Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Full-Body Monoplace or Multiplace Chamber Hyperbaric Oxygen Therapy

Policy #:07.00.03n

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.

MEDICALLY NECESSARY

Full-body hyperbaric oxygen (HBO) therapy is considered medically necessary and, therefore, covered when both the medical requirements and the technical requirements, as listed below, are met.

MEDICAL REQUIREMENTS
Full-body HBO therapy is considered medically necessary and, therefore, covered for the following indications:
  • Actinomycosis, only as an adjunct to conventional therapy when the disease process is refractory to antibiotics and surgical treatment
  • Acute carbon monoxide intoxication
  • Acute traumatic peripheral ischemia, when all of the following criteria are met:
    • in combination with accepted standard therapeutic measures when loss of function, limb, or life is threatened
    • within the first 4-6 hours of the acute event, or for edema or after effects of acute arterial insufficiency if they are persistent after reconstructive surgery has restored large vessel function and perfusion
    • after documented restoration of the blood circulation
  • Acute peripheral arterial insufficiency associated with arterial embolism and thrombosis, when all of the following criteria are met:
    • in combination with accepted standard therapeutic measures when loss of function, limb, or life is threatened
    • within the first 4-6 hours of the acute event, or for edema or after effects of acute arterial insufficiency if they are persistent after reconstructive surgery has restored large vessel function and perfusion
    • after documented restoration of the blood circulation
  • Air or gas embolism
  • Chronic refractory osteomyelitis that is unresponsive to conventional medical and surgical treatment (i.e., prolonged antibiotics therapy preferably directed by appropriate culture and sensitivity information, drainage of the abscesses, immobilization of the affected extremity, and/or surgical debridement with removal of infected bone), when all of the following criteria are met:
    • as an adjunct to continued medical and/or surgical therapy
    • confirmed by imaging findings and bone cultures
  • Compartment syndrome, when all of the following criteria are met:
    • in combination with accepted standard therapeutic measures for decompression or removal of the flow limiting condition of the limb when loss of function, limb, or life is threatened
    • within the first 4-6 hours of the acute event, or for edema or after effects of acute arterial insufficiency if they are persistent after reconstructive surgery has restored large vessel function and perfusion
    • after documented restoration of the blood circulation
  • Crushing injuries and suturing of severed limbs, when all of the following criteria are met:
    • in combination with accepted standard therapeutic measures when loss of function, limb, or life is threatened
    • within the first 4-6 hours of the acute event, or for edema or after effects of acute arterial insufficiency if they are persistent after reconstructive surgery has restored large vessel function and perfusion
    • after documented restoration of the blood circulation
  • Cyanide poisoning
  • Decompression illness
  • Exceptional blood loss (anemia) when blood transfusion is impossible
  • Gas gangrene (clostridial myositis or clostridial myonecrosis)
  • Intracranial abscess
  • Preparation and preservation of compromised skin grafts and flaps, when all of the following criteria are met:
    • as salvage in cases where hypoxia or decreased perfusion has compromised viability
    • not for: primary management of wounds, wounds treated with artificial grafts (i.e. bioengineered or allogeniec skin substitutes), empiric treatment, prophylactic maintenance, or preparation of a site to receive a graft
  • Progressive necrotizing infections (i.e., necrotizing fasciitis) as an adjunct to surgical debridement and systemic antibiotics in settings where mortality and morbidity are expected to be high
  • Prophylactic pre- and post-treatment for individuals who are undergoing non-implant related dental surgery of a radiated jaw when the radiation therapy has been done at least 6 months prior
  • Delayed soft tissue and bony radionecrosis (osteoradionecrosis), when all of the following criteria are met:
    • as an adjunct to conventional treatment including debridement or resection of nonviable tissue in conjunction with antibiotic therapy
    • history of radiation treatment to the region of the documented injury, terminating at least 6 months prior to onset of signs or symptoms and/or planned surgical intervention at the site
    • adjunct treatment for osteoradionecrosis of the jaw is limited to cases with evidence of overt fracture or bony resorption in a previously irradiated mandible
  • Acute thermal skin burns
  • Diabetic wounds of the lower extremities, when all of the following criteria are met:
    • The individual has type 1 or type 2 diabetes and a lower-extremity wound that is due to diabetes
    • The wound is classified as Wagner Grade III or higher
    • The wound has not responded to an adequate course of standard wound therapy
    • The individual meets the criteria for initiation or continuation of full body HBO:
      • Initiation of full-body HBO therapy to treat diabetic wounds of the lower extremities is considered medically necessary and, therefore, covered as adjunctive therapy when at least 30 consecutive days of standard wound therapy alone has produced no measurable signs of healing. Full-body HBO therapy must be used in addition to standard diabetic wound care measures such as: assessment of vascular status; correction of vascular problems in the affected limb if possible; optimization of nutritional status; optimization of glucose control; debridement by any means to remove devitalized tissue; maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings; appropriate off-loading; and necessary treatment to resolve any infection that might be present; OR
      • Continued treatment of diabetic wounds with full-body HBO therapy is considered medically necessary and, therefore, covered if measurable signs of wound healing are evident after a 30-day period of treatment with both full-body HBO therapy and standard wound therapy. Wounds must be evaluated at least every 30 days during administration of HBO therapy. If no measurable signs of wound healing (defined as specific, documented, clinical signs of healing) are evident after any 30-day period, continued treatment with full-body HBO therapy is considered not medically necessary and, therefore, not covered.

TECHNICAL REQUIREMENTS
Full-body HBO therapy for the treatment of the conditions listed above is considered medically necessary and, therefore, covered when all of the following criteria are met:
  • Treatment occurs in a full-body monoplace or multiplace chamber.
  • The individual is provided 100 percent oxygen (systemic).
  • The chamber can reach a pressurization of at least 1.4 ATA.
  • A professional provider is onsite who is qualified and appropriately trained in hyperbaric medicine.

TRAINING AND CERTIFICATION REQUIREMENTS
In the inpatient or outpatient hospital setting, the process of determining appropriate provider training and/or certification should be determined by the facility, taking into consideration the potential need for ICU-level services and/or advanced cardiac life support (ACLS) should a complication occur in the delivery of this treatment.

HBO therapy will be covered in the non-hospital-affiliated setting when the facility demonstrates that all of the following criteria are met:
  1. Direct supervision is provided by a professional provider certified in Hyperbaric Medicine by the American Board of Emergency Medicine (ABEM), the American Board of Preventive Medicine (ABPM), or the American Osteopathic Conjoint Committee of Undersea and Hyperbaric Medicine (AOCUHM) or other entity adopting UHMS training protocol by completion of a minimum 40-hour training experience in a program approved by the American College of Hyperbaric Medicine or the Undersea and Hyperbaric Medical Society.
  2. The supervising provider must be ACLS trained and certified.

PLACE OF SERVICE

This service is only eligible for coverage when performed in the inpatient only setting due to the acute and critical nature of the disease, concomitant conditions, and the need for correlation with other acute, invasive or monitoring services for the following conditions:
  • Gas gangrene
  • Sequelae of acute peripheral ischemia (including reperfusion conditions of arterial embolism and thrombosis, reimplantation and/or crush injuries of the extremities)
  • Necrotizing fasciitis
  • Air embolisms
  • Carbon monoxide/cyanide poisoning

Therefore, HBO therapy for these services is not eligible for coverage in an outpatient or non-acute care setting.

NOT MEDICALLY NECESSARY

When full-body HBO therapy does not meet both the Medical Requirements and the Technical Requirements listed above, it is considered not medically necessary and, therefore, not covered.

All other uses for HBO therapy are considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the treatment of illness or injury.

BILLING REQUIREMENTS

Physician or other qualified health care professional attendance and supervision of HBO therapy, per session, as represented by Current Procedural Terminology (CPT) code 99183 is eligible to be reported when both the Medical Requirements and the Technical Requirements of full-body HBO therapy, as listed in this policy, are met.

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

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

Documentation includes the hyperbaric procedure (logs) with ascent time, descent time and pressurization level. In addition, there should be a treatment plan identifying timeline and treatment goals.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

The Company reserves the right to review HBO services in consideration with the utilization guidelines listed in Attachment A.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, full-body hyperbaric oxygen (HBO) therapy is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as not medically necessary are not eligible for coverage or reimbursement by the Company.

BILLING GUIDELINES

Physician or other health care professional attendance and supervision of HBO therapy may be billed using CPT code: 99183, when performed by a professional provider who is on-site.

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

The number of units reported for G0277 is based upon the time that the patient receives treatment with hyperbaric oxygen. The time spent by the patient under 100% oxygen, descent, air breaks, and ascent are included in calculating the total number of 30 minute intervals to be reported.

An additional unit of service may be reported if the patient is in the chamber receiving hyperbaric oxygen treatment for at least 16 minutes beyond the previous 30 minute period. The following guidelines instruct appropriate reporting of G0277:
  • The first unit reported must be at least 16 minutes in length.
  • The second unit is reported if the session is at least 46 minutes long (first unit = 30 minutes + 16 additional minutes).
  • The third unit is reported if the session is at least 76 minutes long (first and second units = 60 minutes + 16 additional minutes).
  • The fourth unit is reported if the session is at least 106 minutes long (first, second, and third units = 90 minutes + 16 additional minutes).

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Several full-body monoplace and multiplace HBO chambers have received FDA approval.

WAGNER GRADE WOUND CLASSIFICATION

The Wagner classification system is used to assess wound parameters in individuals with diabetes, including the depth of penetration, the presence of osteomyelitis or gangrene, and the extent of tissue necrosis. The wound grades are defined as follows:

Grade 0 - No open lesion
Grade I - Superficial ulcer
Grade II - Ulcer penetrates to tendon, bone, or joint
Grade III - Ulcer penetrates deeper than Grade II and has evidence of abscess or osteomyelitis
Grade IV - Gangrene present in the toes or forefoot
Grade V - Gangrene present in the whole foot

Description

HYPERBARIC OXYGEN THERAPY

Originally developed for the treatment of decompression illness, hyperbaric oxygen (HBO) therapy is now used for the on-label and off-label management of a variety of medical conditions, such as air embolism, acute traumatic, thermal and radiation injuries, infections, and complicated wound management. HBO therapy involves the inhalation of 100 percent oxygen at an elevated (i.e., greater than sea-level) atmospheric absolute (ATA) of at least 1.4, although the pressure is typically between 2 and 3 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 between two and 12 individuals, are pressurized using compressed air; the individuals breathe 100 percent oxygen via mask, head tent, or endotracheal tube. In any of these settings, the arterial partial pressure of oxygen will approach 1,500 mmHg. Individuals typically spend one to two hours in the chamber per session as determined by the professional provider.

Hyperbaric chambers are considered Class II devices by the US Food and Drug Administration (FDA). The indications for HBO therapy that are published by the Undersea and Hyperbaric Medical Society (UHMS) are also cited by the manufacturers of hyperbaric chambers to support the FDA labeling requirements for intended use. In 2011, the UHMS added idiopathic sudden sensorineural hearing loss (ISSNHL) as an indication for HBO therapy. The available peer-reviewed literature, however, including an updated Cochrane Review (2012), and clinical practice guidelines by the American Academy of Otolaryngology – Head and Neck Surgery (2012) support the need for higher quality evidence to determine the effectiveness of HBO therapy for the treatment of ISSNHL.

MECHANISM OF ACTION
HBO is used in the treatment of acute and chronic diseases and conditions in which oxygen delivery to tissue has been compromised by traumatic injury, infection, inflammation, or edema (swelling). The delivery of oxygen to the body under hyperbaric conditions, therefore, raises tissue oxygen levels and promotes recovery. The mechanisms of action for HBO therapy include displacing gas, decreasing edema, aiding the growth of new blood vessels (angiogenesis) and/or connective tissue (fibroblast proliferation), and killing bacteria.

COMPLICATIONS
Potential risks for individuals undergoing HBO therapy include pressure-related traumas (e.g., barotraumatic otitis, pneumothorax, middle ear effusion, and tympanic membrane rupture) and adverse effects (e.g., myopia, seizures) due to oxygen toxicity. Refraction changes are common but usually resolve once treatment is concluded. Hypoglycemia may be induced in diabetic individuals undergoing HBO therapy. Rapid ascent from pressure may cause decompression illness or "the bends." Some individuals may experience claustrophobia due to the confined chamber space.
References


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Peng Z, Wang S, Huang X, et al. Effect of hyperbaric oxygen therapy on patients with herpes zoster. Undersea Hyperb Med. 2012;39(6):1083-7.

Ravi P, Vaishnavi D, Gnanam A, et al. The role of hyperbaric oxygen therapy in the prevention and management of radiation-induced complications of the head and neck - a systematic review of literature. J Stomatol Oral Maxillofac Surg. 2017;118(6):359-362.

Rossignol DA, Bradstreet JJ, Van Dyke K, et al. Hyperbaric oxygen treatment in autism spectrum disorders. Med Gas Res. 2012;2(1):16.

Rossignol DA, Rossignol LW, Smith S, et al. Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial. BMC Pediatr. 2009;9:21.

Rusyniak DE, Kirk MA, May JD, et al. Hyperbaric oxygen therapy in acute ischemic stroke: results of the Hyperbaric Oxygen in Acute Ischemic Stroke Trial Pilot Study. Stroke. 2003;34(2):571-4.

RWTH Aachen University. Hyperbaric oxygen therapy in distal radius fractures: Can it shorten recovery time and increase fracture healing? (NCT01365780). [Clinical Trials Web site]. 11/27/2012 . Available at: https://clinicaltrials.gov/ct2/show/NCT01365780. Accessed February 05, 2018.

Sadri RA, Cooper JS. Hyperbaric, complications. NCBI Bookshelf 2017; https://www.ncbi.nlm.nih.gov/books/NBK459191/. Accessed November 21, 2017.

Sampanthavivat M, Singkhwa W, Chaiyakul T, et al. Hyperbaric oxygen in the treatment of childhood autism: a randomised controlled trial. Diving Hyperb Med. 2012;42(3):128-33.

Scheinkestel CD, Bailey M, Myles PS, et al. Hyperbaric or normobaric oxygen for acute carbon monoxide poisoning: a randomised controlled clinical trial. Med J Aust. 1999;170(5):203-10.

Shao Y, Lu GL, Shen ZJ. Comparison of intravesical hyaluronic acid instillation and hyperbaric oxygen in the treatment of radiation-induced hemorrhagic cystitis. BJU Int. 2012;109(5):691-4.

Sharifi M, Fares W, Abdel-Karim I, et al. Usefulness of hyperbaric oxygen therapy to inhibit restenosis after percutaneous coronary intervention for acute myocardial infarction or unstable angina pectoris. Am J Cardiol. 2004;93(12):1533-5.

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Steele J, Matos LA, Lopez EA, et al. A Phase I safety study of hyperbaric oxygen therapy for amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2004;5(4):250-4.

Sultan A, Hanna GJ, Margalit DN, et al. The use of hyperbaric oxygen for the prevention and management of osteoradionecrosis of the jaw: a Dana-Farber/Brigham and Women's Cancer Center Multidisciplinary Guideline. Oncologist. 2017;22(3):343-350.

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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)

99183


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)

Report the most appropriate diagnosis code in support of medically necessary criteria as listed in the policy.


HCPCS Level II Code Number(s)

G0277 Hyperbaric oxygen under pressure, full body chamber, per 30 minute interval


Revenue Code Number(s)

0413 Hyperbaric oxygen therapy

Coding and Billing Requirements


Cross References

Attachment A: Full-Body Monoplace or Multiplace Chamber Hyperbaric Oxygen Therapy
Description: Utilization Guidelines




Policy History

Revisions from 07.00.03n
03/28/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on hyperbaric oxygen therapy.


Effective 10/05/2017 this policy has been updated to the new policy template format.
Version Effective Date: 12/01/2016
Version Issued Date: 12/01/2016
Version Reissued Date: 03/28/2018

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