Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Topical Oxygenation

Policy #:07.00.09d

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

Topical oxygenation is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by a review of the available published literature.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, topical oxygenation is not eligible for payment under the medical benefits of the Company's products because the service is considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for topical oxygenation.

Description

Topical oxygenation, also referred to as topical hyperbaric oxygenation, is a technique that delivers 100 percent oxygen directly to an open, moist wound at a pressure slightly higher than atmospheric pressure. The theory behind this therapy is that the high concentrations of oxygen diffuse directly into the wound to increase the local cellular tension, which in turn promotes wound healing. During topical oxygenation, a device surrounds the wound area (usually an extremity), and oxygen is delivered under pressure from a source such as a conventional oxygen tank. This therapy has been promoted as a treatment for diabetic and venous stasis ulcers, burns, amputations, infected wounds, frostbite, gangrenous lesions, and skin graft sites. Topical oxygenation may be performed in the inpatient, home, clinic, or office setting. Typically, the therapy is offered for 90 minutes per day for four consecutive days. After a three-day break, the cycle may be repeated.

Topical oxygenation has sometimes been confused with hyperbaric oxygen therapy (HBO), which involves the inhalation of 100 percent oxygen at an elevated (ie, greater than sea-level) atmospheric pressure, typically between 2 and 3 atmospheres absolute (ATA). The delivery system for HBO uses either a full-body monoplace (single-person) chamber or a full-body multiplace (multiple-person) chamber. In monoplace chambers, the entire chamber is pressurized with 100 percent oxygen to the desired ATA. Multiplace chambers, which can accommodate two to twelve individuals, are pressurized using compressed air; the individuals breathe 100 percent oxygen via mask, head tent, or endotracheal tube.

Based on a review of the available published literature, there is minimal and insufficient data to conclude that the use of topical oxygenation results in improved net health outcomes.
References


Camporesi EM, ed; Undersea and Hyperbaric Medical Society. Hyperbaric Oxygen Therapy: A Committee Report. Kensington, MD; 1996.

Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD). 20.29: Hyperbaric oxygen therapy. [CMS Web site]. 06/19/06. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=12&ncdver=4&bc=AAAAgAAAAAAA&. Accessed April 20, 2018.

Edsberg LE, Brogan MS, Jaynes CD, et al. Topical hyperbaric oxygen and electrical stimulation: exploring potential synergy. Ostomy Wound Manage. 2002;48(11):42-50.

Feldmeier JJ, Hopf HW, Warriner RA 3rd, et al. UHMS position statement: topical oxygen for chronic wounds. Undersea Hyperb Med. 2005;32(3):157-168.

Heng MC, Harker J, Bardakjian VB, et al. Enhanced healing and cost-effectiveness of low-pressure oxygen therapy in healing necrotic wounds: a feasibility study of technology transfer. Ostomy Wound Manage. 2000;46(3):52-60,62.

Heng MC, Harker J, Csathy G, et al. Angiogenesis in necrotic ulcers treated with hyperbaric oxygen. Ostomy Wound Manage. 2000;46(9):18-28,30-2.

Heng MC. Topical hyperbaric therapy for problem skin wounds. J Dermatol Surg Oncol. 1993;19(8):784-793.

Heng MC, Pilgrim JP, Beck FW. A simplified hyperbaric oxygen technique for leg ulcers. Arch Dermatol.1984;120(5):640-645.

Kalliainen LK, Gordillo GM, Schlanger R, et al. Topical oxygen as an adjunct to wound healing: a clinical case series. Pathophysiology. 2003;9(2):81-87.

Kleinman Y, Cahn A. Conservative management of Achilles tendon wounds: results of a retrospective study. Ostomy Wound Manage. 2011;57(4):32-40.

Landau Z. Topical hyperbaric oxygen and low energy laser for the treatment of diabetic foot ulcers. Arch Orthop Trauma Surg. 1998;117(3):156-158.

Landau Z, Schattner A. Topical hyperbaric oxygen and low energy laser therapy for chronic diabetic foot ulcers resistant to conventional treatment. Yale J Biol Med. 2001;74(2):95-100.

Landau Z, Sommer A, Miller EB. Topical hyperbaric oxygen and low-energy laser for the treatment of chronic ulcers. Eur J Intern Med. 2006;17(4):272-5.

Leslie CA, Sapico FL, Ginunas VJ, Adkins RH. Randomized controlled trial of topical hyperbaric oxygen for treatment of diabetic foot ulcers. Diabetes Care. 1988;11(2):111-115.

Novitas Solutions Inc. Medicare Local Coverage Determination (LCD). L35021 Hyperbaric Oxygen (HBO) Therapy. 12/31/2015. Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35021&ContrId=331&ver=60&ContrVer=1&CntrctrSelected=331*1&Cntrctr=331&DocType=Active%7cFuture&bc=AgACAAIAAAAAAA%3d%3d&. Accessed April 20, 2018.

Sen CK, Khanna S, Gordillo G, et al. Oxygen, oxidants, and antioxidants in wound healing: an emerging paradigm. Ann N Y Acad Sci. 2002;957:239-249.

Undersea and Hyperbaric Medical Society (UHMS). Indications for hyperbaric oxygen therapy. [UHMS Web site]. Available at: https://www.uhms.org/resources/hbo-indications.html. Accessed April 20, 2018.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

THE FOLLOWING CODE IS USED TO REPRESENT TOPICAL OXYGENATION WHEN PERFORMED AS A PROFESSIONAL SERVICE:

99199


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)



A4575 Topical hyperbaric chamber, disposable

E0446 Topical Oxygen Delivery System, not otherwise specified, includes all supplies and accessories


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions from 07.00.09d
05/23/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on topical oxygenation.


Effective 10/05/2017 this policy has been updated to the new policy template format.
Version Effective Date: 04/08/2015
Version Issued Date: 04/08/2015
Version Reissued Date: 05/23/2018

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