LCD Reference Article Response To Comments Article

Response to Comments: Topical Oxygen Therapy

A56392

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Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

Document Note

The below Associated Contract Numbers for this A/B MAC article were inadvertently omitted:
(A and B and HHH MAC - 11201 - J - M) Palmetto GBA, (A and B and HHH MAC - 11301 - J - M) Palmetto GBA, (A and B and HHH MAC - 11401 - J - M) Palmetto GBA, (A and B and HHH MAC - 11501 - J - M) Palmetto GBA, (A and B and HHH MAC - 11202 - J - M) Palmetto GBA, (A and B and HHH MAC - 11302 - J - M) Palmetto GBA, (A and B and HHH MAC - 11402 - J - M) Palmetto GBA, (A and B and HHH MAC - 11502 - J - M) Palmetto GBA, (A and B MAC - 10211 - J - J) Palmetto GBA, (A and B MAC - 10311 - J - J) Palmetto GBA, (A and B MAC - 10112 - J - J) Palmetto GBA, (A and B MAC - 10312 - J - J) Palmetto GBA

Note History

Contractor Information

Article Information

General Information

Source Article ID
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Article ID
A56392
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Topical Oxygen Therapy
Article Type
Response to Comments
Original Effective Date
03/21/2019
Revision Effective Date
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Revision Ending Date
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CMS National Coverage Policy

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Article Guidance

Article Text

The comment period for the Topical Oxygen Therapy L37873 Local Coverage Determination (LCD) began on October 1, 2018 and ended on November 15, 2018. The comment below was received from the provider community. The notice period for L37873 begins on March 21, 2019 and ends on May 5, 2019. This LCD will become effective on May 6, 2019.

Response To Comments

Number Comment Response
1

We are concerned that the Draft LCD omits important published data supporting the effectiveness of TOT devices to improve healing rates of chronic, non-healing wounds. As described in this letter and the attached monograph, studies evaluating use of the NATROX® System consistently demonstrate that the device improves wound healing rates, improves wound closure rates, and reduces patients’ pain in and around their non-healing wounds. This evidence shows that the NATROX System has led to significantly improved wound healing in wounds that had not previously healed, even after 12 months or more of standard of care treatment. In addition, Palmetto failed to identify and account for published studies gathered by other Medicare contractors evaluating this same issue - the Durable Medical Equipment Medicare Administrative Contractors (“DME MACs”), which recently published a list of relevant TOT publications that expand greatly on the references identified in the Draft LCD. The consistent conclusions of these omitted publications conflict with the reasons Palmetto reached a non-coverage determination for TOT by (1) clearly demonstrating the positive effect of TOT on wound healing, particularly TOT delivered by the NATROX® System; and (2) identifying the appropriate population of patients and wounds that will benefit from use of the NATROX® System.

Thank you for your submission. We have added additional references with analysis of selected literature submitted for consideration. Briefly, the submitted citations have poor to moderate quality of evidence and none provide evidence sufficient to determine that the technology results in a meaningful improvement in the net health outcome of a well-defined patient population. We continue to seek prospective-randomized, controlled multi-center U.S. trials (preferably with a sham control group) of sufficient statistical power to identify specific patient populations that benefit from this technology in ways that are meaningful and measureable.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
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SAD Process URL 1
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Public Versions
Updated On Effective Dates Status
03/13/2019 03/21/2019 - N/A Currently in Effect You are here

Keywords

  • Topical
  • Oxygen