Reimbursement

Recommendations

Persons with wounds and their families should expect that:
1 Timely, holistic assessments are performed in order to appropriately manage both wounds and associated conditions. Level of Evidence
5
2 Continuity of care is maintained in all settings for optimal outcomes. Level of Evidence
5
3 They will be educated on their roles and responsibilities in developing and adhering to comprehensive treatment plans. Level of Evidence
5


Health care professionals should strive to incorporate:
4 All available categories of evidence should be evaluated to provide evidence-informed wound care knowledge is used for timely assessment and re-evaluation of wounds and associated conditions. Level of Evidence
5
5 Appropriate products and therapies (used separately or in tandem) are incorporated into the wound care treatment plan based on the type and severity of wounds and associated conditions. Level of Evidence
5
6 Care is coordinated among all caregivers (professional and non-professional) involved in the patient’s overall health management plan. Level of Evidence
5


Health care policy makers should consider that:
7 Evidence of effectiveness for wound care products and services is not limited to randomized controlled trials and can be established through a combination of scientific evidence, expert knowledge and patient preference. Level of Evidence
5
8 Intermediate wound care outcomes (in addition to complete wound closure) are important benchmarks for evaluating effectiveness of wound care products and services. Level of Evidence
5
9 Early intervention (prevention and treatment) improves both clinical and economic outcomes by reducing healing times, treatment costs and recidivism rates. Level of Evidence
5


Background

Draft statements that are the Guiding Principles for Wound Care Reimbursement and Health Policy were developed for the WUWHS in conjunction with the Coalition of Wound Care Manufacturers and the Alliance of Wound Care Stakeholders. They are based on the value that all patients with wounds have the right to timely access to wound care expertise, devices and supplies to optimize healing. The WUWHS wants to inform wound care policy makers about the interprofessional team approach to all aspects of wound care practice and research and to encourage their recognition of its complexity in the reimbursement for wound care devices and supplies. Therefore, it is necessary to educate all stakeholders: patients, healthcare professionals and payers concerning guiding principles for Wound Care Policy.

With different healthcare systems and reimbursement plans, patients have varying access to care. On the basis of a quantitative study, Eaton (2005) reported on the effect of the change from a traditional reimbursement system to Prospective Payment System (PPS). Comparison of data from 2000 before PPS and 2001 post PPS indicated the deleterious effect on home health care nursing, i.e., ulcer healing, discharge distribution and length of stay were affected negatively. In a recent publication, Fette (2006) discussed such important topics as cost effectiveness studies, the absence of evidence for evidence-based healthcare, guidelines based on case studies and expert opinion, the effect of purchaser negotiations with industrial representatives, and their relationships with reimbursement and quality of wound care.

In decisions about reimbursement, the goal is to provide the best wound prevention and care for the least money. However, one must recognize the importance of interpreting the data appropriately. A good example is the comparison of dressings by Capasso and Munro (2003). A similar rate of wound healing for wet-to-dry normal saline gauze dressings was found compared to amorphous hydrogel dressings in patients with infrainguinal arterial disease and diabetes. However, the cost of wound care was on average $1140.00 higher in normal saline gauze group due to a higher number of home nursing visits. The difference in mean cost of wound supplies was not significantly different even though the mean cost was $47.00 more in the hydrogel dressing group. Despite this, treatment with hydrogel dressings was more cost effective.

One assumes that unbiased economic evaluations and analyses have been completed. Clinical evaluations and cost analyses are done frequently by groups that have a vested interest in the wound products. It is sometimes difficult for clinicians, policy makers and payers to detect conflicts of interest when cost information is provided without appropriate context.

Published reports of the costs involved in preventing and treating chronic wounds are few. The specific costs have been determined and assessed in a variety of ways.

• Direct costs that include nursing and dressing costs have been determined to calculate the cost of care.
• Indirect costs, e.g., time lost from work, effect on quality of life, have been determined less often.
• Cost effectiveness, that describes the cost of care in relation to the clinical outcome, has also been determined.
• Cost utility or cost benefit are methods that have been used to determine the cost of a particular intervention in relation to another intervention.

Recently in discussing the difficulties of persons with diabetic foot disease, Boulton et al (2005) proposed that costing should include more that the cost of treating an ulcer episode; it should include social services, home care, subsequent ulcer episodes, quality of life and final outcome.

The data for making cost determinations are reported to have come from a variety of sources, including the following.

1. Prospective collection of clinical data and/or cost data. For example, Friedberg et al (2002) collected prospective data using a descriptive survey to determine the cost of treating venous leg ulcers in Home Care in a region in Canada. They made the precise determination that the mean treatment time 26 minutes, the mean travel time 17 minutes, for a cost of $80.62. Supply costs were $21.06. They were then able to estimate the regional annual Home Care expenditures to be $1.3 million.

2. Retrospective analysis of national databases or clinical databases. For example, Bennett et al (2004) used a bottom-up approach to estimate the cost of treating pressure ulcers in the UK. Good clinical practice protocols were developed and costs assigned using representative UK NHS unit costs at 2000 prices for the various stages of severity and potential healing trajectories, i.e., normal healing, critical colonization, cellulitis, and osteomyelitis. The cost per patient per day ranged from £38 for normal healing of a Grade 1 ulcer to £196 for a Grade 4 ulcer with osteomyelitis.

Kantor and Margolis (2001) performed an cost effectiveness analysis of data from published clinical trials, meta-analyses, and a database that includes data on 26,599 patients with diabetic neuropathic foot ulcers wounds. Cost:effectiveness ratios for platelet releasate (PR) versus standard care (SC) and becaplermin versus SC were 414.40 and 36.59, respectively. The incremental cost of increasing the odds of healing by 1% over standard therapy was $414.40 for PR and $36.59 for becaplermin.

3. Statistical modelling with assumptions based on clinical or published data that drive statistical determinations of cost predictions. For example, Ghatnekar et al. (2001) used clinical data obtained about the efficacy of becaplermin based on the 20-week healing rate from meta-analysis of clinical trials involving 449 patients. They performed a Markov analysis and predicted that patients who received becaplermin plus good wound care (GWC) would spend 0.81 more months (24% longer) free of ulcers, and have 9% lower risk of a lower extremity amputation than individuals who received GWC alone. With these benefits there were estimated net cost saving in Sweden, Switzerland and the UK, but not in France. Predictions were affected by intercountry differences in wound care and reimbursement practices.

Markov analysis has been used in several other studies of diabetic foot ulcers in the Netherlands to predict the cost-effectiveness of prevention and treatment of the diabetic foot. (Ortegon et al, 2004) and in Austria to determine the costs and benefit of intensified diabetic foot care (Habacher 2007).

Another example is the decision analysis model developed recently by Fleurence (2005) for cost effectiveness of alternating pressure mattress replacements and overlays for prevention and treatment of pressure ulcers. He used epidemiological and effectiveness data from clinical literature; device costs from manufacturers; and treatment costs from literature. Based on data collected and assumptions made to build the model, alternating pressure overlays may be cost effective for prevention, and alternating pressure mattress replacements for treatment of pressure ulcers. Uncertainty exists due to paucity of research to inform model building.

There is a dearth of information about the economics of prevention and treatment of the various wound types, especially pressure ulcers and venous leg ulcers. In addition, the interpretation of economic studies that are needed to inform reimbursement strategies is not well understood. Nevertheless, the impact is felt by patients who need to receive the most efficacious interventions, by professionals whose responsibility it is to provide the most effective and efficient interventions, and by policy makers whose responsibility it is to make cost effective devices and supplies available to professionals and patients.

References

Essential Publications
1 Economic evaluation - pressure ulcers Quality Indicator
 Type:
Bennett G, Dealey C, Posnett J. The cost of pressure ulcers in the UK. Age and Aging 2004;33:230-235.
Estimated costs of treating Stage I to IV pressure ulcers in the UK based on 2000 pricing
2 Review of economics of diabetic foot care Quality Indicator
 Type: Narrative Review
Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, Apelqvist J. The global burden of diabetic foot disease. Lancet 2005;366:1719-1724.
Review of the cost of treating diabetic foot ulcers and lower extremity amputations.
3 Economic evaluation - dressings Quality Indicator
 Type: Retrospective Analysis
Capasso VA, Munro BH. The cost and efficacy of two wound treatments. AORN Journal 2003;77(5):984-1004.
Cost effectiveness of wet-to-dry normal saline gauze dressings compared with amorphous hydrogel dressings in patients with infrainguinal arterial disease and diabetes. Data were collected by retrospective chart review.
4 Economic evaluation - reimbursement systems Quality Indicator
 Type: Retrospective Analysis
Eaton,M.K. The influence of a change in medicare reimbursement on the effectiveness of stage III or greater decubitus ulcer home health nursing care. Policy.Polit.Nurs.Pract., 2005, 6, 1, 39-50.
Study in the US that compared Pre Prospective Payment System (PPS) in 2000 with post PPS 2001 - outcomes ulcer healing, length of stay, discharge disposition.
5 Review of economics in relation to quality of care Quality Indicator
 Type: Narrative Review
Fette A. Discussing the relationship between quality care and cost-effective care in Swiss pediatric wound care. Plastic Surgical Nursing 2006;26(4):184-188.
Review of cost effectiveness studies, highlighting the author's opinions about topics including: the absence of evidence for evidence-based healthcare, guidelines based on case studies and expert opinion, the effect of purchaser negotiations with industrial representatives, and their relationships with reimbursement and quality of wound care.
6 Economic evaluation - bed surfaces Quality Indicator
 Type: Narrative Review
Fleurence RL. Cost-effectiveness of pressure-relieving devices for the prevention and treatment of pressure ulcers. International Journal of Technology Assessment in Health Care, 21:3 (2005), 334–341.
Cost-effectiveness study in which a decision analysis model was created to compare alternating pressure overlays with alternating pressure mattress replacements for patients with pressure ulcers.
7 Economic evaluation - leg ulcers Quality Indicator
 Type: Narrative Review
Friedberg EH, Harrison MB, Graham ID. Current home care expenditures for persons with leg ulcers. J.Wound Ostomy Continence Nurs., 2002, 29, 4, 186-192.
Determination of the cost of treating leg ulcers in a home care settin in Canada using precise prospective data collection methods.
8 Economic evaluation - diabetic foot Quality Indicator
 Type: Narrative Review
Ghatnekar O, Persson U, Willis M, Ödegaard K. Cost Effectiveness of Becaplermin in the Treatment of Diabetic Foot Ulcers in Four European Countries. Pharmacoeconomics 2001; 19 (7): 767-778.
Cost effectiveness determined through modelling based to compare becaplermin with standard care in patients with diabetic foot ulcers in Sweden, Switzerland, the UK and France.
9 Economic evaluation - diabetic foot Quality Indicator
 Type: Narrative Review
Habacher 2007 A model to analyse costs and benefit of intensified diabetic foot care in Austria. Journal of Evaluation in Clinical Practice 2007;13:906–912.
Cost comparison determined through statistical modelling for intensified versus standard treatment of diabetic foot ulcers of Grades A to D until healing.
10 Economic evaluation - diabetic neuropathic foot Quality Indicator
 Type: Narrative Review
Kantor J, Margolis DJ. Treatment Options for Diabetic Neuropathic Foot Ulcers: A Cost-Effectiveness Analysis Dermatol Surg 2001;27:347–351
Cost effectiveness analysis in the US, comparing standard care, standard care in specialized wound care center, platelet releasate (PR), and becaplermin. Effectiveness was assessed as a percentage of ulcers healed at 20 and 32 weeks.
11 Economic evaluation - diabetic foot Quality Indicator
 Type: Narrative Review
Ortegon MM, Rederof WK, Niessen LW. Cost-effectiveness of prevention and treatment of the diabetic foot. A Markov analysis, Diabetes Care 2004;27:901-907.
Cost-effectiveness was determined by statistical modelling to determine the cost of current care versus guideline-based care in the Netherlands.
12 Economic evaluation - diabetic foot Quality Indicator
 Type: Retrospective Analysis
Stockl K, Vanderplas A, Tafesse E, Chang E. Costs of lower-extremity ulcers among patients with diabetes. Diabetes Care 2004;27:2129-2134.
This costing study involved the retrospective analysis of US medical and pharmacy claims data Jan 2000-Dec 2001 to determine direct health costs of an ulcer episode.


Enablers for practice

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