May 2014

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Contemporary Approaches to Wound Clinic Management

WOUND CARE’S

MEDICAL NECESSITY ARE YOU SEEING THE ‘RIGHT’ PATIENTS?

ALSO IN THIS ISSUE: Wound Care Service Line Evolving Role of the PT Business Briefs May 2014 www.todayswoundclinic.com

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The Symposium on Advanced Wound Care

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Volume 8, Number 4, May 2014 • www.todayswoundclinic.com

Table of Contents • Feature Articles 10

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Medical Necessity in the HOPD: Are You Seeing the ‘Right’ Patients?

Protecting Edges of Venous Ulcers: An Evidence-Based Approach

CMS’ motivation for the OPPS has been to allow patients who do not warrant hospital admission the opportunity to receive complex services as outpatients. However, patients should not be seen in the wound center when they could just as easily be cared for in a doctor’s office. Would your clinic pass the “medical necessity” test?

Due to their unique pathophysiology, venous ulcers are at high risk for moisture-associated skin damage at the wound edge and within surrounding skin. This article reviews underlying mechanisms for the changes that are seen at the wound edge and adjacent periwound skin as a result of excessive exposure to moisture.

Caroline E. Fife, MD & Toni Turner, RCP, CHT, CWS

Debra Thayer, MS, RN, CWOCN

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Wound Care Silo Busting: Building A Service Line Across the Continuum At Spartanburg (SC) Regional Medical Center, the outpatient wound clinic is the center of a paradigm shift that has empowered various hospital departments to form a more centralized service line of coordinated patient care. Get the details on how this shift has gone from conceptualization to reality.

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

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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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Examining the Increased Role of the Physical Therapist Within the Wound Care Industry Physical therapists have been serving in wound care since World War I. Have they evolved to their full capacity in your clinic?

Frank Aviles Jr., PT, CWS, FACCWS, CLT

ADVERTISING QUERIES should be addressed to Jeremy Bowden, Publisher, Today’s Wound Clinic®, HMP Communi­cations, 83 General Warren Boulevard, Suite 100, Malvern, PA 19355. Telephone: (800) 237-7285 or (610) 560-4154 Fax: (610) 560-0501. Email: jbowden@hmpcommunications.com DISPLAY AND CLASSIFIED ADVERTISING: HMP Communications, 83 General Warren Boulevard, Suite 100, Malvern, PA 19355, Phone: (800) 237-7285 or (610) 560-0500 x259 CORPORATE OFFICES HMP Communications, LLC 83 General Warren Boulevard Suite 100 Malvern, PA 19355 Phone: (610) 560-0500 or (800) 237-7285 Fax: (610) 560-0502

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EDITORIAL STAFF

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

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

Volume 8, Number 4, May 2014 • www.todayswoundclinic.com

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From the Editor

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Des Bell, DPM, CWS

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TWC News Update USWR Qualifies as CMS Clinical Data Registry

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Business Briefs

Medical Necessity Tops Conversation Topics at SAWC Spring

Kathleen D. Schaum, MS

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

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

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For this month’s editorial,TWC board member Des Bell, DPM, CWS, discusses his support of Dr. Lee Rogers’ run for the US House of Representatives.

EDITORIAL BOARD

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FOUNDING EDITORIAL BOARD MEMBER & EDITOR OF TODAY’S WOUND CLINIC Caroline Fife, MD, FAAFP, CWS

think of myself as an eternal optimist — a mindset I believe is an important part of the makeup of anyone who has dedicated even a portion of his/her career to the specialty of wound care. One of the most gratifying aspects of being a wound care provider to me is the ability to offer hope for healing in situations where none has previously been achieved or offered. But I fear for the survival of our industry as we’ve come to know it. And I can only hope that I’m wrong about that.

FOUNDING EDITORIAL BOARD MEMBERS Dot Weir, RN, CWON, CWS Christopher A. Morrison, MD, FACHM, FCCWS Valerie Sullivan, PT, MS, CWS Kathleen D. Schaum, MS EDITORIAL BOARD MEMBERS

Des Bell, DPM, CWS TWC board member

A PERILOUS STATE FOR WOUND CARE I recently returned from the Symposium on Advanced Wound Care (SAWC), the largest gathering of wound care professionals and members from industry in the US, as you are likely aware. I feel compelled to offer my impressions of this most recent SAWC because I felt something there that I have never felt at any other conference. Instead of a “buzz” being created about a topic pertaining to medicine, the common discussions among many attendees had to do with reimbursement, the impact of Medicare reimbursement changes, the Affordable Care Act, health reform, physician audits, electronic health records, quality measures, Meaningful Use, and, in general, the growing frustration and despair surrounding delivery of care.

For an eternal optimist, the content was rather heavy. These issues are not exclusive to wound care, although we are feeling a major brunt of the changes and I believe wound care as we know it is in great peril.

Cutting reimbursement for wound care-related services has gained momentum over the years. First, it was debridement and perceived “overuse” of its codes. Most recently, skin substitutes have come under fire. Next up, hyperbaric oxygen. I think we will also see a marginalization of wound specialists in favor of, once again, the primary care physician. Not that most of them will want to manage wounds, but specialists such as nurse practitioners will get dinged for unnecessary or duplication of service determinations. The Centers for Medicare & Medicaid Services (CMS) and the insurance companies are further marginalizing wound care — a fact that is not open for debate. “Divide and conquer” among our relatively small community is the M.O., and an effort to cut costs pertaining to our segment of medicine is reality.

I’m not pretending to be psychic here, I just worry that our collective focus on providing the best care to our patients in need has long given way to disgust, outrage, and fear as well as a real concern for the long-term survivability of wound care as a specialty.Why will companies invest in wound care if they will never see reimbursement beyond a few basic products like alginates and hydrogels?

THE POLITICS OF WOUND CARE I must also disclose that politics and the politicians who “represent” us, on both sides of the aisle, have increasingly jaded me. Where I once followed politics quite closely I now find that I experience very little individual integrity by immersing myself in it. Political debates today seem to have the Continued on page 5 4

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

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fromtheeditor Continued substance of professional wrestling interviews. Determining who the “good guy versus the bad guy” is depends on which side you align yourself.These points being stated, I feel compelled to ask you to support the campaign of Dr. Lee Rogers, DPM, as he seeks election to the US House of Representatives from California. As a colleague and friend, I know that he understands what is at stake in both healthcare and wound care among providers and patients. If anyone can answer a committee member’s question, for example, as to whether amputation of a diabetic leg is cost effective, he would be the one. A few years ago, the president stated that doctors were paid $30,000 to amputate a leg (which is erroneous). Does the government want us to prevent amputations or do they feel it more cost effective to sweep these people under the rug?They seemingly want to reduce the cost of the services provided, but they are not comprehending the complexity of what treating a wound entails. But, as a medical director at a California-based amputation prevention center, Lee does. An author of more than 100 scientific papers, articles, and book chapters, Lee has been advancing our understanding of health policy and medicine for years. He’s been named one of America’s “Most Influential Podiatrists” by Podiatry Management magazine, chosen for the Rising Star Award from the American Podiatric Medical Association, and authors a blog for TWC’s sister publication Podiatry Today. His state medical association named him Educator of the Year in 2012 and he has served as chairman of the foot care council for the American Diabetes Association, where he once led on national education and advocacy for preventing amputations.

As we collectively feel beaten down by the legislative changes that have already begun, Lee promises to be our “Voice in Washington.”The decisionmakers with CMS and the insurance companies do not respect what wound care specialists have meant to countless patients. They see only how much money is spent and want to put unqualified doctors, nurses, and allied staff in charge of managing complex wounds among even more complex patients.

“Turn back the clock” is a phrase that is not going to be limited to baseball teams wearing throwback uniforms.

WHAT WE CAN DO Just knowing we could have someone like Lee to speak up for us as well as to educate and persuade others would be a huge asset to wound care as well as healthcare delivery. It doesn’t matter where you live or practice, your party affiliation, or what role you have in wound care, having Lee representing us — his constituents who have been without a real advocate — is a critical step if wound care is to survive as a specialty.

I know unequivocally Lee would represent each of us with his extreme intelligence, compassion, empathy, and determination. His understanding of the issues that are impacting our patients and us is unique. His election to Congress would provide us with a great opportunity to be heard and to bring an end to the lack of understanding and even contempt that our specialty is viewed with by those whose decisions directly impact our fate and the fate of countless others.

For the sake of patients everywhere as well as our specialty, please support Lee as he offers us our own needed version of hope for healing and optimism for a better future that includes the validation of wound care, not its demise. To learn more about Lee and his campaign, visit www.

LeeRogersforCongress.com. n

TWCnewsupdate USWR Qualifies As CMS Clinical Data Registry Officials with the US Wound Registry (USWR), a Medicare physician quality reporting body, have announced its acceptance as a qualified clinical data registry (QCDR) by the Centers for Medicare and Medicaid Services (CMS).

The USWR has performed quality reporting to CMS on behalf of eligible providers (EPs) since the beginning of the physician quality reporting program that uses a combination of incentive payments and penalties to promote reporting of quality information by EPs. The QCDR program allows the USWR to develop its own quality measures for EPs rather than being limited to those provided by CMS. USWR partnered with the Alliance of Wound Care Stakeholders to craft 12 new quality measures that reflect appropriate care of patients with conditions such as diabetic foot ulcers and venous leg ulcers.

Clinicians who report at least nine measures in 2014 will be eligible for a 0.5% bonus to their total Medicare payments in 2016. After 2014, clinicians who fail to report will be at risk for reductions in their Medicare payments.

Measures can be reported from any electronic health record (EHR) that is certified under the first stage of Meaningful Use. CMS has made it clear that the QCDR program is intended to be vendor neutral when it comes to EHRs. The goal is to get as many EPs as possible sharing quality data and reporting their patient outcomes so that it is possible to understand the value of medical interventions in affecting patient outcomes.

The USWR also included a “wound quality of life” tool to better understand the impact that having a chronic, nonhealing wound has on the daily life of a patient. More information can be accessed at www.uswoundregistry.com/ Specifications.aspx.n

Des Bell, DPM, CWS www.todayswoundclinic.com

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Today’s Wound Clinic® May 2014

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businessbriefs Medical Necessity Tops Conversation Topics at SAWC Spring Kathleen D. Schaum, MS

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

W

hile registering at the Gaylord Palms Resort in Orlando, FL, for the Symposium on Advanced Wound Care (SAWC) Spring 2014, a physician tapped me on the shoulder and said,“The hospital-based outpatient wound care department (HOPD), for which I am the medical director, is having an audit by the Medicare recovery auditor. Can you please help me?” Little did I know that was only the beginning of the real-life reimbursement issues and questions that I would answer for several hundred SAWC attendees. While driving home recently and reflecting on the fabulous lectures that I attended, the Wound Clinic Business (WCB) seminar I hosted, an SAWC presentation in which I discussed expected and unexpected reimbursement changes for 2014, and the ICD-10-CM preparation and documentation post-conference, I came to the realization that wound care providers definitely underestimate the need to meet all “medical necessity” requirements in their documentation and before they see patients in HOPDs. Because “medical necessity” was such a big issue at SAWC, I thought I should discuss here some misperceptions the attendees shared with me.

MEDICAL NECESSITY OF CLINIC VISITS & PROCEDURES DURING SAME ENCOUNTER Let’s begin by discussing the subject of the Medicare recovery audit that was facing the 6

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aforementioned HOPD medical director.

He explained that he and the HOPD bill for a clinic visit at each patient encounter, even when procedures are performed.

Recovery auditors reportedly told him that most of the clinic visit charges were not “medically necessary.” The medical director said he assessed the wounds at each weekly encounter and believes the HOPD and he should be paid for that work.

Unfortunately, I did not have great news for him: Each procedure has an inherent evaluation and management component for the decision to perform the procedure.

If the encounter also includes a new problem, a new complaint, a new complication, etc. and if the qualified healthcare professional’s (QHP’s) documentation clearly describes a significant, separately identifiable evaluation and management service above and beyond the usual preoperative and postoperative work of a procedure, then the HOPD and the QHP may be able to bill for the visit and the procedure during the same encounter.In that case,the HOPD and QHP would attach “modifier 25” to the clinic visit/evaluation and management code. Unfortunately, most repeat wound care encounters in which a procedure is performed do not meet the “separate, significantly identifiable” medical necessity requirements.Therefore, everyone reading this article should:1) audit past claims to verify they have not been routinely submitting claims with both a clinic visit/ evaluation and management code and a procedure code;and 2) cease billing for these “medically unnecessary” clinic visits when performing procedures.

SPECIFIC DIAGNOSIS & COMORBIDITIES DETERMINE MEDICAL NECESSITY During the WCB seminar (www. woundclinicbusiness.com), many QHPs wanted me to tell them which diagnosis code they should put on their Medicare claims to

prove“medical necessity”and gain Medicare coverage for specific wound care services/ procedures/products.I explained that QHPs should clearly document each patient’s diagnosis and comorbidities in the medical record. The diagnosis and comorbidities should be reported on the Medicare claim for that specific encounter.If a local coverage determination (LCD) exists for any of the services, procedures, or products performed during that encounter, the QHP should verify whether or not the patient’s diagnosis and comorbidities are listed as covered in the LCD. If they are not covered, the QHP should not change the patient’s diagnosis and comorbidities just to gain coverage. Instead, the QHP should discuss the need for the service/procedure/product with the patient and give the patient an opportunity to sign an advance beneficiary notice (ABN) of noncoverage. Therefore, everyone reading this article should document the patients’ diagnoses and comorbidities to the highest level of specificity.

LCDs PROVIDE MEDICAL NECESSITY GUIDELINES Many QHPs said they did not realize the importance of their Medicare contractors’ LCDs. In fact, many QHPs said they have never read their LCDs because they thought LCDs were “just a guide for their coders and billers.” The QHPs also realized that they have often unnecessarily stopped performing some services/procedures and/or using some products because their claims were denied. After our discussions, the QHPs came to the conclusion that many of the claims were denied because the patient’s diagnosis was not covered per the LCD or because the QHP did not take the time to document the patient’s diagnosis to the highest level of specificity.Therefore, everyone reading this article should: 1) read pertinent LCDs to understand the covered www.todayswoundclinic.com

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businessbriefs diagnosis codes, the utilization guidelines, the documentation guidelines, etc.; and 2) present patients with ABNs when necessary.

FUTURE EFFECTIVE LCDs PROVIDE PREVIEW OF ICD-10 MEDICAL NECESSITY After speaking to many QHPs, I learned that seemingly nobody knew that the Centers for Medicare & Medicaid Services (CMS)mandatedallMedicareadministrative contractors (MACs) to convert all LCDs and articles that contained covered/noncovered ICD-9 diagnosis codes to LCDs and articles with ICD-10 diagnosis codes. The future effective LCDs and articles were required to have a new LCD/article identification number and to be published on the Medicare Coverage Database by April 10, 2014.All of the MACs complied with the CMS mandate, although a few posted their documents after the deadline.The Table at the conclusion of this article includes a sample listing of some wound care-specific future effective LCDs with ICD-10 codes that have been posted by each MAC. CMS has determined that although new LCD/article numbers were assigned to the ICD-10 LCDs, the policies were not considered “new.” CMS considers this type of update to be a coding revision that does not change the intent of coverage/noncoverage within an LCD. Therefore, if a MAC only translates ICD-9 codes to the appropriate ICD-10 codes, the policy does not need to be vetted through the Carrier Advisory Committee or to be sent through the public comment and notice process. However, if a MAC decides to revise more than just the ICD-10 code(s), they must follow the normal LCD development process.

By reviewing the future effective LCDs, QHPs can obtain an excellent preview of the level of diagnosis specificity that they should begin to document. Therefore, everyone reading this article should review the future effective LCDs and articles that pertain to their work and should begin to document their patients’ diagnosis(es) and comorbidities with a greater degree of specificity. QHPs can view the entire list of their MAC’s future effective LCDs at www. cms.gov/medicare-coverage-database/ overview-and-quick-search.asp.

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MEDICAL NECESSITY IN THE ABSENCE OF AN LCD Many QHPs at SAWC were also under the mistaken idea that the absence of an LCD pertaining to a particular service/ procedure/product meant that it was not covered. In the absence of an LCD, national coverage determination (NCD), or CMS manual instruction, “reasonable and necessary” guidelines apply. Section 1862 (a) (1) (A) of the Social Security Act states:“No payment may be made under Part A or Part B for any expenses incurred for items or services not reasonable and necessary for the diagnosis, or treatment of illness or injury, or to improve the functioning of a malformed body member.”

To be considered “reasonable and necessary,”the patient’s medical record must include the following documentation to prove “medical necessity”: • The item or service is for the diagnosis or treatment, or to improve the functioning of a malformed body member.

• The item or service is appropriate for the symptoms and diagnosis or treatment of the patient’s condition, illness, disease, or injury.

• The item or service is furnished in accordance with current standards of good medical practice.

• The item or service is not primarily for the convenience of the patient, or physician or healthcare provider.

• The item or service is the most appropriate supply or level of service that can be safely provided to the patient.

• The item or service is delivered in the most appropriate setting.

• The item or service is ordered and/or furnished by qualified personnel.

• Therefore, everyone reading this article should remember: For any service reported to Medicare, it is expected that the medical record documentation clearly demonstrates that the service/ procedure/product meets all the above “reasonable and necessary” criteria. In addition, remember that all documentation must be maintained in the patient’s medical record and be available to the MAC upon request.

DOCUMENT NOW FOR ICD-10 Many attendees at SAWC revealed they had not begun to refine their documentation for ICD-10.Although Congress has delayed the implementation, CMS has announced its intentions to implement the new system Oct. 1, 2015. Although that may sound like a long way off, most QHPs have a lot of work to accomplish between now and then.

In particular, they have to identify the level of documentation specificity required to properly diagnose patients via the ICD-10 system. Then they have to begin refining their documentation – one major diagnosis at a time. Therefore, everyone reading this article should learn the sections of the ICD-10 codebook that pertain to their work and should start documenting now with the specificity required by ICD-10.

Remember that it takes practice to change documentation habits.

MEDICAL NECESSITY = DIRECT SUPERVISION OF HOPD THERAPEUTIC SERVICES While much has been written and taught about the requirement for “direct supervision” in HOPDs, it was still a major topic of conversation and the subject of numerous questions at SAWC. CMS’ policy about direct supervision is actually quite clear if one knows CMS’ supervision levels definitions: • General Supervision: The procedure is furnished under the physician or nonphysician practitioner’s overall direction and control, but his or her presence is not required during the performance of the procedure.

• Direct Supervision: The physician or non-physician practitioner must be immediately available to furnish assistance and direction throughout the performance of the procedure.He or she does not have to be present in the room.

• Personal Supervision: The physician or non-physician practitioner must be in attendance in the room during the performance of the procedure.

The calendar year 2010 Outpatient Prospective Payment System final rule

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businessbriefs (74FR 60580) discusses “immediately available”and states which QHPs can provide direct supervision and who may personally perform specific therapeutic services under state law and hospital privileges.

The QHP must be immediately available to furnish assistance and direction throughout the performance of the procedure (not “on call”) “without interval of time”and must be interruptible if concurrently engaged in other activities (eg, patient care). The rule also states hospitalists or emergency department physicians can provide direct supervision, if they are interruptible and are licensed, able, and have hospital privileges to

furnish the specific therapeutic service(s).

Nearly all services/procedures/ products performed/supplied in an HOPD require direct supervision in order to be deemed“medically necessary.”

Therefore,if an HOPD has been billing Medicare and receiving payment when direct supervision was not available, the hospital may be asked for a repayment upon an audit.

NOTE: Effective Jan. 1, 2014, the direct supervision regulation also applies to critical access hospitals in order for HOPD services to be deemed “medically necessary.”

NOTE: Only two wound care-related procedures may be performed under

general supervision: 29580: Strapping: Unna’s boot; and 29581: Application of multilayer compression system; leg (below knee), including ankle and foot.

Therefore, everyone reading this article should be sure that no HOPD services (except 29580 and 29581) are performed unless a QHP is scheduled and provides direct supervision. n Kathleen D. Schaum is president and founder of Kathleen D. Schaum & Associates Inc., Lake Worth, FL. She may be reached at 561-9642470 or kathleendschaum@bellsouth.net.

TABLE. SAMPLE LIST OF WOUND CARE-SPECIFIC FUTURE EFFECTIVE LCDs WITH ICD-10 CODES MAC

FUTURE EFFECTIVE LCD ID NUMBER

FUTURE EFFECTIVE LCD TITLE

CAHABA Government Benefit Administrators LLC

L34295 L34290

Surgery: Bioengineered Skin Substitutes (BSS) for the Treatment of Diabetic and Venous Stasis Ulcers of the Lower Extremities Surgery: Debridement Services

CGS Administrators DME MAC

L34820 L33821 L33829 L33831

DRAFT – Pneumatic Compression Devices Negative Pressure Wound Therapy (NPWT) Pumps Pneumatic Compression Devices Surgical Dressings

CGS Administrators LLC

L34053 L33945 L34032 L34034 L34049

Application of Cellular and/or Tissue Based Products for Wounds of Lower Extremities Cerumen (Earwax) Removal Debridement Services Hyperbaric Oxygen Therapy (HBOT) Outpatient Physical and Occupational Therapy (PT and OT) Services

First Coast Service Options Inc.

L33413 L33961 L33566

Therapy and Rehabilitation Services Therapy Services Billed by Physicians/Non-physician Practitioners Wound Debridement Services

National Government Services DME MAC

L34820 L33821 L33829 L33831

DRAFT – Pneumatic Compression Devices NPWT Pumps Pneumatic Compression Devices Surgical Dressings

National Government Services Inc.

L33391 L33614 L33631

Biologic Products for Wound Treatment and Surgical Interventions Debridement Services Outpatient PT and OT Services

NHIC Corp. DME MAC

L34820 L33821 L33829 L33831

DRAFT – Pneumatic Compression Devices NPWT Pumps Pneumatic Compression Devices Surgical Dressings

Noridian Healthcare Solutions LLC DME MAC

L34820 L33821 L33829 L33831

DRAFT – Pneumatic Compression Devices NPWT Pumps Pneumatic Compression Devices Surgical Dressings

Noridian Healthcare Solutions LLC

L34886 / L35008

Noncovered Services

Novitas Solutions Inc.

L35122 L35021 L35036 L35125

Bioengineered Skin Substitutes HBOT Therapy Services (PT, OT, speech-language pathology) Wound Care

Palmetto GBA

L33460 L33431

Debridement of Ulcers and Wounds HbA1c

Wisconsin Physicians Service Insurance Corp.

L34593 L34587

Application of Bioengineered Skin Substitutes Wound Care

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Medical Necessity in the HOPD:

Are You Seeing the ‘Right’ Patients?

Caroline E. Fife, MD & Toni Turner, RCP, CHT, CWS

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n August 2000, the Center for Medicare and Medicaid Services (CMS) created the hospital Outpatient Prospective Payment System (OPPS).

CMS projected that in 2013 the cost of services provided to Medicare beneficiaries under OPPS would be approximately $48 billion. Services provided under OPPS are rendered in a “provider-based setting,” which means that an advanced practitioner must be present for the hospital to bill for these services. One could argue that, from Medicare’s perspective, “wound centers” do not actually exist as unique entities. Despite the vital services provided within them, wound centers represent only a small portion of the services provided within OPPS since this program also includes (for example) services provided in hospital emer-

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gency departments, outpatient radiology, and outpatient oncology. In fact, it may be useful to keep in mind the other services provided under OPPS as we consider who the “right” patients are for the hospital-based outpatient wound care department (HOPD). This article will help wound center directors and providers determine whether or not they are caring for appropriate patients as determined by their “medical necessity.”

ASSESSING OPPS AGENDA

What was the goal of OPPS when Medicare launched this program nearly 15 years ago? The OPPS was established to fund a variety of outpatient services that were previously only available to patients during an inpatient stay.

The goal of the program was to allow patients who were not sick enough to

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warrant hospital admission the opportunity to receive complex services as hospital outpatients. Just as with the inpatient setting, patients in any HOPD accrue charges for both the physician service and the “facility” (hospital).

This holds true for the wound center.

As a result, the cost of care for patients seen in an HOPD is typically higher than if the patients were only seen in a private physician’s office. Although these additional costs normally exceed those of services provided in a doctor’s office, the overall intention of CMS is to reduce overall beneficiary costs by limiting or preventing an even more costly inpatient stay by providing an advanced level of outpatient care that would not typically be available in a physician office setting. In other words, we are not supposed to

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medicalnecessity see patients in the wound center who could just as easily be managed in a doctor’s office. To justify being seen in the wound center, a patient’s condition must pass the test of medical necessity for that service and be in need of the higher level of care delivered in a provider-based setting.

DETERMINING MEDICAL NECESSITY

So, why do HOPD wound care providers really have to concern themselves with medical necessity? In 2013, the Office of the Inspector General’s (OIG) Work Plan, a roadmap for scrutiny and enforcement, included a review of physician billing in the providerbased setting.

In other words, the OIG is going to pay special attention to the physician billing taking place in the setting of OPPS, and that includes what we refer to as “wound centers.” So, that means it is time for wound care physicians to review the true medical necessity of the services provided to patients in their HOPDs as well as the written scope of practice for their facilities in expectation of increased scrutiny from the OIG. Consider the following as a guide: Is your clinic a true HOPD and how can you tell?

Before we discuss which patients are appropriate for our services, perhaps we ought to define a provider-based outpatient wound center. Consider location: Some wound centers are physically inside hospitals and some are located in office buildings. This topic is actually too complex to be properly dealt with here, but we will mention a few important points. (For more on this topic, consult “Determining the Validity of Your Outpatient Wound Center,” TWC Vol. 8 No. 1.) Only licensed hospitals can provide services under the provider-based rules. The entities (let’s call them “wound centers”) eligible for payment under the OPPS system are those that bill for outpatient services using the CMS 1450 form (UB04).

Here are some of the rules that apply: 1. The wound center operates under

the same license as the hospital.

2. The clinical services are fully integrated with those of the hospital, with common privileges, quality assurance, and monitoring (as for any other hospital department).

3. The financial operations of the wound center are fully integrated within the financial system of the main provider and costs are reported in the main provider’s cost centers.

4. The location is held out – by signage and otherwise – to the public and payers as part of the hospital.

5. The wound center has to comply with the same requirements of the Emergency Medical Treatment & Labor Act and billing rules applicable to HOPDs. 6. The hospital must indicate the place of service (22 - outpatient) and bill type (13X) consistent with OPPS. The charges must be processed through the current outpatient code edits and not through inpatient code edits. This topic is too large to properly address in this article, but failure to understand the difference between inpatient and outpatient charge rules is the most common cause for claim denial.

7. All the hospital staff working in the wound center provides services under the direct supervision of an advanced practitioner. The practitioner can be employed by the hospital or in private practice.

Seeing your wound center as payers see you.

It’s important to understand the two distinct sets of rules that govern both the care provided and the reimbursement rules for Medicare patients who are seen in the outpatient setting. Provider-based rules govern the operational setup of the wound center. OPPS rules govern the payment mechanism designed to fund that setting. Medicare has designated local contractors (Medicare Administrative Contractors [MACs]) to help facilitate OPPS rules.

MACs issue the medical policies that providers must use to ensure appro-

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HOSPITAL OUTPATIENT QUALITY REPORTING PROGRAM: DO ‘WOUND CENTERS’ EXIST? On Nov. 15, 2012, the final rule updating polices and rates for hospital-based outpatient departments was published in the Federal Register (www.gpo. gov/fdsys/pkg/FR-2012-11-15/ pdf/2012-26902.pdf). No doubt there will be future articles in TWC discussing the impact of these changes to the wound care industry. However, there is one area which drives home the point that “wound centers” are simply a small part of the much bigger hospital outpatient system: Under the Outpatient Quality Reporting program, hospitals need to successfully report the use of designated quality measures to avoid a 2% reduction in payment.

The payments hospitals receive beginning in 2013 were based on reporting of these measures in 2011. Payments in 2014 are based on quality reporting in 2012, and so forth. These measures are highly relevant to emergency departments and outpatient surgery centers, but poorly relevant to wound centers.The news is better for physicians. On Jan. 1, 2014, 12 new wound care-specific quality measures were added to the Physician Quality Reporting System (PQRS) via a Qualified Clinical Data Registry supported by the Alliance of Wound Care Stakeholders. It is not clear whether CMS will allow any of the new wound care specific PQRS measures to be used by outpatient wound centers at a future time.

What we do know is that wound centers are really part of the larger Outpatient Prospective Payment System picture, one that is about to come under additional regulatory scrutiny. n

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medicalnecessity HOSPITAL OQR MEASURES FOR 2014, 2015, & SUBSEQUENT YEAR PAYMENT DETERMINATIONS Note: OP = Outpatient OP-1: Median time to fibrinolysis OP-2: Fibrinolytic therapy received within 30 minutes OP-3: Median time to transfer to another facility for acute coronary intervention OP-4: Aspirin at arrival OP-5: Median time to ECG OP-6: Timing of antibiotic prophylaxis OP-7: Prophylactic antibiotic selection for surgical patients OP-8: MRI lumbar spine for low back pain OP-9: Mammography follow-up rates OP-10: Abdomen computed tomography (CT) – Use of contrast material OP-11: Thorax CT – Use of contrast material OP-12: The ability for providers with health information technology to receive laboratory data electronically directly into their qualified/certified electronic health record system as discrete searchable data OP-13: Cardiac imaging for preoperative risk assessment for non-cardiac, low-risk surgery OP-14: Simultaneous use of brain CT and sinus CT OP-15: Use of brain CT in the emergency department (ED) for atraumatic headache* OP-17: Tracking clinical results between visits OP-18: Median time from ED arrival to ED departure for discharged ED patients OP-19: Transition record with specified elements received by discharged ED patients** OP-20: Door-to-diagnostic evaluation by a qualified medical professional OP-21: ED-median time to pain management for long bone fracture OP-22: ED-patient left without being seen OP-23: ED-head CT scan results for acute ischemic stroke or hemorrhagic stroke patients who received head CT scan interpretation within 45 minutes of arrival OP-24: Cardiac rehabilitation patient referral from an outpatient setting *** OP-25: Safe surgery checklist use * Public reporting of measure OP-15 has been postponed. Refer to the imaging efficiency measures for more information. ** OP-19 has been removed; however, submission of a “non-blank” value is required through fourth quarter 2013 encounters. *** As of July 8, 2013, CMS had reported a proposal to remove OP-24 due to “continued difficulties with defining the measure care setting that would enable hospital outpatient departments to collect information on patient referrals without creating undue burden on providers.” n

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priate patient selection is being made and specific coding and billing requirements are being followed. There may be a contradiction between the type of patients that your MAC expects you to treat and the patients your center is actually treating.

Just to be clear, the local coverage determinations (LCDs) issued by the MACs do not prevent HOPDs from performing services, they simply determine which services are covered. If a patient who does not meet LCD coverage criteria wishes to continue receiving services at an HOPD, the HOPD can give the patient an advanced beneficiary notice and the patient can pay for the service.

Objectively understanding the difference between what we believe is right to do for our patients and what is reimbursed from a regulatory standpoint can be very difficult. For example, many clinics will continue to follow a patient in the wound center long after the wound is healed, simply to assist with the application of stockings or similar preventive measures. While it may be true that preventive care is cost saving and that some patients have few logical alternatives for treatment, many, if not all LCDs specifically preclude this type of care in an HOPD. Wound care providers must take a concerted look at their mission and scope of practice through the lens of the payers. If you do not understand the implications of the review by the OIG mentioned above, let’s state it another way: Failure to follow the regulations regarding the type of patient conditions that qualify for payment under OPPS is a potential fraud issue for the hospital and the clinicians involved. MACs and their LCDs specify the unique conditions that must be present in a Medicare beneficiary to justify reimbursement for wound care services in a provider-based setting. As more expensive and advanced therapies are

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medicalnecessity RECOGNIZING MEDICAL NECESSITY RED FLAGS A variety of Outpatient Prospective Payment System (OPPS) payment rules impact the wound center, thus there is no single regulatory document that provides a list of “do’s and don’ts” regarding appropriate wound care patients. Different rules apply for different scenarios. We provide some problematic scenarios here. Do any of these examples sound familiar?

1) You are referred an emergency department (ED) patient, a young adult who had sutures placed two days prior. Is it appropriate for this patient to be followed up on in the HOPD wound clinic? a. If the patient is otherwise healthy and has no medical problems, then no, he/she is probably not appropriate for the HOPD setting and should go to a primary care provider (PCP) for this service. b. However, if he/she is frail and living with multiple active comorbid diseases with a complex injury who will require close monitoring since the wound is not likely to heal normally and may ultimately have skin loss with an open ulcer requiring advanced therapeutic intervention, then the patient’s overall condition resulting in poor healing may meet the criteria for your center if documented clearly enough. The ED physician, as well as the wound care doctor’s notes, should reflect the above history and why this complex patient requires the center’s unique services.

2) Your patient’s diabetic foot ulcer closed one month ago. You have continued to see him every two weeks to make sure he is doing well. He has a history of nonadherence with his diabetic footwear and he does better if you keep an eye on him. Is it appropriate to monitor him in the HOPD? a. No. While it may be acceptable to see a patient once to ensure final wound closure, ongoing monitoring of healed or closed wounds is an inappropriate use of OPPS funding. These services can and should be provided by the PCP. 3) You are referred a patient with a surgical wound who is still within a 90-day global period from the procedure performed. Due to the patient’s underlying condition(s), he has a partial dehiscence and is likely to require negative pressure, or perhaps has a jeopardized flap needing hyperbaric oxygen therapy. Is it appropriate to treat him in the outpatient center? a. Yes. The physician’s notes need to reflect the complexity of this patient’s condition, including the date of surgery and the complication that has occurred. b. The surgeon and the wound care physician can agree on the transfer of postoperative care if the surgeon believes the patient will need more advanced follow-up care than the surgeon can provide in a routine office visit. This agreement may be in the form of a letter or an annotation in the discharge summary, hospital record, or ambulatory surgical center record. The transfer-of-care document should follow the patient to the provider performing the postoperative service and indicate the date of the transfer of care. This should remain on file in the patient’s record. Surgical modifiers 54 and 55 would then be necessary to report on both the surgeon and the wound care clinic physician’s claims communicating the arrangement to the payer, allowing for the appropriate division of the global fee to be made to the wound care physician for providing postoperative care (7-20% of the global package). Keep in mind that any services rendered to the patient while within the global period that are allowed to be paid separately should have a distinct modifier that conveys to the payer why they are not part of the routine postoperative care. Without that qualifying modifier, the services provided at the wound center are at high risk of payment denial.

4) A vascular surgeon who sees patients one day per week in your center wants to see his surgical follow-up patients in the wound center that day because it is convenient for him. (After all, he is going to be there all day, so why not have his patients scheduled to see him while he is there?) Is it appropriate for you to schedule and, more importantly, bill for those patient encounters in your HOPD? a. No. These patients do not warrant the additional expense incurred under OPPS simply for the convenience of the doctor to perform routine postoperative care.

5) An elderly patient living with severe edema and recurrent leg ulcers has been followed by you for two years. Her current ulcer has made no progress for four months. She is unwilling to use compression. She is in a nursing home and is brought to you by ambulance twice per month. Your plan of care consists of trying different dressing products. Can you continue to see this patient in the HOPD? a. These cases are frustrating. However, under most local coverage determinations (LCDs), if she is not able to fully participate in her care by complying with the treatment plan prescribed, and thus her wound healing fails to progress, the use of the advanced HOPD is not medically reasonable. The hospital OPPS is designed to fund an enhanced level of therapeutic care that is not typically provided in a doctor’s office. Utilizing the provider-based setting (and the Medicare dollars allocated for this program) to care for patients who really should be cared for in other settings (eg, PCP, routine postoperative management, self-care) has led to increasingly restrictive language of many LCDs. The effect is to limit care for patients who do meet LCD criteria. As Medicare struggles to limit inappropriate use of OPPS through regulatory language, clinicians become increasingly burdened with the documentation needed to justify the need for services and to stay current on changing utilization limits. Poor patient selection is driving Office of the Inspector General scrutiny of the OPPS program and has positioned outpatient wound care as a high-risk target for auditors and other recoupment programs. As an industry, it is “time to get our house in order.” n

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medicalnecessity made available to us, the LCDs have become increasingly detailed regarding the requirements necessary for these treatments to be reimbursed under OPPS.

WOUND CLINIC SELF-ASSESSMENT

Begin with a careful reading of your current LCDs. Without referencing a particular LCD, here are the types of patient conditions that are specifically NOT considered reimbursable by Medicare in the HOPD, based on language from various coverage policies: Examples of conditions not reimbursed by Medicare in the HOPD by some LCDs: 1. Palliative wound care (patients whose wounds are not expected to heal); 2. Wounds that are no longer showing any evidence of improvement; 3. Patients whose care could be provided by self-care or their primary care doctor; and 4. Patients with acute and uncomplicated wounds.

Wound centers commonly see challenging and complex patients. US Wound Registry (USWR) data demonstrate the average wound center patient lives with eight comorbid diseases and 30% of patients being treated for wounds other than diabetic foot ulcers (DFUs) have diabetes as a complicating factor.These patients are referred to the wound center so that they can undergo thorough evaluation of the factors contributing to healing failure and so a treatment plan can be implemented.

Reimbursement for the treatment we conduct is contingent on addressing all of these underlying conditions.

But, do we really do all that we should be doing? When USWR data were reviewed, patients living with venous ulcers left a clinic visit in adequate compression only 17% of the time (the majority were still being told to elevate or were being provided with compression known to be insufficient). Among patients living with DFUs, adequate offloading was documented in only 6%

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of visits (the majority of DFUs were being “offloaded” with choices like shoe modification). An article published by TWC reported on the results of an initiative run in conjunction with USWR that has been successful in increasing physician compliance with clinical practice guidelines for compression, offloading, vascular screening, and nutritional assessment.1 When we are evaluating our services through the lens of the payers, we must remember that from their perspective the purpose of the HOPD is to obtain for the patient an enhanced level of care beyond what’s available in the doctor’s office. Wound centers cannot be merely “dressing-change clinics.”

Even though these services may be provided to patients (eg, negative pressure or compression bandaging), they must be provided in the context of a comprehensive plan to address all the factors the patient needs in order to heal. The activities that are being directly supervised by the wound care expert must include the proper diagnosis of the condition(s) that have inhibited normal phases of healing and the creation of a detailed treatment plan for the patient (not just the wound) and the execution of this treatment plan.

What happens in some wound centers is a form of “supervised neglect” — a faulty medical treatment in which the treating provider enforces therapies that are either not up to date or ineffective.

The patients receive attentive follow up and frequent medical exams that enforce the illusion of being properly treated when, in reality, ineffective care is being given. It must be remembered that ineffective care is expensive care.

(Read more at www.gfmer.ch/ICLS/ Homepage.htm). It is imperative that patient charts reflect the complexity of the conditions and the way in which effective, properly directed care is being provided in the HOPD.

CORRECTING BAD BEHAVIORS

If you’re now concerned that you may not be caring for the most appropri-

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ate patients that you should be seeing in your wound center, modifications can be made. Start by reading the LCDs that are applicable to the services you provide.

Get a clear understanding of which patients you may currently have in service that do not meet the criteria set forth in these LCDs. Review the treatment plans of your patients to ensure they would be considered medically reasonable. Consult your current active patient list and review all patients who have been in service longer than 90 days to identify those patients who may either need a revised treatment plan or to be discharged from service altogether. This process can be time consuming and may necessitate meetings with staff members to get everyone on board, but it provides a great opportunity for you to think about what it means to be an advanced wound care center vs. a busy “dressing-change department.” By clarifying your patient-selection process, you will find that you now have time to see the patients who should be there.You will also find that your healing rates and quality reports will be more accurate and useful for operational management.You will find that your staff is less likely to suffer from “burnout” and you can stop lying awake at night wondering if an auditor will recoup a portion of the revenue you have billed. Next, if you bill under OPPS, make sure the wound center has a written scope of practice. This may be the most important policy the clinic can create. Hospitals have consistently failed to understand the importance of this scope of practice and the uniqueness of this billing model. In so doing, you will see that medical necessity is a “practice” that begins with patient selection at the point of referral, not after you have been paid. n Caroline Fife is clinical editor of TTWC and chief medical officer at Intellicure Inc., The Woodlands,TX.Toni Turner is executive director at InRICH Advisors — Outpatient Auditing Group,The Woodlands,TX. Reference 1. Carey MD. Proving your quality of care compliance: a case study. TWC. 2013;7(1):13.

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WOUND CARE SILO BUSTING: BUILDING A SERVICE LINE ACROSS THE CONTINUUM

A wound clinic at a large healthcare system serves as the hub of a centralized structure to care for patients across the health spectrum.

Debra Miller-Cox, MD, MSc

W

ound care is unique in that it has been an intrinsic component of care among nurses, therapists, podiatrists, and surgeons for many years while medically trained physicians are newest to the field and typically come to it after training in another medical subspecialty.

Initially, wound care was thought to be the exclusive purview of surgical specialists. However, the involvement of physicians trained in family or internal medicine has brought another perspective to the field. These generalists and medicine specialists offer expertise in both diagnosis in the context of the whole patient and all the factors that may be impairing a patient’s wound healing.

Due to this evolution, leadership has shifted in many places from nursing- to physician-led services, sometimes causing friction among healthcare arenas. Yet, with collegial relationships and common goals, involvement by multiple types of practitioners provides a great opportunity to consolidate expertise from each healthcare specialty and to centralize the care for each patient.

Likewise, concepts such as the formation of accountable care organizations (ACOs) that streamline care based on measurable standards are becoming proven ways to improve efficiency, quality, and costs.

Wound care, as an industry that involves multiple medical and nonmedical specialists who in many instances possess advanced training and education, provides an excellent framework to serve as a “hub” for the development of these types of comprehensive, collaborative service lines.

This author, as the director of wound care services at Spartanburg Regional Medical Center (SRMC), a healthcare system based in upstate South Carolina, has helped lead an initiative to unite multiple departments of patient care services within the outpatient wound clinic in an attempt to enhance the patient’s experience throughout the continuum while improving clinical outcomes.This journey has been centralized 16

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on the success of the outpatient center, and services have grown from there.The vision to create continuous care across the system only really started to crystallize once programs on both the inpatient and outpatient sides had evolved and begun direct involvement with physical therapy (PT).

This article will outline the steps taken by the wound clinic and health system as a whole to create a service line that functions much like an ACO without officially being recognized as one.

DEFINING A NEED

The manner in which healthcare delivery has evolved in sophistication while also becoming more specialized, subspecialized, and, thereby, fragmented in a sense is not much different than the way the facilities that house many service lines have changed over the years. Physically, larger hospital systems have grown piece by piece and department by department. Although many of us who work within a large network are literally connected by a series of tunnels and walkways, the reality is that many of our patients who require a combination of inpatient and outpatient services (or even just multiple outpatient services) may find themselves dependent on a cumbersome care continuum as connected as healthcare may appear to be on a global scale.This can lead to less efficient, lower-quality, and more costly care overall.

The wound care services featured within SRMC, a 500-bed, Level I trauma center with an affiliated 48-bed community hospital about 20 minutes from main campus, include an outpatient department (HOPD), an inpatient wound team, an affiliated long-term acute care hospital (LTACH), inpatient hospice, and home health services. Much of the specialty and primary care for SRMC patients is provided by physicians employed by a network closely aligned with the main healthcare system that shares an electronic health record (EHR). Although this major “building block” had been in place to effectively consolidate and communicate

among services, several key factors were still needed in order to create a fully functional and collaborative service line.These factors not only included an updated EHR to span both outpatient and inpatient arenas, but a system that could handle woundspecific data mining as well.Yet, the earliest requirements were actually much more basic. Identifying the “who, what, where, when, and how” of wound care — as in who cares for wound patients, where does wound care occur, how should previously disconnected services and treatment areas be joined, who should lead this effort on clinical and administrative levels, and how should this be structured? What follows is a step-by-step guide that explains how attempts to structure healthcare services around the HOPD took place.

STEP 1: IDENTIFY YOUR LEADERS

Identifying leaders is probably the most important step for influencing growth in any clinical department.This is particularly true if you want to grow and then connect that area to others within a care network.At SRMC, wound care began as a partnership between an enterprising surgical group and a receptive hospital administration with services housed in an outpatient space within a building bridged to the main hospital. In 2003, the administration recruited the author (an infectious disease specialist with a degree in the immunology of infectious diseases) to serve as medical director of the HOPD. Relationships with several medical and surgical specialties within the inpatient arena and, to a lesser extent, the outpatient community, began to take shape. While the surgical practice had developed many relationships within the community, other surgical practices were reluctant to make referrals for what they considered then to be a lateral move.

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Services became specialized for wound care from the standpoint of physicians’ clinical focus to nurse training and competencies for technicians specializing in casting. As the HOPD’s operations, standards of practice, and, consequently, potential were dissected and analyzed, further diversification would soon be needed to help broaden the referral base and reach more patients earlier in their treatment courses.

By 2014, the physician staff within the HOPD included a general surgeon (with 20 years of experience in wound care), two infectious disease physicians, two physician specialists in family medicine, and one internist.

Nursing leadership was also vital to growth. The HOPD’s first nurse manager, Kim Saunders, RN, WOCN was hired in 2005. She possesses a broad range of nursing experience, a passion for learning, and a well-grounded work ethic.With the author, Saunders helped design guidelines for care to standardize the approach taken to the main classes of wounds (diabetic, venous stasis, arterial, pressure, and traumatic) and, among other quality initiatives, helped introduce the ankle-brachial index as a vital sign for patients and for organizing competencies for nursing staff.

During this time, an inpatient wound team was also developed. The hospital’s original inpatient wound care team had been created with two wound, ostomy continence nurses (WOCNs) and the outpatient clinic medical director (for clinical oversight). As the inpatient team continued to grow, Saunders moved over to provide separate nursing management.

Eight WOCN-trained nurses now staff the main hospital, community hospital, home care services, and LTACH. While outpatient care was physician-directed, inpatient care continued to be directed by nursing with clinical and administrative support from the medical director of system-wide wound services. Physician support is also available for the inpatient team by an outpatient wound physician staff for more complex patients or issues requiring a physician liaison.

STEP 2: IDENTIFY DEPARTMENTS PROVIDING WOUND CARE.

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serviceline

Figure 1. Organizational Structure for Wound Healing Services.

Names mentioned in the article are labeled.This is also a work in progress and is subject to change.

Image courtesy of Kim Saunders, RN,WOCN.

home health and floor nurses were often left to make wound care decisions for physicians — some of whom lacked the expertise to do so, but whose signatures were required on all orders.

Additionally, PTs often provided advanced management within their own department while sometimes rendering redundant services with the assistance of nursing and some physician-run areas.

SRMC’s wound care and hyperbarics center had opened in 1991 as a joint venture between a local private surgical practice and the hospital. While wound care was administered throughout the system, there were no common goals, no common vision, and no communication or opportunities for quality assessment. After identification of the various departments and practitioners providing wound care, partnerships then needed to be developed so that each discipline’s skill set and deficits could be understood and a streamline of services and supplies could be provided.

STEP 3: CREATE PROVIDER PARTNERSHIPS

Once departments and providers in wound care were identified, they needed to be connected to work toward a common goal. PTs, while loosely under the direction of physicians, often have a lot of independence in how they manage patients, unless directed by a physiatrist (of which there are none in this system involved with wound care). Advanced practice nurses (APNs) and, in particular, WOCNs also work fairly independently, owning a skill set that differs in many ways

from the physicians with whom they work.

On the inpatient side, admitting physicians, knowing little about wound care, would often pass off the entire responsibility for all things wound related to these nurses despite still having to be the final word in documentation and orders in the chart.

At SRMC, the leadership role of the physicians differs depending upon where patients are being seen. In the outpatient arena, physicians lead the care plan. APNs are not staffed at this time in the outpatient setting, but the nurses are responsible for clinical wound assessments on patients coming in for assessments and dressing changes between physician visits. In contrast, the inpatient team is comprised exclusively of WOCNs. While still fairly independent, there is wound-physician oversight. Initially, the author and the general surgeon from the wound center were the two attending physicians available to see consults considered more complex or in need of more advanced diagnostic or surgical care than the inpatient team could provide.

SRMC is currently in the process of training another wound physician to attend on the inpatient side.

On the PT side, efforts to forge these partnerships paid off and the original administrative vision to bring PT services and wound care together has been realized.

Not only do PTs now work in the wound center, providing advanced-care services such as low-frequency ultrasound, electrical stimulation (e-stim), and whirlpool as well as mobility/seating assessments, they have provided physicians with education in many Today’s Wound Clinic® May 2014

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serviceline of these services that otherwise would not have been exposed.Another outgrowth has been an expansion of casting services. Fulltime technicians specifically responsible for wound care-related castings were hired in 2008 and this program has expanded to techs providing a variety of offloading casts.

Partnerships have also been created among physician specialties. As part of the larger plan to create a multidisciplinary team, administration has been lobbied by physicians to hire a plastic surgeon. Initially, that surgeon was given hours in the HOPD. This cemented a relationship and, again, helped staff understand the value of each specialty’s skill set for patients. While plastic surgery does not still have clinic time in the wound center, that relationship has held strong.

The experience with vascular has been similar. Initially, one of the hospital’s surgeons interested particularly in revascularization of the lower limb was invited to the HOPD. He, too, came to the center and saw consults. Ultimately, his clinic time was eliminated, but again a relationship was cemented.

The decision to no longer have both plastics and vascular surgery in the outpatient clinic was made between the HOPD and the surgeons because it was determined more efficient to use clinic time for general wound patients and to refer those patients necessary to their offices nearby.

Partnerships with other hospital areas such as the emergency department (ED), where discussions related to process improvement have aided the referral process, have also been vital to improving continuity of care. Inpatient admissions from the wound center have also been improved through communication and standardization. Examples include continuing discussions with endocrinology and the network of primary care providers.

As these partnerships continue, SRMC also continues to refine its processes.

STEP 4: ALLOW ADMINISTRATIVE STRUCTURE TO EVOLVE

Growth in services requires growth in leadership structure, and both the outpatient and inpatient departments required restructuring in order to form a centralized service line. Because growth happened 18

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around a centralized idea, the expansion of a new administrative structure has occurred from a single purpose rather than with parallel or — worse — divergent evolution in multiple departments. At SRMC, the inpatient wound team now has its own manager while Saunders has ascended to nursing director of a new “wound services” department (a new nursing division encompassing the HOPD, inpatient wound services, and those services extending to home health, hospice, and LTACH).

This was an idea conceived as a parallel structure to the medical director of wound services (Figure 1). The inpatient team and HOPD staff individual nurse managers whose needs are bridged by Saunders.

In addition to the evolvement of nursing leadership, physician leadership has also been adapted to include a separate director for hyperbaric services — Melissa Fritsche, MD. This has led to more structure and attention to these services, credentialing by the Undersea and Hyperbaric Medical Society, refinement of safety protocols, established standards of practice, and structured quality measurement metrics.

While continued administrative growth on the physician side is expected, this has been a slower process as most physician leaders still retain heavy clinical responsibilities.

Regardless, having both physician and nursing “champions” work together has been necessary to liaise among administration, medical, nursing, and PT staffs and to communicate consistent messages across the system. This has been very effective to gaining administrative and collegial support for the agenda to streamline care.

As growth prompted expansion of leadership, strong leadership has supported continued expansion.

Ultimately, this balanced approach has resulted in effective centralization of inpatient and home health services with staffing, quality reporting, and supply management. For example, supplies are now standardized for wound care across all areas including inpatient, outpatient, LTACH, and home health. While there may be slight variations in some product purchasing, wound supply purchases are now system-wide and vetted by leadership in wound care.

STEP 5: BRINGING COMPONENTS TOGETHER

Efforts to provide system-wide continuous care began when administration brought PT, nursing, and physician services together under the same roof, literally, in the same HOPD. The original intent of this was to bring PT, which can typically fall into a bit of a “silo” in the nurse/doctor-dominant care environment, into wound services.

Collaborative decisions on which modalities are worth maintaining for our patients are now the standard. For example, mobility and seating assessment are still under PT administration, but are also an integral part of the pathway to care among paraplegic and pressure ulcer patients. Other PT services, such as e-stim, whirlpool, and ultrasound, are physically located in the HOPD. PTs have also been more involved with compression wrapping, and should the often medically complex wound patients have an acute condition they can be seen immediately by a physician rather than having to go to the ED or be transported to another clinic for evaluation.”

Having a defined team of leaders overseeing both inpatient and outpatient clinical services has also helped troubleshoot “gaps” in care. Issues that have been addressed have include critically evaluating continuity of care of the patient who has required flap closure of a wound, care of the paraplegic patient in general, continuity in offloading, surgical and infectious disease management for patients living with diabetic foot ulcers, and continuity of care for patients requiring vascular evaluation or compression wrapping both in and out of the hospital.

In general, one major obstacle experienced had been the lack of successfully implementing an outpatient wound treatment plan prior to discharge of inpatients. Previously, the inpatient team would see the patient and on discharge there would be a delay in wound physician assessment and creation of an outpatient plan of care. This had caused confusion of who was responsible for home health wound orders, often resulted in lack of appropriate offloading for a period before the outpatient appointment, and overall exposed the patient to complications due to lack of continuity. For paraplegic patients,

TH

RECO

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2013-

serviceline this would also include sequencing seating evaluations before going in for a flap to attempt to obtain an appropriate cushion for when they healed following surgery.

Now, for example, the diabetic patient living with a neuropathic foot ulcer can get casted prior to discharge so that appropriate offloading could start immediately rather than having to wait for the outpatient wound physician to evaluate. Similarly, patients living with pressure ulcers in need of elective flap closure now get their seating evaluations and cushions or wheelchairs ordered prior to going in for surgery so that they don’t return to sitting on the same chairs and cushions on which they developed ulcers.

STEP 6: EVALUATE COMMUNICATION

Nothing can replace the benefits of effective communication to bind patient care throughout the health system.

Person-to-person communication is the mainstay that ultimately is the focus of this systemwide network.

Daily rounding calls help providers identify patients from the HOPD center who have transitioned to inpatient care and vice versa. This helps to identify patients who may require physician-level input as part of the inpatient wound team’s effort.

While often difficult to incorporate into busy clinical schedules, monthly meetings have been an important opportunity for communication. Physicians and other providers must buy into this. Without participation, one cannot expect the exchange of ideas.

SRMC also utilizes a post-acute care wound committee that includes members from PT, LTACH, home health, hospice services, and wound service clinical directors (from nursing and the clinical medical director). The current EHR provides a way for inpatient and outpatient teams to follow each patient throughout the continuum. While the EHR is not part of the inpatient documentation system for the hospital, it can be accessed from all hospital computers and outpatient arenas.

EVOLVING ASSESSMENT

Since consolidating services, SRMC is now in a position to get much more reliable data related to quality of care throughout the system as well as in individual disposition areas to establish and assess metrics.

Through a detailed review of system services, consolidation, communication, and consistent leadership the creation of a functional service line through wound care has been implemented. Partnership development with administration as well as all clinical areas where wound care is provided has been essential to unifying this system. Moving forward, continued expansion of services and referrals is anticipated. Wound care’s relevance throughout the healthcare system puts SRMC in a perfect position to improve continuity, efficiency, and quality of care. n Debra Miller-Cox is an infectious disease specialist in the immunology of infectious diseases and is director of wound services at Spartanburg (SC) Regional Healthcare System.

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Today’s Wound Clinic® May 2014

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PROTECTING EDGES OF VENOUS ULCERS: AN EVIDENCE-BASED APPROACH With careful assessment and recognition of risk, an effective management plan can be implemented to thwart periwound MASD. Debra Thayer, MS, RN, CWOCN

W

ound healing, in part, depends on epithelial migration (ie, the lateral migration of cells from the wound edge).Viable, healthy wound edges are essential for this process to occur efficiently.1,2 For venous ulcers, this process of epithelialization is thought to contribute significantly to closure.

Healthy wound edges are described as pink or pearl colored and attached to the underlying tissue. The term “open” is used to describe a wound edge that is capable of generating cells for healing. Movement of cells from the wound edge can be halted when the wound edge closes prematurely.

Cell migration can also be compromised when the wound edge is open but excessively hydrated. Due to their unique pathophysiology, venous ulcers are at high risk for moisture-associated skin damage at the wound edge and within surrounding skin. 3 This article will provide a review of the underlying mechanisms for the changes that are seen at the wound edge and adjacent periwound skin as a result of excessive exposure to moisture. Strategies for skin protection will also be discussed.

THE PROBLEM WITH MOISTURE

The stratum corneum is the uppermost layer of the epidermis and provides significant barrier protection. The ideal state for this epidermal layer is dry. When the stratum corneum is exposed to excessive moisture, corneocytes swell, soften, and take on a “soggy” texture with a distinctive color change to white or gray.4,5 Structural changes cause alterations in stratum corneum permeability. This condition has traditionally been described as maceration; 20

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more recently the concept of periwound moisture-associated skin damage (MASD) has been introduced.6 Extended overhydration can cause significant structural damage including cracking and fissuring.

A reduction in natural moisturizing factor (necessary for barrier health) is observed7 and the normally acidic pH of skin shifts into an alkaline range. The net effect of these changes is a compromise of intrinsic skin barrier competence. This potentially increases the likelihood of penetration by irritants, allergens, and microbes. Composition of exudate is also believed to be a factor. Exudate from venous ulcers has been shown to be rich in matrix metalloproteinases and other pro-inflammatory chemicals capable of causing damage independent of moisture.5,8,9 In addition, overhydrated skin is more susceptible to damage from frictional forces and secondary infection.10 Not surprisingly, wound exudate is the primary source for excessive epidermal moisture. For venous ulcers, volume of exudate is not only related to local inflammation, but the magnitude of edema as well. Large amounts of exudate can be expected early in the treatment process or when compression is absent or inadequate.As such, periwound MASD can be a likely consequence.11 Fluid-handling capabilities of compression materials can be another factor contributing to maceration. Most traditional threeand four-multilayer compression systems incorporate a cotton or a synthetic fibrous wrap as the base layer that contacts skin.

These materials were originally intended for cast padding and do not wick or transfer fluid. Instead, moisture can be trapped against

the skin. The potential for damage can be exacerbated if the clinician does not use a primary dressing and relies on the base layer alone for exudate management.

Dressing materials, dressing application technique, and dressing change frequency can also promote wound edge and skin damage. Moisture-related skin changes can result when a primary dressing is used but is poorly suited to the volume of drainage. A dressing that is properly selected but improperly prepared or applied can also expose the edge and skin to excess moisture as the dressing absorbs exudate. If not changed at an appropriate interval, absorbent dressings can serve as a source of wetness. Finally, failure to protect the wound edge and adjacent periwound skin with a moisture barrier leaves the skin vulnerable to excessive hydration.12

PREVENTING PERIWOUND MASD

The significance of edge condition on healing is underscored by inclusion of edge assessment and management in wound bed preparation models.2,13 Once established, periwound MASD around a venous ulcer may be difficult to resolve, especially if exposure has been prolonged and skin changes are severe. For that reason, prevention should be the focus with the primary clinical objective being reduction and management of exudate. Effective compression is the primary approach to venous ulcer management addressing edema and impacting exudate volume. A conformable low-profile, two-layer system (Coban™ 2 Layer Compression System, 3M™) can provide sustained short-stretch www.todayswoundclinic.com

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woundedges compression that is effective for both ambulatory and sedentary patients.

Prior to application of the compression bandage, the wound and periwound skin should be cleansed. Cleansing the surrounding skin is essential to remove debris such as exudate, dead skin, crust, or dressing residue.A primary dressing should then be applied over the ulcer for exudate absorption.13 Moderate to heavily draining wounds are best managed with absorbent dressing materials. Tegaderm™ High Performance Foam Non-Adhesive Dressing (3M) and Tegaderm™ Silicone Foam Border Dressing (3M) are examples of opencell polyurethane foam dressings that can be used as primary or cover dressings.They are ideally suited for exudating wounds due to technology that enables rapid wicking and fluid management.

Wounds with greater depth or drainage may require the addition of an absorbent wound filler such as a calcium alginate dressing (Tegaderm High Integrity Alginate Dressing, 3M). This type of absorbent fibrous dressing should be sized appropriately to the wound margins according to manufacturer’s instructions to prevent overlap of moist or wet dressing onto periwound skin. Hydrating dressing materials such as hydrogels are seldom appropriate.

If preferred, wound fillers may be covered with a superabsorber dressing (Tegaderm Superabsorber Dressing, 3M). Both the compression bandage and the dressing should be changed at an interval sufficient to prevent strikethrough or saturation.

Finally, a protective moisture barrier should be applied to the wound edge and any surrounding skin exposed to wetness.11,14 Traditionally, moisture barrier creams and ointments containing petrolatum and zinc oxide have been used.While capable of repelling moisture and irritants, many of these products are occlusive and will interfere with skin’s normal transepidermal water loss (TEWL), potentially worsening the problem.14 At the time of dressing change, removal of ointments and thick creams, especially those containing zinc oxide, can be uncomfortable for patients and can cause mechanical damage to fragile periwound skin. Removal can also be time consuming for direct-care staff.

Careful consideration of topically ap22

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Application of barrier film. photo courtesy of the manufacturer.

plied products is especially important for the venous ulcer population, where increased risk of allergy to topically applied products has been shown.15 Not surprisingly, vulnerability to potential allergens can be exacerbated when barrier function is compromised. Multi-ingredient cream formulations can contain common sensitizers (eg, preservatives, fragrances).

A liquid barrier film provides an alternative and advantageous method of edge and periwound protection. 6,12,14,16,17 For periwound protection, a product that is noncytotoxic, hypoallergenic, and indicated for use on intact or damaged skin should be selected. CavilonTM No Sting Barrier Film (3M) contains a unique terpolymer dissolved in an alcohol-free solvent system.

When applied to the skin, the solvent evaporates quickly, leaving the terpolymer as a breathable, transparent protective coating.

The film is waterproof, enabling it to repel moisture and irritants. Because the barrier film does not require removal, patient discomfort can be minimized and staff time conserved. In addition, the product offers the advantage of protection from adhesives, which can help to prevent medical adhesive-related skin injuries.18

WHAT DOES THE EVIDENCE TELL US?

Cavilon No Sting Barrier Film is supported by more than 70 pieces of evidence, with numerous studies evaluating its use specifically for wound edge and periwound protection. A meta-analysis analyzed data from 11 controlled trials and concluded the product is a safe and effec-

tive barrier to protect the periwound skin of chronic ulcers with benefits including visibility of wound margins, reduction of erythema, pain control, patient comfort, and reduced staff time.19 Other findings show significant advantages of the barrier film over zinc oxide containing barriers including greater patient comfort (no removal required versus the scrubbing necessary for the zinc barrier); reduced nursing time; ability to visualize the skin for assessment; and better patient and caregiver friendliness.20,21 Another trial evaluated the effect of Cavilon No Sting Barrier film on the periwound skin of patients living with venous ulcers. A 45% reduction in TEWL (considered an indicator of barrier function) as compared to baseline was found.22 The clinical effectiveness of the film in combination with multilayer compression has also been demonstrated.

In a randomized controlled trial of 98 patients,23 the average reduction in ulcer area after 12 weeks of treatment was statistically greater in patients treated with Cavilon No Sting Barrier Film (83%) as compared to the control group (72%) (P=0.046). The study concluded the clinical effectiveness of the multilayer compression bandage as measured by percentage reduction of area was increased by the concomitant use of Cavilon No Sting Barrier Film.

SUMMARY

Periwound MASD does not have to be an inevitable complication of venous ulcer management or management of any heavily draining wound. With careful assessment and recognition of risk, an effective management plan can be implemented. Effective compression, selection of topical dressings appropriate to drainage volume, and use of Cavilon No Sting Barrier Film for protection of wound margins can provide a comprehensive solution to help prevent this troublesome complication. n References available at www.todayswoundclinic.com.

Debra Thayer is a senior technical services specialist with 3M Critical & Chronic Care Solutions, St. Paul, MN. She may be reached at 651-733-1447 or dmthayer@mmm. com.www.todayswoundclinic.com. www.todayswoundclinic.com

5/12/14 1:36 PM

EXAMINING THE INCREASED ROLE OF THE

PHYSICAL THERAPIST WITHIN THE WOUND

CARE INDUSTRY

BY FRANK AVILES Jr., PT, CWS, FACCWS, CLT

Physical therapists have been serving in wound care since World War I. Have they evolved to their full capacity in your clinic?

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Today’s Wound Clinic® May 2014

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PTutilization

A

ny effective multidisciplinary wound care team will typically consist of a well-represented blend of healthcare professionals who lend their individual, unique areas of expertise to form a collaboration that shares a vision to meet the optimal results that patients deserve. Based on a continuously evolving level of training, required education, and scope of practice for the role of the physical therapy professional, physical therapists (PTs) and physical therapists assistants (PTAs) should be considered among key contributors to any wound care team working in any setting within the care continuum.

The utilization of the PT has continued to grow over the years specifically in the hospital-based outpatient wound clinic (HOPD), primarily as it relates to implementing healing strategies that impact offloading, positioning, range of motion, and maximizing overall function and quality of life among those living with chronic, nonhealing wounds. The PT can also be a resource for recommending therapies and assistive devices that improve strength, ambulation/mobility, and overall wound healing. Furthermore, impediments to wound therapy may be reduced or even eliminated when the PT is involved in a collaborative approach to care.

This article will outline the historical role physical therapy has played in wound care, the increased value PTs and PTAs bring to the healthcare delivery system, and the impediments still needing to be overcome in order to maximize these professionals’ true scope of practice within this industry.

A STORIED HISTORY

PTs can trace their wound care roots back to as early as 1917. During World War I, European countries created programs directed at restoring wounded soldiers back to duty or civilian life as soon as possible in a physical condition that would enable them to function at the highest possible degree consistent with their injuries.1 In 1917, the British surgeon general designated a committee to evaluate and report on such a program being 24

conducted in British Army hospitals.

As a result, on Aug. 22, 1917, the Division of Special Hospitals and Physical Reconstruction was established.1 Defined as maximum mental and physical restoration of the individual, “physical reconstruction” was achieved through the use of medicine and surgery and was supplemented by physical therapy; occupational therapy; or curative workshop activities that included education, recreation, and vocational training. “Physical therapy” was described as consisting of hydrotherapy, electrotherapy, and mechanotherapy; active exercise; indoor and outdoor games; and massage.1 During the same war, the US Army began to rehabilitate wounded soldiers who had suffered amputations, burns, cold injuries, wounds, fractures, and spinal cord injuries (SCIs). These workers were referred to as “reconstruction aides” who later became known as “physiotherapists” and, finally, “physical therapists.”1 In modern times, the PT has become more involved in wound therapy due to the benefits that whirlpool baths and electrical stimulation (e-stim) provided.

However, over time, in order to obtain licensure, PTs have required advanced levels of education and have seen additional modalities added to their repertoires to help heal chronic wounds while the use of whirlpool has become limited.

the standard). All physical therapy education programs, except Puerto Rico, offer only DPT programs.2 Not coincidentally, the scope of practice has evolved to allow PTs in all states to perform sharp* debridement of devitalized tissue in addition to other wound healing procedures and energies, such as pulse lavage with suction; e-stim; high-frequency ultrasound; contact and noncontact lowfrequency ultrasound; monochromatic infrared energy; laser; negative pressure wound therapy; ultraviolet light therapy; Unna’s boot application; short-stretch bandaging; multilayer compression bandaging; contact casting; and lymphatic drainage techniques. According to the American Physical Therapy Association’s (APTA’s) Guide to Physical Therapist Practice, the PT provides “application of therapeutic procedures and modalities that are intended to enhance wound perfusion, manage scar, promote an optimal wound environment, remove excess exudate from a wound complex, and eliminate nonviable tissue from a wound bed. Procedures and modalities may include: sharp* debridement; dressings; orthotic, protective, and supportive devices; physical agents and mechanical and electrotherapeutic modalities; and topical agents.3” Those PTs who are members of the APTA are also entitled to join the “special interest section” devoted to clinical electrophysiology, which serves as an additional resource to therapists that promotes research and education.

EVOLUTION OF PTs IN WOUND CARE

DISCUSSION ON DEBRIDEMENT & E-STIM

Over the years, the wound care industry has likewise experienced an increase in the utilization of PTs that essentially could qualify as a reformation. Whether it’s an SCI patient with new skin breakdown in the rehab setting, a debilitated patient with a new pressure ulcer in the nursing home, or a post-surgical outpatient with a dehisced incision, PTs have earned roles in areas throughout the care continuum to aid in healing by utilizing integumentary skills, available tools, and a hands-on approach to care.Today, the PT is required to enter the field with a doctorate of physical therapy (DPT), excluding Puerto Rico (where master’s level is

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The PTs’ scope of practice also lends to the preparation of the wound bed by eliminating nonviable tissue or to simply stimulate the wound bed. These methods include all forms of debridement: autolytic, enzymatic, mechanical, and sharp.* A therapist can use scalpel, scissors, and/or tweezers to perform sharp* debridement for removal of necrotic tissue over several sessions, if necessary, when surgical debridement by the physician is not an option due to the patient’s condition but a large amount of dead tissue exists. Depending on the specific wound, selective dewww.todayswoundclinic.com

5/12/14 1:37 PM

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www.WoundPrepCourse.com Course Faculty Carolyn Cuttino, BSN, RN, CWCN Certified Wound Care Nurse Carolina Wound Care Mount Pleasant, South Carolina Heather Hettrick, PT, PhD, CWS, CLT Associate Professor Nova Southeastern University Department of Physical Therapy Fort Lauderdale, Florida Greg Patterson, Md, FACS, CWS Medical Director General and Vascular Surgery, Bariatric and Metabolic Surgery Archbold Center for Wound Management and Hyperbaric Medicine Thomasville, Georgia Lee C. Ruotsi, MD, CWS, UHM Medical Director, Advanced Wound Healing Centers Catholic Health System Cheektowaga, New York Pamela Scarborough, PT, DPT, MS, CDE, CWS, CEEAA Director of Public Policy and Education American Medical Technologies Irvine, California

2013-WCPC_1pg-Ad_3.indd 1

Dot Weir, RN, CWON, CWS Osceola Regional Medical Center Kissimmee, Florida Intended Learners Physicians, podiatrists, surgeons, physical therapists and PTAs, occupational therapists and OTAs, nurse practitioners, physician assistants, master’s prepared nurses, registered nurses, associate degree nurses, dietitians, sales and marketing specialists within wound care.

Learning Objectives After completing this activity, participants should be able to:  Outline the etiology of chronic wounds and extrinsic factors that contribute to and affect wound-healing outcomes  Describe the phases of wound healing and the associated microenvironment, cellular components, and their functions in wound healing  Identify the anatomy of the skin and other important structures  Assess research and evidence related to wound management  Describe specific diagnostic tests, examination tests, lab tests, and measures related to wound assessment and management  Identify the components of wound assessment and documentation  Identify methods for recognizing soft tissue

and bone infections, bioburden management, and treatment of local and systemic infections Discuss nutritional factors and the underlying deficiencies that impact wound healing  Relate the psychosocial and cognitive aspects to patient outcomes in wound repair  Describe specific treatment interventions for chronic wounds including debridement, topical therapies, and biophysical expertise Activity Overview Taught by three nationally recognized experts and educators in Wound Care, the Wound Certification Prep Course is an intensive 17-hour seminar that provides a comprehensive review of topics related to wound management. The course also includes valuable practice tests and test-taking strategies.

Accreditation North American Center for Continuing Medical Education, LLC (NACCME) is accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

Physicians NACCME designates this live activity for a maximum of 17.0 AMA PRA Category 1 Credits™. Physicians should claim only the 

credit commensurate with the extent of their participation in the activity.

Nurses This continuing nursing education activity awards 17.0 contact hours.

Provider approved by the California Board of Registered Nursing, Provider Number 13255 for 17.0 contact hours.

Podiatrists North American Center for Continuing Medical Education, LLC (NACCME), is approved by the Council on Podiatric Medical Education as a sponsor of continuing education in podiatric medicine.

This program is approved for 17.0 contact hours.

Dietitians North American Center for Continuing Medical Education, LLC (NACCME) is a Continuing Professional Education (CPE) Accredited Provider with the Commission on Dietetic Registration (CDR). CDR Credentialed Practitioners will receive 17 Continuing Professional Education units (CPEUs) for completion of this activity/material.

CDR Accredited Provider #HM001 Level 3 Synthesis Level Physical Therapists North American Center for Continuing Medical Education, LLC (NACCME) has received approval for this course from the

following physical therapy boards:  California: Memorial Medical Center: 1.7 CEU. This symposium has been approved for 17 contact hours. (Approval MMC2014-002)  Florida Physical Therapy Association: 17.0 hour(s) earned. The maximum allowable hours for this program are 17.0. (Provider # 20-425440; Course # CP140322264). Accreditation of this course does not necessarily imply the FPTA supports the views of the presenter or the sponsors.  Louisiana Physical Therapy Board: This course has been approved for 17.0 clinical hours.  Ohio Physical Therapy Association: This course has been approved for 17.0 contact hours. (Approval 14S0027)  Nevada State Board of Physical Therapy: This course has been approved by the Nevada State Board of Physical Therapy Examiners for 1.5 units of continuing education.  Texas Physical Therapy Association: 17 continuing competence unit(s). This symposium has been approved for 17.0 continuing competence unit(s).

(Approval # 55473TX).

If you practice in any other state, please consult its PT Board.

Independent Clinical Reviewer: Robert S. Kirsner, MD, PhD, Vice Chairman, Professor and Stiefel

Laboratories Chair, Department of Dermatology University of Miami School of Medicine, Miami, Florida Nurse Planner: Susie Seaman, NP, Sharp Rees-Stealy Wound Clinic, San Diego, California Requirements for Credit To be eligible for documentation of credit of this live event, participants must attend the full activity and submit a completed evaluation form. Participants who complete the evaluation form online will immediately receive documentation of credit.

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

ADA Statement North American Center for Continuing Medical Education complies with the legal requirements of the Americans with Disabilities Act (ADA) and the rules and regulations thereof.

If any participant in this educational activity is in need of accommodations, please call 609-371-1137.

Copyright © 2014 by North American Center for Continuing Medical Education, LLC. All rights reserved. No part of this accredited continuing education activity may be reproduced or transmitted in any form or by any means, electronic or mechanical, without first obtaining permission from North American Center for Continuing Medical Education.

4/10/14 3:50 PM

PTutilization bridement can be conducted by the PT to achieve desired results. (Some forms of sharp* or other forms of ongoing debridement, such as enzymatic, may still be warranted after surgical debridement is performed by a physician.)

E-stim is another modality used primarily by therapists to enhance chronic wound healing. There are various forms of e-stim, which has been studied on chronic lower-leg wounds and pressure ulcers. E-stim has the ability to restart or accelerate the repair process by imitating the natural electrical current within injured tissue. Additionally, e-stim has been suggested to reduce infection, improve cellular immunity, increase perfusion, and accelerate wound healing.4 Other studies have demonstrated that e-stim aids in perfusion as well as improving venous flow. In 1994, the Agency for Healthcare Research & Quality issued a statement recommending the use of e-stim for pressure ulcers that have proven unresponsive to conventional therapy.5 Various governmental and private payer policies recognize e-stim as “medically necessary” for the management of chronic ulcers when used as an adjunctive therapy on wounds that are not progressing for a certain timeframe (30-days). Their covered indications include venous ulcers, diabetic ulcers, arterial ulcers, and stage III and IV pressure ulcers. In addition, the National Pressure Ulcer Advisory Panel continues to support e-stim as a useful therapy for nonhealing wounds such as recalcitrant stage II, III, and IV pressure ulcers.

sprained ankle) that have to follow the same phases of the healing process in order to improve, even if the patient is an athlete or an older adult. When a therapist works with a patient, including patients with chronic wounds, a separate, thorough multisystem evaluation is needed in order to establish a prognosis, select interventions, and devise an outcome assessment as well as develop a plan of care to match each patient’s needs. When it comes to assessing mobility, the nursing staff typically completes a pressure ulcer risk assessment (eg, Braden or Norton scale) to identify patients at risk for skin breakdowns.

As a therapist, the PT will take an additional view of functioning by assessing each subcomponent of one’s mobility, including assessment of range of motion and contractures; strength, sensation, bed mobility and transferring (as appropriate); sitting and standing balance; wheelchair utilization or ambulation; other usage of available durable medical equipment; and gait deviations. In essence, it is the responsibility of the PT within the wound care team to establish a plan of care to keep and restore function. With lack of mobility comes more pressure-related problems, such as contractures, deterioration of muscle strength, increased risk of developing respiratory problems, possibility of aspiration, and debility. PTs also provide assistance with positioning, contracture management, patient/ family/caregiver education, and selection of support surfaces.

OTHER PT FUNCTIONS

The physical therapy profession has a well-established role as part of the interdisciplinary wound care team. However, often times it is difficult to overcome the image that many conjure of “therapists”— eg, one who assists athletes, or helps patients out of bed, or provides rehab to improve movement function. In fact, in many healthcare settings PTs are still not always directly or indirectly involved with wound patients other than providing functional restoration. Part of this omission may be due to the therapy department’s decision on how therapists

PTs have the ability to assist the wound care team in other aspects of care such as patient education and mobility. According to the APTA, PTs “are healthcare professionals who maintain, restore, and improve movement, activity, and health, enabling individuals of all ages to have optimal functioning and quality of life.”2 PTs typically treat musculoskeletal injuries by utilizing some of the same modalities already referenced in this article. In reality, these injuries are nothing more than closed wounds (eg, 26

CHALLENGES STILL EXIST

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need to be used related to staffing and reimbursement opportunities. Finally, part of the reason PTs may not be involved as much as possible could be due to the individual therapists not having an interest in wound care. When establishing the PT’s role within wound management, it is imperative for HOPD directors and administrators to define the PTs specific duties and scope as team members. If a multidisciplinary team approach is not available, nurses and therapists should still know their respective roles and expectations and be encouraged to establish and maintain an open line of communication to understand how each can improve care, costs, and outcomes. Only when everyone knows their roles can patient care and benchmarks reach maximum potential. As Dr. Meredith Belbin, the renowned management theorist, is quoted:“A team is not a bunch of people with job titles, but a congregation of individuals, each of whom has a role that is understood by other members.” n *For explanations regarding sharp debridement and PT scope of practice, coding, and reimbursement, refer to definitions by state practice acts, the American Medical Association’s Current Procedural Terminology, and the Centers for Medicare & Medicaid Services’ local coverage determinations.

Frank Aviles Jr. is clinical director of therapy services and wound specialist, Louisiana Extended Care Hospital, Natchitoches; owner, instructor, and consultant for Cane River Therapy Services LLC, Natchitoches; and instructor for the Academy of Lymphatic Studies, Sebastian, FL. He may be reached at 318228-5056 or crts@cp-tel.net.

References 1. The Medical Department of the United States Army in the World War. Washington: US Government Printing Office, 1927, vol. XIII. 2. Today’s physical therapy: A comprehensive review of a 21st century health care profession.

APTA. January 2011.

3. Bohmert J, Moffat M, Zadai C (Eds.). Guide to physical therapist practice (2nd ed. rev.).

APTA 2003. Alexandria,VA. 4. Thakral G, LaFotaine J, Najafi B,Talal T, Kim P, Lavery L. Electrical stimulation to accelerate healing. Diabetic Foot Ankle. 2013;4:10.

5. AHCPR treatment guideline for pressure ulcers. US Government Printing Office. 1994. www.todayswoundclinic.com

5/12/14 1:38 PM

ONE-DAY MEETING

The Business of Wound Care

Entrepreneurs, IP & Investment REGISTER TODAY FOR AS LOW AS $300!

HMP Communications (HMP) partnered with the Kirchner Group in 2013 to launch a new venture, The Business of Wound Care (BWC). This initiative provides information, education and networking support for entrepreneurs, scientists and investors within wound care and diabetes care. The Business of Wound Care initiative is built on a foundation created by the synergies of HMP’s communications platform and educational vehicles along with Kirchner Group’s formidable expertise relevant to intellectual property as well as fixing, selling and investing in health and life sciences businesses.

The second annual Business of Wound Care meeting is a unique program designed to provide business information and networking opportunities for entrepreneurs, companies and investors in the fields of wound care and diabetes care.

Thursday, October 16, 2014 Caesars Palace Las Vegas, NV co-located with SAWC Fall 2014 www.sawcfall.com

the symposium on advanced wound care

Tentative Agenda* • 3D Printing and Regenerative Medicine • Emerging Early Stage and Late Stage Companies and Technologies • Investor Roundtable • Wound Care CEO Roundtable • Networking Reception • Free SAWC Fall Exhibit Hall Pass *Agenda subject to change.

Please visit www.businessofwoundcare.com to register for the one-day meeting. , LLC

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4/11/14 3:45 PM

ICD-10-CM ICD-10-CM DIAGNOSIS CODING DOCUMENTATION TIPS FOR ‘COMPLICATIONS’

T

he arrival of ICD-10-CM has been pushed back to October 2015, but Today’s Wound Clinic is still helping wound care practitioners get an early start on refining their documentation skills in preparation for the new coding format.

In an effort to assist our readers as they continue to transition from ICD-9-CM, we’re offering an assortment of ICD-10 documentation tools on particular disease states or medical conditions that have been developed to help improve documentation habits, which will be vital to the success of wound clinics in the ICD-10 environment. The tools may also contain information on coding guidelines where appropriate. This month’s tool covers the category of “complications.”

ICD-10-CM Diagnosis Coding Documentation Tips for “Complications” Topic

ICD-10-CM Code Ranges

Documentation Tips/Guidelines

Complications due to Skin Graft Failure or Rejection

T86.820-T86.829

Skin graft failures and rejections must have specific tissue types documented in the record. For example, the record needs to specify whether failure or rejection is due to allograft or autograft. If not specified, it will be classified to “other and unspecified,” which is not desirable.

Complications due to Artificial Skin & Decellularized Allodermis

T85.613A, T85.623A & T85.693A

For these types of complications, it is important to document the specific complication (such as breakdown, displacement, or shearing).

Complications of Amputation Stumps

T87.30-T87.34 (Neuroma) T84.40-T87.44 (Chronic Infection)

Document the exact type of stump complication in the record. Be sure to document treatment progression.

Complications of a Procedure

by Hematoma or Seroma

Hematomas - see “Hematoma by site”

Hematomas must be documented as hemorrhage, hematoma, intraoperative, postoperative, and documentation of the procedure by site.

Dehiscence of a Wound

T81.30xA Unspecified T81.31xA External T81.32xA Internal T81.33xA Wound repair for trauma

Must specify whether an internal or external surgical operation, or specify that there was a wound repair from a traumatic injury.

T81.83xA

Document the specific anatomical site for the fistula.

Postoperative Persistent Fistula

Seroma - T88.8xxA Infected Seroma - T81.4xxA

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

NOTE: If the treatment for the encounter is directed at the complication, the complication will be the first-listed diagnosis.

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

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May 2014 Today’s Wound Clinic®

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5/7/14 4:34 PM

Chronic Wound Care: The Essentials Edited by Diane L. Krasner, PhD, RN, FAAN

Available in April 2014, Chronic Wound Care: The Essentials should be on every clinician’s shelf as it provides readers with the fundamentals of chronic wound care in one resource.

Our target audience includes: • • • •

Practicing wound care clinicians Healthcare professionals new to chronic wound care Certifying or recertifying wound care practitioners Generalists needing an overview of current chronic wound care practices and research

The Chronic Wound Care book series has become the gold standard for wound care textbooks and Dr. Krasner has compiled 25 essential chapters in an easy to use and access format.

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Advertiser’s Index Derma Sciences (Medihoney)........................................................................................ Cover 2 KCI (CelluTome).......................................................................................................................15 Net Health (WoundExpert)............................................................................................. Cover 3 Organogenesis (Apligraf/Dermagraft)...................................................................... Cover 4, 32 Sechrist Industries (HBOT Chambers)......................................................................................3 SteadMed Medical (Xpansion)..................................................................................................9

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Today’s Wound Clinic® May 2014

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5/13/14 8:41 AM

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

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

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

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

How Supplied: Apligraf is supplied sealed in a heavy gauge polyethylene bag with a 10% CO2/air atmosphere and agarose nutrient medium. Each Apligraf is supplied ready for use and intended for application on a single patient. To maintain cell viability, Apligraf should be kept in the sealed bag at 68°F-73°F (20°C-23°C) until use. Apligraf is supplied as a circular disk approximately 75 mm in diameter and 0.75 mm thick. (8) Patent Number: 5,536,656 Manufactured and distributed by: Organogenesis Inc. Canton, MA 02021 REV: December 2010 300-111-8

Please see complete prescribing information at www.Apligraf.com

Dermagraft® Essential Prescribing Information Numbers in parentheses ( ) refer to sections in the Directions for Use of the product labeling.

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

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

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

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

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

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

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

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

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

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

Caution: Do not use Dermagraft after the expiration date indicated on the labeled unit carton. (5) Adverse Events: In clinical studies conducted to date, the overall incidence of reported adverse events was approximately the same for patients who received Dermagraft compared to those who received the Control treatment. (6) Maintaining Device Effectiveness: Dermagraft must be stored continuously at -75°C ± 10°C. Dermagraft must be thawed and rinsed according to the Preparation for Use instructions. After the initial application of Dermagraft, subsequent sharp debridement of the ulcer should continue as necessary. Additional wound preparation should minimize disruption or removal of previously implanted Dermagraft. (13) Patient Counseling Information: After implantation of Dermagraft, patients should be instructed not to disturb the ulcer site for approximately 72 hours (three days). After this time period, the patient, or caregiver, should perform the first dressing change. The frequency of additional dressing changes should be determined by the treating physician. Patients should be given detailed instructions on proper wound care so they can manage dressing changes between visits. Compliance with off weight-bearing instructions should be emphasized. Patients should be advised that they are expected to return for follow-up treatments on a routine basis, until the ulcer heals or until they are discharged from treatment. Patients should be instructed to contact their physician, if at any time they experience pain or discomfort at the ulcer site or if they notice redness, swelling, or discharge around/from the ulcer. (8) How Supplied: Dermagraft is supplied frozen in a clear bag containing one piece of approximately 2 in x 3 in (5 cm x 7.5 cm) for a single-use application. The clear bag is enclosed in a foil pouch and labeled unit carton.

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

Dermagraft is manufactured using sterile components and is grown under aseptic conditions. Prior to release for use, each lot of Dermagraft must pass USP Sterility (14-day), endotoxin, and mycoplasma tests. In addition, each lot meets release specifications for collagen content, DNA, and cell viability.

Dermagraft is packaged with a saline-based cryoprotectant. This solution is supplemented with 10% DMSO (Dimethylsulfoxide) and bovine serum to facilitate long-term frozen storage of the product. Refer to the step-wise thawing and rinsing procedures to ensure delivery of a metabolically active product to the wound bed. (9) Caution: Federal (U.S.) law restricts this device to sale by, or on the order of, a physician (or properly licensed practitioner).

US Patent Number: 4,963,489; 5,266,480; 5,443,950 Manufactured and distributed by: Organogenesis Inc. La Jolla, CA 92037

Please see complete prescribing information at www.Dermagraft.com

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Net Health TWC Ad.pdf

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5/7/14

10:32 AM

The right color makes all the difference.

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The colors you show have serious implications. In some instances, accurate color can even save your hide. The WoundExpert IRIS Module brings instinctive color calibration out of nature and into the exam room.

Use your cameras to capture the detailed wound coloration seen during treatment. Color corrected photos that show wounds in their best light and improve patient care–another perfectly fitted solution from Net Health.

Learn how an integrated wound image calibration solution can improve your patient records, visit nhsinc.com.

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nhsinc.com The Art of the Right Fit.™ © 2014 Net Health Systems, Inc. All Rights Reserved.

For diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs)

Close with the power of living cells

A leader in wound healing, Organogenesis offers the only two cellular technologies with FDA approval for healing chronic wounds: Apligraf and Dermagraft for DFUs1,2 Apligraf for VLUs1 ®

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Learn more at Apligraf.com and Dermagraft.com References: 1. Apligraf Package Insert. Canton, MA: Organogenesis Inc., 2010.

2. Dermagraft Directions for Use. Canton, MA: Organogenesis Inc., 2012.

© 2014 Organogenesis Inc. OI-A1153 All rights reserved. Printed in U.S.A. 3/14 Apligraf is a registered trademark of Novartis. Dermagraft is a registered trademark of Organogenesis Inc. Please see complete prescribing information at Apligraf.com and Dermagraft.com.

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