INSIDE:

The New Dermagraft.comA New Educational Resource

Health Care Reform The Patient Protection & Affordable Care Act

Meet Lisa SummersDermagraft® Patient Spotlight

Case Study by Dr. Sid ShahRockdale Medical Center Wound Healing Center

Consensus Recommendations

Have You Heard About the NEW Guidelines for Treating Diabetic Foot Ulcers?

OnDermagraft

S U M M E R 2 0 1 0T H E M E d i c a l M a g a z i n E f o R U S E R S o f d E R M a g R a f T ®

®

Any wound that remains unhealed after 4 weeks is cause for concern, as it is associated with worse outcomes, including amputations.

Make the shift to Dermagraft for faster healing times with clinically proven results.

Dermagraft: Delivering living cell therapy.

Make the Shift.Get your diabetic foot ulcer patients back into high gear.

visit us at www. dermagraft.com

visit us at www. dermagraft.com

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Summary of Consensus Recommendations

Advancing The Standard of Care for Treating Neuropathic Foot Ulcers in Patients with Diabetes

diabetic foot ulcers (dfUs) are a common and serious chronic medical condition among many diabetes patients, as estimates show that 15-25 percent of diabetes patients will develop a foot ulcer in their lifetime. an unhealed dfU increases a patient’s risk for serious complications, such as infection, which could—and often does—lead to lower limb amputation, and in some cases, death.

Standard care practices for treating dfUs have typically included preparation of the wound bed, debridement, infection control and offloading. However, despite these efforts, healing rates remain low.

it is with this in mind that advanced BioHeal-ing, inc. (aBH), the makers of dermagraft®, recently supported the initiative to convene a consensus panel of experts in the field of wound care in patients with diabetes to review the evidence and practicalities for the evaluation and treatment of patients with dfUs. comprising the panel were Robert J. Snyder, dPM, cWS; Robert S. Kirsner, Md, Phd; Robert a. Warriner iii, Md, faca, fccP, fccWS, aBPM/UHM; lawrence a. lavery, dPM, MPH; Jason R. Hanft, dPM, facfaS, david J. Margolis, Md, Phd; and Peter Shee-han, Md.

The goal of this panel was “to provide straightforward and practical approaches for clinicians to adopt when treating patients with dfUs, thus working to close the loop between research and practice.”

The resulting consensus manuscript provides

clinicians with the clinical markers, evidence and recommendations that will advance the standard of care for the treatment of neuro-pathic dfUs.

Scientific evidence indicates that prolonged healing times increase the risk for complica-tions. as a result, one of the most important considerations in caring for patients with a dfU is quick and complete wound healing.

The panel, which promotes a multidisciplinary team approach to assessment and treatment of dfUs, offered several recommendations:

Assessment

a comprehensive foot and ulcer evaluation for patients with diabetes encompasses several criteria. The key components include:

• Patient history and physical examination

• laboratory screening

• nutritional evaluation

• neurologic, musculoskeletal and vascular assessment

• Wound status history and a complete and accurate description and measurements of the wound

The panel further recommended that “foot ulcers in patients with diabetes that exhibit ‘stalled’ healing after two to four weeks should be re-evaluated.” This re-evaluation can help clinicians identify wounds that are not responding to standard care and may benefit from early adoption of advanced therapies.

Heard about the new guidel ines for treat ing

diabet ic foot ulcer s?

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OnDermagraft

S U M M E R 2 0 1 0 i n d E X

1 i Consensus Recommendations

2 i The New Dermagraft.com

3 i Health Care Reform Upcoming Conferences

4 i Patient Profile

5 i Case Study

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Treatment

“in patients not responding to standard care, early adoption of advanced care may be more cost-effective than continuing standard care practices for decreasing the incidence of lower extremity amputation.” Treatment should include:

• appropriate preparation and maintenance of the wound bed, which may include aggressive debridement, infection control and offloading.

• Use of advanced therapies and products such as human skin equivalents, wound modulators and growth factors.

Through careful consideration of the advan-tages and disadvantages of a variety of methods used in the evaluation and treatment of dfUs, the consensus reached the following conclusion: “When wound healing stalls, early adoption of advanced therapies is advocated to accelerate wound healing and decrease complications, and should be considered the new standard of care.”

While the panel believes that clinicians should consider its recommendations the new stan-dard of care, the investigators acknowledge that clinicians must recognize the unique challenges presented by individual patients and adjust treatment approaches accordingly.

in response to this manuscript, david g. arm-strong, dPM, Phd, who was not a contribut-ing author, offered the following commentary: “This consensus panel seems to have found a middle ground between evidence-based medicine and the practical realities of the day-to-day pragmatic practice… This practical yet evidence-based guide should go a long way toward facilitating improved outcomes in healing chronic ulcers in patients with diabetes.”

The manuscript, entitled “consensus Recom-mendations on advancing the Standard of care for Treating neuropathic foot Ulcers in Patients with diabetes” was published in the april 2010 supplements of WOUNDS and Ostomy Wound Management.

Summary of Consensus Recommendations continued c oV E R

When wound healing stalls, early adoption of

advanced therapies is advocated to accelerate

wound healing and decrease complications,

and should be considered the new

standard of care.

To download a PDF of the supplement, please visit

www.abh.com/in-the-news.html

advanced BioHealing, inc. (aBH), the makers of dermagraft®, recently unveiled the new dermagraft.com website. aBH redesigned the site to serve as a new educational resource for clinicians on today’s Standard of care in treating diabetic foot ulcers (dfUs).

Visitors to the new website will find updated content about dfUs and dermagraft, and several new resources for clinicians, including an interactive Standard of care timeline, a Wound calculator, an ask the Experts section, a comprehensive case study section, and a detailed reimbursement support center.

aBH reminds all clinicians that any wound that remains unhealed after 4 weeks is cause for concern, as it is associated with worse outcomes, including amputation. We invite you to visit the new dermagraft.com to find out more about how you can achieve faster healing times and get your patients back on their feet.

aBH is also developing a new patient-focused website (www.heal2gether.org) that will give patients information about dfUs to help them take care of themselves and stay healthy.

Unveiling the New Dermagraft.com

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on March 23, 2010 President obama signed the Patient Protection and affordable care act (H.R. 3590) into law. Estimates suggest the bill will expand coverage to more than 30 million americans who are currently unin-sured, and is expected to move the country toward a more primary care-based healthcare system. included in H.R. 3590 are a number of key provisions that will impact healthcare providers and their patients. Some impacts have taken effect immediately, while others will likely take much longer.

Patient Coverage

H.R. 3590 is expected to expand coverage by ending discrimination against patients with pre-existing conditions; ending rescissions; extending coverage to young people and early retirees; requiring employers with more than 50 employees to offer health insurance coverage to their employees; and banning lifetime caps and annual limits on coverage. in addition, the bill will enhance access to healthcare by calling for increased funding for community Health centers and increased numbers of primary care practitioners, while mandating free preventative care for patients under both Medicare and private insurance plans. The bill further advocates for consumer rights by establishing consumer assistance offices and creating new and independent appeals processes to help individuals with complaints and appeals. The bill also aims to hold insurance companies accountable, both for ensuring value for premium plans and for justifying premium rate increases.

Medicare Payment Changes

in addition to patient benefits, H.R. 3590 includes a number of payment improvements for physicians that, combined, will result in immediate Medicare payment increases for many. included in these Medicare payment changes are:

• incentive payments for physicians whose Medicare charges for office, nursing facility and home visits comprise at least 60% of their total Medicare charges;

• an extension of Medicare quality reporting incentive payments;

• and re-establishment of Medicare’s geographic payment adjustment (gcPi) for work by a physician, with an additional reduction of the gcPi adjustment for physician practice expenses in rural and low-cost areas.

Administrative Simplification

Beginning in 2010, national rules will be developed and implemented between 2013 and 2016 to standardize and streamline health insurance claims processing requirements. Physicians will likely benefit from the changes because it will be easier to track claims and, in many cases, should improve physician revenue cycles and lower overhead costs.

Sustainable Growth Rate Formula and Medicare Physician Fee Schedule

on april 15, 2010, President obama signed into law the continuing Extension act of 2010. This law extends through May 31, 2010, the zero percent update to the Medi-care Physician fee Schedule (MPfS) that was in effect for claims with dates of service Janu-ary 1, 2010, through March 31, 2010. con-gress is working on the flawed sustainable growth rate formula (SgR), which will need to be tackled in a separate bill and is not part of the H.R. 3590. according to the american Medical association (aMa), the aMa is work-ing with House and Senate leadership on a long-term SgR solution that will be consid-ered in congress by early June.  

Health Care Reform U P c o M i n g

c o n f E R E n c E S

For more information, please visit www.healthreform.gov or www.hhs.gov

June 24-27Region Western Podiatric

Medical conference Anaheim, CA

July 15-18national 2010 aPMa

annual Scientific Meeting Seattle, WA

August 26-29 acfaoM

Lake Buena Vista, FL

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PA T I E N T P R o F I l E

Dermagraft® Patient Spotlight

Lisa Summerslisa Summers is a 47 year-old, active, single mother of two adult children with diabetes. She resides in conyers, georgia and is a 1st grade teacher at Shoal creek Elementary.

lisa was diagnosed with gestational diabetes while pregnant, but returned back to health after both births. Six years later, she had a wound on her leg that would not heal. She visited her primary physician, who diagnosed her with diabetes.

lisa developed a diabetic foot ulcer from what began as a simple blister she got while exercising on the stationary bike. She visited her primary doctor with a blister the size of a dime and was placed on antibiotics and

scheduled to visit a wound care center. By the time she arrived at the center 10 days later, the wound was the sized of a 50-cent piece. lisa had also contracted MRSa.

once the MRSa infection was cleared, Sid Shah, Md, lisa’s care provider at the wound care center, recommended dermagraft®. lisa and dr. Shah began to see substantial improvement by the 2nd dermagraft application, and every week following. after eight applications, lisa’s foot was back to normal.

for lisa, the healing process was very slow, painful and required patience. “i lived in fear of amputation the first four weeks of treatment,” she said. “The offloading landed me in a wheelchair for a total of 5 months. i taught my 1st graders from a wheelchair, so it shows that with determination anything is possible!”

lisa was enrolled in the Heal2gether Partnership Program as part of her dermagraft treatment. Upon the second application of dermagraft, lisa was contacted by Heal2gether social worker, Phoebe, who provided lisa with information about the dermagraft treatment process and was there to offer support throughout the entire process. Says lisa of the Heal2gether Partnership Program: “it felt like someone really cared about me.”

lisa Summers is back in the classroom without her wheelchair. You will find her back in the gym focused on exercising and maintaining a healthy lifestyle.

Use the included DVD to watch lisa Summer’s success story with Dermagraft and Heal2gether Partnership Program

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D E R M A G R A F T ® C A S E S T U Dy

Date: 8/27/09Pre-dermagraft

Date: 10/6/091st dermagraft application

Date: 10/19/092nd dermagraft application

Date: 10/26/093rd dermagraft applicatiom

Date: 11/9/094th dermagraft application

Date: 11/16/095th dermagraft application

Date: 11/23/096th dermagraft application

Date: 11/30/097th dermagraft application

Date: 12/7/098th dermagraft application

Date: 1/4/10Healed

Presented by

Dr. Sid Shah Rockdale Medical Center Wound Healing Center

Patient History

Patient is a 46-year-old female with type ii diabetes Mellitus, hypertension, and obesity who signed up for an exercise program at a local gym in august 2009. a blister on her foot resulted from working out on a stationary bicycle with ill fitting pedals. Three weeks later she arrived at Rockdale Wound Healing center in conyers, georgia with a large deep wound on the foot. MRSa infection was diagnosed.

Diagnosis

diabetic foot ulcer, plantar surface

Wound Treatment & Outcome

The patient received integrated wound care including serial debridements, iV antibiotic therapy and nPWc therapy. once the MRSa infection was cleared, she received eight applications of dermagraft between September 3rd and october 7th 2009 to see complete wound closure.

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Dermagraft Reimbursement Hotline

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