NIHB Presentation January 2012

1. NIHB Presentation January 2012 Carlyle Begay American Indian Health Management Policy Phone: (602) 206-7992 Email: cbegay@aihmp.com

2. Wound Healing Model Oklahoma City Area Indian Health Service: One Experience

3. Access to care: WoundsHavea Golden “Hour” From theonsetof the wound…IHS patients need wound care sooner than later 30 days to prevent further breakdown, infection, progression to amputation Standard of Care now requires definitive care at or before 4 weeks with the introduction of advanced therapy to treat the wound

4. Complications of Diabetic Foot Ulcers • DFUs that persist more than 4 weeks have 5-fold higher risk of infection.1 • Development of an infection in a foot ulcer increases the risk for hospitalization 55.7 times and the risk for amputation 155 times.1 • “Infected neuropathic ulcerations are the leading cause of diabetes-related partial foot amputations at the Phoenix Indian Medical Center.”2 • Foot ulceration is a significant risk factor for lower-extremity amputation in Native American Indians.3 Amputation Diabetes Neuropathy Foot Ulcer Infection • Lavery et al. Risk Factors for Foot Infections in Individuals With Diabetes. Diabetes Care. 2006;29:1288-93. • Dannels E. Neuropathic foot ulcer prevention in diabetic American Indians with hallux limitus. J Am Podiatr Med Assoc. 1989;79:447-50. • Mayfield et al. A foot risk classification system to predict diabetic amputation in Pima Indians. Diabetes Care. 1996;19:704-9.

5. Amputations are a serious predictor of death…

6. Consequences of Unhealed Neuropathic Ulcers Nearly half of all unhealed neuropathic ulcers result in death within 5 years Neuropathic Ulcer Armstrong DG. Int Wound J. 2007;4(4):286-287.

7. Why Organized Wound Care? For three reasons: Access to care for patients Advanced treatments previously only available private sector providers Ability to collaborate no matter the skill level of the provider for a positive patient outcome

8. Pre-wound model findings… From 2004 to 2005 identified: 76%of the patients had untreated or undertreated wound infections for wound healing The number one choice in dressings was ointment and gauze The average treatment time for patients was 26 weeks !before definitive care was provided There was a great variationamong IHS clinicians on how to provide appropriate wound management principles

9. Barriers to Wound Healing Model • Inconsistent off-loading • Lack of wound specific supplies/advanced therapy • Wait and see medicine • Premature discharges and inappropriate transfers • Funding not readily available for clinic start up • Lack of “buy in” by clinicians and other support services • Personal preference practice • Skipping steps in the pathways/care models • Failing to recognize and treat sub-clinical infections • Inconsistent antibiotic therapy

10. The Solution • Shift from a cost to treat model to a cost to heal model • Cost avoidance by early intervention (more cost efficient to heal simple wounds) and reduction in waste through standardization • Continue to reduce costs • Standardize dressings and treatments to optimize results • Standardize wound care processes at multiple sites for consistent patient care and to increase patient access

11. Non-Reimbursement Driven and Cost Efficient • Best Practice models for advanced therapies designed to be revenue neutral if not revenue positive; and driven by the latest best practice guidelines for wound care

12. Key Clinical Components • Tested Clinical Pathways that produce a consistent >95% heal rate • Best Practice advanced therapy models • Understanding barriers to wound care • Documentation enhancement specifically for wound care and compliance • Enhanced clinical training time

13. Advanced Treatment Modalities • Ultra-sound debridement • Negative pressure wound therapy • Growth factor therapy • Pulsed Electromagnetic wound stimulation • Living Skin Equivalent Grafts for in clinic use • Oxygen Therapy

14. Initial Results • March 1, 2006 thru June 30, 2007 • Average patient load per day: 11 - 14 • 3171 total patient visits • 446 new patients • 333 healed patients • Healing rates reached of 96.86% in 8.43 weeks (industry average of 81-93% in 7 – 16 weeks) • Reduced amputations in program to <2% with reduced overall Area amputations of 36%; less than 3% reoccurance rate • CHS cost savings directly attributed to wound program of over $6 million annually

15. Indirect Results of the Wound Program(represents amputations not associated with the Wound Management Program)

16. With Organized Direct Care Wound Program 42 y/o male with scrotal abscess I&D including brief IHS hospital post-op stay w/referral to wound care Remained outpatient w/return to work in 5 weeks Cost of care: @ $1500 Without Organized Wound Care 44 y/o male with scrotal abscess referred for care at home/private sector management I&D including brief hospital post-op stay w/o referral to wound care Became septic w/exacerbation of other co-morbid conditions hospital readmission and transfer to private sector ICU Cost of care: >$1 million CHS Cost Savings using direct care wound program vs. traditional home self care…for example when comparing similar wounds/patients

17. Perceived Concerns • Staffing • Clinician participation • Equipment for diagnostics • Cost of supplies and medications The solutions to these questions have already been found!

18. Where do we go from here? • Endorsement of the model • Further expansion of the model • Maintain the model as a proven best practice model • Streamline ordering making wound care supplies and equipment ‘store stock’ items • Funding of the model

19. Economic impact of non-healing wounds Don Ayers

20. A Growing Epidemic • The worldwide diabetic population is expected to grow from 171 million to 366 million by 2025 • Foot complications are one of the most common complications in diabetic patients • The lifetime risk of a diabetic foot ulcer (DFU) is 15% to 25% • Approximately 15% of DFUs result in amputation

21. Diabetes Prevalence in Native American Indians • Nationwide, diabetes affects more American Indian/Alaska Natives than any other ethnic group.1 • Barnes et al. Advanced Data (CDC) 2005;356 1-24.

22. Neuropathy Leads to Diabetic Foot Ulcers • Diabetic neuropathy is a primary cause of diabetic foot ulcers.1 • Development of a diabetic foot ulcer increases the risk of a foot infection over 2,000-fold.2 • Boulton et al. The global burden of diabetic foot disease. Lancet. 2005;366:1719-24. • Lavery et al. Risk Factors for Foot Infections in Individuals With Diabetes. Diabetes Care. 2006;29:1288-93.

23. Diabetes and Serious Complications: Neuropathy • "Diabetes is the leading cause of peripheral neuropathy globally."1 • American Indians with diabetes have a greater risk (greater than 2 fold) for developing neuropathy when compared to the adult insured US diabetic population.2 • Habib AA, Brannagan TH 3rd. Therapeutic strategies for diabetic neuropathy. Curr Neurol Neurosci Rep. 2010;10:92-100. • O’Connell et al. Racial Disparities in Health Status: A comparison of the morbidity among American Indian and U.S. adults with diabetes. Diabetes Care. 2010;33:1463-70.

24. Complications of Diabetic Foot Ulcers • DFUs that persist more than 4 weeks have 5-fold higher risk of infection.1 • Development of an infection in a foot ulcer increases the risk for hospitalization 55.7 times and the risk for amputation 155 times.1 • “Infected neuropathic ulcerations are the leading cause of diabetes-related partial foot amputations at the Phoenix Indian Medical Center.”2 • Foot ulceration is a significant risk factor for lower-extremity amputation in Native American Indians.3 Amputation Diabetes Neuropathy FootUlcer Infection • Lavery et al. Risk Factors for Foot Infections in Individuals With Diabetes. Diabetes Care. 2006;29:1288-93. • Dannels E. Neuropathic foot ulcer prevention in diabetic American Indians with hallux limitus. J Am Podiatr Med Assoc. 1989;79:447-50. • Mayfield et al. A foot risk classification system to predict diabetic amputation in Pima Indians. Diabetes Care. 1996;19:704-9.

25. Diabetes Burden in American Indians; Lower Extremity Amputation • The annual rate for a 1st lower extremity amputation in diabetic Oklahoma Indians is 1.8%.1 • Risk of amputation is 18-times higher in diabetic American Indians compared to the adult insured US diabetic population.2 • Lee JS, Lu M, Lee VS, Russell D, Bahr C, Lee ET: Lower extremity amputation. Incidence, risk factors, and mortality in the Oklahoma Indian Diabetes Study. Diabetes. 1993;42:876-82. • O’Connell et al. Racial Disparities in Health Status: A comparison of the morbidity among American Indian and U.S. adults with diabetes. Diabetes Care. 2010;33:1463-70.

26. Healing Neuropathic Ulcers: Results of a Meta-analysis • These data provide clinicians with a realistic assessment of their chances of healing neuropathic ulcers • Even with good, standard wound care, healing neuropathic ulcers in patients with diabetes continues to be a challenge Weighted Mean Healing Rates Margolis et al. Diabetes Care. 1999;22:692.

27. Consensus Conference on Diabetic Foot Wound Care • American Diabetes Association Consensus Development Conference on Diabetic Foot Wound Care convened in April 1999 • Regarding the treatment of diabetic foot wounds, the panel agreed: “Any wound that remains unhealed after 4 weeksis cause for concern, as it is associated with worse outcomes, including amputations.” Note: This consensus statement also was reviewed and endorsed by the American Podiatric Association. Consensus development conference on diabetic foot wound care: 7-8 April 1999, Boston, MA. American Diabetes Association. Diabetes Care. 1999;22(8):1354-1360.

28. Continuing Research: Healing of Diabetic Foot Ulcers After 4 Weeks • Wounds achieving less than 53% closure at week 4 have minimal chance of healing with conventional therapy >53% area reduction at week 4 <53% area reduction at week 4 Sheehan et al. Diabetes Care. 2003;26(6):1879-1882.

29. Role of Tissue-Engineered Skin in theManagement of Neuropathic Diabetic Foot Ulcers • In 2004, Boulton and colleagues developed a Clinical Practice article for neuropathic diabetic foot ulcers published in The New England Journal of Medicine • In discussing tissue-engineered skin, they noted: • “The failure to reduce the size of an ulcer after 4 weeks of treatment that includes appropriate debridement and pressure reduction should prompt consideration of adjuvant therapy.” Boulton et al. NEJM. 2004;351:48-55.

30. Association Between PAR at Week 4 & DFU Closure at Week 12 N=133 N=117 Data was dichotomized by PAR of <50% or ≥ 50% by week 4 to assess the association of PAR with DFU closure by 12 weeks

31. Reduction in days to heal from previous healing data using advanced therapy*: • From: • 59.01 days to heal • To: • 34.09 days to heal • *Dermagraft Better Results Using Best Practice Model: Advanced Therapy

32. Cost of Diabetes and Wound Care • $174 billion: Total costs of diagnosed diabetes in the United States in 20071 • $20 billion: Chronic wounds cost health care systems annually2