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WoundClinic Wound ToDay’s

Volume 5, number 2, www.todayswoundclinic.com

april 2011

Table of Contents Volume 5, Number 3, April 2011

www.todayswoundclinic.com 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.

Feature Articles 9

Top 10 ConCerns

17 DoCumenTaTion: The 30,000-FooT View 20 DoCumenTaTion: Clearing up The role oF ComplianCe 23 laCk oF DoCumenTaTion may Cause loss oF Dollars 28 sTeps To hiring DynamiC proFessionals For a wounD Care program

reprinTs: Bulk professional-quality reprints (minimum quantity 100) of articles may be purchased. Contact the Managing Editor at (610) 560-0500 for information.

31 To CerTiFy or noT To CerTiFy? ThaT is The QuesTion

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

37 FoCus on The praCTiCe managemenT proCess

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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40 physiCian superVision oF hyperbariC oxygen TreaTmenT 44 CliniCal hyperbariC FaCiliTy aCCreDiDaTion: is The JuiCe worTh The sQueeze? 46 are you reaDy? The new meDiCare aDVanCe beneFiCiary noTiCe (abn) 49 keeping up wiTh CoVerage 52 The ForgoTTen paTienTs: wounD Care CenTers anD ampuTees 56 so, There’s really no Free lunCh? 59 Final 2010 meDiCare poliCy: superVision in hopDs 62 The Chamber oF hboT: suCCess in hboT 65 wounD Care in The era oF mrsa: my pearls anD piTFalls


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Table of Contents Volume 5, Number 3, April 2011

68 eQuipmenT exam: aCCessories anD opTions For hyperbariC Chambers 71 CliniC Design: Three big misTakes To aVoiD when DeVeloping a hyperbariC FaCiliTy 73 The Challengers oF negaTiVe pressure wounD Therapy in CliniCal praCTiCe 76 ToTal ConTaCT CasTing anD nueropaThiC FooT wounDs: implemenTing a golD sTanDarD anD oVerComing barriers To CliniCal use 79 a praCTiCal guiDe To ToTal ConTaCT CasTing 82 oFFloaDing: The ToTal piCTure 84 non-inVasiVe VasCular TesTing anD The wounD Care CliniC 88 an oVerView oF Compression Therapy

WoundClinic Wound ToDay’s

Volume 5, number 2, www.todayswoundclinic.com

march 2011

eDiTorial sTaFF CliniCal eDiTors anD FounDing boarD Caroline E. Fife, MD, FAAFP, CWS Dot Weir, RN, CWON, CWS FounDing eDiTorial boarD Kathleen Schaum, MS Christopher Morrison, MD Val Sullivan, PT, MS, CWS managing eDiTor James Calder jcalder@hmpcommunications.com web eDiTor Caitlin Quarles cquarles@hmpcommunications.com

business sTaFF exeCuTiVe ViCe presiDenT Peter Norris pnorris@hmpcommunications.com Vp/group publisher Jeremy Bowden jbowden@hmpcommunications.com naTional sales manager Kristen J. Membrino kmembrino@hmpcommunications.com sales assoCiaTe Sydney Slater sslater@hmpcommunications.com sales assoCiaTe Kelly Lemly klemly@hmpcommunications.com ClassiFieD aDVerTising assoCiaTe Tara Fields tfields@hmpcommunications.com

92 Compression piTFalls: improVing paTienT aDherenCe wiTh Compression Therapy 96 The DebriDemenT Dilemma reTurns 100 2011 DebriDemenT CoDes haVe ChangeD: be sure your wounD Care Team implemenTs The Changes

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Departments 3

introduction Editor’s Note

For more on This issue VisiT www.ToDayswounDCliniC.Com

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


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HMP CoMMuniCations, LLC PREsiDEnt BIll Norton ContRoLLER Meredith Cymbor-Jones ViCE PREsiDEnt, sPECiaL PRojECts Jeff Hall CREatiVE DiRECtoR Vic Geanopulos vgeanopulos@hmpcommunications.com aRt DiRECtoR Bernadette Hazel bhazel@hmpcommunications.com sEnioR PRoDuCtion ManagER Andrea Steiger asteiger@hmpcommunications.com PRoDuCtion/ CiRCuLation DiRECtoR Kathy Murphy kmurphy@hmpcommunications.com auDiEnCE DEVELoPMEnt ManagER Bill Malriat MEEting PLannER Tracy Blithe, CMP MEEting PLannER Mary Beth Kurimay ManagER of WEb DEVELoPMEnt Tim Shaw HMP CoMMuniCations HoLDings, LLC CHiEf ExECutiVE offiCER Jeff Hennessy CHiEf finanCiaL offiCER Dan Rice HuMan REsouRCEs Anthony Mancini DiRECtoR of infoRMation systEMs David Krautheim

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© 2011, 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 Coummunications Holdings LLC. Discover more about HMP's products and services at www.hmpcommunications.com.

introduction

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have told some dirty secrets in these TWC editorials, including how I got started running a wound center. In 1989 I knew a lot about hyperbaric and environmental medicine, and not much about wound care. I kept getting referred patients with chronic wounds since there was no other place to send them in the massive Houston Medical Center. I went to my departmental chairman to complain that “someone” should open a wound center. He replied, “That would be you.” I was horrified! What I knew about chronic wounds was limited to a three-page handout I received from Claude Burton, the famous Duke dermatologist and originator of the “Duke Boot” (Duoderm plus an Unna’s boot), for venous stasis ulcers. Reluctantly, and with considerable trepidation, I started a wound center at the University of Texas Health Science Center in 1990 with a three-page handout on venous leg ulcers and two dressing products on the formulary. Everything I have learned, I had to learn the hard way. There were no courses, no textbooks, and no industry consultants. The problem is that it took more than 20 years to learn all of this the hard way and there is a “perfect storm” of wounds on the radar screen. We have a national epidemic of diabetes and an aging population who are likely to suffer increasingly from wound problems. We need experienced clinicians and efficient wound centers distributed across the entire USA, ready to see a lot of patients immediately. We need a painless, efficient way to disseminate a lifetime of “learning it the hard way” to as many clinicians as possible. That is the mission of Today’s Wound Clinic. When we first began brainstorming about this journal in 2007, the Editorial Board agreed that we would focus on the things clinicians really needed to know to run a successful center. That has been the unspoken theme of every one of the 21 issues we have produced. Each time we begin fleshing out a new issue, we ask ourselves, “What do we wish we had known when we were getting started?” We realized after 4 years of producing this journal that we had created a “not-so-secret recipe” for the ultimate wound center. It occurred to us that we could combine the best articles of the past 4 years into one “must have” issue of “everything you need to know to get started.” It is hard to believe that 21 years have passed since I was “forced” into this business by an unsympathetic Chairman. I started by doing what was necessary to take care of the patients referred to me (and this included opening a lymphedema center, again only because no one else was doing it). I then began to see what was possible (pharmaceutical trials, electronic data management, wound care textbooks, educational opportunities for colleagues), and now feel that we are entering the realm of “doing the impossible” as we collect data for comparative effectiveness studies and prepare for what will likely be a very big change in the reimbursement model for healthcare delivery. That is the nature of projects worth doing. Start by doing what's necessary, then do what's possible, and suddenly you are doing the impossible. We think this special issue is your instruction manual to achieving all that is possible in wound care, and more.

Caroline Fife, Co-Editor of TWC, cfife@intellicure.com www.todayswoundclinic.com

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FEATURE

Getting Started The Tools You Need to Take Your Hospitalbased Wound Clinic from Concept to Care 

Caroline e. FiFe, MD, FaaFP, CWS; anD Dot Weir, rn, CWon, CWS

The beginning is the most important part of the work. — Plato ince the ancient Greeks first put honey in wounds, our comprehension of wound management has been a slow but steady journey. An understanding of the germ theory led to sterile, dry dressings and frequent antibiotic scrubs. The original work by Dr. George Winter, published in 1962, demonstrated the value of a moist wound environment. Now, recombinant DNA technology and genetic engineering hold out the possibility for growing replacement tissues and blood vessels. Between these extremes lie semi-synthetic human skin, dermal scaffolds, hyperbaric oxygen therapy, negative pressure therapy, topical growth factors, and a billion dollar dressing industry. Wound management crosses all disciplines from physical therapy to plastic surgery and includes podiatry and dermatology. Within a single hospital, clinicians manage postoperative wounds from pediatrics to geriatrics, acute wounds from the emergency department to the burn unit, and chronic wounds from the intensive care unit to the long-term care unit. Some wounds improve and some deteriorate. The reality that patients with multi-organ system failure can “outlive their skin” is ignored by public policy that assesses monetary penalties for pressure ulcer formation regardless of comorbid factors. The disconnect between patient or family expectations and physiological reality can create a medicolegal quagmire for a hospital unprepared to handle the collateral damage of patients who are being admitted older and surviving longer, but sicker. Although these insidious problems are pervasive, in a large organization such as a hospital it is easy to understand why administration may not comprehend the full impact of skin and wound care issues on the institution. An estimated 800+ outpatient wound centers are in operation in the US, not including all the wound care rendered by clinicians in their offices. Studies suggest that patient outcomes are better when care is provided in an environment of focused expertise. To quote Dr. Allan Freedline, “... a systematic approach to wound

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FEATURE Table 1: Comparison of the various levels of electronic medical records according to the  National Alliance of Health Information Technology (NAHIT) Level

Data Type

Example

level 1 level 2 level 3

non-electronic data Machine transportable data Machine organizable data (structured messages, unstructured content, text fields) Machine interpretable data (structured messages, standardized content)

Paper, mail, and phone call Fax, email, and unindexed documents Hl7 messages and indexed (labeled) documents, images, and objects

level 4

care ... leads to superior clinical outcomes, positive revenue streams, and well deserved community accolades.” These centers generate income for the hospital via tests and procedures; additionally, the wound center addresses inpatient wound care challenges, helping decrease runaway woundrelated expenditures. A hospital has the potential to reduce inpatient length of stay and address a significant unmet need in the community when a wound center is established. To do so without exquisite preparation and planning can lead to frustration and failure. However, careful planning and early investment in resources can lead to success.

General PlanninG Key players. From the beginning, there must be buy-in both from the folks who approve plans and budgets and those who take the plan to the hospital’s Board of Directors, many of whom are leaders from the community that you will serve. The hospital’s CEO and CFO should be well informed of the options for program development and become champions of the cause. Include your medical staff office, as well as the marketing team, for ideas about future internal and external marketing needs; they are the resources who will plant informational seeds in the community, identify potential referral sources, and ascertain the perception of need in the medical community. Research your service area. Knowledge of the demographics of the community based on known epidemiological data can assist in projecting the potential needs. Additionally, knowing the current diagnostic trends in the inpatient population (ie, diabetes, cardiovascular disease, patients admitted with wounds) can help predict potential wound care needs. Location, location, location. Determine your proximity to other medical services, patient access, visibility, options 6

Wound Clinic Wisdom

automated transfer from an external lab of coded results into a provider’s eHr. Data can be transmitted (or accessed without transmission) by Hit systems without need for further semantic interpretation or translation for expansion, cost per square foot, and the challenges for equipment installation (eg, hyperbaric chambers). Will you be on- or off-campus? A brief consultation with your hospital legal team will help you understand the potential ramifications to your hospital’s global provider status if you elect to utilize a management company in an off-campus situation. Know your competition. Find out if there are other similar outpatient programs in the community. What are their strengths and weaknesses? Will you compete for the same patients or the same physicians? Perform a market analysis. Evaluate your service area mix, starting with the postal codes for your patients. Hospital marketing can help you assess primary and secondary service area populations to allow you to estimate payor mix.

SPace PlanninG Physical plant. The clinic space must include individual treatment rooms with sinks, adequate front office space, offices, waiting area, clinical workspace, a dictation area, storage areas, and clean and dirty utility rooms. If your plans include a hyperbaric program, you also will need patient changing rooms in addition to oxygen supply, fire safety, and floor weight loading, with consideration to the wax on the floor and the types of lights in the ceiling. It is imperative to consult with individuals qualified to assist you with these unique requirements early in the planning. Treatment room equipment. Podiatry chairs or stretchers, Mayo stands, visitor chairs, and either installed or mobile lighting are the minimum for a properly equipped treatment room. Consider whether counter space in the treatment rooms, as well as space for documentation (electronic or otherwise), is adequate. Don’t forget the basics — thermometers, sphygmomanometers, needle boxes, glove boxes, dirty linen containers, trash cans, and hazardous waste receptacles. www.todayswoundclinic.com


FEATURE Ancillary equipment. At a minimum, you must have hand-held Dopplers and cameras. Transcutaneous oximetry or skin perfusion systems must be securely stored — if possible, installed on carts to move from room to room. Additional specialty equipment such as low-frequency ultrasound or pulsed lavage may be added later. Plan for instrumentation such as curettes, forceps, scissors, rongeurs, tissue nippers, and the like. Determine whether reusable or disposable equipment would be more effective, depending on your resources. Office equipment. Copier(s), fax machine(s), locking file storage, desks or cubicles, phones, and all other essential office needs must be considered. “Point of service” electronic documentation will require a computer in every room.

OPeratiOnal PlanninG Front office. Front office functions. Determine how walk-ins, registration, insurance verification, money collection, check-in and check-out processes, billing reports, payroll and timesheets, and end of month reporting will be handled. Privacy policies. HIPAA guidelines must be established and enforced. Back office. Disposable supplies. Assess what dressings are currently stocked in the hospital. What company or supplier contracts are in place? Is there access to basic dressings — what about advanced products? Is there a procedure currently in place for ordering, tracking, and submitting patient bills for tissue replacements? Often the surgery department will have established protocols in place for acquisition of specialty items. Supply ordering/receiving. Who will maintain par levels? By what mechanism will supplies be assessed and shelves be stocked? How will your inventory database be maintained? Pharmaceuticals. How will pharmaceuticals be handled? Who will maintain this information? Who will reorder? Look at the current hospital formulary for drugs and identify what may need to be added. Consider topical and injectable anesthetics, topical creams, debriding ointments, steroids, and antifungal agents, to name a few. Environmental services. Establish arrangements for and documentation of clean utility, dirty utility, housekeeping, and biohazardous waste removal. Establish a plan in writing for the physical path it will take to exit the building.

clinical PlanninG Physicians. Is there a physician champion already involved? Physician staff recruitment should commence with great care. Physician interest based purely on financial rewards holds the potential for disappointment for all parties. Ideally, a full-time Medical Director who has a passion for wound healing and can assist in attracting other multispecialty physicians should be identified. Setting the stage for collaborative practice with the other clinicians who will be staffing the clinic creates the best scenario for success. At the same time, www.todayswoundclinic.com

be cautious of an arrangement where you are simply bringing together a group of physicians with the motive of gaining access to their “book of business” — ie, a starter patient load. Clear expectations for coverage, timeliness, documentation, patient recruitment, skill and education level, continuing education, and possible board certification is best understood from the beginning. Also, choosing a Medical Director who is able and willing to handle physician and staff issues will go a long way toward keeping a happy and fulfilled staff. There are also unique qualifications for hyperbaric services; medical staff services must have a description of these qualifications. Determine if there will be emergency call coverage. Clinic staff. The ideal situation would involve hiring nurses and therapists with wound experience but this is not always feasible or possible. Additionally, hiring in staff from other specialties — eg, critical care or the emergency room — brings in skill sets that can enhance the knowledge level of the entire staff. Wound care and healing can be taught to interested clinicians. Work ethic, individual contribution, and excellence in patient care delivery are desired attributes in each individual hired. Putting an initial training program in place and encouraging attendance at wound inservices and symposia enable educational growth for the staff at any level. Ultimately, a core group of internally recruited and nurtured experts with a cadre of assistants-in-training will go a long way in meeting your financial goals for staffing as well as providing for permanence and stability in your workforce.

HealtH infOrmatiOn tecHnOlOGy PlanninG Regulatory compliance. A thorough understanding of federal and state regulations, Joint Commission requirements, and coding and billing guidelines is essential to the financial health of the center. The use of a qualified consultant to assist in setting up the chargemaster, training your staff in the complexities of coding wound center visits and procedures, and establishing internally compliant documentation requirements is mandatory. Documentation/coding/billing. Documentation must include patient consent for treatment and photography, an initial visit and history form, regular clinic encounter and wound assessment forms, and a clinic charge form. Electronic systems can be used to create an informational database to track outcomes, build reports, show spin-off revenue to the hospital, provide reports and feedback to referring physicians, and a myriad of other information that is overwhelming to track by hand. In general, reimbursement is linked to quality of documentation. Physician reimbursement is controlled by complex regulations (52 pages long) from the Centers for Medicare and Medicaid Services (CMS) — they detail the specific documentation required to achieve different payment levels for initial and follow-up visits. Reimbursement increases (to a point) with number of procedures and “cognitive effort” (tests reviewed, tests ordered, prescriptions given, complexity of procedures Wound Clinic Wisdom

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FEATURE performed, and the like). Documentation must support both necessity and the service and must be linked to the ICD-9 diagnosis code. Payment for Evaluation and Management Codes (E/M) is determined by the complexity of care based on key components (history, physical examination, medical decision making). There are 6,144 possible combinations for a visit; hence, the use of Level 4 EMRs for calculating the level of service provided is increasing. Levels of service. Medicare (the CMS) defines five levels of service in Outpatient Services; however, only three payment amounts are used.The CMS proposed a reimbursement system based on wound size but recent data showed this would not fairly represent the work performed in outpatient wound centers. The Alliance of Wound Care Stakeholders has endorsed use of an acuity scoring instrument that represents the amount of work performed by staff as a model for facility reimbursement. The CMS has not made final decision on how facilities will be paid. Electronic health records (EHRs). The key consideration in selecting an electronic documentation system is its level of functional and semantic interoperability. Many wound center planners who see the obvious benefits of a wound care specific electronic medical record are met with an impenetrable roadblock from their Medical Records, Business Office, and Information Technology Departments — a lack of sophistication in the EHR’s ability to communicate with other systems in the hospital’s Health Information Management System (HIMS). Of CIOs polled in a recent survey, 90% prefer a generic module of the hospital’s global EHR. This involves more typing, scrolling, and hunting than a specialized solution that is not at National Alliance for Health Information Technology’s (NAHIT) Level 4 of interoperability. Systems at Level 3 and below (the majority of specialized wound documentation systems) cannot fluidly communicate with the hospital’s HIMS. This means the physician can write an order or draft a document in the specialized EHR but it cannot be sent to the hospital HIMS electronically; it must be re-keyed, dictated, or scanned, opening the system to flaws and errors that expose the hospital to liability through discontinuity in the legal medical record (see Table 1). With a properly installed Level 4 EHR, patient admission information is entered in the HIMS and automatically populates in the EHR (ie, no “double entry”). Physician orders written in the Level 4 EHR are automatically sent to the HIMS’ lab system electronically. Letters and other documents produced in the Level 4 EHR are transmitted to the HIMS data repository electronically and may be viewed from any workstation in the hospital. Level 4 EMRs can calculate physician and facility level of service (using acuity scoring), incorporate and drive the adherence to evidence-based clinical practice guidelines, perform benchmarking, and interface with the hospital’s EMR directly. Level 3 EMRs cannot perform these functions. Users of a Level 4 EMR can obtain benchmarking analyses in 8

Wound Clinic Wisdom

Resources Medical information Website: www.medicaledu.com   Data Management — intellicure, inc.: www.Intellicure.com Data Management — net Health Systems, inc.: www.woundexpert.com Consultant — Kathleen Schaum, Kathleen D. Schaum & associates: kathleendschaum@bellsouth.net Consultant — toni turner, Protia Health: www.protiahealth.com Health information Management Systems Society: www.HIMSS.org national alliance of Health information technology: www.NAHIT.org acuity Scoring for facility billing: http://www.o-wm.com/article/6649

comparison to other EMR users. Such a system can also track supplies, handle inventory, and perform marketing analyses and many other functions of critical import to a new wound center.While it may take more effort to work through the process of obtaining a Level 4 EMR, the dividends appear to be worthwhile.

manaGement cOmPany Or nOt? Even the abbreviated description of this process is sufficiently daunting to motivate many hospitals to join with management companies in the creation of their outpatient wound centers. While such an arrangement can conservatively commit 75% of wound center revenue in the service of the management contract, “going it alone” can involve costly mistakes. The topic is up for debate.

final tHOuGHtS Planning to open a wound clinic — a massive undertaking — can cause one to lose sight of the goal — that is, to improve the care of patients with nonhealing wounds. It is intriguing to consider the way wound care becomes a mission for the staff. The visual nature of healing wounds provides an emotional reward often lacking in other disciplines. Grateful patients, often elderly and in need of emotional support, find themselves uniquely attached to the wound center caregivers who often spend more time with them than any other clinicians. However, “we must do well to do good.”The wound center program must be financially successful if its mission is to be realized. In that respect, Plato was not entirely correct. The beginning may be the most important work but as Horace noted, “He has half the deed done who has made a beginning.” ■ www.todayswoundclinic.com


inBusiness ately and why we are not receiving adequate payment for our work? ■ Medicare has denied nearly all of our billed clinic visits ever since we opened the HOPD 3 years ago. Unfortunately, I just learned about this situation. Will you help us identify why?

Top 10 Concerns Challenges to Consider as You’re Getting Started

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■ I am the medical director of an HOPD that provides care to patients from three surrounding states. Their wounds often have been managed with a multitude of simple dressings, such as saline-moistened gauze. Many of the patients now require advanced wound care procedures and products. Unfortunately, the HOPD program director is resistant to purchasing advanced wound care products. She claims that the patient will have co-payments for these products and their accompanying procedures. I thought Medicare patients were charged co-payments for all visits and procedures, not just advanced procedures and products. Will you please explain the Medicare co-payment regulations to me?

Kathleen D. Schaum, mS everal times a week, wound care professionals call with questions about their wound clinics. Following are the top 10 questions that were asked in 2006 — common concerns among wound care centers. We present these questions as reassurance: if you have these dilemmas, you are not alone.

have to establish the clinical processes for the HOPD. I do not believe that I can accomplish that part of the assignment by myself because I have not been trained in the business side of wound care. Will you please advise me if the 1-month deadline is realistic? Can you guide me in setting up the business processes for the HOPD?

■ I am a wound care nurse/physical therapist/nurse practitioner in an acute care hospital. The physicians are encouraging the hospital administrator to open a hospital-owned outpatient wound care center (a hospital-owned outpatient department — HOPD). I have been assigned to open the HOPD in 1 month. The 1-month deadline is a nearly impossible goal, even if I only

■ I am the program director of an HOPD that opened 9 months ago. Last week, the vice president to whom I report announced that the HOPD has lost money every month since it opened. I do not receive any financial reports that keep me informed about revenue collected, denied claims, or other financial pitfalls. Will you help me evaluate if we are coding appropri-

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■ We use numerous advanced wound care drugs, dressings, biologics, and procedures in our HOPD. However, our compliance officer, who is responsible for the chargemaster, will only allow us to include clinic visits on our chargemaster. Will you verify if this is correct? ■ An outside durable medical equipment (DME) supplier provides and bills Medicare Part B for the surgical dressings patients use at home between HOPD visits. The supplier tells the patients to bring the dressings to our HOPD for us to use on the day of their clinic visit. Our program director is pleased with the arrangement because she is always under pressure to reduce expenses. I recently read that departments paid by Medicare under www.todayswoundclinic.com


inBusiness the Ambulatory Payment Classification (APC) system are expected to purchase and supply surgical dressings used on the day of the clinic visit. Will you please clarify whether the HOPD should be purchasing the surgical dressings used on the day of the patient’s HOPD visit or if we can continue using the dressings that patients bring from home? ■ The physicians who practice at our HOPD nearly always bill for 11042 Debridement; skin, and subcutaneous tissue even if they simply remove some fibrin with forceps. The staff of the HOPD believe the facility should bill either 97597 Removal of devitalized tissue from wound(s), selective debridement, without anesthesia (eg, high pressure water jet/without suction, sharp selective debridement with scissors, scalpel, and forceps), with or without topical application(s), wound assessment, and instruction(s) for ongoing care, may include use of a whirlpool, per session; total wound(s) surface area less than or equal to 20 cm2 or 97598 for total wound(s) surface greater than 20 cm2, depending on the size of all the wounds treated during the clinic visit. The problem could become that the procedure billed by the physician and by the HOPD will differ. Will you please verify if that is acceptable? ■ After a Medicare audit, our HOPD had to repay Medicare for all of the claims where 29580 Strapping; Unna boot was coded and billed for the application of a multilayer, sustained highcompression bandage system. Our Medicare contractor released a Local Coverage Determination (LCD) disallowing 29580 for compression bandage systems that do not contain zinc paste. Our HOPD had no idea that the LCD existed. Will you help us identify other LCDs that apply to our wound care business? ■ When our physicians write orders for surgical dressings and for negative pressure wound therapy pumps, the DME suppliers frequently call and say 10

Wound Clinic Wisdom

Getting Started in Business: Tips for Hospital-Owned Outpatient Wound Care Departments (HOPDs) Release the program director from patient care responsibilities and allow her/him to develop the business portion of the hOPD for 3–6 months before opening Research how the registration process, chargemaster, coding, and billing processes actually integrate Develop a clinic visit mapping system that represents the work performed by the hOPD staff Identify all diagnostic tests and procedures that will be ordered and performed by the physicians and staff Select a formulary of basic and advanced wound care drugs, dressings, biologics, and equipment that will be used by the wound care professionals who are practicing in the hOPD Prepare a thorough inclusive hOPD chargemaster make every effort to obtain a wound care-specific electronic medical record that will service both the hOPD and the physicians Become best friends with the professional coder(s) assigned to your hOPD. Determine how much coding will be done via the chargemaster. Schedule educational meetings led by the coder(s) on a monthly basis. nOte: In some hOPDs with state-of-the-art wound care specific electronic medical records, the coders also serve as educators and auditors Purchase and review new IcD-9-cm, cPt® , and hcPcS books every fall assign one person to monitor all draft and final medicare national coverage determinations (ncDs) and local coverage determinations (lcDs). this person should educate all hOPD professionals how the coverage determinations will affect their work. all wound care professionals should let their voices be heard regarding draft and final coverage determinations cPt® is a registered trademark of the american medical association

the physician did not supply adequate information to prove medical necessity for the ordered product(s). Will you help us find and learn the guidelines for justifying the medical need for the various products we order for our patients’ use at home? ■ Our HOPD opened 6 months ago. We were told to bill the same clinic visit level as the physician bills, which we have done for the past 6 months. Recently, we were audited and told that we need to write our own clinic

visit level mapping system. Will you please verify if this is really an HOPD requirement? Whether you are contemplating development of, just launching, or working in a mature HOPD, correct coding, coverage, and payment are paramount to your business success. These top 10 questions are an indication that proper attention to “getting started” is vital to the success of your wound business. As the HOPD matures and coding, coverage, and payment rules change, you www.todayswoundclinic.com


inBusiness must continually update your business as if you were getting started anew each year. “In Business” will cover these and other timely real-life coding, coverage, and payment scenarios that are pertinent to HOPDs at all levels of maturity. Guest authors will be invited to offer guidance in their areas of expertise. If you or your co-workers have any coding, coverage, and payment questions or topics that you would like to see covered in the column, please email them to: kathleendschaum@bell-

south.net. We will include the most requested questions and topics in future columns. For now, please see Table I for some important tips to help you get started with developing or improving your HOPD. ■ Kathleen D. Schaum, MS, is President of Kathleen D. Schaum & Associates, Inc., Lake Worth, FL. Ms. Schaum can be reached for questions and consultations by calling 561-964-2470 or through her email address: kathleendschaum@bellsouth.net.

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 and the author do not represent, guarantee, or warranty that the coding, coverage, and payment information is errorfree and/or that payment will be received. the ultimate responsibility for verifying coding, coverage, and payment information accuracy lies with the reader.

Available in APRIL 2007 New Features Include: • SAWC 20th Anniversary Limited Edition Dust Jacket • 20 New Chapters • Updated Content and References for all Other Chapters • Take Home Messages for Practice in Every Chapter

CHRONIC WOUND CARE 4th Edition 20th Anniversary of SAWC Limited Edition Dust Jacket (First 1,000 copies)

Order before the 2007 SAWC and receive the discounted price of $99 (a $10 savings). To Pre-Order Call: (800) 237-7285 ext. 221 Or visit us online at: www.chronicwoundcarebook.com

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Wound Clinic Wisdom

www.todayswoundclinic.com


instruction insufficiency (CVI) patients. A wound care practitioner’s instinctive response is to compress the edematous leg in an effort to control the cause of the wound rather than to simply dress the ulcer. Knowing when to apply compression, what compression or support to utilize, and how to safely compress are critical in the care of these patients.

The overall pICTure

Compression Therapy: Inside the Wrap Words of WIsdoM: GeT a leG up on CoMpressIon sysTeMs Val SulliVan, PT, MS, CWS; and doT Weir, rn, CWon, CWS

M

r. RU Swollen is referred to your clinic from his primary care provider. He walks into the clinic with an antalgic gait then rests in the waiting room. On examination, both lower extremities are edematous, the left greater than the 12

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right. He has purulent draining ulcers over the left foot and leg as well as the right leg. Pedal pulses are weakly palpable and his blood glucose level is 196 mg/dL. Should this patient receive compression for his lower extremities? Compression therapy is considered a standard of care for chronic venous

Assessment. The bedrock of the treatment plan must be a comprehensive patient assessment. Through appropriate clinical testing, the root cause of the edema must be determined. Does the patient have lymphedema, CVI, or a combination of the two? Is the patient experiencing an acute flare or episode related to another diagnosis such as deep vein thrombosis or congestive heart failure (CHF) exacerbation? A thorough history and exam should rule out disease processes (eg, arterial occlusive disease) that would put the limb at greater risk with the addition of a compression therapy. If arterial patency is in question, comprehensive arterial studies should be done before compression therapy is applied. Special consideration and precaution should be given to diabetic patients who may have a deceptively elevated ankle/brachial index (ABI) secondary to disease related atherosclerotic changes and calcification of vessels. If it has been established that the patient’s lower extremity arterial system is adequate and compression would be of benefit, the source of the swelling (ie, edema or lymphedema) must be determined. Patients with lymphedema ideally should have been seen and treated by a clinician trained in manual lymphatic drainage (MLD) and complete decongestive therapy (CDT), a certified CLT-LANA therapist. Although edema and lymphedema patients both are treated with compression therapy, the lymphedema www.todayswoundclinic.com


instruction

Figure 1: Example of double layered tubular bandage in place.

therapy regimen may be quite different from the management of edema resulting from CVI. Wrap of choice. Multiple types of compression wraps are available for use in wound clinics. Selection of the wrap or bandage type requires not only a comprehensive assessment of the patient and the wound, but also a thorough understanding of the patient’s lifestyle including occupational and social needs, shoe wear, and functional status. For example, a construction or landscape worker likely would be challenged to wear a wrap for a full week due to perspiration and potential for external soiling. Additionally, that same construction worker may be required to wear high boots that would not fit over a multilayered wrap. Missing work is not an option for this patient.What are the alternatives? Access to multiple types of wraps and compression systems is not a supply redundancy. Rather, it is almost imperative for the wound center treating large numbers of patients with edema to have multiple options available to meet the needs of this large patient group. The ability to match the compression choice with the patient’s body, leg type and shape, occupation, shoe requirements, and the like is imperative.

opTIons for CoMpressIon Tubular bandages. Tubular bandages are fabric tubes with horizontal rings of elastic. Used as single or double layer, available with latex or latex-free, they are supplied primarily in rolls, but also in single patient “unit dose” type of packwww.todayswoundclinic.com

Figure 2: Example of long stretch bandage and padding.

aging. A single layer provides approximately 8 mm Hg of compression. Because they are available in a variety of graduated sizes, each manufacturer provides a measuring tape to determine the appropriate choice based on the size of the patients calf, and the degree of stretch, low, medium or high. While not an ideal delivery system for adequate long-term compression, these bandages are an alternative when vascular status is being evaluated or when other options fail. Tubular bandages can be removed at night and may be washed and reused.

Many wraps may prohibit patients from wearing not only the shoes worn into the clinic on the day of the initial wrap, but possibly all of their shoes. Examples: Tubigrip (Convatec, Skillman, NJ), Comperm LF (HartmannConco, Rock Hill, SC). (See Figure 1). Long-stretch bandages. Typically, these elastic bandages offer sustained pressure over a longer period of time. They exert pressure from the outside of the leg, expanding and recoiling as the calf muscles contract and relax. These wraps often are inexpensive

Figure 3: Multilayered wrap applied in circle of eight pattern to exert sustained compression to extremity at all times. Wrap is being covered with a cohesive bandage wrapped in spiral fashion.

compared to wraps; they are are washable, reusable, and easy to apply. Most brands are available premarked with guides to indicate the appropriate amount of stretch. Cotton padding can be applied as a first layer to make the wrap more comfortable. Examples: SurePress and SetoPress (Convatec, Skillman, NJ). (See Figure 2). Multilayer systems. Provided in prepackaged kits, multilayer wraps include a soft cotton padding as a skin-side layer that helps absorb skin moisture, provide padding to bony prominences, and add bulk and padding to the ankle, around the heel, and at the post-tibial area, helping to equalize the pressures exerted by the elastic layers. This graduated compression usually equals 40 mm Hg at the ankle. Examples include: DYNA-FLEX (J&J, Somerville, NJ), Profore (Smith and Nephew, Largo, Fla), Proguide (Smith and Nephew, Largo, Fla). (See Figure 3). A newer option to a pre-packaged multilayer wrap provides seemingly sustained short-stretch equivalency. This system includes a foam layer that molds to the shape of the lower leg and provides a more rigid compressive layer and is followed by a prestretched cohesive bandage layer. The overall effect is less bulky; even at greater stretch on application, patients find it comfortable and non-constricting. These wraps can remain in place up to 1 week although some patients Wound Clinic Wisdom

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instruction

Figure 4: Example of paste bandage. Courtesy AAWC.

may require twice-weekly applications. The length of wear of the outer wrap will drive the choice of primary ulcer dressing used. Examples: DYNA-FLEX (J&J, Somerville, NJ ), Profore, Proguide (Smith and Nephew, Largo, Fla), and Coban 2 Layer (3M, St. Paul, Minn). Paste bandages. Historically referred to as the Unna Boot, these paste bandages consist of roll gauze impregnated with zinc oxide, gelatin, and in some cases calamine. A self-adherent elastic wrap is applied over the paste wrap and the entire bandage dries to a semi-rigid bandage, providing approximately 30 mm Hg at the ankle. Unna boots can remain in place for up to 1 week and cannot be removed at night or for bathing. Examples: Viscopaste (Smith and Nephew, Largo, Fla) and Unna-Flex (Convatec, Skillman, NJ) (See Figure 4). Short-stretch bandage. Like the bandages previously mentioned, the short-stretch variety are applied from the base of the toes to the knees or above. Padding is applied directly to the skin, overwrapped by layers of dressing. Short-stretch wraps work well with the calf pump during ambulation and exercise. Although comparatively expensive, they are reusable and washable. Because of the rapid edema loss typically noted, they often need more frequent reapplication than other compression options. Examples: Comprilan (BSN Medical, Hamburg, Germany) and LoPress (Hartmann, Rock Hill, SC). 14

Wound Clinic Wisdom

Figure 5: Simple post op shoe can allow room for bandages and protect foot.

Problems with wraps. Long-term management of edema often requires the patient to wear compression socks or stockings. Worn faithfully, the stockings can mean the difference between maintaining and not maintaining ulcer healing. Compression stockings come with inherent difficulties, not the least of which is cost. Ironically, the Center for Medicare and Medicaid Services (CMS) will pay

Types of  compression used throughout a patient’s treatment may change as the edema is better controlled and the wound heals. for stockings only when the patient has an ulcer, as part of the Surgical Dressing Policy. Further, because compression can be adjusted as the edema reduces and the nature of the treatment lends to drainage and soilage, a disposable system may be preferred. Stockings are a lifetime necessity. More than one pair is required, not unlike personal socks or stockings. This may cause patients to enter a cycle of repeated ulcerations if they cannot afford the stockings.

Figure 6: Severe sliding of multilayered wrap after 1 week.

Additionally, another more enduring challenge with stocking use is that appropriate application requires flexibility and dexterity, making use difficult for some patients. Orthotic devices. Another long-term alternative for compression are orthotic devices consisting of inelastic straps that overlap and are secured with Velcro®. These devices are easier to apply, are durable, and therefore may be more cost effective than stockings. Examples: Farrow Wrap®(Farrow Medical Innovations, Bryan, Tex), CirCaid®, (Coloplast Corp. Minneapolis, Minn).

CaveaTs for Care Managing the patient requiring compression demands a definite level of competency and skill on the part of the staff and necessitates close attention to detail and patient follow-up. The following are important considerations in the management of the compressed patient. Constant assessment. Changes in edema levels and the potential for high ulcer exudate (especially early in the treatment) require frequent assessment of the patient, leg, and ulcer. Care visits may need to be scheduled twice weekly early on, progressing to weekly unless the patient has home health care and the agency providing the care can provide the appropriate type of wrap as well as the skill level of the nurse changing the wraps in the home setting. Calf and ankle measurements should be assessed www.todayswoundclinic.com


instruction

Figure 8: The use of foam to pad sensitive areas before applying compression wrap.

Figure 7: Iatrogenic injury caused by rubbing of wrap at anterior ankle.

at each visit to confirm the adequacy of the edema management. Hygiene and skin care. With each visit, the leg should be thoroughly washed and moisturized. This step is essential not only for the skin health, but also the patient’s sense of well being. Footwear. Many wraps may prohibit patients from wearing not only the shoes worn into the clinic on the day of the initial wrap, but possibly all of their shoes. An inexpensive alternative to have on hand are standard post-op shoes. These can provide safe ambulation and foot protection and can last for the entire episode of care. (See Figure 5). Prevent Sliding. Multilayer wraps tend to be thicker and heavier and as a result can tend to slide as one unit, especially in the case of very irregularly shaped legs. (See Figure 6). This effect can be lessened by wrapping the leg with adequate tension and can be reduced or avoided completely by applying a thick ointment to the leg such as Aquaphor®, (Bieresdorf AG, Hamburg, Germany), Dermabase®, 15

Wound Clinic Wisdom

(Paddock Laboratories, Minneapolis, Minn), or a non-gritty barrier ointment. This will cause the cotton layer to stick and reduce slippage. Additionally, this practice provides excellent moisturization.

Compression wraps may  cause rubbing,  discomfort, and possibly blistering, resulting in  iatrogenic injury and further  ulceration. Avoid wrinkles. Compression wraps may cause rubbing, discomfort, and possibly blistering, resulting in iatrogenic injury and further ulceration. Instructing the patient to dorsiflex the foot during

the application of the wrap will place the foot in an ambulatory position that allows smoother wrap application. Additionally, the use of foam dressings to pad areas such as the anterior ankle and tibial areas, Achilles tendon, and metatarsal heads can provide protection and an added level of comfort. (See Figures 7&8). Moisture-related skin damage. Wound exudate can cause maceration at the very least and skin breakdown at worst. A barrier ointment such as Calmoseptine®(Calmoceptine, Inc. Huntington Beach, Calif) for protection or Xenaderm® (Healthpoint, Fort Worth, Tex) can be applied before the dressing and the wrap. (See Figure 9). Showering and bathing. The wrap applied for a week or even several days at a time makes personal hygiene a challenge because the wrap needs to be kept dry. Consideration must be given to the patient’s stability and strength and specific suggestions should be included in the patient education for bathing. Bathing at a sink is always an option, although not particularly acceptable one depending on the patient’s occupation and daily activity. Getting in a bathtub while keeping the leg out is another option but requires considerable upper body strength and mobility. Many patients will choose to shower with the wrap on and covered. Devices designed to keep dressings and casts dry have the added benefit of a non-slip surface at the foot. For the patient who chooses to shower with a www.todayswoundclinic.com


instruction

Figure 10: The placement of stockinette over a compression wrap to prevent sticking to clothing and bed linens.

Figure 9: Residual barrier ointment shown after wrap and dressing removed.

plastic bag taped over the wrap, very pointed safety education must be provided to prevent falls. Having another person available for assistance or placing towels on the floor of the shower or tub to eliminate the slick surface can reduce the risk of falls. Cohesive wraps can be sticky. The cohesive layer outer wrap tends to be a bit “tacky” at times, causing pant legs to cling, dirt and lint to adhere, and bed linens to restrict movement during sleep. Applying a plain stockinette can alleviate this problem and make it easier to put on shoes without catching the wrap and causing it to bunch-up at the foot. (See Figure 10). Always have a contingency plan. Patient education is vital when compression therapy is used. A critical success factor is whether the patient will wear the wrap for the prescribed length-of-time and maximize the therapy. The patient who removes the wrap “since I was coming into the clinic anyway” can undermine several days’ worth of therapy. By the same token, the patient who does not remove the wrap www.todayswoundclinic.com

when pain or injuries are occurring also may have problems.

The patient who removes the wrap can undermine  several days’ worth of therapy.  The patient who does not remove the wrap when pain or injuries occur also may have problems. ConClusIon Mr. Swollen indeed may be a candidate for compression therapy. Only a comprehensive patient history and assessment will determine if he should receive compression and, if so, the type of compression treatment and the

length-of-time for the treatment verses support. As previously discussed, the patient’s physical/medical needs, occupational and social situation, functional abilities, and financial means must be considered in the compression decision. If any one of these factors is omitted from the equation, the patient may be doomed to failure. The clinician needs to remember that compression therapy is rarely a short-term treatment. Most patients with chronic lower extremity edema will require long-term compression therapy followed by life-long compressive support to prevent the recurrence of limb threatening ulcerations. In wound healing clinics, there is a popular mantra: “Treat the whole patient, not the hole in the patient.” Clinicians always must remember that we are treating not just the wound or the edematous limb but also a disease process. ■

referenCes 1. Brown AC, Coutts P, Sibbald RG. Compression therapies. In: Krasner DL, Rodeheaver GT, Sibbald RG (eds). Chronic Wound Care: A Clinical Source Book for Healthcare Professionals, Third Edition. Wayne, Pa: HMP Communications; 2001:517–524. 2. Homa L, Macdonald, J, Seaman S. Compression Modalities in Chronic Wound Care: What to Use and When to Use It. Post Conference session presented at the Symposium on Advanced Wound Care and Wound Healing Society Meeting.Tampa, Fla. May 1, 2007. 3. Weir D. Pearls of compression. In Falabella AF, Kirsner RS (eds). Wound Healing. Boca Raton, Fla: Taylor & Francis Group 2005:423–437.

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inwhole as a way of tracking the process of care not just for an individual patient, but for groups of patients in the form of benchmarking and clinical research.

GeneRal PRinciPles oF DocuMenTaTion

Documentation: The 30,000-Foot View Caroline Fife, MD, FAAFP, CWS

D

ocumentation is an intrinsic component of every patient encounter.The financial success of a facility depends upon the completeness of the process. The major factor affecting the quality of an organization’s data (and therefore its revenue stream) is the accuracy of documentation. If you are not already convinced of the importance of accuracy in documentation, a study by the Centers for Medicare & Medicaid Services (CMS) found that of all of the improper Medicare benefit payments made during 2001, 43% were due to documentation errors. It is well known that patient quality of care is also related to quality of documentation. Furthermore, documentation is essential to meet the changing demands of regulatory bodies such as the The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), the Office of the Inspector General (OIG), and CMS. www.todayswoundclinic.com

The WhaT anD Why oF The MeDical RecoRD In the 19th century, the medical record was a sort of personalized lab notebook in which clinicians recorded their observations. In the 21st century, the medical record has many functions, including, serving as a basis for planning and documenting patient care, communicating among numerous health professionals, and protecting the legal interests of the patient and healthcare providers. The medical record may supply information for internal hospital auditing and quality assurance, documenting compliance with governmental regulations, and provide data for medical research. It is also a means of determining the billed revenue for physicians and hospitals. Thus, documentation must validate the medical necessity and appropriateness of the diagnostic and/or therapeutic services provided. What is more interesting about today’s medical records is that they serve

This brief article cannot serve as an exhaustive resource on the legal or medical aspects of documentation. However, there are some basic principles.The medical record should be complete and legible. The documentation of each patient encounter should include the reason for the encounter and relevant history, physical examination findings and test results, assessment, clinical impression or diagnosis, plan for care, and date and legible identity of the observer. The patient's progress, as well as response to and changes in treatment must be documented. The billing codes reported on the health insurance claim form should be supported by the documentation in the medical record. Accepted methods for correcting errors and amending records should be used. While signatures are handwritten in paper documents, electronic records now support electronic signatures which append a statement such as electronically signed by after the clinician enters an assigned security code. Ethical principles pertaining to medical records are available from The American Health Information Management Association (AHIMA). Conduct which is not acceptable includes allowing patterns of retrospective documentation to increase reimbursement, misusing sensitive data or violating the privacy of an individual.

Physician DocuMenTaTion Evaluation and Management codes (E/M codes) used for physician billing are copyrighted and maintained by the American Medical Association. The payment system uses two sets of codes: ICD9 is used to identify the patient’s pathology (diagnosis) and support medical necessity; the Common Procedural Terminology (CPT) is used to code the physician’s treatment of Wound Clinic Wisdom

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inwhole that pathology (ie, the services provided). Payment is associated with different degrees of complexity of care based on key components. Each key component has four levels of difficulty. So, a physician using the 1997 Medicare Documentation Guidelines has 42 choices to consider, ultimately representing 6,144 possible combinations in order to select the correct E/M code (May 25, 2000 “Statement to the Health Task Force Committee on the Budget, United States House of Representatives, Medicare Regulatory Burden Imposed on Physicians,” www.acponline.org/hpp/hbstmt.htm). Electronic medical records systems, which automate this process, are becoming increasingly popular.

hosPiTal BaseD ouTPaTienT WounD cenTeR DocuMenTaTion Outpatient wound center facility reimbursement for Medicare beneficiaries is defined by the CMS in the Hospital Outpatient Prospective Payment System (HOPPS). The HOPPS, published on April 7, 2000 in the Federal Register, was intended to revise the outpatient payment system for wound centers which were instructed to use three sets of five E/M codes: new patients—9920199205; consults—99241-99245; and established/follow-up—99211-99215. Although CMS directed facilities to bill using all of these classes of codes, there were, in fact, only three payment groups. These are also known as Ambulatory Patient Classification (APC) Codes— 610, 611, and 612. The Federal Register specified that each facility be expected to, develop a system for mapping the provided services furnished to the different levels of effort represented by the codes. Time, was readily adopted as a means of assessing the billed level of service. While easy to develop, a system based on a subjective assessment of time spent could result in healthcare workers justifying an inappropriately high-billed level of service compared to the actual work provided. In 2004, the American Hospital Association and AHIMA suggested to CMS that facility level of service be based on wound size, similar to the reim18

Wound Clinic Wisdom

bursement model used for suturing acute wounds in emergency departments. An analysis of over 5,000 outpatient wound center visits, published in Ostomy Wound Management, proved this to be an unworkable method of achieving a reasonable distribution of charges due to the relatively small size of most chronic wounds. A method of measuring staff work was much more likely to yield a fair distribution of charges. CMS has yet to make a final decision on this matter but in the interval, most facilities have adopted various acuity scoring systems. These methods utilize a scoring sheet in which the point score tallied from various work elements tracks to a particular APC rate. CMS has emphasized that the ideal billing system would result in a normal distribution (ie, a bell curve) of clinic charges over a large dataset. Clinics must be wary of scoring systems which might skew charges to the right (towards higher levels of service). Furthermore, while the clinic charges might be calculated using a scoring tool, the tool itself is not sufficient documentation of the services provided. The medical chart must still contain all the elements upon which the score is based. This can create a compliance challenge for the facility, even if the scoring method is a sound one.

DocuMenTaTion unique To WounD caRe Author Note: The InStruction article describes in detail the type of documentation unique to wound care. As physical defects, wounds have length, width, and depth. Undermining and tracts can be measured. The standard unit for measurement is in centimeters. The wound bed and the periwound skin can be described. Granulation, slough, eschar, and epithelization can be described and/or assessed in percent of wound surface area. Drainage can be classified by amount and character. Pain should be assessed. Dressing products must be documented. Documentation includes, the plans for the frequency of their change and the duration of these orders. Third party payers often have specific documentation requirements for the provision of medical equipment or dressing products.

Debridement documentation requirements may include a description of the wound before and after the procedure, as well as the type of tissue removed (see the Fall 2007 issue of TWC). While this descriptive process sounds straightforward, it is not. Studies show tremendous variability among caregivers with regard to these documentation practices. These issues are not simple. Some documentation tools have been validated (eg, the BWAT and the PUSH tool).

iT’s 10 aM; Do you knoW WheRe you MeDical RecoRDs aRe? As the way in which we incorporate modern technology into medical practice evolves, our understanding of the medical record must evolve. Historically, the definition of the legal health record was fairly straightforward—it was the contents of the paper chart. With the advent of various electronic media, the definition of the legal health record has become more complex. It consists of the data, stored on any medium, collected and directly used in documenting services to an individual during any aspect of healthcare delivery. Some types of documentation may physically exist in separate and multiple paper-based or electronic or computer-based databases. The HIPAA privacy rule requires that organizations identify their designated record set. As strange as it may seem, each facility must determine the specifics of the patient’s medical record. If one received a subpoena for a patient’s records, where would they go to get them? For example, in this issue photographs are discussed. How are photographs incorporated into the medical record? Does the custodian of medical records know where those photographs are kept if they had to be produced? Another example has to do with electronic databases. Unless the electronic database has been identified as the legal chart, the paper chart remains the legal chart. That means one still needs to print out copies of whatever is put into the electronic database so that the paper chart remains complete. It is best to define the legal chart www.todayswoundclinic.com


inwhole before having to produce it, rather than after being asked to do so. Hospital records custodian can be a big help here, particularly since there are security issues involved. (For help, see the Health Information American Management Association, AHIMA, report, “Guidelines for Defining the Legal Health Record for Disclosure Purposes,” go to, library.ahima.org.)

usinG RecoRDs FoR BenchMaRkinG anD qualiTy assuRance Healthcare providers are expected to participate in continuous quality improvement. This means constantly examining practices to identify inconsistencies in patient care and look for opportunities for improvement. Thus, medical records provide important information about practice patterns on groups of patients, not just one individual. We can evaluate this through benchmarking. The American Productivity and Quality Centre (APC) provides a number of useful benchmarking guidelines, which are relevant to healthcare processes. The first step is for a clinic to know its own data, meaning that clinics must decide what parameters are relevant to its overall management goals. What parameters should staff follow? Healing rates, the number of patients in service after a certain number of days, the number of patients receiving a certain type of therapy, the revenue generated? Then if possible, a clinic must identify a HIPAA compliant way to compare its own data with that of other facilities. The APC has shown that companies that support benchmarking gain operational benefits and see higher financial paybacks in comparison to organizations, that do not. However, the process of benchmarking is almost impossible without some sort of computer technology.

aDoPTinG TechnoloGy The $1.7 trillion dollar US healthcare industry spends twice as much per capita as Scandanavia or Britain. However, the US has poorer health outcomes. One reason for this discrepancy may be slower adoption of electronic medical records www.todayswoundclinic.com

(EMRs). Compared to other US industries, the healthcare system has been slow to effectively incorporate information technology into the work environment. According to former Secretary of Health and Human Services, Tommy Thompson “The most amazing thing about 21st century medicine is that it’s held together by 19th century paperwork.” The Computer-based Patient Record Institute (CPRI) stated that if providers continue with their current paper systems, they will lack the tools needed to manage the quality and costs of healthcare, the scientific basis for healthcare will continue to be undermined, and healthcare reform will be impeded. What is slowing adoption of health information technology (HIT)? HIT is expensive and providers are uncertain as to the value they will derive for their investment. Furthermore, while doctors or hospitals are the ones who have to purchase HIT, as much as 80% of the potential healthcare savings accrue to insurers. And, like all technological advances, HIT is in a constant state of evolution. What if the system purchased today is obsolete tomorrow? What if it is not compatible with some system the hospital already has? For all of these reasons, clinicians find it difficult to decide how to incorporate technology into their practices. Nevertheless, electronic medical records are coming to every hospital, and to every clinic, one way or another.

hiPaa anD The naTional healTh inFoRMaTion neTWoRk In 1996, Congress passed The Health Insurance Portability and Accountability Act (HIPAA). Its original purpose was to set a national standard for electronic transfers of health data, but Congress also saw the need to address growing public concern about the privacy and security of personal health data. The HIPAA Privacy Rule, issued by the US Department of Health and Human Services (HHS), became effective for most healthcare providers on April 14, 2003. The regulations are too broad to be discussed here but they have likely affected some aspect of every practice, particularly in how to handle access to

your medical records. More recently, the situation got even more interesting. In 2004, President Bush issued an Executive Order requiring HHS to develop a national health information network (NHIN) within 10 years, overseen by a new HHS office,The Office of the National Coordinator for Health Information Technology. A number of bills have been introduced in Congress to speed the development of a national system of electronic health records.

so WhaT’s a clinic To Do? Each wound center must critically assess their specific documentation needs. Not only must the mechanism of data storage be determined, but data retrieval must be determined as well. If paper is deemed adequate for individual patient records, then outcomes data and photographs will likely need to be managed by some other mechanism. Questions that follow will consist of:What information is important? How will it be kept? Who will keep it and how will it be used? Medical documentation, like medical care is a process and defining a system to improve your documentation might actually result in improving medical care for the patients. n

For more inFormation visit: the american Health information management association (aHima)

www.ahima.org/about/about.asp

2004 Code of ethics - Body of Knowledge and the 2004 november/ December Journal of aHima

http://library.ahima.org/xpedio/group s/public/documents/ahima/pub_bok1 _024277.html

the american Productivity and Quality Centre

www.apqc.org/portal/apqc/site/?path =/research/index.html

Documentation and Compliance Policies

www.hsc.unt.edu/policies/QuAssure/ Clinical%20Documentation&Complian ceManual042704.pdf)

the office of the national Coordinator for Health information technology

www.hhs.gov/healthit/measuring.html Wound Clinic Wisdom

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DOCUMENTATION: CLEARING UP THE ROLE OF COMPLIANCE Ensuring the Charts Match the Care Received Moira Hayes, MHa, rrT, CHT

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ompliance in the US generally means adherence to laws and regulations. Corporate scandals and breakdowns such as the Enron case in 2001 have highlighted the need for stronger compliance regulations for publicly listed companies. In the medical world, focus is on maintaining regulatory compliance in all activities of documentation and coding for billing professional services. The importance of documentation has been emphasized throughout this issue of TWC. With regulatory organizations closely monitoring activities, patient quality of care at stake, and the financial success of a wound center dependent on the quality of documentation, a compliance process is an absolute necessity. How will wound centers ensure what ends up in the chart accurately reflects the care that was provided to the patient, as well as the services that were billed?

AUDITING OPTIONS Although physician and facility billing are controlled by separate governmental requirements, there are two overarching principles which apply to documentation compliance: 1) Billed level of service must correlate with the level of service documented in the chart. This is applicable for both the physician and the facility. 20

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2) In some circumstances (ie, surgical excisional debridement), the level of service billed by the physician and the facility must correlate with each other.

“HOW WILL WOUND CENTERS ENSURE WHAT ENDS UP IN THE CHART ACCURATELY REFLECTS THE CARE THAT WAS PROVIDED TO THE PATIENT, AS WELL AS THE SERVICES THAT WERE BILLED?� Many healthcare organizations have been scrutinizing the documentation and revenue cycle of their outpatient wound care programs. Some organizations have no audit process at all, while others may audit 100% of charts, involving many hours of resources. However, most audit programs fall somewhere in between. Not only must a facility determine the method of audit, but the sample size. Some facilities may choose to perform a random audit of a specific percentage of charts (ie, one chart in 10). Alternatively, all charts might be audited over a specific time frame (eg, 1 month).

Typically, one of the following three methods is used to determine the billed level of service for either the physician or the facility: 1) Abstraction of the paper chart by a trained expert. 2) Allowing the provider to estimate their level of service and select it on the charge master. 3) Using an electronic medical record (EMR) to directly calculate the billed level of service based on documentation. Abstraction of the chart by a professional coder continues to be the gold standard, particularly in relation to physician level of service. Depending on the training and skill of the coder, this is more than likely the most accurate method of ensuring correct correlation between clinical documentation and billed level of service. Abstraction is the most expensive yet least efficient billing method. Professional coders are also the gold standard for the abstraction of the diagnostic and procedural levels of service provided in a facility. However, there is an almost crippling shortage of qualified medical coders which threatens the revenue cycles of many institutions, as discussed by Kathy M. Johnson in the February issue of the Revenue Cycle Strategist.1 Abstraction of charts might be a reasonable method for performing a www.todayswoundclinic.com


coverstory focused audit of billed charges, but it is not a practical method to determine the billed level of service on a day-today basis for billing purposes. In day-to-day practice, the most common method for determining billed level of service is simply to have the provider estimate the work they have provided, based on their personal assessment of the subsequent clinical documentation. The problems associated with this option in the wound center setting have been described previously. Dr. Fife and colleagues demonstrated that allowing facility staff to estimate the level of service they provided (using time as a metric) consistently resulted in an over-estimation of actual services when compared with specific measures of staff work.2 Physicians may not be any better than nursing staff when it comes to using their own documentation guidelines. A recent study compared the coding accuracy of 600 family practice doctors with professional coders.3 Family physicians agreed with the experts that only 17% of the time for new patient visits, the predominant error being over-coding by physicians. Thus, data suggest that when either physicians or nursing staff estimate their level of service after seeing a new patient, they will over code. The over-coding is probably due to the difference between the work one perceives one has provided, and the necessary documentation to justify this work. Even though a higher level of care might have actually been provided, if the documentation does not support the level of service, which was billed, it is still considered over-coding. Facility billing is an additional alternative to using a template to track specific work related tasks. The concept is to create a paper document listing a variety of work tasks each of which are given a point value. The total point score then tracks to level of service. The template is not really part of the medical record. The work tasks performed must still be documented somewhere in the chart. While templates can be a useful tool, rather than ensuring compliwww.todayswoundclinic.com

ance, templates can actually create compliance problems. There is no feedback system to ensure that only those activities actually performed are marked on the template, unless a dedicated individual is tasked with abstracting the chart (back to option number one). Thus, templates are an example of an open loop system, which can actually create compliance issues. At this time, templates might be the most commonly used option for calculating facility work in hospital based outpatient wound centers. In the absence of a specific Medicare ruling on outpatient billing,

“EVEN THOUGH A HIGHER LEVEL OF CARE MIGHT HAVE ACTUALLY BEEN PROVIDED, IF THE DOCUMENTATION DOES NOT SUPPORT THE LEVEL OF SERVICE, WHICH WAS BILLED, IT IS STILL CONSIDERED OVER-CODING.” there are significant challenges in creating the template, ensuring that the point distribution will yield a normal distribution of charges and not skew charges to the right (ie, toward higher levels of service), and implementing the template consistently when complex work tasks are involved. A third option is to use an EMR to ensure a direct correlation between documentation and billed level of service. In this option, the computer functions like a coder and abstracts the documentation within the electronic medical record to calculate the level of service. This type of calculation cannot be performed with electronic documentation systems, which use text fields. The data fields require a significant amount

of backend programming to make this possible. The EMRs, which can perform these calculations, are referred to as Level 4 EMRs. There might be electronic systems, which the physician or nurse selects the level of service provided by clicking a check box, but such a system is really no different than using a paper template. Only if the calculations are internal to the programming does the system qualify as an electronic medical record. This is a key feature to understand when you are selecting a program for your facility. A Level 4 EMR, which automates billing, is ideal from a compliance standpoint because compliance is also automated. While there is no downside from the standpoint of compliance, clinicians and other healthcare professionals may be wary of having a true electronic medical record. They may be uncomfortable navigating through computer screens rather than flipping through chart tabs. Medial record’s policies and procedures may need to be altered to accommodate a paperless system. Coders and auditors will need training to facilitate hospital revenue cycle management. However, it has been this author’s experience that implementing an electronic medical record system for wound care is well worth the effort. Cheri Conerly, director of revenue integrity, Hospital Partners of America, is a proponent of electronic medical records for the wound care service lines. “Electronic medical records facilitate the coding, nursing, support staff, and physician documentation for each patient,” Conerly says. “Everything ties, and only appropriate charges are entered. The audit process is much easier and faster.” Electronic medical record systems have been used in settings other than wound care to facilitate documentation accuracy. A unique study evaluated emergency services provided by two hospitals, one using a paper-based, template-driven system and the other a specialty specific electronic medical record.4 There was no statistically significant difference between the completeWound Clinic Wisdom

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coverstory ness and accuracy of the electronic records compared to paper systems assessed by expert coders. The electronic medical record incorporated clinical structured terminology, American Medical Association CPT codes, and used clinical algorithms that directed physician documentation of the key clinical elements (in other words, it was a Level 4 EMR). What is more important, the electronic records could be easily surveyed for consistency, something not true of the paper templates.

COMPLIANCE CONSIDERATIONS Accurate and compliant documentation is the cornerstone of both clinical care and fiscal viability. If paper charts continue to be the standard at a facility, then a compliance program must be put in place to assess that certain types of documentation are consistently available in the record (photographs, measurements, and so on), and that billed level of service reflects the documentation. This will necessitate staff member time, and likely the involvement of a professional coder. Furthermore, staff will have to ensure that facility documentation and physician documentation agree with each other in key areas such as debridement. If templates are used to facilitate clinic billing (and for the most part, templates are still used in the context of a paper based medical record), compliance must not only include ensuring that source documentation reflects what is checked in the template, but that the point system used is likely to result in a normal or bell shaped distribution of charges. In other words, a point distribution cannot be intentionally selected to skew points to higher levels of service.1 A template system will likely still require staff member time to ensure compliance, cross checking activities marked on the template with those available in the chart. With paper based systems, it is not feasible to ensure compliance in 100% of medical records. Only some 22

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percentage of records can be assessed. Some standard system must be put in place to perform this function consistently, and if possible, randomly. To ensure compliance with a paper medical record, utilizing a template, a system for assessing the accuracy of documentation must be developed and maintained. The schedule must be compared to the charge sheets, to ensure that all patients have appropriate paperwork for billing. The charges entered into the system must be compared to the paperwork turned in by the clinical staff. And lastly, the charges that were

“ACCURATE AND COMPLIANT DOCUMENTATION IS THE CORNERSTONE OF BOTH CLINICAL CARE AND FISCAL VIABILITY.”

entered must be compared to the medical record for accuracy after the physician dictation has returned to the center. Each chart must be reviewed for accuracy by a designated and trained individual in the center. Any changes or discrepancies must be noted, and the charges adjusted to reflect only those charges that are appropriate. This process is much more difficult than it sounds, given the numerous requirements for procedural documentation, evaluation and management documentation, advanced therapy modalities such as hyperbaric oxygen therapy, negative pressure therapy, dressing selection, and so on. There are mitigating factors in almost every medical record that create innumerable scenarios for billing errors. After the wound care department has determined that the charges are accu-

rate, there should be a check and balance system with the hospital revenue integrity department, or coders. A minimum of a 10% per month audit of the wound care center medical records should take place to ensure the accuracy of the billing and documentation. This is a very time consuming process. An individual patient record can take up to an hour to audit, depending on the complexity of the patient, and the skill of the auditor. The audit results must then be managed and analyzed. If the results were less than stellar, a performance improvement plan must be developed and implemented, and the audit percentage increased to 100% until appropriate results are obtained. Through utilizing an integrated EMR, the burden of assessing compliance is lessened dramatically. Clinical staff perform their documentation, and it is this documentation, which automatically determines the level of service provided. This linkage between documentation and billed level of service assures compliance in 100% of clinical records. No separate audit process is necessary. This is the most efficient and comprehensive compliance tool, but also requires the most commitment to implement. n Moira Hayes, MHA, RRT, CHT is the CEO of Innovations Healthcare Consulting, Inc. of Houston,Tex. She can be reached with questions or consultations via her email address at moira.hayes@sbcglobal.net, or via phone at (713) 301-5707.

REFERENCES 1. Johnson, KM. The massive medical coder shortage. Revenue Cycle Strategist. 2008;5(2):1–3. 2. Fife CE, Walker D, Farrow W, Otto G. Wound center facility billing: A retrospective analysis of time, wound size, and acuity scoring for determining facility level of service: Ostomy Wound Manage. 2007;53(1):34–44. 3. King MS, Sharp L, Lipsky MS. Accuracy of CPT evaluation and management coding by family physicians. J Am Board Fam Pract. 2001;14(3):184–192. 4. Silfen E., Documentation and coding of ED patient encounters: an evaluation of the accuracy of an electronic medical record. Am J Emerg Med, 2006;24(6):664–678

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inbusiness • May 2007: Medicare Payments for Surgical Debridement Services in 2004. • June 2007: Medicare Payments for Negative Pressure Wound Therapy Pumps in 2004. Unfortunately, both reports found that documentation in the medical records of wound care patients did not adequately support medical necessity of the procedure(s) performed and/or the product(s) ordered. The OIG found Medicare overpaid $64 million for false claims involving surgical excisional debridement and $27 million for false claims involving negative pressure wound therapy pumps and supplies.

MEDICarE MEDICaL rEvIEWs

Lack of Documentation May Cause Loss of Dollars Kathleen D. Schaum, mS

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arly in their medical/clinical training, wound care physicians and clinicians learn the caution, if it’s not documented, it’s not done. Few physicians and clinicians, however, realize the enormous financial consequences that the lack of documentation can have on their practices if: • they perform self-audits and find that their documentation did not support the codes that were billed and the payments they received and/or • they receive a Medicare audit and find that their lack of documentation resulted in false claim submissions. In wound care settings a variety of physicians and clinicians practice as a team to achieve excellence. Each 23

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member of that team should take personal responsibility for clearly documenting the work they perform. These professionals should not only use the documentation guidelines learned during their medical training, but should also follow the guidelines of the payers who review their claims for medical necessity. Most Medicare contractors provide educational seminars, webinars, online training, educational documents related to documentation, medical policies, and articles that include documentation requirements.

OIG WOunD CarE rELatED rEpOrts In the middle of 2007, the Office of Inspector General (OIG) released several reports regarding the wound care industry:

Numerous medical reviews have been conducted by Medicare contractors regarding surgical dressings that were not ordered according to the guidelines of the Surgical Dressing Local Coverage Determination (LCD) and its accompanying Article. Most recently, Medicare contractors have been requesting repayments due to the fact that providers have not documented the method of fixation for skin replacements and skin substitutes. Since these are considered surgical procedures, the payers expect to see fully documented procedure reports, including the method of fixation used to secure the skin replacements and skin substitutes. Some contractors recommend the minimal fixation (eg, steri-strips) they require while other contractors leave the decision up to the physician who applies the products. However, all Medicare contractors expect that the medical record will include documentation of the fixation method selected. Therefore, each wound care physician and clinician must take personal responsibility for reviewing the documentation guidelines that the payers provide. One should not become complacent with inadequate documentation just because all claims are currently paid. Remember, repayments can be enormous if medical records are audited and your documentation does not adequately support medical necessity for the fees that were paid. www.todayswoundclinic.com


inbusiness TABLE 1. Example: Surgical Dressing Documentation Guidance • Section 1833(e) of the Social Security Act precludes payment to any provider of services unless there has been furnished such information as may be necessary in order to determine the amounts due such provider. It is expected that the patient's medical records will reflect the need for the care provided. The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

• An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code. • The order must specify (a) the type of dressing (eg, hydrocolloid wound cover, hydrogel wound filler, etc.), (b) the size of the dressing (if appropriate), (c) the number/amount to be used at one time (if more than one), (d) the frequency of dressing change, and (e) the expected duration of need • A new order is needed if a new dressing is added or if the quantity of an existing dressing to be used is increased. A new order is not routinely needed if the quantity of dressings used is decreased. However, a new order is required at least every 3 months for each dressing being used even if the quantity used has remained the same or decreased. • Information defining the number of surgical/debrided wounds being treated with a dressing, the reason for dressing use (eg, surgical wound, debrided wound, etc.), and whether the dressing is being used as a primary or secondary dressing or for some noncovered use (eg, wound cleansing) must be obtained from the physician, nursing home, or home care nurse. The source of that information and date obtained must be documented in the supplier's records. • Current clinical information, which supports the sensibility and necessity of the type and quantity of surgical dressings provided, must be present in the patient's medical records. Evaluation of a patient's wound(s) must be performed at least on a monthly basis unless there is documentation in the medical record which justifies why an evaluation could not be done within this timeframe and what other monitoring methods were used to evaluate the patient's need for dressings. Evaluation is expected on a more frequent basis (eg, weekly) in patients in a nursing facility or in patients with heavily draining or infected wounds. The evaluation may be performed by a nurse, physician or other health care professional. This evaluation must include the type of each wound (eg, surgical wound, pressure ulcer, burn, etc.), its location, its size (length x width in cm.) and depth, the amount of drainage, and any other relevant information. This information must be available upon request.

stEps tO suCCEss The following are some steps to success for identifying payers’ policies that should be followed: • Identify the top payers for the wound care patients. • Identify the Medicare contractors that process the claims for the facility and for the physicians who practice there. (Please note: Currently the facility and the physicians could have different Medicare contractors who write similar or different policies. Over the next few years, the same Medicare contractor will process both the facility and the physician claims; the policies should be more closely aligned once that happens). • Visit the websites of all commercial payers and Medicare contractors who process claims for the facility and for the physicians who practice there. Search for educational materials, policies, newsletters, seminars, webinars, etc. regarding each of the services, procedures, and products that are on your charge sheets and www.todayswoundclinic.com

that are eventually submitted as claims to the payers. • Review and compare the documentation guidance, which is provided for the facility and the physician, with the entire medical and clinical staff of your outpatient wound clinic. • Schedule frequent physician and clinician staff meetings to share every guidance policy that pertains to the services, procedures, and products performed/used. • Assign someone to regularly review the payers’ websites for new and/or updated guidance policies. • Schedule physician and clinician training every time new/updated guidance policies are released. • Conduct self-audits frequently; if compliance issues are found, report them to the corporate compliance officer immediately.

DOCuMEntatIOn GuIDanCE ExaMpLEs Finally, let’s review some examples of the pertinent documentation guidance

that physicians and clinicians will find when they review their Medicare contractor’s LCDs and Articles. Remember, documentation must be present to support medical necessity, which in turn supports your payment. (Please note: The examples provided are only pertinent to the clinicians and physicians under the jurisdiction of the Medicare contractor who developed the LCD/Article. Furthermore, these examples may be out-of-date by the time this column is published. Every clinician and physician should research the LCDs and Articles that are specifically pertinent to their payers and their geographical area. Do not follow the guidelines found in Tables I–IV; they are only provided as examples to show the type of documentation policies that currently exist.) • The DME MAC (Medicare Administrative Contractor) TrustSolutions provides documentation guidance (See Table I) in the LCD for Surgical Dressing (L11449), which can be found at: Wound Clinic Wisdom

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inbusiness www.cms.hhs.gov/mcd/viewlcd.as p ? l c d _ i d = 1 1 4 4 9 & l c d _ ve r sion=36&show=all If surgical dressings are ordered for patient use at home, you should obtain the LCD for Surgical Dressings that pertains to the patients’ specific payers. • The MAC (Medicare Administrative Contractor) TrailBlazer Health Enterprise provides basic wound care and debridement documentation guidance (see Table II) in the LCD for Wound Care- Chronic Refractory Wounds (S-130B-R3), which can be found at: www.trailblazerhealth.com/Tools/L ocal%20Coverage%20Determinatio ns/Default.aspx?ID=2811 Clinicians and physicians should locate their respective payers’ policies regarding required chronic wound care and debridement documentation to prevent future repayments.

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• The Medicare Carrier First Coast Service Options provides documentation guidance for the application of various skin substitutes (see Table III) in their LCD for Skin Substitutes (L13381), which can be found at: www.cms.hhs.gov/mcd/viewlcd.asp ?lcd_id=13381&lcd_version=13&ba sket=lcd. If your facility and physicians offer the state-of-the-art procedures/products, be sure to review the Medicare contractor’s pertinent LCDs and Articles. • The MAC (Medicare Administrative Contractor) Wisconsin Physician Services provides documentation guidance (see Table IV) in their Part A LCD for Hyperbaric Oxygen (HBO) Therapy (L26527), which can be found at: www.cms.hhs.gov/mcd/viewlcd.asp ?lcd_id=26567&lcd_version=3&bas ket=lcd

Facilities and physicians who provide HBO therapy should locate their payers’ documentation guidelines on this topic.

suMMary Now that examples of documentation guidelines have been reviewed, which are provided by several Medicare contractors, one should be motivated to conduct research and find the medical policies that apply to the physicians and clinicians who work in the wound care center for excellence where they work. Educate oneself regarding the documentation requirements. If one needs assistance to interpret the guidance policies, contact the medical director of the payer who wrote the policy and/or request an inservice from the professional coder(s) in the facility and in the physicians’ practices. Ultimately, each physician and clinician should assume the responsibility for their own documentation. This high quality documentation should reduce the

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inbusiness TABLE 2. Example: Chronic Wound Care and Debridement Documentation Guidance • Documentation supporting the medical necessity should be legible, maintained in the patient’s medical record, and made available to Medicare upon request.

• The medical record must include a plan of care containing treatment goals and physician follow-up. The record must document complicating factors for wound healing as well as measures taken to control complicating factors when debridement is part of the plan. Appropriate modification of treatment plans, when necessitated by failure of wounds to heal, must be demonstrated. • The patient’s medical record must contain clearly documented evidence of the progress of the wound’s response to treatment at each physician visit. This documentation must include, at a minimum: o Current wound volume (surface dimensions and depth). o Presence (and extent of) or absence of obvious signs of infection. o Presence (and extent of) or absence of necrotic, devitalized or non-viable tissue. o Other material in the wound that is expected to inhibit healing or promote adjacent tissue breakdown. • When debridements are reported, the debridement procedure notes must demonstrate tissue removal (ie, skin, full or partial thickness, subcutaneous tissue, muscle, and/or bone), the method used to debride (ie, hydrostatic, sharp, abrasion), and the character of the wound (including dimensions, description of necrotic material present, description of tissue removed, degree of epitheliazation, etc.) before and after debridement. • Appropriate evaluation and management of contributory medical conditions or other factors affecting the course of wound healing (such as nutritional status or other predisposing conditions) should be addressed in the record at intervals consistent with the nature of the condition or factor. • Photographic documentation of wounds immediately before and after debridement is recommended for prolonged or repetitive debridement services (especially those that exceed five debridements per wound). Photographic documentation is required for payment of more than five extensive debridements (beyond skin and subcutaneous tissue) per wound. • When ES or ET is used, wounds must be evaluated periodically (no less than every 30 days) by the treating physician. Clear documentation of this must be present in the patient’s medical record. • Debridements of the wound(s), if indicated, must be performed judiciously and at appropriate intervals. Medicare expects that, with appropriate care, wound volume or surface dimension should decrease by at least 10% per month or wounds will demonstrate margin advancement of no less than 1 mm/week. Medicare expects the wound care treatment plan to be modified in the event that appropriate healing is not achieved. • Persons who report debridement services to Medicare must pay close attention to CPT code definitions for debridements. The following coding guideline found in the associated LCD article is repeated here for emphasis: o CPT codes 11040–11044 are used to report surgical removal (debridement) of devitalized tissue from wounds. CPT codes 11040–11044 are payable to physicians and qualified non-physician practitioners licensed by the state to perform the services. o CPT codes 97597–97598 are used to report selective (including sharp) and non-selective debridement of devitalized tissue and are payable to physicians and qualified non-physician practitioners, licensed physical therapists, and licensed occupational therapists. o Removal of non tissue-integrated fibrin exudates, crusts, biofilms or other materials from a wound without removal of tissue does not meet the definition of any debridement code and may not be reported as such. • With appropriate management, it is expected that, in most cases, a wound will reach a state at which its care should be performed primarily by the patient and/or the patient's caregiver with periodic physician assessment and supervision. Wound care that can be performed by the patient or the patient's caregiver will be considered as maintenance care. • Payment for prolonged, repetitive debridement services requires adequate documentation of complicating circumstances that reasonably necessitated additional services. Medicare expects fewer than five debridements involving removal of muscle and/or bone debridements to be required for management of most wounds.

number and amounts of repayments that the facility and the physicians may incur. Remember that above all, documentation is essential for correct payment and clean claims. n Kathleen D. Schaum, MS, is President of Kathleen D. Schaum & Associates, Inc., Lake www.todayswoundclinic.com

Worth, FL. Schaum can be reached for questions and consultations by calling (561) 9642470 or through her email address: kathleendschaum@bellsouth.net. Information regarding coding, coverage, and payment is provided as a service to TWC readers. Every effort has been made to ensure

the accuracy of the information. However, HMP Communications and the author do not represent, guarantee, or warranty that 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 at the discretion of the reader. Wound Clinic Wisdom

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TABLE 3. Example: Skin Substitute Documentation Guidance • Medical record documentation maintained by the treating provider must substantiate the medical necessity of the services being billed. In addition, documentation that the service was performed must be included in the patient’s medical record. This information is normally found in the history and physical, office/progress notes, hospital notes, and/or procedure report.

• Documentation must support the criteria for coverage as set forth in the “Indications and Limitations of Coverage and/or Medical Necessity” section of this policy, as well as, the appropriate diagnosis and response to treatment (ie, progress toward healing). • Documentation must support FDA labeling (where applicable), including the criteria, frequency, and acceptable duration of treatment for any skin substitute product billed • The primary physician, or diabetic’s managing physician, must be identified in the medical record if different from the physician managing the wound care apligraf® / Dermagraft® For treatment of venous insufficiency ulcers, and diabetic foot ulcers the record must identify the duration of the ulcer’s presence with a description of the conservative treatment measures taken. The medical record must contain a description of the wound at baseline (prior to beginning conservative treatment) relative to size, location, stage, and presence of infection. The documentation must provide an updated description of the wound prior to Apligraf® or Dermagraft® application in terms of response to treatment (ie, ulcer measurement and progress toward healing). Following Apligraf® or Dermagraft®, application, continued documentation noting changes in the ulcer must be present. Additional applications must also be noted Integra® Documentation should support that Integra® is being used for post-excisional life-threatening full-thickness or deep partial-thickness burns where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient OasIs® Wound Matrix Documentation must support that prior to treatment with OASIS, the wound/ulcer has been treated with intensive conventional non-surgical therapy and has not decreased in size and/or depth, and the wound/ulcer has not shown any indication (eg, granulation or progression towards closure) that improvement is likely. The documentation must show the patient is competent and/or has the support system required to participate in follow-up care associated with treatment of the wound with the product. OrCel™ For treatment of split thickness donor site wounds in burn patients the medical record must contain a description of the wound at baseline prior to beginning of treatment, relative to size, location, and presence of infection. The documentation must provide an updated description of the wound following the application of OrCel in terms of response to treatment (ie, progress toward healing)

TABLE 4. Example: HBO Documentation Guidance • Hospital/Outpatient records should clearly document the history and physical exam, a reason for the treatment, and a report of the treatment.

• Medical documentation must include: 1. An initial assessment, which will include a medical history detailing the condition requiring HBO. The medical history should list prior treatments and their results including antibiotic therapy and surgical interventions. This assessment should also contain information about adjunctive treatment currently being rendered; 2. Physician progress notes; 3. Any communication between physicians detailing past or future (proposed) treatments; 4. Positive gram-stain smear is required to support the diagnosis of gas gangrene; 5. Culture reports are required to confirm the diagnosis of Meleney’s ulcer; 6. Definitive radiographic evidence OR bone culture with sensitivity studies are required to confirm the diagnosis of osteomyelitis; 7. In the treatment of diabetic wounds of the lower extremities, that the patient has type I or type II diabetes and has a lower extremity wound that is due to diabetes; the patient has a wound classified as Wagner grade III or higher; and the patient has failed an adequate course of standard wound therapy. 8. HBO treatment records describing the physical findings, the treatment rendered and the effect of the treatment upon the established goals for therapy. • Effective January 1, 2005, the following may be included in calculating the total number of 30-minute intervals billable under C1300: (1) time spent by the patient under 100% oxygen; (2) descent; (3) air breaks; and (4) ascent. This must be supported by the documentation. (Please note: A physician order for a 90-minute HBO treatment typically means that the physician desires that the patient be placed under 100% oxygen for 90 minutes. In order to safely achieve 100% oxygen for 90 minutes, additional time may be needed to provide for the descent, air breaks, and ascent. Therefore, the total number of billable 30-minute intervals would not be based solely on the amount of time noted on the physician order. In calculating how many 30-minute intervals to report, hospitals should take into consideration the time spent under pressure during descent, air breaks, and ascent. Additional units may be billed for sessions requiring at least 16 minutes of the next 30-minute interval. For example, 2 units of HCPCS code C1300 should be billed for a session in duration of between 46 and 75 minutes, while 3 units should be billed for a session in duration of between 76 and 105 minutes. Furthermore, 4 units of HCPCS code C1300 should be billed for a session in duration of between 106 and 135 minutes. HBO is typically prescribed for an average of 90 minutes, which hospitals should report using appropriate units of HCPCS code C1300 in order to properly bill for full body HBO therapy. In general, we do not expect that a physician order for 90 minutes of HBO therapy would exceed 4 billed units of HCPCS code C1300.) • Documentation for all services should be maintained on file to substantiate medical necessity for HBO treatment. Documentation must be submitted to Medicare upon request 27

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Linda MiLLer, rn, BSn


10steps

i

n an outpatient wound center or an inpatient wound care program where specific skills are necessary and staff numbers are small, hiring the right person becomes a crucial test of the manager’s knowledge, skill, and experience. What happens when the right person for the position is found? For starters, training costs are reduced, turnover is lower, and compatibility with existing staff is enhanced. However, what happens if the wrong person is chosen? Other staff may become resistant, morale drops, patient care may be compromised, turnover rises, training costs rise, and life for the manager can become a headache. Some people believe that finding the right person to work in a wound care clinic is ‘dumb luck’ or that ‘they will just know if it’s the right person.’ Most managers tend to assume that because they are in healthcare; they are good judges of character. Yet, no matter how good of a judge of character any professional is, there is much more to the process. Linda Miller, vice president of Quality and Education for (Wound Partners, LLC, Louisville, Ky) explains there are 10 steps her company has used over the years that can increase the chances of finding that best-fit person.

1) aSSeSS poSition need and organization aS a whole When someone has left a position, it’s generally assumed that the position needs to be filled.That might be the case, but the questions to ask are: A) Is everyone else as busy and productive as they might be? B) Is there any excess capacity? C) Are there employees whose skills are not being fully utilized? D) And is there anyone who is having difficulty with their skill set or tasks who might need to be supplemented?

2) develop Skill liSt Some hospitals and programs choose to have an all-professional nursing staff.

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While an admirable goal, is it completely necessary or cost effective? In determining what the job duties are in need of filling, consider what duties an LPN or medical assistant might manage safely and efficiently. RNs are needed for nursing assessment, nursing diagnosis, and case management, but how much of their time is spent on non-essential paperwork, phone calls, or tasks such as cleaning and preparing exam rooms, patient set up, removing dressings, checking vital signs, wound measurement and photography, filing, and administrative medical record management?

Some people believe that finding the right perSon to work in a wound care clinic iS ‘dumb luck’ or that ‘they will juSt know if it’S the right perSon.’ 3) develop job deScription Of course, follow hospital policy about job description requirements and format, but now you know what the essential duties are. Write these as though they will be used for a performance evaluation and that makes the review of candidates for the position as well as review of employees currently in the position much easier.

4) determine compenSation Pay scales and compensation policies may already have helped make that decision, but if any changes to the position are made it helps to look at

this again. Salary must provide adequate incentive and be comparable and equitable with similar positions in the system.

5) recruit If the HR department already has a procedure and recruiting process, things are probably in good shape. If not, consider whether to seek candidates through the Internet, newspaper, recruiters, job fairs or word-of-mouth. Good applicants often are referred by existing employees so don’t rule it out.

6) initial Screening The HR department will likely review the resumes, select those candidates that best match the qualifications stated in the job description, and perhaps conduct telephone pre-screening interviews. The person conducting the interviews will select the top candidates and send those resumes to the medical director and/or the hiring manager for review. If there are five extremely good candidates to interview, this will be a great recruiting process. (One may choose to interview all top candidates, but should consider interviewing no less than three candidates.)

7) interviewS Tailor the interview to the job. Use the job responsibilities and analyze the candidates to measure if they have the qualities needed to perform the job. Let the candidate do the talking so as to initiate personal contact. It’s important that the chemistry with the candidate, the company, and the on-site team are compatible. Listening allows the interviewer to see the whole person and not just the capabilities to perform a task. Using well-designed questions and well-developed listening skills, explore the candidate’s propensity to carry out the job responsibilities particularly with regard to the appropriate level of compassion and commitment to productivity the staff is seeking.

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10steps

8) referenceS HR conducts reference checks, verification of licensure (if applicable), and a personality profile test to ascertain whether the candidate has those traits that make the greatest contribution to the overall success of the team. Profiles also provide additional information about the candidate that can be used in the interview process. It is neither a process to eliminate nor to include candidates but does give insight and preferences about candidates. Because of the expense, the top candidates only complete the profile.

9) Second interview A second interview with the two final candidates should be conducted to make the final decision. The most critical consideration when bringing a new employee into the organization is ensuring the selection will support the center’s reputation for being the wound patient’s most effective alternative. The program’s reputation is multi-faceted and includes not only superior clinical capabilities but also the caring support provided by all of 30

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the staff members.This support addresses such issues as patient comfort, potential anxiety, as well as financial and social concerns. Encouraging a patient’s enthusiasm to continue treatment is essential. Employees must be compassionate and in touch with various patient concerns. They must address these concerns with understanding and the application of solid people skills. These attributes generally are not readily extracted from a resume and must be assessed through skillful interviewing.

10) the offer Once the final candidate is selected, the salary is determined (in consultation with HR) and a verbal offer is extended. If the candidate is considering the offer and perhaps ready to accept it, HR often drafts the offer letter and mails it to the selected candidate. The medical director and/or the hiring manager are informed when the offer is accepted and the candidate starts the required paperwork. Once the new employee is on board, the organization must create the most advantageous environment so that per-

son can excel. The orientation program, which includes a mentoring or shadowing process, can be extremely helpful in this endeavor. It helps the employee fit-in and the organization to tailor the initial stages of training for the benefit of both the employee and the organization’s needs. Although the hiring process can prove to be tedious and even expensive at times, there is no doubt that the initial effort spent to find the right person will be extremely beneficial to everybody in the long-run. ■ This article was edited and critiqued by Bella Cibella, VP of Implementation for Wound Partners, LLC, Louisville, KY. Linda Miller, RN, BSN is Vice President of Quality & Education for Wound Partners, LLC. She has more than 16 years of wound management operations experience. She is based in Tampa, FL and can be reached for questions or consultations via her email address at lmiller@woundpartners.com or via phone at (813) 997-2512. www.todayswoundclinic.com


Cynthia FleCk, MBa, BSn, Rn, et/WOCn, CWS, DnC, DaPWCa, FaCCWS


incertification

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s wound care takes center stage with regard to public awareness, government regulations, reimbursement issues, and patient need, perception, and interest in wound care education, preparation and certification has grown. As a result, healthcare professionals who specialize in wound prevention and management have become sought after employees in all areas of patient care, and wound care is becoming recognized as a specialty area of practice. Healthcare professionals in various disciplines are seeking advanced training, specifically related to wound management, to further their knowledge, skills, and marketability. Nurses, physicians, and other allied professionals involved in wound care are frequently interested and yet often confused about the certification process. When clinicians apply for jobs in the wound care arena, they often find the words, ‘board certification required’ or ‘board certification highly desirable’ in the ad or career offering, and wonder what does this mean? Are they qualified? Is there special training required? Which exam is appropriate for their situation? What credentials are accredited? The same uncertainty can be said for employers, other clinical providers, and 32

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the public. This article will provide those interested in wound care education and certification further information on the currently available accredited and nonaccredited exams, the organizations that administer these credentials and the benefits of becoming certified. Keep in mind that anyone can develop a test that

Nurses, physiciANs, ANd other Allied professioNAls iNvolved iN wouNd cAre Are frequeNtly iNterested ANd yet ofteN coNfused About the certificAtioN process.

offers a credential and promote it as wound care certification.

does certificAtioN mAtter? To some, certification is essential and a requirement from their employer. For others it is a matter of pride and a boost to their identity within their specialty and/or their practice. Surprisingly, some individuals want to challenge their knowledge for professional reasons. The question remains, are credentialed individuals better suited to care for patients with wounds? In their research, Zulkowski, Ayello, and Wexler determined significant differences between nurses certified as wound specialists by the Wound Ostomy Continence Nursing Certification Board (WOCNCB) and the American Academy of Wound Management (AAWM) and nurses not certified in wound care or any nursing specialty.1 This substantiates former research by Ayello et al that provides evidence that those nurses certified by an accredited provider, perform at a higher level than those who are not. www.todayswoundclinic.com


incertification Certified wound professionals of accredited exams share their views: Don Mrdjenovich, DPM, CWS, FACCWS; altoona, Pa, has this to say about being certified by the american academy of Wound Management, “I am proud to be part of a nationally recognized body of interdisciplinary wound specialists that bring above standard wound care practices to the most integral part of our team, the patient.” According to Teresa Conner-Kerr, PT, PhD, CWS, FACCWS, CLT; Winston-Salem, nC, “In today’s complex healthcare environment, patients and providers alike need a mechanism to determine who is best qualified to deliver advanced wound management services. The CWS designation provides such a mechanism and signifies a professional who is well qualified to deliver these services” Margaret Falconio-West, BSN, RN, APN/CNS, ET, CWOCN, DAPWCA; Chicago, ill, revealed this about her certification, “Practicing what I went into to nursing to do—making a difference in the life of the patient, respect from peers, colleagues, physicians, patients, and families as well as recognition within your care setting as ‘knowing what she’s doing’ and the ability to ‘go places’—network with other CWOCNs from all over the world.” Chuck Gokoo, MD, CWS, FACCWS, lewisville, tex. stated,“Through accredited wound certification, medical professionals demonstrate knowledge as they progress along the continuum of patient care. Achieving and maintaining certification helps assure employers and patients that the medical professional has met rigorous requirements and continues to meet rigorous requirements in a specialized area of practice.” Joyce Norman, RN, BSN, CWOCN, DAPWCA; tucson, ariz, passionately asserted, “My experiences as a Certified Wound, Ostomy, and Continence Nurse (CWOCN) has lead me on a tremendous journey through my profession to my present position. As I studied, learned and continued to grow, one path always seem to build on another and lead me to new opportunities that helped me to continue forward. The expertise and accredited certification was not only acknowledged, supported and respected by many healthcare professionals, but in many ways was expected.” Joseph McCullock, PhD, Dean, School of Allied Health Professions, Louisiana State University, Baton Rouge, La. “When asked by family, friends, and patients to recommend wound care facilities around the country, it is comforting to know that a critical mass of individuals exist who have demonstrated through certification a common core of knowledge in wound management. Anyone who provides wound management should strive to achieve this certification.” Heather Hettrick PT, PhD, CWS, MLT, FACCWS; hamilton, nJ, says, “I feel having my CWS has opened many doors professionally resulting in many career opportunities. Obtaining the only accredited wound care certification, the CWS was one of the best professional growth decisions I have made.”

whAt’s the differeNce betweeN certificAtioN ANd AccreditAtioN? Certification is granted to individuals who successfully go through a set of standards, which might include a written, practical, and/or oral exam following a course of study or a portfolio that shows a higher degree of specialty practice. Certification concentrates particularly on the person taking the exam and is a mark www.todayswoundclinic.com

of existing knowledge in a specialized field. Keep in mind however, the available tests and credentials do not measure competency, only knowledge. Accreditation is achieved once a certifying or educational program encompassing widespread assessment and evaluation by a separate and external objective review method has successfully taken place. Accreditation reflects the

attainment of an echelon of superiority and deems the program as one that possesses quality in accordance with industry standards. Institutions of learning and educational curriculum can differ broadly in their nature, arrangement, and properties and strive to attain accreditation as a gauge, and evidence of their program's value, certifying programs are similar. Wound Clinic Wisdom

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incertification AccreditAtioN reflects the AchievemeNt of A level of excelleNce, ANd mArks the progrAm As oNe of superiority AccordiNg to iNdustry stANdArds Be aware of any program or credential that is not accredited and has simply ‘applied for accreditation’ or is a ‘member’ of an accrediting body. Accreditation is earned by a certifying or educational program after extensive review by an external review process and approval by an independent accrediting organization. This organization assists the candidate in ensuring that the program meets a set of high standards and the credentials earned from this program have the backing and the strength of this approval 3. Accreditation reflects the achievement of a level of excellence, and marks the program as one of superiority according to industry standards3. Accreditation shows that the credentials given by a qualified program are based on a valid and reliable testing process.3 It means that the structures in place to administer the examinations meet—even exceed the standards of the certification industry from an unbiased and legally defensible perspective protecting the student and ultimately public health3. Only two wound care credentials are currently accredited and widely accepted within the industry. When seeking a legitimate wound care credential, it is crucial to be conscious of programs and exams that 34

Wound Clinic Wisdom

claim a ‘high pass rate.’ An elevated degree of passing scores can potentially cause concern among psychometricians (test development experts) as to the capacity of the exam actually measuring the expertise of the individual and to the validity of the exam. Psychometrics is the science and technology of mental measurement, which includes psychology, behavioral science, education, statistics, and information technology4. With regard to test design, psychometrics is used to measure knowledge, abilities, and the capacity of the exam to justly assess the examinees competencies. This routine therefore increases the passing rate, but does not necessarily equate to a superior exam or process. In addition, any programs that ‘teach to an exam’—a practice that is not synonymous with psychometrics—is considered a conflict of interest. The following represent the two accredited certifying boards for wound management: American Academy of Wound Management (AAWM) www.aawm.org. Established in 1995, the AAWM is a not-for-profit, national, multidisciplinary certifying board for healthcare professionals involved in wound management. The AAWM is independent

from any membership or educational organization and accredited by the National Commission for Certifying Agencies (NCCA), which is the accreditation body of the National Organization for Competency Assurance (NOCA). The AAWM is a full voting member of the NOCA. The AAWM strives to write questions at multiple levels of cognitive domain so that the test is not just pure recall. Additionally, the board does not endorse any textbooks, journals, educational materials, or teach or sanction any course that teaches to the test. In order to be eligible to take the CWS® exam, the applicant must: ● Possess a minimum of a bachelor’s degree. ● Hold the license or designation as one of the following: MD, DO, DPM, PA, DMD, or equivalent, VDM or equivalent, RN, PT or OT. ● Document three years of clinical wound care related experience including direct patient care. The CWS exam requires self-preparation. The AAWM does not generate or endorse any educational programs, seminars or review courses. Several wound care conferences, seminars, and courses are available to the wound care professional, including those www.todayswoundclinic.com


incertification

A miNimum of 6 coNtAct hours of coNtiNuiNg educAtioN iN wouNd mANAgemeNt Are required eAch yeAr to remAiN certified. qualified and endorsed by the American College of Certified Wound Specialists (ACCWS). The ACCWS is a membership organization that functions as the educational resource and advocate for those who have achieved the CWS and the CWCA. Among its numerous member benefits, the ACCWS qualifies and endorses preparatory courses that can assist the examination candidate in preparation for the CWS examination and offers educational programming. Additionally, several current wound management textbooks are recommended for selfstudy and test questions may come from these texts as well as industry journals and literature. A blueprint of the exam subject materials can be found in the AAWM Candidate Handbook online. The AAWM’s National Examination for Board Certification in Wound Management is computer-based and held each April and October at testing centers nationwide. Applicants for certiwww.todayswoundclinic.com

fication must achieve a passing score on the 200-question, multiple-choice examination. Multidisciplinary questions cover general knowledge, anatomy, pathophysiology, diagnosis, physiology, therapeutics, and psychosocial topics. A minimum of 6 contact hours of continuing education in wound management are required each year to remain certified. Re-certification must be accomplished every 10 years. Wound, Ostomy and Continence Nursing Certification Board (WOCNCB) www.wocncb.org Established in 1978, The Wound, Ostomy and Continence Nursing Certification Board (WOCNCB) sets, maintains, and evaluates national standards for certification and re-certification in wound, ostomy and continence care nursing. The WOCNCB is a distinct and financially independent organization from the WOCN Society and from any of the specialty educational programs. The following certifications are available for registered professional nurses only. Wound Care Certifications Offered by the WOCNCB include: ● CWOCN® - Certified Wound, Ostomy, Continence Nurse ● CWCN ® - Certified Wound Care Nurse ● CWON™ - Certified Wound Ostomy Nurse ● CWOCN-AP™- Certified Wound Ostomy Continence Nurse Advanced Practice ● CWCN-AP™ - Certified Wound Care Nurse - Advanced Practice ● CWON-AP™ - Certified Wound Ostomy Nurse - Advanced Practice Similar to the AAWM, the WOCNCB certification examinations are all accredited by the National Commission for Certifying Agencies, which is the accreditation body of the National Organization for Competency Assurance (NOCA).The WOCNCB is a full voting member of the NOCA. In addition, the WOCNCB has established accreditation status from the American Board of Nursing Specialties (ABNS). The ABNS is the

exclusive accrediting source specifically for nursing certification. To be eligible to take the WOCNCB® examination(s) an applicant must accomplish the following requirements: Current licensure as a Registered Nurse (RN), and 1. Hold a bachelor’s degree, and 2. Fulfill one of the following requirements: a. Accredited Education Program Track—Complete a WOC Nursing Education Program that is accredited by WOCN. b. Graduate Level Track— Complete a graduate-level program in nursing with documentation of graduate clinical course work equivalent to 2 semester hours in each specialty for which certification is sought. c. Experiential Track—Have 50 contact hours (CEU) over the last 5 years within each specialty for which certification is sought. Have 1,500 clinical experience hours over the last five years within each specialty for which certification is sought. At least 375 of those hours must be completed within the year prior to certification application. Training courses for the certification exam(s) are offered at nine educational programs throughout the United States. Further details on these curriculums can be found at Wocncb.org. Some programs present the opportunity to participate solely in the wound care specialty track individually in preparation for certification. A number of the Wound, Ostomy, and Continence educational programs publish review books in preparation for the certification exam. The WOCN Society often offers a certification preparation course associated with their annual conference. The WOCNCB also offers an online selfassessment examination (SAE), which provides practice and preparation for the certification exam. Wound Clinic Wisdom

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incertification The computer-based certification exam is offered in quarterly cycles at testing centers across the US. The test consists of multiple-choice questions and is based on recall and application of specialty-related practice principles, as outlined on the published content outline. The exam outline is based on a role delineation/job analysis which is conducted on a regular basis by the testing company to assure that current, evidence–based practice is reflected by test questions. The earned WOCNCB credentials are awarded for a 5-year period. Candidates may recertify via one of two methods, re-examination or the Professional Growth Program that includes submission of a portfolio with specific specialty-related pieces of continuing education, programs/projects, research, publication, teaching, professional organization leadership, and/or academic education.

becomiNg certified by AN Accredited wouNd mANAgemeNt orgANizAtioN is Not NecessArily eAsy, but whAt eNdeAvor thAt eNriches your cAreer ANd self-sAtisfActioN is? A Note About physiciAN oNly wouNd cAre certificAtioN Although the American Academy of Wound Management’s (AAWM) Certified Wound Specialist (CWS) exam is a multidisciplinary accredited exam that is available for physicians (including surgeons and podiatrists), nurses, thera36

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pists, and other allied health professionals with a minimum of a Bachelor’s degree, interest in the expansion of a physicians only exam is being developed and pursued (www.aawm.org). In addition, the American Professional Wound Care Association (APWCA) (www.apwca.org) is also producing a physician specific exam and recently conducted their pilot test. The development of these physician exams is a first step toward the long-term goal of achieving specialty recognition of wound care by the American Board of Medical Specialties, American Osteopathic Association, and the Council of Podiatric Medical Education.Visit their respective websites for more information.

wouNd cAre certificAtioN for those who do Not possess A bAchelor’s degree There are two organizations that offer certification, although neither has attained accreditation), for those possessing less than a Bachelor’s degree. One is the American Academy of Wound Management’s (AAWM) (www.aawm.org) Certified Wound Care Associate (CWCA) exam and credential.This is the same organization that offers the CWS, the only accredited multidisciplinary certification in wound care. The National Association of Wound Care (NAWC) (www.nawccb.org) also offers an exam for individuals who do not possess a Bachelor’s degree, in their Wound Care Certified (WCC) credential. For the purposes of this article, only the accredited programs, those offered by the American Academy of Wound Management (AAWM) and the Wound, Ostomy, and Continence Nurses Society Certification Board (WOCNCB) are covered in detail. Information about the non-accredited exams many be accessed online at the previously mentioned websites.

certificAtioN or bust If you are considering certification, your first steps include investigating the requirements of each credential and the process to become certified. Explore the

respective websites, sign up and embark on your course of study. Becoming certified by an accredited wound management organization is not necessarily easy, but what endeavor that enriches your career and self-satisfaction is? Since a non-accredited program may not meet minimum professional requirements, Bachelor’s prepared clinicians who are interested in pursuing board certification in wound management have two accredited certification options, the Certified Wound Specialist (CWS) exam, administered by the American Academy of Wound Management and given to multidisciplinary clinicians and the Wound, Ostomy, and Continence Nurses Society’s six certified designations, for registered nurses only. Why not get started today on a journey that can last a lifetime? ■ Cynthia A. Fleck, RN, BSN, MBA, ET/WOCN, CWS, DNC, DAPWCA, FACCWS is a certified wound specialist and dermatology advanced practice nurse, writer, speaker, President and Chairman of the Board of the American Academy of Wound Management (AAWM), Member of the Board of Directors of the Association for the Advancement of Wound Care (AAWC), and Vice President, Clinical Marketing for Medline Industries, Inc. Advanced Skin and Wound Care Division. She can be reached at cfleck@medline.com. References 1. Zulkowski K, Ayello EA, Wexler S. Certification and education: do the affect pressure ulcer knowledge in nursing? Adv Skin and Wound Care, 2007;20(1):34-38. 2. Ayello EA, Baranoski S, Salati DS. A survey of nurses’ wound care knowledge. Adv Skin Wound Care. 2005;18(5 Part 1):268-278. 3. Rappl LM, Fleck CA, Hecker D, Wright KD, Fredericks C, Mrdjenovich D. Wound care organizations, programs and certifications, an overview. Ostomy Wound Manage 2007;53(11):28-39. 4. The NOCA’s Basic Guide to Credentialing Terminology, October 2006. www.noca.org accessed October 8, 2007.

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inbusiness Focus on the Practice Management Process LIke FocusIng on the cLInIcaL Process kathLeen D. schauM, Ms

N

ot a day goes by that this author doesn’t receive a phone call or e-mail from a concerned wound care professional working in a hospital-owned wound clinic. The number of questions about the practice management process gives the perception that wound care professionals may not be given adequate orientation, education, and mentoring necessary to manage wound care practices. To verify this perception that wound care professionals may need to increase their knowledge about the ‘business of wound care,’ the author contacted a sampling of several different types of wound management companies and interviewed them about this topic. See Table I for the top 10 practice management issues that these wound management companies encounter. If any of these issues exist within the wound care clinic, be sure to request guidance and assistance from the administrator. When some of the wound management companies were asked to identify the reasons that hospitals seek practice management assistance, the following reasons were given: • Fear of failure • Lack of knowledge/experience in wound care operations process; wound care is a specialty that requires a concentrated focus that includes evidence-based clinical guidelines, reimbursement, initial and ongoing education • Lack of time and resources of a team dedicated to developing the operations side of the business • Worried about billing correctly www.todayswoundclinic.com

• Minimize start-up costs • Need assistance to bring physicians and hospital together • Lack of marketing expertise With these issues in mind, hospitals that are starting a wound care program from scratch, upgrading to a physiciandriven clinic, or attempting to revamp a failing wound care clinic must focus on the practice management processes just like they focus on the clinical practice

processes. Some hospitals can accomplish this work without any outside assistance. Other hospitals may need several days/weeks/months of assistance from one or more outside consultants to assist their staff in identifying and/or implementing steps to improve their practice management process. Still, other hospitals may prefer to transfer the entire burden of developing and/or managing the wound care clinic to an outside consulting firm. Regardless of who manages your outpatient wound clinic, certain steps can lead to success. See Table II for the main steps to practice management success. Keep in mind that there are outside forces beyond control, constantly causing revamping of the wound care practice management process. The major outside forces that should be monitored are:

TABLE I. Top 10 Practice Management Issues that Wound Management Companies Encounter 1. Lack of physician participation (many wound clinics are nurse or physical therapist driven). 2. Inappropriate staffing level (too many or too few). 3. Lack of monitoring and understanding of various coding, coverage, and payment systems for the facility, physicians, and non-physician practitioners. 4. Failure to obtain prior authorization from commercial payers, Medicaid, etc. for various surgical procedures performed in a wound clinic. 5. Lack of documentation (including operative reports) to describe work performed and billed. 6. Lack of objective simple benchmarking tools to track and measure outcomes. 7. Lack of billing/collection expertise. 8. Losing money even though capturing all charges. 9. Little or no audits of coding, coverage, and payment systems. 10. Ineffective/non-existent marketing programs . NOTE: Table I does not represent the opinions of all wound management companies. It is an accumulation of the issues that were gathered from the sample of companies interviewed. Wound Clinic Wisdom

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inbusiness • Coding changes (for procedures, products, clinic visits, etc.) • Coverage changes (including accepted indications, utilization guidelines, and documentation requirements) • Payment system changes (for facility, physicians, non-physician practitioners, etc.); this includes changes in coinsurance for patients. When any of these changes occur, clinic managers must carefully integrate them into their wound care practice management processes. This should include providing education to the wound care professionals; they must understand their responsibility in implementing these required practice

management changes into their clinical practice. To summarize, hospitals must allocate time and resources to orient, educate, and mentor clinic directors and medical directors in practice management issues pertinent to wound care clinics. During the interviews, the wound management representatives offered practice management advice for readers to utilize. See Table III (See Table III on page 12) for their valuable advice and their contact information. ■ Kathleen D. Schaum, MS, is President of Kathleen D. Schaum & Associates,

Inc., Lake Worth, FL. Schaum can be reached for questions and consultations by calling (561) 964-2470 or at kathleendschaum@bellsouth.net. Information regarding coding, coverage, and payment is provided as a service to our readers. Every effort has been made to ensure the accuracy of the information. However, HMP Communications and the author do not represent, guarantee, or warranty that 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.

TABLE II. Steps to Practice Management Success • recruit correct medical director/co-medical directors and physicians based on their knowledge—not based on the politics of organization. • review true staffing needs—make adjustments as needed. • allocate adequate resources and time to orient, educate, and mentor both the wound clinic director and medical director on practice management processes. • Be sure staff and physicians are clinically well trained and practicing evidence-based wound care. allocate resources and time for education programs. consider closing the wound clinic for a few days each year to allow staff and physicians to attend a major wound care symposium together. • Develop and implement a customized marketing program; be sure to allocate adequate staff and resources for this program. remember the slogan: a business without a sign is a sign of no business. • train staff and physicians about the nuances of each other’s coding, coverage, and payment system. • review coding updates annually; educate staff and physicians and update charge description masters, charge sheets, etc. • review and share with wound care professionals all pertinent payer manuals, bulletins, local coverage determinations, articles, and national coverage determinations. • communicate with and educate medical directors of Medicare contractors, commercial payers, Medicaid, etc. regarding the latest evidence surrounding your wound care procedures and products. • Do not ‘series bill’. Bill each clinic encounter as a separate unique visit. • obtain a weekly ‘revenue collected/denied’ report by line-item billed; be sure to check for lost revenue due to non-collection of patient coinsurance. • Install an electronic health record that is appropriate for wound care clinics and physicians, that track clinical and economic outcomes, and that tracks the effectiveness of marketing programs. • annually review equipment costs; be sure utilization/acquisition arrangement is suitable for current volume of business. • conduct internal compliance audits on a quarterly basis; share results of audits with all staff and physicians; provide education on topics that need improvement.

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inbusiness TABLE III.

Wound Management Company Representative Comprehensive Healthcare Solutions, Inc. karin-roemers-kleven President/ceo (800) 232-5070 www.comprehensive-healthcare.com

Diversified Clinical Services, Inc. Patricia (Patty) Pasceri executive Vice President of operations (714) 812-4980 www.diversifiedcs.com

Innovative Medical Services Michael Warshell President (847) 266-7833 www.woundwatch.com

Paradigm Medical Management Diane Boon ceo (310) 538-1110 www.paradigmmedicalmanagement.com

Wound Care Advantage Mike comer ceo (888) 484-3922 www.woundcareadvantage.com

Wound Care Strategies cathy thomas hess President and Director, clinical operations (717) 541-1165 www.woundcarestrategies.com www.todayswoundclinic.com

Practice Management Advice “Understand reimbursement; attend wound care reimbursement seminars. We are participating in healthcare during a very exciting state. We are forced to change to accommodate tighter budgets and create better efficiencies, yet not impede quality of care. To do this, you must use new tools such as electronic medical records, which will also assist with ordering supplies and with the clinic flow.”

“As a wound care community, we have a responsibility to collect data. Whether an outpatient wound care department is hospitalowned or outsourced, we need to come together to collect similar data points that can be measured with the hopes of improving wound care in the future.”

“Identify a program director and provide him/her with adequate resources and time to manage the business process. Ensure you have resources not only for clinical processes, but also for practice management and marketing processes.”

“Make sure physicians are well trained and practice evidencebased wound care. If you engage a wound management consulting company, be sure to assign an in-house executive to work with the consultants as true partners, not as outsiders.”

“Engage a passionate physician champion. A wound specific electronic health record is ‘key’ to your clinical and practice management processes.”

“Know your Medicare contractor’s local coverage determinations. Success is all about implementing a solid clinical and practice management process and having a software program for documentation to support the work performed.”

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Physician Supervision of Hyperbaric Oxygen Treatment Robert A. Warriner, III, MD, FACA, FCCP, FCCWS, ABPM/UHM

Photo courtesy of Kevin McGowan

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inregulation Disclaimer: The opinions expressed in this article are my own and should not be interpreted to represent any official position of Diversified Clinical Services or the Undersea and Hyperbaric Medical Society.

I

n the October 2000 report of the Department of Health and Human Services Office of the Inspector General (OIG) on Hyperbaric Oxygen Therapy, Its Use and Appropriateness1 physician attendance at hyperbaric oxygen treatment sessions was discussed. Two perspectives on the meaning of attendance were identified during the review process: (1) the physician is physically present during the entirety of the treatment and uses that time to manage the patient’s overall care; and (2) physicians remain available to manage rare emergency situations but are not continually present or available. Of particular interest to the question of the value of physician attendance during hyperbaric oxygen treatment sessions was the conclusion drawn by the OIG in that same report. “Our review indicates physician attendance is strongly correlated with quality of care and the reduction of inappropriate billing. Almost twothirds of medical directors do support the notion that physician attendance is necessary to achieve quality. Similarly, our medical review results supported this concept, showing a significant relationship (p<.001) between quality of care variables and physician attendance and between compliance with HCFA guidelines and physician attendance (p<.001). These relationships provide support for requiring physician attendance during all treatments. The strong relationship between quality and attendance suggests a potential for reducing inappropriate payments.” The implication of these observations is that direct physician involvement in the provision of hyperbaric oxygen treatment drives quality and cost effectiveness. www.todayswoundclinic.com

“Confusion has resulted from this desCription beCause of the ambiguity Created by inCluding tWo desCriptions that Could be Considered to refleCt very different performanCe requirements.” AMA CPT 99183 states physician attendance and supervision of hyperbaric oxygen therapy, per session. Confusion has resulted from this description because of the ambiguity created by including two descriptions that could be considered to reflect very different performance requirements. For the remainder of this discussion, only requirements for physician billing for 99183 will be discussed.

HyPerbarIc Oxygen TreaTmenT SuPervISIOn by an unreSTrIcTed lIcenSed PHySIcIan. For a physician to bill 99183, the requirements for direct supervision must be met. According to federal regulations, direct supervision for purposes of hospital outpatient services means that "the physician must be present and on the premises of the location and immediately available to furnish assistance and direction throughout the performance of the procedure." (42 C.F.R. § 410.27; CMS Transmittal B-01-28). For the physician, being in attendance during any key portion of each treatment session, seeing the patient before, during, or after the treatment, and being

immediately available for any emergency or other assistance that is required during treatment should be sufficient for the physician to bill 99183. This interpretation is consistent with the relative value for this procedure assigned by CMS (then HCFA) in 1993 and allows the supervising hyperbaric medicine physician to treatment more than one patient at a time and to see wound care patients in the same or a contiguous area while supervising hyperbaric oxygen treatment. Although CMS (then HCFA) did make an attempt to define specific training and credential requirements for physicians supervising hyperbaric oxygen treatment in 1999, no specific requirements are in place at this time. It is the responsibility of each hospital medical staff to address minimum training, performance, and quality standards although professional organizations such as the Undersea and Hyperbaric Medical Society2 and the American College of Hyperbaric Medicine provide guidance in these areas.

HyPerbarIc Oxygen TreaTmenT SuPervISIOn by an advanced PracTIce nurSe. Nurse practitioners may perform services that would be physician services under Medicare. The statute only requires that such services must be within the scope of the practitioner’s state license (and potentially within the scope of local hospital privileges or credentials). The level of supervision required for such services is only a general level of supervision, ie, the procedure is furnished under the physicians overall direction and control, but the physician’s performance is not required during the performance of the procedure. All of the requirements for physician supervision of hyperbaric oxygen treatment listed above must be met by the nurse practitioner. In addition, a written collaborative agreement must be in place and documentation of that collaboration must be present in the medical record. It is this author’s recommendaWound Clinic Wisdom

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inregulation “speCifiC requirements relative to supervision and performanCe Will vary by state and should be verified prior to permitting physiCian assistant supervision of hyperbariC oxygen treatment.” tion that if hyperbaric oxygen treatment services are provided in a facility outside of the hospital (where immediate physician response in the event of an emergency is required), a

qualified physician should remain in the facility where hyperbaric oxygen treatment is administered. Specific requirements relative to supervision and performance will vary by state and should be verified prior to permitting nurse practitioner supervision of hyperbaric oxygen treatment. The hospital medical staff should provide specific credential.

HyPerbarIc Oxygen TreaTmenT SuPervISIOn by a PHySIcIan’S aSSISTanT. Physician assistants may perform services that would be physician services under Medicare. The statute only requires that such services must be within the scope of the practitioner’s state license (and potentially within the scope of local hospital privileges or credentials). The level of supervision required for such services is only a general level of supervision, ie, the procedure is furnished under the physicians overall direction and control, but the physician’s performance is not required during the performance of the procedure. The physician assistant must meet all of the requirements for physician supervision

of hyperbaric oxygen treatment listed in this article. In addition, evidence of supervision by the sponsoring physician must be clearly evident within the medical record. It is this author’s recommendation that if hyperbaric oxygen treatment services are provided in a facility outside of the hospital (where immediate physician response in the event of an emergency is required), a qualified physician should remain in the facility where hyperbaric oxygen treatment is administered. Specific requirements relative to supervision and performance will vary by state and should be verified prior to permitting physician assistant supervision of hyperbaric oxygen treatment. The hospital medical staff should provide specific credential.

HyPerbarIc Oxygen TreaTmenT SuPervISIOn by a POdIaTrIST. Podiatrist services are included as physician services under section 1861(r)(3) of the SSA but “only with respect to functions which he is legally authorized to perform as such by the state in her performs them.” In order for hyperbaric oxygen treatment services to

Photo courtesy of Kevin McGowan

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inregulation

Photo courtesy of Kevin McGowan

be supervised by a podiatrist, the following requirements must be met. Hyperbaric oxygen treatment should be specifically designated by the state board of podiatric medicine/surgery as within the scope of podiatry practice and podiatry supervision of hyperbaric oxygen treatment limited to those conditions that clearly fall under the scope of podiatry practice (ie, treatment of a diabetic foot ulcer but not decompression sickness or osteoradionecrosis of the mandible). In addition, the local fiscal intermediary and carrier medical policies should be reviewed for other specific requirements or exceptions. Specific medical staff policies for credential podiatrists for supervision of hyperbaric oxygen treatment including minimum mandatory trainwww.todayswoundclinic.com

ing, which should be equivalent to the training required for physicians and designation of the process for providing backup physician support in the event of a treatment complication (seizure, pneumothorax, etc.). All of the requirements outlined in the general requirements for physician supervision must be met. In addition, a designated, qualified physician should be immediately available to support the podiatrist in the event a complication of hyperbaric oxygen treatment occurs where management would fall outside of the scope of practice of the supervising podiatrist. A best practices recommendation for physician supervision of hyperbaric oxygen treatment that meets regulatory and reimbursement requirements and fosters

optimal quality care should require each physician supervising hyperbaric oxygen treatment to: 1. Be credentialed by the medical staff of the hospital operating the hyperbaric facility based upon adequate initial training and continuing education, 2. Provide a complete consultation detailing the indication for hyperbaric oxygen treatment, 3. Document any justification by primary or secondary diagnostic testing for such treatment, 4. Provide an assessment of patient risk for treatment and a description of interventions planned to reduce such risk, 5. Provide specific orders for treatment including treatment profile and number of treatments ordered, and 6. Maintain periodic reassessment notes of the patientâ&#x20AC;&#x2122;s response to therapy justifying the need to continue or the ability to discontinue treatment. This periodic reassessment should occur at a minimum weekly and more often as indicated. In addition, the physician must be physically present within the facility whenever a patient(s) is receiving hyperbaric oxygen treatment. n Robert A. Warriner, III, MD, FACA, FCCP, FCCWS, ABPM/UHM, is the Emeritus Medical Director, Southeast Texas Center for Wound Care and Hyperbaric Medicine, Conroe Regional Medical Center, Conroe, Texas, Chief Medical Officer, Diversified Clinical Services, Jacksonville, Florida, Chairman, Federal and Regulatory Affairs Task Force, Undersea and Hyperbaric Medical Society. References: 1.Hyperbaric Oxygen Therapy, Its Use and Appropriateness, OEI 06-99-00090, Department of Healthy and Human Services Office of the Inspector General, October 2000, p12. 2.UHMS Guidelines for Hyperbaric Facility Operations, W.T. Workman (ed) Undersea and Hyperbaric Medical Society, Kensington, MD 2004 and the Clinical Hyperbaric Facility Accreditation Manual.

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inaccreditation

Clinical Hyperbaric Facility Accreditation – Is The Juice Worth The Squeeze? W.T. Workman, MS, CAsP, CHT, FAsMA

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s many in wound care know, the field of hyperbaric medicine has grown geometrically during the past five to 10 years. In the end, this is a good thing. However, this rapid rate of growth has also produced many challenges for our community—challenges to seek qualified practitioners, maintain the highest level of patient safety, and to demand uncompromised quality of care. It is unfortunate that most newly christened hyperbaric practitioners and healthcare administrators are not aware of the October 2000 Department of Health and Human Services, Office of the Inspector General (OIG) Report titled Hyperbaric Oxygen Therapy: Its Use and Appropriateness (OEI 06-99-00090). Without going into a discussion of specific details, this assessment reported that more than $19 million (38%) of Medicare funds paid to facilities during the period from 1995 to 1998 were in error—for either inappropriate 44

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treatment and/or excessive treatment. Additional findings related to poor documentation; lack of testing and treatment monitoring raised quality of care concerns; limited guidance from the federal government; and, questions over appropriate use along with the potential for significant growth in the field were reported. The recommendations provided by the OIG to the Department of Health and Human Services were as follows: 1) Initiate a more defined national coverage policy related to hyperbaric oxygen therapy. 2) Improve policy guidance (practice guidelines and physician attendance policy). 3) Improve oversight by requiring contractors to initiate edits and consistent medical review procedures, and to explore the possibility of establishing a registry of facilities and physicians providing hyperbaric therapy.

If the author must point to a single event that prompted the Undersea & Hyperbaric Medical Society (UHMS) to establish our Clinical Hyperbaric Facility Accreditation Program, this would be this report. From what professionals have learned from accreditation since 2002, the report accurately portrayed the situation as it existed during the period of review. In essence, the OIG recommended to the Centers for Medicare and Medicaid Services (CMS) that oversight of hyperbaric medicine be increased. To many, this served as a wake-up call to the community that wound care professionals must take ownership of this problem and demonstrate to CMS that we are justly concerned and, more importantly, prepared to take action within our own community to improve the practice of hyperbaric medicine across this county. Who better than the wound care community to address its own problems? Therefore, hyperbaric facility accreditation was created and implemented. Since the first voluntary formal survey in September 2002, we have now initially surveyed 90 hyperbaric programs across the nation. At present, 83 of these are actively maintaining their accreditation. The reasons that the other seven have not been reaccredited range from revocation of status, hospitals being closed due to Hurricane Katrina, programs closing for other reasons, and several who have simply chosen not to reapply. It is unfortunate these few have elected not to reapply. It is this author’s firm belief that they are missing a tremendous opportunity to demonstrate to the patients in their catchment area that they are the best. One facility even stated that their reason for not reapplying was that they did not see any increase in patient volume after being accredited. This is surprising because this author continually receive reports from programs all over the country that are claiming increases in patient volume as high as 45% after initiating an aggressive marketing campaign to educate their referral base that www.todayswoundclinc.com


inaccreditation they were accredited. From this, one must assume that programs claiming no increase in patient volume must not have aggressively marketed their accredited status. The author believes that expectations of increased revenue are NOT a reason to seek accreditation. Accreditation should be sought because it is the RIGHT thing to do. There are 28 facilities already scheduled to undergo survey for 2009. It is important to explore what measurable changes have occurred in the five-plus years of accreditation because it is here where benefit can be clearly demonstrated: Board certification for personnel has been stimulated: a. The number of nurses certified in hyperbaric nursing has increased by 49%. b. The number of technicians certified in hyperbaric technology has increased by 200%. New hyperbaric education programs have been created: a. Safety Director training. b. Acrylic window/tube inspection requirements. Educational level for medical, operational and safety issues has been enhanced: a. Minimum training standards established and expected. b. More than 800 Safety Directors have received specialized training. c. Acrylic inspection criteria, which will defer the high cost of acrylic replacement by extending the service life of the material by an additional 10 years, have been implemented. National safety standards have been refined as a direct result of accreditation: a. Since 2005, over 30 changes have been made to the primary hyperbaric safety standard, NFPA 99, Health Care Facilities, Chapter 20, Hyperbaric Facilities. b. Hyperbaric chamber manufacturers are now providing hospitals the documentation required by the www.todayswoundclinc.com

American Society of Mechanical Engineersâ&#x20AC;&#x2122; Safety Standard for Pressure Vessels for Human Occupancy (ASME PVHO-1). Operational safety issues have been enhanced: a. In-house safety training for part-time and full-time staff has been improved. b. Maintenance of bulk oxygen services and gas cylinder management has improved. c. Overall safety awareness has been raised. Positive impact on quality of care and patient safety has been demonstrated: a. Patient assessment processes have been enhanced. b. Patient education processes have been promoted. c. Quality and completeness of patient treatment documentation has dramatically improved. d. Quality improvement activities has moved beyond patient satisfaction surveys to meaningful, clinically relevant outcomes. e. Issues related to patient confidentiality, adequacy of treatment space, appropriate staffing levels have been successfully addressed following accreditation surveys. For programs that have aggressively marketed their accreditation, increases in patient volumes of up to 45% have been publicly reported. One of the objectives of our program is to become recognized by The Joint Commission as a complementary accrediting body. At present, we are at 83% of that goal. When we achieve our goal of 100 active accredited programs, we will submit our application to the Commission for recognition. If accepted, The Joint Commission will formally acknowledge UHMS surveys conducted in hospital organizations that provide this therapy and for once accept surveyors with the proper skills and understanding of the unique requirements of hyperbaric facilities.

As many know, precedence has been set in Utah by linking Medicaid reimbursement to UHMS specific accreditation. In the future, other agencies and carriers will make reimbursement links as well. The author believes this because BCBS, Aetna, TriCare, HIP Health Plan, Harvard Pilgrim Health Care and others have contacted him to discuss accreditation. This represents a heightened level of awareness and perhaps expectation, even though these other groups have established no requirement for accreditation. The author frequently hears the comment that accreditation is too expensive. It is important to put the cost in perspective. The period of accreditation is three years (36 months). If you were to divide the most recently calculated average total cost of accreditation by 36, the result is approximately $185/month. Based on current CMS reimbursement rates, this represents approximately two 30-minute billable treatment cycles for one patient per month. Therefore, based on this data, UHMS accreditation is the most cost-efficient third-party consultancy that any hyperbaric program can seek. Nowhere else can a facility bring in a team of experts to offer suggestions on process improvement for this cost. In closing, the author trusts that he has created a level of understanding that hyperbaric facility accreditation was created specifically to address a defined need. The value of accreditation continues to be demonstrated and has proactively addressed the concerns and recommendations contained in the October 2000 OIG Report. A major milestone will have been met once Joint Commission recognition has been achieved. n

W.T.Workman, MS, CasP, CHT, FasMA, is the Director of Quality Assurance and Regulatory Affairs at the Undersea & Hyperbaric Medical Society, UHMS Satellite Office in San Antonio, Texas. For additional information on how your facility can join the growing list of accredited facilities, contact Tom Workman at (210) 404-1553 or uhmsqara@aol.com. Wound Clinic Wisdom

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inbusiness Are You Ready?

The New Medicare Advance Beneficiary Notice (ABN) Kathleen D. Schaum, mS

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edicare covers many products and services that are needed to manage chronic wounds. However, Medicare does not always cover the products for all indications at the frequency that physician or the patient would like. When a wound care clinic and/or practitioner believes that Medicare covers the product/service, but does not believe Medicare will cover it for a particular patient, that patient should be given an Advanced Beneficiary Notice (ABN). In addition, if a product or service is utilized, the practitioner is required to give the patient an ABN prior to treatment. If the patient is not given an ABN and Medicare denies coverage of the product or service, the clinic and/or practitioner cannot collect payment from the patient. To help readers understand the new Medicare ABN, this author interviewed Donna Cartwright, MPH, RHIA, CCS, RAC. Cartwright is one of new Editorial Board members for Today’s Wound Clinic. She is a professional coder who brings over 27 years of medical coding expertise to the journal. She currently is the Senior Director of Reimbursement Services for Integra LifeSciences Corporation, Plainsboro, N.J.

KAThleeN SchAuM (KS): Welcome to the editorial board of Today’s Wound Clinic. We are thrilled that you have agreed to share your 46 Wound Clinic Wisdom

expertise with the readers. Please educate TWC readers about the new ABN process. To begin, will you please tell the readers the meaning of an ABN?

DoNNA cARTwRighT (Dc): An Advanced Beneficiary Notice of Non-Coverage is a document that advises Medicare patients of services or products that may not be covered by Medicare prior to their treatment. It gives an estimate of costs by the practitioner of services that would be the patient’s responsibility, and gives the opportunity to the patient to decide whether they wish to have the treatment/item or not. KS: Who is required to issue an ABN? DC: ABNs must be used by providers, practitioners, and suppliers who are paid via Medicare Part B. KS: Why is it so important to fill out these forms correctly? DC: A provider is required to notify a beneficiary in advance when he or she believes that items or services will likely be denied as unnecessary or as constituting custodial care prior to the provision of the item or service. If this notice is not given, providers may not shift financial liability for items or services to beneficiaries should a claim for such services be denied by Medicare. Any provider that gives a defective notice may not claim that he or she did not know that Medicare

would not make the payment as the issuance of a defective notice is clear evidence of knowledge. (If the person knew enough to write up a form but did not take the time to fill it out properly, then this constitutes evidence that the practitioner had prior knowledge that the service was not covered.) KS: What types of events should trigger providers to issue ABNs? DC: Providers should remember three terms in relation to ABNs: initiation, reduction, and termination. Initiation is the beginning of a new patient encounter, the start of a plan of care, or the beginning of treatment. If a provider believes that certain otherwise covered items or services will not be covered an ABN must be issued prior to the provision of non-covered care. For example, when the provider believes that Medicare will deem that the product or service is not reasonable and necessary. Reduction is when a component of care such as frequency or duration is decreased. The reduction in treatment would require an ABN. For example, a patient wants 5 days of physical therapy a week, but the provider believes it can be accomplished in 3 days. Termination is a discontinuation of certain items or services. Termination is discontinuation of a service or item due to a lack of medical necessity. For example, the provider thinks therapy is no longer reasonable and necessary, but the patient wants to continue. KS: What are the mandatory uses for an ABN by a wound care provider? DC: Wound care providers must issue ABNs under these circumstances: A. Services or items are considered unreasonable and unnecessary. B. Medical Equipment and Supplies exceed the number www.todayswoundclinic.com


inbusiness TiPs FOr ABN EdUCATiON PrOGrAM

ABN Education Tips • Only use ABNs for products and services that warrant them. NOTE: ABNs are not for products or services that Medicare or your Medicare contractor never covers. • When completing the ABN: Use language that the patients can understand. Provide a specific reason “why” you think Medicare will not pay. Provide your best estimate of the cost of products or services in question. Be sure to ask the patient to sign and date the ABN. • File the original, sign ABN, and give the patient a copy. • When filing claims: Use modifier GA attached to codes for products or services for which you have a signed ABN. Use modifier GZ when you think a service will be denied and you did not obtain a signed ABN. of items that will be covered by Medicare. C. Medical Equipment and Supplies are denied in advance. For example, if a particular dressing is notcovered an ABN is required. KS: What is the patient’s liability if they were provided a properly executed ABN and they agreed to pay? DC: The patient can be held liable for the bill for the items on the form. If the document is not completed properly or adequate notice was not given, the patient is relieved from liability. KS: What is considered adequate notice? DC: The ABN should be executed prior to the provision of the item or service. KS: Can providers collect money from the patient for non-covered items or services immediately after the ABN is signed? DC: Yes, providers may collect payment immediately after the ABN is signed unless some other applicable Medicare policy, state, or local law prohibits collection of payment in advance of the Medicare payment determination. KS: Once a patient signs an ABN, how long is it effective? DC: A new ABN must be signed each time the patient receives www.todayswoundclinic.com

a product or service, even if the patient signed an ABN for the same product or service in the past. KS: What happens if the patient changes his/her mind? DC: The patient must request to change the original ABN and provide a clear indication of his/her new option selection. KS: I understand that a new ABN form is about to be implemented. What forms will be replaced and what is the new form? DC: The following forms will no longer be valid: 1. Advance Beneficiary Notice ABN-G 2. Advanced Beneficiary Notice ABN-L The new form is CMS-R-131 and is entitled Advanced Beneficiary Notice of Noncoverage. KS:Where can the readers find information regarding ABN’s on the CMS web site? DC: This information can be found in several places: 1. On the Beneficiary Notice Initiative Web page at: www.cms.hhs.gov/bni 2. In the CMS Medicare Claims Processing Manual Chapter 30, there is a Transmittal 1587, change request 6136 dated September 5, 2008 that

provides a detailed description of the revised form and the requirements associated with its use. 3. Via a provider education article available at: www.cms.hhs.gov/MLN MattersArticles/ KS: Are the new forms available in languages other than English? DC: Yes. A Spanish version is available at: www.cms.hhs.gov/bni KS: Exactly when is the effective date for the new ABN form? DC: The new ABN form Advance Beneficiary Notice of Noncoverage CMS-R-131 will be effective on March 1, 2009. KS: Medicare normally has a transition period when they create new forms. Was there a transition period for the new ABN form? DC: CMS allowed a 6-month transition period from the date of issuance (September 5, 2008) of the instructions for the mandatory use of the revised ABN. Therefore, these forms must be implemented by March 1, 2009. KS: What are the major new items of the new ABN form? DC: There is a mandatory field for cost estimates of the items/services that may not be covered. In addition, the beneficiary options are new. The beneficiaries can choose to do one of three things: Wound Clinic Wisdom

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inbusiness 1. Have the service or supply and pay for it right away, but ask the provider to bill Medicare for an official determination on payment. If Medicare does not pay, the beneficiary understands that they are responsible for payment, but can appeal to Medicare. If Medicare pays, the provider will refund any payments made, less co-pays or deductibles. 2. Have the service or supply but do not bill Medicare. The beneficiary will be asked to pay for the service because they will now be responsible. In addition, beneficiaries may not appeal to Medicare because Medicare will not be billed. 3. Not to have the service. Therefore, the beneficiary is responsible for payment. KS: What information should providers place in the blank item D on the new ABN form? DC: Providers should list the item, service, laboratory test, test, procedure, care, supply, or equipment. For repetitive or continuous non-covered care, specify the frequency or duration of the service or item. General descriptions of specifically grouped supplies are permitted. For example, “wound care supplies” would be a sufficient description and an itemized list is generally not required. KS: What information should providers place in item E “Reason Medicare May Not Pay?” DC: Providers should explain, in a language that patients will understand, ‘why’ Medicare may not pay for an item or service. Three commonly used reasons for noncoverage are: 1. Medicare does not pay for this test for the condition. 2. Medicare often does not pay for this test. 48 Wound Clinic Wisdom

3. Medicare does not pay for experimental or research use tests. KS: How should providers determine the estimated cost for item F? DC: Providers should make a good faith effort to provide a reasonable estimate for all items or services listed in section D. The estimate generally should be within $100.00 or 25% of the actual costs, which ever is greater. However, an estimate that exceeds the cost substantially would be acceptable since the beneficiary would not be harmed if costs were less than predicted. KS: If a practitioner is reported as not complying with the ABN of Non-Coverage, and claims that they had no prior knowledge that the claim might be denied, what might Medicare look at to determine if the practitioner had prior knowledge? DC: A provider is responsible for properly identifying to patients the services or items that may not be covered by Medicare using all reasonable efforts. Medicare could review previous claims submitted by the practitioner. For example, if the previous claims were denied, that would demonstrate that the provider had prior knowledge that the service denied. KS: Can providers modify the ABN form? DC:The ABN form may be customized with some pre-printed information, such as the name and address of the provider, and preprinting of known treatment scenarios and costs that may not be covered in order to increase office efficiency. Providers may not pre-select the beneficiary options, which must be completed by the beneficiary. If you choose to customize the form, you should remove letters A-J on the sample form prior to creating your own template. Nothing substantive may be changed on the form.

SuMMARY If wound clinics and practitioners do not establish a process to provide ABNs to patients who come in for a product or service, that Medicare covers but will most likely not be covered for that patient, they may lose thousands of dollars each year. As Cartwright explained, a good ABN process begins by using the correct ABN form. Then wound clinics and practitioners need to identify products or services that were: 1) frequently denied because they were unreasonable and unnecessary; 2) provided more frequently than allowed; 3) considered preventive services; 4) are considered as screening examinations, etc. The clinics and practitioners should also establish reminders that will alert them when a product or service requests an ABN. For example, flag the products or services in your electronic health record, in your super bills/charge sheets, on your Charge Description Master, etc. For convenience and to serve as a reminder, make ABNs accessible by placing them in registration packets, in exam/treatment rooms, etc. Finally, and most importantly, educate all staff and practitioners about the value of using ABNs and how to use the new ABN that will be effective on March 1, 2009. n View the deleted ABN Forms and the new form, visit: www.todayswoundclinic.com/abn-forms Kathleen D. Schaum, MS, is President of Kathleen D. Schaum & Associates, Inc., Lake Worth, Fla. Schaum can be reached for questions and consultations by calling (561)9642470 or at kathleendschaum@bellsouth.net. Information regarding coding, coverage, and payment is provided as a service to our readers. Every effort has been made to ensure the accuracy of the information. However, HMP Communications and the author do not represent, guarantee, or warranty that 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. www.todayswoundclinic.com


inbusiness Keeping Up With Coverage Kathleen D. Schaum, mS

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n order for today’s wound clinics to maintain their status as centers for wound care excellence, the professionals who manage and work there do their best to offer products, procedures, and services that will produce optimal clinical outcomes at affordable prices to the patients and the payers. Not a day goes by that this author does not receive a call or an e-mail asking about coding and payment for some product, procedure, or service. What amazes this author the most is that very few people ask, “Is the product, procedure, or service covered?” When this author reminds the inquirer to be sure to check if their Medicare contractor has a Local Coverage Determination (LCD) regarding the product, procedure, or service in question, the inquirer is often silent or asks, “What’s an LCD?” To assist those professionals who are new to the business of wound care or are confused, this article will answer the question: “How do I know if a product, procedure, or service is reimbursed by Medicare?” When asking this question, remember that reimbursement is composed of three parts: coding, payment, and coverage. The following are three steps to follow when you wish to check if a product, procedure, or service has a verified code, has a Medicare payment rate, and is covered by the Medicare contractor that processes your claims.

STEP ONE: ChECK If ONE Or mOrE COdES havE bEEN CrEaTEd aNd vErIfIEd fOr ThE PrOdUCT, PrOCEdUrE, Or SErvICE. • If the product is a diabetic shoe, a lower/upper limb orthotic, a negative pressure wound therapy pump, an ostomy supply, a support surface, a surgical dressing, etc., you can check if a www.todayswoundclinic.com

HCPCS code has been verified for a particular brand and product number by visiting the Pricing, Data Analysis, and Coding (PDAC) website: https://www.dmepdac.com/dmecsapp/do/search. This website will allow you to learn: a) The exact description of each HCPCS code b) The exact description of each HCPCS modifier c) The current fee schedule rate for each HCPCS code d) The HCPCS code verified for a particular brand – can search by manufacturer, by product name, by product number, etc. • If the product is a skin substitute, you can verify if a HCPCS code has been assigned to a particular brand and product number by visiting the ASP NDC–HCPCS Crosswalk website: www.cms.hhs.gov/McrPartBDrugAvgSal esPrice/01a1_2009aspfiles.asp#TopOfPage When one visits this website, they will find a variety of files which are updated on a quarterly basis. Be sure to select the NDC-HCPCS Crosswalk and the correct year and quarter for which you need information. Although this file is very large, it can be sorted by HCPCS code, by manufacturer name, by product name, by product NDC, etc. • If you are searching for a procedure or service code, you should use one or more of the American Medical Association’s (AMA) current books and subscriptions: a) CPT® Current Procedural Terminology b) CPT® Changes: An Insider’s View c) CPT® Assistant d) CPT® Network

Be sure to visit the AMA’s website where you can order a wealth of coding information: https://catalog.amaassn.org/Catalog/home.jsp STEP ONE Summary: The manufacturers and distributors of wound care related items will often provide you with codes that are relevant to their products. Although that is a welcome service, providers are ultimately responsible for verifying the correct codes for each product, procedure, and service that they provide. If a manufacturer or distributor tells you to use a code that you cannot verify, be sure to ask the representative to provide you with either: 1) A copy of the letter from CMS that verifies the HCPCS code was assigned to the product, or 2) An AMA resource that verifies the CPT® code is relevant to the particular procedure or service.

STEP TWO: ChECK If ThE PrOdUCT, PrOCEdUrE, Or SErvICE haS a PUblIShEd PaymENT raTE ON ThE mEdICarE PaymENT SySTEm ThaT IS PErTINENT TO ThE PrOvIdEr(S). • The Medicare payment system for hospital-based outpatient wound care departments (HOPDs) is known as the Outpatient Prospective Payment System (OPPS). Based on the amount of resources required, all of the payable products, procedures, and services are assigned to an Ambulatory Payment Classification (APC) group. Each APC group is assigned a national average payment rate and a required coinsurance rate. The APC rates can be found for each payable HCPCS and CPT® code in Addendum B of the OPPS system file: http://www.cms.hhs.gov/HospitalOutpatie ntPPS/AU/list.asp#TopOfPage Because CMS updates the OPPS Addendum B on a quarterly basis, providers should be sure to select the correct year and quarter. Pay particularly close attention to the quarterly adjustments to the Average Sales Price of the skin substitutes Q4101-Q4114. Wound Clinic Wisdom

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inbusiness Also, remember that the rates listed in Addendum B are national average rates. Each HOPD director should contact the hospital’s billing or finance department to confirm their hospital’s unique OPPS payment and coinsurance rates. • The Medicare payment system for physicians is known as the Medicare Physician Fee Schedule (MPFS). Most of the payable procedures and services are assigned rates on the MPFS. These rates are adjusted to reflect the variation in practice costs from area to area. By viewing the MPFS look-up files, physicians can learn the rates that pertain to their geographic area: http://www.cms.hhs.gov/PFSlooku p/02_PFSSearch.asp#TopOfPage Physicians should note that the MPFS lists both the Medicare fees for services provided in their offices and for services provided in facilities. STEP TWO Summary: The manufacturers and distributors of wound care related items will often provide you with the national average payment rates for their products, procedures, and services. Although that is a great service, the HOPD should verify their particular payment rate and required coinsurance rate. Physicians should either 1) contact their billing services to verify the MPFS payment rate in their geographical area, or 2) visit the MPFS look-up web site. Unlike the OPPS file, the MPFS does not list the patient’s coinsurance responsibility because it is always 20% of the published rate. In other words, if the procedure/service is medically necessary, Medicare will pay 80% of the rate published in the MPFS. The patient will be responsible for paying the other 20% of the published MPFS for that geographic area.

STEP ThrEE: CONfIrm If ThE PrOdUCT, PrOCEdUrE, Or SErvICE IS COvErEd by ThE mEdICarE CONTraCTOr ThaT PrOCESSES yOUr ClaImS. • Contact your finance, billing and/or coding departments to learn the name 50

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of the Medicare contractor that processes the claims for the HOPD and for the physician(s) who practice there. In the past, the Medicare contractors that processed the claims for HOPDs were called Fiscal Intermediaries (FI) and for physicians were called Carriers. In some states, the FI and Carrier contract was awarded to the same insurance company. In those cases, the medical policies for the HOPDs and the physicians were usually very similar. In other states, CMS awarded the contracts for FI and Carrier to two different insurance companies. That situation proved to be particularly problematic for physician-driven HOPDs. In many instances, the physicians’ Medicare guidelines were different than the HOPDs’ because two different Medicare contractors wrote the medical policies. To remedy this situation, CMS divided the country into 15 Medicare jurisdictions. Bids were accepted for one Medicare contractor (Medicare Administrative Contractor [MAC]) to process the claims for both the HOPD and the physicians in each of the 15 jurisdictions. All of the contracts for the new MACs have been awarded to 10 different insurance companies (NOTE: several insurance companies were awarded contracts for more than one jurisdiction). Some of the MACs have already assumed their responsibilities. Other MACs are in the process of assuming their responsibilities. Newly announced MACS are just getting started. Therefore, HOPDs and physicians should closely monitor which Medicare contractor is processing their claims now and which Medicare contractor will process their claims in the future. Identify the web address for your current and future Medicare contractor. (See www.todayswoundclinic.com for links to the websites of the new MACs) Book mark the website in your “favorites.” Sign-up to receive all pertinent communications from both your current and your future Medicare contractor.

• Assign someone to monthly monitor the Local Coverage Determination (LCD) medical policy section of your current and future Medicare contractor’s web site. That person should review all of active LCDs that pertain to products, procedures, and services that you offer to your chronic wound care patients. As your LCD monitor locates each LCD that pertains to your wound care practice, he/she should: a) Print the LCD b) Before leaving the LCD, scroll to the bottom of the LCD and look under “Related Documents’ for accompanying Articles and under “LCD Attachments” for any additional documents such as Coding Guidelines. If the LCD contains one or more related documents or attachments, click on the hyperlinks to view and print this important additional information. c) Review each LCD and its related documents and attachments with the entire wound care team. Pay particular attention to: - Effective date of LCD - Indications and Limitations of Coverage and / or Medical Necessity - Coding Information (Bill type codes, revenue codes, CPT®/HCPCS codes, ICD-9 codes that support/do not support medical necessity) - Documentation requirements - Utilization guidelines - Revision history explanation • Note that Medicare contractors do not write LCDs about all products, procedures, and services that they cover. That type of coverage is usually referred to as “neutral coverage” and is based on medical necessity. Neutral coverage is actually the best type of coverage because the contractor is not placing a lot of limitations on the utilization of the product, procedure, or service. • Note that Medicare contractors, who choose to control their coverage www.todayswoundclinic.com


inbusiness via LCDs, often have different philosophies. For example: some Medicare contractors’ skin substitute LCDs only describe the products that they cover. Other Medicare contractors’ skin substitute LCDs only describe the products whose utilization they wish to control; all other skin substitutes are covered based on medical necessity. • Be aware that your Medicare contractor may update existing LCDs one or more times throughout the year. Therefore, your LCD monitor should monthly check your Medicare contractor’s website for updates to existing LCDs, for LCDs that are retired, for DRAFT LCDs, and for Notices of new LCDs that are about to be implemented. To assist in this endeavor, your LCD monitor may choose to join the Medicare contractor’s list serve, which sends out notices on a wide variety of topics, including coverage issues. •Pay particular attention to LCD updates during the transition from FI/Carrier to your new MAC. In preparation for their role as a new Medicare contractor, the new MACs are required to assimilate all the LCDs, pertaining to the same subject, which they inherited from the FIs and Carriers into one LCD. Because this LCD assimilation is a huge task, the MACs may inadvertently make a mistake, such as forgetting pertinent ICD-9, CPT®, or HCPCS codes. If providers notice a mistake and inform the MAC medical director, he/she is usually open to correcting LCD mistakes during the transition period. • Take an active role in educating the MAC medical director about evidence-based wound care guidelines and practices by: a) Attending and presenting at ope public LCD meetings when pertinent new DRAFT LCDs are released. The dates, times, registration process, and presentation guidelines, for these open www.todayswoundclinic.com

meetings are announced on the Medicare contractors’ web sites. b) Commenting on DRAFT LCDs during the open comment period. The process for commenting on new DRAFT LCDs is clearly described on each Medicare contractor’s web site. Additionally, most DRAFT LCDs specify the contact name and e-mail address to which providers can submit their comments. The Medicare contractor’s Medical Directors value the education and comments they receive during the open comment period. Unfortunately, most wound care providers do not take advantage of this wonderful opportunity of meeting and communicating with their contractor’s medical director. Providers should keep in mind that a DRAFT LCD is truly a “Draft”. If the providers do not comment on restrictions or guidance that is not consistent with published evidence, with published practice guidelines, etc. the Medicare Medical Director will assume that the DRAFT should become final as proposed. Providers should not allow inappropriate LCD language to become final just because they failed to comment on the DRAFT LCD! c) Using the Reconsideration Process to request an evidence-based update to an existing LCD. This process is clearly outlined on every Medicare contractor’s web site. As evidence and protocols evolve, providers should feel obligated to request changes to LCDs that are based on outdated information. The Reconsideration Process is man dated by CMS to give providers the opportunity to explain how LCDs should be updated. For example: the LCD may not list all of the ICD-9-CM codes that

appropriately describe the medical necessity for a particular product,procedure, or service. STEP THREE Summary: Just because a product, procedure, or service has a code and a payment rate does not mean that the Medicare contractor has a neutral or positive coverage policy that will actually allow them to pay for the submitted claims. Wound care providers must take an active role in monitoring and following LCD guidelines, in requesting evidence-based changes to existing LCDs via the Reconsideration Process, and in educating (via presentations at open LCD meetings and commenting during DRAFT LCD open comment periods) the Medicare contractor why some segments of DRAFT LCDs are not evidence-based or are not following published coding conventions. In order to operate successful wound care businesses, wound care providers must keep up with all three components of reimbursement: coding, payment, and most importantly: Keep Up With Coverage! n Information regarding coding, coverage, and payment are provided as a service to our readers. Every effort has been made to ensure the accuracy this information. However, HMP Communications and the author 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. For an exclusive chart of website addresses for Medicare Adminstrative Contractors (MACs), visit www.todayswoundclinic.com Kathleen D. Schaum, MS, is President of Kathleen D. Schaum & Associates, Inc., Lake Worth, Fla. Schaum can be reached for questions and consultations by calling (561) 964-2470 or through her email address: kathleendschaum@bellsouth.net. Wound Clinic Wisdom

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The ForgoTTen PATienTs: Wound Care Centers and Amputees Joe Sansone, CEO of the Amputee and Prosthetic Center

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inrecovery

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hether you are treating an infection to prevent amputation, or treating an amputee who is fighting a wound on another extremity, wound care centers and amputees spend a lot of time together. The correlation is not surprising, considering that a foot ulcer precedes an estimated 85% of all non-traumatic amputations. Unfortunately, many wound care providers are unwilling participants when it comes to the treatment of amputee patients. Wound care centers, however, are not prosthetic providers and many times they are left feeling helpless when it comes to offering the assistance that their amputee patients so clearly need.

Assembly line oF CAre All too often, by the time a patient loses his or her limb, he or she has been lost in an assembly line of care. They may have been passed along from one healthcare provider to another, left feeling lost with nowhere to turn. The following scenario may not be uncommon: A patient with diabetes visits a primary care physician for a small ulceration on their foot. The PCP then refers the patient to a podiatrist who treats the wound. After weeks or months of unsuccessful treatment, the podiatrist may pass the patient on to an internal medicine specialist, and thereafter to a wound care center. After unsuccessful treatment at the wound care center, an amputation cannot be avoided and the orthopedic surgeon performs the amputation. Following the amputation, the patient lies alone in the hospital bed, looking down where his leg used to be, feeling hopeless and helpless. In all of the confusion, the patient has lost track of who their actual physician is, and has no idea of what the future holds for them as an amputee. Unfortunately, at this stage of the process, the prosthetic provider becomes just another face in the crowd or worse, the provider has never even been contacted. www.todayswoundclinic.com

“Finding a forum to discuss the issues that amputees face on a daily basis is vital and amputee support groups have proved very helpful in assisting amputees.” Where Does The WounD CAre CenTer enTer inTo The ProsTheTiC ProCess? While wound care centers provide an invaluable service in the prevention of amputations, once a patient loses a limb, what is the role of the wound care center? What can we do to ensure the continuity of care to the amputee? Dr. Caroline Fife, Chief Medical Officer for Intellicure, Inc. (The Woodlands, Texas) said that historically, wound care centers end up being ‘the last resort.’ “We are often just a stopover for those who suffer the loss of a limb,” Fife says. “Whether wound care fails resulting in an amputation, or a wound on the residual limb is treated and healed, we treat the wound and sometimes never see the patient again. I don’t usually do any stump management like shrinking or molding. We assume the surgeon does that, but I do wonder.” Dr. Fife is not alone in this disconnect between providers and the amputee that can leave the patient feeling lost in medical bureaucracy.

gAPs in CoverAge Dr. Fife says that the biggest problem faced by amputees is the fact that many insurance companies do not pay for prosthetic devices on par with Medicare, which makes it impossible for many patients to procure the help they need.

“Many of my patients are elderly with poor rehab potential,” Fife said. Often these patients have other health issues, such as heart disease that prohibit them from participating in effective rehabilitation programs. Many amputees do not have the balance to walk on prosthesis so they are wheelchair bound. “Because so many elderly patients don’t drive or use computers, their access to support is nearly nonexistent,” according to Fife. Even though these patients may not be candidates for a limb, moral support for these patients is a critical issue.

AmPuTee suPPorT grouPs Finding a forum to discuss the issues that amputees face on a daily basis is vital and amputee support groups have proven very helpful in assisting amputees. One of the most beneficial roles that support groups play is with helping acclimate newer amputees back to society. Many amputees are hesitant about getting involved in a support group, but the Amputee Coalition of America (ACA) certified peer visitor Jody Graham feels they truly make a difference. The ACA (www.amputeecoalition.org) is a national non-profit amputee organization, which serves as a resource for amputee support groups around the country. Jody is also the leader of Amputees in Action in Houston, Texas.“We don’t really call ourselves an amputee support group; we call ourselves an amputee social group. When we first began meeting it seemed as if our meetings became a complaint session and that’s not what we wanted it to be about,” Graham said. “So now we focus on just having fun. Rest assured when you gather a group of amputees together for an event like bowling or a day at the horse races, the amputees talk with each other about what it’s like to be an amputee. It’s not uncommon to hear discussion on liners or hear another amputee giving tips on driving, or performing various daily tasks.” One of Amputees in Action’s special events was a horseracing event. Wound Clinic Wisdom

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inrecovery meeTing PATienTs’ neeDs Education regarding wound care and management are critical. There are a variety of resources available to amputees; however, many amputees do not know what is available or where to look. Surprising to some, the quickest way to find assistance is to search the Internet. A search utilizing a city’s name and ‘amputee support’ or “prosthetics” will open up a world of possibilities for amputees. The most prevalent assistance for amputees comes in the form of the ACA, which offers a variety of resources to amputees, including a library with hundreds of books, booklets, and videos addressing a range of issues important to amputees from phantom pain and wound care to rehabilitation.

Peer visiTors

You could see how much it meant to not only the amputee, but to his son as well when they learned that there was life after amputation. “They kept to themselves at first and were apprehensive, but soon you could see 54

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the son’s eyes light up as other bilateral amputees talked to his father about what life would be like. You could see how much it meant to not only the amputee, but to his son when they learned that there was life after amputation.”

Perhaps the most valuable resource of the ACA is the services of a peer visitor. A peer visitor is an amputee who visits patients either before or after the loss of a limb to answer any questions and counsel him or her on what it’s like to be an amputee. One call to the ACA, and they will send a certified peer visitor to visit any amputee. Both male and female peer visitors are available in almost any age group. Unilateral, bilateral, upper extremity or lower extremity—in most areas, the ACA can offer assistance. Graham has performed approximately 1000 of these peer visits in the past few years. Graham lost her leg in an auto accident in 2003. “I was sad and debilitated and wondered what would become of my life, and I had no idea what the future held in store for me,” she said. “After months of despondency and worrying, when I received my limb I realized that I was going to be OK, that I could do almost everything that I could before my amputation. And then I remembered what it was like to lay in a hospital bed, stressing over nothing. I would have given anything if I could have talked to an amputee at that time.” After this realization, Graham decided she was determined to help other www.todayswoundclinic.com


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inrecovery warranty work for a period of up to five years,” Falls said. “So when we deliver a limb, we are constantly tweaking it afterwards until we achieve perfection. Practitioners realize that amputees must have an almost perfect fit in order to achieve the results that they want and maintain the lifestyle they desire and deserve.” If an amputee were not content with the care given by the prosthetic provider, it would be in their best interest to seek out another company. Wearing a prosthesis is now a part of everyday life and the patient needs to feel confident that the provider will be there if they need an adjustment, break the limb or needs any other assistance to ensure they are never hindered by a prosthetic device.

WounD CAre’s oPPorTuniTy

amputees in her situation—but she couldn’t find an outlet to help. When Graham heard that the ACA was holding peer visitor training in her hometown of Houston, Texas she jumped at the opportunity. “I couldn’t believe that after having so many doors shut in my face here was a national entity that was here to train me on the very thing that I wanted to do,” she said.

FinDing A ProsTheTiC ProviDer For many, finding a prosthetic company for their patients is an arduous task. Once again the Internet can be a valuable resource, as well as the American Board of Certification in Orthotics and Prosthetics (www.abcop.com). This certifying board requires that providers reach educational and examination achievements as well as adhere to standards of care. A wound care center can also verify that facilities as well as practitioners have been certified. Wound care centers can play a pivotal role in helping their amputee patients choose a provider. There is no one practitioner that can be all things 55

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to all patients; just as in choosing any medical provider, the patient should exercise their right to find their perfect match. Some practitioners excel in upper or lower extremities while some have ample experience fitting the new micro-processor controlled limbs, while some may only fit a few per year. Patients should be encouraged to meet many providers and choose one with whom they are comfortable. Once the prosthetic provider enters the picture, and a limb is delivered, many might think that the patient’s needs have been met and the amputee can then move on. This is not the case. According to Ben Falls, Chief Prosthetist at the Amputee and Prosthetic Center in Houston, Texas good prosthetic care doesn’t stop with the delivery of a prosthetic device. A quality prosthetic provider will follow up with patients, seeing them a minimum of four or five times in the 3 month period following the final delivery of the prosthetic device. “When a provider receives payment for the prosthetic limb, that payment covers all office visits, adjustments, and

Even though the wound care center is not a prosthetic provider, employees can be invaluable tools in assisting amputee patients with their prosthetic needs. Do some homework for your patients and search out the prosthetic providers in your area. Ask the prosthetic questions and ensure that they have an amputee program that treats the entire patient, and doesn’t just “slap on a limb” Create a database of prosthetic providers in your area that truly care for their patients and provide this information to your patients. Finally encouraging patients to enroll in the Amputee Coalition of America ensures that amputees will have a lifeline to resources and that they will receive regular updates on issues of importance to amputees. n

Joe Sansone is CEO of TMC Orthopedic and the Amputee and Prosthetic Center and is the founder of Limbs of Love, a charitable organization that provides prosthetic limbs to patients without insurance coverage. Sansone was named “Professional of the Year” in 2008 by the ACA in recognition for his commitment to advocacy for the amputee community. Visit www.myamputee.com for more information. www.todayswoundclinic.com


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So, There’s Really No Free Lunch? Marcia Nusgart, R.Ph, Dot Weir, RN, CWON, CWS Lynn Shapiro Snyder is a Senior Member of Epstein Becker & Green, P.C., Benjamin S. Martin is an Associate of Epstein Becker & Green, P.C.

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ur readers may remember fondly (or perhaps not so fondly) the days when there were frequent requests from all forms of DME suppliers, home health agencies, infusion providers, and product manufacturers to visit our clinics. This is usually during the lunch hour to provide lunch and talk to the staff about their products or services, or simply to say “thank-you” for the business. Along with the lunch, left behind were piles of pens, pads, mouse pads, can drink covers, and other “reminders”. Additionally there were the boxes of donuts, bagels, and candy passed through the front window with the company logo on a sticker proudly letting the recipients know who brought them. In more distant years there were trips, golf games, sporting events and all sorts of “perks” that came with close relationships to coveted vendors whose products were used fre56

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quently and with whom a close relationship had developed. For many, our hospitals may have placed limits on the free goods, especially meals, unless there was legitimate education being presented during work hours. But there certainly seemed no harm in a few pens and pads. But then with the arrival of January 2009, it all seemed to come to a screeching halt. Most of our vendors gave us a heads up that it was coming, that the rules were changing, and apologetically announced that even the wall calendar that they had always provided would be no more. Note: (Check out the December 2009 issue of Ostomy Wound Management for a free wall calendar provided by HMP Communications.) Most just accepted the changes, as “somebody’s” rules, but this issue of Today’s Wound Clinic seemed the obvious forum for providing the details.

Many state and national medical device and pharmaceutical associations have developed over the years codes of ethics—the ones we will address in this article were conceived and written by two national associations who represent—the Advanced Medical Technology Association (AdvaMed) and the Pharmaceutical Researcher and Manufacturers of America (PhRMA). AdvaMed (www.advamed.org) is the world’s largest association representing manufacturers of medical devices, diagnostic products, and medical information systems. AdvaMed members and subsidiaries manufacture nearly 90 percent of the healthcare technology products purchased annually in the United States and more than 50 percent of the healthcare technologies purchased annually around the world. PhRMA (www.pharma.org) represents the country’s leading pharmaceutical research and biotechnology com-

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ethics&law panies. AdvaMed originally published its Code of Ethics on Interactions with Health Care Professionals in 2003, with an update in 2005. The ‘Code of Ethics’ was revised in 2008 and implemented in July 2009 but many companies began implementing the provisions at the beginning of this year. The goal of the new Code was to find a balance between productive interactions with health care professionals and ethical behavior consistent with fraud and abuse authorities. Although many of us are not familiar with the medical device and pharmaceutical trade associations, we are appreciative that there are organizations that place a ‘Code of Ethics’ at the forefront of their industry. To help us understand the position of AdvaMed and PhRMA, the effect on our industry and clinics, and the role that we in the clinics can play in assuring compliance with the guidelines, TWC solicited the help of Marcia Nusgart, R.Ph, Nusgart is the executive director of the Alliance of Wound Care Stakeholders, a multidisciplinary consortium of over 15 physician, clinician, provider, manufacturer and patient organizations that addresses regulatory and legislative issues impacting wound care. She also serves as executive director for the Coalition of Wound Care Manufacturers and President of Nusgart Consulting, LLC. She previously served as associate vice president, Home Care for the Advanced Medical Technology Association (AdvaMed). The authors also solicited the help of Lynn Shapiro Snyder and Ben Martin, health lawyers from the national health law firm, Epstein, Becker & Green, P.C. (EBG). The law firm has one of the largest health industry law practices in the United States. For more information about EBG, visit their website at www.ebglaw.com. Set forth below are questions and answers related to the purpose of the Codes, the evolution of the changes, and what our role should be in connection with industry compliance. Q: Isn’t the restriction of pads and pens extreme? If I’m making a treatment decision, I don’t look down at my pen for guidance. www.todayswoundclinic.com

A: Both Codes were revised to prohibit the provision of branded items, including those of nominal value, such as pads and pens. This eliminated one of those “gray areas” mentioned above. The government enforcement community has been particularly vocal about its concerns that a vendor’s provision of branded items can improperly influence a prescriber’s choice of product, especially when the branded items have no relationship to patient care or patient education. These items are considered by the enforcement community to be a form of subsidization of a prescriber’s overhead. This would include not only pads and pens, but also coffee mugs, clocks, calendars, and novelty items. Of course, pharmaceutical and medical device manufacturers may still provide truthful and nonmisleading information about their products to prescribers (in compliance with FDA requirements). Q: Is there an example of when it is acceptable and appropriate for a sales representative to provide lunch and an in-service for our staff? A: The days of ‘dine and dash’ - when a vendor provides a courtesy meal for a prescriber’s staff - are over. However, both Codes allow vendors to provide ‘modest’ meals in conjunction with some type of healthcare product education attended by the prescriber and other persons from the prescriber’s staff who have a bona fide professional interest in the information being shared by the vendor. These meals should be limited to in-office or in-clinic settings. Q: Is there a standard for gift cards, books, baby shower gifts, holiday gifts, and other items outside of an educational forum? A: No. None of these items is permitted when there is a professional relationship. Q: Can hospital-owned outpatient wound care departments take samples of wound care dressings, drugs, and bioactive dermal substitute products just to try on patients?

A: The federal Anti-Kickback Statute is very broad in what could fall within the key term of prohibited “remuneration”. These products have value so providing them for “free” could suggest a form of subsidy to a person in a position to purchase or recommend these products. The AdvaMed Code allows manufacturers to provide such items for free to allow for their evaluation, but the number provided should not exceed the amount reasonable necessary to perform that evaluation. However, clinics should not bill for any items they receives for free, as that may potentially expose them to liability risk under the federal False Claims Act. In addition, a product manufacturer may provide demonstration products that are not used with actual patients. Q: Is it still acceptable to refer patients to the manufacturers’ indigent or charity programs and to assist them in completing enrollment forms? A: Yes, it is still acceptable for clinic personnel to refer patients to the various websites and toll-free numbers of manufacturers’ indigent, charity or patient assistance programs and to assist them in completing enrollment forms. Q: There are frequently dinners held in our area by different companies where they bring in a guest speaker to talk about their products. Is that still OK? A: Meals may be provided but only if they are modest and ancillary to educational or product training activities. The setting also must be conducive to effective scientific and medical exchanges. It may not be an entertainment or recreational event. The PhRMA code does not consider a restaurant setting to be appropriate. Q: If I’m at an out of town meeting, are small social group dinners put on by the sales organizations still OK? A: Similar to the question above, the answer is no. The questions and answers section of the PhRMA Code expressly Wound Clinic Wisdom

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ethics&law states that a field sales representative may not conduct an informational presentation accompanied by a meal for a health care professional in a restaurant down the street from the hospital. Q: What guidelines should be followed for company sponsored trips to corporate offices, manufacturing facilities, etc? A: Only the AdvaMed Code has any reference to permitting a subsidized trip to a manufacturer’s facilities and only in very limited circumstances. These limited circumstances are when the product requires special training. In particular, the AdvaMed Code states as follows: “Where there are objective reasons to support the need for out-of-town travel to efficiently deliver Training and Education on Medical Technologies, Companies may pay for reasonable travel and modest lodging costs of the attending Health Care Professionals. “ Q: Can manufacturers offer free services that are normally provided by the hospital, such as insurance verification, prior authorization/ pre-determination, denied claims appeal, etc.? A: The revised AdvaMed Code states that: Permissible activities involving the provision of coverage, reimbursement and health economic information may include, but are not limited to … facilitating patient access to the Company's Medical Technologies by providing Health Care Professionals with assistance in obtaining patient coverage decisions from payors. This assistance may include providing information and/or training on payor policies and procedures for obtaining prior authorization, and providing sample letters and information on medical necessity and appeals of denied claims. In addition, as the request of a Health Care Professional to facilitate patient access to the Company's Medical Technology, and subject to appropriate privacy safeguards, the Company may assist the patient by facilitating the preparation and submission of requests for coverage determinations, prior authoriza58

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tions, pre-certifications and appeals of denied claims, relating to a Company's own Medical Technology; however such assistance should not be provided as an unlawful inducement. As stated, manufacturers should not provide reimbursement-related assistance as an unlawful inducement or in the context of an improper promotional activity. The OIG industry guidance to manufacturers and two OIG Advisory Opinions, all of which predate the revised AdvaMed Code, addressed the potential implications of providing reimbursement-related information and services to customers in certain contexts. See OIG, "Compliance Program Guidance for Pharmaceutical Manufacturers", 68 Fed. Reg. 23,731, 23,735 (May 5, 2003) (OIG stated in this guidance that it also applied to medical device manufacturers); see also OIG, Adv. Op. 06-16, at 4-5 (Oct. 3, 2006); OIG, Adv. Op. 00-10, at 7 (Dec. 15, 2000). Providers therefore should consult their internal compliance function before requesting or accepting such services from manufacturers. Q: Do all of the manufacturers in the wound care industry have to follow these guidelines? What if they aren’t a member of AdvaMed or PhRMA? A: Although compliance with the PhRMA and AdvaMed Codes is voluntary, each trade association has posted on its website the list of trade association member companies that have agreed to abide by the trade association’s respective Code. Other companies may be abiding by other codes of national or state trade associations of which they are manufacturers, such as the Medical Device Manufacturers Association. Of course, a manufacturer that is not a member of any trade association still may elect to adopt and comply with any of the various Codes and could notify its customers of that voluntary decision; however, PhRMA or AdvaMed only post on their websites a list of the actual members of each trade association that agree to comply with the respective Code. Finally, whether or not a manufacturer is a mem-

ber of a trade association or follows its Code, all manufacturers must comply with applicable federal and state laws, which in some cases may be more restrictive than any of the Codes. Q: If a clinic encounters an individual who suggests activities outside of the guidelines, what should they do? A: Of course, the answer to this question depends upon various facts and circumstances. If your clinic’s corporate compliance program includes protocols for this type of circumstance, you should follow that protocol. In the absence of that, then, at a minimum, you may consider educating the company representative that he or she is not following industry guidelines, as you understand them to be. The company representative is then put on notice as to the potential infraction. The company representative now has the opportunity either to explain why the conduct is still permitted or whether the conduct should be stopped. Also, each company often has a compliance hotline or compliance officer available for the filing of concerns related to the behavior of its sales representatives.You may want to reach out to the company in that context as well. n Marcia Nusgart, R.Ph, is the Executive Director of the Alliance of Wound Care Stakeholders, Executive Director for the Coalition of Wound Care Manufacturers and President of Nusgart Consulting, LLC. Dot Weir, RN, CWON, CWS s the coeditor of TWC. She can be reached at dorothy.weir@HCAhealthcare.com Benjamin S. Martin is an Associate in the Health Care and Life Sciences Practice in the Epstein Becker & Green, P.C. Washington, DC office, where he practices in the Pharmaceutical Industry Health Regulatory Group. Lynn Shapiro Snyder is a Senior Member of Epstein Becker & Green, P.C. in the Health Care and Life Sciences and Litigation Practices in the firm's Washington, DC office and she is Strategic Counsel with EBG Advisors, Inc.

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inbusiness Final 2010 Medicare Policy: Supervision in HOPDs Kathleen D. Schaum, MS

Disclaimer: Information regarding coding, coverage, and payment is provided as a service to our readers. Every effort has been made to ensure the accuracy of the information. However, HMP Communications and the author do not represent, guarantee, or warranty that 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.

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ospital-owned outpatient wound care departments (HOPDs) throughout the country anxiously awaited Medicare’s 2010 Outpatient Prospective Payment System (OPPS) Final Rule, which was released on October 30, 2009 and provides nearly 2000 pages of very important policies. As soon as the Final Rule was released, this author did an immediate search to answer the main question that all HOPDs wanted to have answered: Did Medicare change the “direct supervision” requirement for on-campus and off-campus HOPDs in 2010? Medicare, via the OPPS Final Rule, annually updates the 1) payment rules that HOPDs must follow and 2) payment rates that HOPDs may receive from Medicare and Medicare beneficiaries. All wound care providers/employees who work in HOPDs should read the sections of the 2010 OPPS Final Rule that pertain to them. The document can be found at: http://www.cms.hhs.gov/HospitalOut patientPPS/HORD/itemdetail.asp?filte r Ty p e = n o n e & f i l t e r B y D I D = 59 Wound Clinic Wisdom

“Wound care directors may find it beneficial to attend one of the American Medical Association’s CPT® symposiums which are typically held in November and December each year.” 99&sortByDID=3&sortOrder=descen ding&itemID=CMS1230047&intNum PerPage=10 In this issue and in the next few issues of Today’s Wound Clinic, this author will review the major points of the 2010 Final Rules for both the HOPD and the physicians and non physician practitioners who provide wound care to Medicare beneficiaries in this place of service

LOOk Back at 2009 OPPS FinaL RuLe The 2009 OPPS Final Rule, which became effective on January 1, 2009, surprised and worried many providers and employees who work in HOPDs that are not directly supervised by a physician. These HOPDs thought that the availability of physicians in the hospital satisfied the supervision requirements. However, the 2009 OPPS Final

Rule clarified that the original 2000 OPPS Final Rule stated that “direct supervision” is the standard for physician supervision of hospital outpatient therapeutic services. “Direct supervision” means the physician must be present and on the premises at the location (in the department) and immediately available to furnish assistance and direction throughout the performance of the procedure (for as long as patients are being treated in the department). The only physicians who can provide direct supervision in HOPDs throughout 2009 are: • Doctors of medicine or osteopathy • Doctors of dental surgery or of dental medicine • Doctors of podiatric medicine (for certain purposes and to the extent authorized by the State) • Doctors of optometry • Chiropractors The 2009 OPPS Final Rule further clarified that a non physician practitioner may not provide the direct supervision even if their professional service was billed as a nurse practitioner or a physician assistant service and not as a physician service. NOTE: The 2009 OPPS Final Rule greatly affected wound clinics that were directly supervised by non-physician practitioners or, in some cases, were staffed by wound care nurses without any direct supervision. Throughout 2009 hospitals could not bill a facility fee if a physician was not present in the footprint of the wound care departwww.todayswoundclinic.com


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inbusiness ment. If a non physician practitioner provided the service, they could bill for the professional fee, but the hospital could not bill the facility fee.

Review OF 2010 OPPS FinaL RuLe: Medicare stated that the stakeholders provided sufficient information for them to develop a 2010 OPPS Final Rule that took into consideration “current clinical practice and patterns of care, the need to ensure patient access, the associated hospital and physician responsibilities, consistency among requirements for different sites of service, and other important factors.” NOTE: That means that your numerous comments to the OPPS Draft Rule were heard! Following are some major OPPS Final Rule points, pertaining to the “Direct Supervision” requirements for on-campus and off-campus HOPDs, which will be effective January 1, 2010:

PHySicianS ORDeRS: “Services and supplies must be furnished on a physician’s order and delivered under physician/non physician supervision. Each occasion of a service does not need to also be the occasion of the actual rendition of a personal professional service by the physician responsible for the care of the patient. However, during the course of treatment rendered by auxiliary personnel, the physician/non physician practitioner must personally see the patient periodically and sufficiently often enough to assess the course of treatment and the patient’s progress and, where necessary, to change the treatment regimen.”

On-caMPuS SuPeRviSiOn: Medicare redefined the definition of supervision for hospital outpatient therapeutic services provided in the hospital or on-campus provider based departments (PBDs):“For services provided in the hospital or on-campus PBD of the hospital, the supervisory physician or non physician practitioner must be present on the same campus and immediately available to furnish assistance and direction throughout the performance of the procedure.” NOTE: Because “immediately www.todayswoundclinic.com

available” requires the supervising physician/non physician practitioner to be physically present “without interval of time”, that person cannot be performing another procedure or service that he or she could not immediately interrupt. “The physician or non physician practitioner must be prepared to step in and perform the service, not just to respond to an emergency. This includes the ability to take over the performance of a procedure and, as appropriate to both the supervising physician or non physician practitioner and the patient, to change a procedure or the course of treatment being provided to a particular patient. The physician or non physician practitioner is not required to be in the room where the procedure is performed.” Medicare then described “in the hospital”: “…areas in the main building(s) of a hospital or Critical Access Hospital (CAH) that are under the ownership, financial, and administrative control of the hospital or CAH; that are operated as part of the hospital or CAH; and for which the hospital or CAH bills the services furnished under the hospital’s or CAH’s CMS certification number.” NOTE: Medicare clarified that “ownership” pertains to the actual business operation, not solely the physical building. “For 2010, non physician practitioners (clinical psychologists, licensed clinical social workers, physician assistants, nurse practitioners, clinical nurse specialists, and certified nurse midwives) may directly supervise all hospital outpatient therapeutic services that they may perform themselves within their State law and scope of practice and hospital-granted privileges, provided that they meet all additional requirements, including any collaboration or supervision requirements, as specified in the regulations at §§410.74 through 410.77.” “The supervisor must be a person who is “clinically appropriate” to supervise the procedure.” Medicare clarified that “procedure” encompasses “all services and procedures and includes all components of a service or procedure furnished by a

hospital to an outpatient and covered and paid by Medicare, regardless of whether separate payment is made for those component services.” NOTE: Non physician practitioners can obtain further clarification by reading Chapter 15 of the Medicare Benefit Policy Manual: http://www.cms.hhs.gov/manuals/Downloads/bp102c15.pdf

OFF-caMPuS DiRect SuPeRviSiOn: Medicare did not redefine the definition of “Direct Supervision” of hospital outpatient therapeutic services provided off-campus because that definition was very clear in the 2000 OPPS Final Rule. Medicare did enhance the definition to allow non-physician practitioners to provide direct supervision of the services that they may perform themselves in those locations: “For off-campus PBDs of hospitals or CAH’s, the physician or non physician practitioner must be present in the off-campus PBD, and immediately available to furnish assistance and direction throughout the performance of the procedure. This requirement does not mean that the physician or non physician practitioner must be in the room when the procedure is performed.”

MeDicaRe PayMent: “Medicare Part B payment may be made for hospital outpatient services and supplies furnished incident to the services of a physician, clinical psychologist, nurse practitioner, physician assistant, clinical nurse specialist, certified nurse mid-wife services, or licensed clinical social workers – if they are provided as an integral though incidental part of a physician’s services.” “Medicare does not make a payment to the physician or non physician practitioner if they solely provide the direct supervision and do not furnish a direct professional service to the patient.”

enFORceMent OF SuPeRviSiOn RuLeS Many stakeholders questioned the consequences that they may incur if they misinterpreted the direct supervision rule since the year 2000 when the Wound Clinic Wisdom

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inbusiness OPPS began. The 2010 OPPS Final Rule states:

OPPS supervision regulations effective January 1, 2010?

• For On-Campus PBDs in 2009: “We note that the physician supervision policies for hospital diagnostic and therapeutic services as described in the CY 2009 OPPS/ASC final rule with comment period (73FR 68702 through 68702) continue to be in effect for CY 2009. We have not instructed contractors to delay initiation of enforcement actions or to discontinue pursuing pending enforcement actions regarding the physician supervision of hospital outpatient services (74 Federal Register 35365).” • For On-Campus PBDs from 2000 - 2008: Medicare “plans to exercise their discretion and will not enforce situations involving claims where the hospital’s noncompliance with the direct physician supervisory policy resulted from error or mistake.” • For Off-Campus PBDs: Medicare “intends to enforce the off-campus direct supervision policy from 2000-2009 because the April 2000 OPPS Final rule clearly required the supervisory practitioner to be physically present in off-campus PBDs when services were being furnished.”

Remember that the physician or non physician practitioner providing supervision to your wound care department must have hospital-granted privileges to perform the procedures in your department. The fact that they are immediately available to respond does not appear to meet the full intent of the Final Rule. Once you have determined how you will meet the supervision requirements, you need to establish a method of knowing who is supervising your HOPD everyday that you are open for business. For Example:You may choose to post a schedule of supervising physicians/non physician practitioners that every HOPD employee should check when they first arrive to work. Once you have established your supervision protocol, hospital administration must communicate that protocol to each physician/non physician practitioner who will be providing the supervision in your HOPD. If a claim is submitted for work performed in an HOPD that did not have proper supervision, that claim may be paid. However, if an audit uncovers that proper supervision was not available during the patient visit, the payer can recoup your reimbursement. Remember: Just because you were paid does not mean you should have been paid and does not mean that you will be able to keep the payment after an audit. Be proactive NOW to be sure you are in compliance with the 2009 and 2010 OPPS supervision regulations. Then you will 1) be in the best position to ensure access to chronic wound care for your Medicare beneficiaries, 2) be in compliance with Medicare’s regulations, and 3) maintain Medicare’s standards for safe, high quality care. Stay tuned for additional policy changes, which will be reported in this In Business column of Today’s Wound Clinic! n

SuMMaRy: The 2010 OPPS Final Rule allows more direct supervision flexibility to hospitals and critical access hospitals. Wound care providers and employees who work in hospital-owned outpatient wound care departments should immediately consult with their hospital administration and compliance and legal departments to discuss the following issues: •Have you been in compliance with the OPPS direct supervision regulations throughout 2009? •Will your HOPD’s supervision protocol be compliant with the 2010 61 Wound Clinic Wisdom

Kathleen D. Schaum & Associates, Inc., Lake Worth, FL. Ms. Schaum can be reached for questions and consultations by calling 561-964-2470 or through her email address: kathleendschaum@bellsouth.net.

Kathleen D. Schaum, MS, is President of www.todayswoundclinic.com


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SPECIAL FOCUS - THE CHAMBER OF HBOT

Success in HBOT Interview with Jeffrey A. Niezgoda, MD, FACHM, FAPWCA

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oday’s Wound Clinic’s Founding Editorial Board member Dot Weir RN, CWON, CWS spoke with Dr. Jeffrey Niezgoda Medical Director, The Center for Comprehensive Wound Care & Hyperbaric Oxygen Therapy, St. Luke's Medical Center, Aurora Health Care, President and COO Hyperbaric & Wound Care Associates, Milwaukee, WI. Dr. Niezgoda is also the President of the American College of Hyperbaric Medicine, a professional Society, which is dedicated to providing support, education and resources to professionals committed to the appropriate utilization of hyperbaric oxygen therapy. In addition, he is also the President and Chief Medical Officer of WebCME an online wound care and hyperbaric educational company. Dr. Niezgoda is a recognized hyperbaric and wound care expert and we are pleased to provide this interview and insight into the practice of wound care and hyperbaric medicine in Milwaukee.

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Jeffrey A. Niezgoda (JAN): Thank you for this opportunity. I am pleased and honored to be asked to provide this interview for the readers of Today’s Wound Clinic. Today’s Wound Clinic (TWC): Your wound center has been operational for many years. Can you give us a brief history? JAN: Certainly. The hyperbaric facility at St. Luke’s Medical Center was one of the first hyperbaric programs in the country and has been operational and treating patients since 1969. One of the founders and first medical directors of our program was Dr. Eric P. Kindwall. Dr. Kindwall is often referred to as one of “The Grandfathers of Hyperbaric Medicine” and worked clinically in the program for many years. Dr. Kindwall has recently transitioned to consulting, research, and writing. He is the author and editor of the definitive textbook on hyperbaric medicine. Dr. Kindwall is also the executive Director of the American College of Hyperbaric Medicine. I was

asked to serve as medical director for the program in 1998, and I changed the focus of our program from being primarily a hyperbaric center, to first and foremost being a wound care center that has the additional capability of providing hyperbaric services. My philosophy has always been that hyperbaric oxygen therapy is only one of the modalities that can and should be used to provide standard of care to select patients with compromised wounds. TWC: How did this philosophy and the opening of a formal wound care center change the program? JAN: Since I took over the helm as medical director, the program volume has grown from less than 1500 annual visits to combined total volume of over 70,000 in 2009. Patients are not just seen at St. Lukes. We have expanded the program to allow for wound care and hyperbaric services to be provided at 8 other hospitals within the Aurora network. TWC: Tell us more about the hyperbaric chambers at SLMC. I understand Wound Clinic Wisdom

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that you recently installed the largest hyperbaric chamber in the United States. JAN: The backbone of the St. Luke’s hyperbaric program for over 40 years has been our 2 multiplace hyperbaric chambers, affectionately nicknamed Bonnie and Clyde. Bonnie and Clyde were operated nearly every day and have allowed tens of thousands of patients to be treated with hyperbaric oxygen over the years. Unfortunately as with all types of mechanical equipment, our hyperbaric chambers began to show the effects of age and wear and tear. We made the decision to replace Bonnie and Clyde with newer hyperbaric technology. We accepted delivery of our new hyperbaric 63

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chamber in April 2008. Installation and testing were completed in May of last year and we treated our first patients in June of 2009. TWC: Is the new chamber the largest in the country? JAN: It is quite big. The chamber is 52-foot-long and weighs 66-tons. It is a triple lock chamber, which provides us with the capability of treating up to 24 patients at one time. Based on weight it is the largest in the U.S. TWC: I understand that the chamber was transported to Milwaukee from Australia. Why an Australian chamber? JAN: Yes, our chamber was designed and built by Fink Engineering, a hyper-

baric manufacturing company located in Australia. The chamber was fabricated in Australia, shipped to Los Angles and then transported by flat bed truck to Milwaukee. We have been working on this renovation project for over 6 years.At the time Fink was the only company producing a rectangular hyperbaric chamber. We wanted the best and most current technology for our patients and thus we contracted with Fink several years ago. The square design feature provides more patient comfort and space, extra treatment capacity, better esthetics and minimal claustrophobia. This design is now available from many other chamber companies, including US based companies such as Oxy-Heal. TWC: Your facility and new chamber sound impressive. I am sure that you have been providing tours for many individuals since you have opened. JAN: Yes, we certainly have been a medical “tourist attraction” this past year. Would you like to cyber-journey with me to Milwaukee right now? I would be happy to provide a cyber-tour of The Center for Comprehensive Wound Care and Hyperbaric Oxygen Therapy to you and the readership. We will see Bonnie and Clyde as well as our new multiplace. Please follow this link http://www.webcme.net/medicalCME Courses.asp?c=21 TWC: That was fabulous. Thank you for the wonderful experience. What types of patients are typically treated with HBOT? JAN: I am glad that you enjoyed the tour. Hyperbaric oxygen therapy is primarily used to help treat difficult wounds, and when integrated into Wound Care Center or Limb Salvage Program, HBOT can literally save the lives and limbs of patients at risk for lower extremity amputation due chronic medical conditions such as diabetes and arterial vascular disease. HBOT is also used in the management of severe carbon monoxide poisoning and a variety of other medical conditions. On a daily basis we typically treat between 24-30 patients. Our largest volume day was several months ago when we treated 38 www.todayswoundclinic.com


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infectioncontrol patients in one day. Recently we had our first mass casualty disaster and were able to treat 12 patients with carbon monoxide poisoning at one time. Follow this link to hear the details of this event: http://www.webcme.net/medicalCME Courses.asp?c=21. In a typical day, 30% of HBOT patients are being treated for diabetic foot ulcers, 30-40% for radiation tissue injuries, and 30% for necrotizing infections, compromised flaps and grafts, osteomyelitis, and acute arterial insufficiencies and the emergencies such as carbon monoxide and decompression illness. TWC: How many wound care patients are seen at St. Lukes? JAN: On average we will see 40-50 patients per day in our outpatient wound care clinic and another 20-25 patients on our in patient service. TWC: How do you staff for this volume of patients? JAN: The professional staff is provided by HWCA. Five full-time Advanced Practice Nurse Practitioners support the physicians, my partner, Dr. Jack Simanonok, and myself. I cannot say enough about our NPs. They are extremely knowledgeable and skilled in wound care and are fully capable of operating independently.The nursing, technical and administrative staffs are also excellent and Aurora employs them. On a typical day, 8 RNs, 4 wound care and 4 hyperbaric technicians, and 3 secretaries will staff us. TWC: I know that you do a tremendous amount of education, preceptorships, and product trials. Can you tell us a little about these aspects of your program? JAN: We have had the opportunity to trial many new devices and technologies. One of the newest and most exciting products that we have been working with is Wound Be Gone. We are initiating randomized clinical trials based on our initial success with this product. I truly enjoy teaching wound care and hyperbaric medicine. We will often have clinicians, fellows, residents, and medical and nursing students from the local area participate in clerkships or clinical rotawww.todayswoundclinic.com

tions. Occasionally we will have a visiting clinician from outside the state or from another country spend time with us. They come to St. Luke’s for both observational as well as hands on clinical experience. While this type of one on one teaching is rewarding it truly limits our ability to provide educational opportunities on a larger scale. TWC: Is this the motivation behind your online educational efforts? JAN: Yes. I have formed a specialized company that is focused on providing the highest quality of online education. We combine actual clinical video footage with live lectures given by experts in the field of wound care and hyperbaric medicine. These presentations are recorded and then delivered in HD quality via the Internet. This educational format allows for learning that is self-paced and on demand. You learn wherever and whenever you decide is best for you. This learning experience is also much more effective than traditional learning as the student can rewind and review the lecture at any point to provide emphasis of certain elements. It is also more cost effective in that travel, lodging, meal expenses as well as the cost of lost productivity due to time away from the clinic are avoided. Anyone who is interested can visit us at www.WebCME.net. TWC: You are the current President of the American College of Hyperbaric Medicine. Please tell us about this organization. JAN: The American College of Hyperbaric Medicine is an organization that has served as catalyst for new ideas and forum for the exchange of information providing a conduit between the practice of wound care and the field of hyperbaric medicine. The ACHM is credited with several recent achievements including the creation of two certification exams in hyperbaric medicine, one for physicians and one for technicians. In addition the College created a hyperbaric medicine clinical registry to evaluate the effectiveness of HBO for radiation injury. As of December 2009, 2,000 cases have been entered, making this the largest series in the world. An integral

part of the ACHM’s mission is quality assurance and improvement in the practice of hyperbaric medicine. The ACHM has set basic training standards for hyperbaric physicians that have been adopted by numerous hyperbaric facilities and third party payers. I would encourage the readership to consider joining the College, as it is an excellent resource for anyone working in the field of hyperbaric medicine (www.achm.org). TWC: Dr. Niezgoda, we would like to thank you for your time. This interview has been interesting and I truly enjoyed the cyber-tour. Do you have any closing comments? JAN: Thank you once again for giving me the opportunity to share our program with you and Today’s Wound Clinic. During the past decade I have been allowed the true privilege of working with an outstanding group of individuals who are truly dedicated to providing the highest standards and quality of patient care. My successes are only a reflection of their commitment to excellence, and I salute each of them. n Jeffrey A. Niezgoda, MD, FACHM, FAPWCA, is the Medical Director of The Center for Comprehensive Wound Care and Hyperbaric Oxygen Therapy, St. Luke’s Medical Center, Milwaukee,Wisconsin. He is also the President and Chief Operating Officer of Hyperbaric & Wound Care Associates, a medical specialty group serving Southeastern Wisconsin and Northern Illinois, providing professional wound care and hyperbaric services to the Midwest with annual patient visits exceeding 70,000. Dr. Niezgoda is also the President and Chief Medical Officer of WebCME a novel educational company and industry leader in online wound care and hyperbaric education. Dr. Niezgoda is a recognized wound care expert and has served as faculty at both national as well as international conferences. He has participated on multiple Expert Consensus Panels and has appeared before Medicare and Medicaid Services as a wound care consultant. Dr. Niezgoda is the President of the American College of Hyperbaric Medicine and a Fellow of the American Academy of Emergency Physicians and the American Professional Wound Care Association. Dr. Niezgoda received his Medical Degree from the Uniformed Services University of the Health Sciences, F. Edward Hebert School of Medicine, Bethesda, Maryland, and earned a B.S. in Biology from U.S. Air Force Academy, Colorado Springs, Colorado.

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infectioncontrol colonized with or infected by staph aureus. It’s the great masquerader.

LESSonS LEARnEd in tiME

Wound Care in the Era of MRSA:

My Pearls and Pitfalls Harriet Jones, MD, BSN; FAWCP

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lthough it’s been almost 10 years, I’ll never forget the tone and inflection from my attending when she impressed upon me just how serious she considered ‘staph’ to be as a pathogen. At the time I was a new Infectious Diseases Fellow and I remember thinking that surely there must be some other bugs that would rate the same serious consideration. However, what I didn’t appreciate then—I do now.

UndERStAnding StAPh In today’s ecology of microorganisms, the word ‘staph’ automatically brings to mind Methicillin Resistant Staphylococcus 65

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aureus (MRSA). However, over the last several years I have developed a much greater sense of appreciation for something that my attending knew back then—this germ should never be taken lightly. MRSA can cause a broad range of illnesses from simple recurrent furunculosis to severe invasive necrotizing pneumonia. For reasons—some that still elude me—MRSA can be cultured from wounds that seem to be on track toward healing; causing no obvious problem. Likewise, I have also seen MRSA cause severe, tissue/limb/life threatening, fulminant disease in patients who do not have the traditional risk factors of being

In preparation for this article, I reviewed numerous medical publications including full peer reviewed articles and case reports; information available through the CDC; and Emerging Infectious Diseases. All of my resources were recent and published within the last 6 years. In order to fully appreciate MRSA as a pathogen, I think it is worthwhile to take a look at the historical arrival of MRSA on the clinical stage. MRSA was first identified in 1958. By 1961, it was documented as the cause of an infection in the United Kingdom. In 1968, reports of MRSA isolation were noted in the United States. By 1990, MRSA was found worldwide and was recognized as a cause of infection in ‘nontraditional’ patient groups. In 2003, continent specific clones (ie, genetically distinct germs) were identified. We now have region specific clones across the U.S.

MRSA oR not MRSA Whenever a provider writes an order for a ‘culture’, not only is extra cost added to the bottom line but a series of multiple events is set into motion—much like tipping over the first of many closely standing dominos. Hopefully the culture report will provide meaningful information to the provider thus enabling him to make an informed decision regarding possible changes in the patient’s treatment plan. This is why it is so imperative that, when a wound is cultured it is not collected from a haphazardly prepared wound bed or tissue space. For those unfamiliar with what is involved in a microbiology lab in order to identify an organism, the first step is that a technician (or first year Infectious Diseases Fellow) - using the swab that was received in the lab - streaks a small glass slide and then inoculates an agar plate (plastic dish filled with a nutrient rich jelly-like substance that enhances www.todayswoundclinic.com


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infectioncontrol bacterial growth). The agar pate is set aside to incubate; the streaked slide is allowed to dry. Once the slide has sufficently dried, various chemicals are sequentially applied to it, which will strain bacteria - that were hopefully deposited there when it was streaked. This series of steps is called a ‘Gram Stain’; developed in 1882 by and named after Dr. Hans Christian Gram. Bacteria that stain darker violet to bluish purple are called ‘Gram positive’. Those that don’t are called ‘Gram Negative’. By microscopic examination, the now visible stained bacteria can be further described and identified based on their morphologic appearance. If the stained bacteria appear in clusters or in tetrads of round balls (cocci), they are called gram positive cocci (GPC’s), which are Staphylococci. Not known at this point is whether or not the bacteria is Staph aureus or one of many other Staphlyococcus aureus. GPC’s appearing in chains or pairs usually are Streptococci. Unfortunately, the next step in this determination cannot be completed until there is enough growth of the organism on the agar plate to allow the next chemical test to be performed.This usually takes a minimum of 24 hours for a colony of bacteria to appear on an agar plate. Only then can a “coagulase” test be done. This test capitalizes on the fact that Staphylococcus aureus is—of all the GPC’s— the only one with a cell wall protein called “coagulase”. It is one of many cell wall proteins found in Staphylococcus aureus that confers the potentially toxic effects to tissues.Through a one step bench-side test it can be determined whether or not the protein coagulase is present. If the test is positive, the organism is a “coagulase positive GPC”, which means that it is a Staphylococcus aureus. However, what is still unknown is whether the Staphylococcus aureus is MRSA or not. This determination requires testing against a panel of antibiotics and takes an additional 24 to 48 hours. If the coagulase test is negative, the organism is called a “coagulase negative GPC”. By convention, all coagulase negative staphylococci are collectively referred www.todayswoundclinic.com

as ‘coag-negative staph’ and sometimes all non-aureus staph are collectively called ‘staph epidermidis’.

LifE oR dEAth This understanding and my clinical experiences - particularly over the last five years have influenced how I utilize the information offered by the Gram stain. If your lab does not automatically perform this test, you should be sure to order that it be done. It may mean the difference between life and death—or at least potentially severe tissue destruction for your patient. I have a very low threshold for further investigation of any wound (surgical or not) that has redness, edema, or pain that is present beyond the expected, normal phases of wound healing. In 2003, SENTRY, an antimicrobial surveillance group in the U.S. and Canada reported that Staphylococcus aureus accounted for 46% of nosocomial skin and skin structure infections (SSSI) that occurred in 2000. Of these, 14% were identified as MRSA. By 2004, this percentage doubled to 35%. In 2005, the CDC reported that MRSA was responsible for over 94,000 serious infections and over 18,000 deaths in the U.S. There were over 12 million documented physician/healthcare provider visits for suspected MRSA in 2008. MRSA now accounts for 59% of SSSI’s and 14% of invasive disease. Practically speaking, as a caregiver/clinician, you should now take very seriously any Gram stain report that is positive for GPC’s because you may be dealing with MRSA.

MoRE KnoWLEdgE Further classification of MRSA’s developed over the last several years and is based on various genetic characteristics of the MRSA community. Microbiologically speaking, an MRSA can be a hospital acquired (HA) or community acquired (CA) MRSA. HA-MRSA typically has large genetic elements called cassettes. The first 3 of these to be identified were labeled types - I, II, and III. Type II was found to be

the most common in HA-MRSA isolates. It contains multiple drug resistance genes (all closely associated on the gene) confers resistance to multiple classes of antibiotics. The main “clone” that was first identified was named “USA 100”. In contradistinction, the CA-MRSA was found to have a fourth genetic element, which is small, mobile, able to parasitize numerous other host strains, and mediates methicillin resistance. This fourth element is the hallmark of CA-MRSA. It usually does not have such broad antibiotic class resistance as does HA-MRSA and has been more associated with SSSI’s than HAMRSA strains. Will you be able to tell whether or not your patient has an HA-MRSA or CA-MRSA right off the bat? It’s doubtful that you will. Clinically, wounds infected with HA-MRSA or CA-MRSA look the same on patients. As if coagulase isn’t enough to worry about, MRSA sports other proteins that make them particularly nasty bugs. Panton - Valentine - Leukocidin (PVL) is a protein that was first introduced in the 1930’s and is present in over 50% of all MRSA isolates. This protein allows the staph to bore a hole (form a pore) in the host wbc’s, in effect disabling them. Also, some CA-MRSA clones have a protein called ACME (argenine catabolic mobile element) that inhibits wbc formation. You may be asking yourself, what does this mean? No functioning wbc’s = no formation of pus = nothing to ‘drain’ through a therapeutic stab wound = ineffective evacuation of infected and nonviable tissue. Recall that the treatment of an abscess is and always will be drainage. A treatment plan for suspected MRSA SSSI should start with effective evacuation of the involved tissue either locally or formally in the operating room theater. If a patient appears “ill” due to an abscess or SSSI, a broad-spectrum systemic antibiotic is probably in order as adjunctive therapy to removal of the affected tissue. Once the sensitivities from the culture are back from the lab, antimicrobial therapy should be targetWound Clinic Wisdom

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infectioncontrol ed or narrowed if possible. Lengths of antibiotic therapy should be based on clinical response.

thE RiSK fACtoR So, the next time you examine a patients “boil/sore/risen/abscess/suture line/staple line/drainage tube/non healed calcaneal pressure ulcer/post op C-section incision line/or surgically created pain-pump pocket site, take a second look for signs of this often times non-pus forming organism. Clues that I use in order to determine whether or not I believe a patient has a reasonable risk of having MRSA infection in order of most important to less important are: 1) do they have close contact (live in the same home, share toiletries, have sex) with someone who has had MRSA SSSI’s; 2) do they have a personal history of having had MRSA; 3) have they been incarcerated within the last 12 months; 4) do they snort or smoke illicit drugs; is their chief complaint having a “spider bite”; 5) have they had oral or intravenous antibiotics within the last month. 6) and is there paint out of proportion to how the wound looks? Groups at high-risk for developing SSSI’s are: military recruits; native populations; homosexual males; HIV+ patients; those who participate in football, wrestling, gymnastics, fencing teams; homeless and IV drug users. There are also documented cases of patients contracting MRSA from their pets. Depending on other patient factors (co-morbid conditions; systemic signs and symptoms) and what you are able to safely do in your clinic will determine your next steps.

CoMPLEx i&d’S Patients on whom I have chosen to perform complex I&D’s are characterized by not really being too systemically ill as a result of their abscess/infection/SSSI (ie, no persistent fever/chills; not feeling 67

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totally rotten; well demarcated area of induration and erythema). They are able to return to clinic within 48 hours; have adequate support system; are reliable; not on anticoagulants and can demonstrate proper care of the wound. It has been my experience that the area of nonviable subcutaneous tissue mirrors the demarcation of edema/induration/erythema. Not infrequently upon incision of the area, there will be no purulence; nothing to ’drain’. Rather, the exposed subcutaneous tissue appears dusky brown; almost like bad hamburger meat. The nonviable tissue can be evacuated with a small curette, aggressively irrigated; and packed with one of many possible antimicrobial dressings. The benefits of performing this in the outpatient setting include but are not limited to the fact that there has been one less patient with ‘staph’ admitted to the hospital; there has been better stewardship of the use of antibiotics (orals vs. intravenous if used); and there has been better/more efficient use of healthcare resources.

AntibiotiCS If adjunctive emperic antimicrobial therapy is prescribed you should be aware of the MRSA sensitivity patterns in your hospital system and/or community.This information is readily available through the laboratory that performs your cultures. The infection control nurse or your local infectious diseases physician is also a good starting points to retrieve this information. Once an antibiotic has been selected, make sure the patient can obtain the prescription; many are cost prohibitive even with insurance plans. Be aware that tetracycline resistance does not equal minocycline or doxycycline resistance so get the lab to specifically check for this. Try to choose an antibiotic that your patient has a higher likelihood of being compliant with (BID dosing always trumps QID or TID dosing). Always advise and teach patients about the nuances of particular antimicrobial agents such as dosing around cations (magnesium, calcium; cheese; dairy products) so that the drug actually gets

absorbed and not bound with a cation in the GI tract and flushed down the toilet. Double check for drug allergies and potential serious interactions an antibiotic may have with one or more of a patient’s other medications. Depending on these and other factors unique to your patient, it may be prudent to prescribe intravenous outpatient therapy; preferably a once daily agent. I reserve picc lines for patients who are going to receive at least 4 weeks of therapy and do not have Chronic Renal Insufficiency. This always keeps me in good stead with my Nephrology colleagues as these patients will likely need their deeper arm veins for dialysis access.

WASh YoUR hAndS Remember that there are no new oral antibiotics on the horizon so we all must be good stewards of the ones we have. Agents available for oral and/or intravenous treatment for MRSA include clindamycin; tetracycline; bactrim; zyvox; vancomycin and daptomycin. If needed, the selection should be tailored to your patient’s particular needs/considerations. Lastly, we must all commit to adhering to our institutions infection control policies; use of hand cleansing gels and most importantly: Wash Your Hands. Become your clinic’s self-appointed hand washing police and demonstrate good hand hygiene to your patients. Believe me, they will appreciate it. Harriet Jones, MD is the Medical Director and first full-time physician at the Wound Care and Hyperbaric Medicine Center at River Oaks in Flowood, Mississippi. To find out more about her skills and experience you can contact her via email at harriet.jones@hma.com Visit www.todayswoundclinic.com for a list of bullet points for a better understanding of MRSA in the wound care clinic. Perfect for printing out and hanging in the clinic, while keeping the conversation on infection control open. www.todayswoundclinic.com


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SPECIAL FOCUS -  HYPERBARIC OXYGEN THERAPY

EQUIPMENT EXAM: Accessories and  Options  For Hyperbaric Chambers Steve Wood, President Hyperbaric Safety Systems, Inc.

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hen you establish a hyperbaric program, it’s not as simple as buying a chamber or three and starting to treat patients. You also have to consider what ancillary equipment or accessories will be necessary to provide safe and effective treatment. The type of ancillary equipment chosen will impact departmental operations, staffing, and training. So, what additional equipment will you need? We will group our list by: • Things every program must have (reference, safety, and patient care). • Entertainment and comfort. • Monitoring and critical care. But before considering the hardware (or for that matter—chambers), you should decide what type of hyperbaric cases your facility is going to treat. In the quarter century that this author has been involved in hyperbaric medicine, program structures have evolved from traditional “hyperbaric” programs that were established with a mission to treat all of the “approved” indications, to “wound care and hyperbaric” programs that primarily use HBO as an adjunct to problem wound management, and rarely treat other HBO indications. It seems that more facilities are located in outpatient-only clinics, limit their operating hours to 8–5, Monday–Friday, and are staffed by personnel without training or experience in management of

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high-acuity patients. The result of this trend is that a community may have multiple hyperbaric facilities, but only one (or in some cases, none) that is equipped to manage acute indications. This article is not the forum to debate this trend, but it must be considered, given the continued research into the use of HBO in treatment of acute injuries.

SO, WHAT dO YOU NEEd? • Some items are required by NFPA code: ˚ “No Smoking” signs. ˚ Fire extinguisher(s). ˚ Smoke hood, SCBA, or similar device (per NFPA 99, 20.2.4.5.3 and Appendix). ˚ Telephone or other signaling device (fire alarm) at chamber side for tech to call for help. ˚ Patient grounding system. Grounding Systems: • Reusable wrist straps are provided by chamber manufacturers, but spare cables and single-patient use straps or ECG pads should be stocked. • Ground check system. • Though not strictly required by code, there should be a mechanism in place to verify the operational integrity of the patient/chamber ground system. Depending upon facility policy, continuity and resistance of the chamber ground system may be checked regularly using an ohmmeter and cable set.

Additional Items for Multiplace Chambers If you operate a multiplace chamber, there are additional items that may be mandated by NFPA code and integrated into the chamber, though some may only be required under certain operating conditions: • Fire suppression system. • Oxygen analyzer. • CO2 analyzer. • Other gas detectors. • Fire detectors. • Reference material – the bare bones: ˚ At least one general HBO book (Kindwall or Jain). ˚ Hyperbaric Facility Safety. – A Practical Approach (Workman). ˚ Hyperbaric Nursing (Larson-Lohr). ˚ UHMS Committee Report. ˚ NFPA 99, Chapter 20. • Operations manuals for each chamber model and ancillary equipment. • Policy and Procedure manuals, up to date and in compliance with the hospital’s P&P (if a hospital-affiliated program) in both form and content. • Additional Safety Equipment: ˚ Patient education poster (What Not to Bring Into the Chamber). ˚ Quick reference to emergency procedures at chamber side. www.todayswoundclinic.com


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equipmentexam • Tools to perform minor repairs or adjustments (if trained). ˚ A system to document any repairs or maintenance conducted on the chamber. • Spare/replacement parts: ˚ Door gasket. ˚ Filter elements. ˚ O-rings and blank plug for IV ports (if IVs administered). • Air break system (if any treatments are administered at pressures > 2.0 ATA). ˚ Demand valve systems are typical with most monoplace chambers, but I’m not a fan of them—many patients have problems with obtaining a good mask seal, the valve can be an infection vector (particularly when the valve is left in the chamber continuously), and the valve could damage the chamber acrylic if trapped between the gurney and window. Entertainment and Patient Comfort Unlike the safety items listed above, which are mandated by codes or regulatory agencies, entertainment and comfort items are not mandatory, but it is hard to run a program without them. The following items are advisable: • A television with more than three channels and a good audio feed into the chamber. ˚ Most manufacturers now offer bracket systems to mount flat screen televisions directly to the exterior of the chamber. • DVD player and small library of movies. • CD player/radio for patients with visual impairment. • Hydraulically-adjustable gurney to ease patient transfer and save technicians’ backs. • Pressure-relieving mattress. • Wedge and roll pillows to enhance patient positioning. www.todayswoundclinic.com

MONITORING ANd CRITICAL CARE Hyperbaric medicine is at a crossroads with respect to critical care. Fewer facilities have the interest nor capability to manage even the moderately acute case, which leads to less demand for critical care support equipment. Manufacturers are reluctant to produce innovative products for such a small market, resulting in hyperbaric facilities being forced to use near-obsolete technology. Ventilators are a prime example—the only ventilator available for monoplace chambers was introduced in the late 1970’s and has remained essentially unchanged since that time. It has no alarm functions and only an airway pressure gauge. In the early 1990’s a company introduced an airway monitor/alarm system, but dropped it within a few years due to low sales. The decision to treat acutely-ill patients should not be taken lightly, nor without careful pre-planning, staff training, and ongoing competency assessments. The treatment of highacuity patients is a rarity for most facilities, so the challenge is not just having the right equipment, but having the right people to properly utilize that equipment. The facility should have a policy in place that defines what level of acuity the facility will accept, before the facility opens and to communicate that policy to the potential referral base. For each device utilized, the facility should have operational policies and procedures for the use of the device in place, a standardized initial and recurrent training program, and regular competency assessments for all personnel. A program can be equipped with the hardware to support the sickest patient, but if the staff is not competent to utilize that equipment, all parties can be at risk, both medically and legally. In some cases, equipment may require modification to allow its use with a chamber, and some risk managers and biomedical engineers are reluctant to perform the modification or clear a

modified device for use, typically citing concerns with getting in trouble with the FDA over modifying a device. In the following list, we will consider equipment from the most common to the more exotic.

MONITORING/ASSESSMENT • Hand-held Doppler. • TcpO2 monitor. ˚ TcpO2 still remains a valuable device for assessing oxygenation, particularly when used in conjunction with HBO. Some chamber manufacturers provide custom cable sets that allow inchamber studies, or you can purchase a hull penetrator fitting that will fit through a standard door port and allow direct connection of the TcpO2 cable, without the need for adapters. • Laser Doppler. ˚ Growing in popularity for evaluation of microvascular flow – not to be used in the chamber. • ECG monitor. ˚ Useful to monitor for arrhythmias, assuming staff is trained in ECG interpretation. Some training programs recommend that all patients undergo ECG monitoring as a means to determine oxygen toxicity based on heart rate changes, but there is little evidence to show the utility of this technique. Requires modification/adaptation of cables to fit electrical pass-thru ports. • Arterial/Central Venous Pressure monitor. ˚ Typically combined with ECG monitor in a modular format. Will require some type of flush system to prevent clots – the Ethox pressure infuser, with lubricant changed to an oxygen compatible lube is the common adjunct for flush systems. Wound Clinic Wisdom

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equipmentexam Also will require cable modification for use. • Non-Invasive Blood Pressure monitor ˚ CAS Medical Systems manufactured their OscilloMate 1630 non-invasive pressure monitor through 2009, and still provides support. This monitor was designed for use with monoplace chambers and consists of an external pump/monitor, specialized hull penetrator/hose set, and various sizes of cuffs. • Tympanometer. ˚ Used to assess flexibility of the tympanic membrane, a tympanometer can be helpful to screen patients for Eustachian tube dysfunction or ability to successfully autoinflate/clear ears.The typmanometer probe is placed in the external ear canal and the device applies a positive/negative pressure pulse and produces a graph (tympanogram) that indicates the movement of the eardrum. If the test is repeated while the patient performs an autoinflation maneuver, flattening of the tympanogram indicates that the patient is likely to be able to handle pressurization without barotrauma. Exactly how reliable this device is at determining whether patients can “clear” their ears is not known, but it may be a useful adjunct to patient education and evaluation.

THERAPEUTIC/CLINICAL SUPPORT • IV Pump. ˚ Currently there is only one pump designed for use with monoplace chambers, the Hospira Plum A+, which replaced the venerable Abbott 3HB. Accessories for the 3HB pump are no longer manufactured and support is limited. • Ventilator. ˚ The Sechrist 500A is the only ventilator currently 70

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available for use with monoplace chambers. It is designed for use with Sechrist chambers, but has been used with other chambers. Though functional, this ventilator is very limited in its features: no monitors or alarms, no air break capability without modification, and is limited to controlled ventilation only. Management of a patient with substantial lung dysfunction may be extremely difficult if not impossible with this ventilator. Only personnel who are properly trained and well experienced in providing ventilatory support should use it. In some facilities, the respiratory therapy staff handles ventilator management. If this is the case, there should be an ongoing training and competency assessment program for the RT staff to assure that properly trained personnel are available when needed.

WHAT ABOUT A CRASH CART? Crash carts are typically equipped with monitor/defibrillator units, airway support equipment (laryngoscopes/endotracheal tubes/manual ventilators/suction), and emergency drugs and fluids. A method for emergently managing pneumothorax (chest tube, McSwain Dart, or large bore needle/hemostat) is a common addition to crash carts in hyperbaric facilities. The decision to equip (or not to equip) a program with a crash cart raises a number of questions to consider, including: • Do you intend to treat high-acuity patients in your facility? • Is your staff, including physicians, trained and verified competent in ACLS? • Are trained staff on duty at all times patients are in the facility? • Is your unit located within a facility that has a “code team” or formalized emergency response plan? ˚ If so, is your facility included in that plan – do code team

members know how to get to your facility and where the nearest crash cart is located? Do you have pneumothorax management supplies immediately available within the facility if that equipment is not kept on the crash cart? • Do you treat high-acuity patients in a unit located in a non-hospital setting (out-patient clinic, surgicenter, free-standing facility, etc)? ˚ If so, how do you maintain continuity of care for those patients who must be transferred from the referring hospital? • How will you manage acute medical emergencies that occur within your facility? • If your staff trained in BLS? Are they trained to use airway support equipment such as oral or nasal airways, bag ventilators, and suction systems? ˚ If so, do you maintain a “BLS” kit that is equipped with airway support equipment?

SUMMARY As you can see, a hyperbaric facility is not just a chamber. There is a core set of accessories that are necessary for any program to operate in a safe manner. The type and acuity of the patient population treated and the location of the facility largely drive the type of ancillary equipment needed for a facility. The time to decide how ill a patient your facility will treat is before you treat your first patient, then obtain the necessary equipment and train in its use. Failure to do so can put your patients, and your facility at risk. ■

Steve Wood’s 25-year career in hyperbaric medicine has ranged from working as a clinician to building hyperbaric chambers to managing hyperbaric and wound care contract service providers. He is President of Hyperbaric Safety Systems, Inc. a firm specializing in hyperbaric technical consulting and development of innovative safety accessories for hyperbaric chambers. www.todayswoundclinic.com


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SPECIAL FOCUS - HYPERBARIC OXYGEN THERAPY

CLINIC DESIGN

T  hree Big Mistakes to Avoid When Developing a Hyperbaric Facility Steve Wood, President Hyperbaric Safety Systems, Inc.

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utpatient-focused specialty clinics have been around in some form or another since there were hospitals. Architects and builders know what is expected from a design and code compliance standpoint for a typical clinic, but when you add a hyperbaric oxygen (HBO) component, failure to understand and comply with the unique physical and regulatory requirements of a HBO program can be very costly. Taking a hyperbaric facility from concept to completion without triggering an unplanned cost or delay event can be done, provided your design/build team has a thorough understanding of the critical components of a facility. Let’s look at three of the major pitfalls that can derail a program before it gets started:

#1 NOT KNOWING THE CODES AND REGULATIONS There is an alphabet soup of agencies and organizations that influence either the construction and marketing of hyperbaric chambers or the facilities that house them. Some of the standards published are recommendations only, while others are incorporated into law. • Chamber construction: American Society of Mechanical Engineers (ASME)

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• Marketing/Sales: Food and Drug Administration (FDA) • Facility Design: American Institute of Architects (AIA), Undersea and Hyperbaric Medical Society (UHMS) • Construction and Operations: National Fire Protection Association (NFPA) Compliance with ASME and FDA rules is generally not an issue for new chambers, though occasionally you may run across an older multiplace chamber that was constructed prior to FDA oversight. A “pre-amendment” or “grandfathered” chamber may be used, but may trigger a closer inspection by regulators. The most common issues will be related to design and construction of the facility that houses the chambers. Virtually every state references the NFPA standards, often through law, but not every state accepts the most current version, or has incorporated it into law due to legislative delays. You should determine which version is applicable to your facility to avoid conflicts. Some regulatory agencies may choose to apply a more recent standard despite a specific statutory citation. AIA standards are applied by many states, but there are problems with the nomenclature used in the hyperbaric section. In addition, the AIA language is

included as an Annex, which is supposed to be explanatory, rather than a Standard, which has more weight (from a regulatory standpoint). In fact, there is no Standard in the AIA document, but in the absence a Standard, some AHJ’s apply the Annex language, which can impact layout and design of the hyperbaric suite. In addition to national standards, some states (Texas, Arkansas, and North Carolina) and localities have their own specific regulations regarding hyperbaric facilities. The language of these statespecific regulations is often at odds with standard industry nomenclature – for example, what the industry might consider the “foot” end of a monoplace chamber would be referred to as the “head” end. Codes and standards often cross-reference (and contradict) each other, and often, the Authority Having Jurisdiction (AHJ) (which can range from a state healthcare agency to local fire marshal) may have limited understanding of what a hyperbaric chamber is or impose a more stringent requirement based on their interpretation of a particular standard.

#2 NOT KNOWING THE SPACE If your facility will be added to an existing building, it’s critical that you know the conditions of the space before

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specialfocus starting construction. Blueprints may not accurately reflect as-built conditions or dimensions. There may be structural elements that cannot be removed, or hazardous materials such as asbestos that must be removed or abated. Hyperbaric chambers, particularly multiplace systems or multiple monoplace chambers, can impose substantial structural loads that may require reinforcement of floors. A structural analysis should be conducted as part of the design phase of the project. Oxygen supply and piping systems should be carefully evaluated to determine whether the existing system can accommodate the demands imposed by a hyperbaric facility. It is not uncommon to find a liquid oxygen system with an undersized supply tank or piping, which can lead to a complete overhaul of the hospital’s oxygen supply system. In some cases, it can be more cost-effective to install a dedicated oxygen supply for the hyperbaric facility rather than attempting to tie in to an existing system. How will you get the chamber(s) into the facility? Is there a clear route from the loading dock/delivery area to the site? Are corridors wide enough to allow turns around corners? If the facility is located on an upper or lower floor, are the elevators large enough to accommodate the equipment? Nothing is worse than having a shiny new facility on the 4th floor and discovering that the chambers are a foot longer than the elevator.

#3 NOT PRE-CLEARING THE PLANS Once you’ve established a design, determined that the building will support the chamber(s), and verified that you can get the chambers into the site, take some time to have your plans reviewed by the AHJs – before construction begins. This is particularly important in areas that do not require pre-construction approval. Meeting with the agencies and individuals that will inspect the facility and issue certificates of occupancy can help you avoid issues that could delay your project. 72

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The degree to which a given AHJ understands the nuances of hyperbaric facilities varies substantially. In areas with a strong hyperbaric presence, regulators are familiar with the applicable codes, and presuming that you’ve designed the facility to conform, approval is a simple process. If you find that the AHJ is unfamiliar with hyperbaric facilities, tactful education during a pre-approval conference can save you thousands of dollars and time delays. In areas with few hyperbaric programs or inexperienced AHJs, the process can be frustrating. A common problem is misinterpretation or misapplication of code. The AHJ knows that NFPA standards apply, they look up the hyperbaric standard (Chapter 20 of NFPA 99), but fail to see that there are differences between the housing requirements for Class A (multiplace) and Class B (monoplace) chambers. Pre-clearance is particularly important in areas that have their own specific regulations. For example, North Carolina requires that any electrical device have Underwriters’ Laboratories (UL) or similar approval. Until recently, no hyperbaric chamber manufacturer had such approval, and in order to operate a chamber in the state, a separate test had to be conducted on each chamber before it could be put into service. North Carolina has also imposed more stringent requirements on monoplace chamber exhaust hoses, requiring that these hoses be constructed of heatresistant materials. Regardless of what a particular code or standard says, the ultimate authority over your facility is the AHJ, and they have the power to shut down your project or allow it to proceed. Having an architect and builder who have both an understanding of applicable codes and close working relationships with AHJs can make the difference between a smooth opening or a costly delay. There are a few approaches to avoid these mistakes: • Discuss the regulatory and design issues with your architect and project

manager to determine how familiar they are with the unique requirements of a hyperbaric facility. If they’ve never been involved with a hyperbaric project, they should start their research as soon as possible. Chamber manufacturers and oxygen suppliers are generally happy to provide assistance with design and specifications, particularly if you’ve agreed to buy their products. • If you’re concerned about bias from vendors, you might find it reasonable to hire an independent consultant to advise you on specific issues related to project development. An “outside set of eyes” reviewing design or construction issues may find ways to save you thousands of dollars or weeks of time, at a relatively minimal upfront cost. • For those who would prefer not to deal with these issues, there is always the turnkey contract approach. Some contract operators will tell you that a hyperbaric project is too complex for you to develop on your own (they are not, but do require you to do more work). A good contract operator will have a team in place that includes experts in facility development and construction, and be prepared to coordinate with the design/build team to expedite program development, since delays and costs impact them as much as you. Whichever approach you choose, a small investment of time or dollars before breaking ground can lead to a program that is completed on time and on budget. ■

Steve Wood’s 25-year career in hyperbaric medicine has ranged from working as a clinician to building hyperbaric chambers to managing hyperbaric and wound care contract service providers. He is President of Hyperbaric Safety Systems, Inc. a firm specializing in hyperbaric technical consulting and development of innovative safety accessories for hyperbaric chambers. www.todayswoundclinic.com


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The Challenges of Negative Pressure Wound Therapy in Clinical Practice Caroline Fife, MD, FAAFP, CWS Dot Weir, RN, CWON, CWS This article is a joint effort by Dot and Caroline, bringing together perspectives from our combined (too many to confess) years of practice. We have brought our slightly different but complementary viewpoints together on the clinical challenges of Negative Pressure Wound Therapy (NPWT).

For photos included with this article visit www.todayswoundclinic.com/NPWT

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aroline remembers the first patient on whom she used negative pressure wound therapy. It was 1997, only two years after FDA clearance of the first device. The patient was a young, obese woman who had a surgical dehiscence of her abdomen extending from the xyphoid to the pubic symphysis which undermined along both side walls more than the width of her hands. It was the biggest open wound she had ever seen in an ambulatory outpatient. She had been sent home to perform her own saline wet to dry dressings, which she had been doing for weeks. A KCI representative came to Caroline’s office to tell her about “The VAC” and her response was, “You have a machine that sucks on wounds? Why would anyone want to do that?” But she decided this would be the first patient on which to try this odd idea, and within about 16 weeks her enormous abdominal wound was completely closed. She was even very proud of the poor quality Polaroid photos taken of her first use of NPWT. Despite her excellent response however, she did have one complication. Marlex mesh which had been placed to control an abdominal hernia became infected. After the wound closed she developed a small abscess which had to be surgically explored. That was not the “fault” of negative pressure, but was the first of many lessons Caroline learned about the use of it. www.todayswoundclinic.com

Thirteen years (and hundreds of patients) later, we have seen every possible success from negative pressure, and probably every possible complication. Negative pressure is used for reasons other than wound healing, such as in the management of abdominal compartment syndrome and support and bolstering of flaps and grafts. In this article, we will discuss only the challenges associated with the use of negative pressure for wound healing. The first thing to be observed is that negative pressure wound therapy is incredibly safe. Since FDA clearance of the original device in 1995, there have been millions of patient days of therapy with only a handful of significant complications. However, every clinician is aware of the various “challenges” associated with the use of negative pressure. Technique is critical, particularly in its application. Many clinicians are true “artists” when it comes to NPWT application. Then there is the clinical judgment element. How much suction should I use and when should I increase it or decrease it? Should I use intermittent or continuous suction? How do I determine when has the patient has had optimal response? Do we stop when granulation is established or when the process is complete? Do we stop this week or next month? We have only our clinical experience to guide us for most of these decisions. And now that there are many NPWT devices from which to chose we find that we have

even MORE questions than before. Which interface should be used? What is the optimal range of pressure? Without attempting to comment on one device versus another, we thought we would outline some of these clinical issues.

The ComPoNeNTs: Regardless of the device selected, the use of negative pressure requires 4 essential elements: 1) there must be an air tight seal with the dressing, and this necessitates the use of an adhesive drape, 2) there must be some sort of interface with the wound, 3) there must be a source of negative pressure or “suction” (usually a mechanical device) and 4) there must be a connection to the device (usually some sort of connector and tubing). Challenges can arise with each of these elements.

LoCaTioN, LoCaTioN, LoCaTioN: Some of the greatest challenges to NPWT occur due to the location of the wound on the body. Peristomal wounds, genitalia wounds, facial wounds, and wounds on weight bearing surfaces require careful consideration with regard to the placement of the connection to the device and the tubing. Ulcerations from poor placement of tubing can occur by allowing patients to lie or walk on NPWT components. Foam has been most commonly used to allow the suction to be easily moved away from a difficult area to a more convenient area for Wound Clinic Wisdom

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NPWT device placement (commonly called “bridging”). Dressing kits specific to this technique are now available, and as usage of other interface dressings has increased, similar “tricks of the trade” have emerged. Experienced clinicians have many methods to manage wounds in awkward locations, like using stoma paste or pectin rings/strips to border irregular areas and fill in spaces or gaps around abdominal, perineal or groin wounds.

The PeriWouNd: Periwound problems are perhaps the most challenging issues to manage with NPWT. Using registry data from the Intellicure National Wound Registry, periwound issues were among the most common reasons for interruption of NPWT, including maceration and candida. Interruption of therapy often occurred for 7 days allowing the skin time to recover.To protect the periwound skin, use of a skin barrier wipe for protection with each dressing change goes a long way towards prevention, and it is common to use products such as hydrocolloid dressings around the wound attaching the majority of the drape to the hydrocolloid. Additionally, if the interface dressing will possibly lie on intact skin, or needs to be bridged to an adjacent area, it is imperative that adhesive film/drape be applied first to protect the skin. This can be accomplished by either cutting strips to “picture frame” the wound or one large piece can be applied over the wound and forceps and iris scissors used to trim away the drape right at the skin/wound junction for easy and perfect coverage.

muLTiPLe WouNds: The average outpatient seen at a wound center has approximately 2 wounds. Thus, it is common to consider using one NPWT device on more than one wound, if proximity allows. Not all devices on the market allow this, and even if the device makes this technically feasible, it may not be practically possible. Caroline once had a patient with bilateral foot wounds who continued to ambulate. Although they joked about it at the time, connecting both feet together via Y74

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connected tubing in an ambulatory patient was not a viable option. Multiple wounds on one foot can usually be easily bridged together. This example is shown using foam; the various manufacturers with other types of interface dressings can provide tips for accomplishing this. Deep structures: Debate often centers on how to manage exposed deep structures such as bone or tendon. Official recommendations from manufacturers caution against attempting to granulate directly over either, but we all have our favorite story of success doing just that, and at times this may be the only option short of amputation. Allowing a tendon to granulate may make skin grafting possible, even if there is a partial sacrifice of mobility. The greatest success, particularly with tendon that glides as the patient is ambulating, is immobilization of the extremity with an orthotic device that continues to allow ambulation while keeping the tendon stable and unmoving. Vascular structures, organs and viscera must be handled with great care and must be protected from direct exposure to negative pressure.The decision to use NPWT in many cases is the best one to facilitate more rapid granulation tissue into a wound space. It is critical that this is a team decision including the surgeon, and any wound care providers involved in the care. Knowledge of the surgery performed, the anatomical location, potential vulnerable structures/vessels/organs in the vicinity of the wound must be taken into consideration. Local granulation tissue recently developed may not be adequate protection, so a protective interface layer should always be used until the surgeon/wound provider feels it can be eliminated. Adherence to the wound bed and “lost foam:”According to the FDA, retention of foam dressing pieces and foam adhering to tissues or imbedded in the wound were noted in 32 injury reports.The majority of these patients required surgical procedures for removal of the retained pieces, wound debridement, and treatment of wound dehiscence, as well as additional hospitalization and antibiotic therapy. Given the total number of NPWT treated patients over the years, this represents a tiny frac-

tion of patients. However, most of us have seen adherence of sponge or remnants of gauze on the wound bed at one time or another. Careful inspection of the wound bed at dressing changes to identify small pieces of foam or gauze threads enables easy removal with forceps at the time of the dressing change. From a safety and practical standpoint, a singular piece of dressing material should be used whenever possible when packing a wound for NPWT.There will always be times that this is not possible, at which time it is imperative to document in the medical record how many pieces were utilized, and for further safety even marked on the top of the actual dressing film. When small pieces are packed into deep wound pockets, movement of tissue planes can actually cause dressing materials to migrate deeper into the wound spaces and be missed if the clinician removing the dressing is not the same one who applied it.

BLeediNg: In 2009, the FDA posted alerts on its website concerning reports of 6 deaths and 17 injuries associated with bleeding from NPWT systems. Bleeding occurred in patients with vascular grafts (such as femoral and femoral-popliteal grafts), in sternal and groin wounds, in patients receiving anti-coagulant therapy, immediate post-operative wounds and during removal of dressings that adhered to or were imbedded in the tissues. Three years earlier, registry data was accessed from the Intellicure Research Consortium to evaluate the frequency of adverse events with NPWT. The records of 9,119 patients with 20,371 wounds treated from August 2001 to November 2006 were evaluated. NPWT was provided to 931 patients (10% of total patients) and 9.6% of these NPWT patients were on either heparin or coumadin. None of the NPWT patients reported bleeding. A further 29.5% of NPWT patients were on other rheological agents such as plavix or pletal. In one case, the NPWT device was discontinued due to bloody drainage in an exceptionally large wound (initial leg ulcer was 342 cm2, being in the 99th www.todayswoundclinic.com


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NPWT percentile of wound size for all wounds treated at all wound centers). Excessive bleeding with NPWT still remains uncommon, but clinicians must remain vigilant in its application.

iNFeCTioN: There is conflicting data regarding whether NPWT increases or decreases the bacterial burden of the wound bed. NPWT is used more and more often in acute serious processes such as necrotizing infections. Silver containing foam has been shown in animal studies to decrease bacterial colonies, and the gauze product used primarily with NPWT devices is antimicrobial; containing polyhexamethylene biguanide (PHMB), and some devices allow antimicrobial preparations to be instilled. Nevertheless, most clinicians are familiar with the distinctive unpleasant odor common to the use of foam dressings. This odor does not indicate that the wound is infected but can be a clinical frustration and a social issue for patients. Clinical guidelines recommend that if NPWT is used in the presence of acute infection, the infection must be being treated, and consideration should be given to changing the dressing more frequently based on the patient’s condition until the infection is under control.

misaPPLiCaTioN: The opportunities for misapplication of negative pressure are numerous. Early in Caroline’s use of NPWT, the mother of her hospital CEO was hospitalized with a surgical dehiscence. An inexperienced nurse applied NPWT foam over her intact skin. The result was an excellent example of the capability of NPWT to develop granulation tissue through intact skin. In the acute or LTC setting there often are designated staff (either nursing or physical therapy) that may do the majority of NPWT dressing changes. But all staff, particularly nursing, should have regular inservicing and competency updates to troubleshoot alarms, repair leaks and observe for complications.

www.todayswoundclinic.com

misuse By PaTieNTs: Complications may also occur if patients do not properly follow instructions. The importance of continuous suction with no more than 2 hours of the device being turned off is a critical teaching point with patients. Devices may be noisy and interrupt sleep; patients decide to remove the suction while they go to work or out for an evening event. We have seen cases of extreme maceration because patients turned off their NPWT machines thus trapping wound fluid in the wound bed for many hours. Some of the different devices have monitors to allow the clinician to monitor the number of hours NPWT has been used since the patient was last seen, and if it is noted that the patient is not utilizing the suction for the prescribed number of hours, a frank discussion needs to occur with the patient not only about the potential negative effects, but also the lack of therapeutic benefit from poor utilization of the therapy. For patients who have been on long-term therapy, they may just be weary of being constantly connected to the device. Allowing the patient to take a “break” from therapy for a week, what they call in Dot’s clinic a “VAC”-ation can go a long way towards resumption of continuous use, and a happier patient who feels like they still have some control over their situation.

CriTiCaL TeaChiNg PoiNTs: Patient education all along the healing pathway must be made a priority. The various devices should have patient education material available for home use as a reference as questions may arise, as well as phone numbers available for patients to call for technical questions and assistance. Patients must be taught, and provide return demonstration for plugging in and charging the device, how to turn on and off, and how to change the canisters. Patients or their family/caregivers need to understand what normal exudate is and what is not normal. They must be able to remove the dressing and have an alternative dressing available at home.They must

know to call the clinic or go to the emergency room for extremes in pain or drainage. And, most importantly, what to do if frank bleeding should occur. Most likely many patients will be followed by home care nurses for dressing changes at home, with the exception of those that don’t qualify for home care or prefer the dressing changes be done at the clinic. The choice of home care agency is often driven by insurance, but when choices are available, having a few agencies that have nurses well trained in NPWT that can speak the language and understand specific suggestions and orders is ideal. Unless potential harm exists, clinicians in the wound center should try to refrain from being overly critical of dressings done in the home setting so as not to undermine patient confidence. Patients will often compare the dressings done in the two settings, but we must keep in mind that we have elevating chairs/stretchers, the best lighting, and often extra hands if needed. The home setting often is the total opposite. NPWT has become a vital part of our clinical options for treating wounds of all types. No longer reserved for the large wounds only, most utilize it as a short therapy to improve a wound bed or decrease the time to healing for smaller wounds and to improve graft/flap take. When used as a component of a comprehensive wound treatment program, most wound centers cannot imagine practicing without it. ■ Dr. Caroline Fife, is currently Co-editor of Today’s Wound Clinic, is the Director of Clinical Research at the Memorial Hermann Center for Wound Healing, Houston,Tex., and Chief Medical Officer of Intellicure, Inc. She can be reached at cfife@intellicure.com Dot Weir, RN, CWON, CWS is the Wound Care Director for Osceola Regional Medical Center in Kissimmee, Fla. and is coeditor of Today’s Wound Clinic.

To VieW a PhoTo series iNCLuded WiTh This arTiCLe VisiT WWW.TodaysWouNdCLiNiC.Com/NPWT Wound Clinic Wisdom

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ToTal ConTaCT CasTing and neuropaThiC FooT Wounds: implementing a gold standard and overcoming Barriers to Clinical use Kristine Hoffman, DPM; Jeffrey Jensen, DPM, FACFAS; Eric D. Jaakola, DPM

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europathic foot ulcers affect up to 15% of diabetic patients and are the leading cause of hospitalization and lower extremity amputation among this patient population.1,2 Among the diabetic population, amputation is associated with reamputation, contralateral limb amputation, placement in extended care facility, decrease in quality of life and death.3-7 The combination of sensory neuropathy and high plantar pressures is the main factor responsible for the development and maintenance of plantar foot ulcers in patients with diabetes mellitus.8 Ulcer healing requires adequate blood supply, control of infection, appropriate wound care, debridement and off-loading. Off-loading has been proven to interrupt the pathogenesis of ulcer 76

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development and maintenance as well as lead to positive histologic wound changes.9 Other studies have documented the beneficial role of pressure reduction on the healing of neuropathic ulcerations.10-11 The ideal off-loading device reduces plantar pressures while ensuring patient compliance.

MeChanisM oF aCTion oF TCC The TCC is effective in treating diabetic foot ulcers due to redistribution of plantar pressure over a large surface area, decreased shear stress, reduction of edema, enforced compliance and protection.12-15 Multiple studies have demonstrated decreased plantar pressures with TCCs with pressure reduction at the site of ulceration ranging from 64-92%.16-22 Additionally, it has been shown that

patients voluntarily reduce their activity level, taking fewer steps daily, while wearing a TCC.11

TCC The gold sTandard TCCs have been listed by numerous sources as the gold standard for the treatment of diabetic neuropathic foot ulcerations and the beneficial effects of total contact cast have been documented in multiple prospective19,27,32 and retrospective studies.15,19,26,32-3 Consistently high incidence of wound healing, ranging from 73-100%, has been reported with TCC treatment.10,11,15,19,23-31 Several randomized clinical trials in which the TCC was compared with other off-loading modalities demonstrated the effectiveness of the TCC for treatment of neuropathic foot ulcers.10,11,34 www.todayswoundclinic.com


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podiatry in the clinic control TCC group healed after a mean of 44 days.34 A prospective randomized trial conducted by van de Weg et al showed median time for diabetic foot ulcerations to heal was significantly shorter using a TCC (52 days) versus custom footwear (90 days).35 In addition to beneficial clinical effects, TCCs have been shown to have beneficial effects on wound histology. Pressure reduction with total contact casting results in changes in the histopathologic features of neuropathic foot ulcers with a shift from a predominance of inflammatory elements to a reparative pattern consisting of cutaneous annexes, capillaries and granulation tissue.9 Patient compliance with off-loading strategies is generally poor due to the lack of symptoms secondary to sensory neuropathy. Activity monitoring has shown that the majority of patients wear prescribed removable off-loading devices for only 28% of their daily steps.36 Functional advantages of the TCC include maintaining ambulatory lifestyle during the healing period. Additionally, patients have been shown to take fewer steps while wearing the TCC further increasing the off-loading effect.11

laCk oF use By CliniCians

Specifically, a randomized prospective trial by Armstrong et al showed plantar ulcers treated with TCC had a significantly higher healing rate (89.5%) than ulcers treated with removable cast walkers (65%) or half-shoes (58.3%) and significantly fewer days to healing at 33.5 days for TCC compared to 50.4 days for RCW and 61.0 days for the half-shoes.11 Additionally, patients were shown to be significantly less active in the TCC. A Level I study by Mueller et al comparing TCC to TCC with Achilles tendon lengthening reported 88% of ulcers in the 77

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Despite the well-documented success of the TCC, few clinicians use this modality as part of their diabetic foot ulcer treatment regimen. A recent study reported that less than 2% of 895 practitioners that treat diabetic foot ulcers use TCCs for the treatment of plantar foot wounds.37 Several attributes of TCC have been cited as deterrents to their use despite clinical evidence of their effectiveness: cost, patient tolerance, time for cast removal and application, reimbursement issues, familiarity with method of cast application, customizing parts, staffing/ordering supplies, inability to frequently monitor wounds, and risk of iatrogenic cast complications.37-38 Many clinicians avoid TCC use due to concern of iatrogenic cast complications. In a recent study evaluating a series of 398 TCCs, 22 (6%) new ulcerations occurred secondary to cast treatment. The majori-

ty of these ulcerations healed during the remainder of the TCC treatment and the rate of permanent sequelae from castrelated injury was 0.25%.39 A second study examining the safety of TCC in patients with neuropathic foot ulcers reported a total of 14 (17%) complications (majority skin irritation) in 82 consecutive casts, none requiring alteration in the treatment protocol.40 Both studies concluded that the TCC can be safely used in patients with neuropathic ulcers but minor complications should be anticipated. Ensuring the foot is at 90 degrees, applying two casts in first week of use to maintain fit and re-casting all loose or wet casts can minimize complications. Although reimbursement is listed as a concern,TCC has been reimbursed by Medicare under HCPCS code 29445 for years with additional supply reimbursement. Patient tolerance is another factor leading to decreased use of the TCC. A study examining quality of life among patients receiving different off-loading modalities to heal diabetic foot ulcerations showed that quality of life was more impacted by whether or not the wound healed quickly than how the ulceration was treated. Given the high percentage of wounds healed and fast healing rates seen with the TCC, this modality may cause the least detrimental effect on quality of life in patients suffering from diabetic foot ulcers. The need for training and expertise in cast application and removal is another factor listed as a deterrent in use of TCCs. A study by Nabuurs-Franssen et al showed that 76% of diabetic foot ulcers healed in a median of 33 days with a complication rate of 9% new ulcers and 29% pre-ulcerative lesions (all which resolved in the TCC prior to healing of the primary foot ulcer).42 Data in this study included the learning curve of the staff in cast application and learning curve of multiple different cast technicians over the course of the study. This can be addressed by using a standardized technique. There are several absolute and relative contraindications to TCC use including deep infection, poor skin quality, severe www.todayswoundclinic.com


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podiatry in the clinic arterial insufficiency, poor patient compliance, extensive wound drainage, fluid shifts, blindness, and postural instability.43 In regard to both ischemia and infection, Nabuurs-Franssen et al showed that ulcers with moderate ischemia or infection can be treated effectively with TCC.42 In this study, 76% of ulcers, including those with superficial infection or moderate ischemia, healed in a median of 33 days.42 In regard to postural instability, Lavery et al showed sway was significantly greater with TCCs with a heel compared but that this increase in sway can be eliminated by using a TCC with cast boot.44

TCC-eZ Recently, improvements have been made that overcome many of the disadvantages of the standard TCC. The TCCEZ (MedEfficiency; Wheat Ridge, Colorado) consists of a synthetic mesh cast supported by an outer shell that provides additional support and stability for weight bearing. This device provides comparable off-loading to standard TCCs while significantly decreasing the time of cast application. A study by Jensen et al. comparing plantar foot pressure in standard TCC to the TCC-EZ showed lower average and maximum pressures in all areas of the foot except the rear foot in the TCC-EZ.45 Fewer layers has lead to reduction in application and removal times for the TCC-EZ (75s) compared to standard TCC (452s).46 The TCC-EZ is also technically easier to apply than standard TCC requiring less training and decreasing potential for iatrogenic wounds and other cast complications. Additionally, the TCC-EZ design decreases cast weight and improves patient postural stability.

hoW sysTeMs Can overCoMe soMe oF The Barriers To using TCC Wu et al report additional factors affecting TCC usage include customizing parts as well as staffing/ordering supplies.37 Piaggesi et al report that although the TCC is a safe and effective treatment modality it is rarely pursued as a treatment option for many factors including the need for “many different materials to be assembled in a complex way.”9 78

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Preassembled total contact cast systems have the ability to overcome these barriers decreasing cast application time as well as staff time required for supply ordering and assembly.

ConClusion Evidence-based medicine demonstrates that the TCC is the best treatment modality to off-load diabetic foot ulcerations. Recent advancement in TCC technology is making it quicker and easier to implement this gold standard as first line therapy in a busy clinic setting. ■ Kristine Hoffman, DPM is a third year resident at the North Colorado Podiatric Surgical Residency in Greeley, Colorado. Jeffrey Jensen, DPM practices in Denver, CO with the Diabetic Foot & Wound Center at Rose Medical Center. He is the Research and Externship Director at the North Colorado Podiatric Surgical Residency program in Greeley, CO. He is also the founder of MedEfficiency, Inc. Eric D. Jaakola, DPM practices in Denver, CO with the Diabetic Foot & Wound Center at Rose Medical Center. He is the Education Chair at the North Colorado Podiatric Surgical Residency program in Greeley, CO References 1. Boulton AJM, Kirshner RS, Vileikyte L. Neuropathic diabetic foot ulcers. N Engl J Med. 2004;351(1):48-55. 2. Palumbo PJ, Melton LJ. Peripheral vascular disease and diabetes. In: Diabetes in America: diabetes data compiled 1984. Washington, D.C.: Government Printing Office, August 1985: XV-1-XV-21. (NIH publication no. 85-1468). 3. Armstrong DG, Lavery LA, Harkless LB, van Houtum WH. Amputation and reamputation of the diabetic foot. J Am Pod Med Assn. 1997; 87:255-259. 4. Murdoch DP, Armstrong DG, Dacus JB, Laughlin TJ, Morgan CB, Lavery LA.The natural history of great toe amputations. J Foot Ankle Surg. 1997; 36:204-208. 5. Lavery LA, van Houtum WH, Harkless LB. In-hospital mortality and disposition of diabetic amputees in the Netherlands. Diabetic Med. 1996;13:192-197. 6. van Houtum WH, Lavery LA. Outcomes associated with diabetes-related amputations in the Netherlands and in the State of California, USA. J Intern Med. 1996; 240:227-231. 7. Lavery LA, van Houtum WH, Armstrong DG. Institutionalization following diabetes-related lower extremity amputation. Am J Med. 1997; 103:383-388. 8. Cavanagh PR, Simoneau GG, Ulbrecht JS. Ulceration, unsteadiness, and uncertainty: the biomechanical consequences of diabetes mellitus. J Biomech. 1993; 26(Suppl. 1):23– 40. 9. Piaggesi A,Viacava P, Rizzo L, Giuseppe N, Baccetti F, Romanelli M, Zampa V, Del Prato S. Semiquantitative analysis of the histopathological features of the neuropathic foot ulcer. Diabetes Care. 2003 Nov;26(11): 3123-3128.

10. Caravaggi C, Faglia E, De Giglio R, Mantero M, Quarantiello A, Sommariva E, Gino M, Pritelli C, Morabito A. Effectiveness and safety of a nonremovable fiberglass off-bearing cast versus a therapeutic shoe in the treatment of neuropathic foot ulcers. Diabetes Care. 2000;23: 1746-1751. 11. Armstrong DG, Ngyugen HC, Lavery LA, van Schie CHM, Boulton AJM, Harkless LB. Off-loading the diabetic foot wound: a randomized clinical trial. Diabetes Care. 2001;24:1019-1022. 12. Coleman WC, Brand PW, Birke JA. The total contact cast, a therapy for plantar ulceration on insensitive feet. J Am Podiatr Med Assoc. 1984; 74:548-52. 13. Conti SF, Martin RL, Chaytor ER, Hughes C, Luttrell L. Plantar pressure measurements during ambulation in weight bearing conventional short leg cast and total contact casts. Foot Ankle Int. 1996;17: 464-469. 14. Martin RL, Conti SF. Plantar pressure analysis of diabetic rocker-bottom deformity in total contact casts. Foot Ankle Int. 1996;17: 470-472. 15. 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. 1992;74:261–9. 16. Baumhauer JF, Wervey R, McWilliams J, Harris GF, Shereff MJ. A comparison study of plantar foot pressure in standardized shoe, total contact cast, and prefabricated pneumatic walking brace. Foot Ankle Int. 1997;18: 26-33. 17. Wertsch JJ, Frank LW, Zhu H, Price MB, Harris GF,Alba HM. Plantar pressures with total contact casting. J Rehabil Res Dev. 32:205-209, 1995. 18. Lavery LA, Vela SA, Lavery DC, Quebedeaux TL. Reducing dynamic foot pressures in high-risk diabetic subjects with foot ulcerations: a comparision of treatments. Diabetes Care. 1996;19:818-821. 19. 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. 1998; 35:1-5. 20. Hartsell HD, Fellner C, Saltzman CL. Pneumatic bracing and total contact casting have equivocal effects on plantar pressure relief. Foot Ankle Int. 2001; 22(6): 502-6. 21. Shaw JE, Hsi WL, Ulbreht JS, Norkitis A, Becker MB, Cavanagh PR. The mechanism of plantar unloading in total contact casts: implications for design and clinical use. Foot Ankle Int. 1997; 18(12): 809-17. 22. Leibner ED, Brodsky JW, Pollo FE, Baum BS, Edmonds BW. Unloading mechanism in the total contact cast. Foot Ankle Int. 2006; 27(4):281-5. 23. Matricali GA, Deroo K, Dereymaeker G. Outcome and recurrence rate of diabetic foot ulcers treated by a total contact cast: short-term follow up. Foot Ankle Int. 2003; 24(9):680-4. 24. Helm PA, Walker SC, Pulliam G. Total contact casting in diabetic patients with neuropathic foot ulcerations. Arch Phys Med Rehabil. 1984;65: 691-693. 25. Walker SC, Helm PA, Pulliam G. Chronic diabetic neuropathic foot ulcerations and total contact casting: healing effectiveness and outcome probability. Arch Phys Med Rehabil 1985; 66:574. 26. Sinacore DR, Mueller MJ, Diamond JE. Diabetic plantar ulcers treated by total contact casting. Phys Ther 1987; 67:1543-7. 27. Mueller MJ, Diamond JE, Sinacore DR, et al.Total contact casting in treatment of diabetic plantar ulcers: controlled clinical trial. Diabet Care 1989; 12:384-8. 28. Ha Van G, Siney H, Hartmann-Heutier A, Jacqueminet S, Greau F, Grimaldi A. Nonremovable, windowed, fiberglass cast boot in the treatment of diabetic plantar ulcers: efficacy, safety and compliance. Diabetes Care. 2003; 26:2848-2852. 29. Lavery LA,Armstrong DG,Walker SC. Healing rates of diabetic foot ulcers associated with midfoot fracture due to Charcot’s arthropathy. Diabet Med. 1997 14:46-49, 1997. 30. Birke JA, Novick A, Patout CA, Coleman WC. Healing rates of plantar ulcers in leprosy and diabetes. Lepr Rev. 63:365-374, 1992. 31. Mason J, O’Keeffe C, Hutchinson A, McIntosh A,Young R,

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podiatry in the clinic 32.

33.

34.

35.

36.

Booth A. A systematic review of foot ulcer in patients with Type2 diabetes mellitus II: treatment. Diabet Med. 1999; 16:889-909. Walker SC, Helm PA, Pulliam G.Total contact casting and chronic diabetic neuropathic foot ulcerations: healing rates by wound location.Arch Phys Med Rehabil 1987; 68:21721. Ali R, Qureshi A,Yaqoob MY, Shakil M. Total contact cast for neuropathic diabetic foot ulcers. J Coll Physicians Surg Pak. 2008; 18(11):695-8. Mueller MJ, Sinacore DR, Hastings MK, Strube MJ, Johnson JE. Effect of Achilles tendon lengthening on neuropathic plantar ulcers. A randomized clinical trial. J Bone Joint Surg Am. 2003: 85-A(8): 1436-1445. Van de Weg FB, van der Windt DAWM,Vahl AC. Wound healing: total conatct cast vs. custom-made temporary footwear for patients with diabetic foot ulceration. Prosthet Ortht Int. 2008; 32(1):3-11. Armstrong DG, Lavery LA, Kimbriel HR, Nixon BP, Boulton AJM. Activity patterns of patients with diabetic foot ulcerations: Patients with active ulceration may not adhere to a standard pressure off-loading regimen. Diebetes Care. 2003; 26: 2595-2597.

37. Wu SC, Jensen JL, Weber AK, Robinson DE, Armstrong DG. Use of pressure offloading devices in diabetic foot ulcers: do we practice what we preach? Diabetes Care. 2008;31(11): 2118-9. 38. Cavanagh PR, Lipsky BA, Bradbury AW, Botek G. Treatment for diabetic foot ulcers: review. Lancet 336:1725-1735, 2005. Wukich DK, Motko J. Safety of total contact casting in high risk patients with diabetic foot ulcers. Foot Ankle Int. 2004;25:556-560. 39. Guyton GP. An analysis of iarogenic complications from the total contact cast. Foot Ankle Int. 2005 Nov; 26(11): 903-11. 40. Wukich DK, Motko J. Safety of total contact casting in high-risk patients with neuropathic foot ulcers. Foot Ankle Int. 2004 Aug; 25(8):556-60. 41. Armstrong DG, Lavery LA,Wrobel JS,Vileikyte L. Quality of life in healing diabetic wounds: does the end justify the means? J Foot Ankle Surg. 2008 July-Aug; 47(4):278-82. 42. Nabuurs-Franssen MH, Sleegers R, Huijberts MS,Wijnen W, Sanders AP,Walenkamp G, Schaper NC. Total contact casting of the diabetic foot in daily practice: A prospective follow-up study. Diabetes Care. 2005 Feb; 28(2): 243-247. 43. Trepman E, Pinzur MS, Shileds NN. Application of the

total contact cast. Foot Ankle Int. 2005 Jan; 26(1):108-112. 44. Lavery LA, Fleishli JG, Laughlin TJ,Vela SA, Lavery DC, Armstrong DG. Is postural instability exacerbated by off-loading devices in high risk diabetics with foot ulcers? Ostomy Wound Manage. 1998 Jan; 44(1):26-32. 45. Jensen J, Jaakola E, Gillin B, Riley E. Total contact casting: comparison of plantar pressures in two total contact casting systems. Poster presented at: DF Con 2008 Diabetic Foot Global Conference; 2008 March; Los Angeles, CA. 46. Jensen J, Jaakola E, Gllin B, Riley E. TCC-EZ - Total contact casting system. Overcoming the barriers to utilizing a proven gold standard treatment. Poster presented at: DF Con 2008 Diabetic Foot Global Conference; 2008 March; Los Angeles, CA.

For an exclusive article by Peggy Dotson, RN, BS, owner of Healthcare Reimbursement Strategy Consulting, on Reimbursement for Total Contact Casting visit www.todayswoundclinic.com-TCCReimbursement

a praCTiCal guide To ToTal ConTaCT CasTing: a risk vs. Benefit approach Melodie Blakely, PT, MS, CWS

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otal contact casting is an effective and complicated tool in the treatment of neuropathic foot ulcers. In order to gain the most benefit with the least amount of risk one must consider several key variables and, most importantly, must consider the patient as a whole. The following are practical considerations that come to mind when I think about total contact casting after 4 years and a little over a thousand chances to practice and learn.

FirsT Things FirsT TCC application requires specific, specialized materials. Each TCC requires a length of stockinette, specially cut ¼” felt to pad the anterior tibial, dorsal foot and malleolar areas, roll cast padding for additional padding around the top of the TCC and ankle area, ¼” adhesive backed foam to cover toes, 1 plaster and 4 fiberglass rolls, a solid foot plate and a rubber walking surface (a cast boot can be used in place of the foot plate and rubber walking surface). In addition to these consumables, a water bucket for submerging plaster and fiberglass rolls and a cast saw (preferably with vacuum) are 79

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also necessary. It can be challenging to obtain supplies initially as they are often not available through the same outlets other wound dressing supplies are ordered from. Kits containing all needed supplies are available commercially and may be an easier, albeit more costly, alternative to purchasing products separately. Individual supplies can be found through podiatry or orthopedic supply dealers.

hoW To Technical expertise is vital in the application of TCCs because, although the benefits are considerable and well documented, the risks are significant. It is humbling to think that most of the patients who would benefit from the use of TCC have decreased or absent protective sensation, impaired proprioception and likely some degree of small vessel disease. In order to prevent movement in the cast, minimal padding is used. In addition, the wound is unable to be monitored or dressings changed for up to a week at a time. All of these elements demonstrate just how important careful patient assessment and excellent technique in TCC application are. Anyone

endeavoring to apply a TCC should first have both didactic and hands on training.The experience and feedback gained by applying a TCC on a colleague and, even better, having one applied to you is invaluable in developing technical skill. There is nothing that reminds you to make sure your angles are accurate and cast smooth more than the kinesthetic memory of hobbling around on a lopsided cast with an uncomfortable rough spot. Even a small amount of difference in angles from neutral can make walking difficult and even a small rough spot can cause a new wound.

ConsideraTions Medical, environmental, mobility and psychosocial factors should all be considered and assessed on an ongoing basis. From a medical standpoint, the patient should have adequate blood supply. Understanding that most diabetic patients with foot ulcers have some impairment of blood supply, it is practical to ensure that everything has been done to optimize the vascular status (ie, vascular consult and/or intervention) and then weigh risk vs. benefit. It www.todayswoundclinic.com


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podiatry in the clinic should be noted that even patients that show no abnormality on a routine vascular exam could have small vessel disease. This may only become apparent when the wound doesn’t respond as it should or new areas of necrosis show up in telltale “arterial” areas such as over the proximal or distal 5th metatarsal. If wounds worsen or anything other than a minor irritation occurs while the patient is in a TCC, this should tip the scales toward the risk side of risk vs. benefit and use should be reconsidered until the underlying problem is identified and addressed. Significant wound depth should trigger a work up for abscess or bone infection. In general, soft tissue infection and osteomyelitis have to be considered and ruled out or treated. As long as the infection is being treated appropriately and the wound stable, however, the benefit of better off-loading may outweigh the risk of less frequent visualization of the wound. Another less obvious consideration is back and hip pain caused by alteration in gait.This can be related to difference in height between the casted leg and footwear of the opposite leg or the weight of the TCC on one side. Also, it is not uncommon for the cast to cause abrasions on the opposing leg, especially if the patient is an active sleeper.These issues can be allowed for with taller footwear on the opposite leg in the case of height difference or padding via sleeping with a pillow between the legs or wearing a sock on the opposite leg. Neuropathic discomfort can sometimes be heightened with the use of TCC and should be addressed. It is important to think about environmental factors such as whether the patient will need to manage stairs, if they will be able to keep the cast dry or if they will need to drive and the wound is on their right foot. TCCs should not be used on the right foot of patients who must drive. It’s also important to warn patients to wear loose fitting pants or shorts so that they’ll be able to remove them over the cast without cutting them. General mobility can affect whether a TCC is appropriate or what type of walking interface is used. On one hand a rubber footplate that’s built into the cast is stable in the sense that it doesn’t move or 80

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separate but it is small. If you are using a built in footplate it is helpful to educate your patients to take a shorter step and land with their foot flat, therefore engaging the rubber footplate, rather than landing slippery heel first. A cast boot offers a larger walking surface but can shift. Some patients prefer a cast boot because they can remove it at night and not get their sheets dirty, but if they forget to reapply or choose not to wear the boot they will be much less stable, particularly on hard surfaces. Failure to wear the cast boot can also affect the integrity of the cast. Patients with prostheses on the contralateral side should be evaluated carefully to determine if balance is adequate, weighing the benefit of protecting the remaining foot against overall safety and mobility. Psychosocial issues can include anything from claustrophobia to dementia. A TCC should not be used on someone who is unable to understand safety precautions. Of course, determining this is somewhat subjective and family/caregiver support can offset some deficits. Claustrophobia is a common concern. This can be managed via anti-anxiety medications, relaxation techniques, etc; however, the most effective treatment for this that I’ve found is edema management within the cast. It greatly reduces episodes of “tightness” that are often at the root of patient’s anxiety. It works nicely to add a layer of tubular elastic bandage under the stockinet layer, which is then folded over the upper edge of the cast and fixed in place along with the stockinet. Some patients have difficulty with the “stigma” of wearing a cast and the attention they feel it draws. A discussion about the benefits of TCC vs. the possible complications of the wound not healing can help bring things into perspective.

paTienT eduCaTion Patient education is critical when it comes to the TCC. High on the list of important items is that there should be no movement within the cast and that any discomfort is not OK. It’s important to explain that the patient will often lose volume in the leg due to edema reduction, thus allowing movement in the cast. This

Macerated foot from a chronically wet cast.

Degraded cast with exposed tissue after patient had missed three weeks of appointments and done significant walking

Removal of cast by following “cut lines” previously drawn on TCC.

is one of reasons the TCC is changed 2— 3 days after the first application rather than a week. Because there is already some loss of protective sensation the patient may not feel pain from a rub spot until it is too late. Movement needs to be the cue to come in for a cast change rather than discomfort or pain. In addition, any amount of discomfort, even without movement, should www.todayswoundclinic.com


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podiatry in the clinic

Completed TCC with “cut lines” drawn (smiley face optional).

a skilled orthopedic technician can cause serious injury removing a TCC incorrectly. One way to help ensure a TCC is removed correctly is to actually draw cut lines on it before the patient leaves the clinic (see photos). Even if the person removing the cast has never seen a TCC before it should be a cue that this cast is “different” and more information is needed. It is helpful to provide the patient with a written explanation that they can carry with them to show caregivers (one commercially available kit has a patient handout with a wallet sized tear-off). Patients should be educated that the first few steps with the TCC will be awkward, even if they are used to wearing them. Because it’s impossible to make all of the angles exactly the same with every application, each new TCC feels a little different. It’s a good idea to stand by as the patient stands and takes steps for the first time and make sure an assistive device is available if needed.

oTher noTes The Clinician preparing to draw in “cut lines”.

be taken very seriously. The patient must not wait for pain to seek attention but should always err on the side of caution and call or come in with any concern. Another key topic is the difference between an orthopedic cast and a TCC. Orthopedic casts have thick padding under the entire surface of the cast.TCCs are different in that they are used while walking. In order to prevent excess movement with gait they have limited padding, focused mainly over bony prominences. This fact becomes most important when the TCC is removed. Most orthopedic casts are removed by cutting along the medial and lateral sides in a bivalve-type fashion. The bulk of a TCCs padding is along the anterior tibial, dorsal foot, toe and malleolar aspect with almost no padding along the medial and lateral calf and foot. Therefore, a TCC should not be cut off as if it was an orthopedic cast, and the patient should understand this well enough to alert anyone removing the TCC about this. Even 81

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Though TCC is most often used to treat diabetic foot ulcers other types of wounds can benefit. Patients with spasticity in addition to neuropathic wounds may benefit from increased range of motion as well as offloading. In this case the TCC also acts as a serial cast. In situations where fixation is needed the TCC acts as an immobilizer while still allowing ambulation. For patients that have had a transmetatarsal amputation it is still possible to use TCC. The main modification needed is an adjustment of the foam used to cover the toes. Typically the adhesive backed ¼’ foam is folded over the toes in sandwich fashion and the ends of the foam are trimmed, leaving the entire toe area enveloped in foam. If one were to fold the same size foam over a TMA, the edge of the foam on the plantar surface would be over a weight-bearing surface. When the TCC was applied it would leave a “ledge” at the point where the plaster/fiberglass contoured to fit over the foam, thus causing an uneven surface over a weight-bearing surface. If the foam was not used (as no toe protection is needed) it would be dif-

ficult to remove the TCC because this is an area that must be cut. The solution is to cut the foam lengthwise and apply it along just the front and sides of the foot in “bumper" fashion.This leaves you with no ledge and a protected cutting surface.

deal Breakers It should be noted that there are certain situations that I would stop use of or not apply a TCC.The first, as noted above, is a worsening of the wound or development of a new wound over a bony prominence. Second is patient compliance with appointments or safety (see photos).TCCs carry enough risk; applying one to someone who has already missed three weeks worth of appointments, someone who has removed their own cast with a kitchen utensil or power tool or someone who consistently returns to the clinic “swimming” in their broken down, waterlogged cast is just not wise (sorry to say these examples are not arbitrary). Also, a sudden or relatively sudden change in mental status is a serious safety and medical issue and should be worked up before continuing the use of TCC.

in ConClusion In this difficult to treat population options are not always black and white. Many factors have to be continuously considered and assessed. Though I’m sure that this list is not exhaustive, I’ve written about the things that are helpful for me to focus on and remember, and a few little tricks I’ve learned along the way. Fortunately, I’m also a part of a multidisciplinary team of caring, smart professionals that work collaboratively with the same “whole patient,”risk vs. benefit approach. Challenges are a given with use of the TCC, but they can often can be overcome with forethought, creativity, good patient education and an honest assessment of the patient’s abilities. ■

Melodie Blakely, PT, MS, CWS is the Clinical Coordinator for The Wound Healing Center of Osceola Regional Medical Center in Kissimmee, Florida and can be reached at melodie.blakely@hcahealthcare.com www.todayswoundclinic.com


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OFFLOADING — The Total Picture Desmond Bell, DPM, CWS

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o paraphrase an adage, “it is not only what you put on a wound that is important, but what you take off the wound as well.” While dressing selection is important to a degree, offloading plays a critical role in wound healing, especially in diabetic, neuropathic and pressure ulcers of the foot. Conceptually, it is increased pressure over an underlying boney prominence that is often responsible for ulcer formation and non-healing. Prolonged or repetitive pressure over a boney prominence reduces perfusion to tissue, and the resulting lack of oxygen to the tissue results in ulcer formation.

GOALs Goals of offloading are redistribution of focal pressure from one specific area to a broad area of dispersed force. This allows for the phases of wound healing proceeding without disruption from ground reactive force or other external source of pressure. Offloading should move a wound towards healing in as efficient manner as possible. When considering methods of offloading, several considerations should be addressed, including the ambulatory status of the patient, their quality of gait, and willingness of the patient to comply with the proposed methods. The practitioner must consider their lifestyle, activity level, and address the hidden concerns, such as bathing and mobility. The area at the periphery of an ulcer with hyperkeratotic rim represents the area of highest pressure, as well as the area of decreased metabolic activity, and senescent, phenotypically altered cells.1 In a plantar foot ulcer, it is common to see an area of macerated tissue (a white ring surrounding the periphery of the ulcer). This area of increased pressure has been described as the “edge effect.”2 82

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The first step in offloading, especially in plantar foot ulcers, is a thorough debridement of the macerated tissue surrounding the ulcer.

ENsurING OFFLOADING Is EFFEcTIvE For offloading to be truly effective, it must be consistent and continuous, therefore, “24 hours, 7 days a week” is ideal. Patients cannot be relied upon to use offloading devices consistently. Surgeons do not send patients home with scalpel blades and instructions on how to perform self-debridement, so why would a provider entrust patients to perform their own offloading? Ulcers are not the only things that require protection and monitoring; patients must also be protected from themselves.

TEchNIquEs vAry Offloading techniques vary and as previously stated, a variety of factors must be considered when choosing they type of offloading to employ, especially in an ambulatory patient.

ThE GOLD sTANDArD When offloading plantar foot ulcers, the gold standard still remains the total contact cast (TCC). Numerous articles have been written to date on the subject of the TCC. Dr. Paul Brand first used the TCC in the United States during 1965 at the National Hansen’s Disease Center in Carville, Louisiana and there is a long list of studies documenting the utility and success of the TCC.3, 4 TCC has been shown to be safe and effective for complicated ulcers, and when compared with half-shoes and removable cast walkers, TCC achieved faster healing rates than either of the two other treatment options.4,5,6 It also provides constant protection as it is not removable by the patient, and its

weight tends to decrease activity levels, thereby reducing additional trauma to the ulcer. Perceived drawbacks of its use are the time needed to remove and reapply, and the technical knowledge required to apply. Infection and ischemia would be two contraindications for TCC application. Another contraindication would be patients with unsteady gaits or who have no form of transportation other than driving their own car. The TCC would not be suitable for these candidates.

“INsTANT” TOTAL cONTAcT cAsT Armstrong, et al in an attempt to address the time and technical knowledge required in Total Contact Cast application, suggested the use of the “Instant” Total Contact Cast, which involves the application of a fiberglass, plaster or cohesive bandage roll over a CAM walker.This method also reduces the likelihood of a patient removing the cast.7

OThEr METhODs Other methods for offloading include the CROW (Charcot Resistant Orthotic Walker), Ankle Foot Orthoses, CAM Walkers, Bledsoe Boot and the Active Offloading Walker. These are removable devices, worn by patients, that allow for daily dressing changes, if needed, and/or for maintenance of a healed ulcer.

BrING IN ThE ExPErTs Utilizing the services of a Certified Pedorthist is recommended where possible. Casting for custom shoes, AFO’s or CROW walkers can be time intensive and the expertise of a CPed makes them valuable additions to the limb preservation team. A method developed by this author to address offloading, a gait instability and compliance issue has been described as www.todayswoundclinic.com


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podiatry in the clinic the “soft” total contact cast.

“sOFT” TOTAL cONTAcT cAsT The “soft” total contact cast has been described as a hybrid method devised to ensure offloading occurs in patients who may not be candidates for TCC or where a non-removable device is preferred to ensure greater compliance.4 It is comprised of soft materials, including cast padding, a paste bandage and elastic selfadherent bandage wrap. This method has not only proven effective over years of clinical application, but has been found to be well tolerated, easy and inexpensive to apply.

shOEs Among the least effective methods of offloading are surgical shoes and “half ” shoes. These do provide a degree of offloading, but the potential for lack of patient compliance make these the last methods that should be considered. Fleschli, et al found the half-shoe to be the least effective method in an offloading comparison study while Needleman found the device to be useful, but also reported a 30% complication rate, including balance problems, falls and joint pain.6, 7

BEDBOuND Or IMMOBILE PATIENTs Offloading is not limited to our ambulatory patients and creativity must often be employed where bedbound or immobile patients are being managed. When patients are bedbound or immobilized, they are at significant risk to develop pressure ulcers, especially at the heel or other areas of underlying boney prominence. Intervention must occur to prevent skin breakdown. Support surfaces, including air loss mattresses, should be ordered. Additionally, care must be taken to “float” heels to prevent contact with the bed, ground or wheelchair foot pedals.

DEvIcEs Pillows positioned behind the legs are helpful, especially when the patient does not tolerate offloading devices. Devices such as multi-podus boots or 83

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Linard splints are proven to offload heels and feet. However, when using such devices, legs and feet must be inspected at least twice a day for signs of additional skin breakdown. Rigid plastic frames of each may potentially create new pressure areas for frail skin to rest against. Heelift® (DM Systems, Evanston, Illinois) or heel guards are foam devices that protect feet and heels and allow for floating of heels, conceptually similarly as with multi-podus splints. The Heelift style products are entirely made from foam so there are no rigid components that may cause areas of focal pressure. These type devices should also be removed at least twice daily for skin inspection.

ThE chALLENGEs Offloading presents multiple challenges. Regular re-assessment of efficacy of employed methods is essential. Finding the right method patient requires insight by the Provider regarding the lifestyle, gait, compliance and comprehension of the patient. Offloading typically requires customization. One size does not fit all and random dispensing of certain products can do a great disservice to both patient and provider alike. ■ Dr. Desmond Bell is a Board Certified Wound Specialist (CWS)-(American Academy of Wound Management), and a Fellow of the American College of Certified Wound Specialists. He presently serves on the Board of Directors of the American Academy of Wound Management. Dr. Bell is the founder of the “Save A Leg, Save A Life” Foundation, a multi-disciplinary non-profit organization dedicated to the reduction in lower extremity amputations and improving wound healing outcomes through evidence based methodology and community outreach. www.savealegsavealife.com. Dr. Bell is the founder of the Limb Salvage Institute and Wound Care on Wheels, LLC a service providing wound care to patients in the hospital, home or long term care settings. Wound Care on Wheels evolved from his previous practice model, the First Coast Diabetic Foot & Wound Management Center, a free-

standing outpatient wound management center. He also previously served as the assistant Medical Director of the Wound Management Center of Jacksonville, FL. Dr. Bell is a graduate of Tulane University and the Temple University School of Podiatric Medicine. He served his residency training programs at the Department of Veterans Affairs Medical Center in Philadelphia and Delaware Valley Medical Center in Langhorne, Pennsylvania. While at the VA, Dr. Bell received a commendation in part for his role in wound care. He served as Chief Podiatric Surgical resident and was actively involved in the Wound Care Center at Delaware Valley. He is a frequent lecturer and author on the subject of wound care, peripheral arterial disease, and diabetes. Dr. Bell was awarded the First Humanitarian Award by Specialty Hospital for 2009. He is a member of the Speaker's Bureau of Organogenesis and serves as a consultant with Biolife, LLC, SanofiAventis, Libertas Health Company, LLC and LifeCell. He has been in private practice in Jacksonville, Florida since 1997 and is on staff at Memorial Hospital of Jacksonville, St. Luke’s Hospital, St. Vincent’s Medical Center and Specialty Hospital of Jacksonville. Dr. Bell served on the Medical Executive Committee at Specialty Hospital and is active in the Wound Management program there. For more information visit www.savealegsavealife.com; www.wounddr.com References 1. Falanga V. Wound bed preparation and the role of enzymes: a case for multiple actions of therapeutic agents. Wounds 2002; 14 (2): 47-57. 2. Armstrong DG, Athanasiou KA. The edge effect: how and why wounds grow in size and depth”. Clin Pod Med Surg. 1998; 15 (1): 105-8. 3. Birke JA. The contact cast: an updated case study report. Wounds 2000; 12 (2):26-31. 4. Bell D. Evidence –based rationale for offloading treatment modalities. Surgical Technology International XVII. May 2008; 113-7. 5. Nabuurs-Franssen MH, Sleegers R, Huijberts MS, et al. Total contact casting of the diabetic foot in daily practice: a prospective follow-up study. Diabetes Care 2005; 28 (2): 243-7. 6. Armstrong DG, Nguyen HC, Lavery LA, et al. Off-loading the diabetic foot wound: a randomized clinical trial. Diabetes Care 2001; 24 (6): 1019-22. 7. Armstrong DG, Short B, Espensen EH, et al. Technique for fabrication of an “instant total contact cast” for treatment of neuropathic diabetic foot ulcers. J Am Pod Med Assoc 2002; 92 (7): 405-8. 8. Fleischli JG, Lavery LA, Vela SA, et al. Comparison of strategies for reducing pressure at the site of neuropathic ulcers. JAPMA 87 (10): 466-72, 1997. 9. Needleman RL. Successes and pitfalls in the healing of neuropathic forefoot ulcerations with IPOS postoperative shoe. Foot Ankle Int. 1997;18(7): 412-7

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NoN-iNvasive vascular TesTiNg aNd The WouNd care cliNic Caroline Fife, MD, FAAFP, CWS

s

ome months ago a 30-year-old white male came to see me with a non-healing injury to the great toe. He had been followed for a year at another wound center in my city, using a variety of topical products. He had a 20-year history of smoking and was employed full time as a machinist, had a new baby and otherwise appeared well. We have a policy in our wound center that all patients with chronic non-healing lower extremity wounds are screened for vascular disease. However, the staff wondered if this healthy-appearing young man really needed to undergo vascular testing. It was an unusually busy day, and testing takes time. Fortunately, we followed our protocol that day. The transcutaneous oximetry (TCOM) values on the dorsum of his foot were only 8 and 10 mmHg (5070mmHg would have been normal) with a poor response to sea level oxygen. I thought to myself, â&#x20AC;&#x153;Surely these results are in error.â&#x20AC;? I went back into the room to get a little more history. I already knew 84

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that his father had died of an MI at the age of 42, but this time I asked more pointed questions about how far he could walk. On careful questioning, he admitted to cramping in his calves when he walked across the machine shop. I decided to get a skin perfusion pressure test, which also allowed me to evaluate his lower extremity waveforms (more on that below). His skin perfusion pressure was 35 mmHg, borderline for wound healing prediction and an indication of arterial disease. However, worse than that, his pulse volume recording was a flat line. Sure enough, an angiogram revealed that only one of the three vessels below the knee was open. A few days later he underwent peripheral by-pass surgery. This 30year-old man had arterial vascular disease severe enough to prevent him from healing a toe injury. I will use this case to illustrate the pros and cons of two methods of non-invasive vascular testing, but also WHY non-invasive vascular testing is so important.

Why screeN? There are 5 reasons to perform noninvasive vascular testing, although the reasons overlap. They include: 1. Prediction of healing. 2. Screening for arterial disease. 3. Amputation level prediction. 4. Determining response to revascularization. 5. Predicting benefit of Hyperbaric oxygen therapy (HBOT).

ampuTaTioN: a FaTal disease The wound center, which saw this patient for a year and failed to diagnose his vascular disease committed what may be the cardinal sin in the wound care world, namely, failure to recognize arterial disease. Why is this a big mistake? After a major amputation (below the knee or higher), the 5-year survival rate for non-diabetics is 50%. For a diabetic, the 5-year survival rate is only 30%, and only 14% of diabetics with renal failure are alive 5 years after a major amputation. Thus, the 5-year survival of patients after www.todayswoundclinic.com


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podiatry in the clinic a major amputation is worse than that of most cancers. Major amputation can be considered a “fatal disease.” The patients who are likely to require an amputation are those with arterial insufficiency, and who are they? They are patients with diabetes, who smoke, and who develop nonhealing wounds. In other words, they are the patients we see every day. Guidelines recently published by the Wound Healing Society (WHS) state that all patients with lower extremity ulcers should be assessed for arterial disease. (www3.inters c i e n c e. w i l ey. c o m / c g i - b i n / f u l l text/118605281/PDFSTART). However, the ideal way to perform non-invasive vascular screening has not been defined by clinical research. A variety of clinical options exist. One can look at the “macro” circulation (the large blood vessels) or the “micro” circulation (the small blood vessels or tissue perfusion/oxygenation). For many years, the most common method of screening was to assess the macro circulation by assessing the Ankle Brachial Index (ABI). The ABI is the ratio of the ankle systolic blood pressure to the brachial systolic blood pressure. It is technically easy to perform, takes only about 15 minutes and requires only a blood pressure cuff and a hand held Doppler. ABI values of 0.7 or less are considered abnormally low, with values of 0.3 or less representing severe obstruction. (And by the way, ABI is not separately reimbursed; results must be accompanied by printed waveform analysis in order to meet Medicare reimbursement requirements.) The problem is that the ABI can be falsely elevated in diabetics due to the incompressibility of their calcified blood vessels, so ABI values correlate poorly with healing prediction in diabetics. We need some better way to assess the vascular supply or healing prediction.

TraNscuTaNeous oximeTry (Tcom) Transcutaneous oximetry measures the oxygen partial pressure in the skin (TcPO2). The technology is old (1960’s). The device consists of a heatwww.todayswoundclinic.com

ing element and a sensor attached to the skin via a gas permeable membrane in contact with an electrolyte solution. The electrode is heated, usually to 44 or 45 Centigrade, dilating the blood vessels and allowing oxygen to diffuse to the electrode. When a constant polarizing voltage is applied to the gold cathode, oxygen molecules at the cathode are reduced, the silver in the anode becomes oxidized, and a current is generated in proportion to the number of oxygen molecules in solution. This means that the machine is measuring the actual number of oxygen molecules (PO2) in the periwound area, NOT OXYGEN SATURATION! In fact, before pulse oximetry was available, TCOMs were used as a way to noninvasively monitor arterial PO2 in babies. TcPO2 is not a way to determine arterial PO2 in adults because of the thickness of adult skin, among other reasons. However, it can provide an estimate of arterial perfusion to the area. The results are reported in “mmHg” just like an arterial blood gas. It is important to remember that the machine has to be calibrated, the seal has to be air tight, and there is a steep “learning curve” for the technologists. It is an “artsy” test. Examples of devices are those manufactured by Radiometer (Denmark) and Perimed (Stockholm, Sweden). Fifteen studies (1137 patients) have demonstrated that TcPO2 provides better overall predictive capability than Doppler studies, ABI, segmental pressures, or laser fluximetry. However, many factors can cause TcPO2 to be low besides arterial disease. Anything which creates a barrier to diffusion of oxygen will lower TcPO2, so callous, edema, skin diseases such as scleroderma, scar tissue, or placing the electrode over a bony prominence may decrease the readings. Factors, which decrease blood flow, may also decrease TcPO2 such as hypotension, dehydration or vasoconstriction due to cold. Arterial hypoxia will decrease the reliability of the findings, and infection may cause them to be increased or decreased as a

result of local oxygen consumption or vasodilatation. To determine whether a low TcPO2 value is due to a diffusion barrier, the patient is allowed to breathe 100% oxygen via a tight fitting facemask. If the TcPO2 values increase to >100mmHg with sea level oxygen breathing, then the patient is not likely to have arterial disease. Thus, it is important to remember the following things: 1) TcPO2 values are best thought of as “mapping” the extremity (the more values the better). It is important to have more than two sites to use for decision-making, and the more electrodes the better. This can get expensive because the equipment is not cheap. 2) Some sort of “challenge” is important as a method of determining whether a low value is due to arterial disease or a diffusion barrier. If you are not using a challenge, you have not done a complete test. Oxygen is the most commonly used challenge. Leg elevation is also used as a test for arterial disease (if values decrease with elevation, then arterial disease is likely). 3) Values can be diminished for reasons other than arterial disease but this does not mean the TcPO2 values are “false.” A patient with a venous ulcer who has a value of 10 mmHg is not likely to heal spontaneously, but if values increase to 200 mmHg with oxygen, the treatment is edema reduction with compression, not arterial revascularlization. An evidence-based guide to TcPO2 interpretation has been recently published.1 Transcutaneous oximetry has many hundreds of references to support its use, including randomized controlled trials. Interestingly, it is used most often in facilities, which offer hyperbaric oxygen therapy because it is often used as a way of predicting which patients will benefit from HBOT. Diabetic patients whose values during HBOT are >200 mmHg have a significant likelihood of benefitting from hyperbaric oxygen therapy. Patients Wound Clinic Wisdom

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podiatry in the clinic whose “in-chamber” values are <50mmHg are not likely to benefit. 2 “Non-hyperbaric” wound centers have been slower to adopt TcPO2. However, it has long been used for prediction of healing, including prediction of amputation level. It can also predict response to revascularization. TCOM values that increase at least 30mmHg after either endovascular or surgical revascularization are associated with a successful revascularization procedure and with a high likelihood of healing an open wound. TcPO2 has some serious limitations. It cannot be used on most digits because the electrodes are 9 mm wide and thus will not “seal” around most toes. Reliability is affected by callous, so it may not be useful on the plantar foot. It cannot be used in the wound bed itself since the seal around the electrode must be air tight (otherwise the electrode will read the oxygen molecules in the air). It is an estimation of the OXYGYEN SUPPLY to the periwound. Patients who are on supplemental oxygen probably cannot have meaningful TcPO2 studies.

skiN perFusioN pressure (spp) Another non-invasive vascular screening option is the measurement of the capillary opening pressure after occlusion. This involves using a cuff to occlude blood flow, and then slowly deflating the cuff allowing the gradual return of blood flow. The maximal velocity of the returning blood flow is the skin perfusion pressure, as measured by a laser device, which senses the first blood cells moving through the capillaries. This measurement is also in “mmHg” but in this case, it is a unit of pressure similar to blood pressure. An example of this device is the SensiLase System (Vasamed, Eden Prairie, MN). SPP technology has a number of advantages in that it is: • Not affected by vessel calcification. • Not (much) affected by edema. • Not affected by location (can 86

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use this on the plantar foot and the digits). • Not affected by callus or thickened skin. • No calibration is required. Lo and colleagues compared SPP and TCOM in terms of ability to predict healing outcome in 100 patients with lower extremity wounds. A threshold of <30 mmHg was selected as the cutoff below which the test was considered significantly abnormal and indicative of a wound unlikely to heal. SPP alone successfully predicted outcome in 87% of the patients compared to TcPO2 at a rate of 64% (P< 0.0002). Skin perfusion pressure was more sensitive in its ability to predict wound healing relative to TcPO2 (99% vs. 66%).3 SPP is also highly reliable in the prediction of healing after amputation, and it can be used to diagnose limb ischemia4 and thus select patients who need further vascular testing. In addition to the uses above, SPP testing may be useful for planning foot and ankle surgery and ensuring that the patient can tolerate compression therapy for venous ulcers. SPP Interpretation Guideline (in mmHg) • 30 or less = Chronic limb ischemia (CLI), Wound healing unlikely. • 30 to 40 = GRAY ZONE in Wound healing /Likely to Moderate Ischemia. • 40+ = Wound healing probable / Mild to Moderate Ischemia. • 40-50 = Mild Ischemia. • 50 or more = Normal Skin Perfusion.

do Tcpo2 aNd spp measure The same ThiNg? Many people find it confusing that both of these technologies report their results in the same units of measure. However, transcutaneous oximetry measures oxygen MOLECULES (rather like a blood gas) and SPP measures PRESSURE, rather like blood pressure. Both are reported in “mmHg” but they do NOT measure the same thing. This is why the patient I used in

my introduction could have different values for his TCOM and his SPP. Different things were being measured. My patient’s oxygen partial pressure to the skin was only 8-10 mmHg. However, he had probably developed small collateral vessels, which had kept his perfusion pressure at 35 mmHg.There was one more piece of information, which the SPP device was able to provide which helped me understand what was really happening to the large vessels, and that was the pulse volume recording (PVR) of the waveforms. A plethysmograph is an instrument for measuring changes in volume within an organ (usually resulting from fluctuations in the amount of blood it contains). Each time the blood pulses through the leg (or the toe), the volume of the leg changes slightly. The cuff can detect these tiny volume changes and provide information on the pulsatility of this waveform. We are all familiar with the “triphasic” or three “hills” seen in a healthy pulse waveform on an arterial catheter. A less healthy waveform has two phases, and a pulse with only one phase suggests even poorer flow. There are also observable changes within the waveform itself such as steepness of upstroke, shape of the peak, steepness of down stroke and presence/absence of the dichrotic notch. If no waveform can be detected, it is because so little flow enters the organ that the volume inside the cuff has not changed significantly. That was the case with my patient whose flow to the foot was so poor there was no pulsatile waveform at all. SPP has some minor disadvantages. Blood flow occlusion by the cuff may be painful, and the area measured must be an area over which a cuff can be placed, so the face or the trunk cannot be assessed. Such areas are more amenable to TcPO2 assessment. For SPP assessment, patients must be placed supine and must be able to extend their legs, so patients with severe contractures or patients who are not able to lie supine may not be able to be tested with SPP. It is often reported that SPP can be performed more quickly than transcuwww.todayswoundclinic.com


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podiatry in the clinic taneous oximetry. However, if multiple sites are evaluated up and down the leg, I have found that the time to perform SPP and TCOM can be comparable.

complimeNTary TechNologies I have more than 20 years experience with TCPO2 and more than 10 years of experience with SPP. I find the two technologies highly complementary. I use both devices every day, often selecting one over the other for a given patient, and occasionally using one to check the results of the other as I did in the example cited above. Frankly, SPP is the easier technology to learn and implement, and likely less costly to introduce to the clinic. It will not be useful in determining which patients will benefit from HBOT. For a clinic just beginning to perform non-invasive testing, the most logical approach may be to initially screen with SPP, reserving TcPO2 for inchamber testing. However, I find I need both technologies.

coverage policy: Which paTieNTs, hoW oFTeN aNd By Whom? Although they measure different things, both SPP and TCOM are billed using CPT codes 92922 and 93923. I am not a reimbursement expert and am not qualified to provide advice regarding billing and coding. Therefore, I can only point out some potential problems, which the reader needs to research further with a reimbursement expert For example, there are regional variations regarding which Medicare beneficiaries can undergo vascular screening and unfortunately they do not necessarily correlate with evidence-based guidelines for screening. You need to review your local carrier coverage policy. Most evidence based guidelines agree that all patients with non-healing leg ulcers should be screened for arterial disease. However, many carriers will not cover vascular screening for patients with chronic venous stasis ulcers, even though a high percentage of these patients also have arterial disease and www.todayswoundclinic.com

arterial screening is required before venous compression can be initiated. Pre-operative screening prior to elective surgery may also be a medically justifiable reason to perform non-invasive arterial studies, but is often not covered by third-party payers and Medicare. There are also Medicare limits on the frequency of non-invasive screening. So, follow-up testing to assess the success of vascular interventions or to predict the success of HBOT may fall outside the payment guidelines depending on how soon it is performed after the initial study. Medicare reimbursement for non-invasive vascular testing is usually restricted to physicians or to credentialed vascular technicians. However, some regions may allow certified hyperbaric technicians (CHTs) to perform transcutaneous oximetry testing since this is part of their CHT training. At this time, CHT certification does not include SPP training. Thus, it could be argued that CHTs may not be able to perform SPP evaluations even though the same procedure code is used to bill both tests.

The BoTTom liNe Appropriate non-invasive vascular screening can reduce unnecessary amputations and help clinicians make better use of advanced technology, thus saving money and lives. The problem is that even if clinicians are committed to screening, payors may not cover it for the patients who most need it, and the technical component may not be billable if performed by the staff who are trained to do it if their credentials do not meet payor requirements. The equipment is relatively expensive and purchase may only be justified if clinicians can bill for performing the test. Clinicians may be left with choosing between what is right and what is covered. Clinicians should work with their regional carriers for better coverage policies regarding non-invasive testing.

a raTioNal approach To screeNiNg 1. Vascular screening is clinically indicated for all patients with

non-healing lower extremity wounds. (Whether screening is BILLABLE is a separate issue). 2. Patients with low TCPO2 values breathing air should be challenged with 100% oxygen. Patients whose values increase dramatically upon respiring sea level oxygen are unlikely to have large vessel disease. Patients with a low SPP but a normal PVR likely have microvascular disease. 3. Patients whose TCPO2 values fail to increase with sea level oxygen, or who have a low SPP in the presence of a dampened PVR can be referred for anatomical studies to determine whether correctable disease is present. â&#x2013;

Dr. Caroline Fife, is currently co-editor of Todayâ&#x20AC;&#x2122;s Wound Clinic, is the director of Clinical Research at the Memorial Hermann Center for Wound Healing, Houston, Tex., and Chief Medical Officer of Intellicure, Inc. She can be reached at cfife@intellicure.com References 1. Fife CE, Smart DR, Sheffield PJ, Hopf HW, Hawkins G, Clarke D. Transcutaneous Oximetry in Clinical Practice: Consensus Statements from an Expert Panel Based on Evidence. Undersea Hyperb Med. 36(1):43-53, 2009 2. Fife CE, Buyukcakir C, Otto GH, Sheffield PJ, Warriner RA, Love TL, Mader J. The Predictive Value of Transcutaneous Oxygen Tension Measurement in Diabetic Lower Extremity Ulcers Treated with Hyperbaric Oxygen Therapy; a Retrospective Analysis of 1144 Patients. Wound Rep Regen. 10:198-207, 2002 3. Lo T, Sample R, Moore P, Gold P: Prediction of Wound Healing Outcome using skin perfusion pressure and transcutaneous oximetry: A single-center experience in 100 patients; Wounds 2009; 21(11);310-316. 4. Adera HM et al Prediction of amputation wound healing with skin perfusion pressure J Vasc Surg 1995; 21: 823-829. Wound Clinic Wisdom

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An Overview Of COmpressiOn TherApy By Meghan Hegarty, MS

C

ompression therapy has been used to treat a number of conditions ranging from tired, aching legs to varicose veins, chronic venous disease, and deep venous thrombosis (DVT). It has recently gained media attention due to the increased incidence of economy-class syndrome (blood clots resulting from long distance air travel become dislodged and travel to the heart and lungs, causing sudden death).1 Furthermore, as the population ages, chronic venous disease is becoming more prevalent.2 Compression therapy is also finding uses in sports medicine to help athletes recover.3 With respect to wound and ulcer care, the first step in the treatment process involves management of the underlying pathology. Compression therapy plays a key role in this, with healing rates of 40-70% (after 3 months), and 50-80% (after 6 months), being reported.4,5 Bandages, stockings, and intermittent pneumatic compression (IPC) devices can be used to deliver compression therapy. Of these, bandages and stockings are more widely used.

COmpressiOn BAnDAGes There are many different types of compression bandages available on the market. They are mainly divided along the lines of extensibility or stiffness. Short-stretch, or 88

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inelastic and semi-rigid bandages, have a high stiffness factor. They supply large amounts of pressure when the wearer is active by rigidly opposing the increase in calf muscle volume. However, they deliver relatively little pressure when the wearer is at rest. These bandages are often left in place for a number of days, but have a tendency to lose significant amounts of pressure within the first few hours of wear.6,7 Long-stretch bandages are more elastic in nature, utilizing this recoil force to provide compression during both activity and rest. Although they are not able to achieve the same levels of pressure as short-stretch bandages, they are able to maintain a more constant pressure profile for a longer amount of time.6,7 Short- and long-stretch bandages can be used together in a multi-layer system. Bandage systems have an advantage in terms of compression therapy because they can fit an unlimited range of patients. In general, short-stretch bandages are used to provide focal compression, while long-stretch bandages are used to hold this wrapping in place. This is particularly useful for preventing veins from refilling after radiofrequency (RF) and Laser ablation or sclerotherapy procedures.8 Both short- and long-stretch bandages have been shown to achieve similar healing rates, and there is no strong evidence to suggest that one is better than the

other.6 However, the effectiveness of bandages is heavily dependent upon how they are wrapped.5-7 Unfortunately, without some means of feedback, most people cannot accurately gauge the amount of pressure being applied.4,6 If bandages are wrapped too loosely, it may take longer to see a reduction in swelling, and the wound will not close as quickly.5 However, if bandages are too tight, blood flow may be reduced to dangerously low levels and the tissue will become necrotic.5 Many people find long-stretch bandages easier to use6, but safe levels of pressure can be achieved with either provided that sufficient training and feedback is available.7

COmpressiOn hOsiery Compression hosiery can most simply be described as socks or stockings that are knitted to provide the greatest amount of pressure at the ankle, and gradually less at the more proximal aspects of the limb. They are mainly classified based on the amount of pressure provided (specified at the ankle, or B-level), although stiffness and length can also vary. They are similar to long-stretch bandages insofar as they are elastic in nature, meaning that they deliver compression both during activity and rest. However, unlike bandages that require a trained professional for wrapping, compression stockings have defined compression levels, are simpler to apply and remove, and can be changed daily. www.todayswoundclinic.com


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compressiontherapy One study reported that compression stockings significantly reduced healing time and pain compared to short-stretch bandages.5 This study also reported that patients found stockings more comfortable and easier to put on/take off compared to bandages.5 Compression hosiery does, however, have a limited fitting range. The notion of graduated versus uniform compression is based on a study conducted by Siegel et al. in the 1970’s.9 This group investigated the effects of changing the level of pressure in five bladders (ankle, calf, knee, lower thigh, and mid-thigh). They found that gradient pressure increased venous blood flow velocity to a greater extent than comparable levels of uniform pressure.They also concluded that an 18 to 8 mmHg gradient was ideal for a recumbent patient. In a series of two studies, Partsch and Partsch set out to determine the amount of pressure needed to collapse the superficial veins in ambulatory patients.10,11 Narrowing or collapsing of the superficial veins is needed to increase venous blood flow velocity and relieve edema and swelling (this process is discussed in more detail in the Mechanism of Action section). The first study looked at the small sapehnous vein and the posterior tibial vein at the knee level.10 They found that initial narrowing occurred at a median pressure of 30-40mmHg when the person was sitting or standing. Full occlusion was achieved at a median pressure of 20-25mmHg in the supine position, 50-60mmHg in the sitting position, and 70mmHg in the standing position. The authors also noted that higher occlusion pressures were needed for larger veins, but the difference was not statistically significant. The second study looked at the saphenous vein at the mid-thigh level. They reported occlusion pressure of 20, 45, and 71mmHg in the supine, sitting, and standing positions.11 Results, however, were highly variable. Aside from pressure, the stiffness of the stocking must also be considered. Stiffer stockings apply higher levels of pressure when the wearer is active. Van Geest et al. investigated the effects of stocking stiffness by looking at three www.todayswoundclinic.com

types of products (ie, Type 1: low stiffness, 30 mmHg; Type 2: high stiffness, 30 mmHg; and Type 3: low stiffness, 34.5mmHg).12 This study showed that stiffer and/or higher pressure stockings achieved similar effects, resulting in statistically faster healing times compared to less stiff, lower pressure stockings. Unfortunately, stiffer and/or higher pressure stockings are generally harder to put on. This is particularly problematic for elderly or arthritic patients, so lower pressure stockings can be layered in order to attain the desired level of compression. For example, a first layer compression stocking can be applied with additional compression socks or stockings placed over it. If designed properly, the two layers will produce the higher compression levels required for wound and ulcer care. Additionally, if the under-stocking has sufficient compression, the wearer can leave this layer on at night (ie, when they are recumbent), but enjoy the benefits of higher compression when they are ambulatory.

inTermiTTenT pneUmATiC COmpressiOn (ipC) sysTems IPC’s consist of a pump and a bladder(s) that is periodically inflated/deflated according to a pre-defined regimen. Single bladders can be used to deliver uniform pressure, or a system of bladders can be combined to achieve a graduated profile. IPC’s have shown mixed results for improving wound and ulcer healing. Two studies found no significant difference between the use of IPC’s versus compression bandages or stockings.13,14 Other studies have investigated the effects of using IPC’s to supplement conventional treatment with bandages or stockings. Two studies found a significant improvement in healing time, while another study reported no difference.13,15 However, the two studies that reported a significant difference used a sequential compression regimen, whereas the other study used a single bladder to deliver uniform levels of pressure. This finding seems to further advocate the use of a graduated versus uniform compression regimen.9

vAsCULAr meChAniCs 101 While many people seem to have heard of compression therapy, in particular compression hosiery and bandages, the details of its mechanism of action remain unclear. In order to understand why compression is needed, I will briefly review the anatomy and physiology of the peripheral vascular system. The peripheral vascular system can be thought of as containing two sub-systems: the superficial and the deep. Blood normally flows from the superficial veins, to the deep veins, and back to the heart. One-way valves connecting the two help to prevent backflow. However, when these valves start to deteriorate, they become incompetent and blood begins to pool in the superficial system. This increased fluid accumulation causes the veins to become enlarged (varicosed), and pressure increases locally. Fluid can also be forced into the surrounding tissue, resulting in swelling and edema. If this is left untreated and the leg continues to swell, the skin will eventually break down, resulting in the formation of a venous leg ulcer. Oxygen delivery is also disrupted, causing the tissue to become necrotic.

meChAnism Of ACTiOn The mechanism(s) of action of compression therapy is not fully understood. However, it has been shown that compression increases venous blood flow velocity by causing a narrowing of the superficial veins.16 This increased velocity moves more blood back through the deep system and to the heart, and helps prevent dangerous blood clots from forming. Additionally, if compression is applied in a graduated manner (ie, with the most pressure being applied distally), a pressure gradient favoring blood flow back to the heart is created. By preventing pooling, the pressure on the surrounding tissue is relieved, and the filtration-diffusion equilibrium is restored.6,7 Also, simply by applying compression, further swelling is restricted. If ulcers have formed, this reduction in volume allows the wound to close and begin to heal. In general, lower levels of pressure are applied for less critical conditions (ie, Wound Clinic Wisdom

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compressiontherapy Table 1. Stocking Classifications Specified by the Amount of Pressure Supplied at the B-Level (mmHg Testing Standard

UK BSI

Proposed Germany European RAL CEN

US (based on European Standards)

US HCPCS

--

--

10-14

8-15

I. Minor varicose veins, functional venous insufficiency, mild edem

14-17

18-21

15-21

15-20

II. Slight chronic venous insufficiency, mild/moderate edema, post-surgery

18-24

23-32

23-32

20-30

III. Advanced chronic venous insufficiency, leg ulcers, severe edema

25-35

34-46

34-46

30-40

30-40

--

49-56

49-56

40-50

40-50

A. Light Compression

18-30

IV. Very severe chronic venous insufficiency, very severe edema

treatment for tired, aching legs and athletics), or when the wearer is expected to remain immobile for long periods of time (ie, on a long flight or during prolonged bed rest to prevent DVT).6 Higher levels or pressure are used to treat more acute conditions (ie, edema or wound and ulcer care).5,6

ChALLenGes Because the mechanism(s) of action of compression therapy is not well understood, there are disagreements concerning the ideal level of pressure needed to achieve significant improvements. Different classifications and standards (ie, test procedures) for products among countries are partially to blame for this confusion (see Table 1). This makes it difficult to sort through literature reporting on the effects of compression therapy. In Europe, an effort is currently underway to develop a unified classification system (CEN) for compression garments. However, the U.S. currently does not use a defined standard testing system.This has forced many manufacturers to adopt one of the European specifications. (ie, the British/BSI or the German/RAL). With respect to HCPCS descriptions, compression hosiery is defined as providing compression of 18-30mmHg, 30-40mmHg, and 40-50mmHg with no testing specification referenced. Unfortunately, these do 90

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not align accurately with the European standards, adding to the confusion. Additionally, the 18-30mmHg HCPCS range is very broad, and covers stockings that could be used for treating everything from minor varicose veins to chronic venous insufficiency. The manner in which compression products are measured also differs between countries. Additionally, recent studies have revealed discrepancies concerning the quoted pressure levels and those measured in practice17,18 This means that the “same” stocking developed by different manufacturers can deliver different amounts of pressure depending upon what device was used to write the specification. Traditionally, the pressure profiles of medical compression products are extrapolated from tension measurements using LaPlace’s Law: P = T/r (where P is the interface pressure, T is the amount of tension in the fabric, and r is the radius of the limb). The HATRA (Segar Design)19 and the HOSY (Forschungsinstitut Hohenstein)20 are the two most common devices for characterizing compression stockings. However, these devices fail to capture changes to the pressure profile resulting from complex limb geometries, differences in the shape of the limb, and changes to the mechanical properties of the stocking over time.21

The pressure profiles can be directly measured directly using the SIGG-test (SIGaT-Sigvaris Interface-pressure Gauge advanced Tester), HAID-test (modified by M he et al.), and the Borgnis Medical Stocking Tester (MST). The SIGG- and modified HAID-tests use an air-filled bladder worn under the garment, and determine the pressure profile based upon the back-pressure.21,22 The MST device features a thin tube that is placed between the limb and compression garment.21 Air is slowly pumped in to the system until the electrical contacts in the tube separate. While simple, these tests tend to give high readings because the bladders/tubes balloon from the leg, causing pressure spikes.22 In addition to these pneumatic solutions, the Van Der Molen sensor and various piezoelectric sensors have been applied for directly measuring interface pressure.17,22 However, there exists no standard system for measuring pressure beneath a compression stocking while it is being worn. Again, the European Union is trying to agree on a common standard for testing compression garments. Although a movement was made to adopt the HATRA testing device, discussions are still underway in light of relatively recent studies indicating that indirect techniques do not correlate well with direct measurements on the limb. Other issues which must be resolved before a standard is written include: (1) where the measurement points should be located, (2) how stiffness should be quantified, and (3) what procedures for wash-testing and durability should be adopted. Since the U.S. has not adopted a standard testing protocol, most of the stockings sold here are tested using either the BSI or RAL standards.

COnCLUsiOns Compression therapy, which can be delivered in the form of bandages, stockings, or IPC’s, can be used to treat a wide variety of conditions. Each product has its associated advantages and disadvantages. For example, compression bandages and stockings can be worn when a person is up and moving around, but the user must www.todayswoundclinic.com


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compressiontherapy be seated in order to use an IPC device. However, the compression profile delivered by an IPC device can be adjusted on-the-fly, but bandages require a re-wrap and stockings require a new prescription. In terms of wound and ulcer management, compression therapy has been shown to significantly reduce healing times. Factors such as the amount of pressure applied and the stiffness of the material can have an influence on clinical outcomes. Compression therapy could be improved through standardization. This includes developing common definitions for products between countries, as well as devising a method for measuring the pressure being applied by the garment or device while it is being worn. ■ Meghan Hegarty (MS) is a graduate student in biomedical engineering at North Carolina State University. She is a research assistant with the Center for Robotics and Intelligent Machines, and is working to assess the health benefits of compression stockings.

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References 1. Dalen JE. Economy class syndrome: too much flying or too much sitting? Arch Intern Med. 2003 Dec 822;163(22):2674-6. 2. Oehler E, Shnitzler D.Varicose veins and venous insufficiency: Nonsurgical outpatient procedure treats varicose veins. Fact Sheet, Society of Interventional Radiology, Available from: www.sirweb.org/news/newsPDF/facts/Varicose_Veins_fact_sh eet.pdf. Accessed on: 06/25/2009. 3. Ali A, Caine MP, Snow BG. Graduated compression stockings: physiological and perceptual responses during and after exercise. J Sports Sci. 2007 Feb 15;25(4):413-9. 4. Jünger M, Häfner HM. Interface pressure under a ready made compression stocking developed for the treatment of venous ulcers over a period of six weeks. Vasa. 2003 May;32(2):87-90. 5. Polignano R, Guarnera G, Bonadeo P. Evaluation of SurePress Comfort: a new compression system for the management of venous leg ulcers. J Wound Care. 2004 Oct;13(9):387-91. 6. Hafner J, Lüthi W, Hänssle H, Kammerlander G, Burg G. Instruction of compression therapy by means of interface measurement. Dermatol Surg. 2000 pressure May;26(5):481-6; discussion 487. 7. Ramelet AA. Compression therapy. Dermatol Surg. 2002 Jan;28(1):6-10. 8. Weiss RA, Weiss MA. Controlled radiofrequency endovenous occlusion using a unique radiofrequency catheter under duplex guidance to eliminate saphenous varicose vein reflux: a 2-year follow-up. Dermatol Surg. 2002 Jan;28(1):38-42. 9. Sigel B, Edelstein AL, Savitch L, Hasty JH, Felix WR Jr.Type of compression for reducing venous stasis. A study of lower extremities during inactive recumbency. Arch Surg. 1975 Feb;110(2):171-5. 10.Partsch B, Partsch H. Calf compression pressure required to achieve venous closure from supine to standing positions. J Vasc Surg. 2005 Oct;42(4):734-8.

11. Partsch B, Partsch H. Which pressure do we need to compress the great saphenous vein on the thigh? Dermatologic Surgery. 2008 Dec;34(12):1726-8. 12. van Geest AJ, Veraart JC, Nelemans P, Neumann HA. The effect of medical elastic compression stockings with different slope values on edema. Measurements underneath three different types of stockings. Dermatol Surg. 2000 Mar;26(3):244-7. 13. Mani R, Vowden K, Nelson EA. Intermittent pneumatic compression for treating venous leg ulcers. Cochrane Database Syst Rev. 2001;(4):CD001899. 14. Roland J. Intermittent pump versus compression bandages in the treatment of venous leg ulcers. Aust N Z J Surg. 2000 Feb;70(2):110-3. 15. Smith PC, Sarin S, Hasty J, Scurr JH. Sequential gradient pneumatic compression enhances venous ulcer healing: a randomized trial. Surgery. 1990 Nov;108(5):871-5. 16. Agu O, Hamilton G, Baker D. Graduated compression stockings in the prevention of venous thromboembolism. Br J Surg. 1999 Aug;86(8):992-1004. 17. Liu R, Kwok YL, Li Y, Lao TT, Zhang X, Dai XQ. Objective evaluation of skin pressure distribution of graduated elastic compression stockings. Dermatol Surg. 2005 Jun;31(6):615-24. 18. Segers P, Belgrado JP, Leduc A, Leduc O, Verdonck P. Excessive pressure in multichambered cuffs used for sequential compression therapy. Phys Ther. 2002 Oct;82(10):1000-8. 19. Simmons A. Compression hosiery. Available at: 20.“Medical compression hosiery quality assurance ral-gz 387/1,” January 2008. 21. van den Berg E, Borgnis FE, Bolliger AA, Wuppermann T, Alexander K. A new method for measuring the effective compression of medical stockings.Vasa. 1982;11(2):117-23. 22. Gaied I, Drapier S, Lun B. Experimental assessment and analytical 2D predictions of the stocking pressures induced on a model leg by Medical Compressive Stockings. J Biomech. 2006;39(16):3017-25. Epub 2005 Dec 22

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Compression pitfalls: improving patient adherenCe

with Compression therapy Val Sullivan, PT, MS, CWS

i

t is a well-accepted fact that compression therapy is considered the standard of care for patients with chronic venous insufficiency (CVI). In the absence of significant lower extremity arterial disease, the use of different types of compression wraps and garments are often the single most effective component of CVI treatment. The external pressure of the compression wrap on the underlying venous system assists the calf muscle pump in the return of blood to the heart and lungs from the lower extremities, decreasing the venous hypertension that is the causative factor in many lower extremity ulcerations. Observing the effect of compression on patients with ulcers related to CVI can be an incredibly rewarding experience for the clinician because when appropriately applied, edema reduction is rapid and ulcer improvement is sure to follow. However, we are often faced with patients who are unable to maintain these wraps and dressings for the time 92

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period that they are supposed to be worn. It is a frequent occurrence to have patients return to the clinic with their compression wrap out of place or worse, having taken it off at home. Regardless of advanced dressing options and alternative treatments, CVI therapy without adequate compression usually results in further ulcer breakdown. Patients report difficulty tolerating their compression therapy for a multitude of reasons including: • A poorly fitting wrap or garment • Inability to apply garment • Pain • Discomfort related to heat and tightness of the wrap • Cost Other issues noted by practitioners are: • Drainage strike-through leading to a moist, soiled bandage • Patient lifestyle • Practitioner error in application Some issues are patient dependent, some are related to clinician ability and

some issues with adherence to treatment are financially driven. Health care providers who render compression therapy need to be aware of common problems and errors related to the use of compression so that we may help our patients not only to increase their compliance level but also achieve goals and outcomes related to peripheral edema and wound management.

appropriate fit for the patient Just as patients come in all shapes and sizes, so do their extremities. We are all familiar with the “bottle neck” deformity seen with CVI patient but often times, there are other tissue abnormalities seen that will affect the appropriate fit and feel of the compression wrap. Lymphedema and surgical changes can require more complex wrapping skill and forethought by the attending clinician. Extra foam or cotton padding may be required to apply uniform compression over surgical “shelf ” deformities as well as soft tissue folds and hypertrophic www.todayswoundclinic.com


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compressiontherapy for patient specific contours and can be sewn with zippers, allowing a patient to independently donn the stocking. Hosiery that is measured and fabricated to fit the individual patient is less likely to slip, slide and wrinkle.

pression hose application (Sigvaris, Peachtree City, GA). Appropriate moisturizing of the skin will also aid in less traumatic application. Specific donning apparatus may also require the use of either an open toe or close toe variation. This should be considered when prescribing the garment.

patient reports of pain with Compression

Surgically induced soft tissue deformity

Patient with Primary Congential Lymphedema

areas. Boney and painful prominences will require extra care to prevent additional pain and pressure in susceptible limbs. The ability to maintain uniformity of compression over tissue abnormalities will improve patient satisfaction as well as wear time. Ultimately this also affects cost to the patient and/or the clinic, helping to assure the treatment is more efficient as well as cost effective. Extremity shape and contour aren’t just important considerations with compression wraps. Compression hose that aren’t appropriately sized for the patient may result in wrinkles in the garment, causing pressure areas or diminished blood flow circumferential. There are ready sized compression garments that may be appropriate for some patients and are often less expensive, however, custom fit hose will often result in a much better fit and greater adherence with treatment. Custom fit garments can be manufactured to allow www.todayswoundclinic.com

Pressure areas caused by wrinkles in compression hose

patient ability to apply Compression hose. Many of our patients that require the use of compression garments are elderly, obese, have musculoskeletal or neurological disorders and overall, diminished mobility. Donning compression garments requires lower extremity and spinal flexibility, upper extremity strength, hand and finger dexterity and usually, reasonably good eye sight. There are several products on the market designed to assist the less mobile patient with donning and doffing their compression garments. These include: Juzo® Slippie Gator (Juzo USA Inc, Cuyahoga Falls, OH), Mediven Stocking Butler (Medi USA, Whitsett, NC), and the Jobst Stocking Donner(Jobst BSN Medical, Charlotte, NC). In addition, patients may also get a better grip on the hose to pull them on and off by using regular household rubber gloves. If a greater grip is needed, there are ribbed gloves on the market specifically designed for com®

®

When patients report pain with compression, there can be multiple causative reasons. The most crucial that should be assessed is appropriate blood flow. Compressing the arterial system on patients with even mild peripheral arterial disease can cause pain in the best case scenario and ischemia in the worst. Arterial disease should always be ruled out prior to administering compression therapy. If a patient who has been utilizing compression therapy suddenly begins complaining of pain in the affected extremity, the arterial system should be assessed to ensure that an acute event has not occurred. Patients with peripheral neuropathy may also complain of pain with compression. With these patients, a short stretch compression system offering lower resting pressures may be best utilized. Some patients simply need to be graduated slowly into higher compression wraps or even garments, particularly if they’ve never worn them before. Single layer, lighter compression products that may be applied like a sleeve may ease the transition. One example is Tubifast (Molnlycke Health Care, Norcross, GA). The need for medications to assist with pain control must also be evaluated by the prudent practitioner. In some cases, the value of the compression modality needs to be weighed against the level of pain. If the pain level is too great, and the patient is not able to tolerate the compression, compliance with the therapy is doomed. Always take into account patient goals as well as treatment objectives. ®

disComfort related to heat or Climate In hot, humid locations, most of us wear environmentally appropriate Wound Clinic Wisdom

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compressiontherapy clothing (shorts, tee shirts and flip flops). This is not the case for patients wearing compression wraps or garments. Compression wraps for CVI patients are worn from the metatarsal heads to tibial plateau. The entire lower leg is then wrapped in, often, multiple layers of dressing, making this area quite warm and often causing excess perspiration for these folks. If patients can tolerate the warmth of the wrap, as clinicians we need to make sure that the contact layer is absorptive enough to wick away any perspiration formed so that the wrap does not become saturated. There are lighter systems on the market now that tend to be more comfortable for patients in these situations, these include Profore Lite (Smith and Nephew, Largo, FL) and 3M Coban 2 Layer Lite (3M, St. Paul, MN). Patient’s wearing compression garments will report that the synthetic fabric is quite warm, particularly if worn under pants or slacks. Counsel patients on wearing lighter clothing that will allow greater breathability as well as trying to stay in cooler environmental situations if possible. Reinforce the need for the ongoing compression as the lifestyle change that it typically is.

Cost of the Compression system The cost of most compression wrap systems is fairly comparable across the product line and most are now reimbursable. Multilayer compression systems tend to be more expensive than paste bandages but all of these are appropriate during the wound healing phase. For continued treatment of the edema that is not only the causative factor in the ulcer but is the long term symptom of the disease, compression garments are required. These are much more expensive and only reimbursed by federal payers if ordered while the patient has an open ulcer. Custom fit garments are also more expensive than “off the shelf ”, standard fit sizes, but also tend to offer a better, more patient specific fit and feel. Other alternatives to the garments are wraps made from inelastic straps that are secured with Velcro® (Velcro Industries, B.V.) tabs. 94

Wound Clinic Wisdom

Examples include Farrow Wrap TrimTo-FitTM (Farrow Medical Innovations, Bryan, TX) and Juxta-LiteTM (CircAid Medical Products). Patient education and practice on application of these is critical to safe and effective treatment.

patient lifestyle Patient lifestyle can be one of the most important factors in determining whether your patient will adhere to their compression treatment regimen. Patients who are unable or choose not to keep dressings clean and dry will have great difficulty in maintaining wear time in a compression wrap for more than a day or two. Choose compression wrap products that will allow the patient to wear shoes if possible and make sure that the wound dressing under the wrap has the needed absorptive capabilities as well as antimicrobial properties needed for several days wear. This will reduce the chance of embarrassing drainage “strike through” that can soil clothing as well as helping to keep bacteria at bay that may lead to colonization, infection and odor. One dapper patient, treated by this author, insisted on wearing narrow legged pants and tassled loafers.To be able to slide easily into his shoes, he actually used duct tape over his heals as a smooth barrier between the compressive conform layer and the heel of his shoe. This did not diminish the effectiveness of the wrap; it was creative, and definitely “a guy thing”. Gone are the days of all of our compression patients being older, more sedentary and often retired. Many of our patients still lead very active lifestyles and continue to work part if not full time. Again, recognizing and affirming our patient’s goals for treatment and their needs, forces us to look at options that will allow them to maintain their present activity level and therefore improve adherence to the treatment plan with compression. Physically Active patients may also need low profile compression wraps that will allow them to apply regular shoes and clothing.There are options for multilayer lower profile wraps that include previously mentioned Profore Lite (Smith and Nephew, Largo, Fla) and

Patient with duct tape applied to ease shoe wear

Definitely a “guy” thing.

3MTM Coban 2 Layer Lite (3M, St. Paul, MN). Compression hose now also come in a variety of styles and colors, improving their aesthetic value to the patient. Hosiery material that is more comfortable and pleasing to the eye is more likely to be worn in everyday situations by patients. Compression garments that look and feel more like “regular” hosiery and socks make a patient feel less like a “CVI patient” and more like and individual that happens to suffer from CVI.

praCtitioner error in appliCation When patients complain that a compression wrap has slipped down or is uncomfortable, we need establish the reason. Is it that the patient can’t tolerate the pressure or the warmth of the wrap? Was the appropriate type of compression wrap selected and applied to the patient’s extremity? Was peripheral arterial disease ruled out? Was the wrap applied effectively by a skilled clinician? Prior to any compression therapy, as stated earlier, the peripheral arterial system www.todayswoundclinic.com


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compressiontherapy

Poorly applied Unna’s boots

Soft tissue damage as the result of a poorly applied compression wrap

needs to have been assessed objectively by vascular studies if PAD is even remotely suspected. Once, it is established that the patients arterial system is patent, the appropriate type of wrap needs to be selected based on the presence of ulcers or not, the type of compression required, the goals of therapy and the patients abilities and lifestyle. Only a skilled, competency trained clinician should be applying a compression wrap. There is too much room for error in the application of compression wraps whether they are single layer, 2 layer or multilayer. A poorly applied wrap can not only cause breakdown of the existing ulcer and formation of new ulceration but in the worst case scenario, can lead to limb ischemia and loss. The pain from an improperly fitting wrap will cause patients to remove the wrap early and result in less than adequate treatment. Clinics should strive to not simply educate staff on compression, including physiology of venous and arterial flow but the indications and contraindications of therapy. Staff should www.todayswoundclinic.com

then demonstrate competency on the use of every type of wrap used in the clinic as well as the appropriate removal and this skill should be re-evaluated or peer-tested on a regular basis. Patients who require dressing and wrap changes in between clinic visits will often rely on nurses and therapists outside of the clinic to appropriately reapply their bandages and compression. If home health care agency personnel are not appropriately trained in this skill, the progress that may have been previously gained may be lost quickly. If your clinic staff members are noticing errors in wrapping from a particular agency, a good alternative to “firing the agency” is offering a training session for their staff at your clinic. This can be done “one on one”, when shared patients come in for clinic visits. Education opportunities for their entire home care staff can also be provided by trained and certified wound care specialists in your facility.This will not only improve patient care but will spread the wealth of knowledge and can serve as a marketing tool for your clinic. In a competitive healthcare environment where reimbursement is critical, this can be a win-win situation for the clinic and the agency as well as helping to achieve wound healing for your collective patient population.

Cost and reimbursement issues The cost of different types of compression wraps varies just as reimbursement for them ranges from little to adequate depending on the service providing the treatment. More and more, we are finding patients underinsured or uninsured. Cost effective, patient-centered clinics will have at least one person on staff that makes every attempt to stay abreast of reimbursement changes and issues as they relate to not only the different products and modalities used in the clinic but also your Medicare carrier’s local coverage determinations. Maintaining open, friendly lines of communication with product vendors as well as the agencies and facilities that you serve will better alert you to changes in other healthcare

avenues that may ultimately affect the continuity of care for your patients. This enhanced knowledge will allow the physicians in the clinic to prescribe not only clinically sound but cost effective options for patients in a changing healthcare environment.

in ConClusion: The importance of compression therapy is well known by wound care practitioners.This fact needs to be explained to our patients and reinforced on a regular basis as it is more often than not, a lifestyle change and not simply a short term treatment option. Through assessment of our patients and their vascular system is paramount when appropriately prescribing compression be it via wrap, hosiery or pumps. All staff members should be trained not simply on application of a wrap or garment but on the physiology surrounding the disease process. All clinicians should understand why we are treating the patient using these methods and the expected outcomes. Demonstrating clinical competency should be a mandate in each clinic so that patient adherence and goals of treatment are optimized. Full compliance with compression therapy depends on staff knowledge and skill as well as making sure that the patient is a full partner in the treatment process. ■ Val Sullivan is a Physical Therapist and a board Certified Wound Specialist through the American Academy of Wound Management. She is the Clinical Manager of Advanced Wound Care Services and Hyperbaric Medicine at Capital Regional Medical Center in Tallahassee, FL. A clinician and educator in Wound Management for the past 16 years, Val has lectured and presented on local, regional and national levels as well as publishing articles on wound management and education. As a member of the American Physical Therapy Association (APTA) and its Section on Clinical Electrophysiology and Wound Management,Val is the Practice Committee Chairperson for the Wound Management Special Interest Group. She has been an active member of the Association for the Advancement of Wound Care, serving on the Quality of Care Task Force. She is also a member of multiple Clinical Advisory Boards and is on the Board of Directors of the Save A Leg, Save A Life Foundation. Wound Clinic Wisdom

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The DebriDemenT Dilemma reTurns Caroline E. Fife, MD, FAAFP, CWS

i

n 2007, TWC published an issue on debridement, which included a “test” for clinicians to help them assess their ability to properly code these procedures. Kathleen Schaum, Dot Weir and I worked hard on that issue and found that despite the fact we thought we knew the topic very well, the complexities of the system made it a challenging issue to write. Debridement coding is about to get even more complicated. In January 2011, coding for wound debridement will change significantly. Kathleen Schaum’s Business Briefs article explains the specific coding changes.The goal of this article is to provide clinical context for using these revised/new debridement codes. Some background information may be useful to understand what led to these changes. In May 2007, the Office of the Inspector General (OIG) released a report on Medicare Payments for Debridement Services in 2004 (OEI 02-05-00390).The OIG had seen a dramatic increase in the number of Medicare claims submitted for the surgical debridement of wounds under CPT® codes 11040–11044. In 2004, Medicare paid out $188 million for surgical debridement services. However, as much as 64% of surgical debridement services that year did not meet Medicare program requirements. They determined that this resulted in $64 million dollars of improper payments. A variety of problems were noted such as the fact that 47% of miscoded services were not actually surgical debridements. For example 20% were actually routine foot care (e.g. removal of a corn or callus) that should not have been billed as a surgical debride-

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ment. Then there were documentation problems. Specifically, 29% of surgical debridements were either not documented at all or insufficiently documented to justify the billed service. Most concerning were the observations that,“some of these services might have been part of an inappropriate pattern.” For example, one patient had 43 debridements involving muscle within a 9-month period. Presumably, the recent changes in billing codes represent The American Medical Association’s (AMA) response to the way in which surgical debridement codes have been used (and perhaps abused) in the past. There is no argument that debridement remains an important part of chronic wound care. The nonviable material within a chronic wound has been shown to inhibit the development of granulation tissue, enhance bacterial growth and decrease resistance to infection. Different procedures of varying complexity may be required to accomplish adequate debridement. In some cases, only superficial slough needs removing. In other cases, the tissue requiring removal may include necrotic bone. This means that in some situations, debridement is a surgical procedure performed by a trained individual with a scalpel and requiring analgesia, and in other cases can be accomplished with a water pick or even with the right choice of dressing.

Types of DebriDemenT: CliniCal vs. CoDing anD paymenT From a clinical standpoint, debridement techniques have not changed. However, there is a disconnect between

the way we THINK, SPEAK and DOCUMENT about debridement clinically, the way it has historically been coded in the past, and will be coded in the future. From a CLINICAL standpoint, debridement has been divided into the following categories: 1) Surgical and non-surgical “sharp” debridement describes the use of instruments such as scissors, scalpels or curettes to remove tissue. Clinically these may require anesthesia and/or the control of bleeding, and must be performed by a qualified professional. 2) Mechanical debridement may include the use of wet-to-dry gauze dressings, water jet or ultrasonic irrigation. 3) Autolytic debridement is the process by which the wound bed clears itself of devitalized tissue using phagocytic cells and proteolytic enzymes (the body’s own natural enzymes) to liquefy necrotic tissue.This is accomplished by keeping the wound moist with occlusive or semiocclusive dressings. 4) Chemical debridement is the application of topical agents that disrupt or digest extracellular proteins. An example is the enzyme collagenase, derived from the fermentation of Clostridium histolyticum. 5) Maggots represent a form of biological debridement which is relatively painless and specific to necrotic material. (I am personally big fan of maggots, particularly for inflammatory ulcers which may exhibit pathergy if sharp debridement is www.todayswoundclinic.com


debridementdilemma used, but reimbursement is an issue. See the Clinician report in this issue for more details.) I will interject a comment about the code “97602” which is, “Removal of devitalized tissue from wound(s), nonselective debridement, without anesthesia.” This code has not changed from 2010 and continues to be used for wetto-moist dressing debridement, enzymatic debridement, and debridement by abrasion, etc. in 2011. Medicare contractors do not reimburse physicians for this code but they do reimburse the Hospital-based outpatient wound care department (HOPD) for this work. However, just because an occlusive dressing is used does not mean that you SHOULD bill this code. I frequently hear of wound centers which either will not use certain dressing products (eg, hydrocolloids or even hydrogels) because they feel they MUST bill 97602 if they do so, or which ALWAYS bill 97602 if certain dressing products are used.This is a broad over-reading of this code. If an occlusive dressing is not used specifically for the purpose of debridement, you should bill an evaluation/management code for this visit. From a CODING and PAYMENT standpoint, in the past much attention has been given to the terms “selective” and “non-selective” and “sharp” and/or “exicisional.” In general, debridement techniques, which were under the direct control of the clinician, were viewed as “selective” (eg, holding a scalpel) whereas if a bandage or an enzymatic agent performed the debridement (instead of the clinician), it was viewed as “nonselective.” While the term “selective” still appears in the coding language for 97597 and 97598, the importance of this word has diminished as a result of the changes in the codes discussed below. It is important to note that these new codes represent a subtle change in the meaning of the word “sharp.” We used to take the word “sharp” to be synonymous with “scalpel” but the new coding descriptions make it clear that scissors and other tools might be used. The best advice is for clinicians to REFRAIN FROM THE www.todayswoundclinic.com

TERM “SHARP DEBRIDEMENT” AND CLEARLY STATE THE WAY IN WHICH THEY PERFORMED THE DEBRIDEMENT INCLUDING THE SPECIFIC TOOLS USED. For 97597/97598, you must state the METHOD used (since it can be high pressure water jet with or without suction, sharp selective debridement with scissors, scalpel, and forceps). For 97602, you must state the method used to remove the devitalized tissue. For 1104211047, the physician must state the type of INSTRUMENT that was used to debride the tissue. As Kathleen Schaum explains in Business Briefs, the CPT® Codes, 1104011041, for “Surgical Exicisional Debridement” of partial and full thickness skin have been deleted effective January 1, 2011. Providers should now use codes 97597 and 97598. These are not new codes; they are existing codes whose meaning has changed. The code “97598”, which used to be a “primary code,” is now an “add-on” code denoting each additional 20 cm2 debridement size. The first thing to emphasize is that these codes pertain to the debridement of a WOUND. If you debride necrotic debris or skin and find that no wound is present, then you cannot use these codes. A physician asked me this week, “What if I debride a callous and there is no wound underneath? In that case you have done a callous paring, there is no open wound and these debridement codes do not apply. “Routine foot care” is one of the scenarios which the OIG cited as a misuse of the debridement codes. I have struggled with the way the codes 97597 and 97598 replace 11040 and 11041.The wording of this code is “Debridement (eg, … sharp selective debridement …), open wound, (e.g. …devitalized (CF italics) epidermis and/or dermis …) …” In the past when I debrided full thickness VIABLE skin I would have used the code 11041because the code 11042 was not to be used unless the debridement extended into the SUBCUTANEOUS tissue. Now if I do not debride subcutaneous tissue, but only

Simultaneous Debridements of Different Types: Excisional Surgical and Non-Viable Skin • A diabetic patient requires a debridement of muscle from a left lateral foot ulcer measuring 7.5 x 4 cm=30cm2 • On the right plantar foot, he requires the debridment of non-viable skin from an ulcer measuring 5.2 x 3.6=18.72 cm2 •How would you code for this? • The codes 11403 and 11407, “debridement of muscle” are appropriate • Since this ulcer is more than 20 cm2 (30 cm2) you will use the add on code 11406 for each additional 20 cm2. • You can also bill 97597 because this procedure is at a different DEPTH. • So the correct way to bill this is: • 11043 • 11046 x 1 • 97597-59 • 59 modifier identifies a distinct procedural service

debride VIABLE full thickness skin, what code am I to use? The CPT “crosswalk” instructions tell me to use the codes 97597/97598, EVEN THOUGH THE SPECIFIC DESCRIPTION OF THAT CODE SAYS IT IS THE DEBRIDEMENT OF NON-VIABLE SKIN. So, from a clinical standpoint, the CPT® description of 97597/97598 does not really describe the process of debriding full thickness viable skin, but there is no longer a code specifically for this process. The codes 97597/97598 are to be used for the debridement of any tissue which does not involve subcutaneous tissue, muscle, or bone. In some ways this may make coding easier. There seemed to be a lot of confusion in Wound Clinic Wisdom

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debridementdilemma the proper use of codes 11040 and 11041. It may be easier for clinicians to remember that debridement of any material from slough and debris to full thickness skin is now encompassed by 97597 and 97598. Perhaps the most important thing to emphasize clinically is an issue which has NOT changed. The debridement code chosen must be based on the type of tissue removed, and not the tissue exposed after debridement or the grade of wound. The use of the codes 11042, 11043 and 11044 are unchanged from the standpoint of the depth of tissue they represent. They are to be used whenever subcutaneous tissue, muscle or bone are debrided. The challenge comes in correctly using the new “add-on” codes for the additional surface area.

TesT yourself I tried to understand these changes by reading the coding verbiage and it was very difficult.The only way I could work through this complex process was to take actual patient wound measurements and practice coding the procedures. I have provided some of examples in a Power Point posted on the TWC website at http://todayswoundclinic.com/intellicure-debridement-twc. More information is available at the following website http: www.Intellicure.com/CodingHelp. This new system dramatically increases the importance of accurate wound MEASUREMENTS. There are a variety of techniques for wound measurement including longest length x widest width, but it may also be done using the head to toe measurement and taking the width perpendicular to this. These two methods can provide quite different results depending on how irregular the wound perimeter is. There is no universally accepted method for wound surface area calculation and CMS offers no guidance on this matter. Surface area is normally calculated by multiplying length x width. However, this two-dimensional method assumes that the wound’s geometry resembles a rectangle. Wounds may be more likely to resem98

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ble a circle or an oval. While relatively simple calculations could be used to accommodate these other shapes, the most common practice for calculating surface area is the simple “length x width.” There are several automated measuring tools, some incorporated in cameras, which may allow precise surface area measurements to be automated inexpensively in the near future. Despite the dependence of the new codes on measurements, the AMA and the Medicare contractors have provided no particular guidance on measurement technique (other than measurements must be in centimeters). However, the debridement of a 20.1 cm2 wound would be billed at a higher rate than a 20.0 cm2 wound. Given the considerable variability of wound measurements even among the most careful clinicians, it seems likely that the new codes will encourage measurement techniques which maximize surface area calculations. The new system also creates challenges for highly irregular wounds. As long as the total surface area is less than 20 cm2, these individual measurements may not be important, but once the cumulative measurement exceeds 20cm2, the billing implications can be significant.

QuesTions wiThouT answers: There are some questions I have about implementing these new codes for which I do not have answers. One of the biggest questions has to do with undermining. I recently saw a patient who had developed a very large Methicillin resistant staph abscess on her anterior leg. There were several small wounds over the shin whose total wound surface area was less than 20 cm2. However, all these wounds undermined extensively and in fact connected together in the deep subcutaneous fat. After debridement the surface area of the ONE wound was more than 15 cm x 10 cm (150 cm2), several times larger than the sum of all the predebridement wounds. It does not appear that undermining can be used in the calculation of wound surface area. There is also no guidance as to whether we are to use pre- or post-debridement measurements, for calculating billing, but the post debridement measurement would seem the most accurate. (Take special note of Kathleen Schaum’s analysis of the various Medicare contractors’ Local Coverage Determination’s (LCD) verbiage. Some MANDATE post-debridement measurements but do not say which measurements are to be used for coding.)

how muCh will These Changes really affeCT your billing?

anoTher QuesTion is, “whaT if only parT of The wounD neeDs We reviewed data from the U.S. DebriDemenT?”

Wound Registry managed by Intellicure which contains data from 725,000 wound/visits (encounters in which wounds were measured). We found that 84% of wound visits have surface area measurements less than 20 cm2. Therefore, most debridement charges will require only the primary code. According to registry data, the “add-on” codes will be needed in only one in ten debridements. However, when wounds do measure more than 20 cm2, the average area is a surprising 79 cm2. In other words, the majority of wounds seen in hospital based outpatient wound centers are small, but when they are not small, they are very large. So, when an “add-on” code is used, you will likely bill it in multiples.

I recently saw a patient with a very large ulcer involving almost her entire calf, but only about 30% of the ulcer required debridement of an eschar, the rest was beginning to granulate. I had to debride the eschar and clean and dress the entire wound surface area. At this time, the verbiage in the debridement codes says that coding is based on the surface area of the ULCER (and the type of tissue debrided), not the area debrided. Some providers believe they are to code only the portion of the wound that is debrided. When I bill this procedure using the 2011 codes, based on the size of the ULCER, I believe that I should bill for the larger wound surface area that I managed, not just the size of the debrided portion of the wound. Hopefully the www.todayswoundclinic.com


debridementdilemma American Medical Association will provide some clear guidelines to these questions and many other questions that will no doubt arise as we attempt to implement these debridement code changes.

whaT hasn’T ChangeD: The imporTanCe of DoCumenTaTion A major concern expressed by the OIG in their 2007 report was that debridement documentation was inadequate to determine whether the services were either medically necessary or coded accurately. The provider must state exactly “what” and “why” the work is being done; properly document the type of tissue that was debrided; the depth of the debridement; the device, drug, or dressing that was used for the debridement; the size of the wound before and after the debridement; and the condition of the wound after the excision or debridement. The specific documentation necessary differs somewhat according to your Medicare contractor’s LCDs and you are advised to become familiar with your own regional LCDs. Pay special attention to Kathleen’s incredibly helpful chart noting the different requirements of the various LCDs! Note that some specifically require post debridement measurements. LCDs usually require that debridement notes document (at a minimum) the following: 1) Describe the medical condition, including current treatment diagnosis and all relevant diagnoses, of the patient. 2) Describe the wound sufficiently to document medical necessity for the service, including the size and depth of the wound. 3) Document the presence and extent of or absence of signs of infection and/or the presence and extent or absence of necrotic, devitalized, or non-viable tissue. 4) Describe the method of debridement (say what “tool you used!) 5) Include the depth (of tissue) and level of debridement or type of wound care to support the CPT code billed. www.todayswoundclinic.com

6) Describe all dressings and/or treatments. 7) Document the progress of the wound, including factors that would complicate normal healing, and the response of the wound to treatment. 8) Document the total wound surface area (of all the wounds) in square centimeters. If you are getting the idea that the note for even a relatively simple debridement will be long and detailed, you are correct. If you are a physician who still dictates his or her procedure notes, you are going to need a list to remember all these points. Failure to document even one of them might result in a determination that the service was not medically necessary.

global perioDs anD limiTs on ToTal number of DebriDemenTs The “10-Day Global Period” is the day of surgery and post operative care the patient receives after a surgical procedure, during which time the provider cannot bill another service, such as an E/M visit, without a modifier. Previously there was a 10 day global period for the top level surgical excisional debridements (11043, 11044). Under the new Medicare Physician Fee Schedule guidelines, 11043 and 11044 now have A ZERO-DAY GLOBAL PERIOD. This means only additional services performed on the day of the debridement require a modifier. Some Medicare Administrative Contractors (MACs) and Fiscal Intermediaries (FIs) have policies limiting the number of high level surgical debridements per year on a “wound” (11043 and 11044). Although the new codes do change billing so that it is no longer per “wound” but by depth and total surface area, limits on total NUMBER of high level debridements per year may still apply. However, it may take longer to reach those debridement “maximums” since the vast majority of chronic ulcers are rather small. Even if the average patient has two ulcers, both could likely be debrided without exceeding 20 cm2. Thus, it is likely that more individual

debridement “events” may occur on ulcers without those events being translated to billed “procedures” since these activities will not be billed “by the ulcer.”

final ThoughTs These new codes are a particular challenge because the meaning of some old codes has changed, some codes have been deleted, and new codes have been created which link to old codes. It will be particularly challenging to implement these codes because the surface areas of several small wounds may be added together and billed with one debridement code. Conversely, the debridement of one very large wound could require multiple debridement codes. Clinicians must be careful to document both the type of tissue removed (not what is visible afterwards) and the size of the wound(s) in which this/these procedure(s) was/were performed. The clinician must clearly document the type of debridement that was performed. It is more important than ever to document wound SIZE (surface area) in square centimeters. (Clinicians who have been using millimeters need to stop doing that.) Wound care professionals should perform whichever debridement technique is most appropriate based on the needs of the wound. The frequency of debridement must also be based on the needs of the wound and should not be determined by arbitrary protocols (eg, based on calendar days or number of clinic visits). Although the examples on the website are not meant to serve as medical advice or substitute for the advice of a professional coder, we hope they will provide some “practice scenarios” to help put the revised/new debridement codes in context. ■ Caroline Fife, MD, FAAFP, CWS is currently co-editor of Today’s Wound Clinic. She is also the director of Clinical Research at the Memorial Herman center for Wound Healing, Houston, Tex., and Chief Medical Officer of Intellicure, Inc. She can be reached at cfife@intellicure.com. *CPT is a registered trademark of the American Medical Association. Wound Clinic Wisdom

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businessbriefs

2011 Debridement Codes Have Changed –

Be Sure Your Wound Care Team Implements the Changes Kathleen D. Schaum, MS Information regarding coding, coverage, and payment is provided as a service to our readers. Every effort has been made to ensure the accuracy of the information. However, HMP Communications and the author do not represent, guarantee, or warranty that 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.

I

n the fall 2007 In Business column of Today’s Wound Clinic, this author informed wound care professionals about several important debridement issues: A. The Office of Inspector (OIG) recommendations that were agreed to by the Centers for Medicare & Medicaid Services (CMS): • Medicare contractors should strengthen program safeguards and prevent improper payments for surgical debridement services. • Medicare contractors should clarify information that needs to be documented in the medical record to meet Medicare requirements. • CMS should implement edits pertaining to debridement services (e.g., frequency edits). • Medicare contractors should conduct medical reviews pertaining to debridement services. • Medicare contractors should educate providers regarding surgical debridement services: 1) what services are considered surgical debridement, 2) how debridement services should be coded, www.todayswoundclinic.com

and 3) when modifiers may be used. B. Debridement local coverage determinations (LCDs) C. Definitions of surgical excisional debridement, selective debridement, and non-selective debridement D. Documentation guidelines for chronic wound debridement services E. Medicare payment rates for physicians and hospital-owned outpatient wound care departments Despite the educational efforts of this author and speaker, the educational efforts of Medicare contractors, and the educational efforts of professional wound care societies, some wound care professionals and some hospitals appeared confused and did not 1) thoroughly document their debridement services, 2) follow their Medicare contractor’s utilization guidelines, and/or 3) select the codes that properly represented the debridement services provided. These professionals and hospitals had a false sense of security when they received Medicare payments. Then as Medicare implemented more and more medical reviews, some of these professionals and hospitals faced Medicare repayments.

2011 DeBrIDemenT CoDIng CHangeS The American Medical Association (AMA) and CMS worked for several years to solve the debridement coding dilemma. Through their efforts, the following debridement coding changes became effective on January 1, 2011. • “Excision” was removed from the subheading of the Integumentary Section of the CPT® codebook. It now reads “debridement”. The work is still considered a surgical procedure.Therefore, physicians should use

the surgical type of service code (2) when reporting the work on their Medicare claim forms. • The three debridement codes (11010-11012) used when foreign material is removed associated with open fractures and dislocations have been revised to state that they should be used when debridement is performed at the site of an open fracture and/or an open dislocation. • The debridement of partial thickness and full thickness skin codes (11040 and 11041) were deleted. Providers are now directed to use the active wound management codes 97597 and 97598 for debridement of skin (epidermis and dermis). This is considered medical work. Therefore, physicians should use the medical type of service code (1) when reporting the work on their Medicare claim forms. º The description of 97597 and 97598 now includes the term “open wound”. Providers who are providing routine foot care should not use these codes for routine foot care, such as debridement of hyperkeratotic tissue. º Codes 97597 and 97598 are now billed in 20 sq cm increments. In prior years, only one of these codes was used per session: 97597 was used when the total surface area of all wounds debrided was less than or equal to 20 sq cm; 97598 was used if the total surface area of all wounds debrided was greater than 20 sq cm. In 2011: • The medical debridement code 97597 will be Wound Clinic Wisdom

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businessbriefs used for the first 20 sq cm or less of total wound(s) surface area • The medical debridement code 97598 became an add-on code and will be billed, in addition to 97597, for each additional 20 sq cm or part thereof, of total wound(s) surface area Providers should also note that 97597 and 97598 include wound assessment, topical application(s), and instructions – therefore, this work should be included in providers’ documentation. • The following debridement codes (11042, 11043, and 11044) were revised; they are now described by depth of tissue removed and size of surface area (first 20 sq cm or less) of the wound. Providers can no longer bill these codes per wound; they must add together the surface area of wounds that had the same depth of tissue debrided. The revised definitions also allow coding for debridement of subcutaneous tissue, muscle and/or fascia, or bone, even if epidermis and/or dermis are not present. NOTE: The previous years’ definitions of these codes required the debridement of skin plus the subcutaneous tissue, muscle, or bone. • Three new codes (11045, 11046, and 11047) were added to report each additional 20 sq cm, or part thereof, and are to be reported in conjunction with their respective base debridement codes (11042, 11043, and 11044). • The introductory guidelines of the CPT® codebook Debridement Section remind providers to select surgical debridement codes (11042 -11047) by the depth of the tissue that was removed and by the surface area of the wound. Providers are also reminded that codes 11042-11047 are for debridement of injuries, infections, wounds, and chronic ulcers. 101

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º Providers are to code single wounds based on depth of the deepest level of tissue removed º Providers are to code multiple wounds that had the same depth of tissue removed by adding the surface area of all those debrided wounds. Therefore, modifiers such as RT, LT, 50, and TA-T9 will no longer be used with the surgical debridement codes (11042-11047). • If providers debride more than one wound and remove different depths of tissue in each wound, they should itemize the codes for each debridement depth on the claim form. • The introductory surgical preparation guidelines of the CPT® codebook Skin Replacement Surgery and Skin Substitutes Section remind providers not to use 1500215005 for removal of nonviable tissue/debris in a chronic wound (e.g., venous or diabetic) when the wound is left to heal by secondary intention. These codes should only be used when physicians remove appreciable nonviable tissue from a burn, traumatic wound, or a necrotizing infection, OR incisionally release a scar contracture. • Providers should continue to use the other specific debridement codes: 11000-11001 Debridement of extensive eczematous or infected skin 11004-11008 Debridement of necrotizing soft tissue infections 11010-11012 Debridement of an open fracture and/or an open dislocation 11720-11721 Debridement of nails 15002-15005 Surgical preparation 15920-15999 Excision of pressure ulcers 16020-16030 Debridement of burn wound 97602 Debridement, non selective Wound care providers should acquire and read the 2011 CPT® Current Procedural Terminology codebook and the 2011 CPT ®

Current Procedural Terminology Changes: An Insider’s View book for a complete review of all the 2011 procedure code changes. If providers have questions about the 2011 CPT® codes, they should contact the CPT® Network at www.cptnetwork.com for answers straight from the source of the CPT® codes and guidelines. See TABLE I for a comparison of the 2010 and 2011 debridement codes. For a physician’s perspective on the revised/new debridement codes, be sure to read Dr. Caroline Fife’s excellent article. Also be sure to visit the Today’s Wound Clinic web site and test your 2011 debridement code knowledge by coding the procedures provided by Dr. Fife.This is a great opportunity to think about various coding scenarios before you actually encounter them in your wound care practice.

meDICare PaYmenT raTeS for revISeD/neW DeBrIDemenT CoDeS Physicians: The Medicare payment rate for 11042 is slightly increased in 2011 for work performed in the office and in facilities. If physicians debride subcutaneous tissue from wound(s) whose surface area exceeds 20 sq cm, they will also receive the 11045 addon payment. In 2010 two of the excisional debridement codes (11043 and 11044) were assigned a 10 day global period by Medicare. In 2011 those global periods have been removed: now all the debridement codes listed in TABLE I are assigned 0 day global periods. The removal of the global periods from 11043 and 11044 caused a reduction in their relative value units (RVUs). The reduction in the RVUs caused a decrease in the 2011 Medicare payment rate for 11043 and 11044 in the office and in facilities. Like 11042, physicians will receive the 11046 add-on payment in addition to their payment for 11043, if they debrided muscle and/or fascia from wound(s) whose surface area exceeds 20 sq cm. Similarly physicians will receive the 11047 add-on payment in www.todayswoundclinic.com


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businessbriefs Table 1. Comparison of 2010 and 2011 Debridement Codes 2010 CPT® Subsection Heading Excision-Debridement

2011 Debridement

11040

Required excisional debridement of partial thickness skin

Deleted

11041

Required excisional debridement of full thickness skin

Deleted

•Required excisional debridement of skin and subcutaneous tissue •Could be billed per wound

•Revised to debridement of subcutaneous tissue and only includes epidermis and dermis if they are also debrided •Cannot be billed per wound. Instead the total surface areas of all wounds that have subcutaneous tissue debrided are added together. The first 20 sq cm or less is reported with this revised code.

11042

New add-on code to report each additional 20 sq cm, or part thereof of subcutaneous tissue debrided

11045

Did not exist in 2010

11043

•Required excisional debridement of skin, subcutaneous •Revised for debridement of muscle and/or fascia and tissue, and muscle only includes epidermis, dermis, and subcutaneous tissue if they are also debrided •Could be billed per wound •Cannot be billed per wound. Instead the total surface areas of all wounds that have muscle and/or fascia debrided are added together. The first 20 sq cm or less is reported with this revised code.

11046

Did not exist in 2010

11044

• Required excisional debridement of skin, subcutaneous •Revised for debridement of bone and only includes epitissue, muscle, and bone dermis, dermis, subcutaneous tissue, muscle and/or fascia if they are also debrided •Could be billed per wound •Cannot be billed per wound. Instead the total surface areas of all wounds that have bone debrided are added together. The first 20 sq cm or less is reported with this revised code.

11047

Did not exist in 2010

15002-15005

Was used to describe burn and wound preparation or New introductory language states that the codes should be incisional or excisional release of scar contracture result- used to describe the removal of appreciable nonviable tissue to ing in an open wound requiring a skin graft treat a burn, traumatic wound or a necrotizing infection. They may also be used to describe the incisional release of a scar contracture. The intent is to heal the wound by primary intention and these codes are not to be used when the wound is left to heal by secondary intention.

97597

• Was defined as “Removal of devitalized tissue from • The revised definition now states: “Debridement (e.g., wound(s), selective debridement, without anesthesia (e.g., high pressure waterjet with/without suction, sharp selechigh pressure waterjet with/without suction, sharp selective debridement with scissors, scalpel and forceps), open wound, (e.g., fibrin, devitalized epidermis and/or tive debridement with scissors, scalpel and forceps). . .” dermis, exudate, debris, biofilm). . .” The revised definition no longer mentions anesthesia because anesthesia may/may not be used when this type of debridement is performed. • All wound surface areas that received this type of debride- • The use of this code to bill for all wound surfaces that ment were added together. This code was billed if the total received this type of debridement remains the same: this code is billed if the total wound(s) surface area(s) is/are wound(s) surface area(s) was/were less than or equal to less than or equal to 20 sq cm. 20 sq cm.

97598

97602

Was defined the same as 97597 above but was used instead of 97597 if the total wound(s) surface area(s) was/were greater than 20 sq cm

New add-on code to report each additional 20 sq cm, or part thereof of muscle and/or fascia debrided

New add-on code to report each additional 20 sq cm, or part

The 2011 revised definition is the same as the 2011 revised definition of 97597 above. However, this code is now an add-on code and can be billed in addition to 97597 for each additional 20 sq cm, or part thereof.

• Was defined as “Removal of devitalized tissue from • No change to this definition. wound(s), non-selective debridement, without anesthesia • Can only be billed per session (e.g., wet-to-moist dressings, enzymatic, abrasion) . . .” • Could only be billed per session.

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businessbriefs Table 2. 2011 National Average Medicare Payment Rates for Physicians and HOPDs Global Period (FOR PHYSICIANS ONLY)

PHYSICIAN Rate In Office

PHYSICIAN Rate In Facility

HOPD APC Rate

11000

0

$51.98

$29.56

$188.16

+11001

0

$21.07

$14.95

$62.70

11004

0

$585.07

$585.07

Not paid under OPPS

11005

0

$784.18

$784.18

Not paid under OPPS

11006

0

$713.84

$713.84

Not paid under OPPS

+11008

0

$275.55

$275.55

Not paid under OPPS

11010

10

$470.91

$279.29

$350.49

11011

0

$516.78

$300.01

$350.49

11012

0

$693.46

$428.78

$350.49

11040

Deleted

Deleted

Deleted

Deleted

11041

Deleted

Deleted

Deleted

Deleted

11042

0

$86.64

$47.23

$188.16

+11045

0

$30.92

$18.01

$188.16 รท 2

11043

0

$190.61

$122.32

$188.16

+11046

0

$53.68

$38.05

$188.16 รท 2

11044

0

$290.84

$212.35

$584.96

+11047

0

$88.34

$66.25

$584.96รท 2

11720

0

$30.58

$15.29

$62.70

11721

0

$41.79

$25.82

$62.70

15002

0

$332.29

$226.28

$319.74

+15003

0

$72.37

$45.53

$319.74 รท 2

15004

0

$390.73

$273.51

$319.74

+15005

0

$119.94

$90.72

$319.74 รท 2

15920

90

$595.95

$595.95

$350.49

15922

90

$767.53

$767.53

$1534.70

15931

90

$666.96

$666.96

$1646.04

15933

90

$826.31

$826.31

$1646.04

15934

90

$918.38

$918.38

$1534.70

15935

90

$1087.24

$1087.24

$1534.70

15936

90

$886.44

$886.44

$1185.47

15937

90

$1037.30

$1037.30

$1534.70

15940

90

$687.34

$687.34

$1646.04

15941

90

$891.20

$891.20

$1646.04

15944

90

$886.44

$886.44

$1534.70

15945

90

$983.96

$983.96

$1534.70

15946

90

$1635.96

$1635.96

$1534.70

15950

90

$565.03

$565.03

$1646.04

15951

90

$851.11

$851.11

$1646.04

15952

90

$831.74

$831.74

$1185.47

15953

90

$912.61

$912.61

$1185.47

15956

90

$1149.76

$1149.76

$1185.47

15958

90

$1173.21

$1173.21

$1185.47

15999

Set by Carrier

Set by Carrier

Set by Carrier

$350.49

16020

0

$81.20

$56.40

$103.14

16025

0

$145.76

$114.84

$103.14

16030

0

$175.32

$130.81

$103.14

97597

0

$72.03

$24.12

$103.14

+97598

0

$24.12

$11.55

$103.14

97602

Does Not Apply

0

0

$62.70

+ Add-on codes

103

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businessbriefs addition to their payment for 11044, if they debrided bone from wound(s) whose surface area exceeds 20 sq. cm. Physicians should also note that the Medicare payment rate for 97597 increased for work performed in the office and decreased for work performed in facilities. Physicians are not paid for 97602.

HoSPITal-BaSeD ouTPaTIenT WounD Care DeParTmenTS (HoPDS) HOPDs (except in Maryland) are paid by Medicare based on the Ambulatory Payment Classification (APC) system group to which each CPT® code is assigned. The 2011 national average APC payment rates for 11042 ($188.16) and 11043 ($188.16) are essentially the same as they were in 2010. If the physician debrides a total surface area of subcutaneous tissue that exceeds 20 sq cm, the APC payment rate is 50% of the Medicare allowable ($94.08) for each additional 20 sq cm reported with the add-on code 11045. If the physician debrides a total surface area of muscle and/or fascia that exceeds 20 sq cm, the APC payment rate is 50% of the Medicare allowable ($94.08) for each additional 20 sq cm reported with the add-on code 11046. The 2011 national average APC payment rate increased for the debridement of bone. It is $584.96 for total surface area less than 20 sq cm (11044) and 50% of the Medicare allowable ($292.48) for each additional 20 sq cm reported with the add-on code 11047. The 2011 national average APC payment rate decreased by a few cents for 97597 and 97598. However, the HOPD will now be paid more when they debride wounds that exceed 20 sq cm. The APC payment rate is $103.14 for 97597 and is 50% of the Medicare allowable ($51.57) for each additional 20 sq cm reported with the revised add-on code 97598. The 2011 national average APC payment rate also increased to $62.70 for 97602. www.todayswoundclinic.com

meDICal DeBrIDemenTS ProvIDeD To SkIlleD nurSIng faCIlITY PaTIenTS DurIng THe ParT a STaY When physicians and/or HOPDs provide medical debridements 97597, 97598, and 97602 to Medicare Part A covered patients who reside in skilled nursing facilities, they must make arrangements to bill the SNF for these services. These debridements are currently considered part of the consolidated billing that the skilled nursing facilities receive for Medicare Part A covered patients. See TABLE II for the 2011 national average Medicare allowable rates for physicians and for hospital-based outpatient wound care departments (HOPDs). NOTE: The most commonly used chronic wound debridement codes described in TABLE I are shaded, for your convenience, in TABLE II.

DeBrIDemenT loCal Coverage DeTermInaTIonS (lCDS) Per the recommendations of the OIG, every Medicare contractor has released LCDs pertaining to chronic wound debridements. All wound care providers should review their Medicare contractor’s website for changes to LCDs in light of the revised/new debridement codes. At the time this column was submitted for publication all of the eleven(11) Medicare contractors that typically process debridement claims for HOPDs and for physicians released LCDs that were updated to reflect the 2011 debridement code changes. Providers should: • Print their Medicare contractor’s LCD and attachment, • Read the LCD and attachment, and • Establish an implementation plan to follow all the guidelines pertaining to indications, contraindications, coding, documentation, and utilization. If providers read several different Medicare contractor’s LCDs and attachments, they will quickly learn

that the debridement guidelines often vary from one contractor to another. That is why providers should not rely on Medicare debridement coverage information they may receive from other providers who submit claims to different Medicare contractors. • For example, some contractors allow the use of 97597 for the debridement of fibrin, exudate and biofilm, while other contractors require that work to be billed as part of evaluation and management services. • Another example pertains to the place of service where debridement services may be performed. Some contractors will not cover specific debridement services when performed in an office setting, while other contractors will cover those debridement services in office settings. • A final example pertains to the frequency and total number of debridements that are covered by the Medicare contractors. Providers must read their Medicare contractors’ LCDs very carefully to ascertain their contractor’s utilization guidelines, as well as their specific documentation guidelines. Ever since the revised/new debridement codes were released, this author has received many calls pertaining to the three following issues: • Why does the CPT® codebook instruct providers to use the 59 modifier with the add-on code 11045? To the best of my coding knowledge, modifiers are not typically used with the add-on codes. Hopefully, the American Medical Association will clarify that issue for us via their monthly publication call the CPT® Assistant in the near future. • Is the debridement code selection to be based on the pre-debridement or post-debridement size of the wound? Several of the vignettes supplied by the American Medical Association describe measuring the size of the wound Wound Clinic Wisdom

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businessbriefs prior to debridement and then remeasuring it and recording the size post debridement. However, I cannot find an iron-clad answer to this question. Hopefully, the American Medical Association will clarify that issue for us via the CPT® Assistant. • If a wound only requires partial debridement, should providers measure and report the entire surface area of the wound or only the surface area of the debrided portion of the wound? This question never crossed my mind because providers are taking care of the entire wound and getting paid based on the deepest level of skin or tissue debrided. After numerous providers and coders called me with the same question, I went back to the 2011 CPT® reference books and re-read the description of the debridement codes and their clinical vignettes. I came to the same conclusion: the providers should measure the surface area of the entire wound. Realizing that my opinion does not count, I thought I might be able to find this size answer in the Medicare contractors’ revised debridement LCDs. Therefore, I reviewed every Medicare contractor’s LCD pertaining to the debridement codes. I learned that each contractor addressed reporting the size of wound in a slightly different way. See TABLE III (Located Only Online at www.todayswoundclinic.com/bbdebridement for a quick glance at the variety of measurement guidelines found in the Medicare contractors’ LCDs. If providers wish to have a specific answer to the partial debridement measurement question, they should send an e-mail to their respective Medicare contractor’s medical director. Providers should also watch for debridement clarifications in the CPT® Assistant. CAUTION: Providers should read their own Medicare contractor’s LCD in its entirety – DO NOT RELY ON THE QUICK GLANCE TABLE III TO 105

Wound Clinic Wisdom

PROVIDE YOU WITH ALL THE INFORMATION THAT YOU NEED TO MEET YOUR MEDICARE COVERAGE CONTRACTOR’S REQUIREMENTS. Providers must read every word of your Medicare contractor’s LCDs because each sentence in the LCD is very important. Providers often ask me to write a synopsis of the LCDs so they do not have to read the LCDs that pertain to their work. I always decline that request by saying “What part of the LCD don’t you want me to discuss?” Since every sentence of every LCD has a specific direction from a specific Medicare contractor, providers should feel compelled to read every word of every revision of every pertinent LCD and its attachment(s). By the time a synopsis would be written about every sentence in an LCD, the synopsis would be as long as the LCD. The moral of this CAUTION is that providers should read LCDs carefully, highlight them, make implementation notes, and then implement the various guidelines. If the LCD does not provide the answer to a “burning question”, contact the Medicare contractor medical director who wrote the LCD and seek clarification.

SummarY: Wound care providers should study the 2011 revisions to the existing debridement codes and the new 2011 debridement add-on codes. Then providers should make the appropriate changes to their charge sheets/super bills, charge description masters, etc. Be sure you understand how to bill the add-on codes (11045, 11046, 11047, and 97598) in addition to the base codes (11042, 11043, 11044, and 97597). Remember that the 10-day global periods for 11043 and 11044 were eliminated. Wound care physicians and wound care professionals should select the appropriate debridement code based on 1) how the procedure was performed, 2) the type of tissue that was removed, 3) the deepest level of tissue removed, and 4) the size of the wound surface area. Wound care providers should remember not to choose a debridement code

because of the payment rate that is attached to it. Instead, choose a debridement code because it is the best descriptor of the work performed. Providers must carefully monitor their Medicare contractor’s LCDs pertaining to the revised/new debridement codes. Just because the LCDs were updated in January 2011 does not mean that they won’t be updated one or more times throughout 2011. Hopefully, the Medicare contractors and/or AMA will provide clear guidance about 1) the use of the 59 modifier when multiple debridement codes are billed, 2) billing for pre- or post- debridement wound surface, and 3) the wound surface size to report when only a portion of the wound was debrided. Most importantly, detailed documentation should consistently be present in the medical record to support the procedures performed and the code(s) billed. Wound care providers should be sure to meet all the documentation requirements of the Medicare contractor that processes your claims. Keep in mind that the various auditing organizations will use the LCD that existed on the day that you performed a service. They will compare you documentation in the medical record to the LCD requirements. If the medical record does not prove medical necessity and/or meet the LCD guidelines for debridement, providers may face a repayment to the Medicare program. Therefore, NOW IS THE TIME TO IMPLEMENT CORRECT CODING AND DOCUMENTATION FOR SURGICAL AND MEDICAL DEBRIDEMENTS. ■

1. CPT® is a registered trademark of the American Medical Association. Kathleen D. Schaum, MS, is President and Founder of Kathleen D. Schaum & Associates, Inc., Lake Worth, FL. Ms. Schaum can be reached for questions and consultations by calling 561-964-2470 or through her email address: kathleendschaum@bellsouth.net. www.todayswoundclinic.com


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