National Coverage Analysis (NCA) Tracking Sheet

Hyperbaric Oxygen (HBO) Therapy (Section C, Topical Oxygen)

CAG-00060R

Issue

CMS received a reconsideration request to remove the coverage exclusion of Continuous Diffusion of Oxygen Therapy (CDO) from NCD Manual 20.29, Section C. This section of the NCD (Topical Application of Oxygen) considers treatment known as CDO as the application of topical oxygen and nationally non-covers this treatment.

In light of this NCD reconsideration request, CMS is reconsidering section C in NCD 20.29 (Topical Application of Oxygen). The focus of the reconsideration request will be regarding the clinical efficacy of topical oxygen. CMS is not reconsidering any other section of the NCD.

CMS is soliciting public comment relevant to the request. CMS is specifically interested in whether the use of CDO in patients with chronic non-healing pressure ulcers, venous ulcers and diabetic foot ulcers is reasonable and necessary under Section 1862(a)(1)(A) or 1862(a)(1)(E) of the Social Security Act. CMS is interested in public comments that would pertain to clinical studies falling under section 1862(a)(1)(E), that is Coverage with Evidence Development (CED). Under CED, CMS is interested with those studies that report on the functional aspects and quality of life experienced by the Medicare beneficiary as a result of this technology.

National Coverage Determinations

Benefit Category

Incident to a physician's professional Service
Outpatient Hospital Services Incident to a Physician's Service
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Joe Moffett, EO2 Concepts, Inc. View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
07/12/2016
Expected NCA Completion Date
04/12/2017
Public Comment Period
07/12/2016 - 08/11/2016
Proposed Decision Memo Due Date
Proposed Decision Memo Released
01/12/2017
Proposed Decision Memo Public Comment Period
01/12/2017 - 02/11/2017
Decision Memo Released
04/03/2017
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Kimberly Long
kimberly.long@cms.hhs.gov
410-786-5702
Lead Medical Officers
Susan Miller, M.D.

Medicare Benefit Category Determination Date

Actions Taken

July 12, 2016

CMS initiates this national coverage analysis to consider Section C of NCD 20.29. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments within the scope of this NCA, and is particularly interested in clinical studies falling under the coverage with evidence development (CED) paradigm, relevant to the topic under review.

Instructions on submitting comments can be found at: http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html.

To submit a comment, please use the orange "Comment" button at the top of the page. Enter comments directly into the "Submit A Public Comment" webpage.

January 12, 2017

April 3, 2017