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, LLC

TM

an HMP Communications Holdings Company

Today’s

ÂŽ

Contemporary Approaches to Wound Clinic Management

Ancillary Services

for the Wound Clinic Patient

How do the

pieces fit? Legal Issues in Home Health Pain Management Concerns

Also in This Issue: Role of the NP in Wound Care Business Briefs

May 2013 www.todayswoundclinic.com

SAWC FALL www.sawcfall.com

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TODAY’S

®

Volume 7, Number 4, May 2013 • www.todayswoundclinic.com

Table of Contents • Feature Articles 14

10

Avoiding Legal Pitfalls for Home Health Services in Wound Care

The Future of NPs in Wound Care: Delivery of Quality Care & Cost Savings?

All wound care practitioners should protect themselves legally by having a clear delineation of responsibilities established by a written agreement when referring patients to a nursing agency. But what defines “clear”? And what determines “medical necessity” for home care?

Although NPs have struggled to gain acceptance from the medical community, they have come to be viewed as vital to the healthcare team, especially in regards to wound care and management.This article examines the role of NPs and details how wound care centers are benefiting from their utilization when appropriate training and education are considered.

Caroline E. Fife, MD & Kevin Yankowsky, JD

Linda Miller, BSN, RN & Chris Morrison, MD, FCCWS, FACHM

18

22

Incorporating the Nurse Practitioner Into Hospital-Based Outpatient Wound Care

Managing Pain Medication in the Outpatient Wound Clinic

The role of the NP in wound care has grown exponentially, but hurdles related to scope of practice remain. What should HOPDs consider before hiring an NP to provide wound care, and what should an NP evaluate before taking on this role?

FDA officials are considering reclassification of hydrocodone combinations. What does this mean for the way prescriptions are written in the wound clinic? Get the answer here. Michelle Cunningham, MD

Jennifer Hurlow, GNP-BC, CWOCN

25

Handling Abuse of Pain Meds In the Wound Care Clinic Wound care providers need to help their patients manage pain if they’re going to effectively treat their wounds. But what constitutes real pain compared to abusive behavior toward medication? Find out what one wound care clinic learned about identifying and addressing difficult situations. Tere Sigler, PT, CWS, CLT-LANA

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

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

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EDITORIAL STAFF

TODAY’S

CLINICAL EDITORS AND FOUNDING BOARD Caroline E. Fife, MD, FAAFP, CWS Dot Weir, RN, CWON, CWS

®

FOUNDING EDITORIAL BOARD Kathleen Schaum, MS Christopher Morrison, MD Val Sullivan, PT, MS, CWS

Volume 7, Number 4, May 2013 • www.todayswoundclinic.com

MANAGING EDITOR Joe Darrah jdarrah@hmpcommunications.com

Table of Contents

WEB EDITOR Samantha Alleman salleman@hmpcommunications.com

BUSINESS STAFF

Departments 4 6

EXECUTIVE VICE PRESIDENT Peter Norris pnorris@hmpcommunications.com

Joe Darrah, Managing Editor

VP/GROUP PUBLISHER Jeremy Bowden jbowden@hmpcommunications.com

Business Briefs

PUBLISHER Kristen J. Membrino kmembrino@hmpcommunications.com

From the Editor

 ME Medicare Administrative Contractor LCDs Are Important to D Qualified Healthcare Professionals Specializing in Wound Care Kathleen D. Schaum, MS 

SALES ASSOCIATE Brian Hill bhill@hmpcommunications.com

HMP COMMUNICATIONS, LLC

26

28

29 32

TWC News Update  roviding assistance to Boston; Alliance of Wound Care Stakeholders P votes against “skin substitutes”

PRESIDENT BIll Norton VICE PRESIDENT, SPECIAL PROJECTS Jeff Hall MARKETING MANAGER Stephanie Manzo

Ask The Board

CREATIVE DIRECTOR Vic Geanopulos vgeanopulos@hmpcommunications.com

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

ART DIRECTOR Bernadette Zeminski bzeminski@hmpcommunications.com

Industry Insider An Inside Look at Medela Inc.

SENIOR PRODUCTION MANAGER Andrea Steiger asteiger@hmpcommunications.com

Advertiser’s Index

PRODUCTION/ CIRCULATION DIRECTOR Kathy Murphy kmurphy@hmpcommunications.com AUDIENCE DEVELOPMENT MANAGER Bill Malriat

TWC Online

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

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Follow us on Twitter: @TWCjournal

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MEETING PLANNER Cynthia Noonan MEETING PLANNER Trisha Keppler

HMP COMMUNICATIONS HOLDINGS, LLC

Online Exclusive: Wound Clinic Business Blog Use the Correct Payment File to Find Medicare Allowable Rates

CHIEF EXECUTIVE OFFICER Jeff Hennessy CHIEF FINANCIAL OFFICER Dan Rice SENIOR VICE PRESIDENT Anthony Mancini CONTROLLER Meredith Cymbor-Jones

83 General Warren Boulevard, Suite 100, 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. , LLC

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

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fromtheeditor

T

he tragic events of April 15 in Boston provided us all a toocommon reminder: We’re not really safe. Not today. Not tomorrow. Not any time soon. Threats of terrorist attack can no longer be considered anything other than imminent. Will a changing healthcare system be able to clinically and financially support at least the illusion of safety and readiness to respond Joe Darrah moving forward? Statistics compiled by the Global Terrorism Da- Managing Editor tabase show overall occurrence of such acts on US soil is down since the 1970s (especially since 9/11), due in part to improved security. Yet, the number of injuries reported as a result of the marathon bombings ranks among the highest in recent US history for similar incidents (surpassed in the past 20 years only by the 1993 World Trade Center attack and the 1995 Oklahoma City bombing). Although we can take some comfort in knowing our collective awareness remains at a peak, the reality is that we’re not really any more safe. Despite fewer acts of terrorism and the awe-inspiring heroism by people who risked their lives to aid the injured in Boston, the increased sophistication of weapons during recent attacks brings into question our ability to be protected. Thankfully, first-responders and other medical, police, and emergency personnel in Boston curtailed the death toll and the extent of injuries by providing care at the scene and getting patients to multiple Level I trauma centers. And all involved have my utmost praise and respect. But, I can’t help wondering how much of this was the result of good triumphing over evil and confirmation of the true readiness of our healthcare system, and how much was the benefit of logistical luck. Yes, trauma centers spend countless hours participating in disaster drills and preparing for crisis, but would more deaths have occurred if the alleged perpetrators planned differently? (And this is not an attempt to boast that only “a few” deaths resulted from this attack. Even one would have been too many.) Commensurate with the race, medical and safety staff were on-site and in heightened emergency-response mode due to the number of people in the city, particularly the runners. Typical marathon emergency plans for hospitals and on-site caregivers anticipate cases of dehydration, muscle injuries, and, on a more emergent level, heart attacks. Plans aren’t inherently established to predict the off chance of treating crush and blast injuries that rival those suffered during military combat. With the race in mind, Boston-area hospitals were better positioned to handle more than 170 emergency department visits. But what if this was just an otherwise crowded day in the city? True, fewer people would presumably have been at risk, but would the carnage have been greater? It seems the suspects targeted not necessarily Boston, but the “free-living” US — striking on Patriots’ Day in a city that hosts one of our country’s most anticipated sporting events on a day that acknowledges the anniversary of two poignant American Revolutionary War battles.Was the planning by the accused actually convenient for the trauma centers? Regardless, could looming changes to healthcare for 2014 affect disaster or hospitals’ planning and readiness for an annual event? What about the possible financial trickle down of Medicare budget cuts now or in the future? Will more US hospitals close EDs? According to the CDC, trauma centers reduce the risk of patient death by 25 percent. Among those that remain open, that is. This is not a suggestion that Boston is in danger of seeing doors close at any of its centers; it’s just another potentiality for a country that may not be as safe as it could be. Recent data from the American Hospital Association show 339 trauma centers shut down from 1990-2005 while EDs overall closed at a rate of 11%. Many of Boston’s bombing survivors face extensive rehab and wound care. Their ability to recover and afford optimal treatment will come down to many factors not limited to age, access to services, and insurance coverage. For many, the struggle to recuperate will continue long after the admirable life-saving efforts of all those providing care and assistance that day. When “next time” strikes, here’s hoping the impacted healthcare practitioners and other providers are sufficiently positioned to help. n

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May 2013 Today’s Wound Clinic®

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Today’s

®

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

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

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

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businessbriefs

DME Medicare Administrative Contractor LCDs Are Important to Qualified Healthcare Professionals Specializing in Wound Care Kathleen D. Schaum, MS Information regarding coding, coverage, and payment is provided as a service to our readers. Every effort has been made to ensure the accuracy of the information. However, HMP Communications and the authors do not represent, guarantee, or warranty that the coding, coverage, and payment information is error-free and/or that payment will be received.The ultimate responsibility for verifying coding, coverage, and payment information accuracy lies with the reader.

E

ver since this column began, we have repeatedly discussed the reimbursement importance of monitoring, reading, and integrating your Medicare Administrative Contractor’s (MAC) Local Coverage Determinations (LCDs) into your wound care services. However, we have not spent much time discussing how documentation and written orders affect reimbursements for durable medical equipment (DME), prosthetics/orthotics, and supplies (DMEPOS) or the patients’ costs for wound care products used in the home. In an effort to keep consistent with the theme of this month’s Today’s Wound Clinic, consider this your “Business Briefs” potpourri related to ancillary services in wound care.

Meeting DME LCD Requirements Those MACs who oversee DME write LCDs that provide the coverage guidelines for DME suppliers. However, DME suppliers and patients need the assistance of qualified healthcare professionals in order to meet all LCD requirements. In fact, Medicare beneficiaries could be denied coverage for wound care management products if qualified healthcare professionals do not document the patients’ diagnoses to the highest level of specificity, do not fully document medical necessity 6

in the medical record,and/or do not write detailed orders in the medical record. To better appreciate the need for understanding the LCDs set fort by DME MACs, ask yourself the following questions: 1. When I review pertinent LCDs, do I include the DME MAC LCDs for the products I order for home use? 2. Have my patients ever returned to my clinic/office without the surgical dressing or the orthotics that I ordered because the products were “too expensive”? 3. Has the DME supplier ever told me “Medicare does not cover the surgical dressings that I ordered for a patient’s use at home”? If you answered “yes” to these three questions, please read this article very carefully. It is essential that you know the qualified healthcare professional’s obligations for justifying the medical necessity for all products ordered for at-home use. This can be achieved by following the DME MAC LCDs. If Medicare patients purchase the Medicare Part B supplement, they should only be required to pay 20% of the Medicare allowable for their at-home dressings and orthotic footwear. If the patients perceive the products are too expensive, the DME supplier may have been forced to charge the patients for the full price of the products because your written order and your written documentation did not support the medical necessity required by the LCD. If the DME supplier reports that Medicare does not cover the ordered product, that is not usually the exact problem:The real problem usually has something to do with

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a non-specific diagnosis, an incomplete order,and/or incomplete or non-existent documentation to support the medical necessity required by the LCD.

Where To Find Medicare LCDs The Centers for Medicare & Medicaid Services (CMS) maintain an Internet database of all published LCDs (active, draft, future effective, and retired). While you may be accustomed to searching that database for those LCDs published by the MAC that processes your claims, you will also conveniently find LCDs that pertain to the products that you order for patients’ use in the home by searching the same coverage database link and by following the navigation steps itemized below (www.cms.gov/medicare-coverage-database/overview-and-quicksearch.aspx): • indexes • local coverage • LCDs by state (select your state) • active LCDs • submit • DME MACs/program safeguard contractors/regional carriers (Click on the link to your DME MAC). Review the list of LCDs and click on the LCDs that pertain to the products that you order for patients’ use in the home. For example: • ankle-foot/ knee-ankle-foot orthosis • negative pressure wound therapy (NPWT) pumps • orthopedic footwear • surgical dressings • therapeutic shoes for persons living with diabetes. www.todayswoundclinic.com

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businessbriefs What Parts of the DME MAC LCDs are Important to Qualified Healthcare Professionals? First, qualified healthcare professionals should review the “Indications and Limitations of Coverage and/or Medical Necessity” section of the DME MAC LCD. There, you will find the MAC’s coverage criteria that must be met to prevent denial of the claim because the product is not reasonable and necessary. Both the surgical dressing and orthopedic footwear LCDs list the following coverage criteria: • A signed, dated, detailed written order must be received by the supplier before a claim is submitted. • The orthotic footwear LCD also states prosthetic shoes (L3250) are covered if they are an integral part of a prosthesis for a beneficiary with a partial foot amputation and lists specific covered ICD-9 diagnosis codes. (See your LCD for the specific covered ICD-9 diagnosis codes listed in this section and in the section entitled“ICD Codes that Support Medical Necessity.”) The surgical dressing LCD discusses many other issues in this section (see your LCD for specific details): • length of coverage • coverage when used with investigational wound healing therapy • use of dressings with adhesive borders versus use of tape • use of products with Healthcare Common Procedure Coding System codes described as “wound fillers” and “wound covers” • restrictions for use of hydrating dressings and absorptive dressings on the same wound • inappropriate combinations of primary and secondary dressings that have different frequency-of-change guidelines • guidance for selecting appropriate size of dressing to match the wound size • guidance for determining the amount of dressings that should be dispensed at any one time • order requirements for surgical dressings provided in kits • coverage guidelines for each category of surgical dressings that specify: — appropriate wound type — covered frequency of dressing change

TABLE 1. Qualified Healthcare Professionals Authorized to Order DMEPOS Treating Physician

— MD, DO, and DPM (for certain products)

Nurse Practitioner or Clinical Nurse Specialist

— treating patient for condition for which item is needed — practicing independently of physician — using own National Provider Identifier (NPI) to bill Medicare for other covered services — practicing in state where permitted to render services

Physician Assistant

— — — —

— number of dressings/amount of tape covered per dressing change — restrictions when used in combination with another dressing. Second, qualified healthcare professionals should carefully review the “Documentation Requirements” section of the DME MAC LCD and build those requirements into their medical record documentation. Both the surgical dressing and orthopedic footwear LCDs state that the patient’s medical records must reflect the need for the care provided. The patient’s medical records include the physician’s office records, hospital records, nursing home records, home health agency records, test reports, and records from other qualified healthcare professionals. The surgical dressing LCD itemizes additional information that must be documented: • number of surgical/debrided wounds being treated with a dressing • reason for dressing use • use as a primary or secondary dressing or for some noncovered use • clinical information that supports the reasonableness and necessity of the type and quantity of surgical dressings ordered • evaluation of wound on a weekly or monthly basis (see LCD for frequency of evaluation guidelines) requirements: — type of each wound — location of each wound — size (length x width [cm]) and depth of each wound — amount of drainage of each wound — any other relevant information about each wound. Third, qualified healthcare professionals must write orders that include all the

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treating beneficiary for condition for which item is needed practicing under supervision of MD or DO using own NPI to bill Medicare for other covered services practicing in state where permitted to render services

LCD order requirements. (See Table 1 for professionals who are authorized to write orders.) Medicare requires an order for every DMEPOS item. Most items are dispensed based on verbal orders while some items (eg, support surfaces and NPWT) require written orders prior to delivery. Detailed written orders are used to confirm what was ordered by the treating qualified healthcare professional following the supplier’s receipt of a verbal or written dispensing order. Some DME suppliers use preprinted forms that include a listing of many different items for their detailed written orders. The qualified healthcare professional must clearly identify the specific items (eg, by checkmarks, circling items, or other affirmative indicators) that he/ she is ordering for that specific patient. The qualified healthcare professional must sign and date the form. Reminder: The signature must be handwritten or an electronic signature. Stamp signatures are not acceptable. Dispensing orders (verbal or written) that allow the DME supplier to deliver the product should include the following elements: • description of item • name of beneficiary • name of physician • start date of order • signature — written dispensing orders need a qualified healthcare professional’s signature — verbal dispensing orders need the DME supplier’s signature. Detailed written orders from a qualified healthcare professional are required before a DME supplier can submit a claim to a Medicare contractor. The detailed written order is required even if the item was dispensed based on a verbal dispensing order. All detailed written orders should include the following elements: Today’s Wound Clinic® May 2013

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businessbriefs • beneficiary’s name • physician’s name • date of order and start date (if start date is different from date of order) • detailed description of item(s) (See the LCD for specific requirements for selected items.) NOTE:The detailed description may be completed by someone other than the physician. • frequency of change or use and specific amounts to be dispensed. NOTE: “As needed” is not an acceptable order. • duration or length of need • physician signature and signature date. NOTE:The surgical dressing LCD also specifies when new orders are required. Finally, qualified healthcare professionals should review the article(s) that is/are frequently attached to LCDs. These articles often provide additional coverage rules. For example, the article for surgical dressings states: Surgical dressings are covered when either of the following is met:

• they are required for the treatment of a wound caused by, or treated by, a surgical procedure, or • they are required after debridement of a wound. The surgical procedure or debridement must be performed by a physician or other healthcare professional to the extent permissible under state law. Debridement of a wound may be any type of debridement: surgical, mechanical, chemical, or autolytic.

Summary Wound care providers should take the time to download and read the entire LCD and article for surgical dressings and for orthotic footwear, as well as any other pertinent LCD/article. Make a concerted effort to be very specific about the patients’diagnoses,to document (in the medical record) the medical necessity for all work and products that will be ordered, and to write dispensing orders and detailed written orders in the

medical record as well as on DME supplier order forms. In recent Comprehensive Error Rate Testing (CERT) audits on DMEPOS claims, the audits found errors in the following categories: • insufficient documentation • medically unnecessary service or supply • services incorrectly coded • no documentation. Don’t wait for a CERT audit. Instead, compare your medical record documentation and orders to the pertinent LCDs/ articles. Then retrain yourself to document in detail and to write detailed orders in the medical record and on DME supplier order forms. n Kathleen D. Schaum is president and founder of Kathleen D. Schaum & Associates Inc., Lake Worth, FL. She may be reached for questions and consultation at 561-964-2470 or kathleendschaum@bellsouth.net.

Wound Care Revenue Cycle Insights: Multiple Viewpoints Don’t miss this entirely new 2013 program that highlights all the changes you must implement.

New Program and Format for 2013

To accommodate the requests from previous years’ attendees and to address the numerous 2013 “hot reimbursement topics,” our faculty has changed the format of Wound Clinic Business 2013. It will be composed of a series of interactive discussions from the viewpoint of the hospital-based outpatient wound care departments (HOPDs), and the qualified wound care professionals who manage wounds in the HOPD and their offices. Who Should Attend? The evaluations from all previous years have one resounding message: “This was the best wound care reimbursement seminar — I only wish people on my team had attended.” Therefore, plan to bring your entire team so that everyone has the benefit of participating in the interactive discussions: medical directors, physicians and podiatrists, non-physician practitioners, HOPD program directors, therapists, coders and billers, office managers, charge description master directors, corporate compliance officers, health information management directors, revenue integrity auditors, hospital executives, and clinical managers. 7:00 a.m. – 7:45 a.m. Registration and Continental Breakfast with Exhibitors 7:45 a.m. – 12:00 p.m. Sessions 12:00 p.m. – 1:00 p.m. Sit-Down Lunch with Exhibitors and Speakers 1:00 p.m. – 4:15 p.m. Sessions 4:15 p.m. – 4:20 p.m. Program Conclusion

WCB2013

Early-bird and group pricing available! Please visit www.woundclinicbusiness.com for complete agenda, registration fees, and additional information.

WOUND CLINIC BUSINESS

WCB2013 Dates/Locations

Note: Dates and locations subject to change.

Friday, May 17

Friday, June 7

Friday, September 20

Friday, October 4

Hilton Philadelphia Airport

Wyndham Lisle-Chicago Hotel

Crowne Plaza Houston Near Reliant Medical

Embassy Suites St. Louis-Downtown

Philadelphia, PA Friday, May 31

Birmingham, AL

Sheraton Birmingham Hotel

8

Chicago, IL

Houston, TX

Friday, June 14

Thursday, September 26

Friday, October 18

Doubletree Orlando Downtown

Bally’s Las Vegas

The Westin Gaslamp Quarter San Diego

Orlando, FL

Las Vegas, NV

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St. Louis, MO

San Diego, CA

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Avoiding Legal Pitfalls for Home Health Services in Wound Care When referring patients for home health services, wound care providers must ensure and document accuracy in assessment and “medical necessity.” Caroline E. Fife, MD & Kevin Yankowsky, JD

I

t’s already been a busy day in the wound clinic when a nurse rushes in to hand the physician a stack of home care nursing orders to sign. The forms, some of them more than five pages long, have been generated by various home health agencies in response to the one-page wound care orders that had previously been sent to them. The original orders consisted of instructions on how to clean the wound, secure a specific dressing over it, and change the dressing at a given interval for a specific time frame. A day later, the wound center receives documents with ex-

10

haustively detailed care plans for the patient’s many different health complications. One document in particular lists 20 medications the patient is taking (none of which the wound clinic physician prescribed), orders for tube feeding, catheter-care instructions, and a host of other detailed orders. At the bottom of this form is a place for the wound care physician’s signature. What’s wrong with this picture? How could new orders that were not written by the wound care physician need his approval? How should this situation be addressed? This article will help answer these questions.

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A Case In Point

This type of scenario recently played out in a court case against a Texas wound care physician who had been sued regarding his role in the home nursing care of a wound care patient who was living with many comorbidities. The physician had seen the patient just one time. During the visit, the physician suggested a conservative plan of care for the treatment of foot ulcers due to advanced and non-reconstructable vascular disease. Easy-to-follow orders were sent to the home-nursing agency, which then named the provider

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ancillaryservices the “physician of record” for all the patient’s medications and nursing interventions, even though the patient never returned to the wound care clinician. At some point, the care plan reverted to the primary care provider, but it was not clear when. The patient eventually required an amputation for her vascular disease and later died. The family sued the wound care physician, asserting that he was negligent in to properly supervising the complex treatment plan he had signed — the majority of which had been transferred from another physician. Be sure to follow the protocol outlined below when collaborating with a nursing agency on a patient’s wound care. Sign Clear Orders Legally, when a physician signs orders provided by an agency, he/she becomes the “physician of record” for those orders. All wound care physicians should protect themselves by having a clear delineation of responsibilities in any written agreement with an agency. Do not sign orders pertaining to other problems for which you are not the treating physician. It would also be wise to provide orders covering only the treatment period until the patient’s next scheduled visit so that the end date of your order is clear. Validate “Homebound” Status At the Center for Medicare & Medicaid Services (CMS), there are some officials who’ve voiced concerns over the “misuse” of home-nursing services. Patients and their families often pressure providers to order home nursing to a patient who may not qualify, creating an uncomfortable situation for wound care clinicians. Inappropriate use of home health services is a major focus of Medicare audits, but most wound care physicians do not give this aspect of the patient’s care much thought. It is true that many wound care patients are unable to care for themselves. For example, data from the US Wound Registry has shown that 70% of venous ulcer patients cannot dress themselves unaided.1 Many

pressure ulcer patients are even more seriously disabled. Most wound care clinicians are accustomed to utilizing homenursing services to provide interval dressings between visits to the wound center. While patients with private insurance may not have to be homebound to receive home nursing, Medicare patients must meet the definition of “homebound” in order for skilled home nursing to be provided. The Social Security Act of 1935 [Sections 1814(a)(2) (C) and 1835(a)(2)(A)], as amended by Section 4615 of the Balanced Budget Act of 1997, establishes the basic eligibility and coverage requirements for Medicare home health benefits. The act states that home health services shall be provided to beneficiaries who (1) are homebound, (2) have medical necessity (ie, need intermittent, skilled-nursing care; physical therapy; speech therapy; or continued occupational therapy), and (3) are under a physician’s plan of care. While these criteria may seem straightforward, their application is not. Both the use and interpretation of the first two criteria vary widely among Medicare Administrative Carriers. In general, a patient is considered to be homebound if: 1. Leaving the home isn’t recommended because of the patient’s condition. 2. The patient’s condition keeps him/ her from leaving home without help (such as using a wheelchair or walker, needing special transportation, or getting help from another person). 3. Leaving home takes a considerable and taxing effort. “Homebound” patients may still leave home for medical treatment or short, infrequent absences for non-medical reasons, such as attending religious services. More information about this can be found at: www.medicare.gov/ publications/pubs/pdf/10969.pdf. Clinicians who sign-off for homebound status when direct knowledge is available that contradicts the patient being

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homebound are exposing themselves to big dangers, such as prosecution for civil or criminal fraud. Even if there’s a good-faith belief that the patient was homebound, the wound care physician could be found liable of fraud if reasonable steps to evaluate the patient’s status aren’t found to be taken. Nursing home operators can be potentially liable if they provide home nursing care under Medicare for patients they know do not meet homebound criteria. The agency should notify the provider if the wound care patient does not meet any homebound criteria. It is wise to codify this responsibility in any agreement with an agency. If an agency reveals that a patient does not meet the requirements for homebound status, it would be ill advised to send orders to a different agency hoping you will get a different answer. Ensure “Medical Necessity” When an agency receives a referral, the first step in the admissions process is to perform a comprehensive assessment of the patient to identify the patient’s needs for skilled home healthcare. Based upon this assessment, the nurse will create a plan of care based on what is determined to be “medically necessary” for the patient. Medicare only pays for medically necessary services, so if the assessment does not support the medical necessity of a particular service, the agency should not provide it. Additionally, if the wound care physician’s documentation does not support the medical necessity of the services being ordered, the agency would be required to pay any reimbursement back to CMS and the physician would be liable for having certified that services were medically necessary when they were not. Providing medically unnecessary services can be considered an illegal inducement to the beneficiary as well as Medicare fraud. The US Department of Health & Human Services’ Office of the Inspector General and the US Department of Justice routinely review the medical necessity of claims. (Visit www.aihc-assn.org/Portals/3/ HomeHealthCertification.pdf for more

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ancillaryservices information.) For skilled-nursing care of a wound to be considered reasonable and necessary, the size, depth, nature of drainage, and condition and appearance of the surrounding skin must be documented in the clinical findings so that an assessment of the need for skilled care can be made. The plan of care must also contain the specific instructions for the treatment of the wound. Specific requirements to establishing medical necessity for home health skilled nursing can be found at www.cms.gov, but here are six situations in which home health for wounds is covered: 1. o  pen wounds that are draining purulent exudate and for which the patient is receiving antibiotics; 2. w  ounds that require irrigation or instillation and/or packing; 3. r ecently debrided ulcers; 4. wounds with exposed internal vessels or a mass that might hemorrhage; 5. p ostoperative wounds where there are complications; and 6. o  ther open or complex wounds that require treatment that can only be provided safely and effectively by a licensed nurse. It is important to keep in mind that CMS mandates that skilled home nursing service must be provided with the expectation of the patient’s restorative potential. In other words, homenursing services are provided on the condition that the patient “improve materially in a reasonable and generally predictable period of time.” Thus, home nursing is not considered reasonable and necessary if the patient is not able to heal the wound. This means home nursing may not be justified if a wound shows no improvement over the course of care. It is also not necessary when a patient has a transient problem that could reasonably be expected to improve sponta-

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neously. In those cases, the agency may notify the physician that that the family will need to assume responsibility for the care of the wound. (Visit www.cms.gov/Regulationsand-Guidance/Guidance/Manuals/ downloads/bp102c07.pdf, see page 60). The medical necessity of homenursing services for wound care also ends when the wound is healed. Once again, providers could expose themselves to prosecution for civil or criminal fraud for prescribing medically unnecessary services. This would be especially true if the government could show that the physician had direct knowledge that services were unnecessary but signed orders for services anyway.

Face-to-Face Requirement

The Affordable Care Act includes a requirement that healthcare providers conduct face-to-face meetings with patients about their condition(s) in order to receive Medicare payment for home health and hospice care. Intended to be a tool for reducing fraud, waste, and abuse by assuring physicians and other healthcare providers have actually met with potential home health patients to ascertain their specific care needs, the requirement establishes that a face-to-face encounter must have “occurred no more than 90 days prior to the home health start of care date or within 30 days of the start of the home healthcare by including the date of the encounter,” and must include an explanation as to why the physician’s clinical findings support the need for home healthcare, including that the patient is homebound and the need for either intermittent skilled-nursing services or therapy services as defined in 42 C.F.R. §409.42(a) and (c). When meeting with patients, remember: 1.  Face-to-face certification is only required at the actual start of care. 2. The encounter can be done by a non-physician, but a physician must sign the certification.

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3. The certifications must: a) be clearly titled, b) include an attestation that the encounter occurred, and c) state that the patient is homebound and in need of skilled care. 4. Face-to-face certification does not have to be on a separate form, it can be included in some other document, such as a plan of care. On Oct. 11, 2012, the owner of a Dallas-area home health services company admitted his role in a $374 million home health fraud scheme in which he and others conspired to bill Medicare for unnecessary services. Court documents showed that indicted physicians fraudulently certified beneficiaries and billed for services not provided. When Medicare implements a new requirement (such as “face-to-face time” certification), there is usually a reason for the increased documentation burden. Home health services fraud is on the rise. Those physicians who meet faceto-face with a patient cannot credibly claim to have “thought” he/she was homebound, for example. Adding this requirement could easily be a precursor to more aggressive prosecution, and it will certainly make prosecution easier when an MD files something that is incorrect about a patient’s true condition. Skilled home health services can be a vital part of a patient’s wound care, but providers must be sure to read orders before signing them and be sure to adhere to Medicare’s policies regarding homebound status and the medical necessity of treatment. n Caroline E. Fife is co-editor of TWC and chief medical officer of Intellicure Inc., The Woodlands, TX. Kevin Yankowsky is a partner at the law firm Fulbright & Jaworski LLP, Houston,TX. References 1. Fife C, Walker D, Thomson B, Carter, M. Limitations of daily living activities in patients with venous stasis ulcers undergoing compression bandaging: Problems with the concept of self-bandaging. Wounds. 2007:19(10):255-257.

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The Future of NPs in Wound Care: Delivery of Quality Care & Cost Savings?

More wound centers are seeking the services of nurse practitioners to improve outcomes and the bottom line, but appropriate training and ongoing education must be part of the plan. Linda Miller, BSN, RN & Chris Morrison, MD, FCCWS, FACHM

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here is a continually growing need to shift traditional wound care practice into what is now considered “best practice” and “advanced wound care” with the availability of evidence-based information. With this growing body of evidence-based knowledge, there is also a need for specialty wound care at all levels. An increasing number of physician practices that specialize in wound care are developing, and growth in companies that devote resources to managing wound care patients in all settings is evident. As these trends continue, hiring more specially trained nurse practitioners (NPs) will expand both the reach and the knowledge of those who offer advanced wound care. This article will examine the role of NPs and detail how wound care centers in particular are benefiting from their utilization when appropriate training and education are considered.

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ancillaryservices Nurse PractiTIoners: A History Lesson

NPs have struggled to gain acceptance from the medical community as a whole, as the concept of physician extension, both from a consumer and regulatory standpoint, has taken time to develop. This slow-moving appreciation has been exacerbated by the economic pressures placed on physicians, especially those who practice primary care. Some have seen the role of the NP as a threat to revenues as they consider the educational costs for NPs is about 1/4-1/5 the cost of medical school while NP salaries can be as high as half of that for physicians. However, in 1986 the Office of Technology Assessment (OTA) looked at overall performance of NPs and determined they deliver service at equal quality when compared to primary care physicians.1 In time, however, most physicians have come to view the NP as a vital part of the healthcare team who’s needed to deliver the best outcomes at the lowest possible cost. Additionally, patient satisfaction rates for NPs in relation to care and services provided, test results, and health status are similar to what they are for their physicians. The savvy physician recognizes the NP saves time, improves continuity of care, is accepted by patients, and can rival the performance of the physician.1 Today, the expansion of NPs within the wound care market parallels the expansion of their roles within medicine in general. The American Academy of Nurse Practitioners (AANP) reports approximately 155,000 practicing NPs. Despite the fact that this organization doesn’t offer clinical resources for wound care among its 14 specialties available to NPs, the overall growth of NPs in wound care coincides with an increase in the number of wound care practices across the country and the addition of the NP as a key professional for many of these practices. Having a workforce of physicians and NPs improves continuity of care across healthcare venues. When a patient can be seen in the hospital, transferred to

a skilled-nursing facility, and have care completed in an outpatient wound care center, coordination of care and patient outcomes improve. As the wound care specialty continues to develop and the need for wound care specialists continues to expand, the importance of care coordination throughout the continuum cannot be underestimated.The utilization of NPs and even physician assistants (PAs) will continue to grow and become a more integral part of the development of wound care as a specialty. Specially trained advanced registered nurse practitioners (ARNPs) and PAs are uniquely positioned to provide excellent quality and cost-effective care in both acute and post-acute settings, and staffing agencies across the US have seen tremendous success and growth in the recruitment of NPs, PAs, and ARNPs for hospital and skillednursing partners who recognize the importance of such collaboration. However, the importance of initial training and ongoing education that’s required in order to maximize the potential for quality outcomes and patient satisfaction/safety while fostering this collaboration cannot be overemphasized.

Recruitment of NPs

For those wound care centers looking to expand in practice, adding or supplementing staff with an NP can improve the profitability without a reduction in quality of care. Note, however, that development of the competencies and capabilities required to perform this role should be considered the first step for a successful recruitment strategy. How is one going to know when the best candidate is found if one has not defined the need? Competencies in wound care include, but are not limited to, diagnosing wound etiology, evaluating and considering patient complexities (including comorbidities), possessing skills in wound assessment and debridement, and recognizing the atypical wound. But each particular healthcare setting has its differences. An NP in a long-term care (LTC) facility must know the appro-

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priate regulations, the culture, and the needs of primarily geriatric patients. An NP in an outpatient wound clinic will need to be able to function in a fasterpaced environment as well as be able to determine when to use advanced technology such as skin substitutes and hyperbaric medicine. It would be unusual to find an NP who holds both skill sets and inclinations. And although adult primary care or gerontology practice experience is a basic requirement when recruiting for additional positions, expecting extensive wound care experience would be optimistic at best. According to Charleen Ise, MD, medical director with Healogics Specialty Physicians, the nurses who hold the skills that best dovetail with wound care possess dermatologic; surgical; family medicine; and previous wound, ostomy, and continence experience. Anyone recruiting an NP into the wound care setting should set standards that require patient-assessment skills, knowledge of physiology, team orientation, efficiency, and ability to embrace change and manage a lifelong learning process. Because wound care is constantly evolving, staying abreast of the growing knowledge base is critical. Once these requirements are defined, the process of determining where to seek qualified professionals can begin. An online job search for the title of “nurse practitioner” reveals no less than eight sites that specialize in placement of NPs. Professional organizations, nursing schools, and other job boards serve as additional sources, as do direct website job listings. However, using current staff members as resources and investigating their networking contacts can also be useful and may prove to be the best source of appropriate and qualified individuals. Once a pool of candidates is identified, the real work of finding the best fit means having multiple interviews conducted by stakeholders. One strategy is to involve the top candidates in learning the day-to-day role for which they are being hired. After that, the requisite background checks and ref-

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ancillaryservices erences need to be completed before the final negotiation and contractual agreement can be executed. If not performed diligently, this lengthy and involved process may result in job dissatisfaction and turnover, which is very costly with highly qualified professionals. NPs report greatest job satisfaction with collegiality of relationships within the practice along with challenge and autonomy.2 Ensuring the practice can meet those top desires for individual candidates will pay off in better retention. A high-quality recruitment process that matches candidates with the outlined requirements will increase the likelihood of a successful hire.

Providing Appropriate Training

Training to be a wound care practitioner begins with the required core competencies and capabilities previously discussed. It is rare to find an NP who already holds all the requisite skills and knowledge to perform effectively from day one. A program that combines classroom-level didactic work with online courses and required reading materials as well as an individualized preceptor program is fundamental to developing a competent and confident provider. This type of comprehensive training program produces providers who see patients efficiently and effectively while delivering desirable wound care outcomes. Ongoing mentoring from collaborating physicians remains a key part of the training process. All wound care providers need additional resources to be effective. This collaborative approach to care is an important reason that the specialty and business of wound care has grown so dramatically. Beyond receiving consults from their peers, NPs should have access to a certified wound specialist as the supervising physician. Generally, the training process takes between 6-12 months. During this time, NPs will have exposure to a variety of wound types and patient complexities in order to handle most patient care issues in stride. Beyond initial training, additional resources and educa-

tional opportunities should continue to be available, including evaluation of case studies, treating difficult-to-heal wounds, and reviewing patient data and outcomes.

Future Of The NP In Wound Care

Given the anticipated influx of patients as the Affordable Care Act’s impact increases, economic pressures to reduce healthcare costs strengthen, and the evolving role of NPs in all medical specialties is solidified, one can certainly expect NPs to take on a greater role in wound care moving forward. It may be that NPs will serve most roles particularly within the LTC sector, where there are more regulatory stipulations to contend with and probably more of a need for more frequent comprehensive patient assessments provided by a medical practitioner. Primary-care physicians may only see these patients monthly after their initial assessments upon admission to a facility, allowing more time to pass and wounds to develop. LTC patients are often admitted with wounds of various etiologies, and the primary physician may have only extended orders that came with the patient from the hospital. The initial evaluation for wound care is critical to achieving a successful wound care program. A comprehensive evaluation is best performed by a qualified wound care practitioner in order to develop the best treatment plan and achieve positive outcomes. Due to a shortage of primary care physicians that is only expected to worsen, NPs are taking on the assessment role in many settings, such as physician offices, nursing homes, and hospitals. As healthcare officials anticipate seeing more patients, providing effective wound care will continue to become more of a challenge. Projections estimate there will be 198,000 NPs providing direct patient care by the year 2025. This is a 130% increase from 2008, when there were 86,000 NPs providing patient care in the market. It is also estimated that the ratio of physicians to NPs will fall from 5:1

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to 3:1 by 2025.3 Although wound care may be practiced in almost every setting, there may be a significant difference in the quality of wound care treatment based upon the experience and education of the provider. Adding education on preventive strategies as part of the service provided by the NP along with diagnostic, interventionist, and medical oversight required to optimize outcomes makes their services more valuable. In the wound clinic, NPs have been approved to supervise hyperbaric oxygen therapy in many areas, although this differs from state to state and by payer. With the difficulty of finding enough physicians in some of the more rural markets, this may be a viable strategy for primary and secondary medical coverage, as well as for extending clinic hours to accommodate a higher patient caseload.

NP Value To Wound Care

As the specialty of wound care continues to grow, the need for qualified and dedicated NPs will also increase. Recruiting and retaining NPs will pose a challenge that the industry must successfully meet if wound care is to thrive and grow to achieve the best outcomes possible. In view of growth of the elderly population that’s experiencing the greatest number of wounds, a team of oriented professionals who know the industry and the complexities of the wound care population will remain paramount. n Chris Morrison is executive medical director and Linda Miller is director of clinical operations at Healogics Specialty Physicians. References 1. Alpert PT, Fjone A, Candela L. Nurse practitioner: Reflecting on the future. Nursing Administration Quarterly. 2002; 26(5):79-89. 2. De Milt DG, Fitzpatrick JJ, McNulty R. Nurse practitioners’ job satisfaction and intent to leave current positions, the nursing profession, and the nurse practitioner role as a direct care provider. J Am Acad Nurse Pract. 2011; 23:42-50. 3. Scudder, L. Growth of the nurse practitioner workforce. MedCare. 2012. Accessed online: www.medscape.com/viewarticle/761728.

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Incorporating the

Nurse Practitioner Into Hospital-Based

Outpatient Wound Care

The role of NPs in wound care continues to expand, but differences in scope of practice abound state by state. Jennifer Hurlow, GNP-BC, CWOCN

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t’s become common knowledge that wound healing requires a holistic approach. Any healthcare provider caring for the wound patient must consider the wound itself and all existing comorbidities beyond the wound in order to evaluate the patient’s full healing potential as related to the location and etiology of a particular wound. From the business perspective, cost-effective wound care requires attention to patient medical history (eg, cardiovascular disease), to nursing history (eg, self-care ability/ education), to the elements of the moist wound healing process (eg, appropriate dressing availability/use). As qualified healthcare professionals who are specially trained to practice within the unique blend of nursing theory and the medical decision-making model, nurse practitioners (NPs) can provide a valuable perspective to the wound care team within hospital-based outpatient wound care departments (HOPDs). However, these professionals must be set up for success upon being recruited into wound care. This article discusses the requirements needed to effectively practice

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wound care as an NP, the benefits of the integrated NP role in HOPD wound care, and provides practical checklists that will help both the NP provider and facility ensure a beneficial transition.

NP Requirements & Functions

Those considering the route of NP certification into HOPD wound care have much to plan. At the current time, NPs must complete a master’s level education program in order to be credentialed. In most cases, they must also gain certification in a specialty before they can begin to practice. Adult, family, and geriatric care are key specialty areas of focus that are conducive to potential work in an HOPD. Wound care certification is a crucial addition to education for any NP who seeks to work in an HOPD due to the important details regarding chronic wound diagnosis, treatment, and healing that remain absent from most nursing and medical education programs. A nationally recognized wound certification is certainly the most reliable way to ensure an acceptable baseline understanding of wound care. Some national certifications

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require wound care experience in order to sit for certification. Other national certifications offer an option to establish eligibility for certification by successfully completing an accredited educational program. Either way, as in all specialties, successful wound care experience can play an important role in NPs promoting their expertise to an HOPD. Just as with physicians, an NP must have expertise in all procedures performed within the HOPD. NPs can also provide “direct supervision” for procedures performed within an HOPD as long as they are “immediately available.” (NOTE: “Immediate” has not been defined by the Centers for Medicare & Medicaid Services (CMS), either to time or distance. Hospitals must define “immediate” by keeping in mind the safety and quality of care for their patients. The provider must be interruptible and able to be physically present to furnish assistance and direction throughout the performance of the procedures.) Without this direct supervision, HOPDs may not bill the Medicare program.Typically, HOPD staff performs procedures such as application www.todayswoundclinic.com

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ancillaryservices of multilayered high-compression bandage systems and application of negative pressure wound therapy. HOPD-qualified healthcare professionals should also be proficient in surgical procedures, including debridement and tissue biopsy. A direct supervision role requires expertise in all of these procedures as well as any other services/procedures performed in a HOPD. NPs usually practice in HOPDs under their own National Provider Identifier (NPI) number acquired through the National Plan & Provider Enumeration System.As is also the case for any qualified healthcare professional, NPs are required to purchase malpractice insurance. Many US states require NPs to receive some level of oversight by a medical doctor (MD). Liability and insurance premiums for MDs do not increase because of a collaborative relationship with an NP. Furthermore, actuarial data has shown the incidence of lawsuits against NPs is lower than the incidence of lawsuits against MDs.1

NP Practice Autonomy

Although the role of the NP related to wound care and healthcare in general has grown exponentially, there do remain hurdles that many practitioners still face before they are allowed to work within their scope of practice. There are currently 17 states, plus the District of Columbia, that allow independent NP practice. Within the remaining 33 states, NPs cannot practice without developing a contractual relationship with a physician, which involves a written protocol defining NP practice. In 10 of these 33 states, this contract involves delegation of activities to the NP by the physician and supervision of the NP’s practice. In the remaining 23 states, physician involvement provides a less restrictive, collaborative format. The details of these NP/physician relationships vary from state to state. For example: • NP practice in Utah requires collaboration only for the prescribing of Schedule II drugs. (For more information on the prescribing of Schedule II drugs, see “Managing Pain Medication in the Outpatient Wound Clinic” in this issue.) An NP in Utah can independently diagnose and treat as well as prescribe most pharmaceu20

TABLE 1. Checklist for NPs to Consider Before Accepting HOPD Position Do I meet the state practice act requirements for NP practice? Do I have or do I want to earn a nationally recognized wound care certification? Do I have an NPI number? Do I have malpractice insurance? Do I want to be an employee of the HOPD or of a physician group practice, or do I want to be an independent practitioner? Do I understand how I will bill for my services? Am I on the “preferred provider” lists of the payers that insure most of the patients who receive care in the HOPD? Which NP services do those payers cover? Do I have hospital privileges to practice in the HOPD setting? Do I have sufficient understanding of wound care to practice in the HOPD setting? Can I safely and effectively perform procedures typically performed in the HOPD setting (eg, layered compression/negative pressure dressing application, tissue biopsy, sharp debridement)? Do I have sufficient NP/physician support for practice questions/referrals? Do I have a wound treatment protocol in place? If I become an employee of the HOPD and I allow the hospital to use my NPI number, am I sure the hospital has removed me from its cost report? Does the HOPD want me to provide “direct supervision”? TABLE 2. Checklist for HOPDs to Consider Before Adding NP to Professional Staff Can an NP enhance the HOPD’s professional staffing? Does the HOPD need the NP to provide “direct supervision”? Does the NP meet all state practice act requirements? Does the NP have hospital privileges to practice in the HOPD setting? Will the NP be employed by the HOPD, by a physician group, or be an independent practitioner? If the NP is employed by the HOPD, does the hospital understand that the NP cannot be included on the cost report? Is the NP on the “preferred provider” lists of the payers that insure most of the patients who receive care in the HOPD? Which NP services do those payers cover? Does the NP have an NPI number? Is the NP nationally certified in wound care? Does the NP have successful wound care experience? Can this NP safely perform the procedures typically performed in the HOPD?

ticals, but requires MD collaboration to prescribe Schedule II drugs. •N  P practice in California requires general physician supervision/delegation to practice, but not national certification.2 It is interesting to note that in 11 of the 33 “non-autonomous” states, an NP does not require physician involvement to diagnose and treat a patient.3 Adding these 11 states to the 17 states (plus District of Columbia) that support autonomous practice, we have nearly 30 US states that allow NPs to independently diagnose and treat patients without physician involvement. Most of the wound care processes that occur in an HOPD involve diagnosis and nonpharmaceutical treatment, guidance of outpatient testing, various procedures, specialist referrals, ordering of durable medical equipment, and a significant amount of patient education. Therefore, NPs in these states who hold wound expertise can effectively manage and heal wounds without significant need for physician involvement, except for, perhaps, prescriptions

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for an enzymatic debrider or antibiotics. With physician involvement, NPs in these states can, of course, prescribe. If we could develop a greater national respect for the “science” of wound care, a respect that would support more timely referral from the generalist provider (remember wound science is absent from most nursing and medical educational programs) to the professional wound care setting and specialists, then we could significantly decrease incidence of wound infection/complication and the subsequent need for prescriptions. Oddly, at the same time that healthcare reform is promoting new respect for the NP’s role, a new challenge is developing for NP wound specialists who are required some level of MD involvement in order to practice.There is a growing trend toward refining and matching NP/MD specialties. Unfortunately, “woundology” is not a recognized medical specialty.This, coupled with a growing awareness that wound care must be addressed holistically to involve aspects of cardiology, podiatry, dermatology, endocrinology, surgery, www.todayswoundclinic.com

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ancillaryservices neurology, rheumatology, etc., is making it more difficult to find a satisfactory blend of NP/MD specialties. To prevent risk of a figurehead role and to support optimal-care provision, this quandary supports the need to promote respect for both the science of wound care and for those qualified healthcare professionals who currently demonstrate wound care expertise. Since both of these efforts remain ongoing, it is particularly important to the national goal of high-quality, costeffective healthcare delivery that the novice wound care NPs who must receive practice supervision choose an MD with a wound certification and significant wound care practice experience.

NP & HOPD Business Options

Much like the level of autonomy and supervisory structure that an NP practices within a given state will vary, the practice and business model for NPs in an HOPD includes three general options. 1. NP Employed by the Hospital If the NP is already a salaried employee of a hospital and is providing care to acute patients, the hospital is accounting for the cost of the NP on their acute care “cost report.” If the NP decides to move to the HOPD, he/she must be removed from the acute care cost report because, logically, his/her work can no longer be bundled into the costs of that setting. When the NP becomes a salaried, qualified healthcare professional in the HOPD, he/ she will transfer his/her NPI number to the hospital, which will use that number to bill for the NP’s work in the HOPD. NOTE: It is difficult, but not impossible, for the NP to retain inpatient and outpatient responsibilities as a salaried hospital employee. Careful attention must be paid to the risk of overlap between accounting for the NP in the acute care cost report and billing with the NP’s NPI number for services performed in the HOPD. In May 2012, CMS made the decision to support the right of hospitals to grant privileges to NPs.4 If this scenario evolves to practice, an NP could work as a hospital consultant, similar to how many of today’s physicians practice. The wound specialist NP could assist with

acute wound care delivery and could be removed from the hospital’s cost burden. This would lead to a more fluid NP practice environment, which could more easily include the traditional fee-for-service acute and post-acute (includes HOPD) settings as well as the accountable care organization environment. Some physicians have voiced concern that expansion of NP practice could negatively impact the finances of physician practices. However, recent analyses reported by the 2012 National Governor’s Association Paper “The Role of Nurse Practitioners in Meeting Increasing Demand of Primary Care” dispel this concern to be unsupported by fact.5 Physician income has not dropped in states that have granted increased NP autonomy due to complimentary MD/NP roles. Furthermore, these states have enjoyed an overall increase in thoroughness and quality of care delivered to their residents. 2. NP Within Physician Group If the NP is a salaried member of a physician group practice, he/she transfers his/her NPI number to that practice. When the NP provides independent service in the HOPD, the group practice submits claims to the insurance company via the NP’s NPI number and identifies that the services were provided in the HOPD. Typically, this arrangement will require a contractual practice agreement, which should include a practice protocol between the NP and a group physician. While working in a physician group, this author developed a generic wound treatment protocol that was kept on file at the practice site and in the HOPD. 3. NP With Independent Practice Within all states where NPs have the option to begin an independent practice, he/she must practice within state practice guidelines, many of which involve some level of physician collaboration including a protocol to define care guidelines. To practice in an HOPD, the NP must also be credentialed by the hospital system as an approved provider of care within the HOPD. Credentialing involves a review and approval of the provider’s credentials, capabilities, and practice structure. In the

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independent practice model, the NP bills under his/her assigned NPI number for wound care services provided in the HOPD. The key business consideration for the NP is to identify which insurances recognize NP practice and under which situations. For example, Medicare fee-for-service is very supportive of NP practice and reimburses the NP 85% of Medicare’s physician fee scale. However, some Medicare HMOs or Medicare Advantage plans do not reimburse NPs. For dually eligible (Medicare and Medicaid) patients, supplemental Medicaid programs generally reimburse NPs the remaining 20% of the Medicare allowable. Beware: not all state-sponsored Medicaid programs allow NP participation. Many private insurance companies will only reimburse an NP who is contracted with a credentialed physician, while others continue to refuse to recognize any level of reimbursement for an NP in independent practice. As our population ages and chronic wounds prevalence increases, HOPDs will continue to be seen as valuable resources. Refer to Table 1, a checklist that NPs should consider, and Table 2, a checklist that HOPDs should consider, for ensuring optimal NP placement. n Jennifer Hurlow owns her own NP practice: Wound Practitioner LLC, Germantown, TN. She may be reached at jenny.hurlow@gmail.com. References 1. Hooker R, et al. Does the employment of physician assistants and nurse practitioners increase liability? Journal of Medical Licensure and Discipline. 2009;95(2):6-16. 2. State practice environment. American Association of Nurse Practitioners. Accessed online: www.aanp.org/legislation-regulation/ state-practice-environment. 3. Nurse practitioner prescribing authority and physician supervision requirements for diagnosis and treatment, 2011. Kaiser State Health Facts. Accessed online: www.statehealthfacts.org/comparemaptable. jsp?ind=890&cat=8. 4. Turner S. CMS broadens concept of hospital ‘medical staff ’ to provide greater opportunities for nurses and other nonphysician practitioners. Geriatric Nursing. 2012;33(4):302-3. 5. The role of nurse practitioners in meeting increasing demand for primary care. NGA Center for Best Practices. Accessed online: www.nga.org/cms/center. Today’s Wound Clinic® May 2013

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Managing Pain Medication in the

Outpatient Wound Clinic Significant FDA drug changes may be on the way. What does this mean for the future of prescribing pain meds for wound patients and monitoring issues like tolerance and addiction? Michelle Cunningham, MD

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reatment of pain may soon become more challenging within outpatient wound clinics. Abuse, misuse, and diversion have led the FDA to consider reclassifying hydrocodone combinations, traditionally the “workhorses of pain management,” as Schedule II drugs. Previously referred to as triplicate, Schedule II drugs are recognized for their high potential for abuse, which may lead to severe psychological or physical dependence (see sidebar at right). Currently among Schedule III drugs, which are defined as only having a “potential” for abuse, a change to Schedule II for hydrocodone combinations would require more stringent prescription considerations. Many physicians do not feel comfortable prescribing controlled medications such as morphine, hydromorphone, and fentanyl for numerous reasons. As a result, they have either not gone through the process of ordering Schedule II prescriptions or they have ordered them and not used them often or with confidence. Additionally, some pain management specialists refuse to see patients who live with chronic wounds. Many patients face challenges in simply being referred to specialists due to such circumstances as living in a geographical area with limited access and/or long waiting times for appointments. Making matters more difficult, the typical patient requiring a pain specialist isn’t generally ambulatory or healthy, and asking him/her to visit yet another healthcare provider is frequently a burden. Regardless of the FDA’s ultimate decision on hydrocodone (as well as additional changes that could occur in the future), understanding the options available to treat those patients who visit the wound clinic is vital. This article will help wound care providers establish effective drug regimens for their patients when considering the potential for effectiveness as well as dangerous adverse events such as dependency and drug interactions.

Acknowledging Drug Dangers, Misconceptions

First, it is important to note that drug tolerance (a decreased effectiveness of a medication over time) should not be confused with addiction. Some prominent warning signs of addiction (eg, hoarding, increased requests for medications, and moaning) can also be reactions to pseudoaddiction (inadequate pain treatment resulting in traits similar to those of addiction). It can be very difficult to spot the difference, but an abundance of literature exists on this subject and should be consulted. Long-term management of pain may need to play into the wound care provider’s thoughts when conducting initial patient assessments. Some individuals may return frequently with significant pain. Also, where pain resolution is immediately experienced, 22

Controlled Substance Schedules

Section 812 of the Controlled Substances Act (CSA) lists substances that were controlled as of 1970. Since then, approximately 160 substances have been added, removed, or transferred from one schedule to another. The current official list of controlled substances can be found here: www.deadiversion.usdoj.gov/schedules. Below is a primer: Schedule I Controlled Substances Substances in this schedule have no currently accepted medical use in the US, a lack of accepted safety for use under medical supervision, and a high potential for abuse. Schedule II Controlled Substances Substances in this schedule have a high potential for abuse, which may lead to severe psychological or physical dependence. Schedule III Controlled Substances Substances in this schedule have a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. Schedule IV Controlled Substances Substances in this schedule have a low potential for abuse relative to substances in Schedule III. Schedule V Controlled Substances Substances in this schedule have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.

say, with a foot wound, this may lead the patient to walk more than is ideal for wound healing and result in clinical and painful setbacks to be addressed. As such, providers must take additional time to educate their patients about their medications, including how they work and what the side effects could be, to document the treatment and pain management plan, and to provide the necessary prescriptions each month. Many experts also recommend that a written contract between the patient and provider that details the expectations and goals of treatment be drawn up and consulted. This approach adds to the provider/patient relationship and helps ensure that pain is being addressed safely.What follows is a review of pain management modalities based on philosophies borrowed from the fields of internal medicine, geriatric care, and hospice that can and have been integrated within the wound clinic.With a focus on medications, particularly opioids, this discussion does not include other viable options that wound care providers can consider for helping their patients manage pain, such as physical therapy, acupuncture, massage therapy, and psychological

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ancillaryservices therapy. Note that pain may be treated more aggressively and be desired in a hospice situation that is appropriate in a wound clinic.

Pharmacological Options

Most physicians are comfortable with prescribing neuropathic agents, NSAIDS, and acetaminophen. Many also use tramadol, anxiolytics, topical agents, and hydrocodone or codeine. But there is a general reluctance to prescribe other opioids. A commonly repeated phrase is that “stronger” opioids are being considered when the appropriate descriptor is “more potent.” Remember: Morphine and hydrocodone have similar potency. Codeine is ineffective in a substantial group of patients due to its metabolism and is generally not well tolerated. • Acetaminophen: appropriate for mild pain and fever; 24-hour dose limits to 4,000 mg (3,000 mg in the elderly; 2,000 mg with liver disease patients). • NSAIDs: ibuprofen, naproxen; limit use with gastrointestinal and renal effects. • Steroids: multiple side effects; delay wound healing; must be tapered and used sparingly. • Neuropathic pain agents: (antidepressants): duloxetine, amitriptyline; neuroleptics: gabapentin, pregabalin. • Opioids: most commonly hydrocodone, codeine, morphine, hydromorphone, oxycodone, and fentanyl. • Others: tramadol;* muscle relaxants; anxiolytics; topical capsaicin; or lidocaine. *

owers seizure threshold, interacts L with antidepressants, and has a narrow therapeutic window.

Opioids

Opioids are discussed in terms of their relationship to morphine. Morphine IV is equal to one-third of the oral dose. Oral hydromorphone is about five times as potent as oral morphine. A 25 mcg/hr fentanyl patch is about as much as 50 mg of morphine spaced out over 24 hours. Calculating a patient’s morphine equivalent daily dose (MEDD) over 24 hours

allows a prescriber to adjust doses and switch to alternative medications. There are multiple different tables (available on the web and in various publications) to use to help providers calculate equivalent doses. It is important to remember the concept of incomplete cross-tolerance, a physiological response to a medication as a result of tolerance to a pharmacologically similar drug, prior to a medication change. Also remember that neuropathic pain agents may potentiate the effect of opioids, so a lower dose may be necessary. Neuropathic pain: Examples include peripheral neuropathy, phantom limb, shingles, and chronic ulcerations. Many times this pain is chronic and does not resolve completely after tissue damage has resolved.1 Nociceptive pain: AKA “regular” pain. This could be a new wound or ulcer, wound dehiscence, trauma, or other types. As tissue injury heals, the pain resolves.1

Common Opioid Side Effects: “CRAM IT” Constipation Respiratory depression Addiction Miosis Itching  Throwing up (nausea/vomiting — this is not an allergy)

Most side effects resolve after seven days. Constipation does not, and must be managed.

Starting A Regimen

There are multiple issues to consider prior to prescribing pain medication. The first (or primary) determination is choosing the medication to be used. Secondary to this decision is determining how to manage the risks involved. Primary questions to consider in selecting a drug include: 1) Where is the pain? This is important: The wound care provider is not responsible for treating chronic back pain for a wound on the foot. 2) What type of

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pain is present? 3) Is it neuropathic or nociceptive? 4) What are the patient’s goals for pain management? Complete pain relief may have more side effects, and many patients will desire pain reduction to tolerable levels rather than have more side effects. 5) Does the patient have any allergies or previous response to medications that should guide the drug selection? 6) Are there comorbidities that would guide the medication choice? With experience, these questions are easily answered and an appropriate medication can be chosen without much delay. Incomplete cross-tolerance: A physiological response to a medication that occurs when patients get used to one type of opioid, but don’t necessarily tolerate the new opioid at the equivalent dose. When switching medications, calculated doses need to be decreased by about 50% initially.

Secondary questions that help assess whether or not the risk of opioids will be well managed include: 1) Is the patient receiving pain medications from any other provider? If yes, consider referring the patient back to the treating physician or call the treating physician to coordinate care. If no, let the patient know that by asking for pain medications he/she must agree not to attempt to get additional pain medications elsewhere. 2) Does the patient or anyone in his/her family/ household have a history of addiction to alcohol, tobacco, pain medications, or illegal drugs? 3) Is there a risk of diversion? 4) Who will protect and administer the medications? Consider making these particulars part of the patient-provider contract to outline expectations and responsibilities. A sample contract by the American Academy of Pain Management is available online (www.naddi. org/aws/NADDI/asset_manager/get_ file/32898/opioidagreements.pdf). Though the FDA hadn’t reached a final decision on hydrocodone combinations as of press time for Today’s Wound Clinic, wound care providers may want to consider ordering prescription pads for Schedule II drugs and attending relatable continuing education in order to be Today’s Wound Clinic® May 2013

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ancillaryservices prepared. The following patient example may also give appropriate guidance:

Pain Management Pearls

Patient Care Scenario

• Patients who experience severe chronic pain will likely need a long-acting and a short-acting opioid. • Patients with episodic pain do well with short-acting opioids. • Patients with severe neuropathic pain usually do best with both neuropathic pain agents and opioids (ie, “gabapentin 300 mg tid + morphine 5 mg q 2 hrs prn”) • Morphine reaches a peak effect in 60-90 minutes, then there is renal excretion. Patients with renal insufficiency or renal failure may not do well with morphine. Fentanyl may be safer. • Constipation must be prevented when prescribing opioids. All patients need to be educated about this and dose increases will generally require more medications to prevent constipation. • A fentanyl patch takes about 12 hours to start working and is changed every 72 hours. This should never be the first opioid a patient is prescribed. • Methadone should not be prescribed by inexperienced practitioners. It is a very helpful drug, but has more complicated dosing calculations and multiple medication interactions.

A 62-year-old male living with diabetes and a large plantar wound is experiencing “sharp pain with every step and when sleeping at night.” He also complains of chronic “fire” to bilateral feet that has responded well to gabapentin. He is taking hydrocodone/acetaminophen (APAP) 10/325 mg and over the past month averages 12 pills per day, but still can’t sleep at night because of the pain. The patient is “in pain all of the time” and the hydrocodone only “helps for about one hour after each dose.” Dose escalation is not possible due to risk of acetaminophen toxicity. A call to the primary care provider is made, and she asks that the “pain be taken care of while the wound is being treated.” She reassures the patient has no problems with abuse or addiction, which is confirmed by the patient, who also has no renal insufficiency or medication allergies. A pain contract is completed.The average intake of hydrocodone is 120 mg in 24 hours.That is equal to about 120 mg of morphine (MEDD = 120). With incomplete cross-tolerance, 60 mg of morphine would be a good start in a long-acting formulation for chronic pain. It isn’t clear how incomplete crosstolerance will work in this patient, so prn doses of morphine, immediate release, will need to be available to the patient. In addition to educating the patient about constipation and other potential short-term side effects, an appropriate starting order would read: “morphine sulfate controlled release 30 mg PO q 12 hrs scheduled and morphine IR 5 mg PO q 2 hrs prn pain.” Two separate prescriptions would be prepared and the total number of pills to be dispensed would be written numerically and longhand. A copy of the prescriptions would go to the patient’s chart. The patient returns the following week and has used an average of three prn doses each day for the past 48 hours. No changes are needed. Questions that may be raised: 1) What if the patient returns and reports using 10 prn doses every day? 24

When assessing for, treating for, and reassessing for pain, remember:

The MEDD (24-hour dose) is “60 mg of morphine sulfate controlled release + 50 mg prn = 110 mg morphine in 24 hrs.” One option would be to change the morphine sulfate controlled release to “30 mg PO q 8 hrs” and continue the prn dose as previously ordered. Alternatively, the prn dose can be modified to “q 1 hr” or “10 mg q 2 hrs.” New prescriptions would need to be given to the patient with copies made for the clinic chart. 2) What if the patient can’t swallow pills well? Controlled-release morphine sulfate cannot be crushed or split (or it becomes immediate release), so an option would be to use a fentanyl patch. (This should never be the initial opioid a patient uses; this patient has already been on hydrocodone.) Remembering the MEDD (120 mg) and adjustments for incomplete cross-tolerance (about 50%), the appropriate fentanyl patch to start would be a 25 mcg/hr patch.These are distributed in boxes of 10 patches to be changed every 72 hours for a 30day supply. 3)  What if the patient complains of itching? Add an antihistamine for the first week. Nausea? Prochlorperazine or metoclopramide for the first week and after any dosage increase. Rash? Switch to a different opioid.

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Moving Past The Pain

Pain among wound clinic patients should decrease as the wound improves, and the patient should start to decrease his/her requests for opioids. Many patients experience more pain at night, so consider stopping the morning dose of extended-release medication to taper. This allows patients to sleep without waking for prn doses and enables them to use only what they require during the day. If you find the patient’s wound is improving but medication doses remain the same or increase, reassess risk factors for addiction or diversion. Review the type of pain and see if there is a neuropathic component that may respond to gabapentin, pregabalin, or antidepressants. Discuss the possibility of pseudoaddiction or addiction and tolerance with the patient. Ask about anxiety and a fear of pain. Reassure that you are trying to balance the risks and benefits of medications. Reassess the wound for any hidden problems such as underlying osteomyelitis or infection. n Michelle Cunningham, MD, is board-certified in internal medicine, geriatrics, and hospice and palliative care. She currently practices hospice, geriatrics, and wound care in the Houston,TX, region.  

References 1. Differential diagnosis: Nociceptive and neuropathic pain. Am J Manag Care. 2006;12(9 Suppl):S256-62. www.todayswoundclinic.com

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Handling Abuse of Pain Meds In the Wound care Clinic No provider wants to see patients living with chronic pain. But there’s a fine line between helping to manage that pain and enabling abusive behaviors. Tere Sigler, PT, CWS, CLT-LANA

M

y initial exposure to wound care as a physical therapist (PT) was providing whirlpool treatments on an inpatient basis. (And, yes, this was back in the days of Betadine.®) There was not much thought given back then to pain management — if patients complained of pain, we asked the floor nurse to call their doctor and ask for additional medication. As my career progressed and my interest and knowledge in wound care advanced, I found myself treating wounds entirely in an outpatient rehab setting. While we still used some whirlpool (our use of Betadine had ceased), we had also learned to incorporate other modalities such as electrical stimulation and intermittent pneumatic compression. I was personally becoming more cognizant of wound-related pain in my patients. Firstly, it had become evident that while some wounds would be characterized as “non-painful,” the reality is that some wounds are “less painful” than others. Essentially, a patient who is not completely insensate may experience pain in any type of wound, especially while receiving direct treatment. However, as a PT, treatment-related pain was generally the only aspect of pain I could address with my patients, as they had to go to the referring physician for all pain-medication requests. As a healthcare provider, I was frustrated that I couldn’t do more to help my patients manage their ongoing pain.

Treating Pain Today

We may never eliminate pain among wound care patients, but more options are available today beyond prescription drugs that reduce treatment-related pain and allow more options for providers who cannot write prescriptions for pain relievers (eg, barrier films, contact layers, silicone adhesion, and removal techniques).Warming cleansing solutions and the use of topical anesthetics help to minimize pain associated with cleansing and debriding wounds. Advanced dressing materials and

tapes that stretch allow for decreased pain during wear time of the dressing when applied correctly. However, while some of the physical modalities available today are effective in reducing non-treatmentrelated pain in certain individuals, the primary resource remains medication. Now that I’m on staff within a multidisciplinary wound clinic, I have daily, direct access to someone who can prescribe medications, as we are fortunate to have a full-time physician assistant (PA) who’s dedicated to our clinic. Initially, we were fairly liberal in our approach to dispensing pain medications, but things needed to change when we recognized some manipulative behavior among some of our patients. From claims that “someone stole” their pain medication to those patients who would only show up to their wound care appointments when it was time for a refill, we realized that our caring nature was being taken advantage of. There have been times in which our clinic has fielded calls from pharmacists looking to confirm prescriptions that were never called in as well as to advise us that a patient we had prescribed a pain medication to had recently received a full prescription of the same drug from another provider. We had to look at our screening measures related to pain medication. This caused us to swing the pendulum in the opposite direction. As a staff, we refrained from requesting pain meds for patients and instead referred them to outside sources, such as primary care providers (PCPs). While we are still quite conservative in prescribing, over time our approach to assisting with pain management has softened. The following examples and solutions should help guide anyone who may come up against these circumstances in the wound care center: Patients referred to the clinic having already been prescribed pain meds: Typically, these patients are directed back to the source when refills are requested. Patients with surgical wounds

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must have the surgeon prescribe further pain meds. A patient prescribed something for chronic back or joint pain by their PCP who now presents with a painful wound is required to have only one provider managing pain medication. Since it is not our role to manage chronic back or joint pain, we refer to the PCP. Any patient with a history of chronic pain medicine use or abuse must go through the PCP. Patients whose non-treatmentrelated pain is due to underlying wound etiology: We educate everyone who’s living with neuropathic ulcers who complains of neuropathic pain and have them follow up with the PCP for control of those symptoms. We also explain that developing pain in the region of the wound is an important symptom that we don’t want to mask with pain meds. Patients we’re following for wounds related to vascular disease: Those who present with symptoms of acute phlebitis may be given a short course of pain medication; however, we don’t start with pain medication for complaints of chronic “achiness.” We educate on that type of pain being useful to monitoring effectiveness of treatment and explain that if we are adequately reducing and controlling edema, the achiness should resolve. Patients who present with symptoms of arterial insufficiency generally have significant pain and are on pain medication from their PCP. If they are not, our PA will prescribe pain meds until vascular studies are completed. If they are not candidates for an intervention to improve arterial flow, they frequently are referred to a pain management physician. n Tere Sigler is the clinical director of the Archbold Center for Wound Management at Archbold Memorial Hospital,Thomasville, GA. Today’s Wound Clinic® May 2013

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TWCnewsupdate California Wound Center Earns Warriner Excellence Award

MGH, City of Boston Offer Donation Opportunities for Marathon Funds

Sonora (CA) Regional Medical Center has received the Robert A. Warriner III, MD Center of Excellence award for wound healing. According to facility officials, the center earned the award by surpassing rigorous quality standards for two consecutive years. Festivities included a gathering for staff and an award presentation by Healogics Inc., Jacksonville, FL. In 2012, the center achieved a healing rate of 96% in 23 median days for chronic wounds, exceeding the quality standard of 91% in at least 30 median days. In addition, 93.4% of patients rated their overall experience at the center as “excellent,” also exceeding the quality standard of 90%. The Center of Excellence award is named for Warriner, a pioneer in wound care and the former chief medical officer of Healogics. “We’re honored,” said Eden Smith, MD, medical director at the Sonora Center for Wound Care. “It’s a privilege to be part of a great collaborative effort between the hospital and Healogics. Together, we are able to heal patients in our community and get them get back to living happy, healthy lives.” n

In the aftermath of the terroristic events that unfolded at the Boston Marathon April 15, city officials and administration at Massachusetts General Hospital (MGH) have created support opportunities for those seeking to make donations to the local area. One Fund Boston Inc. has been established by Massachusetts Gov. Deval Patrick and Boston Mayor Thomas Menino to help those most affected by the tragedy. Donations can be made online by visiting https://secure. onefundboston.org. The MGH Emergency Response Fund helps support the hospital’s emergency response by providing social services support for victims and families, and will support emergency care, disaster relief, and disaster-preparedness training. Donations can be made online by visiting https://give.massgeneral.org/ boston-marathon-donate. Any questions can be addressed by emailing mghcommunityfundraising@partners.org. Local residents are also encouraged to help by donating blood. To schedule an appointment, call 617-726-8177. n

Alliance of Wound Care Stakeholders Officially Adopts “Cellular and/or Tissue-Based Products” The Alliance of Wound Care Stakeholders has voted to update the term “skin substitutes” with “cellular and/or tissue-based products for wounds” (CTPs). The adoption culminates the Alliance’s yearlong effort of its working group to determine a term that would be broad and inclusive to include both present and future technology. Use of the term “skin substitute” was recognized to be clinically inaccurate by representatives from clinical specialty organizations who work on CPT coding issues. They also determined that if an accurate terminology and appropriate classification system for these biological materials was not created, CMS would be unable to craft proper coverage policy, clinicians would not be paid for using these materials, and patients would not have access to them. Thus, Alliance members decided to update the term since the Agency for Healthcare Research and Quality, in its draft technology assessment on skin substitutes, stated these products were not “skin substitutes” and the Centers for Medicare & Medicaid Services abandoned the term in code descriptors for these products in 2010, when “Q” codes for each individual product were issued by its brand name. In order to achieve a fair, inclusive process for determining this new term, a workgroup of scientists, clinical organizations, and business entities was created from the Alliance to address this issue spearheaded by its chair Charles Drueck, MD. It held many conference calls 26

in 2012 in working toward development of the new term, determined by the following criteria: • be based on science • be inclusive of all products in the marketplace today with an eye towards what is in the “pipeline” • be neutral in regards to FDA (nothing that would be offensive and not allow manufacturers to get their products approved in the future, if needed) • ensure that all products are eligible for Medicare coverage as drugs and biologicals consistent with their US Pharmacopeial Convention monographs • easily understood by clinicians • easily linked to the existing Current Procedural Terminology codes for the application of the products. The Alliance held a decisive call in October with more than 25 scientists, clinicians, and manufacturers who reviewed the historical perspective of the 18 names the workgroup suggested over the past few years and to determine a final term. The group determined that the modified term “CTP” was the most appropriate term to put forward for these products. In discussing this term at a November meeting of the ASTM, an FDA representative had concerns with the term “derived.” Since the FDA does use the term “based” in its regulations regarding “Human Cells, Tissues, and Cellular and Tissue-Based Products,” the Alliance decided to use “based” to be consistent. Therefore, the final term became “Cellular and/or Tissue Based Products for Wounds.” n

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asktheboard In this exclusive column,TWC offers readers the chance to ask industry-related questions to our expert editorial board members. This month’s question comes from Orlando, FL. Donna J. Cartwright, MPA, RHA, CCS, RAC, FAHIMA

Q: Do you agree or disagree with some insurance companies not covering any skin substitutes – and why?

A: By Donna J. Cartwright, MPA, RHA, CCS, RAC, FAHIMA The Today’s Wound Clinic board is not in a position to agree or disagree with the medical directors of insurance companies. Therefore, following is a quick review of how qualified healthcare professionals should educate payers about products with published clinical evidence: Medical directors of the Medicare Administrative Contractors (MACs) do provide coverage for cellular and/or tissue-based products for wounds that have

Dermagraft

®

Human Fibroblast-Derived Dermal Substitute Essential Prescribing Information Numbers in parentheses ( ) refer to sections in the Directions for Use of the product labeling. Device Description: Dermagraft is a cryopreserved human 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 which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot. (2) Contraindications: • Dermagraft is contraindicated for use in ulcers that have signs of clinical infection or in ulcers with sinus tracts. • Dermagraft is contraindicated in patients with known hypersensitivity to bovine products, as it may contain trace amounts of bovine proteins from the manufacturing medium and storage solution. (3) Warnings: None (4) Precautions: Caution: The product must remain frozen at -75°C ± 10°C continuously until ready for use. Caution: Do not use any topical agents, cytotoxic cleansing solutions, or medications (e.g., lotions, ointments, creams, or gels) on an ulcer being treated with Dermagraft as such preparations may cause reduced viability of Dermagraft. Caution: Do not reuse, refreeze, or sterilize the product or its container. Caution: Do not use the product if there is evidence of container damage or if the date and time stamped on the shipping box has expired. Caution: Dermagraft is packaged with a saline-based cryoprotectant that contains 10% DMSO (Dimethylsulfoxide) and bovine serum. Skin and eye contact with this packaging solution should be avoided. Caution: Dermagraft has not been studied in patients receiving greater than 8 device applications. Caution: Dermagraft has not been studied in patients with wounds that extend into the tendon, muscle, joint capsule, or bone. Dermagraft has not been studied in children under the age of 18 years, in pregnant women, in patients with ulcers over a Charcot deformity of the mid-foot, or in patients receiving corticosteroids or immunosuppressive or cytotoxic agents. Caution: To ensure the delivery of metabolically active, living cells to the patient’s wound, do not hold Dermagraft at room temperature for more than 30 minutes. After 30 minutes, the product should be discarded and a new piece thawed and prepared consistent with Preparation for Use instructions. Caution: The persistence of Dermagraft in the wound and the safety of this device in diabetic foot ulcer patients beyond 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

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published evidence such as meta-analysis, randomized clinical trials, etc. If a particular product has published evidence and is not covered by the MAC that processes your claims, you should educate the MAC medical director through the Local Coverage Determination Reconsideration Process. This process is clearly outlined on the website of each MAC. Medical directors of private payers also provide coverage for cellular and/or tissuebased products for wounds that have published evidence. Sometimes coverage criteria are more lenient, the same as, or less lenient than the MAC medical directors’ coverage criteria. If a particular product has published evidence and is not covered by the particular private payer for a specific plan, you should educate the privatepayer medical director through the prior authorization or pre-determination process. n Donna J. Cartwright is senior director of strategic reimbursement services with Integra LifeSciences Corp., Plainsboro, NJ.

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) Customer Assistance: For product orders, technical support, product questions, reimbursement information, or to report any adverse reactions or complications, please call the following number which is operative 24 hours a day: Shire Regenerative Medicine Customer Service (877) DERMAGRAFT or (877) 337-6247 Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician (or properly licensed practitioner). Shire Regenerative Medicine, Inc. US PAT Nos. 4,963,489; 5,266,480; 5,443,950 ©2012 Shire Regenerative Medicine, Inc. All Rights Reserved DERMAGRAFT is a registered trademark of Shire Regenerative Medicine, Inc.

11095 Torreyana Road San Diego, CA 92121-1104

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industryinsider An Inside Look at Medela Inc.

F

or this month’s feature, Today’s Wound Clinic spoke with Mitch Odahowski, vice president.

Medela’s high standards of product quality, customer service, and education are always met.

Today’s Wound Clinic (TWC): How long have you been in wound care, and how did you enter this area of healthcare? Mitch Odahowski (MO): Most of my Mitch Odahowski, vice president professional career has been in wound care or the prevention of wounds through modalities that allow better skin care. My interest in healthcare came quickly in my career, as I saw how both the products and services that I marketed and sold had a positive impact on both the patients and caregivers who utilized them.

TWC: What do you find most rewarding about providing for your industry? MO: Knowing that we provide lifesaving treatment and advancement of patient care. We make a difference in people’s lives. The entire culture of Medela, starting with our breastfeeding business and continuing with healthcare, embraces precious life-progressive care.

TWC: What’s your day-to-day role? MO: As vice president of Medela Healthcare in the US, it is my role to develop, grow, and manage our business in our three areas of medical vacuum technology: negative pressure wound therapy (NPWT), cardiothoracic drainage, and medical-suction applications. I also take a strong personal interest in the application and education of our products by working closely with medical professionals, healthcare providers, payers, patients, and our strategic partners Mölnlycke® Health Care for foam dressing kits and Joerns® for distribution of our NPWT systems. This helps ensure

TWC: How would you describe the overall mission of your company? MO: With more than 50 years of leadership experience in medical-vacuum technology, we continue to remain loyal to our core competency. Through this competence, we continue to innovate and to question conventional methods in order to improve the quality and delivery of patient care. TWC: What’s new with your company in 2013? MO: So far, it’s been an exciting year with the upcoming launch of the Invia® Motion™ NPWT system. Motion is a personal device for every patient, offers a full choice of therapy options, and promotes improved patient mobility and freedom. This represents Medela’s commitment to providing innovative NPWT technology designed to enhance overall performance, improve patient outcomes, and control costs. Collectively, this represents True NPWT.™ In addition, we have launched our PartnerFirst™ program to our durable medical equipment customers to assist them in their efforts to provide

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high-quality NPWT services. TWC: How is your company unique? MO: We continually engage customers in broad research and transform this knowledge into innovative products and services. In wound care, Medela’s True NPWT offering consists of a portfolio of solutions because varying patient needs require varying degrees of therapy. This is why Medela offers a choice of devices, a choice of dressing kits, and a choice of therapy modes. TWC: Why are you passionate about the work of your company? MO: Medela truly cares for our patients’ well-being. Our NPWT system is ideal for today’s work/home environment because it allows patients to continue with normal daily activities while receiving therapy. In addition, our innovative approach helps improve patient therapy acceptance, as devices are discreet and hardly visible to others. Motion patients have commented on how quiet and easy the system is to use. TWC: How is your company approaching challenges in wound care? MO: In my discussions with healthcare professionals, I’ve learned that the most common challenge is how to reduce overall costs while improving patient outcomes. Medela challenges the status quo by not accepting that therapy can only be improved in small steps; we look for opportunities to innovate in the therapies we offer, which is more than just developing new ideas — it requires validating them as well. By support-

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industryinsider ing clinical studies and continuous research, and having ongoing dialogue with healthcare professionals and patients, we promote an evidence-based approach to NPWT. TWC: What are your most popular products and/or services? MO: Because patients present with a variety of NPWT needs, Medela offers two systems: Invia Liberty™ and Invia Motion, which can be used across all care settings. The Liberty’s innovative design delivers flexibility in treating acute and chronic wounds. Patients appreciate Liberty’s ease-of-use, quiet operation, and compact size. The Motion

is a personal pump that enables patients to participate in normal daily activities while providing therapy throughout the period of treatment. Both systems have the flexibility to be used with either gauze or foam dressing kits. TWC: How do you ensure proper training on products and services? MO: There are a number of resources and training programs available for our products and services. Our dedicated team of key account managers and extensive PartnerFirst network actively support our customers by providing ongoing training and education. In addition, there are a number of tools such

as teaching aids, instructional videos, and troubleshooting guides available in print or online for support 24/7. TWC: What are the future goals for you and your company? MO: As a compassionate and dedicated partner, we are committed to shaping wound care and making a difference in people’s lives. Today, our products provide patients with mobility, which can favorably impact outcomes and adherence to therapy. Going forward, we will remain focused on improving patient dignity for those using our products and services by emphasizing simplicity, quality, and hygiene. n

Wound Certification Prep Course ™

Prepare For National Wound Care Board Certification Examinations To Advance Your Career.

Learning Objectives

Select from two different locations in 2013 Las Vegas, NV

September 25 – 26, 2013 Bally’s Las Vegas

$520*

* $400 – S pecial Pricing for Attendees to SAWC Fall (Las Vegas)

• Outline the etiology of chronic wounds and extrinsic factors, which 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, biophysical technologies and the use of HBO therapy.

*This registration fee is in addition to the normal SAWC Fall pricing.

Newark, NJ

October 26 – 27, 2013 Renaissance Newark Airport Hotel

$520 AAWC 25% discount

Faculty

Greg Patterson, MD, FACS, CWS Medical Director General and Vascular Surgery, Bariatric and Metabolic Surgery Archbold Center for Wound Management and Hyperbaric Medicine Thomasville, GA

Intended Learners

Pamela Scarborough, PT, DPT, MS, CDE, CWS Director of Public Policy and Education American Medical Technologies Irvine, CA

Dot Weir, RN, CWON, CWS

Register today for this career-building, 17-hour course.

Osceola Regional Medical Center Kissimmee, FL

Co-located with, and held before, the 2013 Symposium on Advanced Wound Care conference (SAWC Fall in Las Vegas), and a second standalone meeting in Newark, NJ.

Course curricula designed for MD/DOs, DPMs, PTs, NP/PAs, RNs, and other healthcare professionals interested in updating their wound care knowledge.

SAWC FALL

Register online at www.woundprepcourse.com or by calling 800-237-7285, ext. 233. Sponsored by North American Center for Continuing Medical Education, LLC

cancellations received in writing before the above date. No refunds will be issued within 30 days prior to each course date – without exception. Registrations are transferable at any time.

Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

Cancellation Policy Please note the cut-off date for cancellation is 30 days prior to each course date. All cancellations must be received in writing and postmarked by that date. Full registration (less a $75 processing fee) will be refunded only to

Accreditation Information In support of improving patient care, North American Center for Continuing Medical Education, LLC (NACCME) is accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation

Physicians: NACCME designates this live activity for a maximum of 17.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

30

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.

This program is approved 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.

PHYSICAL THERAPISTS: PARKS Institute will apply for pre-approval accreditation in Texas, Nevada, and New Jersey which require pre-approval. If you practice in another state, please consult its PT board.

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

Hardware/Software Requirements: All educational activities are accessible via a PC (Windows 2000/XP/Vista/7) or Mac (Mac OS 10.x or later) computer with current versions of the following browsers: Internet Explorer, Mozilla Firefox, Google Chrome or Safari. Windows Media Player or compatible alternative, sound card, and speakers are required for streamed audio. The latest version of the Adobe Flash Player is suggested (please download here) for video programs. A PDF reader is required

for print publications. Please direct technical questions to webmaster@naccme.com.

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.

Requirements for Credit: To be eligible for documentation of credit, participants must participate in the full activity and complete the evaluation form. ADA Statement: North American Center for Continuing Medical Education complies with the Copyright @ 2013 by North American legal requirements of the Americans with Disabilities Center for Continuing Medical Education, Act and the rules and regulations thereof. If any LLC. All rights reserved. No part of this participant in this educational activity is in need of accredited continuing education activity may accommodations, please call 609-371-1137.

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TWCnewsupdate

classified

contiuned from page 26

Shire Announces ‘Science’ of Wound Care   Grant Officials at Shire Regenerative Medicine have announced the organization is providing the Association for the Advancement of Wound Care (AAWC) with a $100,000 grant to be used for fellowships to advance the science of wound care. The announcement was made during the 2013 Symposium on Advanced Wound Care/Wound Healing Society conference in Denver in early May. In partnership with the AAWC, the unrestricted grant will reportedly be split to sponsor two individual fellowships for the 2014-15 academic year. The fellow selection process will be administered by AAWC, and each fellowship will be open to DPM, MD, and DO candidates to support a post-residency or fellowship program focused on multidisciplinary wound healing and tissue preservation. Programs throughout the US are eligible to receive funding. “Decreasing the number and severity of all types of wounds is what drives me and our organization,” said Rob Snyder, DPM, president of AAWC. “Providing fellowship grants for the scientific advancement of wound care is an incredible opportunity for two future leaders to move the science of wound care forward and ultimately improve patient care in an area where there is still a large unmet need.” According to the Alliance for Regenerative Medicine, chronic wounds affect approximately 5-7 million US patients annually. It is estimated that the US spends $35 billion per year to treat these wounds, and that impact will only continue to grow as the population ages and as diabetes and obesity increase in prevalence. “Proper wound care is an escalating issue, and we are proud to bring such an important fellowship to life,” said Jeff Jonas, MD, president of Shire. “By supporting promising researchers, we hope to advance the science of wound care to ultimately deliver products that show both a clear effect and clinical benefit for patients.” Grant applications will be accepted by the AAWC through 2013. Selections of fellows and their programs will be made by March 2014. Details of the application and selection process for this fellowship program will be communicated at a future date. n

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Elizabethtown, KY  

MANAGER,  WOUND  CARE/VASCULAR  CENTER   JOB  SUMMARY:  This  position  is  responsible  and   accountable  for  daily  operations  of  the  Wound  Care   and  Hyperbaric  Medicine  Center  and  the  Vascular   Center  to  include  fiscal  and  resource  management.   Develops/implements  processes  to  facilitate  timely   patient  throughput  for  Wound  Care  and  Vascular   Center  patients  and  maximize  utilization  of  rooms   and  time.  Schedules  patients  appropriately,  working   in  collaboration  with  referral  sources  to  maximize   efficiencies.  Collects  and  analyzes  data  to  ensure   targets  are  met.  Assists  in  marketing  the  (WCHMC)  to   physicians  and  the  community  within  the  service   area.  Maintains  open  communication  and   professional  relationships  with  members  of  the   medical  staff.     QUALIFICATIONS:  Current  unrestricted  license,  as  a   RN  in  Kentucky  required.  Successful  completion  of  an   approved/accredited  hyperbaric  medicine  training   course  within  60  days  of  hire  required.  Certification   as  a  Certified  Hyperbaric  Technician  (CHT)  or  Certified   Hyperbaric  Registered  Nurse  (CHRN)  within  18   months  of  hire  required.  Minimum  of  5  years  of   recent  clinical  experience,  two  years  of  wound   specialty  experience  required.  BLS  certification  within   90  days  of  hire  required.  BS  in  nursing  or  related  field   required.  Management/supervisory  experience   preferred.  Wound  Care  Certification  by  the  Wound   Ostomy  Continence  Nursing  Certification  Board   preferred.  Must  be  able  to  multitask.  Must  have   commitment  to  customer  service.  Must  be  familiar   with  CMS  and  Joint  Commission  regulations.   Please  visit  our  website  to  learn  more  about  our   wound  care  facility  at:   http://www.hmh.net/hmhwebsite/Location.aspx?P ageID=11.   Contact:   Lisa  Miller  or  Julianne  Hart,   Coordinators,  Recruitment/Retention   (270)  706-­‐1762  or  (270)  706-­‐1613   Email:    lmiller@hmh.net  or  jthart@hmh.net     Visit  us  on  the  web  at  www.hmh.net  to  apply  and   submit  resume.  

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Apligraf® Essential Prescribing Information Numbers in parentheses ( ) refer to sections in the main part of the product labeling. Device Description: Apligraf is supplied as a living, bi-layered skin substitute manufactured from cells processed under aseptic conditions using neonatal foreskin-derived keratinocytes and fibroblasts with bovine Type I collagen. (1) Intended Use/Indications: Apligraf is indicated for use with standard therapeutic compression in the treatment of uninfected partial and/or full-thickness skin loss ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy. (2) Apligraf is indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness foot ulcers of neuropathic etiology of at least three weeks duration, which have not adequately responded to conventional ulcer therapy and extend through the dermis but without tendon, muscle, capsule or bone exposure. (2) Contraindications: Apligraf is contraindicated for use on clinically infected wounds and in patients with known allergies to bovine collagen or hypersensitivity to the components of the shipping medium. (3, 4, 5, 8) Warnings and Precautions: If the expiration date or product pH (6.8-7.7) is not within the acceptable range DO NOT OPEN AND DO NOT USE the product. A clinical determination of wound infection should be made based on all of the signs and symptoms of infection. (4, 5) Adverse Events: All reported adverse events, which occurred at an incidence of greater than 1% in the clinical studies are listed in Table 1, Table 2 and Table 3. These tables list adverse events both attributed and not attributed to treatment. (6) Maintaining Device Effectiveness: Apligraf has been processed under aseptic conditions and should be handled observing sterile technique. It should be kept in its tray on the medium in the sealed bag under controlled temperature 68°F-73°F (20°C-23°C) until ready for use. Apligraf should be placed on the wound bed within 15 minutes of opening the package. Handling before application to the wound site should be minimal. If there is any question that Apligraf may be contaminated or compromised, it should not be used. Apligraf should not be used beyond the listed expiration date. (9) Use in Specific Populations: The safety and effectiveness of Apligraf have not been established in pregnant women, acute wounds, burns and ulcers caused by pressure. Patient Counseling Information: VLU patients should be counseled regarding the importance of complying with compression therapy or other treatment, which may be prescribed in conjunction with Apligraf. DFU patients should be counseled that Apligraf is used in combination with good ulcer care including a non-weight bearing regimen and optimal metabolic control and nutrition. Once an ulcer has healed, ulcer prevention practices should be implemented including regular visits to appropriate medical providers. Treatment of Diabetes: Apligraf does not address the underlying pathophysiology of neuropathic diabetic foot ulcers. Management of the patient’s diabetes should be according to standard medical practice. How Supplied: Apligraf is supplied sealed in a heavy gauge polyethylene bag with a 10% CO2/air atmosphere and agarose nutrient medium. Each Apligraf is supplied ready for use and intended for application on a single patient. To maintain cell viability, Apligraf should be kept in the sealed bag at 68°F-73°F (20°C-23°C) until use. Apligraf is supplied as a circular disk approximately 75 mm in diameter and 0.75 mm thick. (8) Patent Number: 5,536,656 Manufactured and distributed by: Organogenesis Inc. Canton, MA 02021 REV: December 2010 300-111-8

Please see complete prescribing information at www.Apligraf.com © 2013 Organogenesis Inc. OI-A1112 All rights reserved. Printed in U.S.A. 03/13 Apligraf is a registered trademark of Novartis.

Advertiser’s Index

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ACell Inc. (MatriStem).......................................................................................................................................... 19 BSN Medical (Cutisorb Ultra)................................................................................................................................ 5 Derma Sciences (TCC-EZ)..........................................................................................................................Cover 2 KCI (V.A.C.)..................................................................................................................................................Cover 3 Medela (Invia)......................................................................................................................................................... 3 Net Health (WoundExpert)..................................................................................................................................... 9 Organogenesis (Apligraf).......................................................................................................................Cover 4, 32 Sechrist Industries (HBOT).................................................................................................................................. 13 Shire Regenerative Medicine (Dermagraft)....................................................................................................27, 28 32

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May 2013  

Ancillary Services for the Wound Clinic Patient: How Do the Pieces Fit?; Legal Issues in Home Health; Pain Management Concerns; Role of NP i...

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