“Unilateral health care decision making without integral physician involvement is symptomatic of our legislative process in Washington”

Editor’s Note:  In the following interview, a Professor of Surgery at the Johns Hopkins School of Medicine discusses how CMS’ competitive bidding program may harm patient care.

From: Out of the Storm News

Q&A With Dr. Fred Eckhauser: Effects of CMS Competitive Bidding on Medical Technology

by Matthew Glans

In this Q&A, Out of the Storm News spoke with Dr. Fred Eckhauser, Professor of Surgery at the Johns Hopkins School of Medicine. In the Q&A, OOTS and Dr. Eckhauser discuss negative pressure wound therapy (NPWT), how he uses it in his practice, and the effect of new competitive bidding rules that restrict the use and availability of the pumps used in NPWT. Dr. Eckhauser argues that NPWT is an effective technology and that the efforts by CMS to regulate the use of NWPT through its competitive bidding program without sufficient studies of its effectiveness and without physician involvement in the decision making process is a mistake. The Q&A below is an edited transcribed copy of a telephone interview.

OOTS: Tell me about your practice.

FE:       The majority of my practice includes re-operative surgery on patients who had extensive procedures done elsewhere with less than ideal outcomes. This includes patients with or without open wounds who require complex abdominal wall reconstruction.

OOTS: How long this sort of practice?

FE:       I completed my surgical residency at Johns Hopkins in 1976 and spent the next 25 years as a faculty member in the Department of Surgery at the University of Michigan. I returned to Baltimore and joined the full time faculty at the Johns Hopkins School of Medicine 10 years ago.

OOTS: How does VAC therapy fit with your practice?

FE:       Many of the patients whom I treat present with open wounds or complex gastrointestinal fistulas or stomas that disrupt the integrity of the abdominal wall. The use of NPWT for this population of patients is enormously beneficial: it allows the patient to move easily about the hospital facility or at home, it increases patient compliance and satisfaction by reducing the need for frequent, painful dressing changes, and it promotes wound healing and thereby reduces the need for hospital readmissions and additional surgery. I cannot imagine how we managed complex wounds before the advent of this technology…it has truly changed the practice of complex wound management since its inception in the 1990s.

The CDC (Center for Disease prevention and Control) has studied the issue of health care associated infections or HAIs and estimates that 1.5 million such infections and 100,000 associated deaths occur annually in this country. Approximately 20% of HAIs are associated with surgical site infections or SSIs. The complications of SSIs include such things as delayed wound healing, inflated direct medical costs related to increased hospital length of stay, increased societal costs related to loss of work productivity, as well as decreased patient satisfaction and quality of life. We also know that certain groups of patients are at higher risk to develop SSIs. These risk factors include but are not limited to obesity, smoking, cardiovascular disease, malnutrition, cancer, and diabetes mellitus.

OOTS: Tell me how Negative pressure Wound Therapy (NPWT) works.

FE:       NPWT consists of placing a piece of porous sponge material against the clean surface of a freshly closed surgical incision or against an open wound. It is important to interpose a piece of non adherent dressing between bare skin and the overlying sponge to prevent injury or damage to the skin. The sponge is then covered with a piece of clear adhesive material to create a closed or sealed system. A hole is cut in the adhesive material and covered with a T.R.A.C pad that is connected via vacuum tubing to a negative pressure pump. Negative pressure is applied to the sealed system and can be varied from 50 mm Hg to as high as 150 mm Hg.

NPWT promotes wound healing by a number of factors: 1) holding closed incision edges together, 2) realigning and reducing tensile forces across the incision, 3) reducing inflammation and edema by removing tissue fluids, 4) improving local blood flow or perfusion that in turn stimulates angiogenesis (new blood vessel formation) and formation of granulation tissue, and 5) reducing the bacteriological burden within the wound and protecting the incision or wound from external contamination.

OOTS: So NPWT seems to have real efficacy, at least in open wounds.

FE:       That is correct. There are several hundred published scientific articles, including 13 randomized medical trials, which provide evidence to support the use of NPWT for open wounds. However, comparable data to support the use NPWT to promote healing of clean surgical incisions, although existent, is limited and less compelling since it has not been subjected to rigorous scientific studies. Additional studies are sorely needed since the indications for NPWT are continually expanding and there is currently no consensus regarding absolute or relative indications and/or contra indications of NPWT.   This is important not only to patients but also to health care providers, especially since the Agency for Healthcare Research and Quality has grouped HAIs as patient safety indicator (PSI) that will ultimately be used as a quality indicator and pay for performance indicator by some organizations.

OOTS: There are proposed bidding rules that CMS has put out that would likely restrict the use of NPWT among some patient populations. What do you think would be the health care effects federal legislation that severely limited or restricted the use of NPWT?

FE:       Unilateral health care decision making without integral physician involvement is symptomatic of our legislative process in Washington. There is insufficient clinical data regarding the safety and efficacy of NWPT for promoting wound healing and reducing the risk of SSI in closed surgical incisions to substantiate or justify any legislative mandates about the technology.  Moreover, there is a paucity of economic studies that address the true costs associated with using NPWT to treat clean incisions. I am not suggesting that NPWT should be considered for all closed surgical incisions. However, there is reason to believe that NPWT may have considerable applicability and cost effectiveness in selected groups of patients, namely those with clean-contaminated wounds in whom the risk of SSI and resulting morbidity approaches 20%.

At Johns Hopkins we are designing an Institutional Review Board-approved clinical study to evaluate the clinical efficacy, safety and cost effectiveness of NPWT in reducing the risk of SSI and promoting primary wound healing in patients with clean- contaminated wounds. Since SSIs can inflate economic health care costs by leading to increased length of hospital stay, increased nursing costs, additional dressing charges, readmissions to the hospital, and the need for additional surgery, we feel strongly that a potentially beneficial intervention such as NPWT deserves, if not demands, to be studied with rigorous scientific scrutiny. The potential cost savings in direct and indirect medical costs to the United States economy could approach billions of dollars. I hope that our government leaders will appreciate the potential clinical and economic importance of this evolving technology (NPWT) and thereby provide investigators such as myself and others with financial support to conduct meaningful and rigorously controlled scientific studies.

Thank you for the opportunity to discuss these matters with you.