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National Coverage Analysis (NCA) Tracking Sheet

Air-Fluidized Beds for Pressure Ulcers

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Issue

Prompted, in part, by requests from various manufacturers of support surfaces for coverage of their products, the Health Care Financing Administration (HCFA) requested the Blue Cross Blue Shield Association's Technology Evaluation Center (TEC) to conduct an assessment of the various types of support surfaces in July of 1997.

The TEC assessment indicated that "available data are insufficient to evaluate the health outcomes of treatment with air-fluidized therapy as compared to either treatment with Group I or Group II pressure reducing support surfaces in patients at risk of developing pressure ulcers or in patients with established pressure ulcers". HCFA is reviewing our pressure reducing therapy policy, in light of information brought to our attention subsequent to the TEC assessment, to determine which types of support surfaces meet the reasonable and necessary provision at §1862(a)(1)(A) of the Medicare statute.

Since posting the above notice, we have been contacted by members of the support surface community with questions regarding the review process. Therefore, we are requesting that all interested parties send HCFA information on the following:

  1. Medical and scientific evidence which shows that air-fluidized bed therapy is more effective in promoting ulcer healing than air-flotation bed therapy or powered pressure reducing air mattresses (alternating pressure low air loss or powered flotation without low air loss) in the home setting.
  2. Evidence which shows that the use of air-fluidized bed therapy prevents subsequent hospital admissions for treatment of pressure ulcers.
  3. Information on the type of training and necessary skills required for care givers (including the number of hours per day of care) who are caring for patients receiving air-fluidized bed therapy for pressure ulcers.
  4. Evidence of clinical benefit or change in outcome from use of various types of support surfaces with specific emphasis on those types of support surfaces mentioned above.

National Coverage Determinations

Benefit Category

Durable Medical Equipment

Requestor Information

Requestor Name Requestor Letter
Internal N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
02/04/2000
Expected NCA Completion Date
06/16/2000
Public Comment Period
03/06/2000 - 04/06/2000
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
06/12/2000

Contacts

Lead Analysts
Lorrie Ballantine
Lead Medical Officers

Medicare Benefit Category Determination Date

Actions Taken

November 5, 1999

Intent to review Medicare's support surface coverage policy posted on HCFA's website.

February 4, 2000

Posted questions on HCFA website for comments from concerned parties.

March 13, 2000

Posting of clarification of the TEC assessment's conclusion and clarification of question #4 above.

May 12, 2000

Due date extended to May 19, 2000. Submissions dated May 4, 2000 were received from 2 parties in response to this notice, which was to have been closed on May 5, 2000. We expect to complete our review of this material by the revised due date.

May 26, 2000

Due date extended to June 16, 2000. We raised four questions relating to the use of air-fluidized bed therapy in the home setting and requested medical and scientific evidence to answer them. Two responses were received, both after the original closing date. We had hoped to complete our review of this material and its impact on the Technical Assessment that prompted the original posting by May 19, 2000. We have found that we will require additional time to complete this activity.

June 12, 2000
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