Medical Policy: 02.01.13
Original Effective Date: September 1999
Reviewed: April 2015
Revised: April 2015
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy 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 will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Hyperbaric oxygen therapy (HBO) is a technique of delivering higher pressures of oxygen to the tissues. Two methods of administration are currently available:
- Systemic hyperbaric oxygen administration: Hyperbaric oxygen therapy is a treatment in which a patient breathes near 100% oxygen intermittently while inside a treatment chamber at a pressure higher than sea level pressure (i.e. >1 atmosphere absolute; atm abs). Treatment can be carried out in either a monoplace or multiplace chamber.
- Monoplace Chamber: This accommodates a single patient, the entire chamber is pressurized with near 100% oxygen and the patient breaths the ambient chamber oxygen directly.
- Multiplace Chamber: This holds two or more people (patients, observers, and/or support personnel), the chamber is pressurized with compressed air while the patients breathe near 100% oxygen via masks, head hoods or endotracheal tubes.
According to the Undersea & Hyperbaric Medical Society (UHMS) definition, breathing near 100% oxygen at 1 atmosphere of pressure or exposing isolated parts of the body to near 100% oxygen does not constitute hyperbaric oxygen therapy. The patient must receive the oxygen by inhalation within a pressurized chamber. Current information indicates that pressurization should be at 1.4 atm abs or higher.
- Topical oxygen therapy: is a technique of delivering 100% oxygen directly to an open, moist wound at a pressure slightly higher than ambient pressure. It is theorized that the high concentrations of oxygen diffuse directly into the wound to increase the local cellular oxygen tension, which in turn promotes healing. According to the Undersea and Hyperbaric Medical Society, topical oxygen should not be termed hyperbaric oxygen since doing so suggests topical oxygen treatment is equivalent or identical to hyperbaric oxygen. UHM does not recommend the application of topical oxygen outside the structure of a clinical trial because its use in wound healing has yet to be adequately supported by scientific data.
Examples of topical oxygen administration include a semi-rigid chamber or a polyethylene bag placed over an extremity or trunk wound and secured in place to create an airtight seal. High flow rate oxygen (10 Lpm) is directed into the chamber or bag and passes over the wound. Another device, the TransCu 02 (E02 Concepts Inc., San Antonio, TX) is an electrochemical low-dose, oxygenation system intended for use with advanced wound dressings to treat difficult to heal wounds such as venous leg ulcers, diabetic foot ulcers and pressure ulcers, according to the manufacturer's web site.
Practice Guidelines and Position Statements
Undersea & Hyperbaric Medical Society (UHMS)
The following indications are approved uses of hyperbaric oxygen therapy as defined by the Hyperbaric Oxygen Therapy Committee:
- Air or gas embolism
- Carbon monoxide poisoning
- Carbon monoxide poisoning complicated by cyanide poisoning
- Clostridial myositis and myonecrosis (gas gangrene)
- Crush injury, compartment syndrome and other acute traumatic ischemias
- Decompression sickness
- Arterial insufficiencies
- Cranial retinal artery occlusion
- Enhancement of healing in selected problem wounds
- Severe anemia
- Intracranial abscess
- Necrotizing soft tissue infections
- Osteomyelitis (refractory)
- Delayed radiation injury (soft tissue and bony necrosis)
- Comprised grafts and flaps
- Acute thermal burn injury
- Idiopathic sudden sensorineural hearing loss
American College of Hyperbaric Medicine (ACHM)
The following indications are approved by the American College of Hyperbaric Medicine and are reimbursable through CMS:
- Air or gas embolism
- Acute carbon monoxide intoxication (cyanide poisoning)
- Acute peripheral arterial insufficiency
- Chronic refractory osteomyelitis
- Clostridial myonecrosis (gas gangrene)
- Compromised skin grafts/tissue flaps
- Crush injuries
- Compartment syndrome and acute traumatic ischemias
- Decompression illness
- Diabetic foot ulcer
- Necrotizing soft tissue infections
- Soft tissue radionecrosis
If sufficient data demonstrates that hyperbaric oxygen therapy is associated with a favorable risk-benefit ratio for an indication, which is not currently on the approved list from the Centers of Medicare and Medicaid, The Undersea and Hyperbaric Medical Society or a Commercial Insurance Carrier, the ACHM will endorse the application of hyperbaric therapy for the supported indication. Indications that meet these criteria and are supported by the ACHM as appropriate for hyperbaric oxygen therapy include:
- Acute thermal burns
- Acute central retinal artery occlusion
- Acute frost bite
- Actinomycosis (only as an adjunct to conventional therapy when the disease process is refractory to antibiotics and surgical treatment)
- Brown recluse spider bites
- Intracranial brain abscess
The ACHM supports the treatment of patients with non-approved indications only in a research setting using a protocol that has been approved by an Institutional Review Board. The ACHM supports the continued performance of well-designed clinical trials in these areas, especially those that are prospective, randomized, controlled trials. The ACHM does not support the treatment of non-approved conditions for financial gain, without investigational treatment protocols. College members who intentionally mislead the patient or family into believing that hyperbaric therapy is an approved indications or is supported by peer reviewed literate will be dismissed by the College.
Systemic hyperbaric oxygen (HBO) may be considered medically necessary in the treatment of the following conditions:
- Decompression sickness
- Acute carbon monoxide poisoning
- Gas gangrene (i.e., clostridial myositis and myonecrosis)
- Compromised skin grafts or flaps
- Prophylactic pre-operative and post-operative treatment for patients undergoing dental surgery (non-implant-related) of an irradiated jaw
- Chronic non-healing wounds
- Profound/severe anemia with exceptional blood loss: only when blood transfusion is impossible or must be delayed
- Acute cyanide poisoning
- Air or gas embolism
- Progressive necrotizing infections (necrotizing fascitis)
- Acute peripheral arterial insufficiency
- Osteomyelitis refractory to conventional medical and surgical management
- Acute traumatic ischemia e.g.crush injuries, reperfusion injury, compartment syndrome
- Actinomycosis, only when refractory to antibiotics and surgical treatment
- Diabetic wounds of the lower extremities meeting all of the following criteria:
- Type I or II diabetes mellitus
- Wound classification as Wagner grade III or higher
- History of failed standard wound therapy as defined below
- Initiation of HBO: Covered as adjunct therapy when at least 30 consecutive days of standard wound therapy alone has produced no measureable signs of healing. 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 means to remove devitalized tissue; maintenance of a clean moist bed of granuation tissue with appropriate moist dressings; appropriate off loading; and necessary treatment to resolve any infection that might be present.
- Continued HBO: If measurable signs of wound healing are evident after a 30 day period of treatment with HBO therapy and standard wound therapy. If no measurable signs of wound healing are evidence after the 30 day period, continued treatment with HBO therapy is considered not medically necessary and, therefore, not covered.
- Idiopathic sudden sensorineural hearing loss (defined as a hearing loss of at least 30dB occurring within 3 days over at least 3 contiguous frequencies) and when treatment is initiated within 14 days of symptom onset
- Central retinal artery obstruction when treatment is initiated within 24 hours of vision loss
- Delayed radiation injuries (soft tissue and bony necrosis) (e.g. induced tissue injury, especially in gynecologic malignancies, cystitis, radiation enteritis, proctitis and osteoradionecrosis)
- Acute thermal burns: deep partial thickness (second degree) and full thickness burns (third degree)
- Intracranial abscess (i.e. ceregral abscess, subdural empyma, and epidural empyma)
- Acute frost bite
Systemic hyperbaric Oxygen Therapy (HBO) is considered investigational for all indications not listed above including, but not limited to, the following diagnoses or circumstances as there is insufficient evidence in the medical literature to establish that systemic hyperbaric oxygen therapy is more effective then conventional therapies:
- Acute cerebral edema
- Acute thermal burns (except as descrbed above)
- Refractory mycoses (other than actinomycosis as described above)
- Crohn's disease (includes fistulizing Crohn's disease)
- Migraine headache
- Cerebral palsy
- Acute coronary syndromes and as adjunct to coronary artery interventions including but not limited to percutaneous coronary interventions and cardiopulmonary bypass
- Idiopathic sensorineural hearing loss (other than as described above)
- In vitro fertilization
- Neurologic conditions
- Cerebrovascular disease, acute (thrombotic or embolic) or chronic
- Bone graft
- Acute carbon tetrachloride poisoning
- Fracture healing
- Hydrogen sulfide poisoning
- Intra-abdominal abscesses
- Lepromatous leprosy
- Pseudomembranous colitis (antimicrobial agent-induced colitis)
- Demyelinating disease e.g. multiple sclerosis, amyotropic lateral sclerosis
- Parkinson's disease
- Retinopathy, adjunct to scleral buckling procedures in patients with sickle cell peripheral retinopathy and retinal detachment
- Pyoderma gangrenosum
- Sickle cell crisis and/or hematuria
- Brain injury, acute, traumatic head injury and/or spinal cord injury
- Early treatment (beginning at the completion of radiation therapy) to reduce side effects of radiation therapy
- Autism spectrum disorders
- Idiopathic femoral head necrosis
- Chronic arm lymphedema following radiotherapy for cancer
- Radiation-induced injury of the head and neck
- Tumor sensitization for cancer treatments including but not limited to radiotherapy or chemotherapy
- Preconditioning to improve myocardial function and/or reduce postoperative complications in patients undergoing coronary artery bypass grafting (CABG)
- Bell's palsy
- Alzheimer's disease
- Heart disease
- Sport's injury
- Motor dysfunction associated with stroke
- Multiple sclerosis
- Brown recluse spider bite (necrotizing arachnidism)
Topical Oxygen Therapy: According to the Undersea and Hyperbaric Medical Society, topical oxygen should not be termed hyperbaric oxygen since doing so suggests topical oxygen treatment is equivalent or identical to hyperbaric oxygen. All applications of topical oxygen therapy, including electrochemical low-dose oxygenation systems, and those described as hyperbaric are considered investigational as the application of topical oxygen therapy cannot be recommended outside of a clinical trial setting based on the volume and quality of supporting evidence available, additional clinical trials are needed. Also, there is insufficient evidence in the medical literature to establish the effectiveness in the treatment of chronic wound healing.
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, not involving subcutaneous tissue
Grade II - Deep ulcer with penetration through the subcutaneous tissue potentially exposing tendon, bone, or joint capsule
Grade III - Deep ulcer penetrates deeper than Grade II and has evidence of abscess (pus) or osteomyelitis (bone infection)
Grade IV - Gangrene present in the toe(s)
Grade V - Gangrene of the foot requiring amputation
Thermal Burn: The depth of the burn injury is related to contact temperature, duration of contact of the external heat source, and the thickness of the skin. Because the thermal conductivity of skin is low, most thermal burns involve the epidermis and part of the dermis. The most common thermal burns are associated with flames, hot liquid, hot solid objects and steam. The depth of the burn largely determines the healing potential and the need for surgical grafting.
The traditional classification of burns as first, second, third degree was replaced by a system reflecting the need for surgical intervention. The term term fourth degree is still used to describe the most severe burns. The current designations of burn depth are classified as the following:
- Superficial or epidermal (first degree): superficial or epidermal burns involve only the epidermal layer of skin.
- Partial thickness (second degree): partial thickness burns involve the epidermis and portions of the dermis. They are characterized as either superficial or deep.
- Superficial: These burns characteristically form blisters within 24 hours between the epidermis and dermis.
- Deep: These burns extend into the deeper dermis and are characteristically different from superficial partial thickness burns. Deep burns damage hair follicles and glandular tissue.
- Full thickness (third degree): these burns extend through and destroy all layers of the dermis and often injure the underlying subcutaneous tissues.
- Fourth degree-are deep and potentially life threatening injuries that extend through the skin into underlying tissues such as the fascia, muscle and/or bone.
Procedure Codes and Billing Guidelines:
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
- 99183 Physician attendance and supervision of hyperbaric oxygen therapy, per session
- A4575 may be used to report topical hyperbaric oxygen therapy
- E0446 Oxygen delivery system, NOS, includes all supplies and accessories
- G0277 Hyperbaric oxygen under pressure, full body chamber, per 30 minute interval
- Landau Z. Topical hyperbaric oxygen and low energy laser for the treatment of diabetic foot ulcers. Archives of Orthopaedic and Trauma Surgery 1998;117:156-158
- Leslie CA, Sapico FL, Ginunas VJ, Adkins RH. Randomized controlled trial of topical hyperbaric oxygen for treatment of diabetic foot ulcer. Diabetes Care 1988; 11:111-115.
- Colombel JF, Bouault JM, Lesage X, Zavadil P, Quandalle P, Cortot A. Hyperbaric oxygenation in severe perineal Crohn's disease. Diseases of the Colon and Rectum 1995; 38:609-614.
- Lambert PM, Intriere N, Eichstaedt R. Management of dental extractions in irradiated jaws: A protocol with hyperbaric oxygen therapy. Journal of Oral and Maxillofacial Surg 1997; 55:268-274.
- Sipahi AM, Damiao AOMC, de Sousa MM, Barbutti RC, Trivellato S, Esteves C, D'Agostino M, Laudanna AA. Hyperbaric Oxygen: A new alternative in the treatment of perianal Crohns disease. Revista do Hospital das Clinicas; Faculdade de Medicina de Universidade de Sao Paulo. 1996; 51(5):189-191.
- Wilkerson R, Paull W, Coville FV. Necrotizing Fasciitis; review of the literature and case report. Clinical Orthopedics and related research March 1987;216: 187-192.
- Bakker D. Selected Aerobic and Anaerobic Soft Tissue Infections. In E.P. Kindwall and H.T. Whelan ( eds.), Hyperbaric Medicine Practice (pp. 575-597) Flagstaff, AZ: Best Pub. Co.
- Gordillo GM, Sen CK. Revisiting the essential role of oxygen in wound healing. Am J Surg. 186 (2003) 259-263.
- Sheikh AY, Gibson JJ, Rollins MD, Hopf HW, Hussain Z, Hunt TK. Effect of Hyperoxia on Vascular Endothelial Growth Factor Levels in a Wound Model. Arch Surg. 2000;135:1293-1297.
- ECRI. Hyperbaric Oxygen Therapy for Brain Injury, Stroke, Multiple Sclerosis, Cerebral Palsy, and Autism. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2008 January 8. 13p. (ECRI Hotline Response).
- ECRI. Hyperbaric Oxygen Therapy for Chronic Wound Healing. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2007 August 23. 11p. (ECRI Hotline Response).
- ECRI. Hyperbaric Oxygen Therapy for Soft Tissue Radionecrosis. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2008 January 8. 10p. (ECRI Hotline Response).
- ECRI. Hyperbaric Oxygen Therapy for Hemorrhagic Cystitis. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2007 September 20. 7p. (ECRI Hotline Response).
- Rossignol DA, Rossignol LW, Smith S et al. Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind controlled trial. BMC Pediatrics 2009; 9:21.
- Bennett M, Hart B. UHMS Position paper. Treatment of children with autism spectrum disorder with hyperbaric oxygen therapy. December 5, 2009.
- Londahl M, Landin-Olsson M, Katzman P. Hyperbaric oxygen therapy improves health-related quality of life in patients with diabetes and chronic foot ulcer. Diabet Med. 2011 Feb;28(2):186-90. doi: 10.1111/j.1464-5491.2010.03185.x.
- Londahl M, Katzman P, Hammarlund C et al. Relationship between ulcer healing after hyperbaric oxygen therapy and transcutaneous oximetry, toe blood pressure and ankle-brachial index in patients with diabetes and chronic foot ulcers. Diabetologia. 2001 Jan;54(1):65-8. Epub 2010 Oct 9.
- Eskes A, Ubbink DT, Lubbers M et al. Hyperbaric oxygen therapy for treating acute surgical and traumatic wounds. Cochrane Database Syst Rev. 2010 Oct 6;(10):CD008059.
- Spiegelberg L, Djasim UM, van Neck HW et al. Hyperbaric oxygen therapy in the management of radiation-induced injury in the head and neck region: a review of the literature. J Oral Maxillofac Surg. 2010 Aug;68(8):1732-9. Epub 2010 May 20.
- Gothard L, Haviland J, Bryson P et al. Randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphedema after radiotherapy for cancer. Radiother Oncol. 2010 Oct;97(1):101-7. Epub 2010 May 31.
- Camporesi EM, Vezzani G, Bosco G et al. Hyperbaric oxygen therapy in femoral head necrosis. J Arthroplasty. 2010 Sep;25(6 Suppl):118-23. Epub 2010 Jul 15.
- Cope A, Eggert JV, O'Brien E. Retinal artery occlusion: visual outcome after treatment with hyperbaric oxygen. Diving Hyperb Med. 2011 Sep; 41(3):135-8.
- Butler FK Jr, Hagan C, Murphy-Lavoie H. Hyperbaric oxygen therapy and the eye. Undersea Hyperb Med. 2008 Sep-Oct; 35(5):333-87.
- Menzel-Severing J, Siekmann U, Weinberger A et al. Early hyperbaric oxygen treatment for nonarteritic central retinal artery obstruction. Am J Ophthalmol. 2012 Mar; 153(3):454-59.e2. Epub 2011 Oct 11.
- Stachler RJ, Chandrasekhar SS, Archer SM et al. Clinical practice guideline: sudden hearing loss. Otolaryngol Head Neck Surg. 2012 Mar; 146(3 Suppl):S1-35.
- Murphy-Lavoie H, Piper S, Moon RE et al. Hyperbaric oxygen therapy for idiopathic sudden sensorineural hearing loss. Undersea Hyperb Med 2012; 39(3):777-92.
- Craighead P, Shea-Budgell MA, Nation J et al. Hyperbaric oxygen therapy for late radiation tissue injury in gynecologic malignancies. Curr Oncol. 2011 Oct; 18(5):220-7.
- Allen S, Kilian C, Phelps J et al. The use of hyperbaric oxygen for treating delayed radiation injuries in gynecologic malignancies: a review of literature and report of radiation injury incidence. Support Care Cancer. 2012 Jan 14. [Epub ahead of print].
- Bennett MH, Feldmeier J, Smee R et al. Hyperbaric oxygenation for tumor sensitization to radiotherapy. Cochrane Database Syst Rev. 2012 Apr 18; 4: CD005007.
- Kranke P, Bennett MH, Martyn-St. James M et al. Hyperbaric oxygen therapy for chronic wounds. Cochrane Database Syst Rev. 2012 Apr 18; 4:CD004123.
- Li Y, Dong H, Chen M et al. Preconditioning with repeated hyperbaric oxygen induces myocardial and cerebral protection in patients undergoing coronary artery bypass graft surgery: a prospective, randomized, controlled clinical trial. J Cardiothorac Vasc Anesth. 2011 Dec; 25(6):908-16. Epub 2011 Aug 25.
- Jeysen ZY, Gerard L, levant G et al. Research report: the effects of hyperbaric oxygen preconditioning on myocardial biomarkers of cardioprotection in patients having coronary artery bypass graft surgery. Undersea Hyperb Med. 2011 May-Jun; 38(3):175-85.
- Holland NJ, Bernstein JM, Hamilton JW. Hyperbaric oxygen for Bell's palsy. Cochrane Database Syst Rev 2012; 2:CD007288.
- Feldmeier JJ, Hopf HW, Warriner III RA et al. UHMS position statement: topical oxygen for chronic wounds. Undersea Hyperb Med. 2005 May-Jun; 32(3): 157-68.
- Bennett MH, Lehm JP, Jepson N. Hyperbaric oxygen therapy for acute coronary syndrome. Cochrane Database of Syst Rev. 2011; 8:CD004818.
- Ghanizadeh A. Hyperbaric oxygen therapy for treatment of children with Autism: a systematic review of randomized trials. Med Gas Res 2012; 2:13.
- Rossignol DA, Bradstreet JJ, Van Dyke K et al. Hyperbaric oxygen treatment in autism spectrum disorders. Med Gas Res 2012; 2(1):16.
- ECRI Institute: Windows on Medical Technology Policy Statement, Hyperbaric Oxygen Therapy for Chronic Wound Healing
- ECRI Institute-Hyperbaric Oxygen Therapy for Chronic Wound Healing, published 04/01/2011
- ECRI Institute-Topical Oxygen Therapy for Chronic Wound Healing, published 03/29/2011
- Hypebaric oxygen therapy for Brain Injury, Stroke, Multiple Sclerosis, Cerebral Palsy and Autism, published 03/07/2011
- Undersea and Hyperbaric Medical Society, Hyperbaric Oxygen Therapy Indications.
- American College of Hyperbaric Medicine FAQ, What are the Approved Indications for Hyperbaric Oxygen Therapy.
- ECRI Institute: Transcutaneous Oxygen Monitoring for Managing Chronic Wounds, Published 02/05/2013
- FDA Consumer Health Information. Hyperbaric Oxygen Therapy: Don’t be Mislead. www.fda.gov/consumer
- Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) for Hyperbaric Oxygen Therapy (20.29). www.cms.gov
- Agency of Healthcare Research and Quality, Evidence Report/Technology Assessment, Number 85, Hyperbaric Oxygen Therapy for Brain Injury, Cerebral Palsy and Stoke. AHRQ Pub. No. 03-E049 September 2003. www.ahrq.gov
- National Guideline Clearinghouse. Clinical Practice Guideline: Sudden Hearing Loss. March 2012. www.guideline.gov.
- National Guideline Clearinghouse. Traumatic Brain Injury Medical Treatment Guidelines. November 2012. www.guideline.gov
- National Guideline Clearinghouse. Guideline for Primary Care Management of Headache in Adults. July 2012. www.guideline.gov
- National Guideline Clearinghouse. Crohn’s Disease: Management in Adults, Children and Young People. NICE clinical guideline; no. 152, October 2012. www.guideline.gov
- National Guideline Clearinghouse. Management of Crohn’s Disease in Adults. Practice Parameters Committee of American College of Gastroenterology, Management of Crohn’s Disease in Adults. Am J Gastroenterol, 2009 Feb; 104(2):465, 484. www.guideline.gov
- National Institute for Health and Care Excellence (NICE), Clinical Guideline 170. Autism, The Management and Support of Children and Young People on the Autism Spectrum. Issued August 2013.
- Undersea and Hyperbaric Medical Society (UHMS) Position Statement: Topical Oxygen for Chronic Wounds. UHM 2005, Vol. 32, No. 3.
- Transcutaneous Oximetry in Clinical Practice: Consensus Statements from an Expert Panel Based on Evidence. UHM 2009, Vol. 36, No. 1.
- PubMed Hyperbaric Oxygen Therapy for Multiple Sclerosis. Also available at www.ncbi.nlm.nih.gov/pubmed/20415839
- American Family Physicians, Evaluation and Treatment of Brown Recluse Spider Bites, Am Fam Physician 2005 Oct 1; 72(7):1372-1376
Date Reason Action
August 2011 Annual review Policy revised
August 2012 Annual review Policy revised
July 2013 Annual review Policy revised
May 2014 Annual review Policy revised
April 2015 Annual review Policy revised
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*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.