August 2012

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Today’s

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Contemporary Approaches to Wound Clinic Management

Would Your Clinic

Survive an

Audit?

Also in This Issue:

Our clinical case files could hold the answer

ABCs of Governmental Auditors Business Briefs SAWC Fall Preview

August 2012 www.todayswoundclinic.com

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SAWC FALL

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THE SYMPOSIUM ON ADVANCED WOUND CARE

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Today’s

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Volume 6, Number 6, August 2012 • www.todayswoundclinic.com

Table of Contents • Feature Articles 12

18

The Coming Audit Storm For any Southerner, the threat of a natural disaster looms quite frequently. But no matter where you practice wound care, the threat of an auditing “disaster” can be just as common if you’re not adequately and comprehensively conducting documentation.When you’re audited, will you be prepared?

Toni Tuner, RCP, CHT, CWS

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The ABCs of Wound Care Auditing

Most clinicians stand by their oaths to conduct patient care with honesty and integrity. However, some have “gamed” the system by making fraudulent reimbursement claims.Today, the list of governmentally based auditors is extensive in an attempt to avoid fraud.This overview will help providers understand who’s out there and what they’re looking for.

Signs of an Impending Audit: Are You Waving Red Flags?

Caroline Fife, MD, FAAFP, CWS

Wound centers are likely targets for an audit.To help you recognize potential problematic issues in your place of business, Today’s Wound Clinic offers these hypothetical clinical case files that provide real examples of questionable situations, as well as their resolutions.

Caroline Fife, MD, FAAFP, CWS & Dot Weir, RN, CWON, CWS (Introduction by Des Bell, DPM, CWS)

TODAY’S WOUND CLINIC® (ISSN 1938-6311), is published by HMP Communications, 83 General Warren Boulevard, Suite 100, Malvern, PA 19355.

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Editorial Staff

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Volume 6, Number 6, August 2012 • www.todayswoundclinic.com

Founding Editorial Board Kathleen Schaum, MS Christopher Morrison, MD Val Sullivan, PT, MS, CWS Managing Editor Joe Darrah jdarrah@hmpcommunications.com

Table of Contents

Web Editor Samantha Alleman salleman@hmpcommunications.com

Departments

Business Staff

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From The Editor

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Business Briefs

Executive Vice President Peter Norris pnorris@hmpcommunications.com VP/Group publisher Jeremy Bowden jbowden@hmpcommunications.com

Caroline Fife, MD, FAAFP, CWS

How to Conduct Internal Audits in the Wound Care Clinic

Donna J. Cartwright, MPA, RHA, CCS, RAC, FAHIMA

& Kathleen D. Schaum, MS

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

Clinician’s Report

Associate Publisher Kristen J. Membrino kmembrino@hmpcommunications.com Classified advertising Associate Christine Gabel cgabel@hmpcommunications.com

HMP Communications, LLC PRESIDENT BIll Norton

Management Solutions

30 Industry Insider

An inside look at PathoGenius Laboratories 34 Conference Connection

Preview of the SAWC 2012 Fall conference in Baltimore, MD; inaugural SAWC scholarship winners announced

Controller Meredith Cymbor-Jones Vice President, Special Projects Jeff Hall Marketing Manager Stephanie Manzo Creative Director Vic Geanopulos vgeanopulos@hmpcommunications.com Art Director Bernadette Zeminski bzeminski@hmpcommunications.com

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TWC Online

Production/ Circulation Director Kathy Murphy kmurphy@hmpcommunications.com

www.todayswoundclinic.com Exclusive: The Medicare Trust Fund: Should Clinicians Be Worried?

Depending on how you calculate the effect of the Affordable Care Act, Medicare will go bankrupt in either 2024 or 2016, perhaps sooner. Really?

Audience Development Manager Bill Malriat MEETING PLANNER Tracy Blithe, CMP MEETING PLANNER Mary Beth Kurimay

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83 General Warren Boulevard, Suite 100, , LLC Malvern, PA 19355 Editorial Correspondence should be addressed to Managing Editor, Today’s Wound Clinic®, HMP Communications, 83 General Warren Boulevard, Suite 100, Malvern, PA 19355. Telephone: (800) 237-7285 or (610) 560-0500 /Fax: (610) 560-0502.

Editorial policy: TODAY’S WOUND CLINIC® seeks to provide practical, timely insight into clinical and operational issues inherent to the success of an outpatient wound center. Program Directors, Medical Directors, and Clinical Managers (including Nurse Practitioners and other professional wound care providers across multiple disciplines) will benefit from the interactive nature of feature articles and regular departments that address medical and practice management options and perspectives affecting fiscal and, most importantly, patient outcomes of wound clinics. Articles from knowledgeable, experienced practitioners are invited and will be subject to Editorial Board review.

Director of e-Media and Technology Tim Shaw

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Sr. Manager, IT Ken Roberts

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Invia Liberty ®

SIMPLIFYING NEGATIVE PRESSURE WOUND THERAPY The innovative design of the Medela Invia Liberty NPWT System delivers user friendly functionality with a simple set-up and easy operation for the clinician and patient. The Invia Liberty NPWT System can be used in a hospital, home or long term care setting, easing transitions and avoiding the need for clinicians and patients to learn a new pump. Medela provides foam and gauze wound dressing kits, along with multiple drain options to help you fully manage the clinical needs of your patients.

Invia ® Liberty Negative Pressure Wound Therapy

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Precious life – Progressive care 1547741 A 0112 © 2012 Federal law restricts this device to sale or rental by or on the order of a physician. Avance Dressing Kits distributed by Medela, Inc. Medela and Invia are registered trademarks of Medela Holding AG. Liberty is a trademark of Medela, Inc. Avance is a registered trademark of Molnlycke. Medela, Inc. 1101 Corporate Drive, McHenry, IL 60050, USA Phone: 1 877 735 1626 Fax: 1 815 307 8942 suction@medela.com www.medelasuction.com

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FromtheEditor

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Today’s

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s you have undoubtedly heard, the Supreme Court recently upheld the constitutionality of the Affordable Care Act (ACA) by a vote of 5-4.While the 193-page opinion written by Chief Justice John Roberts is full of surprises, one glaring revelation is that individual states can opt out of the law’s sweeping expansion of Medicaid. Ironically, this will significantly reduce the number of Americans who gain healthcare insurance. If you’re wondering what the impact on wound care will be, the Medicaid rulCaroline Fife ing may play a big role in determining that. Expansion of Co-Editor of TWC Medicaid within the ACA was expected to extend health insurance coverage to about 17 million Americans. By 2019, the program was expected to cover everyone below 133 percent of the federal poverty line (an annual income of $14,500 for an individual).

Editorial Board

Rightly Stated

Andrew J. Applewhite, MD, CWS, UHM

The ACA provides financial incentives to entice states into the Medicaid expansion. The federal government will cover the entire cost of all these new patients for the first three years. (Usually states have to contribute something to the cost.)

However, the match starts to decrease in 2017, with the feds paying 90 percent of the bill. That may still sound like a high percentage, but it may not be enough to entice states that are already struggling under the weight of growing Medicaid bills. The financial burden would be higher on the states that have traditionally had less expansive Medicaid programs. In my state of Texas, for example, which only covers parents up to 26 percent of the federal poverty level, the state would spend an estimated $2.6 billion on the coverage expansion between 2014 and 2019. The expansion would cover an additional 1.8 million people in Texas who do not currently have insurance. Under the original wording of the ACA, if a state would have failed to implement the expansion, it stood to lose all Medicaid funding. This component of the ACA has been viewed by Roberts as “coercive” and was struck down by a 7-2 decision. Meanwhile, those states that opt into the expansion could create an insurmountable deficit in each respective budget, possibly causing bankruptcy. If a state opts out, some of the poorest Americans could end up in a “no man’s land” and not be covered by federal entitlement programs and not be eligible for subsidized insurance. No matter your personal political views, the fundamental question is: Can this country, which is struggling under the weight of a multi-trillion dollar deficit, afford the ACA? More people than ever before are going to have healthcare coverage, but the money to pay for that coverage is limited. Efforts at controlling healthcare reimbursement will be redoubled under a variety of programs. This will effectively be “rationing” under other names. The effect on wound care is not yet known.

Focus on Fraud We can now expect the government’s anti-fraud enforcement to take center stage.The ACA contains amendments to the federal False Claims Act, the government’s principal enforcement statute. The US Department of Justice and the US Department of Health and Human Services will be under pressure to expand their civil and criminal fraud enforcement activities, as this will have a profound effect on wound care practice. I think you’ll find this issue of Today’s Wound Clinic, which reviews what clinicians need to know about the numerous recoupment programs that exist to be one of the most important and timely we’ve published.

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

Editorial Board Members

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

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83 General Warren Boulevard, Suite 100, Malvern, PA 19355 © 2012, HMP Communications, LLC. All rights reserved. Reproduction in whole or in part prohibited. Opinions expressed by authors, contributors, and advertisers are their own and not necessarily those of HMP Communications, LLC, the editorial staff, or any member of the editorial advisory board. HMP Communications, LLC is not responsible for accuracy of dosages given in articles printed herein. The appearance of advertisements in this journal is not a warranty, endorsement or approval of the products or services advertised or of their effectiveness, quality or safety. HMP Communications, LLC disclaims responsibility for any injury to persons or property resulting from any ideas or products referred to in the articles or advertisements. Content may not be reproduced in any form without written permission. Reprints of articles are available. Contact HMP Communications, LLC for information.HMP Communications, LLC (HMP) is the authoritative source for comprehensive information and education serving healthcare professionals. HMP’s products include peer-reviewed and non-peer-reviewed medical journals, national trade shows and conferences, online programs and customized clinical programs. HMP is wholly owned subsidiary of HMP Communications Holdings LLC. Discover more about HMP’s products and services at www.hmpcommunications.com.

Caroline Fife, co-editor of TWC, chief medical officer at Intellicure Inc., cfife@intellicure.com 4

August 2012 Today’s Wound Clinic®

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Potential Payment May Now Be Available for Every Application As of January 1, 2012, the Centers for Medicare and Medicaid Services (CMS) is eliminating the physician 90-day global surgical period for skin and dermal substitute procedures.

For more information, please visit the News page on the Healthpoint Biotherapeutics website at www.healthpointbio.com/news.

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

Š2012 Healthpoint Biotherapeutics Healthpoint is a registered trademark of Healthpoint, Ltd. TM1302-0112

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businessbriefs How to Conduct Internal Audits in the Wound Care Clinic Donna J. Cartwright, MPA, RHA, CCS, RAC, FAHIMA & 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. HMP Communications and the authors do not represent, guarantee, or warranty that the coding, coverage, and payment information is error-free and/or that payment will be received.The responsibility for verifying coding, coverage, and payment information accuracy lies with the reader.

D

uring the first 6 months of 2012, Today’s Wound Clinic editorial board members Donna Cartwright and Kathleen Schaum offered Clinical Documentation Improvement (CDI) webinars that stressed the importance of thoroughly documenting the important work that wound care professionals provide to patients. If you missed the CDI webinars, you can still register to listen to the archived programs, which will help you and your team build a strong “documentation house” as opposed to a “documentation house made of cards” (www.icd10codingworkshop.com).

In addition, the one-day Wound Clinic Business seminar taught by Andrea Clark, RHIA, CCS, CPCH, chairman, chief executive officer, and founder of Health Revenue Assurance Associates, Plantation, FL, and Schaum has received excellent evaluations from attending physicians, podiatrists, non-physician practitioners, program directors, clinical managers, coders, billers, revenue integrity directors, compliance officers, and other support personnel for wound clinics throughout the country. This year’s theme is “Investigate Your Team’s Wound Care Revenue Cycle.”

In this action-packed seminar, Clark and Schaum discuss organizational pro-

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cesses, physician orders and signatures, documentation, coding, billing, coverage, auditing, and much more. Both speakers emphasize they are concerned more about wound care professionals keeping payments they’ve already received than they are about the wound care professionals “getting paid.” If you and/or your wound care management team wish to take part in this timely seminar, you can register at www.woundclinicbusiness.com.

By participating in one or both of these educational opportunities, you will clearly learn the importance of conducting internal audits of your documentation, coding, and billing before external auditors come knocking at your door.

One of the most frequently asked questions that wound care professionals ask at these programs is: “What wound carerelated topics should we audit?” Beginning on page 8 you’ll find audit topics and documentation you should expect to encounter in order to pass your audit and keep payments that you already received.

These audit topics and documentation needed to pass an audit should be some of the first items on your internal audit to-do list.

Even topics that you think are not questionable in your facility are often found to be problematic during internal and external audits.

By now you know the implementation of ICD-10-CM has been extended until Oct. 1, 2014, by the Centers for Medicare & Medicaid Services. While the information provided to you in this article is pertinent to auditing your documentation at the present time, you should begin to further refine your documentation to support the ICD-10CM diagnosis coding system.

August 2012 Today’s Wound Clinic®

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The new coding system allows for more granularity (specificity) of disease states and, therefore, will require refinement of your documentation in order to select the appropriate ICD-10-CM Diagnosis code(s). Some of the changes that ICD-10-CM will bring are: • I nformation relevant to ambulatory and managed care encounters • Expanded injury codes •C reation of combination codes to reduce the number of codes needed to fully describe a condition • Addition of 6th and 7th characters to the existing 5 characters •C lassifications specific to laterality (right, left, bilateral) •C lassification refinement for increased granularity of data.

The adage, “Old habits die slow,” applies to teaching medical professionals to change their documentation habits.

Therefore, wound care professionals should start transitioning documentation one disease state at a time. Then, begin conducting internal audits of that documentation. We must begin now to improve our documentation to meet today’s requirements and to prepare for the ICD-10-CM requirements of the near future. n Donna Cartwright is senior director of strategic reimbursement for Integra LifeSciences Corp., Plainsboro, NJ. She can be reached at 609-936-2265 or via donna.cartwright@ integralife.com.

Kathleen D. Schaum is president and founder of Kathleen D. Schaum & Associates Inc., Lake Worth, FL. She can be reached for questions and consultations at561-9642470 or kathleendschaum@bellsouth.net.

www.todayswoundclinic.com

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The pressure is off.

Off of you, off the wound, off the patient.

Total Contact Cast System vs Other Off-Loading Modalities 3

TCC-EZ® eliminates those problems. It’s a best-in-class off-loading system providing: • A simplified casting process • Significantly reduced application time • Greater patient comfort • Same optimal off-loading outcomes

100%

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50.4

50

70% 60% 50%

70

33.5

65.0%

58.3%

40

40%

30

30%

20

20% 10

10% 0%

Total Contact Removable Casting Cast/Walker

Mean Days to Complete Healing

Proper off-loading is one of the most important factors in managing diabetic foot ulcers. Total contact casting (TCC) is the one modality that has demonstrated optimal healing rates - in multiple controlled studies - and is recognized as the Gold Standard of Care in off-loading. But concerns regarding tissue damage, complex and time consuming application, and patient comfort have discouraged physicians from using TCCs.

Percent of Wounds Completely Healed

88% of wounds managed with total contact casting heal in 43 days.1 No other DFU therapy can say that.

0

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TCC-EZ® offers a one-piece, roll-on, woven design that simplifies the application process while reducing the potential for causing additional tissue damage. The result is a process that takes about ¼ the amount of time of traditional casting systems2,3 and a product that gives greater patient comfort. All while providing gold standard off-loading for optimal clinical outcomes.

For a TCC-EZ® product demonstration, please contact your local representative or visit our website.

Quicker application. Greater comfort.

With TCC-EZ® it’s easy to take the pressure off.

www.dermasciences.com or call 800.445.7627 1.

Bloomgarden, ZT; American Diabetes Association 60th Scientific Sessions, 2000. Diabetes Care 24:946-951, 2001.

2.

Bohne, G; Cost Effectiveness and Implementation of an Easy to Apply Total Contact System for Diabetic Grade 2 Neuropathic Foot Ulcers in Multi Physician Clinic. CSASWC Conference, 2009.

3.

Shah, S; The Economics of Total Contact Casting. SAWC Spring Conference, April 2011.

4.

Armstrong, et al; Diabetes Care, June 2001.

Scan this QR code now with your smart phone to view educational information and product videos on the TCC-EZ website.

© 2012 Derma Sciences, Inc. All rights reserved. .

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businessbriefs Internal Audit Topic Physician Supervision of HospitalBased Outpatient Wound Care Department (HOPD)

Basic Rules

Documentation to Support the Rule During an Audit

HOPDs must have “direct supervision” for every patient encounter. The supervision can be provided by physicians, podiatrists, and non-physician practitioners.

HOPDs should post a schedule of physicians, podiatrists, and/ or non-physician practitioners who will provide “direct supervision” for every patient encounter. Schedules should be filed for at least 7 years in case they are needed for an audit.

NOTE: Providers who are scheduled to provide “direct supervision” should have appropriate hospital credentialing and should be practicing within their respective state’s scope of practice.

The person who creates the “direct supervision” schedule should ensure the wound care professional scheduled for “direct supervision” will not be performing another procedure or service that cannot be interrupted during the time he/she is responsible for “direct supervision.” In addition to schedules, key entry systems [that log physicians in and out of the facility on a time clock] may be able to demonstrate the physician is/was on site and is/was available to immediately assist.

Monthly Series Bills vs.

Single-Visit Bills

HOPDs are not one of the departments that should use monthly series bills. Each patient encounter should begin with a new registration and should be billed after each visit.

Registration records should show a new HOPD registration for each patient. The physician should document, in the medical record, the exact reason for each patient encounter and the exact diagnosis code(s) that pertain(s) to that encounter: the reason for the visit and the diagnosis code are often different from visit to visit.

NOTE: Audits should reveal an individual medical record and a claim for each patient encounter. Be sure that the auditors are aware of how your medical records are organized: help them easily find the information needed.

New vs. Established Clinic Visit Codes

For a patient’s first visit to the HOPD, a new patient clinic visit should only be billed if the patient has not been registered anywhere in the entire hospital system for the past 3 years.

NOTE: The HOPD clinic visit level may vary from the physician’s evaluation and management (E/M) level: Physicians can bill for a new patient E/M as long as the patient has not been seen by any physician of the same specialty who belongs to the same group practice within the past 3 years.

Diagnosis Codes That DO NOT Reflect Documentation

Diagnosis codes submitted on insurance claims should match the documentation found in the patient’s medical record. Diagnosis codes should not be selected just to cause payment of the claim.

By using the Master Patient Index during the patient’s registration, the Registrar should verify whether the patient has a medical record number anywhere in the health system for the past 3 years. If the patient has previously received a diagnostic service that does not require a face-to-face encounter with the patient (eg, an X-ray), this patient is still considered a new patient.

NOTE: Audits should reveal the appropriate “new“ or “established“ clinic visit levels for HOPDs and evaluation and management levels for physicians. Even though the HOPDs and physicians use the same CPT® codes to represent these services, the coding rules are different. Therefore, the HOPD and physician clinic visit codes will rarely match.

The physician, podiatrist, or non-physician practitioner should diagnosis the patient’s condition at each encounter. That diagnosis should be validated in that day’s documentation (ie, history and physical, progress notes, orders, and procedures or services).

Although this seems like common sense, some hospital billing systems obtain the diagnosis code from the registrar and fail to go back and obtain the actual diagnosis code from the documentation in the medical record. In some electronic medical records, previous diagnoses are brought forward to the current encounter even though they may not be pertinent to the current encounter. These diagnoses should be removed or inactivated on the problem list.

NOTE: Audits should reveal that the diagnosis code is supported by the documentation in the medical record for a specific patient encounter. The diagnosis in the medical record should exactly match the diagnosis on the claim for that encounter.

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businessbriefs Internal Audit Topic Modifiers That DO NOT Reflect Documentation

Basic Rules

Documentation to Support the Rule During an Audit

A modifier should only be used when the documentation in the medical record justifies the use of the modifier. Modifiers should not be used just to cause payment of the claim.

The modifiers that are often used without adequate documentation are: Modifier 25 - Significant, separately identifiable E/M service by the same physician on the same day as the procedure or other service.

Reporting an E/M service with modifier 25 is only appropriate if one of the following conditions has been met and clearly documented in the medical record: A. T he patient requires evaluation “above and beyond” what is typically expected as part of the evaluation prior to the procedure.

B. The patient’s condition has changed or worsened and the patient needs to be re-evaluated.

C. The patient presents with a new, separate problem than what prompted the procedure.

Modifier 22 - Increased Procedural Service should be billed with supporting documentation. The documentation should reflect the work was substantially greater than normal. It must also state the reason causing the additional work, such as increased time, intensity, technical difficulty, or severity of the patient’s condition.

Modifier 24 - Unrelated E/M service by the same physician during the postoperative period. Practitioners should clearly document the reason the service is unrelated to the original procedure, such as a new problem.

NOTE: Auditor should be able to identify documentation in the medical record to warrant use of the appropriate modifiers.

Surgical Procedures That ARE NOT Appropriately Documented

Surgical procedures such as surgical debridement (11042-11047) and application of skin substitute grafts (15271-15278) should only be used when appropriate surgical procedure notes that meet the payer’s requirements are documented in the patient’s medical record.

The physician, podiatrist, or non-physician practitioner who performed the surgical procedure in an HOPD must thoroughly document his/her work just as if it were performed in the operating room. The operative report or procedure progress note should contain the following information: • Preoperative and postoperative diagnosis • Wound location • Wound stage or grade, if appropriate • Wound appearance (color, texture, temperature, or signs of infection) • Wound margin description • Anesthesia used • Instruments used • Type of tissue removed, if any • Wound size before and after debridement, if performed • Blood loss or fluid replacements • Product name and size • Amount of product used (in sq cm) • Amount of product discarded (in sq cm) • Method of fixation • Dressings applied • Complications, if any ostoperative orders such as offloading, dressing-change frequency, •P medications, etc.

NOTE: The audit should reveal a thorough operative report or procedure progress note from the physician, podiatrist, or non-physician practitioner who performed each surgical procedure. Documentation with words such as “debrided wound” or “applied skin substitute” is not adequate.

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businessbriefs Internal Audit Topic Inappropriate Number of Billing Units

Basic Rules

Documentation to Support the Rule During an Audit

When products and/or procedures are provided that include units of measure in their descriptions, the medical record should document the units of measure provided/performed. In addition, the insurance claim should match the documented units of measure.

Units of measure documented in the medical record must match the units billed on a claim. Many CPT® and Healthcare Common Procedure Coding System codes for procedures and products involve units of measure such as: Sq cm for debridements/application of skin substitutes.

Per sq cm for skin substitute products. (NOTE: Remember to document amount of product used and product wasted.)

Per treatment time (ie, every 15 minutes).

Per session for physician coding of hyperbaric oxygen therapy.

Be sure to check your Charge Description Master (CDM) to ensure proper units of measure are listed for each code. Improper units on the CDM will cause claims to be over- or under-billed.

NOTE: The auditor should be able to match the units documented in the medical record to the units submitted on the insurance claim.

Physician Orders and Signatures

HOPD personnel cannot perform any services/procedures or provide any products without a physician’s order and signature.

Because HOPDs are required to have “direct supervision,” physicians, podiatrists, or non-physician practitioners must write and sign an order in the medical record before HOPD nurses (even when wound care certified) can perform a service or procedure, or can apply a different dressing or apply a piece of equipment. The signature must be legible and must match the hospital’s signature authentication document.

Authentication requirements, rules, and responsibilities for orders should be documented in the medical staff’s bylaws, rules, and regulations.

NOTE: The auditor should be able to match every service and/or procedure and every new product used back to a legible order signed by the physician, podiatrist, or non-physician practitioner.

Place of Service on Physician, Podiatrist, and Non-Physician Practitioner Claims

When physicians, podiatrists, and non-physician practitioners perform work in an HOPD, they should use the Place of Service code 22, outpatient hospital, on their Medicare claims. They should not use Place of Service code 11, office.

“It is extremely important that you correctly code the place of service on Part B claims. Using non-facility Place of Service codes for services that are actually performed in hospital outpatient departments or Ambulatory Surgical Centers (ASCs) often results in overpayments. You must ensure that you have adequate controls in your (or your billing agent’s) billing routines to identify potential Place of Service coding errors.”

Audit Finding of the Office of the Inspector General (OIG) The OIG conducted an audit to determine whether physicians correctly coded non-facility Places of Service on selected Part B claims submitted to and paid by Medicare contractors. That report, “Review of Placeof-Service Coding for Physician Services Processed by Medicare Part B Carriers During Calendar Year 2007,” is available to the public at http:// oig.hhs.gov/oas/reports/region1/10900503.asp on the OIG website.

The OIG found, in many instances, physicians are incorrectly coding the Place of Service code. Specifically, in a very large portion of the claims audited, physicians used non-facility Place of Ser heir claims for services that were actually performed in hospital outpatient departments or ASCs. This led to overpayments by Medicare on these claims. Medicare does recover these overpayments, so it is critical to code correctly and avoid overpayments.” Source: MLN Matters® Number: SE1104

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businessbriefs Internal Audit Topic Compliance with Medicare Local Coverage Determinations

Basic Rules

Documentation to Support the Rule During an Audit

HOPDs, physicians, podiatrists, and non-physician practitioners should verify the name of the Medicare contractor who processes their claims. They should keep in mind the contractor who processes HOPD claims may be different than the contractor who processes the claims of the physicians, podiatrists, and non-physician practitioners.

It is extremely important to download all associated medical coverage policies for your wound care business. The medical policies contain a large amount of information relative to coverage, coding, documentation, and billing instructions.

Once the Medicare contractor(s) is/are identified, someone should be assigned to obtain the Local Coverage Determinations (LCDs) pertaining to all services, procedures, and products provided to patients in the HOPDs. The person designated to this task should check for updates, drafts, and new LCDs on a monthly basis.

The HOPD manager, coding staff, or other qualified individual should do a complete search for all insurance medical policies affecting their business, especially your top 10 procedures). The search for each payer’s medical policy (ie, Medicare parts A and B, Medicaid, private payers, etc.) should include policies that mention the following terms: wound care, debridement, skin substitutes, bioengineered or tissue-engineered skin, human skin equivalents (research each type used in the HOPD), wound dressings (research each type used in the HOPD), negative pressure wound therapy, non-covered services, use of CPT® modifier rules, enzymatic debriders, and any other types of specialized therapies provided by the HOPD.

The entire professional team that works in the HOPD should review all LCDs and should have easy access to them when they are providing wound care to their patients. If the patient does not meet the LCD medical necessity requirements, the wound care professional should be prepared to provide the patient with an Advanced Beneficiary Notice of Non-Coverage (ABN).

Medicare has 15 Medicare Administrative Contractor (MAC) jurisdictions. Each MAC has one or more medical director who creates his/her own medical policies for their jurisdiction. Likewise, on the private payer side: all private payers have their own medical directors who write their own medical policies. It is important to remember that many private payers have a variety of medical plans with varying levels of benefits. Therefore, the private payer benefits may widely vary based on the specific plan purchased by the individual or the employer. For example, one plan may cover a certain treatment while another may not cover the same treatment.

The following link goes to the Medicare Coverage Database, where you can begin your search for LCDs: www.cms.gov/medicare-coverage-database/ overview-and-quick-search. Many private payers’ policies can only be viewed by providers via their provider ID number. HOPDs can obtain their provider ID number by requesting it from the billing or coding department.

As you locate the pertinent LCDs and medical policies, print them and place them in a binder(s) that is/are easily accessed by the physicians and HOPD staff.

By reading and frequently referring to the LCDs and medical policies, healthcare providers will be able to identify procedures and products that are covered and not covered. Most LCDs and medical policies specify the documentation requirements that must be followed carefully to stand up under audit. If coverage is only provided for certain disease processes, the covered ICD-9-CM diagnosis codes will be listed in the LCD or policy.

The policies may outline the frequency of treatments allowed for certain products, and may even give guidance on the use of CPT® modifiers. For instance, policies for skin substitutes may require specific modifiers for wastage and define modifiers for “used as a graft” or “not used as a graft.” Toward the end of the policy, the medical directors often provide the reference sources that were used. CAUTION: Some LCDs and medical policies have related articles and attachments. Hyperlinks to these important guidance documents are usually found toward the end of the LCD and policy. It is very important to read and print each article/attachment.

If the physician has information about the patient’s insurance medical policies, they can discuss all options for care. If, for any reason, the recommendation for treatment is not covered by Medicare, the physician should take the time to discuss the non-coverage with the patient and give the patient the opportunity to accept the treatment and agree to pay for the treatment or to decline the treatment. The physician should also obtain a signed ABN from the patient.

A copy of the HOPD and physician charge sheets should be available to assist the physician or practitioner to advise the patient on exactly what they may be responsible for paying out-of-pocket. This charge information is also required on the ABN. The following is the link to the Medicare ABN and instructions completion: www.cms.gov/BNI/Downloads/ABNFormInstructions.zip.

www.todayswoundclinic.com

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Today’s Wound Clinic® August 2012

11

8/8/12 3:46 PM

The ABCs of

Wound Care Auditing

Healthcare providers have an obligation to familiarize themselves with the governmental bodies that exist to survey and audit their finances. This overview will help.

Caroline Fife, MD, FAAFP, CWS

A

lthough most clinicians are committed to excellence in patient care and honesty in service charges, the actions of unscrupulous practitioners and companies are bringing increased scrutiny on everyone.

In February, federal authorities in Dallas arrested a Texas doctor and six others for perpetrating a scheme that cheated the government out of nearly $375 million in Medicare and Medicaid fees by registering homeless people for home healthcare services they never received.

With only four doctors and 15 nurses on staff, the company owned by the physician in question is said to have certified more than 11,000 patients since

2006, more than any practice in the US. The US attorney’s office in Manhattan described the magnitude of the fraud as “astonishing.” It also raises the question: Why did it take so long to figure out there was a problem?

The answer likely lies within the numbers. Medicare provides health coverage for 47.5 million people. It processes more than 1.2 billion claims annually, or more than 4.5 million claims per day.

In 2010, Medicare spent $516 billion for covered items and services.

As this article will show, all efforts aimed at uncovering those who file improper payments are focused on the detection of statistical anomalies in various aspects of claims analysis. (This is a theme that is more thoroughly explored in the article “The Coming Audit Storm” on page 18.)

Despite the efforts of claims-processing contractors, Medicare remains among the top three federal programs with “improper payments.” To combat this problem, the federal government has launched new audits that organizations and providers must contend with. As clinicians, we must recognize that there are people out there who take advantage of the reimbursement system and be knowledgeable as to what can raise red flags regarding our own practices.

Healthcare providers who are involved in an audit may find themselves overwhelmed in their attempts to comprehend and/or prepare for the investigation.

The purpose of this article is to help clinicians make sense of the “alphabet soup” that the scope of auditing can appear to be and to present an overview of current governmental auditors, their respective scopes, and the appeals processes that exist.

12 August 2012 Today’s Wound Clinic®

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Governmental Auditors

There are more than a dozen US governmental auditing bodies currently at work in our healthcare system, which has most recently seen additions that include Recovery Audit Contractor (RAC) audits and Zone Program Integrity Contractor (ZPIC) audits.

Other audits such as Comprehensive Error Rate Testing (CERT) have existed for many years, and their auditors may have overlapping jurisdiction.

Governmental auditors are authorized to investigate claims submitted by any entity or provider that provides Medicare beneficiaries with procedures, services, and treatments. In addition, anyone who submits claims to Medicare and/or one of its fiscal intermediaries, regional home health intermediaries, Medicare Administrative Contractors (MACs), durable medical equipment suppliers, and/or carriers is also subject to investigation.

Below are brief descriptions of the major auditors and their objectives. We focus on the RAC programs first, then provide an alphabetized list of auditors.

RAC

The Tax Relief and Health Care Act of 2006 made permanent the RAC program to identify improper Medicare payments in all 50 states. RACs engage in two types of claims reviews in order to identify improper payments: automated reviews and complex reviews.

An automated review is a review of claims data without a review of the actual records supporting the claim. A complex review consists of a review of actual medical records and is used in situations where there is high probability that a claim includes an overpayment.

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8/8/12 3:55 PM

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7/31/12 5:13 PM

audit Online Exclusive: Should We Be Worried About The Medicare Trust Fund?

Depending on how you calculate the effect of the Affordable Care Act of 2010, Medicare will go bankrupt in either 2024 or 2016, perhaps sooner. Clinicians and hospital administrators who have “gammed the system” have brought increased government scrutiny down on everyone. Read more at www.todayswoundclinic.com.

RAC auditors work strictly on commission, receiving anywhere from 9-12.5 percent of everything they collect, and they can extend their reviews as far back as 36 months. The RAC program’s mission is to reduce improper Medicare payments through the detection and collection of overpayments, the identification of underpayments, and the implementation of actions that will prevent future improper payments. Many of these procedures involve data-mining activities based on billing information.

Some industry experts have suggested RAC audits may impose the largest operational impact to healthcare organizations and providers, in part due to their contingency basis. Recent changes have increased RAC record requests to 500 records every 45 days. The RACs use proprietary software programs to identify potential payment errors in such areas as duplicate payments, fiscal intermediaries’ mistakes, medical necessity, and coding.

Again, remember that these auditors are looking for statistical anomalies. Thus, it is imperative that you know not only whether you can justify your billed level of service, but whether the distribution of your charges falls in an acceptable range from a statistical standpoint.

To understand just how successful the RAC program has been, consider these numbers: • From March 2005-March 2008, RACs succeeded in correcting more than $1.03 billion in Medicare improper payments, according to the Centers for Medicare and Medicaid Services (CMS). Approximately 96 percent ($992.7 million) were overpayments collected from providers while the remaining 4 percent ($37.8 million) were underpayments repaid to providers. As part of this demonstration project, RACs were given six

14

years of claims data for all Medicare providers to review.

• The improper payments identified by RACs included: 1.

Payments made for services that did not meet Medicare’s “medical necessity” criteria (eg, therapy sessions that were excessive).

2.

Payments made for services that were coded incorrectly or failed to comply with Medicare/Current Procedural Terminology® guidelines (eg, principal diagnosis on the claim did not match principal diagnosis on the medical records).

3. Failure to support claims with proper medical documentation (eg, medical records did not adequately describe the procedures reported on the claim).

4. Submittal of claims to Medicare that should have been submitted to another insurer (eg, failure to meet Medicare “secondary payer” criteria).

5. Other reasons, such as submitting duplicate claims or using outdated fee schedules.

(For examples of what should constitute a red flag within your practice, see the feature article “Signs of an Impending Audit” on page 22.) It is important to remember that CMS approves the issues for RACs to review. Each RAC website lists the approved issues they will target (visit www.mgma.com). Also, Medicare’s Quarterly Provider Compliance Newsletter (www.mgma.com/policy/ default.aspx?id=1366156) provides information on specific infractions, including problem descriptions and how providers can avoid them.

Understanding Medicare billing requirements, especially issues that CMS and RACs are targeting, is the best way to prepare for and avoid a RAC audit.

August 2012 Today’s Wound Clinic®

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If a Medicare provider or supplier receives a claim denial, or a finding of overpayment is made as a result of a RAC review, this denial will be subject to the Medicare Part A and Part B appeals process. The regulations governing this process are contained in the Federal Register. Although medical providers cannot prevent a RAC audit, they can immediately get systems in place for tracking record requests and responding in a timely way. However, the best defense is a good offense. It’s better to understand billing rules and create compliant programs.

Medicaid RAC

These RACs are tasked with identifying and recovering overpayments made in the Medicaid system as well as reporting fraud and criminal activity.

CERT

Implemented by CMS to measure improper payments in the Medicare Feefor-Service (FFS) program, the CERT program chooses all claims at random and is designed to pull a random electronic sample of claims processed. CMS outlines the procedure for how records are requested for the CERT program through its Improper Medicare Fee-for-Service Payments Report, which is available at www.cms.gov/apps/er_report.

DOJ

The Department of Justice (DOJ) collaborates with many auditing agencies, including the Office of Inspector General (OIG) and the Department of Health and Human Services (HHS).

DOJ auditors can work on various civil fraud cases such as healthcare fraud.

When a federal or state investigative agency identifies a subject that is under current investigation in multiple states or jurisdictions, the information is sent to the DOJ to develop a nationwide strategy to coordinate resources.

HEAT

The goal of the Health Care Fraud Prevention and Enforcement Action Team (HEAT) is to prevent fraud

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audit and abuse in the Medicare and Medicaid programs.

Increased HEAT audits are considered to be the top compliance risk because the program has been incredibly successful in building partnerships between DOJ, HHS, and other agencies. In 2011, the US government dedicated an extra $60.2 million to fund additional teams and investigations.

MAC

MAC audits are used to determine whether particular billed services are medically necessary and should be covered under Medicare.

All claims submitted to MACs are put through a “scrubber” to check against claim edits and ensure payments are made to certified providers as part of their pre-payment review. In other words, MACs primarily review claims on a prepayment basis. However, the MACs’ prepayment edits can be sent to the RAC for retrospective review. It is anticipated that in the future, the MACs will work more closely with the RACs. According to American Health Information Management Association, if an organization receives a MAC review and identifies a billing or coding error, it is best to self-report any past discharges in order to stop a potential RAC retrospective review.

MIP & MIC

The Deficit Reduction Act of 2005 created the Medicaid Integrity Program (MIP).

CMS has two broad responsibilities under MIP: 1) to hire contractors to review provider activities, and 2) to support states in their efforts to combat fraud and abuse. The Medicaid Integrity Group oversees the MIP through Medicaid Integrity Contractors (MICs) and State Program Integrity Operations.

MICs conduct audits of Medicaid claims. Unlike RACs and Zone Program Integrity Contractors (ZPICs), whose appeals processes are determined by federal regulations, MIC appeals processes vary by state.1

16

MFCU

The State Offices of the Medicaid Inspector General (OMIG) represents a group of independent agencies within the individual state departments of health. Their purpose is to improve the integrity of state Medicaid programs by coordinating the fraud and abuse activities of the multiple state agencies that provide Medicaid-funded services. Each OMIG is different but they often work with agencies such as the Department of Mental Health, Office of Children and Family Services, and Office of People with Developmental Disabilities.

OIG

PERM

The OIG’s mission is to protect the integrity of HHS programs as well as the health and welfare of the beneficiaries of those programs.

The OIG’s activities are under the authority of the US Inspector General.

Since 1993, the OIG has performed audits and investigations of fraud and abuse within governmental programs.

If you are notified of an OIG investigation or audit, depending on the nature of the violation, you probably need legal counsel. Note: A RAC auditor may also target issues resulting from an OIG investigation. (Reference the May 2007 OIG report on surgical debridement services.) Clinicians can rest assured that debridement is on the RAC work plan.

In addition, the OIG has recommended that RACs focus on evaluation/management (E/M) coding and has provided RACs with the names of 17,000 physicians who are billing high E/M levels of service. RACs have reportedly noted a 17 percent increase in level four and five E/M codes, and have targeted physicians who bill these most frequently. The need for constant statistical data on billed charges will further drive the adoption of electronic health records that are capable of performing the necessary calculations and producing the reports clinicians need to monitor their activity. Therefore, clinicians and hospitals must be capable of conducting the “statistical sampling” that auditors are conducting to avoid audit targets.

August 2012 Today’s Wound Clinic®

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OMIG

Medicaid Fraud Control Units (MFCUs) are certified by HHS and are responsible for conducting state initiatives aimed at investigating and prosecuting providers that defraud the Medicaid program.

MFCUs may also review complaints of abuse or neglect of nursing home residents or the misappropriation of a patient’s private funds. Their jurisdiction also includes investigating fraud allegations within any federally funded healthcare program. Most are located in each state attorney general’s office.

The Payment Error Rate Measurement (PERM) program measures improper payments in the Medicaid program and the Children’s Health Insurance Program (CHIP). CMS has expanded PERM so that it includes Medicaid FFS claims as well as managed care claims and beneficiary eligibility in both the Medicaid and CHIP programs.

ZPIC

ZPICs became effective in 2009 and are located in seven national regions.1 ZPIC auditors look for cases of fraud by analyzing claims data.While ZPIC audits are similar in many ways to other Medicare audits currently being performed, they do differ in one very important aspect – potential Medicare fraud implications. Of all the current CMS audit initiatives, these audits are often the most concerning for organizations and providers. They use statistical data sampling and extrapolation methods that allow them to recoup overpayments totaling hundreds of thousands of dollars. ZPIC audits should not be taken lightly and organizations should handle these types of audits with due diligence. n Caroline Fife is chief medical officer of Intellicure Inc., The Woodlands, TX, and co-editor of TWC.

References and additional resources for this article can be found online at www. todayswoundclinic.com.

www.todayswoundclinic.com

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The Coming Audit Storm For many clinicians, looming audits are a certainty. Are you prepared?

Toni Tuner, RCP, CHT, CWS

T

hose of us on the Gulf Coast know that even on an otherwise beautiful, sunny day, complacency about the weather can be dangerous. With that, anyone who runs a business or owns a home near the coast is encouraged to have a “disaster-preparedness plan” in place in the event of an emergency. In developing such a plan, people are instructed to identify potential hazards, assess possible vulnerabilities that exist, and analyze the potential impacts of an emergency and the state of one’s business and/or home. Specific preparations are then expected to be enacted.This article intends to apply these concepts to the wound care clinician’s responsibility to have a preparedness plan in place in the event of an audit to safeguard against any financial and/or legal “disasters.”

Preparing For ‘Disaster’ We often speak figuratively of “storm clouds gathering” when we see prob-

lems developing within an industry. The various recoupment programs currently underway by Medicare through the Affordable Care Act (ACA) are an example of such a storm for the wound care industry. It will be very big, very protracted, and potentially very devastating for those who are unprepared. So, how do you get prepared for the impending storm of audits on the horizon? When a hurricane develops, some of the most valuable information is obtained from satellite images that allow us to track the trajectory of a storm in order to predict where it will make landfall. That “30,000-foot view” is critical to disaster preparedness. But how do you use that information to get your wound center, your private practice, or your hospital prepared for an audit?

As a compliance auditor, I am often asked to evaluate wound centers and physician’s practices to assess their risk for recoupment, should they be audited.

Given the fact that the recoupment pro-

grams put into place by the ACA are vital to Medicare’s solvency, the question is not “If?” but “When?” will a wound center’s program be audited. Hospital and physician practices simply cannot afford to be unprepared. Most hospitals have formed Recovery Audit Contractor (RAC) committees to proactively seek out the areas in which they are at most risk for loss. Understandably, hospitals tend to focus attention on the services that have the highest collection ratio, and since many hospital administrators believe wound centers generate little revenue, they incorrectly perceive the risk of an audit occurring within these programs as “low.” Many wound centers do have unrealized revenue potential. However, the pitfalls that make billing wound care services properly so challenging are the very issues that could make a RAC audit more likely.

Remember, when you create a RAC audit plan, you are asking not just how you get paid but how you stay paid. This may be a shift in mindset for some clinicians who believe (for example) that if “Mr. Jones” needed his dressing changed twice per week, there was no reason not to see Mr. Jones twice per week as long as the services were coded properly and the claim was paid. However, the payer’s perspective is not the same as the clinician’s. Unless the documentation in Mr. Jones’ chart justifies the medical necessity of his frequent visits, those charges may not stand up to a RAC audit.

“Necessity” & Staying Paid

Failure to document medical necessity is likely to deal a serious blow to wound and hyperbaric oxygen therapy (HBOT) programs around the country as more complex reviews unfold. Hospitals performing internal audits often review documentation only to ensure that the correct billing codes are reported on a claim. Administrators often overlook the lack of supporting infor-

18 August 2012 Today’s Wound Clinic®

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mation that is equally necessary to justify medical necessity. Hospital auditing practices should mirror payers’ auditing practices when it comes to establishing medical necessity.

As an industry, wound care and HBOT medicine are made more vulnerable by the lack of well-written, nationally recognized standards of practice.

We are thus more often at the mercy of regional Medicare intermediaries or private payer policy guidelines that are subject to frequent and seemingly random changes. The absence of clear national standards gives individual auditors even more discretion in how they interpret medical necessity. This is particularly true in HBOT. Electronic health records (EHRs) can help in establishing medical necessity because they can standardize certain documentation. Some physicians believe that “pasting” excerpts from practice guidelines (for example) will completely satisfy medical necessity requirements (eg, statements such as “hyperbaric oxygen therapy is beneficial in the management of failing flaps because of its ability to mitigate ischemic reperfusion injury”). However, what an auditor is looking for is why an intervention such as HBOT is warranted for the patient at that particular point in time. Pasting “cookie cutter” phrases into your EHR from practice guidelines may be a very useful tool, but will not provide sufficient substantiation unless the comments are linked to the details of this particular patient. As you evaluate potential vulnerabilities within your wound care center, ask yourself whether or not your HBOT charts sufficiently make the case for the medical necessity of the HBOT treatments that have been provided to each patient. Do your charts contain the supporting documentation that is needed (eg, bone scan results, operative reports, laboratory studies) and reflect the clinician has reviewed them?

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audit is debridement.

We know debridement services are on the RAC work plan because the Department of Justice published a report in 2007 detailing specific problems with these services. The unique rules that apply to hospital-based outpatient departments (HBODs) hold that hospital staffs provide services “incident to” the care of the advanced practitioner (eg, a physician). Although this is a shared encounter, the physician is responsible medically and legally for the care provided by all other clinicians, even though those caregivers are not always employed by the physician.

(In this case the “incident to” rules apply only to the care provided by the physician and do not apply to the payment rules that operate in a physician’s private practice.) When the physician signs the chart in the outpatient wound center, he or she is also acknowledging the documentation of all the individuals in the chart and is attesting: 1) that he/she has read the chart and is familiar with its contents, and 2) he/she knows of the treatments performed and is responsible for the care provided by all staff. The EHR should not allow more than one chart to be signed at a time, and once the chart is signed by the advanced practitioner, it must be permanently saved in a manner that forbids subsequent alteration.

My audits of wound centers have shown the following areas of vulnerability with regard to debridement documentation: 1) nursing notes that aren’t in agreement with physician documentation, 2) numbers of debridement per wound/ patient in excess of the limit set by the Medicare fiscal intermediary without medical documentation to support the medical necessity of these services, and 3) documentation that fails to support the level of debridement performed. Here is an example of this point: A nurse’s assessment states “75 percent of the wound has healthy granulation tissue” and a photo shows a clean wound. Then, the physician enters a debridement note documenting “debridement of 100 percent of the wound surface area to the level of muscle.” Clearly, there is a conflict with these statements. Rest assured that RAC

auditors will look closely at whether the level of debridement described is logical based on all the assessments in the chart. Internal “disagreement” between staff member documentation, failure to provide documentation of medical necessity for debridement services, and incomplete documentation are the perfect storm for recoupment of debridement charges for both the hospital and the physician. It is likely that RAC audits will substantially impact wound centers and wound care physicians in this area.

In other words, you can expect the storm to make landfall squarely in the area of debridement charges.

Devising Wound Center Plan

A disaster preparedness plan focusing on establishing the medical necessity for wound center services might look like this: • Potential vulnerability: Ask yourself whether your charts sufficiently make the case for the medical necessity of treatments like HBOT that have been provided to each patient. Ask yourself whether the frequency and type of your debridement charges exceed limits that might have been set by your Medicare fiscal intermediary and whether the documentation in your charts is internally consistent and defendable when examined in light of the depth of tissue exposed or the photos in the chart.

•P otential impact: Repayment of all services for which you cannot demonstrate medical necessity, which, in the case of HBOT or debridement services, could be significant for both the hospital and the physician.

• S pecific preparation: Start now to determine how medical necessity for the most financially significant wound center services should be documented.

Create reports that help evaluate the appropriateness of procedures such as debridement (eg, number of debridements per patient, depth in relation to wound stage). If you are using a wound care specific EHR, harness the EHR to create these reports for you and use them. Ensure your EHR does not allow staff members to alter documenta-

tion after the physician has signed off and that the charting of all staff members is in agreement.

How Payers See You

In 1999, when HBODs were created, the Centers for Medicare and Medicaid Services (CMS) repurposed the physician Evaluation and Management (E/M) Codes for facility billing. CMS instructed all HBODs, including wound centers, to “develop a system for mapping the provided services furnished to the different levels of effort represented by the E/M codes.” CMS continues to allow each facility leeway to develop its own method of facility billing, but it has been very clear that it expects to see a “normal” (bell-shaped) distribution of charges across the five levels of service. (It is this distribution of charges that CMS is auditing.) Ask yourself, “What sort of activity would cause my program to come to the attention of an auditor?” The answer is: statistical anomalies in the distribution of charges over many visits. Nevertheless, hours of effort are expended by hospital auditors worrying about whether or not an individual encounter has been tabulated correctly, rather than the 30,000-foot view of whether the distribution of all E/M charges over the past year has created a pattern that would attract the notice of an auditor. At this point, RAC auditors haven’t been authorized by CMS to evaluate E/M codes at the individual-encounter level, only the facility’s distribution over all five.

It is, in fact, very difficult to develop a tool that can accurately represent the use of hospital resources, fit a unique clinical activity like a wound center, and produce a normal distribution across five different levels of service. That’s why CMS allows each hospital to develop its own system rather than mandating one. (In fact, in 2005 CMS decided to mandate facility billing by wound size, but retracted this proposal when it was demonstrated that such a system could not accurately represent staff resources.1) A wound center is vulnerable to a RAC audit over facility E/M visits if: 1) there’s no system for determining facility E/M See Coming Storm on page 38

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Signs of an impending Audit: Are You Waving Red Flags?

Wound centers are likely targets for an audit.

The following clinical vignettes offer providers examples of questionable situations that can arise, as well as their resolutions.

Caroline Fife, MD, FAAFP, CWS & Dot Weir, RN, CWON, CWS

Editor’s note:The introduction to this article was contributed by Des Bell, DPM, CWS. For information on further internal audit topics and the documentation found during an audit, see “Business Briefs” on page 6.

T

he “business of medicine” may sound like an oxymoron, but unless one’s bills are paid each month, even the most talented clinicians cannot provide their services. As anyone in a private or solo practice knows, being a steward of the organization’s finances is critical on several levels. Like any other business, an appreciation of the value of each dollar spent and earned develops over time.

My “appreciation” began when, after launching the mobile aspect of my wound practice (Wound Care on Wheels) in 2008, I came under audit by the Centers for Medicare & Medicaid Services (CMS). I wasn’t prepared for the critical eye the government would develop regarding my business and finances as I broadened my horizons in an attempt to meet the continuing needs of others in my community. Before long, I was involved in an ongoing pre-payment review that lasted more than a year, and it took its toll on me not just emotionally but physically and financially — ultimately leading to the restructuring of my organization and the discontinuation of home wound care services.

Several issues were raised by CMS regarding my practice (which I share with my wife De Anna, a nurse practitioner and fellow wound specialist) from the start of my mobile expansion, the primary concerns being why we were providing wound care in patients’ homes and the level of service provided during hospital rounds. Additionally, working as a mobile provider automatically put me outside the

“bell curve” when CMS compared my business to my colleagues and other wound care-providing organizations, meaning that I was reporting services either more or less frequently than what is statistically the norm for similar providers.

My favorite question I fielded from my case manager at the time was, “Do you perform a lot of wound care?” Imagine trying to convince CMS officials that, like them, I was the steward of an organization’s money.

I wasn’t convincing enough to ward off inspection, but I was able to correct the main issue, which, according to CMS, was level of service provided to hospital patients. Upon adopting an electronic health record (EHR), I discovered that we were inadvertently under-billing for our services and not being credited for all the work we were doing.The other eye-opener came from the power of seeing our healing rates and further validation that our model was and could be successful beyond doubt.

After auditing ended, we decided the emotional stress of the experience, combined with the continued financial hardships we faced, were not worth continuing the venture. Having to wait several weeks beyond what is typically expected to receive Medicare reimbursements as our documentation went under formal review created lengthy gaps and disruptions in our payments.We decided to discontinue home visits after little more than one year. Today, we’re proof that going through any type of audit can certainly be a career-changing event. Though miser-

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able and taxing, my auditing experience proved to be valuable in the sense that the knowledge gained made me stronger and wiser, professionally and personally. Being proactive and diligent with documentation is the best advice I can offer fellow providers, and the best way to be proactive, in my opinion, is by utilizing a reputable EHR that’s wound care-specific.

Hypothetical Clinical Case files Physician Supervision of Hospital-Based Outpatients Typical Scenario: Regional Medical Center’s busy hospital outpatient wound care department (HOPD) is open five days per week, has seven treatment rooms, and generally maintains a full schedule.

The Problem: Dr. Doeslittle, an internist/gastroenterologist and the HOPD medical director, works in the HOPD every day except Thursday mornings (when he performs endoscopy procedures) and Friday afternoons (when he does consults in his office, which is about seven miles away).

Dr. Toe, a podiatrist, works in the HOPD on Thursday mornings. The HOPD nurses perform “nurse only visits” on Friday afternoons. Dr. Doeslittle still covers the hyperbaric patients on Thursday mornings and Friday afternoons, with the staff calling him for any issues.

What Should Happen? First, the HOPD program director and medical director should carefully review the hyperbaric oxygen therapy (HBOT) supervision

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audit requirements set forth by the Centers for Medicare & Medicaid Services, the Medicare contractor that processes their claims, and Undersea and Hyperbaric Medical Society guidelines. Then, all should verify whether or not the regulations, as well as the hospital bylaws and Dr. Toe’s hospital privileges, permit Dr. Toe to supervise HBOT therapy. If “yes,” all need to ensure Dr. Toe’s Thursday morning schedule includes time for him to be in the HBOT unit at the appropriate times. If “no,” all need to staff another physician to provide the appropriate HBOT unit supervision on Thursday mornings. A physician must be scheduled to work on the HBOT unit on Friday afternoons. Supervising an HBOT unit from miles away will not meet any stakeholders’ regulations and guidelines.

Serial Billing Vs. Episodic Billing (Billing Frequency) Typical Scenario: Mr. Jones is receiving care in the hospital-based outpatient wound and hyperbaric department (HOPD) for a Wagner grade-III diabetic foot ulcer. During the month of April, he undergoes 17 hyperbaric oxygen therapy (HBOT) treatments as well as the application of Apligraf® and two MIST Therapy® therapy sessions.

The Problem: Our Lady of Serial Billing Hospital has chosen to bill its wound and HBOT charges on one monthly claim. The monthly claim for Mr. Jones lists “diabetes” as the first diagnosis code and lists “ulcer” as the secondary diagnosis code. Consequently, the Medicare contractor denies payment for the application of both Apligraf and MIST. In order for these treatments and procedures to be covered by the contractor processing the hospital’s claims, the hospital should enter the primary diagnosis in the first diagnosis position on the claim. NOTE: the primary diagnosis is the condition that is responsible for that particular encounter.

In some instances, the contractor’s local coverage determinations (LCDs) provide specific directions regarding the covered diagnosis. In this example, the Medicare contractor’s HBOT LCD requires the diagnosis of “diabetes” (eg, 250.8X) to be listed first on the claim and “ulcer” (eg, 707.X) to be listed as secondary. Contrarily, the contrac-

tor’s LCD for bioengineered tissue requires “ulcer” to be listed as the primary diagnosis code (eg, 707.X) with “diabetes” (eg, 250.8X) to be listed as secondary.

Why does it matter which diagnosis is listed first on the claim? The payers use the diagnosis codes to identify medical necessity for the treatment or procedure. Many LCD’s have specific limitations of coverage when other diagnoses are listed as the first diagnosis. For example, if a product is only approved for use on a diabetic ulcer and the primary diagnosis code is recorded as a “vascular ulcer,” the procedure might be deemed “experimental and investigational” for that use. When the hospital submits a monthly serial bill, all services (including services from other departments) for the patient’s care for that month are submitted on the same claim. Therefore, all diagnosis codes for those services compete for the first diagnosis space and the limited number of secondary spaces on the claim. In fact, some diagnosis codes may never make it on a serial bill due to the lack of space.

What Should Happen? The facility should have registered the patient at each visit or treatment and should have submitted a separate bill for each visit.That could have ensured the appropriate primary and secondary diagnosis codes were on the claim in the correct order to support medical necessity for the services, the procedure, or the product. When facilities submit monthly serial bills, they often lose money due to unnecessary denials for lack of medical necessity.

New Vs. Established E/M Clinic Visit Codes Typical Scenario: Mr. Frail returns to the hospital-based outpatient wound department (HOPD) after an absence of two years. Previously, he received care by Dr.Vein, a vascular surgeon, for a small venous stasis ulcer and was otherwise healthy for his age. Since then, Mr. Frail has been in a car accident that resulted in paralysis.

Subsequently, Mr. Frail has developed multiple stage IV pressure ulcers. He is on 15 new medications and has a four-inch-thick stack of medical records to review.

The Problem: During Dr. Vein’s vacation, his colleague Dr. Frustrated, a physician

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in the same vascular surgery group, sees the patient to care for his new pressure ulcer. Dr. Frustrated bills Medicare for a level V newpatient visit (99205). The HOPD has been incorrectly advised that its coding should always match the physician’s. Therefore, the HOPD also bills for a new-patient clinic visit (99205). When the coders for Dr. Frustrated and for the HOPD prepare the actual claims, they down-code both claims to 99215 on the grounds that the care of Mr. Frail’s new wound is actually an established visit.

What Should Happen? Despite 1) seeing the patient for the first time; 2) evaluating a new problem with an extensive history, physical, and medical decision making; and 3) impeccable documentation in the medical record, the vascular surgeon should have used the established-visit code (99215). This is based on the Medicare regulation that the physician can only bill for follow-up visits if the patient has received services either by the same physician or any physician of the same specialty in the same group practice (within the preceding three years). For more information, visit the Medicare Quarterly Provider Compliance Newsletter at www.cms.gov.

The HOPD should have used an established-visit code. This is based on the Medicare regulation that the HOPD can only bill for follow-up visits if the patient has a medical record number anywhere in the healthcare system during the previous three years.

However, the HOPD clinic visit level should be based on its clinic visit level mapping system. It should not be based on the physician’s evaluation and management (E/M) level.

NOTE: If the physician and/or HOPD accidently was/were paid for a new E/M clinic visit, when they should have been paid the established-visit rate, upon an audit they may be asked to repay the Medicare program.

Diagnosis Codes That Don’t Reflect Documentation Typical Scenario: St. Elsewhere Hospital has an extremely busy, large outpatient wound care department (HOPD) located in a metropolitan area that’s also home to several other HOPDs. St. Elsewhere advertises heavily and provides regular chronic wound care education to the providers in its community. The professional staff at the HOPD takes pride in its “center of excellence” that

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INCREASING EFFICIENCY o Precision controls and display allow for easy viewing and adjustment by the technician o The communication system provides the ability hear the patient via the control panel speaker or through the handset for private two-way communication o The easily accessible ventilation control allows for adjustment of the gas flow through the chamber to allow for Oxygen Conservation and the adjustment of gas flow to the chamber are easily achieved through the convenient and accessible ventilation control on the front panel

audit excels in wound-bed preparation and early intervention with advanced modalities such as bioengineered tissues.

The Problem: To that end, St. Elsewhere routinely stocks several types of bioengineered tissues (frozen and temperaturemonitored) in the supply room. If patients aren’t healed after 4-6 weeks, the physician makes the decision to use one of the bioengineered tissues during a visit. This gets tricky with patients who have, for example, a traumatic wound to the lower extremity or a pressure ulcer to the heel. If the physicians make the medical decision to use one of the bioengineered tissues, they change the patient’s diagnosis to reflect a diabetic foot ulcer or venous leg ulcer (if they state that the diagnosis is a venous leg ulcer, they add extremity compression to the treatment plan).

What Should Happen? St. Elsewhere staff is not allowed to change the diagnosis to a condition that does not accurately describe the patient’s condition. This is particularly problematic if a diagnosis is changed just to obtain reimbursement. Treatment options should always be discussed with the patient.

If a particular treatment is normally covered

by Medicare, but is not covered for a particular condition, St. Elsewhere staff should review the Advanced Beneficiary Notice of Noncoverage (ABN) with the patient. The ABN should clearly explain the costs the patient will incur (to the physician for his/ her work, and to the HOPD for its work and the product) if he/she wishes to proceed with the treatment. The patient should mark his/ her decision on the ABN and should sign the ABN. By doing so, staff will know if the patient wishes to proceed with the treatment.

Modifiers That Don’t Reflect Documentation Typical Scenario: Nurse Jones is working in your average hospital-based outpatient wound care department (HOPD) under the direct supervision of a physician. She performs a negative pressure wound therapy (NPWT) dressing change.When these charges are entered into the billing system and they cross over to the business office, the hospital coder notes that the NPWT procedure code (97605) is linked to the 420 revenue code on the HOPD’s charge description master.

The Problem: The coder knows the

420 revenue code must be accompanied by a therapy modifier or it will be rejected.Therefore, the coder attaches a modifier (eg, GN, GO, or GP).The modifier communicates that either a physical therapist (PT), occupational therapist, or speech therapist performed the service. When Medicare pays this charge it will be based on its physician fee schedule, which is paid at a lower rate than the rate for an HOPD. More importantly, if audited, the chart will not reflect that this service was provided by a PT and that a PT’s plan of care will not be present in the medical record.

What Should Happen? The NPWT service should not have been linked to the 420 revenue code in the HOPD’s charge description master. The coder should have read the medical record to verify if a therapist performed the service before adding the therapy modifier to the code.

Surgical Procedures That Aren’t Appropriately Documented Typical Scenario: Dr. Lightfoot is a podiatrist with a busy private practice and works in a hospital-based outpatient wound care department (HOPD). He’s often at odds with the revenue integrity department because of frequent queries related to his documentation of procedures he has done in the HOPD. The Problem: His debridement documentation simply states that a “subcutaneous debridement” was performed, with no reference to the type of tissue that was removed.

For heel pressure ulcers that began as stage IV, he documents muscle debridement each time because “once a stage IV, always a stage IV.” If there is tendon exposed and he curettes the surface, he documents a muscle debridement.

HOPD staff members are not comfortable charging for the higher-level debridements, but Dr. Lightfoot’s documentation is vague for any level of charge. When challenged by the revenue integrity department, Dr. Lightfoot says, “I document and charge the same way in my private practice, and I have no issues.” Therefore, he is not willing to change his documentation to correctly describe the surgical procedures he performs.

What Should Happen? To accurately represent the procedure performed, Dr. Lightfoot must document the level of any tissue removed during the debridement procedure. The rule for assignment of debride-

ment codes is to “select the code by the type of tissue that was debrided and removed, rather than the deepest level of the wound seen.” Coding rules apply to physicians and HOPDs. Dr. Lightfoot is personally responsible for his claims should he be audited, just like the HOPD is responsible for its claims should it be audited.The HOPD medical director and/or hospital’s chief medical officer should discuss this inadequate documentation with Dr. Lightfoot. If Dr. Lightfoot does not document a full accurate procedure report when he debrides, debridement should not be billed by the HOPD and by the physician.

Inappropriate Number of Billing Units Typical Scenario: Dave Diabetes has a 70 sq cm diabetic foot ulcer. Dr. Foot applies 75 sq cm of Dermagraft® on March 10, 2012. Because Dermagraft is available in 37.5 sq cm pieces, the HOPD orders two pieces for each application. Dr. Foot’s documentation in the medical record is thorough and correctly explains the 24 application steps.

The Problem: When the physician completes the charge sheet, he correctly states that he performs one unit of 15275 and two units of 15276. Unfortunately, Dr. Foot forgets that he is supposed to report the product code (Q4106) per sq cm. Instead, he marks the charge sheet with two units, because in his mind he used two pieces. As such, the coder does not abstract the medical record to see how many sq cm were used and wasted. Therefore, she bills 2 sq cm on March 10 and 2 sq cm on March 17. As a result, the hospital-based outpatient wound care department (HOPD) is reimbursed for 2 sq cm of product ($66.04 [80% of allowable]) rather than the $2,476.68 Medicare allowable for the two pieces.

What Should Happen? The physician should have completed the charge sheet correctly with one unit of 15275 and two units of 15265 for the application of the product to a 70 sq cm wound, and with 75 sq cm of Q4106 for the product itself.

NOTE: HOPDs are required to submit the Current Procedural Terminology® code for the application of the product and the Healthcare Common Procedure Coding System code for the product itself on the same date of service on the claim.

See Signs of an Impending Audit: Are You Waving Red Flags? on page 38

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MATRIX for success

Wound Care & Hyperbaric Medicine Consultation

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patient care while increasing your bottom line Through a variety of management or consulting options, we can create a custom plan to optimize your wound care program and help you increase your revenues, decrease your liabilities and speed the healing of problem wounds with our proven system.

Program Elements: • • • •

Management of Wound Care/HBOT Programs Procurement & Installation of Equipment Physician & Staffing Coordination & Training Implementation of Clinical & Operational Procedures

• Policies & Procedures, Guidelines, and Forms • Billing & Coding • Outcomes Trending • Community Relations Programs • Reimbursement Strategies • Performance Improvement

MATRIX provides a framework that integrates education with execution to increase both the physical and fiscal health of your wound care program. That’s our MATRIX for success.

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clinician’sreport

Management Solutions

The Center for Wound Healing Inc.

Healogics

WEBSITE: www.centerwh.com CONTACT: 855-443-2532 LOCATION: Tarrytown, NY FOUNDED: 1999

WEBSITE: www.healogics.com CONTACT: 800-379-9774; development@healogics.com LOCATION: Jacksonville, FL FOUNDED: 1984

Company description: The Center for Wound Healing Inc. (CFWH) develops and manages wound care centers that offer specialized wound care and hyperbaric medicine services in conjunction with acute care hospitals.With nearly 50 comprehensive wound centers across the US, CFWH contracts with hospitals to manage wound care facilities and is responsible for the management of and/or assistance with such services as patient scheduling, hospital billing (patient services are billed directly by hospitals to insurance companies), and oversight of all non-medical staff. CFWH also takes responsibility for designing and installing the necessary leasehold improvements of hospital-provided space and supplying appropriate furniture, fixtures, and equipment (including hyperbaric chambers) used in wound centers. Through medical leadership based upon a multidisciplinary team of physicians and defined clinical standards, CFWH is committed to achieving extraordinary patient results while simultaneously providing physicians and hospitals with professional and economic opportunities. CFWH often partners with hospitals on multi-year contracts with fixed or variable fee schedules based on services provided.

Company description: Healogics is the largest provider of

Most popular product or service: Comprehensive wound care management with advanced modalities and therapies. n

Comprehensive Healthcare Solutions Inc.

WEBSITE: www.comprehensive-healthcare.com CONTACT: Karin Roemers-Kleven, RN, CWS, FACCWS; 800-232-5070

LOCATION: Tacoma, WA FOUNDED: 1998 Company description: Comprehensive is a wound management company that helps US hospitals develop successful outpatient wound and hyperbaric programs. Comprehensive offers turnkey management services and hybrid services, and provides consultation to develop programs or enhance existing programs. Comprehensive is unique in that it offers a shorter duration for contracts with excellent results.

Most popular product or service: Consultation services for time-limited periods, especially during the transition from a turnkey management agreement. n 28

wound care and related disease management in the US.The network manages more than 500Wound Care Centers® in more than 10 percent of US hospitals. Through its vibrant and connected networks of care and sustainable clinical excellence, Healogics achieves clinical, operational, and financial results. Healogics provides hospitals with the innovation,resources,and talent to provide more patients with affordable access to lifesaving wound care.

Most popular product or service: Outpatient wound care centers; comprehensive web-based outcomes management system and wound information database; and accredited education and training programs taught by internationally known wound care experts. n

Matrix Health Services LLC WEBSITE: www.aboutmatrix.com CONTACT: 504-906-1024; bevenson@matrixhealthservices.net LOCATION: Madisonville, LA FOUNDED: 2003 Company description: The Matrix business model is based on more than 30 years of healthcare experience,including administration of programs, implementing clinical/technical wound care procedures, and dealing with financial/reimbursement issues.The company was designed on the belief that a strong clinical base serves as the foundation for success, aided by the clear understanding that appropriate pre-certification, documentation, coding, and billing are essential for a center to be successful and improve quality of life for patients.The Matrix staff is well-versed in every aspect of wound care and hyperbaric medicine,having extensive experience in problem wound management. As a result, Matrix provides medically appropriate, evidence-based, state-of-the-art programs that are clinically effective and financially sound.

Most popular product or service: The Quick Launch to Excellence program. Many client hospitals have the capital and manpower to develop a comprehensive wound center, but want to save money and time by hiring Matrix to guide them through the arduous process of developing a wound center.This program is designed to offer the “start up” support that is needed, develop ongoing clinical and operational processes, and provide the tools and plans for continued success. n

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PathoGenius® . . . A S C E R TA I N A S D N A !

The proprietary DecodEx® test by PathoGenius® Laboratories comprehensively defines the wound bioburden, with DNA level certainty (including fungi).

MICROBIAL REALITY: • 99% of chronic wounds are polymicrobial, with high abundance.

• Traditional cultures can identify < 5% of known microbes. Further, these microbes regularly make up < 1% of wound bioburden.

• In a recent clinical trial (J Wound Care 2011: 20(5); 232), PathoGenius® testing in combination with patient specific topical gels, demonstrated a wound closure rate ~100% greater in every period, compared to traditional culture directed therapy (n = 1378 patients).

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industryinsider An Inside Look at PathoGenius Laboratories

A

n interview with John P. Kennedy, RPh, PhD, clinical advisor, PathoGenius Laboratories

TWC: How did you enter wound care?

JK: My career started as a researcher in the pharmaceutical industry. I did not have a direct link to wound care in “Big Pharma,” unless you consider antibiotics, but I did get a relatively strong background in chronic diseases.As it turned out, many of John P. Kennedy, RPh, PhD the same biological Clinical Advisor, PathoGenius Laboratories signals and pathways are involved in inhibiting tissue growth (cancer) as promoting tissue growth (wounds); therefore, that experience has proven to be more relevant than I would have anticipated. I began to focus on chronic infection in 2000, which led me to biofilm-based investigations that included chronic wounds.In 2006,I started working more in academia, which included a clinical component.Coming full circle, I now had the opportunity to work again with patients as a clinician while pursuing my wound research interests. At this academic post, I continue to focus my clinical and research efforts on bioburden and biofilm-based wound care strategies.

TWC:What’s your day-to-day role?

JK: Serving as a clinical advisor to wound care providers treating patients, especially those that leverage our diagnostic services.Diagnostic reports,no matter how advanced and accurate, must be translated into treatment regimens in order to impact patient outcomes. Therefore, quite early in our history we began to identify 30

expert clinical advisors as a resource to our provider network. My other focus is the expansion of current service offerings through development and continuous improvement. Due to the significant differences I have witnessed our services make in the lives of patients, our work to date has to be some of the most rewarding work I have been a part of professionally.

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

JK: This is an easy answer - impacting the quality of patients’ lives.When I was an industry-based researcher,I lost sight of the patients who ultimately benefitted from our research.The patients were simply too far downstream, almost virtual.Too often, we also had little input into what “problem” we would attack with the research resources at our disposal. Now that I am independently back in the clinic, I see on a daily basis the impact our work has on our patients’ quality of life. It’s real, tangible,and unfiltered — and it gets personal.

Such a perspective drives an expediency that, like it or not, you personally “feel.”

The expediency is impossible to avoid and you don’t have the luxury of scheduling a roundtable of scientists to debate it.

TWC: What’s new with PathoGenius?

JK: Technically, I would say the expansion of our rapid detection panel leads the charge.This will significantly increase the utility of our 24-hour, level 1 report, especially for chronic wound specimens. This new panel should decrease the time from diagnosis to treatment for many patients.

“Time is tissue,” so we are always looking to move patients from diagnosis to therapy as soon as possible. Even a couple of days is not a trivial time period to us.

Clinically, I would highlight that we have

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more outcomes data than ever before.We certainly expect that to continue, but the evidence has now surpassed critical mass.

The adoption of our services by clinical sites across the nation has expanded our clinical experience and successes immensely. It’s the kind of “win-win” we hoped for. Historically, we have focused on outpatient services; however, in 2012 we are introducing our services to more acute settings than ever. It’s a logical progression that we are glad to see transitioning to institutions.

TWC:How is your company unique?

JK: Literally, we are as unique as every wound on every patient.That is the nature of DNA-guided personalized medicine.

While the process for wound evaluation and diagnosis is protocol-driven, the actual therapy cannot be automated or massproduced due to the microbial diversity within wounds. For chronic wounds, the diversity is broad. Bacteria, yeast, and fungi have all proven significant; therefore, the treatment consults generated by our discipline-specific clinical advisors reflect that diversity. The result is an extremely targeted therapeutic regimen that’s unique to each patient. That said, this integrated diagnostic/treatment protocol essentially provides wound care the ability to diagnose microbial bioburden accurately, and then to treat. No more trial and error.That is not unique in medicine. One could argue this defines modern medicine; regardless, this is the first time such an objective approach has been available in wound care, especially for bioburden.

TWC:Why are you passionate about your company?

JK: I know firsthand from the clinic the difference it makes in outcomes and www.todayswoundclinic.com

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®

Dermagraft : Human Fibroblast-Derived Dermal Substitute Essential Prescribing Information Numbers in parentheses ( ) refer to sections in the Directions for Use of the product labeling.

Device Description: Dermagraft is a cryopreserved human fibroblastderived dermal substitute. (1) Intended Use/Indications: Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than 6 weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot. (2) Contraindications: • Dermagraft is contraindicated for use in ulcers that have signs of clinical infection or in ulcers with sinus tracts • Dermagraft is contraindicated in patients with known hypersensitivity to bovine products, as it may contain trace amounts of bovine proteins from the manufacturing medium and storage solution (3) Warnings: None (4) Precautions: Caution: The product must remain frozen at -75°C ± 10°C continuously until ready for use.

Caution: Do not use any topical agents, cytotoxic cleansing solutions, or medications (e.g., lotions, ointments, creams, or gels) on an ulcer being treated with Dermagraft as such preparations may cause reduced viability of Dermagraft.

Caution: Do not reuse, refreeze, or sterilize the product or its container.

Caution: Do not use the product if there is evidence of container damage or if the date and time stamped on the shipping box has expired.

Caution: Dermagraft is packaged with a saline-based cryoprotectant that contains 10% DMSO (Dimethylsulfoxide) and bovine serum. Skin and eye contact with this packaging solution should be avoided.

Caution: Dermagraft has not been studied in patients receiving greater than 8 device applications.

Caution: Dermagraft has not been studied in patients with wounds that extend into the tendon, muscle, joint capsule, or bone. Dermagraft has not been studied in children under the age of 18 years, in pregnant women, in patients with ulcers over a Charcot deformity of the mid-foot, or in patients receiving corticosteroids or immunosuppressive or cytotoxic agents.

Caution: To ensure the delivery of metabolically active, living cells to the patient’s wound, do not hold Dermagraft at room temperature for more than 30 minutes. After 30 minutes, the product should be discarded and a new piece thawed and prepared consistent with Preparation for Use instructions.

Caution: The persistence of Dermagraft in the wound and the safety of this device in diabetic foot ulcer patients beyond 6 months has not been evaluated. Testing has not revealed a tumorigenic potential for cells contained in the device. However, the long-term response to these cells is unknown.

Caution: Always thaw and rinse product according to the Preparation for Use instructions to ensure the delivery of metabolically active, living cells to the patient’s wound.

Caution: Do not use Dermagraft after the expiration date indicated on the labeled unit carton. (5) Adverse Events: In clinical studies conducted to date, the overall incidence of reported adverse events was approximately the same for patients who received Dermagraft compared to those who received the Control treatment. (6)

30_32_TWC_August_industry.indd 32

Maintaining Device Effectiveness: Dermagraft must be stored continuously at -75°C ± 10°C. Dermagraft must be thawed and rinsed according to the Preparation for Use instructions. After the initial application of Dermagraft, subsequent sharp debridement of the ulcer should continue as necessary. Additional wound preparation should minimize disruption or removal of previously implanted Dermagraft. (13) Patient Counseling Information: After implantation of Dermagraft, patients should be instructed not to disturb the ulcer site for approximately 72 hours (3 days). After this time period, the patient, or caregiver, should perform the first dressing change. The frequency of additional dressing changes should be determined by the treating physician.

Patients should be given detailed instructions on proper wound care so they can manage dressing changes between visits. Compliance with off weight-bearing instructions should be emphasized. Patients should be advised that they are expected to return for follow-up treatments on a routine basis, until the ulcer heals or until they are discharged from treatment. Patients should be instructed to contact their physician, if at any time they experience pain or discomfort at the ulcer site or if they notice redness, swelling, or discharge around/from the ulcer. (8) How Supplied: Dermagraft is supplied frozen in a clear bag containing one piece of approximately 2 in x 3 in (5 cm x 7.5 cm) for a single use application. The clear bag is enclosed in a foil pouch and labeled unit carton.

Caution: Dermagraft is limited to single-use application. Do not reuse, refreeze, or sterilize the product or its container.

Dermagraft is manufactured using sterile components and is grown under aseptic conditions. Prior to release for use, each lot of Dermagraft must pass USP Sterility (14-day), endotoxin, and mycoplasma tests.

In addition, each lot meets release specifications for collagen content, DNA, and cell viability.

Dermagraft is packaged with a salinebased cryoprotectant. This solution is supplemented with 10% DMSO (Dimethylsulfoxide) and bovine serum to facilitate long-term frozen storage of the product. Refer to the stepwise thawing and rinsing procedures to ensure delivery of a metabolically active product to a wound bed. (9) Customer Assistance: For product orders, technical support, product questions, reimbursement information, or to report any adverse reactions or complications, please call the following number which is operative 24 hours a day: Advanced BioHealing Customer Service: 1-877-Dermagraft (1-877-337-6247) Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

Manufactured and distributed by: Advanced BioHealing, Inc. 10933 N. Torrey Pines Road Suite 200 La Jolla, CA 92037 US PAT Nos 4,963,489; 5,266,480; 5,443,950 Dermagraft is a registered trademark of Advanced BioHealing, Inc. Registered in US Patent and Trademark Office ©2011 Advanced BioHealing, Inc. All Rights Reserved.

industryinsider the quality of life for our patients. At the same time, that is our primary challenge. What can we do more, or better, to encourage providers to simply try an integrated and personalized approach? As a clinical advisor, my contribution requires personal relationships, which take time. Creating relationships one clinician at a time, often regarding a single patient, is the only approach I really know. Besides, I am a clinician myself, and, if I’m honest, I can be quite skeptical.While I like to think I am open to alternate approaches, ultimately I need to see for myself, regardless of any recommendation or even (dare I say it) evidence. As a researcher, I know far too well what a fleeting imposter some “evidence” can be when transferred to a real-world clinic. That said, when I start working with a clinical site, I am never anxious. I am more impatient for the results than the clinic! I am eager and comforted by the fact that I know with confidence a priori that their patients will indeed get improved outcomes.

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

JK: Improved patient outcomes. We are confident of the impact our protocols have on absolute healing and average days to healing. We have internal challenges as well. While effective, DNA-guided personalized medicine is still new to many clinicians, including wound care specialists. Therefore, we will always bear the burden of education for adoption in routine practice.

TWC:What are your most popular products/services?

JK: The integration of molecular diagnostics and personalized wound care. It’s nothing short of DNA-guided personalized medicine for wound care providers and the patients they serve. (Or, as my students would say,“Pretty cool stuff, Dr. K.”) TWC: How do you ensure proper training on products and services?

JK: We provide webinars, live continuing education, video, and print materials. The most common subject areas are biofilms, specimen collection, report interpretation, treatment options, and how to handle specific clinical scenarios such as combination with other treatment options like dermal substitutes. Clinical advisors such as myself are also available to address any specific case directly.

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

JK: Expanding our diagnostic capabilities and treatment options. Our rapid detection panel will be expanded significantly to increase our 24-hour turnaround utility, a significant improvement for specimens as diverse as chronic wounds. We are constantly expanding our bioinformatic scope, making our library of DNA and associated therapeutics more comprehensive. n For more information on PathoGenius Laboratories, call 806771-1134 or email info@pathogenius.com. www.todayswoundclinic.com

8/8/12 3:17 PM

The symposium on

adv an ced wound care

SAWC FALL

®

AAWC

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

2012

September 12–14 B altimore Convention Center B altimore,

Maryland

Where Wound Care Clinicians Go For Answers

O

ver the last quarter century, the S ymposium on Advanced Wound Care (S AWC) has become internationally known as the premier educational program in wound care. N o other fall meeting has more programs and sessions geared to clinicians at wound care clinics. S AWC Fall offers up to 16 AMA PRA Category 1 Credits™, 41 new clinical sessions and a specific Wound Care Clinic track.

R obert Kirsner, MD, PhD V ice Chairman and S tiefel Laboratories P rofessor D epartment of D ermatology and Cutaneous S urgery U niversity of Miami Miller S chool of Medicine Miami, FL

D ot Weir, RN , CWON , CWS Clinical Coordinator, Wound Care O sceola R egional Medical Center Kissimmee, FL

TOP Se ssion s Y o u Won’t F ind A t O t her Wo und Care Conferen

ce s

• Crisis 2012: The P andemic O f Wounds • What Y ou S hould Know About D rugs That Inhibit Wound H ealing • D o Wound Clinics Benefit P atients?

• Growth Factors And Advanced Therapies For Wounds: D oes The FD A E xpect Too Much?

• N egative P ressure Wound Therapy: D o The D ata S uck?

• E merging Treatments For D iabetic Foot U lcers • What’s D own The P ike For V enous Leg U lcers?

• Getting P aid: The Finances O f Wound Care • R eality Check: What Y ou S hould Know About P alliative Wound Care • E merging Insights O n P ost-Amputation R ehabilitation

E ndorsed by the

F or more information and a full list of sessions, please visit www.sawcfall.com.

Who Should A ttend: This conference is designed for physicians, researchers, podiatrists, nurses, physical therapists and dietitians involved in wound healing or wound care issues. S AWC Fall provides attendees who study and treat wounds with state-of-the-art reviews of clinical problems and research information.

L earning O bjectives: After attending this conference, participants should be able to do the following: • Illustrate key factors that may delay or inhibit wound healing • E xamine proven and emerging scientific rationale behind wound care principles and how to translate them to clinical practice • D iscuss the latest advances in current and emerging diagnostic and healing techniques, and review ongoing or recently completed trials involving wound therapies • R ecognize the mechanisms behind the development of unusual wounds • Assess current and emerging healing techniques in wound care • Investigate critical elements associated with proper management of unusual and pediatric wounds, and review ongoing or recently completed clinical trials involving wound therapies •A ppraise the evidence base of commonly used wound management strategies • E xplore the realities of delivering healthcare beyond clinical issues such as wound clinic office politics and the finances of wound care • P rovide optimal healthcare delivery through improved understanding of sites of service and payment schema

SAWC_FALL_2012_1-PAGE_TWC.indd 2

Acc reditation Information In support of improving patient care, N orth America Center for Continuing Medical Education, LLC (N ACCME), is accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE ), and the American N urses Credentialing Center (AN CC) to provide continuing education for the healthcare team.

Physicians: N orth American Center for Continuing Medical E ducation, LLC (N ACCME ), designates this live activity for a maximum of 16 AMA PRA Category 1 Credits™. P hysicians should claim only the credit commensurate with the extent of their participation in the activity.

Nurses: This continuing nursing education activity awards 16.0 contact hours.

P rovider approved by the California Board of R egistered N ursing, P rovider N umber 13255 for 16.0 contact hours.

Podiatrists: N orth American Center for Continuing Medical E ducation, LLC (N ACCME ), is approved by the Council on P odiatric Medical E ducation as a sponsor of continuing education in podiatric medicine. This program is approved for 16 contact hours.

Dietitians: N orth American Center for Continuing Medical Education, LLC (N ACCME), is a Continuing Professional Education (CPE ) Accredited Provider with the Commission on D ietetic R egistration (CDR ). R egistered dietitians (RD s) and dietetic technicians, registered (D TR s) will receive 16 continuing professional education units for completion of this program.

CDR Accredited P rovider #HM 001 Level 3 S ynthesis Level

Physical T herapists: N orth American Center for Continuing Medical E ducation, LLC (N ACCME ), will apply for pre-approved accreditation in Florida, Louisiana, N evada, O hio, and Texas which require pre-approval.

N ACCME will apply for pre-approval in California for targeted sessions. If you practice in another state, please consult your P T board.

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

R equirements for Credit: To be eligible for documentation of credit for each session attended, participants must participate in the full activity and complete the online general survey and the online evaluation form for each session by O ctober 14, 2012. Complete the forms at www.myexpocredits. com/naccme; once done, participants may immediately print documentation of credit.

Copyright © 2012 by N orth American Center for Continuing Medical E ducation, LLC. All rights reserved. N o part of this accredited continuing education activity may be reproduced or transmitted in any form or by any means, electronic or mechanical, without first obtaining permission from N orth American Center for Continuing Medical E ducation.

ADA Statement: N orth American Center for Continuing Medical E ducation complies with the legal requirements of the Americans with D isabilities Act and the rules and regulations thereof. If any participant in this educational activity is in need of accommodations, please call 609-371-1137.

INFORMATION CONTAINED WIT HO UT NOTI CE .

HEREIN IS SUB JE CT TO CHAN GE

7/31/12 4:59 PM

conferenceconnection W

ith more than two decades of providing the interdisciplinary wound care community with an opportunity gather, network, learn, and socialize, the Symposium on Advanced Wound Care (SAWC) has become the largest wound care conference in the US. This regular column offered by Today’s Wound Clinic will feature conference previews, reviews, and assorted news items.

SAWC FALL

®

THE SYMPOSIUM ON ADVANCED WOUND CARE

SAWC Fall Coming to Baltimore, MD

The Symposium on Advanced Wound Care (SAWC) Fall 2012 conference will be held Sept. 12-14 at the Baltimore (MD) Convention Center. Up to 40 new clinical sessions as well as a major exhibition of products and services for wound care professionals will be available.

SAWC Offers National Cert Prep

Highlighting Wound Care Sessions At SAWC Fall 2012

Physicians, nurses, physical and occupational therapists, physician assistants, advanced practice nurses, and other wound care providers interested in a comprehensive review of current wound care practices are being offered the opportunity to participate in The Wound Certification Prep Course,TM a 17-hour, intensive seminar taught by nationally recognized experts and educators in wound care.A co-located event being held in conjunction with SAWC, the course will take place Sept. 10-11 in the Baltimore Convention Center and provide a comprehensive review of topics related to wound management. The course also includes practice tests and test-taking strategies. For more information, visit www.wcpcfall.com.

Among the 40 new clinical sessions that will be available to wound care professionals at the Symposium on Advanced Wound Care (SAWC) Fall 2012 conference in Baltimore, MD, are:

Wound Care Education Tracks Offered at SAWC Fall Healthcare providers who attend the Symposium on Advanced Wound Care (SAWC) Fall 2012 conference in Baltimore, MD, Sept. 12-14, will have the opportunity to choose among three clinical tracks that offer a variety of sessions in order to tailor one’s experience. The three tracks are: 1) “Translating Science to Practice,” which discusses proven and emerging scientific rationale behind many of the core wound principles and treatments such as impaired wound healing, stem cells, and emerging therapies; 2) “Advanced Treatment of Difficult Wounds,” which features a clinically focused collection of sessions that recognize the mechanisms behind the development of unusual wounds, including proper assessment methods and a review of ongoing or recently completed clinical trials involving wound therapies and 3) “Wound Care Clinic,” which provides a practical overview of critical issues clinicians frequently encounter in the wound care center, such as non-healing wounds and the appropriate use of compression, engineered skin, and negative pressure wound therapy.

34

Translating Science to Practice: Skin Care — Can You Prevent Pressure Ulcers?

When: Sept. 12.

Moderator/speaker: Joyce M. Black, PhD, RN, CPSN, SWCN, FAAN Speaker: Aamir Siddiqui, MD Synopsis: Investigate the spectrum of opinion regarding pressure ulcers and whether they are truly preventable.

Advanced Treatment of Difficult Wounds: Why Did My PAD Patient Die? — Risk Factor and Outcomes Modification When: Sept. 12.

Moderator/speaker: Diane Treat-Jacobson, PhD, RN, FAHA, FAAN Speaker: Dan Federman, MD Synopsis: Enhance your understanding of the importance of earlier diagnosis and risk factor modification in patients with pre-existing or established cardiovascular disease in improving patient outcomes.

Wound Care Clinic: Post-Amputation Rehabilitation When: Sept. 13.

Moderator/speaker: Robert Gailey, PhD, PT Speaker: John R. Fergason, CPO Synopsis: Learn how to build an individualized, comprehensive rehabilitation plan for the amputee.

Wound Care Clinic: The Science of Compression Therapy for the Swollen Limb and Venous Ulcer When: Sept. 14.

Moderator/speaker: Terry Treadwell, MD, FACS

August 2012 Today’s Wound Clinic

34_35_TWC_SAWC.indd 34

www.todayswoundclinic.com

8/8/12 3:13 PM

sawcfall2012 Synopsis: The key to successful venous ulcer management lies in the use of compression therapy; however, various factors can impede a clinician’s ability to achieve

effective compression.

For the full SAWC Fall 2012 agenda, visit http://fall.sawc.net/agenda.

NACCME, SAWC Introduce Scholarship Program The North American Center for Continuing Medical Education LLC (NACCME), the continuing education sponsor of the Symposium on Advanced Wound Care (SAWC) spring and fall conferences, has announced in conjunction with SAWC and HMP Communications (publisher of Today’s Wound Clinic) the inaugural class of five scholarship winners who have been selected in cooperation with several prominent wound care societies and associations for their contributions to the industry. Winners were chosen based on nominations from several major wound care societies and associations, as well as key opinion leaders, and were honored during the annual SAWC VIP Party held April 19

in the Georgia World Congress Center, the hosting site of SAWC Spring 2012. Each scholarship winner earned complimentary registration to SAWC Spring 2012 along with a framed certificate. The inaugural list of winners included Susan Girolami, BSN, RN, CWOCN; Jeffrey S. Danetz, MD, FACS; Kenneth Finnson, PhD; Malgorzata “Gosia” Plummer, MD; and Jaimee Haan, PT, CWS. SAWC will honor fall scholarship winners at the next SAWC convention in Baltimore, MD, Sept. 12-14.

Below is a preview of the inaugural scholarship winners. For full bios on the first winning class, please visit www.todayswoundclinic.com.

Clinician: Susan Girolami, BSN, RN, CWOCN Presenter: Terry Treadwell, MD, FACS, president, Association for the Advancement of Wound Care Scholarship Award: Wound Care Nursing Scholarship Clinician: Jeffrey S. Danetz, MD, FACS, medical director of wound care at Edward White Hospital, St. Petersburg, FL; Largo (FL) Medical Center; and St. Petersburg (FL) General Hospital Presenter: Robert Kirsner, MD, PhD, co-chairperson, SAWC Scholarship Award: Wound Care Training Scholarship Clinician: Kenneth Finnson, PhD, research associate, Montreal General Hospital, McGill University Health Center, Department of Surgery

Presenter: Harriet Hopf, MD, president, Wound Healing Society Scholarship Award: Wound Healing Research Scholarship Clinician: Malgorzata “Gosia” Plummer, MD, assistant professor of clinical surgery, wound healing and tissue repair, University of Illinois at Chicago Presenter: William Ennis, DO, MBA, FACOS, president, American College of Wound Healing and Tissue Repair Scholarship Award: Wound Healing Fellow Scholarship Clinician: Jaimee Haan, PT, CWS, team leader, physical therapy wound management, rehabilitation services, Indiana University Health Presenter: Rose Hamm, DPT, CWS, president, American Physical Therapy Association Wound Management Special Interest Group Scholarship Award: Wound Care Therapist Scholarship

Online Exclusive: Meet the SAWC Scholarship Winners Today’s Wound Clinic recently spent time with the inaugural class of SAWC scholarship winners. Read their thoughts on the wound care industry and get a glimpse of their career sketches, available exclusively only at www.todayswoundclinic.com. www.todayswoundclinic.com

34_35_TWC_SAWC.indd 35

Today’s Wound Clinic August 2012 35

8/8/12 3:14 PM

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7/16/12 7/19/12 10:04 6:41 PM AM

audit Coming Storm continued from page 20

visits, 2) it uses the physician E/M level of service to select the facility E/M level of service (amazingly, some clinics still do this, despite Federal Register instructions to develop a system to represent “hospital staff ” work), 3) a paper audit tool is in use but there’s no compliance audit to ensure that what was “checked off ” is actually documented in the chart, or 4) the “point spread” of the audit tool is manipulated in order to lower total point scores and allow for billing a higher level of service (thus destroying the normal distribution and skewing charges to higher levels of service). A disaster preparedness plan for your wound center facility E/M revenue might be as follows:

• Potential vulnerability: Ask yourself whether your facility E/M services during the past year (there is no reason to look at smaller periods of time) create a pattern that would raise a red flag for an audit.

• Potential impact: Repayment of all services in question, penalties, and possibly sanctions.

• Specific preparation: Allow the tool to fit the clinical operation. It will not be possible for a hospital to have a universal tool that works in all outpatient clinics.

If you want to survive the coming storm, you will need to know your business better than auditors do. Remember,

the goal of disaster preparedness is to identify potential hazards, assess vulnerabilities, analyze potential impacts, and make specific preparations based on those assessments. After that, you can enjoy the good weather and not worry about those clouds on the horizon. n Toni Turner is executive director at InRICH Advisors - Outpatient Auditing Group,The Woodlands,TX. Reference 1. 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. 53(1):34-44, 2007.

Signs of an Impending Audit: Are You Waving Red Flags? continued from page 26

Physician Orders and Signatures

Typical Scenario: Dr. Dizzy practices at three hospital-based outpatient wound care department (two of which are in the same hospital system). The system with the two HOPDs has an electronic health record (EHR) that enables her to enter, review, and sign orders in the HOPD and remotely. The EHR allows her to stay current with her documentation and orders.The third HOPD uses paper documentation. Therefore, orders for work performed in the HOPD or for the work the nurses performed based on her telephone orders tend to accumulate.

The Problem: She signs the orders, dating them with the date on which she signs them.The HOPD wants her to date the orders for the date that the order was given verbally, since that’s when it should be signed per Joint Commission regulations.

What Should Happen? Orders must be written and authenticated based on hospital policy.An EHR makes this process easier, but the physician is responsible for signing orders within hospital policy time frame.

Place of Service Typical Scenario: Dr. Sew specializes in physical medicine and rehabilitation, but does not have an official office practice. He maintains an office strictly for business purposes. He works clinically at a local hospital outpatient wound care department (HOPD) three days per week. In addition, he works

38

onsite in a hospital-based long-term acute rehab center two days per week.

The Problem: When he sees patients in the rehab center, he documents the site of service as the “hospital.” When he sees patients in the HOPD, he documents the site of service as the “office.” His reasoning for billing the HOPD as his office is that he considers the HOPD “his private office” since he does not have a “private practice.”

What Should Happen? Dr. Sew should include the HOPD as the site of service on his claim forms. The overhead costs are paid by the HOPD. Therefore, the HOPD is not Dr. Sew’s office. When he provides medical services in the rehab facility, he should report that site of service on his claim form. The hospital is not the site of service and should not be reported on the claim form. For more information, visit the Medicare Quarterly Provider Compliance Newsletter at www.cms.gov.

Local Coverage Determinations Typical Scenario: Dr. Scalpel, whose Medicare Administrative Contractor (MAC) is located in Portland, has a Local Coverage Determination (LCD) limiting his surgical debridements to five per problem (eg, five per ulcer). He performs eight debridements on a diabetic foot ulcer over two months.

The Problem: Dr. Scalpel does not document any justification as to “why” more than five debridements are medically necessary.

What Should Happen? Even if his

August 2012 Today’s Wound Clinic®

18_20_TWC_august_feature2.indd 38

charges escape the edits of the LCD, Dr. Scalpel and the facility should be prepared to repay the MAC for three debridements, if audited. The likelihood of an audit is high because Dr. Scalpel and the hospital outpatient wound care department (HOPD) consistently exceed the LCD limit for surgical debridement.This billing pattern is an example of a Comprehensive Error Rate Testing (CERT) error.The CERT program measures improper payments in the Medicare Fee-forService (FFS) programs. CERT is designed to comply with the Improper Payments Elimination and Recovery Act of 2010; Public Law 111-204. Physicians should always have the latest LCDs and medical policies on file in a place where all medical professionals in the HOPD can access them while caring for Medicare-covered patients. In this case, Dr. Scalpel should have read the MAC’s debridement LCD. When he determined that it was medically necessary to surgically debride the wound for the sixth time, he should have stopped and discussed the situation with the patient. He should have given the patient an Advance Beneficiary Notice of Noncoverage, which includes the payment for the service that is expected to be denied coverage and payment. The patient then could decide to proceed and pay or decline service. n

Caroline Fife is chief medical officer at Intellicure Inc.; Dot Weir is clinical coordinator at Osceola Regional Medical Center

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8/8/12 3:24 PM

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Apligraf® Essential Prescribing Information Numbers in parentheses ( ) refer to sections in the main part of the product labeling.

Device Description: Apligraf is supplied as a living, bi-layered skin substitute manufactured from cells processed under aseptic conditions using neonatal foreskin-derived keratinocytes and fibroblasts with bovine Type I collagen. (1) Intended Use/Indications: Apligraf is indicated for use with standard therapeutic compression in the treatment of uninfected partial and/or full-thickness skin loss ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy. (2) Apligraf is indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness foot ulcers of neuropathic etiology of at least three weeks duration, which have not adequately responded to conventional ulcer therapy and extend through the dermis but without tendon, muscle, capsule or bone exposure. (2) Contraindications: Apligraf is contraindicated for use on clinically infected wounds and in patients with known allergies to bovine collagen or hypersensitivity to the components of the shipping medium. (3, 4, 5, 8) Warnings and Precautions: If the expiration date or product pH (6.8-7.7) is not within the acceptable range DO NOT OPEN AND DO NOT USE the product. A clinical determination of wound infection should be made based on all of the signs and symptoms of infection. (4, 5) Adverse Events: All reported adverse events, which occurred at an incidence of greater than 1% in the clinical studies are listed in Table 1, Table 2 and Table 3. These tables list adverse events both attributed and not attributed to treatment. (6) Maintaining Device Effectiveness: Apligraf has been processed under aseptic conditions and should be handled observing sterile technique. It should be kept in its tray on the medium in the sealed bag under controlled temperature 68°F-73°F (20°C-23°C) until ready for use. Apligraf should be placed on the wound bed within 15 minutes of opening the package. Handling before application to the wound site should be minimal. If there is any question that Apligraf may be contaminated or compromised, it should not be used. Apligraf should not be used beyond the listed expiration date. (9) Use in Specific Populations: The safety and effectiveness of Apligraf have not been established in pregnant women, acute wounds, burns and ulcers caused by pressure.

Patient Counseling Information: VLU patients should be counseled regarding the importance of complying with compression therapy or other treatment, which may be prescribed in conjunction with Apligraf.

DFU patients should be counseled that Apligraf is used in combination with good ulcer care including a non-weight bearing regimen and optimal metabolic control and nutrition. Once an ulcer has healed, ulcer prevention practices should be implemented including regular visits to appropriate medical providers.

Treatment of Diabetes: Apligraf does not address the underlying pathophysiology of neuropathic diabetic foot ulcers. Management of the patient’s diabetes should be according to standard medical practice.

How Supplied: Apligraf is supplied sealed in a heavy gauge polyethylene bag with a 10% CO2/air atmosphere and agarose nutrient medium. Each Apligraf is supplied ready for use and intended for application on a single patient. To maintain cell viability, Apligraf should be kept in the sealed bag at 68°F-73°F (20°C-23°C) until use. Apligraf is supplied as a circular disk approximately 75 mm in diameter and 0.75 mm thick. (8) Patent Number: 5,536,656 Manufactured and distributed by: Organogenesis Inc. Canton, MA 02021 REV: December 2010 300-111-8 References: 1. Veves A, Falanga V, Armstrong DG, Sabolinski ML; Apligraf Diabetic Foot Ulcer Study. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. Diabetes Care. 2001;24(2):290-295. 2. Data on file, Organogenesis Inc. 3. Apligraf® [package insert]. Canton, MA: Organogenesis Inc; 2010.

Please see complete prescribing information at www.Apligraf.com © 2011 Organogenesis Inc. All rights reserved. Printed in U.S.A. 01/11 Apligraf is a registered trademark of Novartis.

classified Wound Care Director Sanford HealtH - Bemidji, MN Sanford Health of Bemidji, MN has an opening for a Wound and Hyperbaric Center Director. Currently Sanford of Bemidji offers outpatient wound services and is looking for an experienced director in hyperbarics to establish and operate an integrated wound and hyperbaric center.

Sanford Bemidji has the largest Minnesota based clinic in the Sanford system. The multi-specialty group of 100+ physicians covers 23 different specialty areas and supports a 118-bed acute care hospital.

Live and work in a community that offers exceptional Organogenesis_PI_0211.indd schools, a state 1university with NCAA Division I hockey and community symphony and orchestra. With over 500 miles of trails and 400 surrounding lakes, this active community was ranked a “Top Town” by Outdoor Life Magazine. Enjoy a fulfilling lifestyle and rewarding career.

To learn more about this excellent career opportunity contact: Celia Beck, Recruiter Phone: (218) 333-5056 – Fax: (218) 333-5360 Email: Celia.Beck@sanfordhealth.org AA/EOE

Advertiser’s Index Advanced BioHealing..............................................31, 32 Comprehensive Healthcare Solutions Inc.....................21 Derma Sciences.............................................................7 Healthpoint Biotherapeutics..........................................5 Hill Laboratories Company............................................17 InRich Advisors............................................................13 KCI ..................................................................... Cover 3 Matrix Health Services LLC..........................................27 Medela..........................................................................3 MTI..............................................................................37 2/1/11

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Net Health Systems............................................ Cover 2 Organogenesis Inc. ...................................... 40, Cover 4 PathoGenius Laboratories...........................................29 Progressive Wound Care Technologies.......................19 Sechrist Industries Inc. .......................................... 24,25 Spiracur.......................................................................15 Total Wound Care Solutions........................................39

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August 2012 Today’s Wound Clinic®

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www.todayswoundclinic.com

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New Ideas For Your Paper.

The WoundExpert software allows you to easily navigate the complexity of wound care management by offering paperless, dynamic, real-time collection, analysis, and visualization of your wound care program’s progress. And, as a Certified EMR, it has the most complete clinical dataset and benchmarking solutions for wound management.

Spend less time with paper, and more time caring for your patients.

To learn more about WoundExpert’s end-to-end paperless solution, visit WoundExpert.com.

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

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WoundExpert.com 1-800-411-6281 7/17/12 7/31/12 11:09 5:21 AM PM

for pressure ulcers

There’s a reason they’re called Pressure Ulcers.

Heal me now or I may have to be readmitted!

Heal me soon or costs may skyrocket!

Heal me early or I may stick around longer!

V.A.C.® Therapy has been shown to be effective at healing pressure ulcers1,2 and reducing pressure on you by helping to lower: •

Acute care re-hospitalization1

•

Need for emergent care1

•

Length of stay in home care2 V.A.C.® GranuFoam™ Bridge XG Dressing Simple Application, Proven Healing.

For more information on how V.A.C.® Therapy can help heal advanced pressure ulcers, call 1-800-275-4524 or visit www.kci1.com

*Stage III & IV pressure ulcers 1. Schwien T, Gilbert J, Lang C. Pressure ulcer prevalence and the role of negative pressure wound therapy in home health quality outcomes. Ostomy Wound Management.

2005 Sep;51(9):47-60. Acute care re-hospitalization (5% vs. 14%, p<.01) and emergent care needed (0% vs. 8%, p<.01) for wound problems for pressure ulcer patients was reduced when comparing the V.A.C.® Therapy group to the control group.1 2. Baharestani MM, Houliston-Otto DB, Barnes S. Early versus late initiation of negative pressure wound therapy: examining the impact on home care length of stay. ® Ostomy Wound Management. 2008;54(11):48-53. Early initiation of V.A.C. Therapy (within 30 days of starting home health care, n=65) resulted in a 48% overall reduction (p≤ .0001) in home care length of stay in patients with a Stage III or IV pressure ulcer vs. the group who received V.A.C.® Therapy after the 31st day of home health care.2 NOTE: Specific indications, contraindications, warnings, precautions and safety information exist for KCI products and therapies.

Please consult a physician and product instructions for use prior to application. Rx only. ©2010 KCI Licensing, Inc. All trademarks designated herein are proprietary to KCI Licensing, Inc., its affiliates and/or licensors.

DSL#12-0188.TWC (Rev. 8/12)

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

Healing Wounds.

Healing Lives.

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

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

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