Hyperbaric oxygen therapy (HBOT) is a useful adjunctive treatment for selected complicated wounds, including severe diabetic lower extremity ulcerations and compromised skin grafts or flaps. The Sars-CoV-2 (COVID-19) pandemic has disrupted healthcare delivery, with its effects extending to delivery of HBOT. During the pandemic, paediatric patients in our geographic region who were referred for HBOT faced challenges as centres temporarily closed or were unprepared to treat younger patients. Our monoplace HBOT centre modified existing practices to allow for treatment of these patients. This study aims to outline the steps necessary to adapting a pre-existing HBOT centre for the safe treatment of paediatric patients … read more
Tag: hyperbaric oxygen therapy
The Healing Power of Oxygen, by Dr. Joseph P. Cavorsi
Oxygen is an abundant chemical within our atmosphere that is essential for most living things. Everyone associates oxygen with breathing and the lungs, but the process goes far beyond. All cells in the body need oxygen to create energy to live. Inadequate oxygen delivery to the cells can lead to dysfunction of the cells, contributing to many disease states, and in severe cases may lead to cell death … read more
Hyperbaric oxygen therapy for chronic diabetic foot ulcers: An overview of systematic reviews
Researchers assessed clinical evidence of hyperbaric oxygen therapy in the management of diabetic foot ulcers, via this overview of systematic reviews. They analyzed systematic reviews (SRs) assessing the impacts of hyperbaric oxygen therapy in individuals with diabetic foot ulcer. Inclusion criteria were fulfilled by 11 SRs/MAs. They found limited clinical evidence in favor of hyperbaric oxygen therapy in the management of diabetic foot ulcers, routine application of hyperbaric oxygen therapy to all patients with diabetic foot ulcers, particularly those with non-ischemic diabetic foot ulcers, is not advised. Certain potential of hyperbaric oxygen therapy to promote ulcer healing as well as decrease amputation rate in patients with ischemic diabetic foot ulcers has been observed, but because these results are supported by low quality and small quantity of the SRs/MAs, widespread recommendations require high-quality studies with rigorous … read more
Decision Memo for Hyperbaric Oxygen (HBO) Therapy
(Section C, Topical Oxygen) (CAG-00060R)
The Centers for Medicare & Medicaid Services (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.
After examining the evidence, CMS has decided that no National Coverage Determination is appropriate at this time concerning the use of topical oxygen for the treatment of chronic wounds. We will amend NCD 20.29 by removing Section C, Topical Application of Oxygen and Medicare coverage of topical oxygen for the treatment of chronic wounds will be determined by the local contractors.
Summary:
Chronic wounds are prevalent in the Medicare population and cause a disproportionate burden on beneficiaries and their families and caretakers. CMS recognizes the need for new therapies that will heal wounds and the standardization of wound care in general. Overall, since the evidence on chronic wound healing from topical oxygen therapies has increased over the past few years, CMS believes a national non-coverage decision is no longer appropriate. CMS received 17 public comments and most of the commenters support this position. However, given the inability to identify the characteristics of chronic wounds that best respond to topical oxygen therapy and the type of patients’ best suited to use this therapy, we are not able to define a patient population that would benefit from topical oxygen therapy in a national coverage determination at the present time. Ongoing research in the US and Europe and pending publications may provide additional evidence that may support a national determination in the future. CMS realizes that double blinded RCTs cannot always be used in order to answer questions regarding the outcomes of exposure to various treatment regimens in the wound care space. However we acknowledge that various investigative groups have, and are currently, studying the treatment of chronic wounds by TOT through randomized controlled trials. CMS reviewed a number of articles from commenters, considered all additional information and has determined to finalize the proposed decision.
Conclusion
The Centers for Medicare & Medicaid Services (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.
After examining the evidence, CMS has decided that no National Coverage Determination is appropriate at this time concerning the use of topical oxygen for the treatment of chronic wounds. We will amend NCD 20.29 by removing Section C, Topical Application of Oxygen and Medicare coverage of topical oxygen for the treatment of chronic wounds will be determined by the local contractors.
HBOT, sham procedure lead to similar wound healing rates
Adults with diabetes and chronic lower limb wounds randomly assigned to 6 weeks of hyperbaric oxygen therapy or a sham procedure met similar amputation criteria and experienced similar wound healing rates at the conclusion of treatment, according to research in Diabetes Care.
In a prospective, double blind, randomized controlled trial, Ludwik Fedorko, MD, PhD, FRCPC, of Toronto General Hospital and University Health Network in Ontario, Canada, and colleagues analyzed data from 107 adults with type 1 or type 2 diabetes and chronic lower limb wounds persisting for a minimum of 4 weeks. Within the cohort, 49 participants were randomly assigned to 30 daily sessions of hyperbaric oxygen therapy lasting 90 minutes each (breathing oxygen at 244 kPa); 54 participants were assigned to a sham procedure (breathing oxygen at 125 kPa; equivalent to breathing 27% oxygen by face mask), in addition to receiving comprehensive wound care …
“The adjuvant [hyperbaric oxygen therapy] care provided no incremental benefit in improving measures of wound healing,” the researchers wrote. “These results are in contrast to several cohort and open-label randomized trials where no sham placebo was used.” – by Regina Schaffer
Hyperbaric oxygen add-on may not aid wound healing in diabetes
The addition of hyperbaric oxygen therapy to standard care did not substantially improve outcomes in adults with diabetes with an ischemic wound compared with standard care treatment alone, according to findings published in Diabetes Care.
Dirk T. Ubbink, MD, PhD, of the department of surgery at Academic Medical Center in Amsterdam, and colleagues evaluated data from the DAMO2CLES trial on 120 adults with diabetes and an ischemic wound randomly assigned to standard care with (n = 60) or without hyperbaric oxygen therapy (n = 60) to determine whether hyperbaric oxygen therapy is beneficial for ischemic wound treatment. Participants were recruited between June 2013 and December 2015. The primary outcomes included limb salvage and wound healing after 12 months. Follow-up visits occurred at 3, 6 and 12 months after recruitment … read more
Medicare reimbursement for hyperbaric oxygen therapy
In an atmosphere of changing reimbursement, it’s important to understand indications and utilization guidelines for healthcare services. Otherwise, facilities won’t receive appropriate reimbursement for provided services. This article focuses on Medicare reimbursement for hyperbaric oxygen therapy (HBOT).
Indications and documentation requirements
The Centers for Medicare & Medicaid Services (CMS) National Coverage Determination for HBOT lists covered conditions for HBOT, as do the individual Medicare Administrative Contractor’s (MAC) Local Coverage Determination policies and/or articles. (See Conditions for which CMS approves use of HBOT.) Providers should thoroughly review the indications and utilization guidelines to ensure coverage criteria are met for each clinical condition … read more