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National Coverage Analysis (NCA) Tracking Sheet

Air-Fluidized Beds for Pressure Ulcers

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Issue

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.

National Coverage Determinations

Benefit Category

Durable Medical Equipment

Requestor Information

Requestor Name Requestor Letter
Internal request N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
11/30/2000
Expected NCA Completion Date
02/22/2002
Public Comment Period
12/29/2000 - 01/29/2001
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
02/19/2002

Contacts

Lead Analysts
Lorrie Ballantine
Lead Medical Officers
Madeline Ulrich, MD

Medicare Benefit Category Determination Date

Actions Taken

November 1, 2000

Effective date of revision to national coverage policy on air-fluidized beds.

February 16, 2001

After reviewing evidence received on this posting, we determined that there are additional aspects that require further review. Therefore, we are requesting that the Agency for Health Research and Quality (AHRQ) assist us in a review and assessment of peer reviewed scientific literature and other evidence in an attempt to determine the specific benefit of air-fluidized beds when compared to the use of other support surfaces in the treatment and prevention of decubitus ulcers. We are also interested in what constitutes appropriate wound care while a patient is on an air-fluidized bed. Therefore, we submitted a request to AHRQ to conduct further analysis on this issue. The following represents the draft questions that we are asking AHRQ to consider while doing its review:

  • Is there objective evidence to show that use of an air-fluidized bed improves/heals Stage 3 and/or Stage 4 pressure ulcers?
  • At what point in the treatment of decubitus ulcers should air-fluidized therapy be introduced?
  • Is there objective evidence to show that the use of an air-fluidized bed is superior to the use of a Group II support surface? If so, what are the patient indicators/criteria that determine when a Group III should be introduced over a Group II?
  • What constitutes proper wound care while on an air-fluidized bed?
  • Are there special requirements as to types of dressings and dressing change schedules unique to patients receiving air-fluidized therapy?
  • Are standard wound care elements contraindicated because of air-fluidized therapy?
  • Is there scientific evidence that air-fluidized therapy in the home setting prevents subsequent hospitalization?

    • May 8, 2000

    CMS held a meeting with AHRQ to discuss the scope of the study and refine the analytical questions. AHRQ will assign an independent evidence-based practice center (EPC).

    August 31, 2001

    AHRQ secured a contract with an independent EPC, ECRI, to begin the study on air-fluidized beds. AHRQ expects the report to be complete by November 8, 2001. The estimated due date has been adjusted accordingly to January 7, 2002, 60 days following delivery of the technology assessment report.

    November 10, 2001

    The Technology Assessment (PDF, 324KB) prepared by ECRI on the use of air-fluidized beds has been completed and was submitted to us on November 8 for our further review of this matter. (Also see ECRI Response to Reviewers' Comments.)

    January 7, 2002

    Additional time is needed for internal agency review of material. We will extend the deadline to February 22, 2002.

    February 19, 2002

    Coverage Decision Memorandum  posted announcing intent to reaffirm the current national coverage policy.
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