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Chronic Refractory Osteomyelitis

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). We will be discussing Chronic Refractory Osteomyelitis (CROM). 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) 20.29. Continued 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. [1] 

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


  HBO request requirements checklist   |  Sample Physician Order   | $ ICD-10 Crosswalk   |    Treatment Table

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

  • Enhance bacterial killing activity of white blood cells 
  • Augment 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 therapy (HBOT) 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 may 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


  • 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.
  • Sample history: Mr. Jones comes to us with a non-healing fracture of the left tibia. This was due to trauma several years ago. It was treated with internal fixation by plate and screws. In the past 2 months, a pinhole opening was noted in the previously healed incision line. He was seen by Dr. Smith, his orthopedic surgeon. After laboratory and x-ray evaluation, Mr. Jones has a draining osteomyelitis of the left tibia. Dr. Smith took Mr. Jones to the operating room and removed all of the hardware. Bone cultures grew primarily Staph and Strep with an antibiogram. Culture-directed IV antibiotics for 6 weeks was undertaken. The osteomyelitis remains present and draining. Dr. Smith took Mr. Jones to the operating room last week for incision/drainage and saucerization of the osteomyelitis . We were consulted to provide adjunctive HBOT due to the chronic/refractory nature of this wound.

Evaluation

    • 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.  
      • Complete Blood Count (CBC)
      • Erythrocyte Sedimentation Rate (ESR) 
      • C-reactive protein (CRP)
      • Nutritional Assessment
      • Glucose
      • Hemoglobin A1c
      • Pre-albumin
      • Albumin
    • Nutritional Assessment
    • Wound culture
    • X-ray
    • Nuclear Medicine Imaging (Tagged WBC 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 advanced wound care as necessary

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 are usually provided daily
  • Treatments may be twice daily during the first two to three postoperative days in limb-threatening cases. 
  • The duration of HBO therapy must be judged on the basis of clinical response.
  • The best clinical results are obtained when HBOT is administered in conjunction with appropriate surgical debridement with bone culture as required for culture-directed antibiotics 
  • Where clinical improvement is seen, the present regimen of antibiotic and HBOT should be continued for 4-6 weeks. 
  • Hyperbaric oxygen treatments continue until a good granulation bed has formed and no clinical signs of osteomyelitis are 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 after 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 HBOT 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 HBOT will help maximize the overall chances for treatment success. 
  • Visual Acuity Assessment for progressive myopia Visual acuity assessment
  • Wound assessment with photography as indicated, generally weekly in the wound clinic.

Treatment Period

 20-40 HBOT sessions will be required to achieve sustained therapeutic benefit. (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 appropriate, bone-penetrating antibiotics is selected to ensure antibiotic coverage is continued throughout the time necessary for surgically debrided bone to undergo revascularization and healing. This is usually in conjunction with an Infectious Disease specialist, if possible.
  • Antibiotic specificity and compliance with the prescribed treatment regimen are important. Usually IV antibiotics have better bone penetration than oral, however, new antibiotics have been shown to be effective in oral administration. 
  • If diabetes mellitus is present, blood glucose should be checked within an hour prior to treatment and immediately post-HBOT by unit personnel. 
Primary Sources: Whelan and Kindwall [2]Weaver [3], [4]

DOCUMENTATION

While no randomized clinical trials exist, the overwhelming majority of published animal data, human case series, and prospective trials support HBOT as a safe and effective adjunct to the management of refractory osteomyelitis. Further, when used appropriately, HBOT appears to reduce the total need for surgical procedures, required antibiotic therapy and, consequently, overall healthcare expenditures. [1]

In most cases, the best clinical results are obtained when HBOT is administered in conjunction with culture-directed antibiotics and scheduled to begin soon after thorough surgical debridement. A course of 4-6 weeks of combined HBOT 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 HBOT (30-40 sessions), then additional surgical bony debridement will likely be required to eradicate residual infection. 

The medical record documentation must support medical necessity (and evidence of complex medical decision making) of the services and provide and accurate description and diagnosis of the medical condition supporting the use of HBOT is reasonable and medically necessary.

Sample documentation:

"Mr. Jones has been aggressively managed by Dr. Smith (Ortho), Dr. Abrams (ID), and Dr. Black (Wound Care) over the past 6 weeks. He is now at HBOT number 40. His clinical blood markers (CRP and ESR) have regressed but are now climbing again. Imaging shows a continued bony defect with a fistulogram/sinogram suggesting that the bone is the source of drainage. A bone biopsy and saucerization is scheduled for next week. Based on the clinical course, we have agreed to continue HBOT to a total of 60 treatments."

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 and provide sample statements that can be adapted to suit your needs. See also:

  •   HBO request requirements checklist   

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 4-6 weeks.
  • Documented evidence of bone culture sensitivities, plain X-ray, Tagged WBC bone scan, CT, or MRI demonstrating osteomyelitis.
  • Documented consideration of removal of all orthopedic hardware or other foreign bodies within the infected bone.
  • Document CRP and ESR response and trends
  • 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

Impression

  • Chronic Refractory Osteomyelitis Refer to ICD-10 Crosswalk

Plan

"A typical hyperbaric regimen for a patient with chronic refractory osteomyelitis consists of daily hyperbaric oxygen treatments at 2.0 or 2.4 ATA for 90 to 120 minutes of oxygen breathing at pressure. The site of the infection is monitored on a regular basis. Consultation with the orthopaedic surgeon and infectious disease specialists will occur throughout the patient’s treatment period. Hyperbaric oxygen treatments continue until there are signs of healing and no osteomyelitis present. The number of treatment generally varies between 30 and 40, however can be extended to 60 depending on the severity of the disease process."

Risk and Benefit of Hyperbaric Oxygen Therapy 

Please refer to topic "Documentation HBO: Risks and Benefits"

Indication for Hyperbaric Oxygen Therapy (HBOT)

"Refractory osteomyelitis is a chronic osteomyelitis that persists or recurs after appropriate interventions have been performed, or where acute osteomyelitis does not respond to accepted management techniques. Hyperbaric oxygen, when combined with appropriate antibiotics, nutritional support, surgical debridement and reconstruction, provides a useful clinical adjunct in the management of refractory bone infections. Addition of hyperbaric oxygen to appropriate clinical management produces an infection arrest rate of nearly 80%. 

Hyperbaric oxygen benefits healing by enhancing bacterial phagocytosis activity of white blood cells. Next, certain antibiotics require an oxygen-mediated pathway in order to transport the medication across bacterial walls.  Third, there is evidence that osteogenesis and osteoclast remodeling is an oxygen-dependent activity. Finally, osteomyelitis is characterized by both acute and chronic forms of hypoxia. Hyperbaric oxygen raises tissue levels of oxygen, decreases edema, decreases tissue hypoxia, enhances neovascularization, and supports new collagen and bone formation."

Sample Order

Sample Physician Order

    CLINICAL EVIDENCE AND RECOMMENDATIONS  

    We suggest inclusion of adjunctive HBOT, 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 CROM) 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 (CROM), 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 CROM 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 CROM 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, there is low-certainty evidence (evidence level C) or expert opinion support the use of HBO to promote healing of CROM. 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), HBOT is a safe and an effective adjunct to management of CROM if guidelines are followed.[5][6] For cases graded 1C, the benefits of adjunctive HBOT outweighs the risks of side effects and complications. Data from animal and clinical studies suggest that management with culture-directed antibiotics, debridement and HBOT is the strategy most likely to achieve CROM healing.  Medicare covers HBOT for CROM as long as requirements are met (e.g., osteomyelitis must be chronic and refractory to usual standard of care management, described above. HBOT for osteomyelitis that is not documented to be chronic and refractory to conventional treatment, and HBOT not provided in an adjunctive fashion, is not covered) [7][8] While HBOT is costly, its addition to management of CROM 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 

    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 HBOT to promote healing of CROM. As to date no RCT has been carried out and no systematic reviews/ meta-analyses have been published, evidence is drawn from 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 HBOT in management of CROM stratified by topographical site/indications was drawn from case series/observational studies, and thus classified as low-certainty (evidence level C). One exception is CROM in diabetic foot ulcers (DFU), which is covered in another topic (link pending “Diabetic Foot Ulcers - HBO”). Use of adjunctive HBOT to treat CROM in DFU is supported by meta-analyses of 5 RCT (118 participants) that concluded that adjunctive HBOT is effective in reducing risk of amputation in patients with CROM and DFU [RR 0.31, 95% confidence interval (0.13-0.71)]  [7] [10]
    • The 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.  
    • While there is no Level 1 evidence (Randomized Controlled Trials), the case series and small clinical case studies show an abundance of Level 2 evidence for adjunctive use of HBOT in CROM. Level 2 evidence generally mirrors what we describe as "good clinical practice." In many cases, strong Level 2 evidence is more beneficial to clinical decision making than Level 1, highly controlled RCT studies. 

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    REFERENCES

    1. Brett B. Hart, MD et al. Undersea and Hyperbaric Medical Society, Hyperbaric Oxygen Indications, 13th edition: Refractory Osteomyelitis . 2014;.
    2. CMS. National Coverage Determination (NCD) for Hyperbaric Oxygen Therapy (20.29) . 2017;.
    3. 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. 2017;volume 47(1):24-32.
    4. Novitas Solutions, Inc et al. Local Coverage Determination for Hyperbaric Oxygen (HBO) Therapy (L35021) . 2015;.
    5. 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. 2005;volume 92(1):24-32.
    6. 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. 2015;volume 29(2):206-214.
    7. Undersea and Hyperbaric Medical Society Hyperbaric Oxygen Committee,, et al. Hyperbaric Oxygen Therapy Indications . 2014;.
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