eMeasure Title

CDR 9: Appropriate Use of Cellular or Tissue Based Products for Patients age 18 or older with a Diabetic Foot Ulcer or Venous Leg Ulcer

eMeasure Identifier (Measure Authoring Tool) 435 eMeasure Version number 0.0.008
NQF Number None GUID 6c9894fa-6cb8-4a4e-b317-9c51b2a4f801
Measurement Period January 1, 20XX through December 31, 20XX
Measure Steward US Wound Registry
Measure Developer US Wound Registry
Endorsed By None
Description
Percent of patients 18 or older with venous or diabetic foot ulcer who receive cellular and/or tissue derived products appropriately as demonstrated by meeting all of the numerator targets of this problem and patient level composite measure: venous ulcer or diabetic foot ulcer did not achieve 30% closure within 4 weeks, patient underwent vascular screening, wound bed preparation with debridement of necrotic tissue, venous ulcer had adequate compression at each visit and diabetic foot ulcer had adequate off-loading at each visit.
Copyright
None
Disclaimer
None
Measure Scoring Proportion
Measure Type Process
Stratification
None
Risk Adjustment
None
Rate Aggregation
None
Rationale
A variety of terms have been used to describe cellular and/or tissue based products in the past including “Allografts,” “Skin Substitutes,” “biologic products,” and “bioengineered tissue. CTP has been accepted by the ASTM (American Section of the International Association for Testing Materials). The products referred to in this measure contain viable or non-viable cells and/or are derived from biological tissue. CTPs are considered medically necessary when wounds, for myriad reasons, fail to close or fail to progress through healing stages in a timely fashion, increasing complications and costs. These products stimulate or support healing through incorporation in whole or part into the regenerating tissue by stimulating and augmenting the wound’s intrinsic healing pathways. CTPs are distinguished from “dressings” which must be physically removed periodically and which function primarily to help shield the wound against the environment without exerting any direct biological effect. 

Prior to the application of a CTP, patients should undergo vascular assessment to exclude ischemia, control bioburden, and debride necrotic material, as well as provide other appropriate basic interventions such as compression of a venous ulcer or off-loading of a diabetic foot ulcer. Excellent consensus guidelines support the above approach as a way to appropriately use these advanced therapeutics and thus ensure that they are provided in a cost effective manner.  

Gap in Practice:
Data from the USWR suggest that patients with VLUs receive cellular and/or tissue based products but may not undergo adequate compression. Similarly patients with DFUs may undergo treatment with these products without undergoing adequate off-loading. Unpublished data from the USWR suggests that only about 10% of DFU patients undergo any type of vascular assessment with ABI, transcutaneous oximetry or skin perfusion pressure although as a result of the USWR vascular screening quality measure, the percentage of patients with leg ulcers undergoing vascular screening is improving.

Currently the benchmark rate is only 23% which is what would be expected given the variability in both vascular screening and off-loading. We believe that this measure will increase in popularity due to Medicare audits of appropriate use of CTPs. We encourage providers to utilize this measure as part of clinical practice improvement activities.
Clinical Recommendation Statement
 
Improvement Notation
None
Reference
Fife CE, Carter MJ, Walker D: Why is it so hard to do the right thing in wound care? Wound Repair Regen 18: 154, 2010.
Reference
Bickers DR, et al. J Am Acad Dermatol. 2006;55(3):490–500. 2Steed DL, et al. Wound Rep Reg .2006;14:680–692. 3Whitney J, et al. Wound Rep Reg. 2006;14 663–679. 4Robson MC, et al. Wound Rep Reg. 2006;14 649–662. 5International Consensus on Acellular Matrices for Chronic Wounds. Wounds International 2011. Available at: http://www.woundsinternational.com/clinical-guidelines/acellular-matrices-for-the-treatment-of-wounds
Reference
Karr, Jeffrey C., DPM. “Retrospective Comparison of Diabetic Foot Ulcer and Venous Stasis Ulcer Healing Outcome Between a Dermal Repair Scaffold (PriMatrix™) and a Bi-layered Living Cell Therapy (Apligraf®), Accepted for publication in Advances in Skin & Wound Care: 2011
Reference
Mostow, Eliot N., et al. “Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: A randomized clinical trial”, Journal of Vascular Surgery. May 2005: Volume 41: Number 5: 837-843.
Reference
Niezgoda, Jeffrey A., et al. “Randomized Clinical Trial Comparing OASIS Wound Matrix to Regranex Gel for Diabetic Ulcers”, Advances in Skin & Wound Care: June 2005: Volume 18: Number 5: 258-266.
Reference
Reyzelman, A., et al. “Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcers: a prospective, randomised, multicentre study,” (Abstract). International Wound Journal: June 2009: Volume 6: Number 3: 196-208.
Reference
Falanga, V., & Sabolinski, M., " bilayered living skin construct (Apligraf) accelerates complete closure of hard-to-heal venous ulcers," Wound Repair and Regeneration, vol. 7, No. 4, July-August 1999.
Reference
Olin, J.W., Beusterien, K.M., Childs, M. B., Seavy, C., Griffiths, R.I., "Medical costs of treating venous stasis ulcers: evidence from a retrospective cohort study," Vascular Medicine, volume 4, pp. 1-7, 1999.
Reference
Cadaveric Allograft as Adjunct Therapy for Nonhealing Ulcers, Snyder, et al., Journal of Foot and Ankle Surgery, March/April, 1999 (Abstract).
Reference
Veves et. al., Graftskin, A Human Equivalent, is Effective in the Management of Noninfected Neuropathic Diabetic Foot Ulcers, 291 Diabetes Care (Feb. 2001).
Reference
Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial. Mostow EN, Haraway GD, Dalsing M, Hodde JP, King D; OASIS Venus Ulcer Study Group. J Vasc Surg. 2005 May;41(5):837-43.
Reference
Karr, Jeffrey, DPM, “Retrospective Comparison of Diabetic Foot Ulcer and Venous Stasis Ulcer Healing Outcome Between a Dermal Repair Scaffold (PriMatrix) and a Bilayered Living Cell Therapy (Apligraf),” Advances in Skin & Wound Care, Volume 24, number 3, March 2011.
Reference
Snyder, David L, PH.D; Sulliva, Nancy, B.A.; Scholles, Karen M., M.D., S. M., F.A.C. P, “Skin Substitutes for Treating Chronic Wounds” at http://www.ahrq.gov/research/findings/ta/skinsubs/HCPR0610_skinsubst-final.pdf
Reference
Angirasa, A., Willrich, A., Cooper, B., Stuck, R. (2006). Combining bioengineered human dermal replacement and multilayered compression dressings to manage ulcers in a person with diabetes. Ostomy Wound Management, 52: 5.
Reference
Hanft, J. R., & Surprenant, M. S. (2002). Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis. Journal of Foot and Ankle Surgery, 41, (5) 291-299. 
Reference
Mostow, E.N., Haraway, G.D., Dalsing, M., Hodde, J.P., King, D. (2005). Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial. Journal of Vascular Surgery, 41 (5): 837-43.
Reference
AHRQ Technology Assessment. Usual care in the management of chronic wounds: A Review of the Recent literature. 3/8/2005.
Reference
Mostow EN, Haraway GD, Dalsing M, et al. Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: A randomized clinical trial. J Vasc Surg. 2005 May;41(5):837-43.
Reference
Brem H, Kirsner RS, MD, Falanga V. Protocol for the successful treatment of venous ulcers. American Journal of Surgery, 2004;188(1).
Reference
Brem H, Young J, Tomic-Canic M, et al. Clinical efficacy and mechanism of Bilayered Living Human Skin Equivalent (HSE) in Treatment of Diabetic Foot Ulcers. Surgical Technology International, XI:2003;23-31.
Reference
Curran MP, Plosker GL. Bilayered Bioengineered Skin Substitute (Apligraf®) A Review of its Use in the Treatment of Venous Leg Ulcers and Diabetic Foot Ulcers. BioDrugs, 2002;16(6):439-455.
Reference
Falanga V, Sabolinski M. A Bilayered Living Skin Construct (APLIGRAF®) Accelerates Complete Closure Of Hard-To-Heal Venous Ulcers, Wound Repair and Regeneration, 1999.
Reference
Gentzkow GD, Iwasaki SD, Hershon KS, et al. Use of Dermagraft, a Cultured Human Dermis, to Treat Diabetic Foot Ulcers. Diabetes Care, 1996;19(4):350-354, 1996.
Reference
Margolis DJ, Kantor J, Berlin JA. Healing of Diabetic Neuropathic Foot Ulcers Receiving Standard Treatment. Diabetes Care, 1999;22:692-695
Reference
Marston WA, Hanft J, Norwood P, et al. The Efficacy and Safety of Dermagraft in Improving the Healing of Chronic Diabetic Foot Ulcers. Diabetes Care, 2003;26(6):1701-1705.
Definition
None
Guidance
Higher score indicates better quality
Transmission Format
TBD
Initial Population
Venous Leg Ulcers or Diabetic Foot Ulcers of patients age 18 or older that have received treatment with CTP.
Denominator
Same as Initial Population
Denominator Exclusions
 
Numerator
Those ulcers that have received treatment with CTP appropriately:

Prior to receiving treatment with CTP diagnosed VLUs and DFUs must have met the following criteria – 
•	Not achieved 30% closure after four weeks of treatment
•	Wound bed preparation with debridement of necrotic material
•	VLU: Adequate compression therapy at each visit for four weeks of treatment
•	DFU: Adequate offloading of the diabetic foot ulcer at each visit for four weeks of treatment
•	Vascular screening performed
Numerator Exclusions
None
Denominator Exceptions
None
Supplemental Data Elements
For every patient evaluated by this measure also identify payer, race, ethnicity and sex.

Table of Contents


Population Criteria

Data Criteria (QDM Variables)

Data Criteria (QDM Data Elements)

Supplemental Data Elements

Risk Adjustment Variables


Measure Set
None