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Air-Fluidized Beds Used for Treatment of Pressure Ulcers in the Home Environment

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Centers for Medicare and Medicaid Services (CMS) received a formal request to review the national coverage policy on air-fluidized beds. We are reviewing the current clinical evidence on the home use of air-fluidized beds to treat Stage III and Stage IV pressure ulcers. Based on this request and our initial analysis, we are reviewing certain aspects of our current national coverage policy, as well as evidence on the comparative effectiveness of air-fluidized therapy relative to the effectiveness of powered pressure reducing air mattresses (alternating pressure low air loss or powered flotation without low air loss). We also are seeking to define what sub-population of patients would benefit from air-fluidized therapy and/or powered pressure reducing air mattresses.

In particular we are seeking evidence to determine if modifications to the revised national coverage policy on air-fluidized beds, which was effective November 1, 2000, are necessary. We will review the requirements of conservative treatment that must be tried before initiating air-fluidized therapy to determine if a policy exception to the conservative care requirement would be appropriate. In particular, we will examine the requirement for use of a Group II support surface, either in or out of the hospital, for one month prior to initiating air-fluidized therapy.

We ask that any interested party knowledgeable in this matter send evidence to CMS for home use of air-fluidized beds. In particular, the formal request asks that we consider the following:

  1. Modification of language found in the Coverage Issues Manual at 60-19, which defines air-fluidized therapy and the coverage criteria.
  2. Exceptions to the requirement that conservative treatment be tried for one month, in particular the requirement for use of a Group II support surface.
  3. Exceptions to the Group II support surface when patient is placed on air-fluidized therapy in a hospital.

ECRI Response to Reviewers' Comments on Technology Assessment:
Air-fluidized Beds Used for Treatment of Pressure Ulcers in the Home Environment
November 7, 2001

1. Dr. David Brienza

Additional wording was added to emphasize that the objective of this report was to determine the efficacy of support surfaces in the treatment of Stage III and IV pressure ulcers in order to provide supporting information for CMS policy NCDs. Therefore, we excluded clinical trials of prevention in our analysis of efficacy.

Corrections were made in direct response to per page and line comments except for explaining the selection of 1985 as a cut off date for reference inclusion.

2. Dr. David Margolis

In the discussion of the normalized healing rate, "wounds" was changed to "pressure ulcers" to reflect that the references for this measurement refer only to pressure ulcers.

3. Dr. George Xakellis

No changes were necessary

4. CMS

The discussion of what types of support surfaces belong in Groups 1, 2, and 3 was enlarged with a more detailed description of each group. Because water mattresses are only included in group 1, one of the clinical studies included in our analysis of Group 2 support surfaces was removed. The data from this study was moved to Question 3's discussion of pressure ulcer healing during the first 30 days of treatment.

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