ACS Views on Legislative, Regulatory, and Other Issues

Medicare Coverage Issues—

staff contact: Jean Harris, jharris@facs.org

• Statement to the Medicare Coverage Advisory Committee RE: Usual Care of Chronic Wounds 3/29/05
• Statement of Josef E. Fischer, MD, FACS, to the Medicare Coverage Advisory Committee on Bariatric Surgery—November 4, 2004
• Letter To Jeffrey L. Kang, MD, MPH, 8/29/00

Wound care management ranges all the way from the fundamental steps that include basic wound care to quite sophisticated surgical and non-surgical wound care. We understand that the Centers for Medicare and Medicaid Services (CMS) has limited the discussion today to the basic care of wounds. They have also limited the discussion to venous ulcers, arterial ulcers, pressure ulcers, and diabetic ulcers. We have no objection to that limitation for today's discussion, but hope that CMS will keep in mind that there are other types of chronic wounds, including, but not limited to, nonhealing traumatic and surgical wounds, ischemic wounds due to non-arterial insufficiency, and vasculitic ulcers.

There certainly is sufficient evidence to address the health benefit of the modalties of debridement, cleansing, dressing, compression, antibiotics and off-loading listed by CMS. As those who cared for wounds decades ago learned of the importance of such things as cleaning the wound, they adopted it into practice and knowledge regarding efficacy proliferated over time. Such fundamental things about wounds were learned well before the development of the current gold standard—RCTs. Although there is not evidence-based medicine to support the basic modalities, no institutional review board (IRB) would let an RCT be performed now on cleaning a wound vs. not cleaning it or on any other of the basic modalities of treatment. No one familiar with wound care would suggest there is any hint of clinical or theoretical evidence to question the efficacy of cleansing and debridement for wound care.

One clinical situation for which there is strong clinical evidence, however, is compression treatment for chronic venous ulcers. The pathophysiology that prevents these ulcers from healing is incompetence of the venous valves allowing increased pressure in the tissue. Extrinsic compression counteracts that increased pressure, and provides an environment that allows and promotes healing that will otherwise not occur.

There is an addition that should be made to both the evaluation and treatment of patients with chronic wounds and to the process measures used to assess their healing. This is assessment for arterial and venous insufficiency. Correction of arterial and venous insufficiency are dramatic drivers of wound healing, and yet we find that a substantial portion of patients with chronic ulcers have not undergone these vascular evaluations. We frequently find that a community physician manages a patient for six months or so before seeking an assessment of vascular function. Education of the community physician about the importance of vascular sufficiency is needed. In addition, the adoption of a process measure on vascular sufficiency will help assure that the subject will be considered in all cases.

Documentation of an arterial pulse examination should be present for all patients who have nonhealing wounds. For those patients who do not have readily palpable and normal pulses, noninvasive arterial evaluation should be undertaken. For the subset who have abnormal noninvasive results, formal vascular consultation should be considered. Likewise, all patients with chronic nonhealing ulcers in the lower calf or adjacent to the ankle should be assessed for the possibility of chronic venous insufficiency. If there is any question about this diagnosis, formal noninvasive evaluation of deep and superficial vein function is indicated. In order to assure quality, noninvasive arterial and venous examinations should be performed in accredited facilities and/or by credentialed vascular technologists.

The process measures that CMS listed, consisting of time to complete healing, partial healing rate, recurrence, elimination of infection, amputation, reduction of pain, and resumption of normal activity are commonly and appropriately used to assess the healing of chronic wounds. To these, we would add an evaluation of arterial inflow in all cases of nonhealing wounds and of venous outflow in all nonhealing ulcers in the lower calf or adjacent to the ankle. We do not see any need to further add to the list of outcomes measurements now or in the future.

In considering the effectiveness of the six modalities and the treatment of arterial and venous insufficiency, we define "significant heath benefits" as the balance between health risks and benefits, including complications of all therapies. We believe the literature supports the treatment(s), used either singly or in combination, and their use can result in significantly increased health benefits. The majority of the measures have been in use for many years. The six modalities have become common practice and are generally accepted as modalities that produce clinically significant net health benefits in the treatment of chronic wounds. The role of treatment of vascular insufficiency has been well documented in the literature.

It is quite likely that the usual care can be generalized to the aged Medicare population and to community providers. As we indicated above, community providers need to become more aware of the importance of arterial and venous sufficiency in the treatment of chronic wounds.

We believe the biggest knowledge gap is objectively analyzed, sufficiently powered, blinded RCTs to demonstrate that sophisticated and expensive new dressing regimens will result in faster and/or better healing compared to the older and less expensive treatments. A number of topical dressings are being used, some of them apparently quite expensive. Much the same can be said of debridement, where laser therapy, therapeutic ultrasound, electrotherapy, and electromagnetic therapy are all being used.

Often, these are not advanced as RCTs but case studies that show at the end point a well-healed wound. A confounding factor is that often these therapies are applied in a variety of types of chronic wounds, making conclusions regarding the specific therapeutic benefits more difficult to draw. Finally, many of these studies are sponsored by manufacturers or suppliers of these products, and are therefore suspect to some degree.

Well designed, and objectively analyzed, randomized controlled trials will provide objective data regarding different wound treatment modalities. These data will allow determination of the appropriateness of each modality on chronic wound care. Units of analysis and covariates to be considered may include time to complete healing, partial healing rate, wound recurrence, elimination of infection, amputation, reduction of pain, and return to normal activity.

In conclusion, the College supports greater scientific rigor in studying some of the newer methods of the six modalities, especially in debridement and topical dressings. We believe that greater awareness of the importance of vascular sufficiency is needed and, to encourage the assessment of vascular sufficiency, we have proposed a new measure of it.

Revised May 2, 2005

ACS Views on Legislative, Regulatory, and Other Issues

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