September 2013 by HMP Communications, LLC

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Today’s

Contemporary Approaches to Wound Clinic Management

Quality

Assurance

in Wound Care

Are you HIPAA/HITECH Compliant? Developing “Meaningful” Wound Care Data

Also in This Issue: Intro to ICD-10 Challenging CMS Mandates Business Briefs SAWCSPRING September 2013 www.todayswoundclinic.com

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the symposium on advanced wound care

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Today’s

Volume 7, Number 7, September 2013 • www.todayswoundclinic.com

Table of Contents • Feature Articles 10

HIPAA and HITECH in 2013: What You Don’t Know Can Hurt You

Wound Care Quality in Numbers: Compiling Discrete Data Drives Meaningful Reports

The use of social media and mobile devices has grown among healthcare professionals. Make sure you aren’t breaking related PHI laws.

As timelines for Meaningful Use and ICD-10-CM merge, wound care providers can maximize EHR utilization by carefully constructing outcome and healing rates. Here’s how.

Kevin W. Yankowsky, JD & Caroline Fife, MD, CWS

Cathy Thomas Hess, BSN, RN, CWOCN

Exercising the Wound Care Provider’s Right to Ensure Care Quality

M C 0 1 ICD

Wound Healing Through Medical Data: Get Ready for ICD-10-CM Classification Improvements

Concerned that a pending CMS mandate could compromise the delivery of patient care, a group of healthcare providers is making sure its collective voice is heard by Congress.

The US will soon be moving past ICD-9-CM, and all wound care providers will need to adapt quickly. Here’s an overview of what to expect.

Peggy Dotson, RN, BS

Andrea Clark, RHIA, CCS, CPC-H

Examining the Effectiveness of Type 1 Activated Hydrolyzed Collagen in Wound Care

Enhancing Perfusion Assessment of Chronic Wounds Through the Utilization of Fluorescence Angiography

Alec O. Hochstein, DPM, DABPS, FASPS, AAPWCA & Angela Savage, BSN, RN, MA, WCC, CWCA, AACCWS, DAPWCA

C. Andrew Salzberg, MD

TODAY’S WOUND CLINIC® (ISSN 1938-6311), is published by HMP Communications, 83 General Warren Boulevard, Suite 100, Malvern, PA 19355. TODAY’S WOUND CLINIC® website, www.todayswoundclinic.com, is registered with all major Internet search engines. Full content is available online to TODAY’S WOUND CLINIC print subscribers. Subscriptions: TODAY’S WOUND CLINIC® annual rates for US subscriptions: $99.00 annual; single copies, $39.00. Single or replacement copies of TODAY’S WOUND CLINIC® are subject to availability. To subscribe to TODAY’S WOUND CLINIC®, call (800) 237-7285, ext. 221, write to TODAY’S WOUND CLINIC®, Circulation Department, HMP Communications, 83 General Warren Boulevard, Suite 100, Malvern, PA 19355, or visit us online at www.todayswoundclinic.com. Reprints: Bulk professional-quality reprints (minimum quantity 100) of articles may be purchased. Contact the Managing Editor at (610) 560-0500 for information.

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Editorial Staff

Today’s

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

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

Volume 7, Number 7, September 2013 • www.todayswoundclinic.com

Managing Editor Joe Darrah jdarrah@hmpcommunications.com Web Editor Samantha Alleman salleman@hmpcommunications.com

Table of Contents

Business Staff Executive Vice President Peter Norris pnorris@hmpcommunications.com

Departments 4

VP/Group publisher Jeremy Bowden jbowden@hmpcommunications.com

From the Editor Dot Weir, RN, CWON, CWS

Publisher Kristen J. Membrino kmembrino@hmpcommunications.com

6 Business Briefs CMS Continues to Educate Wound Care Providers:

Sales Associate Brian Hill bhill@hmpcommunications.com

Are We Paying Attention? Kathleen D. Schaum, MS

Classified Sales Associate Michael Deleo mdeleo@hmpcommunications.com

Clinician’s Report

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Management Solutions

PRESIDENT BIll Norton

Industry Insider An Inside Look at BSN Medical

Vice President, Special Projects Jeff Hall

TWC News Update

Creative Director Vic Geanopulos vgeanopulos@hmpcommunications.com

Diabetes Drug Heart-Safe, Study Shows; New Ambulatory Wound System

Ask the Board

Advertiser’s Index

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Why are my claims for debridement of multiple wounds denied?

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TWC Online

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Online Exclusive: Photo Slideshow - Examining the Effectiveness of Type 1 Activated Hydrolyzed Collagen in Wound Care Get an exclusive look at patient photos that coincide with the feature article on page 21.

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

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fromtheeditor

Today’s

began practicing in an outpatient wound clinic in 2001, and I have to admit that I was a bit overwhelmed when first introduced to the “rules” of caring for wound care patients. The billing codes and regulatory issues took some time to understand, but they finally did seem to sink in at some point. LookDot Weir ing back now — wow, everything seems like it was Co-Editor of TWC so much simpler back then! With all the billing and coding requirements (which change on a near-constant basis), documentation procedures, and healthcare regulations we’re faced with currently, I can’t imagine how daunting it might be to be a young nurse or physician today. Then again, with the just as near-constant rate that we continue to see improvements to the overall practice of wound care, it’s a great time to be in wound healing, whether you’re a novice or a veteran. I’m excited and hopeful that I’ll get the chance to meet many of you at SAWC Fall this month. If you’re actually reading this at SAWC Fall in Las Vegas, you’re being exposed to all the various new presentations being offered, including more than 40 live sessions featuring the popular “wound center” track as well as a lively, crowded exhibit hall with more than 100 vendors present this year. The convention also serves as the official meeting place of the Association for the Advancement of Wound Care, providing an extraordinary opportunity for networking amongst wound care clinicians from across the country. With that said, I am constantly in awe of the talent we have not only on hand at SAWC in terms of educators and colleagues, but by our very own TWC editorial board. Just as those who are rubbing shoulders with you at SAWC, we offer leaders who cover the business, clinical, and regulatory landscape of wound care to provide readers with the most timely, current, and necessary information about their practice. And this issue alone is a prime example of that.

Editorial Board

Maintaining Quality Assurance

Tere Sigler, PT, CWS, CLT-LANA

In this issue, we focus on numerous aspects that wound care providers must concern themselves with in order to promote quality in their practice. Co-editor Caroline Fife, MD, CWS, and Kevin Yankowsky JD, take a thought-provoking approach to their discussion on HIPAA and HITECH by posing the following question to readers: Do you know what you’re legally accountable for regarding protected patient health information as it stands in 2013? As you’ll see beginning on page 10, what you don’t know can “hurt” you. Andrea Clark, RHIA, CCS, CPC-H, tackles another complex issue with her primer on ICD-10-CM, which gives an overview of some of the coming changes to the new coding structure — and even silences a few myths.Then, there’s a personal, passionate article by Peggy Dotson, RN, BS, who shares a firsthand account of one group of providers attempts at challenging a pending mandate by the Centers for Medicare & Medicaid Services regarding new requirements for durable medical equipment in wound care. If nothing else, this piece will inspire you to take the initiative to investigate and raise concerns whenever you question or struggle with a regulation that could affect patient care in your wound clinic. Of course, this is just a sampling of what the current issue of TWC has to offer. I hope you’ll find it as uplifting and educational as I do. See you in Vegas! n

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

Editorial Board Members Andrew J. Applewhite, MD, CWS, UHM Leah Amir, MS, MHA Desmond Bell, DPM, CWS Donna J. Cartwright, MPA, RHA, CCS, RAC, FAHIMA Moira Hayes, MHA, RRT, CHT Cathy Thomas Hess, BSN, RN, CWOCN Harriet Jones, MD, BSN, FAPWCA Robert S. Kirsner, MD, PhD Trisha Markowitz, MSN, MBA-HCM, RN, CWCN, DAPWCA Pamela Scarborough, PT, DPT, MS, CDE, CWS Susie Seaman, NP, MSN, CWOCN

Pamela G. Unger, PT, CWS, FCCWS Randall Wolcott, MD, CWS

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Dot Weir, RN, CWON, CWS 4

September 2013 Today’s Wound Clinic®

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businessbriefs

CMS Continues to Educate Wound Care Providers: Are We Paying Attention? Kathleen D. Schaum, MS HMP Communications and the authors do not represent, guarantee, or warranty that the coding, coverage, and payment information is error-free and/or that payment will be received.The ultimate responsibility for verifying coding, coverage, and payment information accuracy lies with the reader.

his author enjoys educating all the physicians, podiatrists, nurse practitioners, physical therapists, program directors, coders, billers, corporate compliance directors, and other wound care stakeholders who remain actively in contact through phone calls, e-mails, and regional and national wound care conventions. Often, one’s need for assistance and guidance is related to not receiving payment for a service/procedure/product or due to an audit that has resulted in a large repayment. When this author consults with these numerous stakeholders, we usually come to a conclusion that they were not originally aware of and/or did not understand the legislative/regulatory and/or coding/ billing guidelines pertaining to the reimbursement issue in question. For example, during a recent call a program director at a hospital-based outpatient wound care department (HOPD) nervously explained that her hospital administrator ordered that the HOPD code and bill for a clinic visit each time a patient was seen (even when the physician performed a scheduled “minor” surgical procedure) because the HOPD was “losing money.” Concerned that she could not justify this action, the program director did not know where to find the appropriate regulations and coding/billing rules pertaining to clinic visits and minor surgical procedures occurring on the same day. 6

Another example saw a program director reach out to ask how she could convince her HOPD coder that the facility was supposed to bill for the number of square centimeters (sq cm) of cellularand/or tissue-based products for wounds (CTPs) [old term “skin substitutes”] that the physicians opened for each patient. The coder has reportedly been changing all units on the claim to “1” to match the number of units reported for the Current Procedural Terminology® (CPT) code pertaining to the application of the CTP. These examples may be tough to believe, but such is a day in the life of a wound care reimbursement consultant. The Centers for Medicare & Medicaid Services (CMS), which write the regulations and billing guidelines and the Medicare Administrative Contractors (MACs) who process wound care claims, continue to educate us about the regulations, the problems they find with submitted claims, the issues that are being audited, and the list goes on. Today, we have to ask ourselves whether or not we are paying closeenough attention to the information being provided. During the summer months, CMS and the MACs released many educational documents, newsletters, webinars, etc. This column is not large enough to discuss everything that pertains to wound care,but it will cover a few important topics that you may have missed while you were on summer vacation. It would be wise to share this information with your entire team, including your coders and billers.

CMS assigned Q4126 to a new ambulatory payment classification (APC) group: 01452. • Q4134 hMatrix, per sq cm CMS assigned Q4134 to APC group 01453. Also effective July 1, CMS has assigned the following APC status indicator (SI) to both of these APC groups: K Paid under OPPS;separate APC payment. Effective July 1, CMS also has changed the SI for APC group 01419 (Q4122 DermACELL, per sq cm). The new APC SI is: G Pass-through drugs and biologicals. Effective Oct. 1, 2013, the following products will be added to the list: • Q4135 Mediskin, per sq cm CMS assigned Q4135 to APC group 01461 • Q4136 EZ Derm, per sq cm CMS assigned Q4136 to APC group 01462 Also effective Oct.1,2013,CMS assigned APC SI to both of these APC groups: K Paid under OPPS;separate APC payment.

Effective July 1, the following products have been added to CMS’s skin substitute product list: • Q4126 MemoDerm, Dermaspan, TranZgraft, or InteguPLY, per sq cm

NOTE: The existence of a Healthcare Common Procedure Coding System (HCPCS) code and a payment rate does not mean the product(s) are covered.As we have discussed many times before in this column, qualified wound care professionals must read their Medicare Local Coverage Determination (LCD), if one exists, to determine whether or not the product is covered by their MAC. If an LCD does not exist, the product may be covered based on medical necessity. Before applying any CTPs on patients insured by private payers, managed Medicare payers, Medicaid,Worker’s Compensation,etc.,verify the coverage and obtain prior authorization, when required.

September 2013 Today’s Wound Clinic®

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Skin Substitute List Additions

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businessbriefs

TABLE 1. 86 Edits in I/OCE

Edit Number

Description

Edit Number

Description

Invalid diagnosis code

Diagnosis and age conflict

Multiple medical visits on same day with same revenue code without condition code G0 (see Appendix B)

Diagnosis and sex conflict

Transfusion of blood product exchange without specification of blood product

Medicare secondary payer alert (v1.0 – v1.1)

Observation revenue code on line item with non-observation HCPCS code

E-diagnosis code cannot be used as principal diagnosis

Inpatient separate procedures not paid

Invalid procedure code

Partial hospitalization condition code 41 not approved for type of bill

Procedure and age conflict (not activated)

Service is not separately payable

Procedure and sex conflict

Revenue center requires HCPCS

Non-covered under any Medicare outpatient benefit, for reasons other than statutory exclusion

Service on same day as inpatient procedure

Service submitted for denial (condition code 21)

Non-covered under any Medicare outpatient benefit, based on statutory exclusion

Services submitted for FI/MAC review (condition code 20)

Multiple observations overlap in time (not activated)

Questionable covered service

Separate payment for services is not provided by Medicare (v1.0 – v6.3)

Observation does not meet minimum hours, qualifying diagnoses, and/or “T” procedure conditions (v3.0 – v6.3)

Code indicates a site of service not included in OPPS (v1.0 – v6.3)

Code G0378 and G0379 only allowed with bill type 13x or 85x

Service unit out of range for procedure

Multiple codes for the same service Non-reportable for site of service

Multiple bilateral procedures without modifier 50 (See Appendix A) (v1.0 v6.2)

55 56

Inappropriate specification of bilateral procedure (See Appendix A)

Evaluation/management (E/M) condition not met and line item date for observation services code G0244 is not 12/31 or 1/1 (Active v4.0 – v6.3)

Inpatient procedure

Composite E/M condition not met for observation and line item date for code G0378 is 1/1

Mutually exclusive procedure that is not allowed by NCCI even if appropriate modifier is present (combined with edit 20, # deleted v13.2, retroactive to earliest non-archived version)

G0379 only allowed with G0378

Code 2 of a code pair that is not allowed by NCCI even if appropriate modifier is present

Clinical trial requires diagnosis code V707 as other than primary diagnosis (Edit deleted in v11.2, retroactive to date of establishment or earliest nonarchived version)

Medical visit on same day as a type “T” or “S” procedure without modifier 25 (See Appendix B)

Use of modifier “CA” with more than 1 procedure not allowed

Service can only be billed to the durable medical equipment regional carrier

Invalid modifier

Code not recognized by OPPS; alternate code for same service may be available

Invalid date

Date out of OCE range

This occupational therapy code only billed on partial hospitalization claims (See appendix C) (v1.0 – v13.3)

Invalid age

Activity therapy service not payable outside the partial hospitalization program (See appendix C) (v1.0 – v13.3)

Invalid sex

Revenue code not recognized by Medicare

Only incidental services reported

Code requires manual pricing

Code not recognized by Medicare for outpatient claims; alternate code for same service may be available

Service provided prior to FDA approval

Service provided prior to date of National Coverage Determination (NCD) approval

Service provided outside approval period

“CA” modifier requires patient status code 20

Code lacks required device code

Service not billable to the FI/MAC

Incorrect billing of blood and blood products

Units greater than 1 for bilateral procedure billed with modifier 50

Patient hospitalization service for non-mental health diagnosis

Insufficient services on day of partial hospitalization

Partial hospitalization on same day as “ECT” or type “T” procedure (v1.0 –v 6.3)

Partial hospitalization claim spans 3 or less days with insufficient services on at least 1 of the days (v1.0 – v9.3)

Partial hospitalization claim spans more than 3 days with insufficient number of days having partial hospitalization services (v1.0 – v9.3)

Partial hospitalization claim spans more than 3 days with insufficient number of days meeting partial hospitalization criteria (v1.0 – v9.3)

Incorrect billing of modifier “FB” or “FC”

Trauma response critical care code without revenue code 068x and CPT 99291)

Only Mental Health education and training services provided

Claim lacks allowed procedure code

Extensive mental health services provided on day of electroconvulsive therapy or type “T” procedure (v1.0 – v6.3)

Claim lacks required radio-labeled product

Incorrect billing of revenue code with HCPCS code

Mental health code not approved for partial hospitalization program

Mental health service not payable outside the partial hospitalization program

Terminated bilateral procedure or terminated procedure with units greater than 1

Inconsistency between implanted device or administered substance and implantation or associated procedure

Charge exceeds token charge ($1.01)

Mutually exclusive procedure that would be allowed by NCCI if appropriate modifier were present (combined with edit 40, # deleted v13.2, retroactive to earliest non-archived version)

Service provided on or after effective date of NCD non-coverage

Code 2 of a code pair that would be allowed by NCCI if appropriate modifier were present

Claim lacks required primary code

Claim lacks required device code or required procedure code

Manifestation code not allowed as principal diagnosis

40 41

Invalid revenue code

Add-On HCPCS/CPT Codes An add-on code is an HCPCS code or CPT code that describes a service that is always performed in conjunction with another primary service. An add-on code is eligible for payment only if it is reported with an appropriate primary procedure performed by the same practitioner on the same date of service. CMS has learned from recovery-audit reports that some providers are billing only add-on HCPCS/CPT codes without their respective primary codes, which has resulted in overpayments. Because HOPDs and physicians surgically and medically debride many large wounds that require the use of add-on codes, be sure to review claims to ensure the coder has used a primary code and

the appropriate number of add-on codes. The same is true for the application of CTPs (aka “skin substitutes”).

Resubmission of Rejected Debridement Claims CMS was recently made aware of erroneous rejections (based on skilled nursing facility [SNF] consolidated billing) of HOPD claims containing CPT surgical debridement codes 11042, 11043, and/or 11044. These rejections are occurring because the codes were not removed from the minor surgery inclusion list in the 2013 SNF Consolidated Billing File for fiscal intermediary (FI) billing. Medicare contractors have now been instructed to bypass the SNF Consolidated Billing Common Working File

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businessbriefs edits for outpatient hospital bill types 13x and 85x with dates of service on or after Jan. 1, 2013, when one or more of these CPT codes is/are present on the HOPD claim. HOPDs need to adjust/resubmit any claims that may be affected by this change. Because many HOPDs provide wound care services for SNF patients, providers should advise their billing departments to investigate if there are any claims with these surgical debridement codes that were erroneously rejected and that need to be resubmitted.

I/OCE Changes The Integrated Outpatient Code Editor (I/OCE) is used by MACs to edit Outpatient Prospective Payment System (OPPS) Claims and non-OPPS claims for HOPDs, community mental health centers, all non-OPPS providers, and for limited services when provided in a home health agency not under the Home Health Prospective Payment System or to a hospice patient for the treatment of a nonterminal illness. It can be found online at www.cms.gov/OutpatientCodeEdit/. The I/OCE identifies individual errors and indicates which actions should be taken (and the reasons these actions are necessary). In order to accommodate this functionality,the I/OCE is structured to return lists of edit numbers. Currently, there are 86 different edits in the I/OCE. The structure of the I/OCE facilitates the linkage between the actions being taken, the reasons for the actions, and the information on the claim (eg, a specific diagnosis) that caused the action. See Table 1 on page 7 for a list of the edits. One of the recent edits pertained to autologous platelet rich plasma: G0460 Autologous platelet rich plasma for chronic wounds/ulcers, including phlebotomy, centrifugation, and all other preparatory procedures, administration and dressings, per treatment is subject to edit No. 68 - service provided prior to date of National Coverage Determination approval, retroactive to July 1, 2012. The occurrence of an edit can result in one of six claim dispositions. See Table 2 at right for a list of claim dispositions. 8

CMS typically releases I/OCE specification updates quarterly, about two months before their implementation. This gives providers time to make any adjustments to their charge description masters and to their claims processing system. Several I/OCE special processing conditions are very important to HOPDs: • One reminds us that certain wound care services may be paid an APC rate or from the Medicare Physician Fee Schedule (MPFS), depending on the circumstances under which the service was provided. The I/OCE will change the SI and remove the APC assignment when these codes are submitted with therapy revenue codes or therapy modifiers. • Another reminder tells us if a “sometimes therapy” code such as 97597/97598, 97602, and/or 97605/97606 is performed by a therapist, a therapy revenue code and a therapy modifier should be used on the claim. In that case, the claim will not be paid by the APC system. Instead, it should be submitted on a CMS 1500 claim form and paid according to the MPFS. • Another reminds us that certain CTPs will be separately paid based on their standard SI/APC assignments, only when billed with specified CTP (aka “skin substitute”) application procedure codes. If one of the specified application procedure codes is not present on the same date as the CTP, the CTP will be packaged (will have its SI changed to “N”). • Another states that certain claims will be returned to the provider if a specified add-on code is submitted without a code for a required primary procedure on the same date of service. The I/OCE also generates National Correct Coding Initiative (NCCI) Edits. All applicable NCCI edits are incorporated into the I/OCE. Modifiers and coding pairs in the I/OCE may differ from those in the NCCI because of differences between facility and professional services. The NCCI edits are applied to services submitted on a single claim, and on lines with the same date of service. NCCI edits address unaccept-

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TABLE 2. 6 Claim Dispositions in I/OCE Disposition

Description

Claim Rejection

There are 1 or more edits present that cause the whole claim to be rejected. A claim rejection means the provider can correct and resubmit the claim, but cannot appeal the claim rejection.

Claim Denial

There are 1 or more edits present that cause the whole claim to be denied. A claim denial means the provider cannot resubmit the claim, but can appeal the claim denial.

Claim Return to Provider (RTP)

There are 1 or more edits present that cause the whole claim to be returned to the provider. A claim returned to the provider means the provider can resubmit the claim once the problems are corrected.

Claim Suspension

There are 1 or more edits present that cause the whole claim to be suspended. A claim suspension means the claim is not returned to the provider, but is processed for payment until the FI/MAC makes a determination or obtains further information.

Line Item Rejection

There are 1 or more edits present that cause 1 or more individual line items to be rejected. A line item rejection means the claim can be processed for payment with some line items rejected for payment. The line item can be corrected and resubmitted, but cannot be appealed.

Line Item Denials

There are 1 or more edits present that cause 1 or more individual line items to be denied. A line item denial means the claim can be processed for payment with some line items denied for payment. The line item cannot be resubmitted, but can be appealed.

able code combinations based on coding rules, standards of medical practice, two services being mutually exclusive, or a variety of other reasons. In some cases, the edit is set to pay the higher-priced service, in other cases the lesser-priced service. In some instances, both codes in an NCCI code pair may be allowed if an appropriate modifier is used that describes the circumstances when both services may be allowed.The code pairs that may be allowed with a modifier are identified with a modifier indicator of “1”; code pairs that are never allowed, whether or not a modifier is present, are identified with a modifier of “0.” (Modifiers that are recognized/used to describe allowable circumstances are: 24, 25, 27, 57, 58, 59, 78, 79, 91, E1-E4, F1F9, FA, LC, LD, LM, RI, RC, RT,T1-T9, and TA).NOTE: If you have not been reading the quarterly updates to the I/ OCE, you should add this to your list of things to do. n Kathleen D. Schaum is president and founder of Kathleen D. Schaum & Associates Inc., Lake Worth, FL. She may be reached at 561-964-2470 or kathleendschaum@bellsouth.net. www.todayswoundclinic.com

9/9/13 12:36 PM

HIPAA and HITECH in 2013: What You Don’t Know Can Hurt You The use of social media and mobile devices has grown among healthcare professionals. Make sure you aren’t breaking related PHI laws. Kevin W. Yankowsky, JD & Caroline Fife, MD, CWS

et’s begin with the cautionary tale of Dr. Alexandra Thran, an emergency room physician who was fired from her job while working in Rhode Island (and reprimanded for unprofessional conduct by the state medical board) for posting information about a patient on Facebook. Even though she did not include the patient’s name, she was descriptive enough in what she wrote that others in the community could have identified the patient. Not many of us feel sympathy for a clinician who is this unprofessional, but she sadly represents a growing number of healthcare professionals who have gotten into trouble with inappropriate use of social media. The potential for breaching protected health information (PHI) in this “digi-

tal age” is greater than ever and has led to a dramatic increase in federal regulations surrounding electronic data. Many physicians and healthcare institutions believe the only professional legal trouble they are likely to face pertains to malpractice. However, it is increasingly likely that both clinicians and institutions will face civil (or even criminal) actions from the dramatic increase in governmental healthcare regulations designed to manage privacy and digital information. Perhaps the biggest example is the expansion of HIPAA (Health Insurance Portability and Accountability Act of 1996) and the HITECH (Health Information Technology for Economic and Clinical Health Act of 2009). There are really three sto-

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ries that converge here through these mandates. The main theme is HIPAA and its bigger, broader, more sweeping penalties written by the US Department of Health and Human Services (HHS) published Jan. 25; although, the compliance deadline for virtually every provision is Sept. 23. These provisions affect clinicians at many levels. Healthcare professionals incorporate social media into their daily lives just like everyone else and, like Thran, some forget their professional obligations to protect patient privacy. We will not discuss this important topic further except to emphasize that PHI is covered by the HITECH Act when it involves electronic communication. Thran was fined a mere $500 for her breach of www.todayswoundclinic.com

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qualityassurance patient confidentiality online — almost nothing compared to the fine that could have been levied under the HITECH Act, as you will read below. However, the themes of HIPAA and electronic communication converge in another related topic: mobile devices and data security.

Mobile Devices & Data Security

Recent surveys of healthcare institutions confirm that 81% of these organizations permit employees and medical staff to use their own mobile devices (eg, smartphones or tablets) to connect to their networks or enterprise systems such as email. However, 54% of hospitals are not confident that these personally owned mobile devices are “secure.” It is not just the mobile devices that must be secured (since they can be used to transmit, copy, or otherwise compromise PHI); healthcare organizations also have to secure vast quantities of data that generally reside on a “computing cloud.” The 2012 Ponemon Study on Patient Privacy and Data Security revealed that 91% of hospitals are using cloudbased data services (meaning they do not store patient or administrative data on their own computer servers), but 47% are not confident the data hosted by these other data services are secure. They are right to be concerned, since 94% of healthcare organizations have had at least one data breach in the past two years and 45% had more than five incidents.1 The types of patient data lost or stolen most often are medical files and billing and insurance records. Remember, the data a hospital needs for billing purposes are exactly the data needed for identify theft (ie, patient name, social security number, date of birth, home address). Sadly, insider negligence is a common cause of data breach, often due to lost or stolen computing devices. However, criminal attacks are on the rise and may now be the most common cause of data breaches. From 2009-12, there were 495 reported data breaches that compromised 21.1 million medical records, each one affecting an average of

42,659 records. It took the institution an average of 68 days to notify the appropriate individuals or entities of the breach, and the estimated cost of coping with these breaches during that time frame was $4.1 billion. Hospitals and physician practices are the mostbreached institutions in the US after governmental institutions — and the leading cause is theft, with PHI being the typical target. In 21% of cases, the breaches involved “business associates,” which we will have more to say about below.1

HITECH Breaches: New Reporting Requirements

Under the old HITECH rule, notifying patients of unauthorized accessed or utilization of their electronic PHI was only required if the use or access constituted a “breach,” which is defined as unauthorized use or access of electronic PHI that posed a “significant risk to the finances or reputation of the individual whose data was breached.” However, under the newly amended rule, any unauthorized use or disclosure of PHI will be presumed to be a breach, unless the “covered entity,” (ie, health plan and care providers) demonstrates that one or more exceptions apply. This significant change turns one of HITECH’s most important provisions on its head. Previously, providers could potentially avoid HITECH penalties and/or repercussions by simply reaching the (perhaps selfserving) conclusion that the unauthorized access and/or use of patient PHI did not constitute a breach. Today, however, those same covered entities must affirmatively establish an exception to the breach rule to avoid HITECH’s implications for unauthorized electronic PHI use. Some specific factors that can defeat the presumption of a HITECH breach include the nature and extent of the electronic PHI at issue, the identity of the unauthorized person who used or accessed the electronic PHI or to whom the disclosure was made, whether electronic PHI was actually viewed, and the extent to which the risk to patients from

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the unauthorized use or accessing of electronic PHI has been mitigated. Further, if the HITECH breach affects 500 or more individuals, HHS must be notified at the time the individuals are notified. Breaches affecting fewer than 500 individuals can be logged and reported to HHS on an annual basis. There are some exceptions to the breach notification. One, “safe harbor,” occurs if the PHI is encrypted or had been disposed of according to rules already detailed in HITECH, making encryption a very important part of an institution’s action plan for these new rules. The Security Rule reinforced by the HITECH Act requires covered entities and business associates (CFR §164.306) to have a security-management process in place “to implement policies and procedures to prevent, detect, contain, and correct security violations.” The security standards include general requirements to ensure the confidentiality, integrity, and availability of all electronic PHI; protect against any reasonably anticipated threats to the security of such information; protect against any reasonably anticipated uses or disclosures; and ensure compliance with the law by the workforce. There must be physical safeguards for PHI (eg, locking office doors), but these do not substitute for technical safeguards (eg, passwords and encryption).

Identifying “Business Associates” Related to PHI

By law, the HIPAA Privacy Rule applies only to covered entities; however, most healthcare providers cannot carry out all of their healthcare functions without using the services of other businesses. The Privacy Rule allows covered entities to disclose PHI to their “business associates” if they obtain assurances that the associate will safeguard the information. For example, business associates cannot use PHI for their own business purposes (eg, directly re-selling data). Much of the Privacy Rule and all of the Security Rule now apply directly to business associates and their subcontractors. Today’s Wound Clinic® September 2013

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qualityassurance (For more information about business associates, visit www.hhs.gov/ ocr/pr ivacy/hipaa/understanding/ coveredentities/businessassociates. html). Any facility conducting wound care likely has several agreements with business associates; for example, if electronic health records (EHRs) are used that makes the EHR provider a “business associate” of the facility. Subcontractors of business associates are now considered business associates if they create, receive, maintain, or transmit PHI. It is important to know that just because there isn’t a formal contract between the parties doesn’t mean they are not “business associates.”

When Patients Want Copies of PHI

The final rules confirm that individuals have a right to request copies of PHI in any form they choose, provided PHI is “readily producible” in that format. If the PHI requested is maintained electronically in one or more designated record sets, the covered entity will be required to produce an electronic copy of PHI if the individual requests it. Although individuals are entitled to request PHI in any form they choose (within reason) for practical purposes, patients are likely to accept PHI in whatever readable format is suggested by the covered entity. Wound care providers should be ready to make suggestions to avoid an unreasonable request by the individual, so begin to decide now how you would like to provide electronic copies of PHI.

Investigations and Fines

HHS is required to conduct compliance reviews and investigate complaints when a “preliminary review of the facts” suggests a violation due to “willful neglect” by the covered entity or business associate. The agency no longer has the option to disregard certain reported security breaches and individual complaints. This means there will be many more compliance reviews and complaint investigations. Providers can also expect to see more formal investigations and settlement orders, since informal resolution is no lon-

Translating HIPAA Penalties into $ Figures Degree of Culpability

Mechanical System

Powered System

Violation was not known and could not have been discovered with reasonable diligence.

$100-$50,000

$1,500,000

Reasonable cause for violation, not due to willful neglect.

$1,000-$50,000

$1,500,000

Violation due to willful neglect, but corrected in 30 days.

$10,000-$50,000

$1,500,000

Violation due to willful neglect, not corrected in 30 days.

$50,000

$1,500,000

ger mandatory. In cases of a HITECH breach, there often will have been at least two violations: an impermissible use or disclosure of PHI (the HITECH violation) and a safeguards violation (the potential HIPAA Security Rule violation). Violations are counted “based on the nature of the … obligation to act or not act.” New factors have been added to the way penalties are calculated, including the number of people affected by the violation and potential harm to their reputations. The agency states that penalties will be separately tallied on a per-person and a per-day basis. HHS retains the authority to charge for multiple violations related to a single event. Even though the maximum annual cap of $1.5 million is applied on a “perprovision” basis, it can still be multiplied several times over depending on the number of provisions violated. For example, violations of two different provisions could result in a total annual cap of $3 million, and violations of three provisions could result in a total annual cap of $4.5 million. Even though it is not completely clear how HHS will tally the proposed monetary penalties, it is clear that the totals will be much larger than was possible prior to the HITECH Act. If a violation is discovered, the provider must correct it promptly and in no more than 30 days. Delaying past 30 days will foreclose certain defenses that could decrease monetary penalty amounts.

What Does Everything Mean?

We’ve discussed that HHS is now required to conduct compliance reviews

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and investigate complaints, during which they will always requests copies of HIPAA policies in these reviews. So, the time has come for all wound care providers to update their HIPAA policy books. The nature of healthcare privacy has changed. Under the new 2013 regulations, one’s Notice of Privacy Practices must change to address key situations involving access to PHI. Is it OK to leave your work computer in the back seat of your car? How do you deal with the proliferation of mobile devices in your organization? Your staff will need to be trained again about PHI, about using mobile devices in the work environment, and about protecting shared data. Any business that doesn’t have a social media policy will need to create one. Are your networks secured? Do you have antivirus software in place? Is “data at rest” adequately protected, and are encryption schemes used for data on laptops or mobile devices? The Federal government means business, and there are no more excuses for not understanding the latest HIPAA rules related to privacy and security. n Caroline E. Fife is co-editor of TWC; medical director at the Wound and Hyperbaric Clinic, St. Luke’s Hospital,The Woodlands, TX; and chief medical officer at Intellicure Inc. Kevin W. Yankowsky is a partner at Fulbright & Jaworski LLP, health law/ health litigation department, Houston, TX. Reference 1. Third annual benchmark study on patient privacy and data security. Ponemon Institute. December 2012. Accessible online at www2. idexpertscorp.com/ponemon2012. www.todayswoundclinic.com

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Wound Care Quality in Numbers: Compiling Discrete Data Drives Meaningful Reports As Meaningful Use and ICD-10-CM timelines merge, wound care providers can maximize EHR utilization by carefully constructing outcome and healing rates.

Cathy Thomas Hess, BSN, RN, CWOCN

he mandate from the federal government regarding patient safety and quality assurance is quite clear: Capture, analyze, and report data in a “meaningful way.”This is accomplished through the use of a certified electronic health record (EHR), the Meaningful Use EHR Incentive Program, and strategic facility planning for ICD-10CM. By capturing data in discrete, reportable fields, the options for report generation are nearly limitless. But how is data best compiled in a meticulous fashion as it relates to wound care? The answer lies in how one optimizes available technology and the creativity established in one’s data mining.

Blended Timelines: Meaningful Use & ICD-10-CM

The coming year will be a memorable one in healthcare as we implement Stage II of Meaningful Use and 14

transition to ICD-10-CM. The path to Meaningful Use focuses on technology while ICD-10-CM focuses on billing with a clear intersection focusing on clinical documentation. To successfully implement and achieve both mandates, the wound care community needs to embrace three key building blocks: 1. Workflow – optimize clinical, operational, and financial processes to fully leverage technology. 2. C ertified Specialty Wound Care EHR and Reporting Suite – discrete data fields focused on specific wound care elements and medical-necessity requirements that support documentation standards, enhance outcomes, and optimize reimbursement.1 3. Meaningful Data Reports – develop core reports to manage wound care practice; generate quality reports and utilize the data to im-

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prove patient and facility outcomes; provide Meaningful Use reports for provider attestation.

Achieve Meaningful Use

Transitioning to a certified EHR is vital to meet Meaningful Use criteria set forth by the Centers for Medicare and Medicaid Services (CMS) in order to:2 • improve quality, safety, and efficiency, and reduce health disparities; • engage patients and family; • improve care coordination, population, and public health; and • maintain privacy and security of patient health information. The objectives of Meaningful Use over five years include:1 • Stage I - focus on data capture and sharing (2011-12) • Stage II - focus on advanced clinical processes (2014) www.todayswoundclinic.com

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qualityassurance • Stage III - focus on improved outcomes (2016).

Figure 1

Implement and Monitor ICD-10-CM

Next, let’s take a look at the mandate for the ICD-10-CM coding system, for which conversion in the US must be met by Oct. 1, 2014. According to CMS,3 the newly redefined classification system will provide much better data needed to: • measure the quality, safety, and efficacy of care; • reduce the need for attachments to explain the patient’s condition; • design payment systems and process claims for reimbursement; • conduct research, epidemiological studies, and clinical trials; • s et health policy; • support operational and strategic planning; • d esign healthcare delivery systems; •m onitor resource utilization; • improve clinical, financial, and administrative performance; • prevent and detect healthcare fraud and abuse; and • t rack public health and risks. Whether meeting the regulations for Meaningful Use and/or implementing changes for ICD-10-CM, remember that a successful transition and implementation requires a well-planned and well-managed process. At the heart of each process is the data.

Discrete Vs. Non-discrete Data

A patient’s episode of care is captured in a number ways: handwritten notes on paper (filed in a standalone chart), voice recognition software text reports (often standalone text in an “open notes field”), static documents scanned into an electronic filing system (ie, interfaced records, patient’s history), and/or within an EHR. Non-discrete or unstructured data can not be electronically processed nor used for clinical decision support, outcomes or benchmarking reports, or analysis to improve quality of care. Forgoing accurate data in functional and manageable formats will not allow meaningful data to be captured. Capturing discrete or structured data provides the information necessary to

meet Meaningful Use and ensure the integrity of healthcare data, decision making, and quality patient care (see Figure 1). A compliant specialty wound care EHR that’s standardized to capture the work and assessment data using discrete data fields is critical to comply with regulations and reportable data. Integrating evidencebased guidelines and templates, standardized dropdown lists, and searchable tables can assure quality data is captured and reported to support a meaningful platform. And, to make the clinical data meaningful and rich with information, data must be captured in a codified way.

Managing Process With Meaningful Data

Imagine if all wound care facilities – from the single-physician practice to health organizations – documented by using a certified specialty wound care EHR to capture their work. The output would be powerful. The influence behind the data collected and analyzed could: • provide a clear roadmap for managing disease states; • improve healthcare delivery; • streamline documentation workflows to increase efficiencies;

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• enable compliance to enhance quality and patient safety; and • provide valuable (consistent) information to CMS for payment related to wound care services, products, supplies, and procedures. To efficiently manage a wound care practice, consider implementing these methodologies: 1. O ptimal workflows: It is important to review current processes, documentation components, and data flows as well as identify gaps in best practices and guiding recommendations for improvement in the clinical and operational workflow. This critical process will maximize clinical and operational efficiencies, enhance clinical quality and patient safety, and streamline current workflow to improve care coordination. Ensure the wound care practice’s workflow is up-to-date and customization of the specialty wound care EHR is accurate. Moreover, business management will now be attainable through correct documentation (data) and reporting. Today’s Wound Clinic® September 2013

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qualityassurance 2. Capture accurate documentation: It is prudent for clinicians to document clinical and financial outcome data in a specialty wound care EHR. The data collected can be used to advance critical pathways, improve product formularies, validate contract fees with payers, improve patient and physician satisfaction, and comply with the federal mandates. 3. Robust data reporting: Utilizing a reporting module tied to a specialty wound care EHR is key. The data collected allows for observational trends across wound and patient types as well as clinical practices and operations. The data also allows for a comparison of clinical, operational, and financial outcomes through EHR storage. To effectively interpret the report, it is important to understand the report requirements as well as the data inclusion and exclusion requirements. A complete understanding of the data report will guide one’s business efficiently and effectively. For clarification, we’ll review three sample reports focused on an outpatient wound care department and discuss how each can assist practice management.

Wound Healing Percentage Report

- Report description: Illustrates healing percentages over a given timeframe and provides a more accurate picture of healing success (see Figure 2). This report compares the number of wounds healed to the number of wounds closed and demonstrates how effectively the patient’s wounds are managed. - Report Snapshot: In looking at this sample report, all wounds within the specified date range had a positive outcome related to clinical management practices with the exception of surgical wounds. Surgical wounds had an 83% wound healing outcome. At this point, it is prudent to conduct further research to deter-

Figure 2

Wound Healing Percentage Report Date Range: 7/1/13-7/31/13

Arterial Ulcer Diabetic Ulcer Lymphedema Skin Tear Surgical Wound Trauma Wound Venous Ulcer

83%

0 20 40 60 80 100

Figure 3

Volume Reduction Report Date Range: 2/1/13-7/31/13 46.15%

Abrasion Arterial Ulcer Burn Cellulitis Diabetic Ulcer Laceration Lymphedema Malignant Wound Neuropathic Ulcer Pressure Ulcer Skin Tear Surgical Wound Trauma Wound Vasculitic Ulcer Venous Ulcer

66.67% 50.00%

50.00% 40.74%

83.33%

76.92%

60.00% 60.00% 59.57% 59.80% 45.00%

100.00%

82.35%

81.82%

0 20 40 60 80 100

continued on page 38 16

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Exercising the Wound Care Provider’s Right to Ensure Care Quality Concerned that a pending CMS mandate could compromise the delivery of patient care, a group of healthcare providers is making sure its collective voice is heard by Congress. Peggy Dotson, RN, BS Editor’s Note:The author of this article is co-chair of the AAWC regulatory committee.

ave you ever questioned a new coverage policy or a new regulation issued by a payer, Congress, or the Centers for Medicare & Medicaid Services (CMS)? Have you ever thought, “This doesn’t seem right for patients, but what does it matter what I have to say?” or “I’m only one voice in a sea of noise; no one is going to care or listen to me”? Well, despite the challenges that may exist in making one’s presence felt, what you have to say can and could make a difference in the lives of your patients if you take it to a higher power. So, whenever you find yourself asking these questions or making these generalizations, consider the following scenario, as it may encourage you to voice any and every opinion or concern you may have the rest of your healthcare career.

How One Nurse Practitioner May Initiate Big Change

It all started this past May when a nurse practitioner (NP) who specializes in wound care was perplexed by the pending activation of statute “Public Law 111-148, 124 STAT, Sec 6407,” better known as the “physician only” requirement to document that a face-to-face encounter occurred within six months, by a physician or a non-physician practitioner, before durable medical equipment (DME) can be ordered for a Medicare patient. An NP who practices in Tennessee and is a newly elected board member of the Association for the Advancement of Wound Care (AAWC), as well as a new volunteer member of the AAWC’s regulatory committee, was confused by the statute, which was to be enacted by CMS July 1 but www.todayswoundclinic.com

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qualityassurance is being delayed until Oct. 1. Specifically, she struggled to find the logic behind the new rule mandating that non-physician providers (NPPs), particularly nurse practitioners, who can evaluate and treat patients in most states with or without physician supervision, must seek out a physician to sign a form documenting that a patient visit occurred within six months of ordering DME. Citing an existing shortage of primary care physicians, the NP was concerned that the stipulation would negatively impact her patients by delaying their release from a hospital or skilled nursing facility to home health (or home in general) while waiting for DME orders to be cleared. “This regulation goes against all that CMS has been doing to promote the use of NPPs to help expand patient access to care,” the nurse practitioner said. Her inquiry began a chain of events that has led an AAWC subgroup of physicians, NPs, and nurses to participate in a meeting with the House Ways & Means Committee’s Subcommittee on Health in late August.Their interchange has lead to a future meeting with the Senate Finance Committee, whose members were instrumental in drafting the legislation in question, later this September.

Making One’s Voice Heard

So, what did it take to go from having this complaint to essentially requesting a personal conference? For starters, a

quick phone call by the NP to Marilyn Tavenner, BSN, MHA, the administrator and chief operating officer at CMS, to discuss her opinions “nurse to nurse” regarding the new mandate went a long way. By taking this type of initiative, the voices of the NP and AAWC committee members have been considered by CMS officials and resulted in an invitation to discuss the matter further with CMS staff. In the weeks that have followed the scheduling of the discussion with CMS, the AAWC committee prepared an “issues and impact” document identifying its concerns related to the mandate from both a patient care and financial standpoint. (Its contents are too lengthy to list here.) AAWC then conducted a conference call with a group of staff members from CMS’ compliance group in its Office of Financial Management. Through this process, the group learned that CMS actually shared the same concerns — that the pending statute would not be advantageous for patients.While administrative limitations prevent CMS from changing regulations passed by Congress, AAWC received guidance on how best to approach the Ways & Means Subcommittee on Health to attempt to reverse the mandate that requires physician-only signatures. AAWC also addressed with CMS the added annual costs to reimburse physicians to document that a visit occurred, based on the assumptions CMS used to determine how much DME is written

by NPPs. AAWC argued to CMS and Ways & Means that the mandate “adds absolutely no benefit to the patient and does nothing to reduce fraud and abuse of DME.” The reality remains that the documenting physician, if not already the patient’s doctor, does not have to see the patient, review the patient’s chart, evaluate if the correct DME has been ordered by the NPP, or even know the patient. The only requirement is to document a visit with a physician or NPP has occurred within six months of the DME order, and that concerned us. Our group also went a step further by preparing recommendations for the actual statute language modifications we believe is needed to “correct” the regulation, using clinical knowhow and a passion for patient advocacy as motivation to achieve our goal of securing one-on-one time with Ways & Means. Regardless of the ultimate outcome of what the initiative brings, we are confident that our drive to have our opinions and concerns formally addressed will entice others to speak up whenever questioning a policy or regulation by contacting their local public office and/or sending communication to the payer, CMS, or Congress to inform them of the issue(s) of contention. After all, who knows what’s best for patients more than the practitioners who care directly for them? n Peggy Dotson may be reached at peggy_dotson1@yahoo.com.

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Wound Healing Through Medical Data: Get Ready for ICD-10-CM Classification Improvements The US will soon be moving past ICD-9-CM, and all wound care providers will need to adapt quickly. Here’s an overview of what to expect. Andrea Clark, RHIA, CCS, CPC-H

he healthcare industry is facing the most revolutionary update it has seen in more than 30 years – the International Classification of Diseases, 10th Edition, Clinical Modification (ICD-10-CM). The compliance date for implementation of ICD-10-CM is Oct. 1, 2014, for all covered entities of the Health Insurance Portability and Accountability Act. From a timeline prospective, the World Health Organization developed ICD-9 for worldwide use and the US developed the clinical modification (ICD-9-CM), which is currently used today, in 1979. Let’s face it, ICD-9-CM is outdated for many reasons while healthcare technology has changed and will continue to be innovated. As such, ICD-9-CM cannot support any new initiatives.

Setting ICD-10 Straight

It is necessary to tackle fears and myths contributing to inaccuracy of the upcoming ICD-10-CM data system. First, many entities believe ICD-10-CM was developed without clinical input, which couldn’t be further from the truth. A number of medical specialty societies contributed to the development of the coding systems, including the American Numeric or Alpha (E or V)

Numeric

1 4 Category

0 0 Etiology, anatomic site, manifestation

TABLE 1. ICD-10-CM Structure ICD-9-CM (14,000 codes)

ICD-10-CM (69,000 codes)

3-5 digits or characters

3-7 digits or characters

1st character is numeric or alpha (“E” or “V” codes)

1st character is alpha (all letters used except “U”)

2nd-5th characters are numeric

2nd-7th characters can be alpha or numeric

Decimal placed after first 3 characters

Decimal placed after the first 3 characters

17 chapters; V & E codes “supplemental”

21 chapters incorporate all codes

Academy of Dermatology. Second, is the myth that there will be unnecessarily detailed medical record documentation requirements that will put a hardship on providers. Studies have demonstrated much of the detail contained in ICD-10-CM is already in the medical record documentation, but is not currently needed for ICD-9-CM coding. Third, there’s the belief that an increase in the number of codes will make ICD-10-CM “impossible” to use. CM codes are designated for use in documenting diagnoses and are moving from 14,000 ICD-9-CM to 68,000 ICD-10-CM. But just as the size of an increased dictionary doesn’t make one more difficult to use, to the contrary, it’s easier to find the right code. ICD-10 will be much more specific, clinically accurate, and a logical structure, as well as considerably easier to use than ICD9-CM. Finally, people are worried that

3 2 Category

3-5 Characters

Figure 2A: ICD-9-CM Structure - Format

ICD-10-CM aligns seamlessly with Health 2.0, which refers to a number of related concepts including telemedicine, electronic medical records, mobile devices, and the use of the Internet by patients so that they can have greater insight and control into information generated about them. The benefits of ICD-10-CM can empower the future momentum of Health 2.0 by: – ➢ measuring quality, safety, and efficiency of care; ➢ conducting research, epidemiological studies, and clinical trials; Additional Characters

1 0

Etiology, anatomic site, manifestation

A Added code extensions (7th character) for obstetrics, injuries, and external causes of injury

3-7 Characters

Figure 2B: ICD-10-CM Structure - Format

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2 Always Numeric 3-7 Numeric or Alpha

Alpha (Except U)

ICD-10-CM-based super bills will be too long or complex to use. However, it’s important to note that practices may continue to create super bills that contain the most common diagnosis codes used in their practice. Neither super bills in ICD-9-CM nor ICD-10CM provide all possible code options for many conditions.

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qualityassurance ➢ setting health policy; ➢ designing payment systems; ➢ improving clinical, financial, and administrative performance; ➢ preventing and detecting healthcare fraud and abuse; and ➢ tracking public health and risks. Primary changes for ICD-10-CM are in its structure and code format. Table 1 compares/contrasts ICD-9-CM and ICD-10-CM. The new structure has the ability to be easily expanded to allow for flexibility, reflection of current medical terminology, and expanded detail that’s relevant to ambulatory and managed care encounters. The format of the index and tabular list of ICD-10-CM is eerily similar to ICD-9-CM, with a few minor exceptions: Chapter restructuring and sense organs (eye and ear) are separated from the nervous system chapter and moved to their own chapters. The index remains the same, with the main terms listed in alphabetical order and indented sub-terms listed under the main terms. For ease of identification, ICD-10-CM continues to support an alphabetic index of diseases and injuries, alphabetic index of external causes, table of neoplasms, and table of drugs and chemicals. Also, ICD-10-CM codes will continue to be identified by diagnostic terms in the alphabetic index, then verified by the character coder in the tabular list. The new features allow for greater specificity and clinical accuracy as the medical code data begins the lead indicator for future healthcare data analytics. The use of data analytics with ICD-10-CM can begin to predict financial models, improve quality of patient care, and facilitate evaluation of medical processes and outcomes — all with the goal of lowering costs. There are some examples that lend themselves to reimbursement and quality problems with ICD-9-CM. Let’s take a patient who presents with a decubitus ulcer on the right upper-back, who, a month later, develops the same ulcer on the left lower-back. ICD-9-CM does not identify left versus right, let alone the specificity of the back. With ICD-10CM, the assignment will have laterality

TABLE 3. ICD-10-CM New Features Laterality (left, right, bilateral)

Combination codes for certain conditions and common associated symptoms and manifestations

Combination codes for poisonings and their associated external cause

Inclusion of clinical concepts that do not exist in ICD-9-CM (for example, Underdosing, Blood Type, Blood Alcohol Level)

A number of codes are significantly expanded (for example, Injuries, Diabetes, Substance Abuse, Postoperative Complications)

Codes for postoperative complications are expanded and a distinction is made between intraoperative complications and post-procedural disorders

Physician NPP ICD-10-CM CPT/HCPCS

ICD-10-CM CPT/HCPCS

Home Health DME ICD-10-CM CPT/HCPCS

Hospital Payors

Skilled Nursing Long-Term Care Hospice ICD-10-CM CPT/HCPCS

FreeStanding Ambulatory Surgical Center*

Inpatient ICD-10-CM ICD-10-PCS

ICD-10-CM ICD-10-PCS CPT/HCPCS

ICD-10-CM CPT/HCPCS

Outpatient* ICD-10-CM CPT/HCPCS Outpatient Diagnostic/ Therapy Centers Laboratory Radiology PT/OT ICD-10-CM CPT/HCPCS

Chiropractors EMS All Other

Pharmacy (National Council for Prescription Drug Programs) ICD-10-CM

ICD-10-CM CPT/HCPCS

Figure 4: ICD-10-CM/PCS Final Regulation for All Entities *Check current payers and managed care contracts regarding ICD-10-PCS requirements.

and site specificity for the back.Also, note that the staging was unspecified, which will continue to drive to a single ICD10-CM code: laterality, site, and staging. Currently in ICD-9-CM, it takes two separate codes to identify both site and stage. By adopting the new coding system and incorporating greater specificity, the clinical information results in improved ability to measure healthcare services and decrease the need to include supporting documentation with claims. With a number of countries already using ICD-10-CM (including United Kingdom, Australia, and Canada), the time is now for the US and its healthcare providers and entities to embrace the power of the new coding system. Fears, myths, and anxiety aside, the healthcare community has been underserved by an outdated coding system for so long that

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Mental Health

it has quite literally “dumbed down” the ability of qualified healthcare providers to translate 21st century medicine into reportable codes. Now, it’s time for US healthcare providers to show what they know with the robust ICD-10 coding system and to begin to report 21st century medicine. ICD-10-CM will allow healthcare individuals, groups, and organizations to adopt and embrace this change in the revolution of medical code data in which it speaks … and all will have to listen. In preparation, wound care providers should begin to review their most frequent ICD-9-CM diagnosis codes and possible systems and applications affected by the groundbreaking change. n Andrea Clark is chairman, CEO, and founder of Healthcare Revenue Assurance Associates, Plantation, FL. www.todayswoundclinic.com

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Examining the Effectiveness of

Type 1 Activated Hydrolyzed Collagen in Wound Care Alec O. Hochstein, DPM, DABPS, FASPS, AAPWCA & Angela Savage, BSN, RN, MA, WCC, CWCA, AACCWS, DAPWCA

Online Extra: Photo Slideshow

For a full view of the wound healing progression for each patient in this article, visit the TWC homepage.

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oday’s marketplace offers wound care providers an extensive variety when it comes to utilization of collagen. The human body’s most abundant protein, collagen has been identified as having multiple functions in the healing process. The effective use of collagen in treating wounds is well established by numerous studies supporting its broad use. However, the functionality, efficiency, and effectiveness of respective collagens can be just as varied. This article provides an overview related to favorable wound care outcomes that have been experienced as a result of treating an assortment of chronic wounds with CellerateRX® collagen gel, as well as its cost-effectiveness. Each of the following four cases depicts the care rendered to patients who presented with chronic, nonhealing wounds and represents the versatility of the product, which produced quicker healing rates due to the benefit of collagen molecules that are a fraction of the size of native collagen and that bind with fibroblasts in the body immediately upon application.

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qualityassurance CASES 1 & 2

Patients cared for by Angela Savage, BSN, RN, MA, WCC, CWCA, AACCWS, DAPWCA, within the private practice of Steven Snively, MD, plastic surgeon, Parker, CO. De-gloving Injury In the case of avulsions, where an extensive area of skin is severed from the underlying tissue, CellerateRX has proven successful in healing the wound when other treatment efforts failed. A 54-yearold male suffered a forklift accident that resulted in an injury to his right lower extremity (RLE). He was treated for a de-gloving injury along with two fractures to the RLE. He received a skin graft to treat the injury. However, the graft had approximately a 60% take 30 days after the injury. The patient visited the clinic for a second opinion and was very adamant that he did not want another graft surgery. We created a POC where the inner and outer aspect of his RLE was treated with CellerateRX gel, which was applied twice per week and covered with a secondary dressing followed by a self-adherent wrap. Due to the simplicity of the CellerateRX application, the patient’s wife was able to conduct dressing changes and, therefore, the need for home healthcare was eliminated. The expectations of the healthcare provider and the patient were exceeded, as the wound healing times were better than expected. The rate of healing not only saved the patient’s insur-

CASES 3 & 4

Patients cared for by Alec O. Hochstein, DPM, DABPS, FASPS, AAPWCA, Great Neck, NY. Diabetic Ulceration The following case is an excellent example of the successful use of CellerateRX on a total contact cast (TCC) where the patient and provider had no access to the wound for a week or more at a time. Prior to referral, the patient presented to the hospital with ongoing complications including a deep infection of the right forefoot. The abscess

Case 1: Before (A); after (B) de-gloving injury

ance provider thousands of dollars, it also provided an alternative to surgery. Total length of time from initial application to healed wound: 116 days. Failed Skin Graft A 64-year-old female had surgery to repair a ruptured Achilles tendon. During the two years following the procedure, the patient experienced multiple dehiscences and multiple episodes of yeast and thick, pseudomonas growth, along with chronic pain. Her wound comorbidities included diabetes, obesity, lower extremity edema, hypertension, failed skin graft in the Achilles area, and arthritis. Treatments for this patient included negative pressure, iodine gel, additional grafting, silver alginate, wound gel, cell matrix, and petroleum dressings. At the time the patient presented to the clinic, the size of her wound was

required amputation of the digits, and the surgical site was left open to heal by secondary intention.The hospital treated the ulceration initially with sharp debridement, wet-to-dry dressings, and a surgical shoe. When the wound healing became stagnant, the patient was referred to the clinic. The patient, a 46-year-old male, had an infected neuropathic ulceration of the right forefoot. Additionally, he presented with diabetic neuropathy, had a belowthe-knee amputation of the contralateral limb, and multiple digital amputations of

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Case 2: Before (A); after (B) failed skin graft

larger than during previous treatments, so her care plan was changed. The initial wound presentation was a reddishpink, moist bed approximately 1.8 cm long and 1.3 cm wide, with a superficial depth. Given that the wound was two years old, some periwound discoloration was noted.The wound edges were treated with silver nitrate to jumpstart healing and foam dressing was applied. In addition, the caregiver applied CellerateRX gel 2-3 times per week.When the patient returned 30 days later, the wound was one-third in size and healing well. The same treatment regimen was prescribed. One month later, the patient presented with a healed wound area. CellerateRX was found to reduce office visits and the patient’s pain associated with the wound. Total length of time from initial application to healed wound: Approximately three months.

Case 3: Before (A); after (B) diabetic ulceration

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qualityassurance the affected limb comorbidities. The patient’s wound was moist, but would need to remain so underneath a TCC. The properties of CellerateRX gel would help donate moisture to the wound bed while encouraging autolytic debridement of the wound using the body’s own processes to promote healing. The initial treatment included sharp debridement of the right foot wound. CellerateRX was applied topically, and the TCC was set in place on a fibrogranular wound base with serosanguinous exudate. This patient was seen on a weekly basis at the clinic for dressing and TCC changes. By the third week, sharp debridement of the wound was again used, and CellerateRX and the TCC were re-applied on a fibrogranular wound base with scant serous exudate. The wound showed significant improvement at this point. Note that there was no patient or family treatment during the intervening weeks. At five weeks, the same regimen was conducted with sharp debridement, application of CellerateRX, and a TCC. The healing was again measurably improved. The wound was smaller, with only a superficial depth.The wound base was granular and the exudate was still scant serous. By eight weeks, the wound was nearly healed. The size was fractional. The wound base was epithelial, and there was no exudate. The patient received another sharp debridement, application of CellerateRX, and ad-

Conclusion

The authors believe the CellerateRX product has proven to have favorable results in significantly increasing healing times. In addition, the authors’ experience with this product would suggest that it decreases pain. While healing advanced wounds can be complex, the application of this product and its versatility when used in conjunction with other modalities allows it to be a first-line therapy in any wound care setting. A biocompatible and biodegradable product that allows the clinician to use any other appropriate dressing and

vanced to a custom-molded shoe instead of the cast. In this case, the treatment was virtually carefree in between clinic visits. Total length of time from initial application to healed wound: 12 weeks. Necrotizing Fasciitis One favorable feature of CellerateRX is its ability to mitigate pain by protecting nerve endings. Use of the gel in drier wounds provides relief from pain and discomfort associated with dryness. Additionally, when a wound is weeping, infected, or fluid-filled, the CellerateRX powder can absorb up to 30 times its weight in exudate, likely resulting in a more comfortable treatment experience. This patient was a 46-year-old male living with diabetes. His wound included right fifth-digit amputation and partial ray resection to surgically combat necrotizing fasciitis. The initial treatment included sharp debridement of the right foot wound edge. An application of CellerateRX gel, petroleum gauze, moist gauze, and a light compressive top-cover were applied over a granular wound base with the extensor tendon exposed and moderate serosanguinous exudate. At three weeks, sharp debridement was again used with the same application of CellerateRX gel and dressings. The wound size was noticeably smaller with decreased tendon exposure and scant serosanguinous exudate. At the seven-week visit, sharp de-

combine it with antimicrobials, CellerateRX has a recommended application of every 2-3 days, if necessary — a timesaver for those providers who conduct daily collagen dressing changes. In a budget-conscious environment, CellerateRX provides clinical efficacy while reducing overall cost of closing wounds. Many patients can require upwards of 15 products to treat the wound, but CellerateRX reduces this product need to two or three. The authors recommend this product for any wound care setting including podiatry, home health,

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B Case 4: Before (A); after (B) necrotizing fasciitis

bridement of the wound was repeated with the same gel and dressings.The size of the wound was improved, with only a superficial depth.The wound base was granular with no tendon exposure and scant serous exudate. Gel was applied every 2-3 days with the same layered bandaging throughout the treatment (in between sharp debridement sessions). Necrotizing fasciitis is a challenging and difficult entity for the podiatric surgeon. This case was no different. Having a large amount of soft tissue loss and exposed tendons presented a unique challenge that needed to be addressed. In the past, hospitalization, as well as application of skin graft or skin graft substitute, would have been required. The ease-of-use of the CellerateRX activated collagen was the cornerstone of treatment. The gelatinous nature of the activated collagen was paramount in the ability to keep the exposed tendon and the structures moist to avoid desiccation and ultimate salvage of the patient’s limb function and appearance.Total length of time from initial application to healed wound: eight weeks.

long-term care, inpatient hospitals, and wound care clinics. n Alec O. Hochstein is board certified in foot surgery by the American Board of Podiatric Surgery and maintains a full-time podiatry practice, Great Neck (NY) Family Foot Care. Angela Savage is a board certified wound and ostomy nurse and director of clinical services at the Center for Wound Healing and Hyperbaric Medicine, Swedish campus, Denver, CO. At the time of this study, she worked alongside Dr. Snively and continues to work with him in private practice. For more information, contact 888-830-3609 or sales@welldynehealth.com. www.todayswoundclinic.com

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Enhancing Perfusion Assessment of Chronic Wounds Through the Utilization of Fluorescence Angiography C. Andrew Salzberg, MD

ne of the biggest challenges today in wound care clinics is the assessment of the vascularity of the wound and the ability of the patient to heal. For many years, there has not been a surefire way to assess overall blood flow to any tissue that may be ischemic or compromised by a lack of vascularity, such as with diabetic neuropathy. The ability to influence and gain information regarding the inflow and outflow to any wound bed is of great value to the wound clinician and staff. Historically, injection of fluorescence dye and a Woods lamp have been used in surgery (as is laser Doppler) in an attempt to assess blood flow. These modalities can be confusing and cumbersome, however, and are associated with potential side effects. This article examines the use of fluorescence angiography in wound care and considerations that should be made for those clinicians seeking to incorporate it into practice.

Covering The Basics

Fluorescence angiography is an effective, real-time imaging tool for measuring blood flow in vessels and micro-vessels as well as for tissue and organ perfusion during medical procedures. The technology is based on a fluorescence agent known as indocyanine green (ICG) that absorbs light in the near-infrared (NIR) spectrum. Advances in technology have allowed the use of fluorescence angiography in open, robotic, and endoscopic surgical procedures in the operating room under complete control of the surgeon and without the ionizing radiation and contrast potential nephrotoxicity safety concerns associated with traditional Xray in certain patient populations such as those living with diabetes, renal insufficiency, or congestive heart failure. Although used experimentally in the late 1990s, this technology was being used by the mid-2000s by cardiac and plastic surgeons.1,12,13 For the first time, surgeons

could immediately visualize perfusion in the operated tissues multiple times throughout a procedure as their needs changed. Most importantly, use of the dye and the laser has been proven to be safe in humans.7, 12-26 ICG is a water-soluble tricarbocyanine dye originally developed by the Eastman Kodak Company for use in infrared photography and was first approved by the FDA for use in the US in 1959. Introduced into clinical practice in the form of a stable lyophilized powder at the Mayo Clinic, ICG was once referred to as “Fox Green” after the cardiologist Dr. Irwin Fox, who was responsible for its initial use to assess cardiac output by means of a dyedilution technique.2 ICG was also later used to assess arteriovenous fistulae3 and renal blood flow.4 The observation that ICG is metabolized exclusively via the liver and excreted completely into bile led to its use in assessing liver function and blood flow.5,6 Near-infrared absorption and emission of light ICG makes it particularly well suited to visualizing small blood vessels. In the early 1970s, Dr. Robert Flower leveraged the near infrared absorption and emission of light properties of ICG to develop techniques for acquisition of fluorescence angiograms of the microvasculature in the retinal choroid in the eye.7,8 Use of fluorescence-imaging technologies and techniques today continues to be based on the angiography principles developed by Flower. Fluorescence angiography systems are comprised of an imaging camera, which houses a laser (806-nm diode) that provides near-infrared illumination. During a procedure, the operator positions the camera above the area of interest and (following administration of ICG) activates the NIR laser light source and camera. Real-time moving images are then displayed instantly onto a computer screen. Because ICG

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remains within the vascular space and has the benefit of a short half-life, multiple images may be taken within a single procedure. The ability to view and evaluate blood flow in or around any open wound and assess real-time fluorescence angiography to gauge the status of the lower extremity or other area of concern is invaluable in assessing whether a treatment modality such as hyperbaric oxygen or negative pressure wound therapy are providing necessary healing. Fluorescence angiography has become a vital part of the author’s practice in the wound care center.

Launch of Fluorescence Angiography

The first fluorescence angiography system (SPY® by Novadaq® Technologies, Mississauga, ON) was developed for use during coronary artery bypass graft (CABG) surgery to confirm the patency of bypass grafts. Initially approved for use during CABG in Canada, Europe, and Japan in 2001 and in the US by the FDA in January 2005, SPY has been compared to X-ray angiography through multiple reports in that its use resulted in the detection of nonfunctioning bypass grafts in 4-8% of patients.12–22 SPY fluorescence angiographic technologies have also subsequently been cleared by regulatory authorities to include other cardiovascular and peripheral vascular procedures, solid organ transplantation (including liver and kidney23,24 and pancreas25), gastrointestinal procedures, general surgery, and robotic and minimally invasive surgery. In late 2007, SPY technology was then cleared for use during plastic and reconstructive as well as microsurgical procedures. Today, the use of the SPY Elite® system for perfusion assessment in plastic reconstructive surgery is rapidly expanding. Several peer-reviewed journal articles have shown that the use of SPY imaging in breast and other reconstruction procewww.todayswoundclinic.com

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qualityassurance dures results in significantly lower rates of tissue necrosis compared to historical necrosis rates.25,26 More recently, in part because of the increase in the number of medical practitioners who treat chronic, nonhealing wounds and have used this technology in other parts of their plastic or general surgery practice, application of fluorescence angiography has organically expanded to include perfusion assessment in the wound-healing environment. Introduced in March 2013, the latest generation of fluorescence angiography technology — LUNA™ (Novadaq Technologies) — has also been embraced by wound care specialists for the treatment of patients who live with chronic, nonhealing wounds.27,28

Addressing Advantages, Precautions for ICG

One of the more notable advantages of ICG over other fluorescent agents, such as fluorescein, is its rapid clearance from the tissues and its confinement to the intravascular compartment — making it an ideal blood pool contrast agent that can be used multiple times in the same patient during a single treatment setting. By contrast, fluorescein leaks into the interstitial space, causing staining, and therefore can only be used once in a single setting. Fluorescein, unlike ICG, which travels in circulation, gives no information about dynamic perfusion. Following intravascular administration, ICG is rapidly and extensively bound to plasma proteins, with a-lipoproteins being the major carrier in humans.9 The plasma half-life of ICG is very short, approximately 3-5 minutes in humans. ICG is taken up by the liver and excreted completely into the bile without any further metabolism, making it an ideal agent for use in patients whose renal function is of concern.10 Since its introduction into clinical practice, ICG has shown an excellent safety profile, including a low incidence of adverse reactions (about 1 in 42,000 patients). However, ICG contains iodide, so it should be used with caution or in combination with pre-treatment regimens in patients who have sensitivity to iodides. Most reported reactions, if any, have been called mild in nature, such

Figure 1: Left foot; dorsal view

as experiencing a feeling of warmth or sore throat. Reports of anaphylaxis are extremely rare.11 n C. Andrew Salzberg is associate professor of plastic surgery, New York Medical College, Valhalla. References 1. Pestana IA, Coan B, Erdmann D, et al. Early experience with fluorescent angiography in free-tissue transfer reconstruction. Plast Reconstr Surg. 2009; 123:1239–44. 2. Wood EH. Diagnostic applications of indicator dilution technics in congenital heart disease. Circ Res. 1962;10:531–68. 3. Samet P, Bernstein WH, Jacobs W, et al. Indicator dilution curves in systemic arteriovenous fistulas. Am J Cardiol. 1964;13:176–87. 4. Schillig S. Indicator-dilution techniques in the estimation of renal blood flow. Am Heart J. 1964;68:675–81. 5. Ketterer SG, Weigand BD. The excretion of indocyanine green and its use in the estimation of hepatic blood flow. Clin Res. 1959;7:71. 6. Leevy CM, Stein SW, Cherrick GR, et al. Indocyanine green clearance: a test of liver excretory function. Clin Res. 1959;7:290. 7. Flower RW, Hochhelmer BF. A clinical technique and apparatus for simultaneous angiography of the separate retinal and choroidal circulations. Invest Ophthalmol. 1973;12:248–61. 8. Flower RW. Choroidal angiography using indocyanine green dye: a review and progress report. Opthalmol Dig. 1974;36:18–27. 9. Ott P. Hepatic elimination of indocyanine green with special reference to distribution kinetics and the influence of plasma protein binding. Pharmacol Toxicol. 1998;83 (Suppl 2):1–48. 10. Desmettre T, Devoisselle JM, Mordon S. Fluorescence properties and metabolic features of indocyanine green (ICG) as related to angiography. Surv Ophthalmol. 2000;45:15–27. 11. Benya R, Quintana J, Brundage B. Adverse reactions to indocyanine green: a case report and a review of the literature. Cathet Cardiovasc Diag. 1989;17:231–3. 12. Rubens FD, Ruel M, Fremes SE. A new and simplified method for coronary and graft imaging during CABG. Heart Surg Forum. 2002;5:141–4. 13. Taggart DP, Choudhary B, Anastasiadis K, et al. Preliminary experience with a novel intraoperative fluorescence imaging technique to evaluate the patency of bypass grafts in total arterial revascularization. Ann Thorac Surg. 2003;75:870–3. 14. Reuthebuch O, Kadner A, Lachat M, et al. Early bypass occlusion after deployment of nitinol connector devices. J Thorac Cardiovasc Surg. 2004;127:1421–6.

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Figure 2: Right foot; lateral view 15. Reuthebuch O, Haussler A, Genoni M, et al. Novadaq SPY: intraoperative quality assessment in off-pump coronary artery bypass grafting. Chest 2004;125: 418–24. 16. Balacumaraswami L, Abu-Omar Y, Anastasiadis K, et al. Does off-pump total arterial grafting increase the incidence of intraoperative graft failure? J Thorac Cardiovasc Surg. 2004;128:238–44. 17. Takahashi M, Ishikawa T, Higashidani K, et al. SPY: an innovative intra-operative imaging system to evaluate graft patency during off-pump coronary artery bypass grafting. Interact Cardiovasc Thorac Surg. 2004;3:479–83. 18. Balacumaraswami L,Abu-OmarY, Choudhary B, et al.A comparison of transit-time flowmetry and intraoperative fluorescence imaging for assessing coronary artery bypass graft patency. J Thorac Cardiovasc Surg. 2005;130:315–20. 19. Desai ND, Miwa S, Kodama D, et al. Improving the quality of coronary bypass surgery with intraoperative angiography: validation of a new technique. J Am Coll Cardiol. 2005;46:1521–5. 20. Desai ND, Miwa S, Kodama D, et al. A randomized comparison of intraoperative indocyanine green angiography and transit-time flow measurement to detect technical errors in coronary bypass grafts. J Thorac Cardiovasc Surg. 2006;132:585–94. 21. Desai ND, Moussa F, Singh SK, et al. Intraoperative fluorescence angiography to determine the extent of injury after penetrating cardiac trauma. J Thorac Cardiovasc Surg. 2008;136:218–9. 22. Waseda K, Ako J, Hasegawa T, et al. Intraoperative fluorescence imaging system for on-site assessment of off-pump coronary artery bypass graft. JACC Cardiovasc Imaging. 2009;2:604–12. 23. Sekijima M,Tojimbara T, Sato S, et al. An intraoperative fluorescent imaging system in organ transplantation. Transplant Proc. 2004;36:2188–90. 24. Kubota K, Kita J, Shimoda M, et al. Intraoperative assessment of reconstructed vessels in living donor liver transplantation, using a novel fluorescence imaging technique. J Hepatobiliary Pancreat Surg. 2006;13:100–4. 25. Komorowska-Timek E; Gurtner GC. Intraoperative perfusion mapping with laser-assisted indocyanine green imaging can predict and prevent complications in immediate breast reconstruction. Plastic and Reconstructive Surgery. 2010; 125(4):1065-1073. 26. Liu DZ, Mathes DW, Zenn MR, Neligan PC. The application of indocyanine green fluorescence angiography in plastic surgery. J Reconstr Microsurg. 2011;27:355-364. 27. Howard RT,Valerio IL, Basile PL, Nesti L. The use of intraoperative fluorescent angiography to maximize fasciocutaneous flap coverage of battle field extremity injuries. Supplement to Plastic and Reconstructive Surgery. Vol. 128, No. 4 (2011):79-80. Abstract. 28. Lepow BD, Perry D, Armstrong D. The use of SPY intra-operative vascular angiography as a predictor of wound healing. Podiatry Management. 2011;141-148.

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clinician’sreport Comprehensive Healthcare Solutions Inc. Location: Tacoma, WA Founded: 1998 Website: www.comprehensive-healthcare.com Contact: 800-232-5070;KRK@comprehensive-healthcare.com Company Description: Comprehensive Healthcare Solutions Inc. is a 15-year-old wound management company that helps hospitals develop or enhance their own wound/hyperbaric program. Comprehensive is involved in creating programs that are prepared to adapt to the pay-for-performance model of the future.

Most Popular Product/Service: Comprehensive leads clients through the maze of healthcare and reimbursement changes started by the Affordable Care Act. We bring all the materials, training, policies, and procedures to replace what the turnkey management company removes and make the transition into “flying solo” seamless. No matter where the hospital is with its wound care and hyperbaric program, Comprehensive’s team of experts in wound care, hyperbaric services, reimbursement, and marketing come onsite regularly and teach your team everything it needs to know to operate the program successfully in this ever-changing healthcare environment. n

Healogics Location: Jacksonville, FL Founded: 1984 Website: www.healogics.com Contact: 800-379-9774; development@healogics.com Company Description: Healogics is the nation’s largest provider of advanced wound care services. Healogics and 30

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Management Solutions

its affiliated companies manage more than 550 Wound Care Centers® in the nation and see nearly 200,000 patients per year through a connected network of centers, partner hospitals, academic medical centers, patients, and families. Leveraging its scale and experience, Healogics utilizes an evidence-based systematic approach to chronic wound healing in treating an underserved and growing patient population.

Most Popular Product/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 Location: Madisonville, LA Founded: 2003 Website: www.aboutmatrix.com Contact: 504-906-1024; bevenson@matrixhealthservices.net 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, evidencebased, state-of-the-art programs that are clinically effective and financially sound. Most Popular Product/Service: 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 needed, develop ongoing clinical and operational processes, and provide the tools and plans for continued success. n www.todayswoundclinic.com

9/10/13 4:52 PM

industryinsider An Inside Look at BSN Medical

or this month’s feature, Today’s Wound Clinic spoke with Keith Galloway, president – North America.

Today’s Wound Clinic (TWC): How long have you been in wound care, and how did you enter this area of healthcare? Keith Galloway, Keith Gallopresident – North way (KG): My America academic background includes a bachelor’s from Shippensburg (PA) University a master’s from Lehigh University (Bethlehem, PA), and postgraduate business certification from Wharton (University of Pennsylvania). Most recently, I completed doctoral residency in business with a focus in marketing and adaptive leadership. I have been privileged to work the majority of my corporate career over the past 25 years with leading medical companies – Roche Diagnostics,Agilent (formerlyVarian), and now with BSN Medical. Working in senior executive management on a global basis in a variety of progressively challenging and multidiscipline technologies and markets has prepared me well for my current leadership responsibilities with BSN. I take a lot of pride in the opportunity to work with many talented and committed professionals, with the support of a leading global healthcare company. TWC: What’s your day-to-day role? KG: I am responsible for commercial operations within the US and Canada.We actually have two field sales organizations, one for hospitals and clinics, the other for home medical equipment (HME)/ pharmacy.The focus of the hospital team is fracture management and acute and 32

advanced wound care, while the HME/ pharmacy team focuses on compression therapy (including lymphology) and retail orthopedics. TWC: What do you find most rewarding about providing for your industry? KG: I never tire of hearing remarkable examples every day of how our products and services positively impact and enhance the lives of our patients and the performance of medical professionals. Being able to help improve healing rates with our Cutimed® Sorbact,® an alternative to antimicrobial dressings,and with Cutimed Off-Loader, our total contact casting technology, is very rewarding. Also, utilizing our unique therapy concept from JOBST® Comprifore® to UlcerCARE® and ultimately to gradient compression therapy, in order to provide a lifetime of improved patient care and comfort, is rewarding. TWC: How would you describe the overall mission of your company? KG: The purpose that drives our North American business is very specific. Our purpose is to help our customers prosper in an uncertain healthcare environment and to become the business partner our customers really need. We want to work with our customers to provide insight through every facet of our organization – products, services, people, and processes – to make our customers successful in providing their customers – patients and practitioners – with the highest quality outcomes. We continue to work very hard every day to align our business to this single purpose. TWC: What’s new with BSN? KG: In 2012, BSN enjoyed our best year ever, even in a challenging economic and healthcare environment. The

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year was enhanced by our acquisition by EQT, which has a solid track record of helping its assets grow and succeed in a variety of disciplines.Wound care is a rapidly growing area within BSN fueled by our Cutimed, Leukomed,® and Coverlet® brands. Additionally, our JOBST brand, a market leader for more than 60 years, continues to be the No. 1 physician-recommended brand in compression therapy, while our wide range of FLA® orthopedics remains the No. 1 recommended brand by pharmacists. TWC: How is your company unique? KG: As a global company, BSN benefits from the ideas and innovation provided from our affiliates around the world.We are able to test products in a variety of markets and modify, when necessary, to meet local needs. Our diverse product lines offer our customers a multitude of options to meet the needs of their patients and customers. We have a growing number of market-leading brands, and we continue to seek and provide innovation in everything we do. TWC: Why are you passionate about the work of your company? KG: I am extremely proud to lead a team of healthcare professionals that is passionate about its products and services, and of how we can individually and collectively positively impact the health and well-being of patients and the care that our customers provide to them. We continue to constantly raise the bar of everything that we do, so ultimately our customers and their patients will benefit. This is what drives us every day. n

Online Extra Visit Industry Insider at www. todayswoundclinic.com to learn more about BSN Medical. www.todayswoundclinic.com

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TWCnewsupdate Tactile Medical Unveils Ambulatory Wound System Minneapolis-based Tactile Medical (formerly Tactile Systems Technology Inc.) has launched what it’s calling a first-of-its-kind ambulatory device for patients living with chronic wounds. The ACTitouch Adaptive Compression Therapy system reportedly combines intermittent and sustained compression in one device to heal venous leg ulcers. “For decades, there has been little tangible progress in establishing new methods to improve outcomes for the most challenging patients with chronic venous disease,” said Alan T. Hirsch, MD, chief medical officer of Tactile Medical, a developer and provider of home therapy devices. “New products must treat

these conditions with real-world comfort and sustained efficacy. The ACTitouch Adaptive Compression Therapy system offers the benefits of dual-compression therapy in one easy-to-wear device, giving patients the freedom to stay active while receiving safe and effective treatment.” According to Tactile officials, experts suggest the addition of intermittent pneumatic compression to treat venous leg ulcers may be particularly effective for patients who: • have wounds resistant to healing; • are noncompliant or intolerant of compression bandage systems; or • are immobile or have impaired calf muscle function.

Some compression therapies are uncomfortable or difficult to use, creating barriers to utilization for many patients. The ACTitouch system’s lightweight, wrap-around sleeve is easy to apply and can be removed for bathing or sleeping, officials said. Air-filled chambers and a padded undersock provide a comfortable fit, and the device can be worn discreetly beneath clothing and with regular shoes. The system also includes a “Therapy Tracker” to further support and improve patient utilization. The tracker automatically records and displays average daily use in each of the two compression modes, generating data that clinicians can use to reinforce patient therapy goals. n

New Diabetes Drug Heart-Safe, Study Shows Onglyza® (saxagliptin), a new drug approved for the treatment of diabetes, has no effect on a patient’s risk for heart attack, whether for better or worse, a recent study claims. Researchers from Brigham and Women’s Hospital in Boston did, however, reportedly learn of a rise in hospitalizations for heart failure among those who took the medication compared to those who didn’t, according to a report by HealthDay. The study was funded by AstraZeneca and Bristol-Myers Squibb, the drug’s manufacturers, and questions and concerns about the impact of diabetes drugs on the heart have been highly debated since the drug Avandia was reported to result in a 43 percent increase in [heart attacks] and a 64 percent increase in death from “cardiovascular causes” through a highly publicized meta-analysis in 2007, which prompted the FDA to issue a new mandate regulating that “preapproval and postapproval studies for all new antidiabetic drugs rule out excess cardiovascular risk.” The Ong-

lyza trial involved nearly 16,500 patients from 26 countries living with type 2 diabetes. Participants also reportedly had risk factors for heart disease and were given either saxagliptin at 5 mg per day (or 2.5 mg daily in patients with reduced kidney function), or a placebo. Over more than two years, researchers found the patients who took the diabetes drug were at no greater risk for heart attack. The study also showed that cardiovascular death, heart attack, stroke, or hospitalization for unstable angina, coronary revascularization (angioplasty), or heart failure occurred in about 12.8% of patients who took the drug, compared to 12.4% of those in the placebo group. However, “our data also show an increase in hospitalization for heart failure in patients who received saxagliptin, which was not expected and deserves further study,” said cardiologist and study chairman Eugene Braunwald. But “patients who received saxagliptin also had better control of blood sugar levels and a reduced need for insulin therapy,”

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said physician Itamar Raz, co-principal of the study. Raz added that the diabetes drug also prevented the progression of microalbuminuria, a condition that occurs when a type of protein called albumin is spilling into the urine due to kidney damage. Additionally, two diabetes experts unconnected to the study said the findings should help ease the minds of patients and physicians. “The treatment of patients with diabetes has been challenging in recent years,” said Sripal Bangalore, director of research in the cardiac catheterization laboratory at NYU Langone Medical Center, New York. “It is reassuring to see a mega trial . . . reassuring the cardiovascular safety of saxagliptin given for a median of two years.” Physician Tara Narula, associate director of the cardiac care unit at Lenox Hill Hospital, New York, is hopeful the study’s investigators will publish more data from the trial showing improvement in microvascular events, according to the HealthDay report. n

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TWCnewsupdate SteadMed Medical Names Chief Financial Officer Britt Ingebritson has been named the new chief financial officer at SteadMed Medical, an international provider of wound care medical devices and therapeutic products based in Fort Worth, TX. Ingebritson will be responsible for the company’s financial and operational departments, as well as strategic direction, according to officials. Britt Ingebritson, CFO “Britt comes to SteadMed Medical with an in-depth leadership background and expertise in streamlining the corporate finance function,” said Michael Steadman, president and CEO. “I am confident that his past experience and insight will greatly contribute to our growth strategies and sustained profitability.” Ingebritson brings a wealth of experience to the company, including more than 20 years of association with Williamson-Dickie Mfg. Co. in Fort Worth, where he still serves as a member of the board of directors. Previously, he held titles of chief financial officer, vice president of supply chain management, vice president of marketing,

and corporate controller. Ingebritson is a certified public accountant and holds a master of business from Southern Methodist University and a bachelor of business from the University of Texas at Arlington. He completed his postgraduate studies at the Massachusetts Institute of Technology. n

Net Health Partners With Industry Leaders on EHR Software Officials at Net Health, Pittsburgh, PA, a developer of certified electronic health records, have announced a collaboration with Organogenesis Inc. and Soluble Systems® in relation to an update to its cell and tissue-based products module available through the WoundExpert® software. The enhancement to the Net Health Connections program facili-

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TWCnewsupdate tates insurance verification, submission of supporting documentation, and automated ordering with order status updates completely electronically, while eliminating the need for paper order forms for cell- and tissue-based applications such as Apligraf® and TheraSkin,® officials said. “Partnering with industry leaders like Organogenesis and Soluble Systems represents the next phase in connectivity for providers across the healthcare spectrum,” said Christopher Hayes, Net Health’s chief technology officer. “Combining our resources to make every step in the ordering process a direct, electronic

exchange allows for better patient care by saving clinicians time and improving order accuracy.” Updates will reportedly be available in fall 2013. n

PA-Based Wound Center Earns Hyperbaric Accreditation The Advanced Wound Healing Center at Carlisle (PA) Regional Medical Center recently became one of a few centers in its region to receive accreditation through the Undersea Hyperbaric Medical Society (UHMS).

According to hospital officials, three hyperbaric chambers are in use at the facility, allowing for 9-12 patients to be treated per day. “The rationale behind our UHMS accreditation was to set us apart from the other wound care centers in the area,” said program director Suzanne Peper. “UHMS is strictly quality and safety for hyperbaric medicine.” Nancy Clawson works on staff as a certified hyperbaric technician who has helped the wound center’s staff earn a patient satisfaction rating near 97%, while the heal rate at the facility is 94% within 23 days, according to officials. n

asktheboard In this exclusive column,TWC offers readers the chance to ask industry-related questions to our expert editorial board members.

Q: Why are my claims for debridement of multiple wounds denied?

A: By Kathleen D. Schaum, MS Kathleen D. Schaum, MS This month, TWC received numerous questions pertaining to denied claims for both surgical and medical debridement. Most questions were similar to: • “I surgically debrided subcutaneous tissue from wounds on both feet: 5 sq cm on the right foot and 10 sq cm on the left foot. I billed 2 units of 11042. I was paid for only 1 unit. How should I code this claim so that I get paid for the work I performed on both feet?” • “I medically debrided devitalized epidermis and dermis from wounds on both feet: 8 sq cm on the right foot and 6 sq cm on the left foot. I billed 2 units of 97597. I was paid for only 1 unit. I even tried using modifier 50, but was only paid for 1 unit. How am I supposed to code this claim to receive payment for the bilateral work that I did?” The answers to these questions, and to all similar debridement coding questions, point to a lack of knowledge/misunderstanding about the descriptions of these debridement codes. Surgical debridement codes are described by and reported by the depth of tissue removed and by the surface area of the wound, not by the number of wounds debrided. If more than one wound is debrided to the same depth, qualified healthcare professionals (QHP) should add together the surface area of

all debrided wounds. For example: The work described in the first question was debridement of a total of 15 sq cm of subcutaneous tissue. The QHP should have coded the claim as 1 unit of 11042 because the wound surface area did not exceed the code description of 20 sq cm.Therefore, the QHP was actually paid correctly. If the total wound surface area debrided had exceeded 20 sq cm, the QHP would have billed 1 unit of 11042 for the first 20 sq cm and 1 unit of 11045 for the additional 10 sq cm. Medical debridement codes are reported by the total surface area of the wound(s) debrided, not by the number of wounds debrided. For example:The work described in the second question was debridement of a total of 14 sq cm of epidermis and dermis. The QHP should have coded the claim as 1 unit of 97597 because the wound surface area did not exceed the code description of 20 sq cm.Therefore, the QHP was actually paid correctly. If the total wound surface area debrided had exceeded 20 sq cm (for example 40 sq cm), the QHP would have billed 1 unit of 97597 and 1 unit of 97598. QHPs should pay close attention to changes in codes, to their descriptions, and to the explanations for their use. Upon close review of the surgical and medical debridement codes, QHPs will understand that the location of the debrided wounds and the number of wounds debrided do not determine the selection of the debridement codes. For an in-depth discussion of debridement codes and other wound-specific codes, consider attending a 2013 Wound Clinic Business seminar: www.woundclinicbusiness.com. n For a full disclaimer regarding this information, please refer to Business Briefs in this issue.

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qualityassurance continued from page 16

mine why 17% of wounds did not experience a successful outcome. - Query the data by reflecting on clinical practices: Was there a delay in seeking treatment or were patients’ comorbidities impeding the wound healing outcome? Or, were less-thanoptimal wound management pathways implemented? Answering these questions helps improve one’s comprehensive outcomes. - Importance of data: This report can serve as a report card, allowing clinicians to compare their healing rates to the overall healing rates of the department. Also, reflecting on this report can assist in improving performance-improvement plans.

Volume Reduction Report

- Report description: Illustrates, over a given timeframe, display of (see Figure 3): 1. wounds having successfully met desired goals; and 2. wounds that didn’t meet minimum healing percentage “outliers.” - Report Snapshot: The goal of this report is to identify patients who are missing healing milestones. In looking at this sample report, only 45% of vasculitic ulcers met the healing goal during the reported timeframe. - Query data by reflecting on clinical practices: Are the current wound management pathways clinically effective? Is the clinical team following the appropriate pathways in place? Answers to these questions should allow for early interventions and a return to healing trajectory. - Importance of data: From a clinical and operational perspective, this report is a vital tool to a department’s quality assurance and performance-improvement plans.

Facility Statistics

- Report description: Illustrates the vital wound statistics of specifically targeting admission and visit-volume trends as well as critical patient discharge trends over a specified timeframe (see Figure 4).

Figure 4

Facility Statistics

Date Range: 2/1/13-7/31/13 500 400 300 200 100 0

Feb 13

Mar 13

nn Admissions nn Average Visits per Discharged Patient nn Discharged Patients nn Hyperbaric Treatments nn New Admissions

May 13

Jun 13

Jul 13

nn New Wounds nn Surgical Debridements nn Visits nn Wound Visits

-R eport Snapshot: In looking at this sample report, if new patient admissions are proportionally smaller than the total number of previously admitted patients, this may indicate a referral pattern trending downward. -Q uery the data by reflecting on clinical practices: Report results may prompt a review of marketing strategy and discussion of ways to increase referrals. This report sample also demonstrates increased number of wound visits with a decrease in hyperbaric oxygen therapy (HBOT) treatments. At this juncture, consider running additional clinical data reports to determine the cause of HBOT decline. - I mportance of data: Use this data report to determine whether a wound care department is growing or stagnating and establish department goals accordingly.

Comparative Data Using Reports

Reports can also be cross-referenced to maximize the significance of data collected and improve overall facility trends (see Figures 3 and 4). For example, reviewing the volume reduction report in combination with the facility statistics report would demonstrate the

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outlier percentages are inversely proportional to the average visits per discharged patients. The outcome of this data demonstrates that patient wounds are not meeting healing goals and are likely to result in lengthier admission periods or increased visits.

Conclusion

Many regulations and accrediting bodies direct the way data is structured, collected, and collated. The value of quality, discrete data will evolve as Meaningful Use and other reporting measures are implemented. Understanding how to manage one’s work to produce accurate data is key. n Cathy Thomas Hess is vice president and chief clinical officer at Net Health. She may be reached at cthess@nhsinc.com. References 1. Hess, C.Value of a specialty wound care electronic medical record. Advances in Skin & Wound Care. 2013;26(1):48. 2. Meaningful use definitions & objectives. Accessed online at www.healthit.gov/ providers-professionals/meaningful-usedefinition-objectives. 3. ICD-10-CM/PCS the next generation of coding. Accessed online at www.cms.gov/ Medicare/Coding/ICD10/downloads/ICD10Overview.pdf. www.todayswoundclinic.com

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Advertiser’s Index BSN Medical (Cutimed Sorbact)......................................................................................................................... 3 3 Comprehensive Healthcare Solutions (Wound Care & HBO Programs)............................................................. 2 9 Derma Sciences (TCC-EZ)........................................................................................................ Cover Tip, Cover 2 Healogics (Corporate).......................................................................................................................................... 31 KCI (Graftjacket)..........................................................................................................................................Cover 3 Medela (Invia)......................................................................................................................................................... 3 MTI (Chairs)......................................................................................................................................................... 37 Net Health (WoundExpert)................................................................................................................................... 13 Novadaq (Luna).................................................................................................................................................... 27 Organogenesis (Apligraf).......................................................................................................................Cover 4, 40 Sechrist Industries (OmniPressure Mattress)....................................................................................................... 9 Spiracur (SNaP)..................................................................................................................................................... 5 WellDyne (CellerateRX & WoundSmart App)...................................................................................................... 23

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

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