Augustine Medical will meet with Centers for Medicare & Medicaid Services officials in January or February to design a new study of the Warm-Up wound healing system to rectify deficiencies cited in a ¹ Jan. 14 CMS national Medicare non-coverage decision.

The Warm-Up system features a non-contact, "domed" wound cover that radiates heat from a removable infrared card connected to a battery power source. The device is the only FDA cleared non-contact, normothermal wound therapy (NNWT), according to the Minneapolis company.

The Warm-Up system is designed to raise the temperature of a wound site to match core body temperature. According to the company, hypothermia at the wound site is a primary inhibitor of healing and the reason why wounds become chronic. By maintaining space between the covering and the wound, the domed configuration prevents trauma to the wound bed, allowing wound exudate to drain and keeping the wound environment humid.

CMS conceded that "there is indirect evidence that such features are beneficial to wounds." In vitro studies by Hee-Young Park, PhD, Boston University, have shown that wound fluid inhibits the growth of fibroblasts, an important contributor to cell growth.

In addition, a humid and moist environment inhibits desiccation of new cells and promotes epidermal migration, according to a 2000 study by J. Thomas Millington, MD, St. John's Pleasant Valley Hospital.

However, "none of the studies [of the Warm-Up] reviewed here are of a high-quality study design," CMS claims. While many noted a beneficial effect from NNWT, "methodological shortcomings" prevented CMS from drawing a definitive positive conclusion about the device.

The memorandum notes that the studies used a variety of treatment protocols, variable benchmarks, and, in some cases, inadequate follow-up. Some studies were poorly controlled for patient selection bias and other factors that may have contributed to a patient's outcome, such as the type of mattress used.

While some of the studies randomized patients between NNWT and standard wound therapy, none demonstrated that both the non-contact cover and heat card were essential to wound healing. "Any study investigating the use of NNWT [should] be designed so that an understanding of which of these features (e.g. non-contact, sealed chamber/and or radiant heat) produces any observed benefit," CMS said.

CMS suggested that the domed wound cover alone, without the heating card, might create a sufficiently warm, humid environment to produce "part or all of the beneficial effect" observed in the trials.

It is also possible that heat alone, such as that provided by a "less involved method" like a heating pad or extra blanket would aid healing, according to the agency. Medicare coverage of NNWT is not justified if a simpler technique produced the same results, CMS states.

Therefore, CMS recommended that Augustine conduct a well-controlled trial of three arms. One set of patients would receive standard, "well-defined" wound care, one set NNWT, and a third "sham group" would be treated with the Warm-Up wound cover with the heating card turned off.

If the healing rates reported by the sham patients are significantly slower than those of the NNWT group, the agency says it will be convinced that the Warm-Up system provides tangible benefits unobtainable from heating or non-contact coverage alone. All other aspects of patient therapy, including nursing care, should be controlled for the new groups, according to CMS.

Augustine Medical R&D staff plan to meet with CMS staff in the next several weeks to design a new study in support of a new request for a coverage determination. The company says it does not intend to appeal the agency's Jan. 14 decision.

Medicare coverage of the Warm-Up system to promote healing and to reduce rates of infection and complications associated with pressure ulcers, venous stasis ulcers, diabetic/neuropathic ulcers, non-healing surgical wounds, and other chronic wounds was requested on Oct. 2, 2001. However, studies were not submitted in support of the last two indications.

FDA 510(k)-cleared the Warm-Up in March 1997, based on substantial equivalence to several pre-amendments wound care devices. No clinical data regarding the Warm-Up was reviewed by FDA, which barred Augustine from claiming healing acceleration or curative properties for the Warm-Up.

Augustine Warming Up New Trial Following CMS Non-Coverage Decision

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