes from drug-administration services and 2014 add-on codes assigned to device-dependent APCs. The charts in the November/December column depict that, due to packaging of the add-on debridement codes, CMS allows the same APC payment rate for the debridement of a 120 sq cm wound as is allowed for debridement of a 10 sq 6

cm wound. Many readers asked if they should still report the add-on codes.The answer is “yes.” Medicare’s Claims Processing Manual states:“Therefore, it is extremely important that hospitals report all Healthcare Common Procedure Coding System (HCPCS) codes consistent with their descriptors; Current Procedural Terminology and/or CMS instructions and correct coding principles, and all charges for all services they furnish, whether payment for the services is made separately or is packaged.” Therefore, the HOPD should report the appropriate surgical or medical debridement base code for the first 20 sq cm debrided. If more than 20 sq cm is debrided, the HOPD should still report the appropriate add-on code(s) based on the total wound surface debrided. The HOPD will not be double paid by CMS because the Medicare Administrative Contractor (MAC) who processes claims has been informed never to pay for add-on codes. NOTE: CMS still allows payment for both the base code and appropriate add-on codes to qualified healthcare professionals (QHPs) who perform surgical or medical debridement. Packaging of add-on codes does not apply to QHPs.

Packaged Add-On Codes for Application of Cellular and/or TissueBased Products for Wounds (CTPs) [Old Term “Skin Substitutes”] The charts in the November/December column also depict that CMS packaged the add-on codes into the base codes for the application of CTPs. CMS does not always allow a higher APC payment for application of CTPs to larger wound surface areas. In fact,CMS allows the same APC payment for this work performed, regardless of wound surface area, on anatomic locations such as

January/February 2014 Today’s Wound Clinic®

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the foot. For the anatomic locations such as the leg, CMS allows 1 APC payment rate for wounds up to 100 sq cm and a higher APC payment rate for wounds ≥ 100 sq cm.

Packaged CTPs In addition to packaging the add-on codes for the application of CTPs, CMS is now packaging the payment for the products into the APC payment for the procedure based upon CMS’ designation of each product as either a “high cost” or a “low cost” product. As described previously, HOPDs should still report the appropriate add-on code(s) based on the total size of wound surface that received the application of the CTP. In addition, HOPDs should still report the “Q” code assigned to the product that was applied and should still report the number of sq cm applied, the appropriate charge, and any required modifiers. NOTE: This packaging of application of CTP add-on codes does not apply to QHPs. In addition, the packaging of the product in the application codes does not apply to QHPs who purchase CTPs and apply them in their offices. CMS still allows payment for both the base code and appropriate add-on codes to QHPs who apply CTPs. If the QHP purchases the CTP and applies it in his/her office, CMS still allows payment for the application and payment for the product if the product is covered by the MAC. Packaging of add-on codes and CTPs does not apply to QHPs.

Packaged Clinical Diagnostic Laboratory Tests Let’s now discuss CMS decision to package payment for clinical diagnostic laboratory tests. Since the launch of OPPS, CMS has excluded clinical diagnostic laboratory tests from the OPPS. Therefore, laboratory tests provided in www.todayswoundclinic.com

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businessbriefs TABLE 1. Comparison of 2013 vs. 2014 National Average Medicare APC Allowable Rates for Clinic Visits 2013 HCPCS Code

2013 APC Group

2013 Allowable Rate

2014 HCPCS Code

2014 APC Group

2014 Allowable Rate

99201

0604

$56.77

G0463

0634

$92.53

99202

0605

$73.68

99203

0606

$96.96

99204

0607

$128.48

99205

0608

$175.79

99211

0604

$56.77

99212

0605

$73.68

99213

0605

$73.68

99214

0606

$96.96

99215

0607

$128.48

HOPDs were paid separately at Clinical Laboratory Fee Schedule rates. Effective Jan. 1, CMS changed this policy when it was concluded that laboratory tests (other than molecular pathology tests) should be packaged when they are integral, ancillary, supportive, dependent, or adjunctive to a primary service or services provided in the hospital outpatient setting (ie,when they are provided on the same date of service as the primary service and when they are ordered by the same practitioner who ordered the primary service). A laboratory test will not be packaged when the test is: 1. the only service provided to the Medicare beneficiary on that date of service, OR 2. conducted on the same date of service as the primary service but is ordered for a different purpose than the primary service by a practitioner different than the practitioner who ordered the primary service. This may or may not be a common occurrence in your HOPD. One laboratory test that this author often sees ordered and performed in HOPDs is glucose blood tests (82962). Like the other CMS packaged procedures/products, HOPDs should continue coding for the packaged laboratory tests.You may view the laboratory test codes that are packaged in Addendum P of the 2014 OPPS Final Rule: www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/ HospitalOutpatientPPS/HospitalOutpatient-Regulations-and-NoticesItems/CMS-1601-FC-.html www.todayswoundclinic.com

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Clinic Visits – 1 OPPS Payment Now, let’s discuss how CMS implemented a similar payment change for HOPD clinic visits. Prior to 2014, HOPDs were required to use the 5 “new patient” clinic visit codes (9920199205) and the 5 “established patient” clinic visit codes (99211-99215). Each HOPD was required to develop a resource-based mapping system that converted resources consumed into a single “new patient” or “established patient” clinic visit code. In addition, each HOPD was required to write a policy and procedure that could be used to educate existing staff, new employees, auditors, etc. on how to use their unique clinic visit mapping system. It should not surprise anyone that 2014 is the year that CMS has decided to change the way payment is made for HOPD clinic visits. CMS eliminated the APC allowable payment rates for the 10 “new patient” and “established patient” clinic visit codes. Instead, CMS will allow only 1 APC payment rate for HOPD clinic visits.To accomplish this, CMS created a new HCPCS code (G0463 Hospital outpatient clinic visit for assessment and management of a patient) for HOPDs to use to report clinic visits to CMS. In addition, CMS has ceased recognizing a distinction of “new patient” and “established patient” clinic visits. See Table 1 above for a comparison of the 2013 APC allowable clinic visit rates versus the 2014 APC allowable payment rate for G0463. Now, you are probably wondering if you should keep your clinic visit mapping

system. Because HOPDs will most likely need to continue reporting the 9920199205 and 99211-99215 clinic visit codes to non-Medicare payers, this author suspects most HOPDs will continue using their clinic visit mapping system. Then they will most likely set up their coding and billing system by: 1. Entering into their charging system either G0463 for Medicare-covered patients or 99201-99205/9921199215 for non-Medicare-covered patients, OR 2. Entering into their charging system 99201-99205/99211-99215 for all patients.The billing system will then convert Medicare-covered patients to G0463. HOPDs should have a meeting with their hospital’s charge description master (CDM), coding staff, and billing personnel to determine the clinic visit coding and billing system that will work best for their facilities. NOTE: QHPs still use 99201-99205 and 99211-99215 to code for their evaluation and management services performed in HOPDs. The G0463 HCPCS code does not pertain to QHPs.

Noninvasive Vascular Diagnostic Studies APC Payment Many HOPDs have inquired whether noninvasive vascular diagnostic studies have been packaged for Medicare payment. The answer is “no.” CMS still pays HOPDs separately for both single-level (93922) and multiple-level (93923) vascular diagnostic studies. In fact, the 2014

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businessbriefs APC payment rate increased for both studies. See Table 2 at right.

TABLE 2. Comparison of 2013 vs. 2014 National Average Medicare APC Allowable Rates for Clinic Visits

Non-Ophthalmic Fluorescent Vascular Angiography APC Payment

HCPCS Code

APC Group

2013 Allowable Rate

2014 Allowable Rate

93922

0097

$66.52

$70.18

93923

0096

$108.61

$131.06

Finally, let’s look at the changes for non-ophthalmic fluorescent vascular angiography when it is used by QHPs who work in HOPDs. As we discussed in the June/July 2013 Business Briefs column, CMS established (in April 2012) a temporary pass-through code (C9733) for the procedure. CMS originally assigned the new pass-through code to APC group 0397. Effective Jan. 1, CMS discontinued APC Group 0397 and reassigned C9733 to APC Group 0263. Therefore, C9733 continues to be separately payable by CMS when the procedure is deemed medically necessary. Please note that CMS assigned the “Q2” status indicator to APC group 0263.The “Q2” status indicator means that no separate payment is provided when C9733 is billed with other procedures that are

TABLE 3. Comparison of 2013 vs. 2014 National Average Medicare APC Allowable Rate for Non-Ophthalmic Fluorescent Vascular Angiography HCPCS Code

2013 APC Group

2013 Allowable Rate

2014 APC Group

2014 Allowable Rate

C9733

0397

$330.97

0263

$317.91

assigned a “T” status indicator. See Table 3 above.

SUMMARY HOPD program directors, CDM directors, coders, and billers should be communicating and cooperating to make the appropriate coding and charging changes in their paper and/ or electronic systems. Once the changes

are made, HOPDs should confirm that the changes are working correctly by processing test claims. 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.

Clarification: There were omissions related to Table 2 from the Nov/Dec column Business Briefs. For the updated table, please visit www.todayswoundclinic.com.

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DETERMINING THE VALIDITY OF YOUR

OUTPATIENT

WOUND CENTER So, you’re planning to open an outpatient wound clinic? Are you sure your clinic meets the appropriate criteria to open its doors? Read on to determine just how “ready” your facility needs to be. Caroline Fife, MD, FAAFP, CWS & Toni Turner, RCP, CHT, CWS

www.todayswoundclinic.com

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Today’s Wound Clinic® January/February 2014

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2/11/14 10:22 AM


openingyourwoundclinic

O

n April 7, 2000, the Centers for Medicare and Medicaid Services (CMS) (then named the Healthcare Financing Administration) issued requirements for provider-based departments and entities as part of the final rule that implemented the Prospective Payment System for Outpatient Hospital Services (OPPS). From the payment perspective, “provider based” means the entity is considered part of the hospital and services furnished within that entity may be billed as “hospital services.” Historically, this meant the provider-based unit could appear on the hospital’s cost report and receive an allocation of the hospital’s overhead costs. Wound care and hyperbaric medicine are examples of the types of services that are commonly found in a provider-based setting. What was the CMS goal with this rule? The OPPS was established to fund a variety of outpatient services that were previously available only during an inpatient stay. The goal of the program was to allow patients who were not sick enough to warrant hospital admission the opportunity to receive complex services as hospital outpatients. Just like the inpatient setting, patients in the hospital-based outpatient department (HOPD) accrue charges for both the physician service and the “facility” (hospital). As a result, the cost of care for patients seen in an HOPD is typically higher than if they were seen in a private physician’s office. Although these additional costs normally exceed those of services provided in a doctor’s office, the goal of CMS was to reduce overall beneficiary costs by limiting or preventing an even more costly inpatient stay. To be covered in an HOPD, Medicare beneficiaries must pass the test of “medical necessity,” meaning they must require a higher level of care than can be delivered in a doctor’s office. A future issue of Today’s Wound Clinic will discuss the issue of medical necessity for wound center services in more detail. This article is intended to help clinicians who are launching an outpatient wound clinic assess whether or not their clinic can function properly as an out10

patient center from Day 1. (For an assistive reference to help guide the wound clinic director through the maze of wound clinic competence, see our Getting Ready Checklist in this issue on page 20.)

DEFINING “HOSPITAL PROVIDERBASED OUTPATIENT CENTER”

What constitutes a provider-based outpatient wound center? Does it have to do with physical location, staffing, or only the way services are billed? Some wound centers are physically located within hospital walls and some are located in office settings. This topic is actu-

A facility is not simply entitled to be treated as provider-based. ally very complex, but we will mention a few important points: Only licensed hospitals can provide services under the provider-based rules. CMS reimburses hospitals for outpatient therapeutic services only if those services are furnished in the hospital or a department of a hospital that has provider-based status in relation to the hospital. [Federal Register: 42C.F.R. § 413.27(a)(1)(iii)] The “entities” (let’s call them wound centers) eligible for payment under OPPS are those that bill for outpatient services using the CMS 1450 form (UB04). Thus, therapeutic services — as opposed to diagnostic services — may not be furnished under arrangements in a nonhospital setting and billed by the hospital as outpatient hospital services. Wound centers can be either “on campus” or “off campus” with regard to the hospital. “On campus” is defined as the physical area immediately adjacent to the provider’s main buildings; other areas and structures that are not strictly

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contiguous to the main buildings but are located within 250 yards of the main buildings; and any other areas determined to be part of the provider’s campus on an individual basis by the CMS regional office. To meet provider-based criteria in an “off-campus” setting, the location of the facility or entity/clinic must be located within a 35-mile radius of the campus of the hospital or critical access hospital that is the potential main provider. A facility or organization is not entitled to be treated as provider-based simply because it believes it is providerbased. A formal process is available to providers who wish to attest to provider-based status and receive an official determination from Medicare that the outpatient clinic meets the necessary criteria to bill as such. However, currently, attestation is optional and many hospitals have not submitted an attestation. If a provider does not submit an attestation and it is later determined by Medicare that the provider was not eligible for provider-based billing, a recoupment of past payments may be required. CMS may allow a facility a period of time to come into compliance with any deficiencies, entirely at CMS discretion.

CONSIDERING COMPLIANCE

All hospital staff members working in the wound center provide services under the direct supervision of an advanced practitioner (AP) (ie, physician, podiatrist, or nurse practitioner). The practitioner can be employed by the hospital or in private practice. This topic is a complex one. Providing a few examples of misconceptions can help: There have been cases in which providers’ alleged failures to satisfy provider-based criteria have given rise to charges via the False Claims Act. What does that mean? If there is no AP directly supervising at all times in the wound center, no services can be provided by anyone. The concept of a “nurse only” visit may be viable for some services, such as changing a negative pressure www.todayswoundclinic.com

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openingyourwoundclinic wound dressing, but the AP still has to be immediately available to on-campus clinics and physically inside the building for off-campus clinics at all times, even if he or she did not see the patient. In other words, if there is no AP who can immediately step in and take over, then no services can be provided. Unfortunately, Medicare used the words “incident to” in two different situations, and this has caused great confusion with regard to physician billing and supervision. Within OPPS in the wound center environment, “incident to care” rules mean the patient care has to be conducted under direct supervision of an AP. However, this is different than the “incident to payment” rule in private practice for the physician, which is part of Medicare Part B regulations. When a physician employs a staff member in his/her own office under the Part B payment rules, he/she can bill for services provided by staff as if the physician performed the service. It is important not to confuse the “incident to care” rules of OPPS with the “incident to payment” rules of Medicare Part B. It has come to CMS officials’ attention that there is a high volume of hospitals billing provider-based services. However, these hospitals may not all be compliant with the requirements already described. Since there is a high risk of noncompliance, CMS intends to scrutinize facilities more closely in the future through audits. (For more information on auditing, refer to TWC Vol. 6 No. 6.) The recently released changes to OPPS rules proposed a unique modifier to be reported on off-campus provider-based claims, but was not implemented due to the fact that hospitals have such difficulty appending modifiers of any kind on their claims. CMS is evaluating other options such as the development of a new revenue code or place-of-service code that will be unique to the provider-based status. The take-home message: Facilities must be compliant with provider-based rules. www.todayswoundclinic.com

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The physician’s place of service (POS) must be reported as POS 22 (hospital outpatient). Medicare reduces the physician’s payment rate in this setting in consideration of the fact that he or she does not have to pay overhead or nursing salaries when practicing within the hospital setting. If physicians fail to report the POS correctly, this is considered an overpayment by Medicare. There have been cases of wound center-based physicians having to repay substantial sums to CMS as a result of incorrect POS designation. It is important to know that physicians who work in HOPDs do not have

The take-home message: Be compliant with provider-based rules. to “rent” space, or otherwise pay overhead to the hospital. The hospital is not able to provide services under OPPS unless the AP is physically present. Therefore, the physician does not have to lease space from the hospital in order to have adequate facilities to care for patients in the hospital clinic setting, or to attend to administrative duties related to that service. A lease between the physician and hospital may be required if the physician is utilizing office space for services unrelated to the wound center (eg, physician-employed billing staff). Remember, the physician’s revenue is reduced by CMS to account for the fact that the hospital has provided the necessary infrastructure for operations.

SOME RULES THAT APPLY TO PROVIDER-BASED STATUS:

1. The wound center operates under the same license as the hospital. 2. Clinical services are fully integrat-

ed with those of the hospital, with common privileges, quality assurance, and monitoring (as is for any other hospital department). 3. Medical records for patients treated in the facility or organization will be integrated into a unified retrieval system (or cross reference) of the main provider. This means that those professionals practicing at either the main provider or the provider-based site must be able to “obtain relevant medical information about care in the other setting.” 4. T he financial operations of the wound center are fully integrated within the financial system of the main provider and costs are reported in the main provider’s cost centers. 5. The location is held out — by signage and otherwise — to the public and payers as part of the main hospital. 6. The on-campus wound center has to comply with the same requirements of the Emergency Medical Treatment & Labor Act and billing rules applicable to HOPDs. 7. The hospital must indicate POS 22 (outpatient) and bill type (13X) consistent with OPPS. (The charges should be processed through the current outpatient code edits and not through inpatient code edits.) 8. All hospital staff members working in the wound center provide services under the direct supervision of an AP. There are many steps that need to take place prior to a wound center’s opening to ensure the applicable rules and regulations have been complied with, otherwise hospitals and physicians run the risk of submitting improper claims for the services they render. Are you sure you are planning to open an outpatient wound center? Better confirm. n Caroline Fife is clinical editor of TWC. Toni Turner is executive director at InRICH Advisors – Outpatient Auditing Group,The Woodlands,TX.

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PREPARING YOUR STAFF FOR WOUND CLINIC LAUNCH: COMPREHENSIVE EDUCATION & TRAINING Effectiveness and competence in the wound clinic are a direct result of the effectiveness and competence of one’s staff. Here’s what needs to be known at Day 1. Valerie Sullivan, PT, MS, CWS

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any of the principle guidelines for appropriately preparing healthcare staff for the opening of a new wound clinic from an education perspective are more true today than ever before. However, with a changing healthcare climate that includes increasing competition and decreasing reimbursement, the “must have” knowledge list for practitioners has expanded and the need to have the most comprehensive competency baseline within the clinic is imperative if it’s going to provide the best care possible for patients while ensuring that compensation for care is acquired. Whether opening a new clinic, training new staff members, or continuing to educate existing staff within an established clinic, education that is ongoing and evolving education is critical. When thinking about training staff members, we must remember that the education should be directed at the clinical members as well as the operational, managerial and physician staffs. Each member of the clinic staff needs to understand the

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openingyourwoundclinic individual and unique roles of all other members as well as their own distinct role on the wound management team. All duties and aspects of the successful clinic relies on the effective functioning of each individual piece and how that piece fits into the overall puzzle of the cohesive working department.

is a must for all financial management personnel, as is the ability to review this information routinely. Patient confidentiality and HIPAA regulations are as important for these staff members as they are for the clinical staff and should be a component of annual ethics training.

OPERATIONAL FUNCTION

BASIC PATIENT ASSESSMENT

Anticipation of healthcare coverage changes and the implementation of the Affordable Care Act have altered the way companies look at reimbursement as well as what is expected from providers. The office manager, reimbursement staff, and coding personnel should be actively involved in ongoing education on the nuances of differing insurance carriers, required authorization, Medicare requirements for payment, current ICD-9 codes, and upcoming ICD-10 coding. Knowing where to obtain critical information about Local Coverage Determinations

Thorough assessment of the patient population in the wound clinic begins with, at all times, a basic patient assessment. This requires us to evaluate the patient in general, not simply the wound. Critical to establishing the etiology of the wound is understanding what is going on with the patient as a whole. Just as with any other healthcare appointment, vital signs should be taken during each visit. All clinical staff members need to be educated on the appropriateness of assessing and monitoring basic vital information, irregularities in laboratory data, and

the importance of medical and surgical history as well as social history components and medications. Much of this is data required for HITECH Meaningful Use stimulus funds. Various comorbidities including diabetes mellitus and peripheral arterial disease (PAD) point us almost automatically toward particular wound etiologies. Wound specialists must also be in tune with less-obvious disease processes and the possible wound cause. If a patient is not diagnosed with PAD but has a history of cardiac disease or myocardial infarction, peripheral vascular status must be closely addressed. Certain autoimmune disorders may result in integument alteration and subsequent ulcerations. Atypical wound types are also correlated with unassuming comorbidities, an example of which is the relationship between Crohn’s disease and pyoderma gangrenosum. Differential diagnosis is critical to understanding wound eti-

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openingyourwoundclinic ology. Possessing a strong knowledge base in basic pharmacology is important and, as new medications are introduced into the market, providers must be aware of potential interactions with other medications as well as side effects. Most electronic health records (EHRs) in the wound care setting are programed to flag these very aspects, but should be evaluated closely and realistically. A formal vascular exam and neurological testing can be done later in the assessment by qualified persons, but basic pulses, capillary refill testing, and sensory testing should be done on each new patient. While a full gait analysis can be done by a podiatrist or physical therapist, abnormal gait and restrictions in mobility must be recognized at each visit by all who are rendering the patient care. Understanding the role of the podiatrist, physical therapist (PT), occupational therapist (OT), orthotist/prosthetist, infectious disease specialist, interventional cardiologist, vascular surgeon, orthopedist, nutritionist, and even the psychologist on the wound healing team will help providers refer their patients for the specific care they may need to augment healing.

WOUND ASSESSMENT

Clinical staff members, whether new to wound management or to a particular clinic, must be proficient in wound assessment. This can be learned through competency-based training. These competencies should include measurement; wound and skin description; photography; lowerextremity assessment; sensory testing; and basic vascular assessment including capillary refill, checking peripheral pulses, and ankle-brachial index (ABI)testing. These concepts must be a part of all new clinician orientation as well as annual competency training. Like every physiological system in the body, deviation from the norm in the integument can have multiple causes, etiologies, and compounding factors. The well-trained eye can differentiate between different types of wounds and be tuned into those with mixed 14

etiologies. This type of skill comes with practice and working closely with seasoned practitioners. Once etiology is determined, the appropriate staging system should be employed and staging must be done accurately. The difference in staging pressure ulcers, diabetic foot ulcers (DFUs), those related to arterial insufficiency, burns and chronic venous hypertension is all done differently. Documentation must include correct staging for clinical accuracy, reimbursement, and direction toward appropriate treatment — be it support surfaces for pressure ulcer patients or hyperbaric medicine treatments for those patients living with DFUs. The National Pressure Ulcer Advisory Panel’s stages, the Wagner Grading System for staging diabetic foot infections, and the Payne-Martin Classification System for skin tears are basic tools recommended for staging in the wound center, as is understanding the anatomical differences between superficial, partial-thickness, and full-thickness ulcers. The University of Texas’ diabetic wound classification system is another valuable tool, though a bit more labor intensive for clinic staff. Many of these staging/ classification systems are built into or can be built into current wound care EHRs for ease of clinician use. The documentation used should be uniform for all staff members and, again, a comprehensive wound EHR can help accomplish this. Education on this documentation should come from the clinical manager and/or staff mentor in one-on-one teaching situations. Clinical consultants with each particular EHR company should be used to assist with understanding the nuances of the system for ease and consistency of documentation. The nurse, physical therapist, physician, and midlevel practitioner must all understand the importance of different wound characteristics and speak a common lexicon. When training staff on appropriate wound terminology, a helpful tool is the Association for the Advancement of Wound Care’s

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wound care glossary. A common vocabulary will help prevent documentation variances between clinicians. It is important to ensure staff is using the appropriate terminology when assessing the wound and using a universal wound language that others in the clinic are using for the same characteristics. There is a difference between “fibrin” and “slough” and “erythema” versus “cellulitis.” Having a common set of terms used in documentation makes the patient’s chart look seamless regardless of clinician documenting and throughout his or her healing process in the clinic. When describing wound color, tissue present or debrided, drainage, odor, periwound, and the surrounding skin, all members of the healthcare team must be proficient in articulating and documenting exactly what is present. The terminology used should be consistent regardless of practitioner and must support what is being assessed and treatment being rendered. More detailed vascular assessment including ABI and the use of more specific testing equipment to measure arterial and venous patency are usually relegated to clinicians who are licensed (if required) or trained to perform these assessment techniques. Again, all of these skill sets should be tested annually, and if specific equipment is required, as is the case with certain vascular testing modalities, the competency testing should be done according to manufacturer and practice guidelines.

TREATMENTS

Patients come into the wound clinic expecting a high level of care with successful outcomes. Often times, these patients have exhausted all other treatment options or have been trying to care for their ulcers on their own or with a primary care physician. Wound care providers are expected not only to provide advanced healing techniques but to also be extremely proficient in rendering care. Advanced wound treatments include biocompatible wound dressings; sharp, autolytic, continued on page 39 www.todayswoundclinic.com

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EFFECTIVELY MARKETING THE HOSPITAL-BASED WOUND CARE CENTER Are you getting the word out on your wound care center appropriately? Doing so could determine the success of your new wound clinic. Christopher A. Morrison, MD, FACHM, FCCWS & Jessica Taft

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hronic wounds affect millions of people, yet awareness of the epidemic is extremely limited. As wound care professionals, it is our responsibility to be stewards of the chronic wound epidemic by educating our physicians and communities to help get more patients the care they need and deserve.To effectively raise awareness, we must not only help potential referring physicians understand the advantages of advanced wound care, but teach them how to identify patients who would benefit from advanced treatment. This article will establish the fundamental processes, tools, and resources needed to successfully market the outpatient wound care center.

ROADMAP TO SUCCESS

Development and implementation of a comprehensive marketing plan is pivotal to an effective marketing plan. The first step to develop that plan is to understand your market. Consider patient demographics in your primary and secondary service areas and determine from which ZIP codes your patients generally live. While it is imperative to understand the patient population, you must become intimately familiar with the pool of potential referring physicians in the community. You must understand whom your top referral sources are while keeping your finger on the pulse of one-time referring physicians or those who have not referred in more than 6 months. Visiting those inactive physicians and dis16

covering why they stopped referring can give great insight into how you should adjust your strategies or messaging. Don’t forget to market to your internal hospital audience. Next, develop strategies for marketing your service. Look at patient volumes by wound type to help determine on which etiologies you will focus. Focus on a particular wound type by quarter and assign tactics to support your strategies. Build your physician list based on the specialists who tend to see the types of wounds on which you are concentrating for the quarter and develop messages specific to those specialists. Effective planning is only one piece of the marketing puzzle; next is developing and disseminating effective messages to appropriate audiences.

STAYING ON TRACK

Once you have identified strategies and tactics to support your marketing plan, there are tools available to help you stay on track. It is important to identify tools from which you can glean measurements of effectiveness so you can monitor and adjust plans accordingly. One of the most effective tools available is a customer relationship management (CRM) platform. CRM platforms enable you to proactively plan your physician visits, record visit information, and set follow-up reminders and alerts. Some CRMs have the capability to create dynamic groups that target physicians by specialty or wound type. These systems

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also offer comprehensive analytics to help measure the return on investment. There are a number of CRM platforms from which to choose; check with your hospital to see if they currently work with a CRM for other service lines. A less-sophisticated yet effective tool for planning and monitoring activities is a simple spreadsheet to record visits to referring physicians, document the content and result of each visit, and indicate which marketing materials were left with them. A digital calendar can also be used to set reminders for follow-up appointments or phone calls.You should update the spreadsheet whenever a physician refers a patient so that you can measure the effectiveness of your efforts.

GETTING THE MESSAGE OUT

Your plan is in place, your strategies have been identified; now it is time to get the message out. Perhaps the most valuable way to communicate your message is through face-to-face conversation. Invest the time and energy necessary to build long-standing relationships with community physicians and serve as the community wound care expert. Communicate frequently about patient progress, educate physicians about trends in wound care, and share industry research that is relevant to their patients’ needs. Involve your medical director in conversations with referring physicians. Ask your medical director to call and personally thank physicians each time a patient is rewww.todayswoundclinic.com

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openingyourwoundclinic ferred. Leverage the relationships of your panel physicians and ask them to introduce you to those in their circles so you may initiate those conversations. Another important relationship to develop is with the hospital marketing department. Hospitals often buy bulk media contracts that allow them to frequently change messages. For instance, the hospital may purchase a year of radio spots at a bulk rate. As part of the package, the hospital can feature a physician on a monthly medical news show. The marketing department is usually in charge of sourcing the physicians and providing compelling content for the show. Find out from your hospital marketing department if any of these opportunities exist and work with your physicians to develop interesting topics to pitch. Your willingness to help carry some of the content development burden will nurture your relationship with hospital marketing and earmark the wound center as a valuable resource. Leverage your hospital marketing and public relations contacts’ media relation-

ships; provide relevant, press-ready stories to further identify the wound center as a resource for valuable content. Words of caution:When considering articles, make sure they are newsworthy; include photos or video when appropriate and, in the case of patient testimonials, make sure you have all appropriate release forms signed. You’ve made your visits, paid for advertising, and distributed press releases; now it’s time to measure your results.

EVALUATING YOUR EFFORTS

You can market, advertise, and have conversations on end, but have you been effective? Are patients coming through the clinic doors? Do you have new referral sources? One of the most important yet overlooked aspects of a marketing plan is evaluation of efforts. There are a couple of metrics to consider: new patients and new referral sources. Look at your patient volumes and referral sources before and after your targeted marketing campaign and measure the lift in both. These numbers should tell a story about how effectively

you are marketing your wound center. It is advisable to intermittently measure your efforts and make any necessary adjustments to message or delivery as appropriate.

CONCLUSION

Marketing your wound center can be, at times, a daunting task. Putting a comprehensive plan in place saves you time and makes your visits more effective. You must know your audience and address its needs and the needs of the patients. Remember, it is the wound care clinician’s responsibility to spread the word about the virtues of advanced wound care. Right now, we are only reaching a fraction of the patients who need our help. New wound centers can make a difference. n Christopher Morrison is executive medical director for Healogics Specialty Physicians, Healogics Inc., Jacksonville, FL. Jessica Taft is director of marketing for Healogics Inc., Jacksonville, FL.

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GETTING YOUR WOUND CLINIC READY FOR BUSINESS: A COMPREHENSIVE CHECKLIST T

aking your wound clinic from concept, to construction, to completion, to compliance is an arduous process. With this checklist, Today’s Wound Clinic provides to-be wound clinic directors with an overview of the many parameters that must be considered when opening a new outpatient center. From documentation coding to fire codes, we’ve got you covered.

Information for this guide was collected and crafted by the following authors: Caroline Fife, MD, FAAFP, CWS;Toni Turner, RCP, CHT, CWS; Kathleen D. Schaum, MS; Valerie Sullivan, PT, MS, CWS; Donna J. Cartwright, MPA, RHIA, CCS, RAC, FAHIMA; M. Darlene Carey, MBA; Susie Seaman, NP, MSN, CWOCN; Cathy Thomas Hess, BSN, RN, CWOCN; Christopher A. Morrison, MD, FACHM, FCCWS; Rex A. McCarty, MBA, CHT; and Joe Darrah, managing editor of TWC. CHECKLIST Category

Checklist Items

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Building Your Chargemaster

•C ollaborate with clinical staff to validate supplies and procedures that will be rendered. •C rosswalk procedures and visits to payer-acceptable revenue codes that identify clinic services, not surgery or therapy. •E nsure pricing is not below Medicare allowable rates and supports commercial contract payment terms. •E nsure charge-entry staff is educated to unique differences between charge description master’s, if hardcoding any modifiers.

q

Are You an HOPD Wound Center?

• Is your hospital licensed? •P roviders (eg, doctors, nurse practitioners) have privileges through the hospital and undergo the same quality monitoring as hospital providers. •W ound center medical records are integrated into a unified retrieval system of the main provider. • F inancial operations of the wound center are integrated with the main provider and costs are reported in main provider’s cost center. •L ocation is designated with signage to the general public as part of the hospital. • “ On-campus” wound center follows the same Emergency Medical Treatment & Labor Act rules as the hospital. •H ospital indicates “Place of Service 22” on bills and charges processed through outpatient code edits. •H ospital staff provides services under the direct supervision of the advanced practitioner. •A ttestation has been provided to the Centers for Medicare & Medicaid Services, if needed.

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Specialty Credentialing of Staff

•C onsider all available wound care and healthcare-related specialty credentials. •C learly communicate management’s expectations regarding credentialing and continuing education during times of interview/ hiring process. •E ncourage credentialing renewal and provide staff members with contact information for credentialing bodies. • I ncentivize earning of credentials with monetary and other types of recognition/reward whenever possible. •P romote all specialty credentialed staff members to patients by communicating through clinic signage and on any promotional/ marketing/advertising materials.

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Opening a Hyperbaric (HBO) Facility

q q

1. Contract

• Management company or consultant? • Payers identified?

2. Space Considerations

• • • •

3. Electronic Health Record

• Must be HBO-specific. • Interface capability: charges/documentation/equipment. • Reporting.

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4. Staff (Medical & Clerical)

• • • • • •

Establish hiring preferences. Orientation program. Credentialing protocol. Annual competencies developed. Policies/procedures established. Facility departmental integration.

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5. Revenue Cycle

• • • • • • • • • • •

Facility platform. General ledger. Patient registration. Chargemaster. Charge entry – manual or Detailed financial transaction? Charge reconciliation. Coding. Claim generation. Billing. Collection. Denials.

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Staff Training on Protocol, Procedures, Patient Care, Etc.

•P rovide basic orientation that educates on all policies and procedures related to the clinic as well as any organizational standards that will be expected to be met at the time of hire for all staff members and clinicians. •C onduct orientation at the time of hire related specifically to wound care assessment, diagnosis, procedures, etc. •S chedule annual competency training for all staff members and clinicians. •P rovide ongoing education as needed. •D evise a system that allows for unified documentation and evaluate all activity related to the process ongoing. •B e sure to delegate and designate staff responsibilities that adhere to the individual’s scope of practice.

Site selection. Design elements. Architect designated. Contractor assigned.

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openingyourwoundclinic CHECKLIST Continued from page 20 Category

Checklist Items

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Key Reports to Maintain/Track/Utilize

q q

Utilize a reporting module tied to your specialty wound care electronic health record (EHR). The data collected and analyzed could:

• Provide a clear roadmap for managing disease states. • Improve healthcare delivery. • Streamline documentation workflow. • Enable compliance to enhance quality and patient safety. • Provide valuable information for payment related to wound care services, products, supplies, and procedures. • Observe trends across wound and patient types, clinical practices, and operations from data collected within your business. • Understand the report requirements as well as the data inclusion and exclusion requirements when interpreting the report. • Understand how to manage your work to produce accurate data, thereby optimizing reports. • Compare clinical, operational, and economic/financial outcomes through the data stored in the EHR system to manage your business efficiently and effectively. • Consider coordinating key reports to manage your clinical, operational, regulatory, economic/financial, and marketing business such as (this list is not all inclusive): a) Benchmark reports (eg, debridement, days to heal, healing percentage) b) Comprehensive wound outcome report c) Corporate reporting d) Current Procedural Terminology-4 procedure summary report e) Facility statistics report f) Forms-requiring-signature report g) Hyperbarics eligibility report h) Out-of-date progress notes report i) Patient list report j) Payer mix report k) Referring physician report l) Volume reduction report m) Wound type report n) Zip code report.

Facility Design/Construction

• • • • • • •

Central nurses station. Clinician offices as appropriate/space provides. Waiting area with check-in window. Large chairs for obese patients in all patient areas. Supply room clearly marked. “Dirty room” for instrument processing clearly marked. Exam room to include: Exam table (podiatry chair with powered rise is critical to decrease staff member back injuries); exam light; Mayo stand; desk for electronic health record with stool on rollers; supply cabinet for commonly used products; sink/cast sink in at least 1 exam room for contact casting; wall-mounted gloves and sharps containers; chair for family member.

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Facility Equipment/Supplies/ Products

• • • • • • • • • • • • •

Dressings – specialty and gauze. Compression wraps. Contact casting supplies. Waterproof drapes. Sterile instruments – scissors, scalpels, curettes, pickups (reusable or one-time usage.) Plastic bags for patients to carry home any unused supplies from visit. Neurological testing supplies – 10 gm monofilament, 128 Hz tuning fork, reflex hammer. Doppler with speaker and conducting gel. Dermal thermometer. Trash receptacles with and without biohazard waste disposal. Laundry and linens – sheets, blankets, towels, pillows, pillowcases. Infection control wipes or spray for cleansing room/equipment between patient visits. Samples of compression stockings.

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Marketing

• Ask hospital to distribute press releases to local media announcing center’s opening and appointment of medical director. • Obtain physician list from hospital. • Develop comprehensive marketing plan. • Implement plan and tracking tool (and keep updated). • Measure and report results of marketing/advertising efforts.

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Facility Accreditations

•C omplete and return the accreditation survey application and the requested supporting documentation with the application fee to the accreditation body. • Preparation phase: After an inspection date is chosen, begin analysis and tracking compliance of all related standards. • Compliance phase: Any identified gaps will need to be corrected to bring staff and facility into compliance. • Final preparation phase: Compile all documentation, verifying code compliance and operations in reference to outlined standards. • Survey: Assigned survey team will report on assigned date to assess facility safety, operations, and compliance of standards.

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HIPAA Privacy & Security

•R equire all employees to undergo HIPAA Privacy and Security education/training at times of orientation and at least once annually thereafter. • Establish clear policies for staff, vendors, and patients that are easily monitored and enforceable related to use of mobile devices in the facility that could be used to capture and transmit protected health information (PHI) (ie, mobile phones and tablets). • Refrain from posting anything related to PHI on any social media platform and ensure that polices restrict staff, vendors, and patients from doing the same. • Remind staff, vendors, and patients of any policies related to HIPAA by posting notices throughout the clinic (ie, patient rooms, waiting rooms, common areas) that clearly communicate the information and are easily visible. • Ensure that facility’s electronic health record software and any programs that contain PHI are “secure” through password protection/ employee-specific sign-in. • Implement and train staff on protocol in the event of a PHI data breach (unauthorized access and/or use) of any kind. This includes contacting those individuals whose information was accessed. • Obtain confirmation (ie, signed and dated policy) from any business associate permitted access to any PHI that acknowledges an understanding of the restrictions to that PHI (eg, cannot be sold or distributed to other parties). • Establish and communicate clear standards that explain how patients can acquire electronic or hardcopy information related to PHI and advise them of how to safeguard their materials when leaving the clinic. • Assure that all staff members are aware of where all PHI information is stored in the event of a compliance review by the US Department of Health and Human Services (HHS). • Frequently refer to the HHS for updates related to HIPAA Privacy and Security rules.

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openingyourwoundclinic CHECKLIST Continued from page 21 Category

Checklist Items

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Documentation/Coding/Reimbursement

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1. Coding Process

•H ire a certified coder who is skilled in coding and documentation regulations/guidelines for both the hospital-based outpatient wound care department (HOPD) and the qualified healthcare professionals (QHPs) who will provide the professional services. •P urchase updated coding manuals (eg, Current Procedural Terminology [CPT], Healthcare Common Procedure Coding System [HCPCS], ICD-9-CM/ICD-10-CM, National Correct Coding Initiative Edits/Modifiers) on an annual basis. • I dentify services, procedures, diagnostic tests, and products that will be performed/provided. • I dentify CPT and HCPCS codes that are relevant to the services, procedures, diagnostic tests, and products that will be performed/provided. • Learn coding regulations/guidelines for pertinent CPT and HCPCS codes. • Implement a process to convert from ICD-9-CM to ICD-10-CM codes by Oct. 1, 2014. • Determine if private payers require: a) M apping system to determine clinic visit levels for “new patient” (99201-99205) and “established patient” (99211-99215) clinic visits OR if they will use the new G0463 hospital outpatient clinic visit for assessment and management of a patient to represent all clinic visits b) 1 5271-15278 will be used to represent the application of all cellular and/or tissue based products (CTPs) for wounds [old term “skin substitutes”] OR if 15271-15278 will be used to represent the application of “high cost” CTPs and C5271-C5278 to represent the application of “low cost” CTPs c) Separate claims reporting of HCPCS “Q” codes for CTPs d) S eparate claims reporting of add-on codes for procedures such as surgical debridement, medical debridement, and application of CTPs.

2. Payment Process

• I dentify the major payers of the patient population that you expect to serve. a) Review hospital contracts with major payers to verify the contract includes payment for the HOPD and that negotiated payment rates are adequate. If not, work with the contracting department to amend the contracts. b) Request (from each non-Medicare payer) a coding and billing inservice, a copy of their coding and billing manuals, and copies of the medical policies that pertain to the services/procedures/products/tests you will perform/provide. •R eview the current Medicare Final Rules that pertain to the Outpatient Prospective Payment System (OPPS) and to Medicare Physician Fee Schedule (MPFS). • Identify all steps in your revenue cycle process, meet with the leader of each business unit, and test each step in the revenue cycle (from registration, to charge entry, to claims submission, to claims denials, to claims appeals, to revenue report review). •E stablish a “per clinic visit” (not monthly) registration process that includes scheduling appointments, verifying insurance benefits for top 10-20 services/procedures/products performed, obtaining prior authorization requirements, etc. • Work with chief financial officer to establish charges for all services/procedures/products/tests that will be performed/provided. •C reate a thoroughly detailed charge description master (CDM) that complies with major payers’ coding and billing regulations. Establish a process to update the CDM as new services/procedures/products/diagnostic tests are added/deleted, as prices change, and as payment system regulations change. •C reate separate charge sheets for the HOPD and for the QHPs who will provide professional services in the facility. •C reate a policy and procedure for “direct physician supervision” and implement a QHP staffing schedule that provides “direct supervision” when required. •E stablish a process to provide advance beneficiary notices of noncoverage to patients who require services/procedures/ products/tests that are normally covered but are not covered for a particular condition. • Negotiate contracts with skilled nursing facilities, long-term care hospitals, and home health agencies that wish to send patients to your wound clinic. • I dentify whether your hospital and/or QHPs are participating in any type of risk sharing programs with governmental and/or private payers. Proactively develop programs to participate in those programs.

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3. Coverage Process

•E stablish a process to obtain all Medicare Local Coverage Determinations (LCDs) that pertain to the services/procedures/ products/tests performed/used in the HOPD. The process should include educating all clinical and medical staff about LCDs; researching revised, draft, and future effective LCDs on a monthly basis; commenting on draft LCDs; and challenging clinically incorrect LCDs via the LCD Reconsideration Process: a) Identify medical-necessity guidelines b) Identify covered diagnosis code(s), CPT codes, and HCPCS codes c) Identify required modifiers d) Learn utilization guidelines e) Learn documentation guidelines. •E ncourage your QHPs to communicate with and educate your major payers’ medical directors. • I dentify and work with the Medicare Carrier Advisory Committee representative for each of your QHP’s professional societies.

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4. Documentation Process

• Purchase an electronic medical record that will meet the documentation and quality-measure reporting requirements of both the HOPD and the QHPs who will provide the professional services. •E ducate staff to document to meet the specificity requirements of diagnosis codes and to meet documentation guidelines of Medicare LCDs and private payer medical policies. •E ducate staff to document comorbidities as well as primary diagnoses.

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5. Audit Process

•E stablish a regular audit process via internal and/or external auditors. •R eview a list of concerns and audit topics from the major auditing programs (eg, Office of Inspector General, comprehen sive error rate testing, and recovery audits.

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Miscellaneous

•C onfirm that your wound clinic adheres to any fire safety established within your respective municipality, and schedule routine fire drills with staff in the event of an emergency. •R efer to Title 3 of the Americans With Disabilities Act (ADA) to ensure compliance issues related to for-profit and nonprofit entities and confirm that all universal design standards set forth by the ADA are met. •S chedule regular sanitation/cleaning routines conducted by in-house staff or an outside vendor. •P repare and distribute discharge instructions (ie, diagnosis elements, medication information, home treatment plans) that can be tailored to individual patients for each clinic visit. •A ssure that enough staff coverage is assigned to conduct clinic business during all hours of operation. • Distribute and post in the workstation the names and contact information for all medical staff, including emergency on-call providers. •P roperly label all exist (including at least 1 emergency exit) and regularly inspect all rooms, doorways, hallways, etc. for potential hazards that could affect an emergency evacuation. • Post and follow any building-related occupancy codes that must be complied with.

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ACHIEVING EFFICIENT WOUND CLOSURE WITH AUTOLOGOUS SKIN Recent advancements in a wound care method that has roots running a century deep is proof that pathways to wound closure will continue to evolve. David J. Smith, Jr., MD, FACS

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ore than 100 years ago, Ollier performed the first reported split-thickness skin graft (STSG) containing epidermis and dermis.1 A century later, wound closure remains the therapeutic imperative and the goal of caring for any wound.2 Wound closure can occur in three ways: 1) primary closure by wound edge approximation with healing by first intention; 2) secondary closure by spontaneous healing with contraction and epithelialization with healing by secondary intention; and 3) tertiary closure by skin graft or flap with healing by third intention. Surgical incisions and traumatic lacerations are closed by wound approximation. Chronic wounds and large-surface burn wounds cannot be closed by primary intention. Many advanced wound dressings, skin substitutes, and peptide growth factors have been used with varying success to help healing by secondary intention.3 Tertiary closure by pedicled (free flaps), or by STSG fulfills the “gold standard” for wound closure; ie, closure with autologous skin.4 In a symposium on wound management, Tobin stated that the goal of management of all wounds is successful closure to increase function and to decrease hospital stay and disability.5 As early as 1929 in discussing the advantages of STSG wound closure versus healing by secondary intention, Blair and Brown stated, “Early, quick, and permanent surfacing of cutaneous defects conserves health, comfort, function, time, and money; while unnecessary waiting spells economic waste.”6 24

Figure 1. Micrografting Basis

There are many reports in the literature of STSGs being used to close chronic wounds such as diabetic foot ulcers (DFUs), venous stasis ulcers, and pressure ulcers.4,7-10 All suggest that a successfully applied skin graft can decrease time to healing, minimize morbidity, and decrease cost of wound care. There are few carefully randomized controlled trials directly comparing the results of STSGs and standardized care with dressings leading to spontaneous healing. One such report by Mahmoud, et al demonstrated that DFUs treated with STSGs healed in 28 days versus 122 days for conservative wound care.7

ENHANCING STSG EFFECTIVENESS

It is clear from reviewing the experience of STSGs for chronic wound closure that the key is proper wound bed preparation prior to the STSG. All necrotic tissue must be removed from the wound. Debris, slough, bacteria, and deleterious cytokines must also be removed. Products such as hypochlorous acid* and hydroconductive dressings** have been demonstrated to be effec-

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Figure 2. Graft Mincing

tive for wound bed preparation prior to grafting.11-13 Historically, STSGs have been performed in the operating room (OR) and have required sizable donor sites. To eliminate the necessity of in-hospital OR time and expense for skin grafting, a new disposable microautografting kit*** has been developed that utilizes the concept of micrografts that can be performed under local anesthesia in the outpatient wound clinic.14 Clinically, a wound that is not progressing satisfactorily toward wound closure in a timely manner can be micrografted in the clinic using the device. Following proper wound bed preparation, a very small (postage stamp-sized) graft can be harvested with a designed dermatome preset for uniform thickness (0.0120.016 in.). The graft is then minced in 2 perpendicular directions to yield small fragments of graft (approximately 0.8 mm sq). The STSG fragments are then spread over the wound defect. The special instruments in the kit allowing procurement and mincing of the autolowww.todayswoundclinic.com

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

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autologousskin

Figure 3A. Recipient Site

Figure 3B. Donor Site

Figure 4A. Recipient Site

Figure 4B. Donor Site

gous skin grafts into micrografts make the device unique. Micrografts have been reported by Boggio et al to induce faster re-epithelialization of chronic leg ulcers that had failed to heal despite good conservative local therapy.15 They also stated that they could repair very large ulcers with small fragments of skin requiring small donor sites. In this study, researchers reported a 90% success rate with the micrografting technique. The concept behind the micrografting is based on Meek’s theory of expansion using mincing of STSGs.16 (See Figure 1 on page 24.) Using the disposable microautografting kit, a given STSG can be expanded 100-fold following mincing of the graft.17 (See Figure 2 on page 24.) Wound contraction is minimized due to the minced micrografts containing both dermis and epidermis. As can be seen in the accompanying clinical example, the prepared wound is covered with microautografts and heals with minimal scar26

ring of both the recipient and donor sites as seen at 6 weeks. (See Figure 3A and Figure 3B above.) Long-term follow up demonstrates the result at 5 months. (See Figure 4A and Figure 4B above.) When adequate wound bed preparation followed by application of autologous skin is conducted in the clinic, wound closure should be attainable without hospital admission, thereby conserving costs, time, and resources. n David J. Smith, Jr. is the Richard G. Connar Professor and Chairman in the department of surgery at the University of South Florida,Tampa. * Vashe Wound Cleanser, SteadMed Medical LLC, Fort Worth, TX ** Drawtex Hydroconductive Wound Dressing, SteadMed Medical LLC, Fort Worth, TX *** Xpansion Micro-Autograft Kit, SteadMed Medical LLC, Fort Worth,TX

References

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1. Ollier LXEL: Greffes cutaneous ou autoplastiques. Bull Acad Med de Paris. 1872;1:243. 2. Robson MC, Krizek TJ, Wray RC: Care of the thermally injured patient. In Ballinger, Rutherford, and Zuidema, (eds.) The Management of Trauma. 2nd Ed, W.B. Saunders Co., Philadelphia, 1973. 3. Robson MC, Cooper DM, Aslam R, Gould LJ, Harding KG, Margolis DJ, et al: Guidelines for the treatment of venous ulcers. Wound Rep Regen. 2006;14:649-662. 4. Anderson JJ, Wallin KJ, Spencer L: Split thickness skin grafts for the treatment of nonhealing foot and leg ulcers in patients with diabetes: A retrospective review. Diabet Foot Ankle. 2012; 3.doi: 10.3402/dfa.v3i0.10204. Epub 2012 Feb 20. 5. Tobin GR: Closure of contaminated wounds: Biologic and technical considerations. Surg Clin N Amer. 1984;64:639. 6. Blair VP, Brown JB: The use and uses of large split thickness skin grafts of intermediate thickness. Surg Gynecol Obstetr. 1929;49:82. 7. Mahmoud SM, Mohamed AA, Mahdi SE, Ahmed ME: Split-skin graft in the management of diabetic foot ulcers. J Wound Care. 2008;17(7):303-306. 8. Rosenblum B, Berglund A: Split thickness skin grafts used for diabetic wound healing. Podiatry Management. 2012 June/July 141146. 9. Ramaanujam CL, Stapleton JJ, Kilpadi KL, Rodriguez RH, et al: Split-thickness skin grafts for closure of diabetic foot and ankle wounds: A retrospective review of 83 patients. Foot Ankle Spec. 2010 Oct; 3(5): 231-240. 10. Wood MK, Davies DM: Use of split-skin grafting in the treatment of chronic leg ulcers. Ann R Coll Surg Engl. 1995;77(3):222-223. 11. Liden BA: Hypochlorous acid: Its multiple uses in wound care. Ostomy Wound Manage. 2013;59(9):8-10. 12. Robson MC: Advancing the science of wound bed preparation for chronic wounds. Ostomy Wound Manage. 2012;58 (11):10-12. 13. Spruce P: Preparing the wound to heal using a new hydroconductive dressing. Ostomy Wound Manage. 2012;58 (7):2-3. 14. Svensjo T, Pomahac B,Yao F, Slama J, Wasif N, Eriksson E: Autologous skin transplantation: Comparison of minced skin to other techniques. J Surg Res. 2002;103:19-29. 15. Boggio P, Tiberio R, Gattoni M, Colombo E, Leigheb G: Is there an easier way to autograft skin in chronic leg ulcers? “Minced micrografts,’ a new technique. J Eur Dermatol Venereol. 2008; 22(10):1168-1172. 16. Meek CP: Successful microdermagrafting using the Meek-Wall micro-dermatome. Am J Surg. 1958;96:557-558. 17. Hackl F, Bergmann J, Granter SR, Koyama T, Kiwanuka E, Zuhaili B, et al: Epidermal regeneration by micrograft transplantation with immediate 100-fold expansion. Plast Reconstr Surg. 2012;129:443e-452e. www.todayswoundclinic.com

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ICD-10-CM ICD-10-CM DIAGNOSIS CODING DOCUMENTATION TIPS FOR CURRENT BURNS/CORROSIONS CURRENT BURNS/CORROSIONS (T20-T25 CATEGORY)

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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. 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 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. This month’s tool covers the category of current burns/corrosions. (Refer to our October 2013 issue for the tool on infectious diseases and the November/December 2013 issue for neoplasms.) ICD-10-CM Diagnosis Coding Documentation Tips for Current Burns/Corrosions Current Burns/Corrosions (T20-T25 Category) Topic

ICD-10-CM Code Ranges

Documentation Tips/Guidelines

Burn Classification

Category T20-T25

Burns are classified by depth, extent, and agent. Depths are classified as 1st degree (erythema), 2nd degree (blistering), and 3rd degree (fullthickness). Be sure to document these elements in the medical record.

Nonhealing Burns

Nonhealing burns are coded as “acute” burns.

Burns of the Same Local Sites

Burns of the same local site are coded to the highest degree (eg, 2nd- and 3rd-degree burn of the forearm; code only 3rd degree).

Large Burns of Multiple Sites

Assign a separate code for each documented burn site. Be sure to document laterality (right/left/bilateral). Notes should document each wound by depth, degree, and anatomic site.

Infected Burns

Code the appropriate burn code and use an additional code to describe the infection from the infectious disease chapter. (See TWC Vol. 7 No. 8 for infectious disease tool.)

Sequela of Burns

“S”

Encounters for late effects of a burn such as scars or contractures should have a 7th character of “S” for sequela.

Sequela With Late-effect and Current Burns

“A”

Use 7th character “A” while the patient is receiving active treatment for the burn.

Sequela With Late-effect and Current Burns

“D”

The 7th character “D” subsequent encounter is used when patient has received active treatment and is now receiving routine care during the healing and recovery phase.

NOTE: A detailed operative report will assist in the appropriate identification of site, depth, and size of a burn wound. The operative report is very specific and surgeons usually identify sites, size, and depth clearly in the operative report. Record the place that the burn occurred and the circumstances surrounding the encounter. RESOURCE: 2014 ICD-10-CM Official Guidelines for Coding and Reporting 2014

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

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!

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

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facilityinfocus Wound Healing in Las Vegas A Safe Bet at Desert Springs The stakes are high in many ways in “Sin City.” But a dedicated wound care staff is making sure patients get a second chance with their chronic wounds.

By Joe Darrah

Desert Springs Hospital Medical Center, Las Vegas

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as Vegas — Delvin Lee has lived with HIV nearly 25 years. Not coincidentally, he was diagnosed with toxoplasmosis more than 12 years ago, his vision progressively worsening and seizures occurring throughout his life as a result. A cancer survivor as well, Lee, 51, has learned to live and survive on his own since the age of 16, even with a healthcare history that reads like a novel. But a nonhealing wound nearly killed him last summer. Had he not met Minh H. Nguyen, MD, WCC, medical director at the Advanced Wound Care Center at Desert Springs Hospital Medical Center, soon after enduring his most recent grand mal seizure, Lee is certain that he would not be alive today to share his story — a story of how true inner strength can help one on the road to healing — a story that really begins off the Carib30

Photo courtesy of the facility.

bean coast on the island of Antigua and has spanned many parts of the globe. It’s also a tale of rescue — a rescue by a collaborative wound care and allied healthcare team that dramatically changed its long-suffering patient’s life in a matter of weeks.

EARLY INTRODUCTION TO ADVERSITY

Lee was born in New York in 1962. His parents met in the Big Apple and most likely had plans to raise their family there as best as Lee can remember, but when his younger sister was born 1 year later with Down syndrome, the family uprooted to be with his mother’s family in the West Indies, where Lee grew up as a boy very close to nature who learned “every nook and cranny” that the island had to offer. “The way nature heals itself has always been fascinating to me,” Lee said.

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“So, as part of nature I feel I can do the same if I have the right mindset.” One who was always a productive student, Lee graduated high school from St. Joseph’s Academy on the island as the school’s Student of the Year and from there traveled to St. Mary’s University in Halifax, Nova Scotia. Although he’d leave school early prior to earning a degree, Lee would “continue” his education by traveling the world, ending up back in the US full time by the mid 1980s. With no specific reason to consider himself unhealthy, he mutually volunteered to undergo HIV testing at age 30 when he entered into a new relationship and both he and his partner wanted to be tested as a precaution. To his surprise, his test came back positive.To his dismay, he learned from a social worker that he’d actually been living with the disease for at least 3 years. Records showed that an employer who screened him in 1989 as part of a job application had led to a positive result. However, laws at the time did not require third parties to notify anyone beyond local health officials regarding HIV status. With the amount of traveling Lee had already done by that point, he believes he would have been tough to trace anyway. However, one certainty remained: He showed no signs of the disease. “I had no symptoms, nothing that would lead me to believe that I was carrying HIV,” said Lee, who recently spoke with Today’s Wound Clinic during a visit to Desert Springs, a 293bed acute care facility located in the city’s southeast section that’s become a staple in the community for its longstanding Diabetes Treatment Center www.todayswoundclinic.com

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facilityinfocus (see sidebar at right) and, more recently, its wound care and hyperbarics center. At the time of the visit, Lee was nearing his 30th oxygen therapy treatment of an anticipated 60 indicated for a radiation burn that formed more than 10 years ago after extensive treatment for anal squamous cell carcinoma, a condition that developed following a case of human papillomavirus (HPV), both of which his HIVweakened immune system may have been susceptible too. What’s not debatable is that Lee tried unsuccessfully to self-treat the open wound for more than a decade, using a range of overthe-counter pharmaceutical products from petroleum jelly and Vagisil (for its numbing agent) to toilet paper, diapers, and even Maxi pads for bandaging. His vision poor enough to the point that he could not see for himself that the wound was not properly healing, he relied on total sensation to care for it, as pain would fluctuate based on his body temperature (the pads allowed more venting than the diapers), and how often he would have bowel movements during a given day. “I was worried about losing my sight some day, so I wanted to teach myself to see with my fingertips,” he said. “I did my best to take care of it by making sure that it was always clean and dry.” As the years passed, the attention that he found himself dedicating to the wound began consuming his time and his life to immeasurable and even dangerous levels. “I ‘became’ the wound — I was so worried about getting an infection that it’s all I thought about, all day every day,” Lee related. “The burn just became this big hole in my body that I tried to keep clean and had no time for anything else.” Even to the point that he felt too overwhelmed to seek medical treatment for it and, even worse, began to seriously neglect his HIV and toxoplasmosis medication regimen. He estimates that after about 7 years he was no longer taking any of his meds. “I just became so obsessed with the wound because I could feel it getting larger and larger that I didn’t realize www.todayswoundclinic.com

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A Head Start on Being Resourceful The Diabetes Treatment Center at Desert Springs predates its wound clinic … by about 20 years. Las Vegas — Despite the universal understanding that the wound care population has been and will be dominated by those living with diabetes and (more increasingly) obesity, convenient access to a dedicated diabetes center for outpatient wound clinics is not nearly as automatic. The odds are even less in favor for clinics to have an extension to bariatrics. But at Desert Springs Hospital Medical Center, the wound clinic is in reality an extension to a diabetes center that opened in 1990. Officials at the facility didn’t want to waste time in earning accreditation, offering a director’s position to Joyce Malaskovitz, PhD, RN, CDE, and asking her to seek accreditation immediately. Today, the center has long been the first in Nevada to be accredited by the American Diabetes Association and the American Association of Diabetes Educators. Malaskovitz, a nurse who chose to dedicate her career to diabetes as a youth after her grandfather died suddenly of a heart attack due to disease complications without a chance to say their goodbyes, is most proud of the specialty allied centers the hospital has built and likewise acquired accreditation in support of the patient population (ie, bariatrics, stroke, cardiovascular, sleep, and wound care, among others). “It’s about all the service lines that we’re offering that in the long run improves the patients’ overall well-being,” said Malaskovitz, director of health and wellness at the medical center. “From a business perspective, you can keep people coming through your doors by letting them and referring physicians know that we offer all these programs to help manage their disease.” Malaskovitz and her staff collaborate with the wound clinic by offering patients a comprehensive program of diabetes education based on their individual needs learned through comprehensive assessments conducted upon wound clinic admission. “We also conduct our own assessments, identify their needs, educate them, and provide extra one-on-one if there are any learning disabilities,” Malaskovitz said. “We know that you can’t heal a wound if the glucose is running 300 or 400.” Group diabetes classes are held monthly. More often than not, patients are candidates for bariatric surgery, which requires specific bariatric consultation to determine the patient’s chances of successful outcomes related to diet, overall health, and compliance. The diabetes center is also known in the community for its annual heath fair, an event that has brought local patients, providers, and vendors together the last 22 years. “We get a few thousand people each year; it’s something that we’ve been able to grow through our reputation,” Malaskovitz said. “People are offered free screenings, free blood work, eye exams, foot exams. It’s all about exposing people to options to help them be healthy.” — Joe Darrah Today’s Wound Clinic® January/February 2014

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Desert Springs Wound Clinic and Allied Health Staff: From left are Anthony V. Carrozza, MD; Gladys Torres, front office coordinator; Kim McMickens, BSN, RN; Dina Cazares, MSN, RN, CDE; Brandie Figueria, medical assistant; and Ronald Shockley, MD. Photo credit - Corey Krejcik

how much I wasn’t paying attention to other things,” said Lee, who at the time of his cancer diagnosis was living in Cleveland, but specifically targeted Vegas as his new home due to it’s close proximity to the Mojave Desert and the “spiritual energy” believed to be present within. Though cancer-free, the side effects of the radiation (48 sessions plus concurrent chemotherapy) had left him visibly and physically deteriorated. And, for the first time in his life, questioning his will. “I had started to feel the effects of the chemo — the pain was all over my body and I dropped from 150 to 118 pounds,” Lee said. “I basically needed to learn to walk again because of where the condyloma was, and my body was reacting to the ‘poison’ that healed the cancer.” A lifelong artist who has made a part-time career out of selling original artwork, paintings, jewelry, and greeting cards, Lee would also see the sagging economy deplete his ability to earn a comfortable living. Today, he qualifies for Medicare coverage. “But I was in good spirits,” he said. “I’ve always tried not to go the nega32

tive route when it comes to health and most things, because that does nothing for me.” And then, last June, his hiatus from the toxoplasmosis meds caught up to him.While lying around at home, painting in one of the only comfortable positions he could muster with the wound, he experienced another grand mal seizure that culminated in a stroke. Had it not been for a visitor who soon afterwards came to the door and called 911 for him, he would have likely died in his own living room. Instead, he ended up in the emergency department at Desert Springs. A few weeks later he was on an acute rehab floor in the care of Nguyen, who promptly inquired about the wound. “Dr. Nguyen told me he thought he could do something for me, so I said, ‘Have at it.’”

A WOUND WORTH HEALING

Despite the location of the burn, extensive comorbidities, and time elapsed, Nguyen remained confident that he and his staff could heal Lee’s wound — measured at 6 cm long, 3 cm wide,

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and 4.5 cm deep — in accordance with their wound care benchmarks, which call for at least a 50 percent reduction at 4 weeks. Beyond that, length of stay is based on wound severity, which is determined by evaluations made during initial assessment and ongoing by Nguyen and respective members of Desert Springs’ multidisciplinary physician staff, an eight-member panel that includes specialists in restorative medicine (Dr. Nguyen), emergency medicine (Anthony V. Carrozza, MD), and infectious disease (Ronald Shockley, MD), among others. “Our initial evaluations are very comprehensive,” Nguyen said. “Everything starts with a thorough history so that we can answer the main questions: Why is the wound chronic and nonhealing? Is it a nutritional factor? Is it an infectious disease issue? Is it an offloading issue? Is it a circulation issue? Is there a red flag that nobody has raised yet? We maximize wound healing potential by considering all possibilities.” As a preemptive measure to closure, all patients are also given a host of clinical workups on first visit that inwww.todayswoundclinic.com

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facilityinfocus

Patient Lee: Las Vegas resident Delvin Lee takes in a movie during a recent HBOT treatment session. Photo credit - Corey Krejcik

cludes hemoglobin A1C, blood sugar, ankle-brachial index, and bone scans, if necessary. “We can’t trust anyone else’s data,” Nguyen said. “We need to piece everything together ourselves so that we can be sure that we’re not missing any pathology.” Neurological evaluations are also conducted upon referral in an attempt to gauge one’s ability to help care for his or her wound while away from the clinic as well as cultures for MRSA. “And not a lot of physicians will check for that from the get-go, but we do,” Nguyen said. “That’s a lot of ground to cover on a first visit, but we like to be as comprehensive as we can. We then slot the patient for the appropriate specialist and protocol that best fits their wound care needs from the start.”

A CHALLENGING POPULATION

As unique as Lee’s case appears to be, at Desert Springs it’s not uncommon for wound care staff to encounter patients who’ve gone longer with self-treating their chronic wounds. “When I meet a patient, I actually expect them to tell me it’s been many years that they’ve had their wound,” said

Kim McMickens, BSN, RN, clinical coordinator, who recently left home care full time to be in a setting equipped to produce better long-term outcomes for wound care patients, a population she’s cared for more than 10 years.“People just seem to learn to live with their wounds until the pain becomes so severe or until they’re infected. Unless they’re referred by a primary physician, the wound just becomes a way of life for many of them.” Located minutes from the Strip, Desert Springs also plays host to patients in the region who are on extended vacations and are likely on foot for long stretches of the day. As such, walk-ins are to be expected, out-of-state providers are inclined to call in travelers’ referrals, and a willingness and ability to be accommodating is a must, McMickens said, especially when considering environmental factors that can frequently impact not just the patient population’s health in general but people’s willingness and physical ability to be healthcare conscientious. “Vegas gets extremely hot in the summer and, when we do get inclement weather in the winter, there’s a lot of wind, and cold, and rain – flooding

even,” Kim continued. “Some of our compromised patients are living with multiple comorbidities and socioeconomic issues. They’re sitting at the bus stop, and some buses don’t even accommodate wheelchair access. There are a lot of challenges we and they face to getting their wound care consistent.” Lee has not been immune to that. As of TWC’s visit, his wound had been reduced to 1.5 x 1 x 4; but there’s been some struggle, including an allergy to sulfur. “And an opening in that area is very tough to heal because there’s recurring trauma and pressure,” Nguyen said. “We’ve educated him to be diligent and to clean and sanitize the area after every bowel movement. But we’re all happy with the level of progress he’s seen thus far.” As is Lee, who is also now fully compliant with all medications and is observant to a difference in the care at Desert Springs as compared to past experiences. “This group here, as varied as they are individually [as providers], comes together as a unit,” he said. “They communicate with one another. I’ve been to hospitals where it’s not like that. Everyone here has one focus – to make sure you get what you need when you need it.” Though he’s still looking at several weeks of recovery, he’s assured his mindset is where it needs to be. His caregivers agree. “He was in need of a healthcare team to provide guidance to understand what was important for him to heal his wound,” Nguyen said. “If patients aren’t given direction and confidence, they’re not going to know what’s important. But if they are given more direct, clear guidance, they’re going to be more grateful and more compliant, and they’ll trust you — that’s the key.” n Joe Darrah is managing editor of Today’s Wound Clinic.

ONLINE EXCLUSIVE: DESERT SPRINGS PHOTO SLIDESHOW For more photos from our visit to Desert Springs Hospital Medical Center, visit www.todayswoundclinic.com. 34

January/February 2014 Today’s Wound Clinic®

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TWCnewsupdate Innovative Wound Imaging Debuts in Outpatient Clinics A wound care service company has helped bring new technology into the outpatient wound clinic setting that is expected to help providers see wounds in a new, improved way. Wound Care Advantage (WCA) recently partnered with Pristine, a telehealth communications solutions company based in Austin, TX, that’s reportedly the only company to develop commercially available glassbased software that meets HIPAA regulations, to bring Google Glass into an outpatient wound care setting for the first time. Google Glass is a wireless, hands free, wearable computer of sorts that rests upon one’s face as traditional glasses would and allows for close first-person perspective imagery. The device will be implemented at Wound Care Advantage’s partnering wound centers, according to WCA officials. “The fastest way to treat a patient is to have the experts see the issue as

“Telemedicine is no longer the future, it is here and cutting-edge companies like Wound Care Advantage and Pristine have created an approach to successfully meet HIPAA compliance, improve the patient experience, and conquer wound care from a distance with Google Glass,” said Kurt Arisohn, chief operating officer of WCA. n

quickly as possible, allowing for rapid treatment,” said Mike Comer, chief executive officer of WCA. “The longer it takes to get a patient to appropriate experts, the higher the likelihood that the wound can become either lifethreatening or require an amputation. Pristine’s Google Glass app, EyeSight, goes a long way to helping WCA enable better outcomes.” The product is expected to improve clinical productivity and enable clinicians to see and treat greater numbers of patients.

COMING TO A CITY NEAR YOU!

Rural Wound Care Event Coming to Louisiana A newly launched rural health educational venue is inviting wound care providers to learn about their industry from providers and vendors during an event in Natchitoches, LA, March 13. The second installment of Wound Healing Roundtable will be hosted and moderated by Frank Aviles Jr., PT, CWS, WCC, FACCWS, CLT, and feature a panel of speakers including Daniel T. Ferraras, DPM, FAPWCA; William A. Ball Jr., MD,

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FACS; and others. Topics of discussion will include diabetic care, diabetic infections, and dressings/advanced modalities (eg, negative pressure, honey dressings, and low-frequency ultrasound). “The purpose is to educate attendees regarding wound healing in a relaxed, multidisciplinary setting while demonstrating the science behind the products,” Aviles said. “It is important for all of us to concentrate on basic fundamentals, current research, and expected outcomes in order to select appropriate interventions.The physicians will be asked questions regarding their specialty while the vendors will be discussing appropriate use of their products.” The first roundtable event was held in November 2013. Future events are expected to be held once per fiscal quarter www.todayswoundclinic.com

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and/or as requested. For more information, contact Aviles at 318-228-5056. n

WOCN Announces Top Resources

The Wound, Ostomy and Continence Nurses Society (WOCN) has revealed its most frequently downloaded and purchased products for each specialty during the 2013 fiscal year. The following were most sought after for wound care: • Guideline for Prevention and Management of Pressure Ulcers: A guideline that provides evidencebased information about pressure ulcers and an overview covering the background, significance, and physiological aspects of pressure ulcers. Also presented is the etiology

of pressure ulcers, overall management goals, and recommendations for prevention and treatment. • Clean Vs. Sterile Dressing for Management of Chronic Wounds: This document originated in 2001 as a joint position statement from WOCN and the Association for Professionals in Infection Control and Epidemiology Inc. Its purpose is to review the evidence on clean vs. sterile technique and present approaches for wound management. • Ankle Brachial Index (ABI) Quick Reference: This document provides relevant information about ABI including definition, limitations, indications, contraindications, and guidelines, as well as a research-based protocol to use in performing the test and interpreting the results. n

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continued from page 14

biologic, and ultrasonic debridement; compression therapies; application of cellular- and/or tissue-based products; offloading; pressure redistribution; hyperbaric oxygen therapy; and bioelectric modalities including ultrasound and electric stimulation. All clinical staff should be trained to understand all of these treatments and procedures and be able to articulate to the patient the appropriateness of use and the benefits of certain treatment regimens over others based on wound etiology and patient characteristics. A comprehensive orientation will allow the new member of the staff to visit other departments and clinicians to observe their techniques and particular roles in wound healing. This includes the nurse or PT’s knowledge base on physician debridement as well as the physician’s understanding of bioelectric modalities offered by the PT and OT departments to augment healing. Do not overlook those pieces that seem so simple but can be forgotten or not thought of during the clinic visit, such as gait training and assistive device prescription for those patients wearing total contact casting and other offloading devices. Specific treatment may require certain advanced training and licensure as well as certain credentialing for reimbursement purposes. State practice acts will often dictate who is able to perform which type of service(s) within a wound center and, subsequently, which levels of reimbursement the clinic may receive for said treatments. Look to Medicare local coverage determinations for documentation and licensure requirements required for reimbursement of various treatments and modalities. Many different staff members may have previous training on various treatments, but the clinic may not be eligible for payment unless performed by certain personnel. Look at your clinic model and decide who is able to perform treatments most effectively and legally based on state practice act, licensure, and reimbursement guidelines as well as who can conduct these procedures to garner www.todayswoundclinic.com

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openingyourwoundclinic the appropriate reimbursement. These treatment tasks should be included during orientation and competency should be demonstrated at least annually. This can be accomplished through formal workshops or peer-review activities as long as accepted parameters are explicitly communicated and expectations outlined. All documentation of orientation and competency training must be kept available in the event that a reviewing or accrediting body audits the facility.

CASE MANAGEMENT

One of the areas most critical not only to successful patient healing but to clinic function and financial solvency is case management. Sound case management skills will ensure there are appropriate steps in place prior to a patient’s appointment and set a standard for judicious use of resources to produce the most efficient and effective route to healing for patients when they leave the clinic. Those who are case managing or handling certain aspects of a particular case must be aware of a constantly changing healthcare environment. Will the patient’s insurance cover advanced wound care services and will it cover patients in your clinic, or are they contracted with another provider? Is prior authorization needed for wound evaluation, clinic visits, diagnostics, treatments, or referral? Which insurance providers contract with which durable medical equipment and supply companies? Does the patient have coverage for prescription medications needed, or are there free options or other resources that can be utilized to achieve the best outcome? Wound care providers must also be aware of the constraints faced by allied health members including home healthcare agencies, skilled-nursing facilities, community clinics, and rehabilitation hospitals so they are not being asked to provide a service outside their scope. Appreciation of one’s limitations and capabilities is needed in order to direct patients to appropriate and realistic care. We must respect our patients’ limitations as well.

If patients are uninsured or underinsured, how do we offer the treatments that will save their limbs and perhaps their lives, and how do we do this in an outpatient department without overburdening emergency departments and hospitals? Many of these particular parameters can be covered during staff and physician meetings. A case management “champion” should be named within each clinic, often the clinical manager. This person assumes responsibility for staying current on frequent changes in the field and educates the staff at regular intervals on such changes.

EDUCATION, ONWARD

Education for wound clinic staff should begin at orientation and should be ongoing. All clinic staff members should participate, including operational staff, physicians, and the clinical members. Policies should be in place defining routine competency training and staff education. All staff should be encouraged to pursue outside education as well, including journal articles, conferences, online courses, and local collegial meetings that bring healthcare providers together to discuss wound care and the like. Membership in professional organizations and associations related to wound care should also be encouraged. A portion of staff meetings can be devoted to presentation of the latest research, technology, or regulatory issues affecting patient care and the clinic. Webcast presentations from multiple organizations and providers are something that can easily fit into one’s day and be used to educate many at the same time. Be creative when educating staff and remember that the diligence and consistency will pay off for the clinic and for the patients. n Valerie Sullivan is a physical therapist and a board-certified wound specialist through the American Academy of Wound Management. She is also clinical manager of advanced wound care services and hyperbaric medicine at Capital Regional Medical Center, Tallahassee, FL.

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Advertiser’s Index Advanced Tissue (Wound Care Supplies).................................................................................8 Angelini Pharma (BioPad)........................................................................................................15 Comprehensive Healthcare Solutions (Wound Care & HBOT Programs)...............................29 Derma Sciences (TCC-EZ)............................................................................................. Cover 2 Healogics (Wound Care Management)................................................................................... 17 KCI (CelluTome).......................................................................................................................35 Matrix Health Services (Wound Care & HBOT Programs)......................................................37 MTI (Chairs).............................................................................................................................33 Net Health (WoundExpert)............................................................................................. Cover 3 Organogenesis (Apligraf)......................................................................................... Cover 4, 40 Progressive Medical Technology (IodoFoam BlackGold)........................................................13 Sechrist Industries (HBOT Chambers)......................................................................................3 Smith & Nephew (OASIS)..........................................................................................................5 SteadMed Medical (Xpansion & Drawtex).........................................................................23, 25

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

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

Quicker application Greater comfort

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

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Think Apligraf® FIRST after FOUR weeks of failed conventional therapy.

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Recent evidence has demonstrated the presence of living keratinocyte stem cells in Apligraf.1 The only bioengineered, bilayered, living cell–based product with FDA approval for healing both diabetic foot ulcers and venous leg ulcers.2 Now, turn healing on and transform lives.

For information on support programs and tools available from Organogenesis Inc., call 1.888.HEAL.2.DAY (1.888.432.5232–Option 3). Please see accompanying essential prescribing information, or visit www.apligraf.com for complete prescribing information. References: 1. Carlson M, Faria K, Shamis Y, Leman J, Ronfard V, Garlick J. Epidermal stem cells are preserved during commercial-scale manufacture of a bilayered, living cellular construct (Apligraf®). Tissue Eng Part A. 2011;17(3-4):487-493. 2. Apligraf® [package insert]. Canton, MA: Organogenesis Inc.; 2010.

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