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Chronic Refractory Osteomyelitis

Chronic Refractory Osteomyelitis

INTRODUCTION

Treatment Protocol Guidelines

The following hyperbaric medicine treatment protocol is based upon the recommendations of the Hyperbaric Oxygen Committee of the Undersea and Hyperbaric Medical Society.  Clinical protocols and/or practice guidelines are systematically developed statements that help physicians, other practitioners, case managers and clients make decisions about appropriate health care for specific clinical circumstances.  

Protocols allow health providers to offer evidence-based, appropriate, standardized diagnostic treatment and care services to patients undergoing hyperbaric oxygen therapy (HBOT). Evidenced-based medicine offers clinicians a way to achieve improved quality, improved patient satisfaction, and reduced costs. Utilization Review should be initiated when clinical decisions result in deviation from or modification of treatment protocols. This includes any course of treatment at or above the recognized threshold limits. 

Medical Necessity

Medicare.gov defines "medically necessary" as "health-care services or supplies needed to prevent, diagnose, or treat an illness, injury, condition, disease, or its symptoms and that meet accepted standards of medicine."

The following condition meets coverage indications per the National Coverage Determination (NCD) 20.29Continued HBO therapy without documented evidence of effectiveness does not meet the Medicare definition of medically necessary treatment. Thorough re-evaluation should be made at least every 30 days for documentation of response to therapy. 


The following hyperbaric medicine treatment protocol is based upon the recommendations of the Hyperbaric Oxygen Committee of the Undersea and Hyperbaric Medical Society.  Clinical protocols and/or practice guidelines are systematically developed statements that help physicians, other practitioners, case managers and clients make decisions about appropriate health care for specific clinical circumstances.  

Protocols allow health providers to offer evidence-based, appropriate, standardized diagnostic treatment and care services to patients undergoing hyperbaric oxygen therapy (HBOT). Evidenced-based medicine offers clinicians a way to achieve improved quality, improved patient satisfaction, and reduced costs. Utilization Review should be initiated when clinical decisions result in deviation from or modification of treatment protocols. This includes any course of treatment at or above the recognized threshold limits. 


TREATMENT PROTOCOL


Background
Refractory osteomyelitis is defined as a chronic osteomyelitis that persists or recurs after appropriate interventions have been performed or where acute osteomyelitis has not responded to accepted management techniques. 

Goals of HBOT

  • Enhances bacterial killing activity of white blood cells 
  • Augments the bactericidal activity of aminoglycosides and likely has similar effects on other antibiotics    
  • Osteogenesis and osteoclast remodeling is an oxygen-dependent activity
  •  Osteomyelitis is characterized by both acute and chronic forms of hypoxia. Hyperbaric oxygen raises tissue levels of oxygen and decreases tissue hypoxia.
  • Hyperbaric oxygen (HBO) decreases edema, enhances neovascularization, and supports new collagen and bone formation. 

Diagnosis 

  • Bone Cultures are the gold standard in confirming the diagnosis of osteomyelitis
  • X-rays, bone scan, Computerized Tomography (CT), Magnetic Resonance (MR), sinogram or tomograms that demonstrate osteomyelitis.
  • When appropriate surgical or antibiotic interventions fail (4- 6 week course) and osteomyelitis progresses, recurs or presents a high probability of morbidity or mortality

Hyperbaric Criteria


  • Refractory osteomyelitis is a chronic osteomyelitis that persists or recurs after appropriate interventions have been performed after a 30 day period
  • where acute osteomyelitis does not respond to accepted management techniques.      
  • Failure to resolve following surgical debridement and appropriate antibiotics regimen of 4-6 weeks preferably selected from appropriate culture and sensitivity information, drainage of abscesses, suitable immobilization of the affected part and debridement with the removal of infected bone.

Evaluation

Evaluation of CROM is a 4 step process:  
    • Past Medical History
    • The Examination helps to confirm the diagnosis, define the extent of the infection, and plan strategies for managing chronic refractory osteomyelitis (CROM).
    • Laboratory Studies are useful and include: bone cultures not only confirm the diagnosis of osteomyelitis but also are instrumental in determining antibiotic selection. 
    • The Cierny-Mader classification of the osteomyelitis can be used as a guide to determine which patients will most likely benefit form HBO2 therapy.
    • Complet Blood Count (CBC)
    • Erythrocyte Sedimentation Rate (ESR) 
    • C-reactive protein (CRP)
    • Nutritional Assessment
    • Glucose
    • Hemoglobin A1c
    • Pre-albumin
    • Albumin
    • Wound culture
    • X-ray
    • Nuclear Medicine Imaging (Bone Scan or Indium scan)
    • Single photon emission computed tomography (SPECT-CT)
    • Magnetic Resonance (MR)
    • Consider removal of internal fixation hardware and other foreign materials that do not directly contribute to osseous stability of the site. 
    • Debridement and appropriate dressing changes as necessary
    • Evaluation of Tympanic Membranes pre and post-treatment as needed

Treatment

  • 2.0 to 2.5 ATA for 90 minutes of oxygen breathing. (Table 1 or Table 2)
  • Initial HBO treatment at 2.5 ATA may provide physicians with the best theoretical balance between clinical efficacy and oxygen toxicity risk.
  • Treatments may be provided daily, or twice daily during the first two to three postoperative days, in limb-threatening cases. 
  • 20-40 postoperative HBO sessions will be required to achieve sustained therapeutic benefit. 
  • Treatments may be extended to 60 depending on the severity of the disease process. Utilization review is recommended.
  • The duration of HBO therapy must be judged on the basis of each patient's clinical response.
  • The best clinical results are obtained when HBO therapy is administered in conjunction with culture-directed antibiotics and scheduled to begin soon after thorough surgical debridement. 
  • Where clinical improvement is seen, the present regimen of antibiotic and HBO therapy should be continued for four to six weeks. 
  • Hyperbaric oxygen treatments continue until there are signs of healing and no osteomyelitis present. 
  • In cases where extensive surgical debridement or removal of fixation hardware may be contraindicated (e.g. cranial, spinal, sternal, or pediatric osteomyelitis), a trial of limited debridement, culture-directed antibiotics, and HBO therapy prior to more radical surgical intervention provides a reasonable chance for osteomyelitis cure.
  • The osteomyelitis will be serially monitored with the surgeon and Infectious disease consultant    
  • Repeat X-rays and/or MRI of the affected area at 20 and 40 treatments
  • Continued wound evaluation and management with photography as indicated

Follow-Up

  • If prompt clincial response is not noted or osteomyelitis recurs after this initial treatment period, then continuation of the existing antibiotic and HBO treatment regimen is unlikely to be affective.  
  • Clinical management strategies should be reassessed and additional surgical debridement and/or modification of antibiotic therapy implemented without delay.
  • Reinstitution of HBO therapy wil help maximize the overall chances for treatment success. 
  • Patient will continue long term follow up with referring physician
  • Visual Acuity Assessment for progressive myopia
  • Wound assessment with photography as indicated

Treatment Period

20 – 40 treatments (Utilization review should be requested after 40 treatments)

Coding

Refer to the ICD-10 Guideline for the appropriate ICD-10 code

Comments

a 4-6 week treatment course of antibiotics was selected to ensure antibiotic coverage is continued throughout the time necessary for surgically debrided bone to undergo revascularization.
It appears that as long as adequate antibiotic serum and bone concentrations are maintained throughout this four to six coverage period, antibiotic specificity and compliance with the prescribed treatment regimen are more important than the specific route of administration. 

If diabetic, blood sugar should be checked 1 hour prior to treatment and post HBO by unit personnel. 
Primary Sources: Whelan and Kindwall [1]Weaver [2]National Baromedical Services [3]


DOCUMENTATION

While no randomized clinical trials exist, the overwhelming majority of published animal data, human case series, and prospective trials support HBO2 therapy as a safe and effective adjunct to the management of refractory osteomyelitis. Further, when used appropriately, HBO2 therapy appears to reduce the total need for surgical procedures, required antibiotic therapy and, consequently, overall healthcare expenditures. [4]

In most cases, the best clinical results are obtained when HBO2 therapy is administered in conjunction with culture-directed antibiotics and scheduled to begin soon after thorough surgical debridement. A course of four to six weeks of combined HBO2 and antibiotic therapy should be sufficient to achieve the desired clinical results. If osteomyelitis fails to resolve or recurs after a total of 6 weeks of continuous culture-directed antibiotics and HBO2 treatment (30-40 sessions), then additional surgical bony debridement will likely be required to eradicate residual infection. 

The medical record documentation must support medical necessity of the services and provide and accurate description and diagnosis of the medical condition supporting the use of HBO2 is reasonable and medically necessary.

The submitted medical record must support the use of the selected ICD-10 code(s). The submitted CPT/HCPCS code must describe the service performed. 

Below we explain in detail what needs to be documented. See also:

History and Physical

  • An initial assessment including a history and physical that clearly substantiates the condition for which HBO is recommended.
  • Prior medical, surgical and/or hyperbaric treatments.
  • Past medical records must be available to document chronicity, and the refractory nature of the disease.

Physical Exam

  • Documentation of the failure to resolve the following: surgical bony debridement and appropriate course of antibiotics.
  • Documentation of specific antibiotic administration for a minimum of four to six weeks.
  • Documented evidence of bone culture sensitivities, X-rays, Bone Scan, CT or MRI demonstrating osteomyelitis.
  • Documented consideration of removal of all orthopedic hardware within infected bone.
  • Documented evidence of wound chronicity despite standard wound care.
    • Initial Ulcer size - beginning of 30 days of standard wound care.
    • Ulcer size – (current) Following standard wound care
  • Documentation of optimization of nutritional status
    • Albumin
    • Pre-Albumin

Risk Assessment

  • Risk benefit ratio in favor of offering hyperbaric oxygen therapy, example statement:

The patient was informed of the possible risks and complications of hyperbaric oxygen therapy. These include, but are not limited to, fire, barotrauma of the ears, sinuses, and lungs to include air embolism, central nervous system oxygen toxicity resulting in seizure, cataracts, myopia, and exacerbation of congestive heart failure.

Having no absolute contraindication to hyperbaric oxygen therapy, the patient will be offered treatment 2.0 ATA for 90 minutes OR at 2.5 ATA for 90 minutes with two inter-current ten minute air breaks (Where pseudomonas or E. coli is isolated). Forty treatments will initially be provided on a once daily basis Monday through Friday. Thereafter, a re-evaluation of the patient’s clinical progress will be in order to determine if additional treatments may be required.

Impression

Refer to ICD – 10 crosswalk – Single diagnosis code meets medical necessity for Chronic Refractory Osteomyelitis

Plan

Example Statement supporting the role of hyperbaric oxygen therapy:

Mechanisms by which HBO has been shown to be beneficial include the following:

    1. Enhanced host immune competency - leukocyte oxidative killing requires oxygen as a substrate (~30mmHg) to allow for the leukocyte oxidative burst.  Increased oxygen partial pressures, achieved only under hyperbaric conditions, provide greater diffusion of oxygen and, thus greater tissue concentrations of oxygen in tissues at risk.
    2. Antibiotic synergism – oxygen is a crucial substrate in the mechanism by which many antibiotics penetrate bacterial and fungal cells. Increased tissue oxygen levels enhance antibiotic efficacy in the setting of necrotizing infections where microvascular injury typically compromises tissue oxygenation.
    3. Toxin inhibition and inactivation – toxins elaborated by Clostridial species, particularly the alpha and cardiac toxins, significantly contribute to the high mortality and morbidity of this disease. Rapid tissue destruction resulting from the highly diffusible alpha toxin is the primary pathophysiological process of this devastation disease. Hyperbaric oxygen has been shown to inhibit alpha toxin production thus limiting the extent of tissue destruction. This inhibition also provides a clear demarcation of viable tissue thereby limiting the extent of surgical debridement. Cardiotoxin is also inactivated preserving cardiac function in an otherwise critically ill patient.
    4.  Direct cidal activity – oxygen, at hyperbaric pressures, can be bacteriocidal to true anaerobic and microaerophilic strains of bacteria i.e. those bacterial lacking antioxidative defenses such as superoxide dismutase and catalase.
  1.  Hyperbaric Oxygen Therapy 2.0 ATA for 90 minutes breathing 100% oxygen.
  2.  Where pseudomonas or E. coli is isolated, consider 2.5 ATA for 90 minutes breathing 100% oxygen.
  3.  Treatment to be provided Q day
  4.  Total treatments ordered: 20 - 40
  5.  Institute air breaks as indicated.
  6.  Treatments are given on a QD basis
  7.  X-rays and/or MRI of affected area at 20 and 40 treatments
  8.  Consider weekly CBC and sedimentation rate
  9.  Consider weekly C & S of affected area
  10.  Dressing changes as needed
  11.  Re-evaluate and document weekly for wound status (appearance and dimensions).

Sample Order

Sample Physician Order

    CLINICAL EVIDENCE AND RECOMMENDATIONS  

    We suggest inclusion of HBO therapy in the patient’s treatment regimen, along with surgical debridement and culture-directed antibiotics for adult patients with osteomyelitis that is refractory to 4-6 weeks of appropriate surgical and antibiotic interventions (definition of chronic refractory osteomyelitis, or CRO) in cases:

    • 2C
      With uncomplicated extremity osteomyelitis (Grade 2C), OR
    • 2C
      In which significant patient morbidity or mortality is not likely to occur (Grade 2C)

    We recommend inclusion of HBO therapy in the patient’s treatment regimen in the following cases:

    • 1C
      As an adjunctive therapy with antibiotics and surgical debridement, for adult patients with osteomyelitis of long bones or miscellaneous sites that is refractory to 4-6 weeks of appropriate surgical and antibiotic interventions only (CRO), with osteomyelitis classified as Cierny-Mader 3B or 4B (Grade 1C)
    • 1C
      As an adjunctive therapy with antibiotics, prior to surgical debridement (and after minimal debridement) for adult patients with CRO which results in high probability of mortality and morbidity (with osteomyelitis involving the spine, skull, sternum or other bony structures associated with a risk for high morbidity or mortality (Grade 1C)
    • 1C
      As an adjunctive therapy with antibiotics, prior to surgical debridement (and after minimal debridement) for children with CRO in any site (Grade 1C)
    • 1A
      As an adjunctive therapy for osteomyelitis in patient with diabetic foot ulcers (DFU) Wagner 3 or 4, refractory to 30 days of standard wound care (Grade 1A)  (See “HBO treatment - Diabetic Foot Ulcers”)

    Rationale:  In general, low-certainty evidence (evidence level C) or expert opinion support the use of HBO to promote healing of CRO. As to date no RCT has been carried out and no systematic reviews/ meta-analyses have been published, evidence is drawn from several animal studies, case series and observational studies. [5] [6] According to the main guidelines in the field (by the UHMS and ECHMG), HBO therapy is a safe and an effective adjunct to management of CRO if guidelines are followed. [5] [6] For cases graded 1C, the benefits of adjunctive HBO outweighs the risks of side effects and complications. Data from animal and clinical studies suggest that management with culture-directed antibiotics, debridement and HBO is the strategy most likely to achieve CRO healing.  Medicare covers HBO for CRO as long as requirements are met ( osteomyelitis must be chronic and refractory to usual standard of care management - i.e., prolonged antibiotics therapy preferably directed by appropriate culture and sensitivity information, drainage of the abscesses, immobilization of the affected extremity, and surgical debridement with removal of infected bone. HBO for osteomyelitis that is not documented to be chronic and refractory to conventional treatment, and HBO not provided in an adjunctive fashion, is not covered) [7] [8] While HBO is costly, its addition to management of CRO when following guidelines appears to be associated with fewer surgical procedures, less antibiotics and shorter hospital length of stay  [5]

    CODING

    See ICD-10 Coding for CROM

    APPENDIX

    Summary of Evidence -  HBO for Chronic Refractory Osteomyelitis (back to text)

    1. Guidelines:

    • The 2014 UHMS HBO Therapy Indications Book (Guidelines) and the 2017  European Committee for Hyperbaric Medicine Guidelines support the use of HBOT as an adjunctive therapy to treat chronic refractory osteomyelitis, and although the guidelines use different evidence grading methodologies, they are in agreement regarding strength of recommendation . [5] [6] See table below:

    HBO therapy for chronic refractory osteomyelitis

    UHMS, 2014

    ECHMG, 2017

    HBO + antibiotics + debridement in the treatment of chronic refractory osteomyelitis

    AHA Class II (conflicting evidence and/or divergence of opinion)

    Grade 2C (weak recommendation, conditions do not allow for proper RCTs but there is ample and  international expert consensus)

    HBO + antibiotics + debridement for patients with CRO of long bone or miscellaneous sites, classified as more severe Cierny-Mader Class 3B or 4B disease

    AHA Class IIa (Weight of evidence/opinion is in favor of

    usefulness/efficacy)

    n/a

    HBO + antibiotics for patients with osteomyelitis involving the spine, skull, sternum or other bony structures associated with a risk for high morbidity or mortality or for children, prior to debridement

    AHA Class IIa (Weight of evidence/opinion is in favor of

    usefulness/efficacy)

    n/a

    HBO + antibiotics + debridement for patients with associated Wagner Grade 3 or 4 diabetic ulcer

    AHA Class I (Conditions for which there is evidence, general

    agreement, or both that a given procedure or treatment is

    useful and effective)

    n/a

    HBO + antibiotics + debridement for compromised patients

    n/a

    Grade 2C

    HBO protocol be individualized based  on the condition and compliance of the patient

    n/a

    Grade 2C

    Evaluate effects of HBO repeatedly during and after treatment using the same  diagnostic methods as used pre HBOT. Perform at least 11−12 weeks of HBOT, approx. 60 sessions, before any significant clinical effect should be expected.

    n/a

    Grade 1C

    We reviewed the guidelines and studies published since guidelines were last updated.  Applying the GRADE framework to the combined body of evidence, we found that:

    • In general, low-certainty evidence (evidence level C) or expert opinion support the use of HBO to promote healing of CRO. As to date no RCT has been carried out and no systematic reviews/ meta-analyses have been published, evidence is drawn from several animal studies, case series and observational studies. The UHMS guideline [5] based its recommendations on 9 prospective animal studies, and 31 human studies, most case series (classed AHA level of evidence 5) or observational studies  (AHA level of evidence 3 or 4). In general, these studies support HBO therapy as safe and an effective adjunct to management of CRO. The ECHMG did not cite any published sources of reference and thus assigned a score Grade 2C using the Grade system through an expert consensus. [6]. Since the latest UHMS update, another clinical retrospective study was published in 2015. This study evaluated the effectiveness of HBO therapy as an adjunctive therapy for 23 patients with chronic refractory osteomyelitis found that 82.6% of patients presented with successful or improved outcomes. The study is observational, with small sample size (evidence level C) [9]
    • Evidence gathered from studies on HBO in management of CRO stratified by topographical site/indications was drawn from case series/observational studies, and thus classified as low-certainty (evidence level C). One exception is CRO in diabetic foot ulcers (DFU), which is covered in another topic (link pending “Diabetic Foot Ulcers - HBO”). Use of adjunctive HBO to treat CRO in DFU is supported by meta-analyses of 5 RCT (118 participants) that concluded that adjunctive HBO is effective in reducing risk of amputation in patients with CRO and DFU [RR 0.31, 95% confidence interval (0.13-0.71)]  [7] [10]
    • The following hyperbaric medicine treatment protocol is based upon the recommendations of the Hyperbaric Oxygen Committee of the Undersea and Hyperbaric Medical Society.  Clinical protocols and/or practice guidelines are systematically developed statements that help physicians, other practitioners, case managers and clients make decisions about appropriate health care for specific clinical circumstances.  

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    REFERENCES

    1. CMS. National Coverage Determination (NCD) for Hyperbaric Oxygen Therapy (20.29) . Date of publication 2017;.
    2. Mathieu, Daniel; Marroni, Alessandro; Kot, Jacek et al. Tenth European Consensus Conference on Hyperbaric Medicine: recommendations for accepted and non-accepted clinical indications and practice of hyperbaric oxygen treatment. Diving and hyperbaric medicine. Date of publication 2017;volume 47(1):24-32.
    3. Novitas Solutions, Inc et al. Local Coverage Determination for Hyperbaric Oxygen (HBO) Therapy (L35021) . Date of publication 2015;.
    4. Roeckl-Wiedmann, I; Bennett, M; Kranke, P et al. Systematic review of hyperbaric oxygen in the management of chronic wounds. The British Journal of Surgery. Date of publication 2005;volume 92(1):24-32.
    5. Skeik, Nedaa; Porten, Brandon R; Isaacson, Erin; Seong, Jenny; Klosterman, Deana L; Garberich, Ross F; Alexander, Jason Q; Rizvi, Adnan; Manunga, Jesse M; Cragg, Andrew; Graber, John; Alden,... et al. Hyperbaric oxygen treatment outcome for different indications from a single center. Annals of Vascular Surgery. Date of publication 2015;volume 29(2):206-214.
    6. Undersea and Hyperbaric Medical Society Hyperbaric Oxygen Committee,, et al. Hyperbaric Oxygen Therapy Indications . Date of publication 2014;.