Aetna HBOT policy

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Clinical Policy Bulletins

Number: 0172

Subject: Hyperbaric Oxygen Therapy (HBOT)

Important Note

Even though application of the Clinical Policy Bulletin below may find that

a particular service or supply is considered medically necessary, this

conclusion is based upon a review of the available clinical information

(including clinical outcome studies in the peer-reviewed published medical

literature, regulatory status of the technology, evidence-based guidelines

of public health and health research agencies, and evidence-based

guidelines and positions of leading national health professional

organizations) and does not mean that the service or supply will be covered

under your particular benefit plan. Each benefit plan contains its own

specific provisions for coverage and exclusions. You need to consult the

terms of your own benefit plan to determine if there are any exclusions or

other benefit limitations applicable to this service or supply. If there is

a discrepancy between this policy and your plan of benefits, the provisions

of your benefits plan will govern. However, applicable state mandates will

take precedence with respect to fully insured plans and self-funded

non-ERISA (e.g., government, school boards, church) plans. Unless otherwise

specifically excluded, Federal mandates will apply to all plans. With

respect to Medicare and Medicaid members, this policy will apply unless

Medicare and Medicaid policies extend coverage beyond this Clinical Policy

Bulletin. Medicare and Medicaid policies will only apply to benefits paid

for under Medicare or Medicaid rules, and not to any other health benefit

plan benefits. CMS's Coverage Issues Manual can be found on the following

website: http://cms.hhs.gov/manuals/pub06pdf/pub06pdf.asp.

Policy

* Aetna considers hyperbaric oxygen therapy to be medically necessary for

the following conditions:

* Non-healing infected deep ulcerations (reaching tendons or bone) of the

lower extremity in diabetic adults unresponsive to at least 1 month of

meticulous wound care (including aggressive debridement, maximal antibiotic

therapy, tight glycemic control, and appropriate treatment of arterial

insufficiency, including revascularization if necessary). Hyperbaric oxygen

therapy is not indicated for superficial lesions

* Acute carbon monoxide poisoning

* Decompression illness ( " the bends " )

* Acute air or gas embolism

* Gas gangrene (Clostridial myositis and myonecrosis)

* Cyanide poisoning (with co-existing carbon monoxide poisoning)

* Acute traumatic peripheral ischemia (including crush injuries and

suturing of severed limbs) when loss of function, limb, or life is

threatened and when HBOT is used in combination with standard therapy, and

not as a replacement

* Acute peripheral arterial insufficiency (e.g., compartment syndrome)

* Progressive necrotizing soft tissue infections, including mixed aerobic

and anaerobic infections (necrotizing fasciitis, Meleney's ulcer)

* Chronic refractory osteomyelitis, unresponsive to conventional medical

and surgical management

* Compromised skin grafts and flaps

* Radiation necrosis (osteoradionecrosis, myoradionecrosis, and other soft

tissue radiation necrosis) as an adjunct to conventional treatment

* Actinomycosis or other mycoses, only as an adjunct to conventional

therapy when the disease process is refractory to antibiotics and surgical

treatment

* Exceptional blood loss anemia only when there is overwhelming blood loss

and transfusion is impossible because there is no suitable blood available,

or religion does not permit transfusions

* Pneumatosis cystoides intestinalis

* Prophylactic pre and post treatment for patients undergoing dental

surgery of a radiated jaw

* Acute cerebral edema

* Idiopathic sudden deafness, acoustic trauma or noise-induced hearing

loss within 3 months after onset of disorder.

* Aetna considers the use of HBOT to be experimental and investigational

for the following conditions because there is insufficient evidence in the

medical literature establishing that HBOT is more effective than

conventional therapies:

* Superficial and/or non-infected diabetic ulcers

* Non-diabetic cutaneous, decubitus, pressure and venous stasis ulcers

* Chronic peripheral vascular insufficiency

* Acute renal arterial insufficiency

* Acute or chronic cerebrovascular insufficiency/accident (including

thrombotic or embolic stroke)

* Anaerobic septicemia and infection other than clostridial

* Aerobic septicemia and systemic aerobic infection

* Pyoderma gangrenosum

* Intra-abdominal abscess, pseudomembranous colitis (antibiotic-induced

colitis)

* Intracranial abscesses

* Skin burns (thermal)

* Acute thermal and chemical pulmonary damage, i.e., smoke inhalation

(e.g., carbon tetrachloride, hydrogen sulfide) with pulmonary insufficiency

* Tetanus

* Organ transplantation and storage

* Pulmonary emphysema

* Senility

* Non-vascular causes of chronic brain syndrome (e.g., Pick's disease,

Alzheimer's disease, Korsakoff's disease)

* Multiple sclerosis

* Migraine or cluster headaches

* Meningitis

* Closed head and/or spinal cord injury

* Myocardial infarction

* Cardiogenic shock

* Sickle cell crisis or hematuria

* Radiation-induced cystitis, myelitis, enteritis, proctitis

* Bone grafts or fracture healing

* Arthritic diseases

* Ophthalmologic diseases (including diabetic retinopathy, retinal

detachment, central retinal artery occlusion, radiation injury to the optic

nerve)

* Hepatic necrosis

* Lepromatous leprosy

* Rheumatoid arthritis

* Avascular necrosis of the femoral head

* Cystic acne

* Melasma

* Actinic skin damage

* Lyme disease

* Cerebral palsy

* Reflex sympathetic dystrophy (complex regional pain syndrome).

* Aetna considers hyperbaric oxygen therapy to be experimental and

investigational for members with any of the following contraindications to

HBOT, as the safety of HBOT for persons with these contraindications to

HBOT has not been established:

* Pneumothorax

* Treatment with doxorubicin, cisplatin, or disulfiram

* Premature birth

* Previous chest surgery

* Any lung disease

* Viral infections

* Recent (within the previous 2 months) middle ear surgery

* Optic neuritis

* Seizure disorders

* Uncontrolled high fever

* Congenital spherocytosis

* Psychiatric problems, especially claustrophobia.

* Aetna considers topical hyperbaric oxygen therapy administered to the

open wound in small limb-encasing devices to be experimental and

investigational because its efficacy has not been established through

controlled clinical trials.

Background

Hyperbaric oxygen therapy (HBOT) is defined as systemic treatment in which

the entire patient is placed inside a pressurized chamber and breathes 100%

oxygen under a pressure greater than one atmosphere. It is used to treat

certain diseases and conditions that may improve when an increased partial

pressure of oxygen is present in perfused tissues.

The literature states that HBO therapy should not be a replacement for

other standard successful therapeutic measures. Depending on the response

of the individual patient and the severity of the original problem,

treatment may range from less than 1 week to several months' duration, the

average being 2 to 4 weeks. Requests for coverage of hyperbaric oxygen

beyond 2 months, regardless of the condition of the patient, should be

referred for medical review.

HBOT has been shown to be an effective method for treating diabetic foot

wounds in carefully selected cases of lower extremity lesions. Although the

results of multiple retrospective studies involving a significant number of

patients have consistently indicated a high success rate in patients who

had been refractory to other modes of therapy, several recent prospective,

randomized studies have only supported the adjunctive role of systemic

hyperbaric oxygen therapy in the treatment of non-healing infected deep

lower extremity wounds in patients with diabetes. Such evidence is lacking,

however, for superficial diabetic wounds and non-diabetic cutaneous,

decubitus, and venous stasis ulcers.

Aetna does not cover topical hyperbaric oxygen therapy administered to the

open wound in small limb-encasing devices because it does not meet the

definition of systemic HBOT therapy and its efficacy has not been

established due to the lack of controlled clinical trials. In addition, in

vitro evidence suggests that topical hyperbaric oxygen does not increase

tissue oxygen tension beyond the superficial dermis. Examples of topical

hyperbaric oxygen therapy devices are TOPOX portable hyperbaric oxygen

extremity and sacral chambers (Jersey City, NJ), Oxyboot and Oxyhealer from

GWR Medical, L.L.P. (Chadds Ford, PA).

Place of Service:

Inpatient, but may be given outpatient if the condition does not require

hospitalization

The above policy is based on the following references:

* U.S. Department of Health and Human Services, Health Care Financing

Administration. Hyperbaric Oxygen Therapy. Coverage Issues Manual §35-10.

Baltimore, MD: HCFA, August 11, 1997.

* Leach RM, Rees PJ, Wilmshurst P. Hyperbaric oxygen therapy. Br Med J.

1998;317:1140-1143.

* Agency for Health Care Policy and Research. Treatment of Pressure

Ulcers. Clinical Guideline Number 15. AHCPR Publication No. 95-0652.

Bethesda, MD: AHCPR, December 1994.

* The Undersea and Hyperbaric Medical Society, Hyperbaric Oxygen Therapy

Committee. Guidelines: Indications for Hyperbaric Oxygen. Kensington, MD:

UHMS, 2000. Available at: http://www.uhms.org/Indications/indications.htm.

Accessed January 22, 2001.

* Tibbles PM, Edelsberg JS. Hyperbaric oxygen therapy. N Engl J Med.

1996;334(25):1642-1648.

* Zamboni WA, Wong HP, son T, et al. Evaluation of hyperbaric

oxygen for diabetic wounds: A prospective study. Undersea Hyperbar Med.

1997;24(3):175-179.

* Faglia E, Favales F, Aldeghi A, et al. Adjunctive systemic hyperbaric

oxygen therapy in treatment of severe prevalently ischemic diabetic foot

ulcer: A randomized study. Diabetes Care.1996;19(12):1338-1343.

* Paw HG, PN. Pneumatosis cystoides intestinalis confined to the

small intestine treated with hyperbaric oxygen. Undersea Hyperb Med.

1996;23(2):115-117.

* Lukich VL, Poliakova LV, Sotnikova TI, et al. Hyperbaric oxygenation in

the comprehensive therapy of patients with rheumatoid arthritis

(clinico-immunologic study). Fiziol Zh. 1991;37(5):55-60.

* TR, Griffiths ID, s J. Hyperbaric oxygen treatment for

rheumatoid arthritis; failure to show worthwhile benefit. Br J Rheumatol.

1988;27(1):72.

* Saikovskii RS, Alekberova ZS, Dmitriev AA, et al. Place of

hemocarboperfusion and hyperbaric oxygenation in the treatment of patients

with rheumatoid arthritis with systemic symptoms. Ter Arkh.

1986;58(7):105-109.

* Shank ES, Muth CM. Decompression illness, iatrogenic gas embolism, and

carbon monoxide poisoning: the role of hyperbaric oxygen therapy. Int

Anesthesiol Clin. 2000;38(1):111-138.

* Caplan ES. Hyperbaric oxygen. Pediatr Infect Dis J. 2000;19(2):151-152.

* Mitton C, Hailey D. Health technology assessment and policy decisions on

hyperbaric oxygen treatment. Int J Technol Assess Health Care.

1999;15(4):661-670.

* Sheridan RL, Shank ES. Hyperbaric oxygen treatment: A brief overview of

a controversial topic. J Trauma. 1999;47(2):426-435.

* Stone JA, Cianci P. The adjunctive role of hyperbaric oxygen therapy in

the treatment of lower extremity wounds in patients with diabetes. Diabetes

Spectrum. 1997;10(2):118-123.

* Mathews R, Rajan N, fson L, et al. Hyperbaric oxygen therapy for

radiation induced hemorrhagic cystitis. J Urol. 1999;161(2):435-437.

* Weiss JP, Neville EC. Hyperbaric oxygen: Primary treatment of

radiation-induced hemorrhagic cystitis. J Urol. 1989;142(1):43-45.

* Del Pizzo JJ, Chew BH, s SC, et al. Treatment of radiation induced

hemorrhagic cystitis with hyperbaric oxygen: Long-term followup. J Urol.

1998;160(3 Pt 1):731-733.

* Bevers RF, Bakker DJ, Kurth KH. Hyperbaric oxygen treatment for

haemorrhagic radiation cystitis. Lancet. 1995;346(8978):803-805.

* Weiss JP, Boland FP, Mori H, et al. Treatment of radiation-induced

cystitis with hyperbaric oxygen. J Urol. 1985;134(2):352-354.

* Rijkmans BG, Bakker DJ, Dabhoiwala NF, et al. Successful treatment of

radiation cystitis with hyperbaric oxygen. Eur Urol. 1989;16(5):354-356.

* Norkool DM, Hampson NB, Gibbons RP, et al. Hyperbaric oxygen therapy for

radiation-induced hemorrhagic cystitis. J Urol. 1993;150(2 Pt 1):332-334.

* Weiss JP, Mattei DM, Neville EC, et al. Primary treatment of

radiation-induced hemorrhagic cystitis with hyperbaric oxygen: 10-year

experience. J Urol. 1994;151(6):1514-1517.

* U.S. Department of Health and Human Services, Public Health Service.

Hyperbaric oxygen therapy for treatment of soft tissue radionecrosis and

osteoradionecrosis. Health Technology Assessment Reports. DHHS Publication

No. (PHS) 84.3371. Washington, DC: DHHS, 1982.

* Saunders P. Hyperbaric oxygen therapy in the management of carbon

monoxide poisoning, osteoradionecrosis, burns, skin grafts and crush

injury. West Midlands Development and Evaluation Service Report.

Birmingham, UK: University of Birmingham, April 2000.

* Mitton C, Hailey D. Hyperbaric oxygen treatment in Alberta. Alberta

Heritage Foundation for Medical Research, 1998:39.

* Medicare Services Advisory Committee. Hyperbaric oxygen therapy.

Assessment Report. Canberra, Australia: Medicare Services Advisory

Committee (MSAC), 2000.

* Wang C, Lau J. Hyperbaric oxygen therapy in treatment of hypoxic wounds.

Agency for Healthcare Research and Quality Contract No. 270-97-0019.

Boston, MA: New England Medical Center Evidence-Based Practice Center;

November 2, 2001.

* Lamm K, Lamm H, Arnold W. Effect of hyperbaric oxygen therapy in

comparison to conventional or placebo therapy or no treatment in idiopathic

sudden hearing loss, acoustic trauma, noise-induced hearing loss and

tinnitus. A literature survey. Adv Otorhinolaryngol. 1998;54:86-99.

* Ennis RD. Hyperbaric oxygen for the treatment of radiation cystitis and

proctitis. Curr Urol Rep. 2002;3(3):229-231.

* Denton AS, Andreyev HJ, Forbes A, Maher EJ. Systematic review for

non-surgical interventions for the management of late radiation proctitis.

Br J Cancer. 2002;87(2):134-143.

* Wang J, Li F, Calhoun JH, Mader JT. The role and effectiveness of

adjunctive hyperbaric oxygen therapy in the management of musculoskeletal

disorders. J Postgrad Med. 2002;48(3):226-231.

* Edsberg LE, Brogan MS, Jaynes CD, Fries K. Topical hyperbaric oxygen and

electrical stimulation: Exploring potential synergy. Ostomy Wound Manage.

2002;48(11):42-50.

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