Request for Information - Topical Oxygen Therapy Used for Wound Care

DME MAC Joint Publication

Posted on September 14, 2017

The DME MACs announce the solicitation of scientific articles regarding the subject of topical oxygen therapy (TOT) used for wound care. We are requesting that interested parties provide relevant clinical evidence regarding the generally accepted uses for the topical application of oxygen in clinical practice.  The Centers for Medicare and Medicaid Services (CMS) has recently announced that the National Coverage Determination for TOT will be removed.  TOT provided by durable medical equipment will fall within DME MAC jurisdiction.  The information received from this solicitation will assist the DME MACs in this coverage evaluation.

Those interested in responding to this solicitation should take note that CMS requires that MAC contractors make coverage determinations using an evidence-based medical standard.  This standard for clinical evidence is described in the CMS Program Integrity Manual (Internet-Only Manual, Pub. 100-08, Chapter 13, and Section 13.7.1) which states (in relevant part):

 [S]hall be based on the strongest evidence available.  The extent and quality of supporting evidence is key... The initial action in gathering evidence … shall always be a search of published scientific literature for any available evidence pertaining to the item or service in question. In order of preference:

  • Published authoritative evidence derived from definitive randomized clinical trials or other definitive studies, and
  • General acceptance by the medical community (standard of practice), as supported by sound medical evidence based on:
    • Scientific data or research studies published in peer-reviewed medical journals;
    • Consensus of expert medical opinion (i.e., recognized authorities in the field); or
    • Medical opinion derived from consultations with medical associations or other health care experts.

There are limitations to the type of evidence that can be used for a MAC coverage determination.  The CMS Program Integrity Manual section above goes on to state:

Acceptance by individual health care providers, or even a limited group of health care providers, normally does not indicate general acceptance by the medical community. Testimonials indicating such limited acceptance, and limited case studies distributed by sponsors with financial interest in the outcome, are not sufficient evidence of general acceptance by the medical community. The broad range of available evidence must be considered and its quality shall be evaluated before a conclusion is reached. [Emphasis added]

The DME MACs encourage respondents to consider these requirements as materials are collected and submitted.

The DME MACs are specifically interested in clinical trials using TOT performed during the last 10 years (September 2007- September 2017).

We request that full-text copies of all clinical articles be submitted.  Abstracts, poster presentations, case studies, and other non-peer reviewed material will not be considered.  All information must be submitted electronically in PDF format.  The PDF must be unprotected and submitted as a readable, unencrypted document and not be a scanned image (OCR).  Please email these documents to:

Deadline for Submission of Information is 45 days from the publishing of this article: October 30, 2017.

The DME MACs appreciate your assistance. 

Publication History

Publication Date: September 14, 2017

Originally Published

Last Updated Wed, 13 Sep 2017 11:51:58 +0000