![]() | Medical Policy |
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Description/Scope |
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This document addresses the use of hyperbaric oxygen therapy (HBOT), which can be applied systemically, topically, or to one or more limbs alone. HBOT involves the use of pressurized room air, 100% oxygen, or room air enriched with a specific concentration of oxygen. The premise of HBOT is that the increased pressure results in increased oxygen levels in systemic circulation and the body's tissues with the goal of improving healing of wounds, injuries or to support oxygen transport in acutely anemic or hypoxic individuals.
Position Statement |
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Medically Necessary:
Systemic hyperbaric oxygen pressurization is considered medically necessary in the treatment of any of the following conditions when performed in accordance with Undersea and Hyperbaric Medical Society (UHMS) guidelines:
Not Medically Necessary:
If the wound fails to show measurable signs of healing within 30 days of initiating and at each subsequent 30 day interval of systemic hyperbaric oxygen pressurization, continued therapy is considered not medically necessary.
Investigational and Not Medically Necessary:
Topical hyperbaric oxygen is considered investigational and not medically necessary in all cases.
Limb specific hyperbaric oxygen pressurization is considered investigational and not medically necessary in all cases.
Systemic hyperbaric oxygen pressurization is considered investigational and not medically necessary for all other conditions not previously listed, including but not limited to the treatment of tinnitus.
Rationale |
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Systemic Hyperbaric Oxygen
The position regarding systemic hyperbaric oxygen is based on guidelines published by the Undersea and Hyperbaric Medical Society (2008). These guidelines provide recommendations for indications where hyperbaric oxygen therapy has been demonstrated to provide clinical benefits. For the majority of these indications, there is adequate data to provide guidance regarding treatment duration, frequency and depth of pressurization. One exception is idiopathic sudden sensorineural hearing loss, which is discussed separately below.
Undersea and Hyperbaric Medical Society Guidelines:
The Undersea and Hyperbaric Medical Society's (UHMS) 2014 Hyperbaric Oxygen Therapy Committee suggests utilization of systemic hyperbaric oxygen therapy pressurization or "HBOT" guidelines as described below:
In 2012, the American Academy of Neurology and the American Headache Society released guidelines regarding the use of complementary treatments for episodic migraine prevention in adults (Holland, 2012). These guidelines concluded that the data are conflicting or inadequate to support or refute hyperbaric oxygen for migraine prevention.
The use of HBOT has been proposed for a wide range of conditions in addition to those addressed by the UHMS. Most, including cerebral edema, spinal cord injury, and heat trauma have little in the way of clinical data to support HBOT therapy. Further study of the impact of this treatment method for these conditions is warranted.
Systemic HBOT treatment for Tinnitus and Idiopathic Sudden Sensorineural Hearing Loss
Hyperbaric oxygen therapy (HBOT) has been proposed as a treatment for tinnitus that frequently accompanies sudden sensorineural hearing loss (SSHL). In a meta-analysis of the peer-reviewed literature, Bennett and colleagues (2005) evaluated the safety and efficacy of hyperbaric oxygen therapy (HBOT) for the treatment of ISSHL and tinnitus. In a single trial, 50 subjects were assessed for improvement in hearing and tinnitus after treatment with HBOT. Despite reporting improvement in hearing, the significance of any improvement in a subjective rating of tinnitus following HBOT could not be assessed due to poor reporting. The authors concluded that due to the small study population, methodological shortcomings, and the poor reporting, there is a lack of clinical evidence of a "beneficial effect" of HBOT on the chronic presentation of tinnitus. A randomized controlled trial of "high methodological rigor is justified to define those patients (if any) who can be expected to derive most benefit from HBOT" (Bennett, 2005).
A recent search of the literature identified a nonrandomized, retrospective controlled study involving 48 subjects with ISSHL who received standard care plus HBOT compared to 44 subjects who received standard care (Ohno, 2010). No significant differences were noted between groups with regard to mean hearing gain. The authors conclude that "the effectiveness of secondary HBOT for ISSHL patients in either subacute or chronic phase remains unproven, and thus, the decision to administer HBOT should be made with caution."
Cvorovic (2013) published the results of another small randomized controlled trial (RCT) involving 50 subjects with SSHL assigned to either HBOT (n=25) or intratympanic steroid treatment. There were significant differences between hearing thresholds at all frequencies before and after the HBOT. Similarly, there were significant differences between hearing thresholds at most frequencies (except 2 kHz) before and after the treatment in the intratympanic treatment group. The subgroups of participants with pure tone average less than 81 dB (decibels) and those who were 60 years of age or younger had better response to HBO treatment than those with profound deafness and in the elderly. Unfortunately this study was too small and methodologically weak to generalize its findings to a wider population.
In 2014, Gaitanou and colleagues published a report of a prospective case series study involving 56 subjects with ISSHL. All subjects were treated with 100% oxygen at 2 ATA for 120 minutes 5 times a week. Treatment was conducted in five phases over several months. Significant loss to follow-up was reported between phases. All subjects completed the first two phases, while only 76.8%, 23.2%, and 10.7% completed the third, fourth and fifth phases, respectively. The authors stated that overall, significant improvements were noted with regard to change in audiograms from baseline to final measurements (p<0.001), as well as tinnitus evaluation score, intensity, and tinnitus-related problems (p<0.001). No differences were noted between subjects who received or did not receive adjunctive corticosteroids. This small uncontrolled study indicates that there may be some benefit to HBOT therapy for ISSHL. As with the Cvorovic study, the weak methodology of this study significantly lessens the generalizability of these findings.
Lui and colleagues (2011) published the results of a large retrospective case series study involving 465 subjects with SSHL, of which 353 received pharmacologic treatments alone (76 systemic steroid treatment only; 277 received steroids and dextran); and 112 were treated with hyperbaric oxygen in addition to steroids and dextran. In subjects with initial hearing loss of > 90 dBHL (decibels hearing loss), the addition of hyperbaric oxygen to steroids and dextran resulted in a significant hearing gain difference of 24.5 ± 2.7 dB vs. with steroid only (12.9 ± 3.7 dB) or steroid-dextran (15.6 ± 2.7 dB), (p=0.030 for both comparisons). Subjects with initial severe (71-90 dBHL) and less severe (≤ 70 dBHL) hearing loss responded to the addition of hyperbaric oxygen treatment with less favorable recoveries. The authors concluded that when applied as an adjuvant to pharmacologic agents, hyperbaric oxygen benefits individuals with initial profound SSHL. While this study was fairly large, the lack of prospective methodology and blinding impair the utility of these results.
In October of 2011, the UHMS added ISSHL to their list of indications. The rationale for this recommendation is based upon the findings reported in a Cochrane Review from 2010. However, a reference for this specific report is not provided and a search for this report on the Cochrane website did not locate any relevant reports for that year. In contrast, the Cochrane Library published a report on the use of HBOT for ISSHL by Bennett and others in 2012. The conclusions of this report were as follows:
For people with acute ISSHL, the application of HBOT significantly improved hearing, but the clinical significance remains unclear. We could not assess the effect of HBOT on tinnitus by pooled analysis. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously. An appropriately powered trial is justified to define those patients (if any) who can be expected to derive most benefit from HBOT.
There is no evidence of a beneficial effect of HBOT on chronic ISSHL or tinnitus and we do not recommend the use of HBOT for this purpose.
In 2012, the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) published their clinical practice guideline for sudden hearing loss. In this document they state; "The panel offered as options that clinicians may offer (1) corticosteroids as initial therapy to patients with ISSNHL [Idiopathic Sudden Sensorineural Hearing Loss] and (2) hyperbaric oxygen therapy within 3 months of diagnosis of ISSNHL." This recommendation is based on aggregate evidence quality "Grade B, systematic review of RCTs with methodological limitations."
Overall, the evidence supporting the use of HBOT for the treatment of SSHL and ISSHL is currently insufficient to draw reasonable conclusions about the efficacy of this therapy.
Traumatic Brain Injury
Miller et al. published the results of a double-blind, sham controlled RCT involving 72 subjects with post-concussion symptoms due to traumatic brain injury. Subjects were randomized to undergo treatment in a 1:1:1 fashion to one of the following: 40 HBOT sessions at 1.5 ATA, 40 sham treatments with room air at 1.2 ATA, or no supplemental treatments. While a significant difference was reported between both supplemental groups and the no-supplemental groups, (p=0.008), no differences were reported between the hyperbaric and the sham treatment groups.
Topical and Limb Specific Hyperbaric Oxygen Therapy
Topical (including limb specific treatment) and systemic HBOT are distinct technologies and are applied by different methods. As such, the outcomes associated with systemic HBOT cannot be extrapolated to topical therapy. Topical HBOT has been primarily investigated as a treatment of chronic wounds, but other conditions have also been proposed as possible indications. There is currently insufficient published data from controlled trials to permit conclusions regarding topical HBOT. Additionally, evidence in the form of data from in vitro studies of limb specific HBOT have failed to demonstrate that this treatment method increases tissue oxygen tension beyond the superficial dermis, a key factor in the efficacy of HBOT. At this time the use of topic and limb specific HBOT are not supported by the available scientific evidence.
Background/Overview |
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Systemic Hyperbaric Oxygen Therapy
Systemic hyperbaric oxygen therapy (HBOT) involves the inhalation of pure oxygen gas while enclosed in a high-pressure chamber (defined as pressure greater than standard atmospheric pressure). The pressures used are usually between 1.4 to 3.0 atmospheres absolute (atm abs or ATA). The therapy works by supersaturating the blood tissues with oxygen via increased atmospheric pressure as well as increased oxygen concentrations. Studies have demonstrated that this therapy increases the available oxygen to the body by 10 to 20 times normal levels. Treatment may be carried out in either a monoplace chamber pressurized with pure oxygen or in a larger, multiplace chamber pressurized with compressed air, in which case the individual receives pure oxygen by mask, head tent, or endotracheal tube. The number and duration of treatment sessions and the atmospheric pressure during treatment varies depending on the specific condition being treated, the severity of the condition, and the procedures developed by individual hospitals and clinics. These individual procedures vary widely and have made the evaluation of the efficacy of hyperbaric oxygen therapy difficult. However, the medical specialty society which represents the physicians who specialize in this type of medical treatment, called the Undersea and Hyperbaric Medical Society (UHMS), created treatment recommendations for a wide variety of conditions for which HBOT has been proven to provide significant benefits.
Topical Hyperbaric Oxygen Therapy and Limb-specific Hyperbaric Oxygen Therapy
Topical HBOT involves the delivery of pure oxygen directly to an open, moist wound at a pressure slightly higher than atmospheric pressure. Limb-specific HBOT involves the use of a plastic container into which the limb to be treated is inserted and then sealed with pliable gaskets. The limb is then subjected to increased pressure and oxygen concentrations. The rest of the body is not exposed to this treatment. Much of the research on this form of therapy has focused on the treatment chronic wounds arising in individuals with diabetes–specifically foot wounds responsible for significant mortality and morbidity.
Definitions |
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Anemia: A reduction in the number of circulating red blood cells or in the total hemoglobin content of the cells.
Atmospheres absolute (ATA): The combination (or the sum) of the atmospheric pressure and the hydrostatic pressure is called atmospheres absolute (ATA). In other words, the ATA or atmospheres absolute is the total weight of the water and air above us.
Carbon monoxide poisoning: Toxicity that results from inhalation of small amounts of carbon monoxide (a poisonous gas) over a long period of time or from large amounts inhaled for a short time, which leads to decreased oxygen delivery to the body and cerebral toxicity.
Chronic: Of a long duration; a disease that persists or progresses over time.
Cierny-Mader system for osteomyelitis:
Anatomic type:
Stage 1: medullary osteomyelitis
Stage 2: superficial osteomyelitis
Stage 3: localized osteomyelitis
Stage 4: diffuse osteomyelitis
Physiologic class:
A host: healthy
B host:
Bs: systemic compromise
Bl: local compromise
Bls: local and systemic compromise
C host: treatment worse than the disease
Compartmental syndrome: Any condition in which a structure, such as a nerve or tendon, is being constricted in a space and is no longer able to move freely in the compartment.
Decompression sickness: A condition that develops in divers subjected to rapid reduction of air pressure after coming to the surface following exposure to compressed air.
Gangrene: The death of tissue or bone, usually resulting from a deficient or absent blood supply.
Gas embolism: Obstruction of a blood vessel by a gas bubble.
Ischemia: A local and temporary deficiency of blood supply due to an obstruction of the circulation.
Limb specific hyperbaric oxygen: A therapy that involves sealing an individual's leg or arm into an airtight container and exposing that limb to pure oxygen greater than one atmosphere of pressure.
Mycosis: Any condition caused by a fungus.
Necrosis: A condition where cells or tissues are dead or dying.
Osteomyelitis: Inflammation of the bone due to infection.
Osteoradionecrosis: Death of bone following irradiation.
Prophylactic: Any agent or treatment that contributes to the prevention of infection or disease.
Pyoderma gangrenosum: A condition of the skin leading to open ulcers.
Systemic hyperbaric oxygen: A therapy that involves sealing an individual inside a room or container, then exposing the individual to pure oxygen at greater than one atmosphere of pressure.
Thermal: Related to heat.
Tinnitus: A condition where an individual has the perception of sound in their head when no outside sound is present. It is typically referred to as "ringing in the ears" or "head noise," but other forms of sound have been described such as hissing, roaring, pulsing, whooshing, chirping, whistling and clicking.
Topical hyperbaric oxygen: A therapy that involves sealing skin wounds under a plastic cover and then exposing the wound to pure oxygen at greater than one atmosphere of pressure; an alternate form of this therapy involves the application of a mist of water droplets to the wound that are saturated with dissolved oxygen.
Coding |
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The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
When services are Medically Necessary:
CPT |
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99183 |
Physician or other qualified health care professional attendance and supervision of hyperbaric oxygen therapy, per session |
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HCPCS |
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G0277 |
Hyperbaric oxygen under pressure, full body chamber, per 30 minute interval |
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ICD-10 Procedure |
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5A05121 |
Extracorporeal hyperbaric oxygenation, intermittent |
5A05221 |
Extracorporeal hyperbaric oxygenation, continuous |
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ICD-10 Diagnosis |
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A42.0-A42.9 |
Actinomycosis |
A48.0 |
Gas gangrene |
B36.0-B36.9 |
Other superficial mycoses |
B37.0-B37.9 |
Candidiasis |
B46.0-B46.9 |
Zygomycosis |
B48.0-B48.8 |
Other mycoses, not elsewhere classified |
B49 |
Unspecified mycosis |
D62 |
Acute posthemorrhagic anemia |
G06.0 |
Intracranial abscess and granuloma |
H34.10-H34.13 |
Central retinal artery occlusion |
H70.201-H70.229 |
Petrositis |
I74.2-I74.9 |
Embolism and thrombosis of arteries (upper/lower extremities, iliac artery) |
I96 |
Gangrene, not elsewhere classified |
I99.9 |
Unspecified disorder of circulatory system |
K62.7 |
Radiation proctitis |
L08.0-L08.9 |
Other local infections of skin and subcutaneous tissue |
L59.8-L59.9 |
Other disorders of the skin and subcutaneous tissue related to radiation |
L88 |
Pyoderma gangrenosum |
M27.2 |
Inflammatory conditions of jaws |
M72.6 |
Necrotizing fasciitis |
M79.9 |
Soft tissue disorder, unspecified |
M79.A11-M79.A9 |
Nontraumatic compartment syndrome |
M86.30-M86.69 |
Chronic osteomyelitis |
M86.8X0-M86.8X9 |
Other osteomyelitis |
M86.9 |
Osteomyelitis, unspecified |
N30.40-N30.41 |
Irradiation cystitis |
S07.0XXA-S07.9XXS |
Crushing injury of head |
S17.0XXA-S17.9XXS |
Crushing injury of neck |
S28.0XXA-S28.0XXS |
Crushed chest |
S38.001A-S38.1XXS |
Crushing injury of abdomen, lower back, pelvis and external genitals |
S45.001A-S45.099S |
Injury of axillary artery |
S45.801A-S45.999S |
Unspecified injury of other blood vessels at shoulder and upper arm level |
S47.1XXA-S47.9XXS |
Crushing injury of shoulder and upper arm |
T20.20XA-T20.29XS |
Burn of second degree of head, face, and neck |
T20.30XA-T20.39XS |
Burn of third degree of head, face, and neck |
T21.20XA-T21.29XS |
Burn of second degree of trunk |
T21.30XA-T21.39XS |
Burn of third degree of trunk |
T22.20XA-T22.299S |
Burn of second degree of shoulder and upper limb, except wrist and hand |
T22.30XA-T22.399S |
Burn of third degree of shoulder and upper limb, expect wrist and hand |
T23.201A-T23.299S |
Burn of second degree of wrist and hand |
T23.301A-T23.399S |
Burn of third degree of wrist and hand |
T24.201A-T24.299S |
Burn of second degree of lower limb, except ankle and foot |
T24.301A-T24.399S |
Burn of third degree of lower limb, except ankle and foot |
T25.211A-T25.299S |
Burn of second degree of ankle and foot |
T25.311A-T25.399S |
Burn of third degree of ankle and foot |
T31.0-T31.99 |
Burns classified according to extent of body surface involved |
T57.3X1A-T57.3X4S |
Toxic effect of hydrogen cyanide |
T58.01XA-T58.94XS |
Toxic effect of carbon monoxide |
T65.0X1A-T65.0X4S |
Toxic effect of cyanides |
T66.XXXA-T66.XXXS |
Radiation sickness, unspecified |
T70.3XXA-T70.3XXS |
Caisson disease [decompression sickness] |
T79.0XXA-T79.0XXS |
Air embolism (traumatic) |
T79.A0XA-T79.A0XS |
Compartment syndrome, unspecified |
T79.A11A-T79.A9XS |
Traumatic compartment syndrome |
T86.820-T86.829 |
Complications of skin graft (allograft)(autograft) |
When services may be Medically Necessary when criteria are met:
For the procedure codes listed above, for the following diagnosis codes
ICD-10 Diagnosis |
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E08.00-E11.9 |
Diabetes mellitus |
E13.00-E13.9 |
Other specified diabetes mellitus |
I73.89 |
Other specified peripheral vascular diseases |
I73.9 |
Peripheral vascular disease, unspecified |
L89.000-L89.95 |
Pressure ulcer |
L97.101-L97.929 |
Non-pressure chronic ulcer of lower limb, not elsewhere classified |
L98.411-L98.499 |
Non-pressure chronic ulcer of skin, not elsewhere classified |
S01.00XS-S01.95XS |
Open wound of head [range with 7th character S] |
S11.011S-S11.95XS |
Open wound of neck [range with 7th character S] |
S21.001S-S21.95XS |
Open wound of thorax [range with 7th character S] |
S31.000S-S31.839S |
Open wound of abdomen, lower back, pelvis and external genitals [range with 7th character S] |
S41.001S-S41.159S |
Open wound of shoulder and upper arm [range with 7th character S] |
S51.001S-S51.859S |
Open wound of elbow and forearm [range with 7th character S] |
When services are Not Medically Necessary:
For the procedure codes listed above, when the situation listed in the Position Statement section as not medically necessary applies.
When services are Investigational and Not Medically Necessary:
For the procedure codes listed above, for all other diagnoses not listed; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.
When services are also Investigational and Not Medically Necessary:
HCPCS |
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A4575 |
Topical hyperbaric oxygen chamber, disposable |
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ICD-10 Diagnosis |
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All diagnoses |
References |
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Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
Websites for Additional Information |
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Index |
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Air embolism
Extreme chamber therapy
Extremity oxygen therapy
Osteomyelitis, acute and chronic
Osteoradionecrosis
Tinnitus
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
Document History |
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Status |
Date |
Action |
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03/29/2018 |
The document header wording updated from “Current Effective Date” to “Publish Date.” Updated Coding section to include ICD-10-CM diagnosis L59.8. |
Reviewed |
08/03/2017 |
Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Definitions, Coding and References sections. |
Revised |
08/04/2016 |
MPTAC review. Minor typographical revision in position statement. Updated Rationale and Reference sections. Updated Coding section and removed ICD-9 codes. |
Reviewed |
08/06/2015 |
MPTAC review. Updated Rationale and Reference sections. |
Reviewed |
11/14/2013 |
MPTAC review. No change to the position statement. Updated Rationale and Reference sections. |
Reviewed |
11/08/2012 |
MPTAC review. Updated Rationale and Reference sections. Updated Coding section with 01/01/2013 CPT descriptor change. |
Reviewed |
11/17/2011 |
MPTAC review. Updated reference section. |
Revised |
11/18/2010 |
MPTAC review. Moved HBOT treatment of tinnitus to investigational and not medically necessary section from MED.00073 Treatment of Tinnitus which was archived. Updated Rationale and Reference sections. |
Reviewed |
02/25/2010 |
MPTAC review. Updated Reference section. |
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10/01/2009 |
Updated Coding section with 10/01/2009 ICD-9 changes. |
Revised |
02/26/2009 |
MPTAC review. Clarified use in chronic wounds to require reassessment at each subsequent 30 day interval. Added central retina artery occlusion (CRAO) as a medically necessary indication. Added central retina artery occlusion (CRAO) as a medically necessary indication. Changed “profound” anemia to “severe” anemia in medically necessary section. Deleted “acute” osteomyelitis and cerebral edema from the medically necessary section. Revised medically necessary statement regarding radiation necrosis to read “delayed radiation injury”. Deleted list of I/E and NMN indications, leaving it to read I/E and NMN “for all indications”. Updated Rationale, Background, Coding and Reference sections. |
Revised |
08/28/2008 |
MPTAC review. Added radiation cystitis as medically necessary when used as an adjuvant therapy. Added tinnitus to investigational and not medically necessary section. Deleted “intracranial abscess” from investigational and not medically necessary section. Revised Rationale section. Updated Coding section with 10/01/2008 ICD-9 changes. |
Reviewed |
05/15/2008 |
MPTAC review. Updated Coding and Reference sections. |
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02/21/2008 |
The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting. |
Reviewed |
05/17/2007 |
MPTAC review. Updated Coding and Reference sections. |
Revised |
06/08/2006 |
MPTAC review. Moved radiation cystitis from Investigational and Not Medically Necessary to Medically Necessary. Updated Coding and Reference sections. |
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11/22/2005 |
Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD). |
Revised |
07/14/2005 |
MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization. |
Pre-Merger Organizations | Last Review Date | Document Number | Title |
Anthem, Inc. | 04/28/2005 | MED.00005 | Hyperbaric Oxygen Therapy (Systemic/Topical) |
WellPoint Health Networks, Inc. |
04/28/2005 |
2.01.01 |
Hyperbaric Oxygen Therapy: Systemic |
|
09/23/2004 |
2.02.01 |
Oxygen Therapy (Low Pressure) for Wound Care |