LCD L37873: Topical Oxygen Therapy

Background

After examining the evidence, the Centers for Medicare & Medicaid Services (CMS) responded to a reconsideration request to remove the coverage exclusion of continuous diffusion of oxygen therapy (CDO) from the National Coverage Determination (NCD) Manual and decided that no NCD was appropriate concerning the use of topical oxygen for the treatment of chronic wounds. CMS amended NCD 20.29 by removing Section C. In their decision, CMS allowed coverage of topical application of oxygen for the treatment of chronic wounds to be determined by the local contractors and Medicare coverage of topical oxygen.

Definitions and Scope

This is a non-coverage local coverage determination (LCD) for topical oxygen therapy (TOT). TOT administered to the open wound in small limb-encasing devices is not typically hyperbaric oxygen (HBO) therapy, and its efficacy has not been established due to the lack of controlled clinical trials. In addition, in vitro evidence suggests that TOT does not increase tissue oxygen tension beyond the superficial dermis. Examples of TOT devices are TOPOX portable HBO extremity and sacral chambers (Jersey City, NJ), Oxyboot and Oxyhealer from GWR Medical, L.L.P. (Chadds Ford, PA).

This A/B MAC considers TOT to be a method whereby a local supply of oxygen is applied to a wound (Dissemond, Kroger, Storck, Risse, & Engels, 2015). It is delivered by 1 of 2 techniques (Woo, Coutts, & Sibbbald, 2012). In the first, oxygen may be delivered intermittently through an airtight chamber or soft sided ‘bag’ that is sealed around a wound present on the trunk or limb of the body. The bag or chamber is filled with 100% oxygen at high flow rates (e.g., 10L /min) from an external source to pressures slightly above atmospheric (e.g., 1.004 – 1.013 atm abs) and is delivered to the patient on an intermittent dosing schedule (Feldmeier et al., 2005; Howard et al., 2013). In the past, this type of oxygen delivery was known by some as topical HBO therapy, a term that is less commonly used today due to the low pressures delivered (Brimson & Nigam, 2013). Topical oxygen can also be delivered to a wound when applied continuously by a tube supplying pure oxygen at a normobaric pressure and low flow rate (3-12 ml/hour) under an occlusive dressing (Howard et al., 2013). These devices have been variously termed transcutaneous oxygen, transdermal continuous oxygen therapy (TCOT), low flow oxygen, topical continuous oxygen therapy, continuous topical oxygen and CDO (Dissemond, Kroger, Storck, Risse, & Engels, 2015; Howard et al., 2013; Lowell, Nicklas, Weily, Johnson, & Lyons, 2009; Orsted et al., 2012; Woo et al., 2012).

Neither intermittent nor continuous provision of topical oxygen is dependent on the systemic circulation reaching the wound, as is the case with HBO. However, because these systems directly apply oxygen to the wound site, it is thought by some that the oxygen can penetrate directly into the injured area, and therefore, improve healing of cutaneous lesions (Brimson & Nigam, 2013; Howard et al., 2013; Orsted et al., 2012; Woo et al., 2012). Typically, intermittent TOT treatments would be administered 4 to 5 days a week for approximately 90 minutes per session (Howard et al., 2013), though there can be other variations of dosaging noted in the clinical protocols. HBO must be provided in medically supervised environments; however, intermittent TOT may be provided in the home setting by a well-trained patient or caregiver. Though infrequent, side effects of HBO can be significant and include the possibility of pneumothorax, ear and sinus barotrauma, pulmonary edema, worsening of congestive heart failure, seizures and retinal damage (Howard et al., 2013). There are also significant concerns among some in the wound care community regarding TOT administered intermittently. For example, some believe that intermittent TOT may impede arterial or capillary circulation, inhibit angiogenesis, and decrease collagen synthesis and fibroblast proliferation; all circumstances which would delay or inhibit healing of a wound (Mutluoglu, Cakkalkurt, Uzun, & Aktas, 2015). TOT may not be appropriate for wounds covered in eschar or those that are deep and penetrating. Moreover, when used on open, exposed wound surfaces, TOT may cause desiccation of the area (Howard et al., 2013). TOT has been proposed in the treatment of skin ulcerations resulting from diabetes, venous stasis, post-surgical infections, gangrenous lesions, pressure ulcers/decubitus ulcers, infected residual limbs, skin grafts, burns and frostbite.

The goal of topical continuous oxygen therapy is to provide an uninterrupted and continuous supply of oxygen to a moist wound. The dressing is designed such that the oxygen is supplied in a manner that most closely approximates the normal diffusion of oxygen in moist tissues, yet a rate sufficient to fuel the increased oxygen demands required in healing tissues. With this therapy, the dressing helps provide an environment for optimal wound healing while managing wound exudate levels, protecting against wound dehydration and protecting against external contamination. Contraindications to this wound therapy includes wounds with inadequate perfusion to support healing; ulcers due to acute thrombophlebitis; ulcers due to Raynaud’s disease; necrotic wounds covered with eschar or slough; wounds with fistulae or deep sinus tracts with unknown depth.

The following are Federal Drug Administration (FDA)-approved TOT devices:

• EPIFLO TCOT (Ogenix) consists of a small, silent, disposable, oxygen concentrator and a long sterile cannula (tube). It is used with any fully occlusive sterile wound dressing to continuously blanket the wound with near 100% oxygen. The patient is free to ambulate and can continue with normal daily living activities while being treated 24 hours per day. EPIFLO can be worn near the wound beneath clothing without impairing its operation. EPIFLO extracts oxygen from the air, concentrates it to near 100%, and “pumps” the oxygen through the cannula to blanket the wound. The wound is covered with a fully occlusive dressing of the provider’s choice. The dressing does not inflate and the patient has no sensation of air movement. EPIFLO provides a silent, continuous, slow flow of oxygen (3 ml/hr for 15 days) that will not dry out the wound.

• TransCu O2 wound care device or EO 2 system (EO2 Concepts) is a portable oxygen delivery system that provides a continuous flow of oxygen to a wound. Through a dressing attached to the device, oxygen is provided directly to the wound for 24 hours per day, 7 days a week. Oxygen is an important part in the wound healing process. The EO 2 system employs a TransCu O2 device, which uses fuel cell technology to continuously generate pure humidified oxygen at adjustable flow rates from 3-15 ml/hr and delivers it directly to the wound bed environment within the OxySpur dressing. The OxySpur Oxygen Diffusion Dressing is an all-in-one dressing for medium to high exudating wounds. Its design allows distribution of oxygen over the entire wound.

• O2Boot and O2Sacral (GWR Medical, Inc) are portable and 1-time use devices applied and secured to the body by a hypo-allergenic adhesive seal. The area surrounding the wound receives 100% oxygen at 1.03 atm for 90 min for 4 consecutive days, followed by 3 days without treatment. The weekly treatment regimen is self-administered in the patient’s home and continued as directed by the healthcare provider.

The Undersea and Hyperbaric Medical Society issued the following policy statement on topical oxygen, often referred to as "topical hyperbaric oxygen therapy" (Feldmeier et al., 2005): "1. Topical oxygen should not be termed HBO since doing so either intentionally or unintentionally suggests that TOT is equivalent or even identical to HBO. Published documents reporting experience with topical oxygen should clearly state that topical oxygen not HBO is being employed. 2. Mechanisms of action or clinical study results for HBO cannot and should not be co-opted to support topical oxygen since HBO therapy and topical oxygen have different routes and probably efficiencies of entry into the wound and their physiology and biochemistry are necessarily different. 3. The application of topical oxygen cannot be recommended outside of a clinical trial at this time based on the volume and quality of scientific supporting evidence available, nor does the Society recommend third party payor reimbursement. 4. Before topical oxygen can be recommended as therapy for non-healing wounds, its application should be subjected to the same intense scientific scrutiny to which systemic hyperbaric oxygen has been held".

Limb-specific TOT entails sealing an individual's arm or leg into an air-tight plastic container that is sealed with pliable gaskets and exposing the limb to pure oxygen greater than 1 atm of pressure. Much of the research on this form of therapy has centered on chronic wounds arising in individuals with diabetic foot ulcers (DFUs). However, there is currently insufficient evidence from routine clinical trials (RCTs) to determine the effectiveness of limb-specific TOT.

In 2008, Banks et al. examined the effectiveness of the EPIFLO device as an adjunct treatment modality in chronic wound management. This study included 3 men with spinal cord injury (SCI), who each presented with a stage IV pressure ulcer in the pelvic region. They were treated with the EPIFLO device as an adjunct therapy. In Case 1, the patient was monitored for 9 weeks, whereas in Cases 2 and 3, the patients were monitored for 5 weeks. Healing was determined on a weekly basis by wound dimensions and volume, which were compared before and after the intervention. Comparison of pre- and post-treatment outcome measurements showed significant improvement with EPIFLO in each case. The authors concluded that EPIFLO seems to have had a positive effect on the healing rate of chronic pressure ulcers in individuals with SCI. The findings of this small case-series study need to be validated by well-designed studies.

In 2008, Bakri et al. tested the hypothesis that local transdermal delivery of oxygen improves oxygenation in sternotomy wounds after cardiac surgery; the secondary hypothesis was that supplemental inspired oxygen improves sternal wound PsqO(2). After undergoing cardiopulmonary bypass, a total of 30 patients randomly received EPIFLO oxygen generators that provided oxygen at 6 ml/hr into an occlusive wound dressing, or identical-appearing inactive generators. PsqO(2) and temperature were measured in the wound approximately 5 mm below the skin surface. PsqO(2) and arterial oxygen (Pao(2)) were measured 1 hr after intensive care unit admission (Fio(2) = 60%) and on the 1st and 2nd post-operative mornings at Fio(2) of both 30% and 50% in random order. Data from 4 patients were excluded for technical reasons. Patient characteristics were similar in each group, as were type of surgery and peri-operative management. Increasing Fio(2) from 30% to 50% improved Pao(2) from 99 [84 to 116] to 149 [128 to 174] mm Hg (p