Is an open osteochondral allograft (Bio-Uni) to the lateral femoral condyle medically necessary for a patient with a focal, full-thickness cartilage lesion and disabling knee pain, despite not meeting all selection criteria, including completion of supervised physical therapy and presence of an intact meniscus?

Osteochondral Allograft is NOT Medically Necessary at This Time

The proposed osteochondral allograft to the lateral femoral condyle should be denied because three critical mandatory prerequisites have not been met: (1) no documentation of at least 6 weeks of supervised, in-person physical therapy, (2) severe meniscal deficiency requiring concurrent meniscal allograft transplantation, and (3) inadequate assessment of the opposing tibial articular surface. 1

Critical Missing Prerequisites

Supervised Physical Therapy Requirement

• The American Academy of Orthopaedic Surgeons mandates completion and documentation of at least 6 weeks of supervised, in-person physical therapy with objective documentation of compliance and failure to achieve adequate symptom relief before osteochondral allograft can be considered medically necessary 1
• The patient only reports "OTC medication, Home exercises for Range of Motion and Conditioning since 01/2025" - home exercises do not satisfy the requirement for supervised, in-person physical therapy 1
• This is a non-negotiable prerequisite that must be completed and documented with objective evidence of failure before proceeding 1

Meniscal Deficiency Must Be Addressed

• The MRI demonstrates "very little lateral meniscal tissue remaining" from the previous partial lateral meniscectomy, which represents severe meniscal deficiency 1
• The American Academy of Orthopaedic Surgeons requires either documentation of adequate remaining meniscal tissue OR planning concurrent meniscal allograft transplantation when meniscal deficiency exists 1
• An intact meniscus is essential for normal weight distribution within the joint - without adequate meniscal tissue, the osteochondral allograft is at high risk of failure due to abnormal load distribution 1
• Studies demonstrate that osteochondral allograft with concomitant meniscal allograft transplantation achieves 86% graft survivorship at 5 years when appropriately indicated 2
• The current surgical plan does not include meniscal allograft transplantation despite documented severe meniscal deficiency 1

Opposing Articular Surface Assessment

• The American Academy of Orthopaedic Surgeons requires definitive imaging assessment of the tibial plateau to confirm the opposing articular surface is free of significant disease or injury 1
• Bipolar lesions (both femoral and tibial involvement) are absolute contraindications for isolated osteochondral allograft 1
• The current documentation does not provide clear assessment of the tibial plateau cartilage status - the MRI report focuses on the femoral condyle and meniscus but lacks specific description of tibial articular cartilage integrity 1
• X-ray alone is insufficient; dedicated MRI assessment of the tibial plateau articular cartilage must be documented 1

Criteria That ARE Met

Lesion Characteristics

• The 2 x 4 cm (8 cm²) full-thickness cartilage defect on the lateral femoral condyle meets size criteria (≥2 cm diameter) for osteochondral allograft 1, 3
• The defect is appropriately sized for allograft rather than autograft - lesions 2-6 cm² are first-line indications for osteochondral allograft 1, 4
• Full-thickness (grade 3-4) cartilage loss on weight-bearing surface of the femoral condyle is documented 1

Patient Demographics and Knee Stability

• Age 34 years falls within the acceptable range (≤50 years) with best outcomes reported in patients younger than 30-40 years 1, 5
• Previous ACL reconstruction provides knee stability - physical examination confirms negative Lachman, anterior drawer, posterior drawer, and pivot shift tests with firm endpoints 1
• Knee alignment appears appropriate based on available imaging 1

Required Actions Before Approval

Mandatory Documentation Needed

1. Complete 6 weeks of supervised, in-person physical therapy with objective documentation including:

   • Therapist notes documenting attendance and compliance 1
   • Specific exercises performed and progression attempted 1
   • Objective measures of persistent symptoms despite therapy 1
   • Documentation that conservative treatment failed to provide adequate symptom relief 1

2. Address meniscal deficiency by either:

   • Revising surgical plan to include concurrent lateral meniscal allograft transplantation 1, 2
   • OR providing detailed imaging documentation that adequate functional meniscal tissue remains (which appears unlikely given MRI description) 1

3. Obtain definitive tibial plateau assessment including:

   • Specific MRI description of lateral tibial plateau articular cartilage status 1
   • Confirmation that opposing tibial surface is free of significant arthritis or cartilage damage 1
   • Documentation ruling out bipolar lesion 1

Clinical Context and Prognosis

Expected Outcomes When Criteria Are Met

• Osteochondral allograft demonstrates 94% graft survival at 5 years and 84% at 10 years when appropriate patient selection criteria are followed 3
• Return to sport rates reach 88% with average time of 9.6 months when properly indicated 3
• Long-term studies show graft survival rates between 70-91% at greater than 10 years 6

Risk of Premature Surgery

• Proceeding without adequate meniscal tissue creates abnormal load distribution that significantly increases graft failure risk 1
• Skipping mandatory conservative treatment (supervised physical therapy) violates evidence-based treatment algorithms and may result in unnecessary surgery 1
• Unrecognized bipolar lesions are absolute contraindications and will lead to graft failure 1

Alternative Considerations

• The patient previously had cartilage biopsies obtained for possible MACI (matrix-induced autologous chondrocyte implantation), which remains an alternative for lesions of this size, though it requires two surgical procedures 3
• Best outcomes for osteochondral allograft are reported when treatment is performed within 12 months from symptom onset - this patient's symptoms date to 2018 ACL injury, though acute worsening may have occurred more recently 5

Recommendation: Non-certification with Letter of Intent requiring completion of supervised physical therapy, definitive tibial plateau assessment, and surgical plan revision to address meniscal deficiency before reconsideration.