Kinetic Concepts, Inc. (KCI), a medical technology company, has issued the following statement regarding the results of AHRQ's technical assessment in response to a draft report issued April 10, 2009 by the Agency for Healthcare Research and Quality (AHRQ). This technical assessment was conducted on negative pressure wound therapy (NPWT) devices reimbursed by the Centers for Medicare and Medicaid Services (CMS).
The AHRQ, while affirming in its report that KCI is the only NPWT provider with significant clinical evidence, was not able to make out therapeutic distinctions between different NPWT systems because of a lack of significant studies comparing one NPWT system to another. Following its own defined research protocol, the AHRQ found after reviewing 38 NPWT clinical studies that all of the clinical trials involved the evaluation of KCI’s V.A.C.(R) Therapy System against control groups treated with advanced wound care therapies, but none of the control groups used any other NPWT system or product. Especially, the AHRQ also did not conclude in its recent report that the NPWT systems they assessed were similar in function or efficiency.
“We understand and support the need to reduce the cost of care for patients across America,” said Catherine Burzik, president and chief executive officer of KCI. “KCI strongly endorses and promotes evidence-based medicine and outcomes-based reimbursement. The AHRQ draft report confirms that only KCI has conducted significant clinical trials of NPWT – a fact that is already well-known by institutions and care providers utilizing this technology. The fact that the AHRQ was unable to find comparative NPWT studies does not imply an absence of significant differences between the KCI V.A.C. Therapy System and other NPWT products. Indeed, despite significant competition in the NPWT space, KCI’s V.A.C. Therapy remains the NPWT system of choice, each and every day, for tens of thousands of physicians and caregivers across the globe.”
The company believes that since 2005, CMS has improperly grouped together KCI’s clinically-proven V.A.C. Therapy with multiple, lower-technology NPWT products that lack meaningful clinical evidence, and thereby has disregarded the importance of clinical efficacy, the primary driver of cost-savings in the system. It is the efficiency of the NPWT system in these clinical settings, and not the price of the therapy, that drives down healthcare costs. In addition to it, KCI also believes that any follow-on CMS coding or reimbursement decisions that do not suitably make out the unique mechanisms of action and proven clinical efficacy of V.A.C. Therapy could unfortunately lead to a potential reduction in the access to and quality of wound care received by Medicare patients, which could ultimately drive higher healthcare costs.
The company also points out that in the acute care environment, where there is no separate CMS reimbursement for NPWT, KCI has seen the average length of treatment decrease by about 20% over time as a result of the efficacy of the V.A.C. Therapy System. Numerous studies have been conducted to determine the average cost of a single day of care in the hospital environment, which ranges between $1,500-$2,000 per day. A one to two day cut in the length of treatment, therefore, would save an average hospital $1,500-$4,000 per patient, far less than the cost of V.A.C. Therapy for that patient. Further, in one randomized controlled clinical trial, V.A.C. Therapy was shown to cut the rate of diabetic amputations by 60% versus the control patients. Studies have estimated that an amputation takes place in America once every 30 seconds.
Since 10 years, KCI has build up a library of more than 15 randomized controlled clinical trials and about 500 peer-reviewed journal articles supporting the unparalleled clinical efficacy and cost-effectiveness of the KCI V.A.C. Therapy System.