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    v1.0.31
    OpenPayerPolicy UpdatesOrthopedics/MusculoskeletalAetna Core Decompression Coverage & Prior Auth | O…
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    CurrentAetnaPolicy 0753

    Core Decompression for Avascular Necrosis

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    This policy governs the medical necessity and coverage of core decompression for avascular necrosis of the hip and lists interventions considered experimental/investigational. It affects providers and members under Aetna's coverage for treatment of femoral head/neck osteonecrosis.

    Policy Summary
    PayerAetna
    PolicyCore Decompression for Avascular Necrosis
    Policy CodePolicy 0753
    Change TypeNo material change noted
    Effective DateApr 25, 2008
    Last ReviewOct 4, 2023
    Next Review DateAug 8, 2024
    Key ActionObtain prior authorization for hip core decompression (HCPCS S2325) with documentation of early/pre-collapse stage, lesion extent, and prior conservative therapy.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    I–IIEligible AVN stages
    III+Late/collapse stages
    10k–20kAnnual US cases (est.)
    60–80%Selected series 5–10 yr success
    84%Steinberg I success

    Coverage Criteria — Core Decompression

    inv-01: Medical necessity: Core decompression (hip, early stages)

    Covered when ALL of the following are met

    Core decompression medical necessity

    • Anatomic site: Femoral head and/or neck (hip).

      Policy applies to hip only; AVN of other joints is considered investigational per policy.

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    Policy Summary
    PayerAetna
    PolicyCore Decompression for Avascular Necrosis
    Policy CodePolicy 0753
    Change TypeNo material change noted
    Effective DateApr 25, 2008
    Last ReviewOct 4, 2023
    Next Review DateAug 8, 2024
    Key ActionObtain prior authorization for hip core decompression (HCPCS S2325) with documentation of early/pre-collapse stage, lesion extent, and prior conservative therapy.
    SourceLink
    On This Page
    Coverage Criteria — Core DecompressionCoding — Procedure and Diagnosis CodesProvider Actions, Authorization & DocumentationBackground & EpidemiologyDefinitions & Key TermsPolicy Revision History

    inv-03: Hip — preservation (pre-collapse) indication — Core decompression for the femoral head may be considered medically reasonable when ALL of the following are met:

    Core decompression for the femoral head may be considered medically reasonable when ALL of the following are met:

    Eligibility for hip core decompression: 1) Diagnosis of osteonecrosis of the femoral head; 2) Disease is early/pre-collapse (eg Ficat/ARCO/Steinberg stage I–II); 3) Necrotic lesion size is small or medium as documented by MRI (not a large lesion); 4) Symptoms correlate with imaging findings and conservative management (eg protected weight-bearing, analgesics) has been inadequate or joint-preserving surgery is indicated.

    inv-04: Adjunctive augmentation — Adjuncts and technique considerations that may influence effectiveness:

    Adjuncts and technique considerations that may influence effectiveness:

    Adjuncts with supportive but limited evidence: Implantation of autologous bone‑marrow mononuclear cells or concentrated bone marrow (BMMC/BMAC), use of platelet-rich products (PRP/PRF), and non‑vascularized autologous bone grafting have shown improved pain, delayed progression, or prolonged time-to-collapse in small randomized or observational studies; however, studies are limited by small sample sizes, heterogeneity of techniques, and variable follow-up.
    Technique specifics to document: When adjunctive biologic materials or grafts are used, documentation should specify cell source and processing, concentration/scaffold (eg tricalcium phosphate, CaSO4–CaPO4), and graft type because outcomes vary by technique.
    Limitations and caution: Some augmentation approaches (eg CD combined with demineralized bone matrix or certain injectable synthetic bone graft substitutes) have reported high long‑term failure or conversion-to‑THA rates in small series and require cautious interpretation and further evidence.

    inv-05: Other joints — limited evidence — Core decompression for other joints (knee, ankle, shoulder):

    Core decompression for other joints (knee, ankle, shoulder):

    Knee/ankle/shoulder core decompression evidence: Evidence is currently insufficient to support routine use of core decompression for AVN of the knee, ankle, and shoulder; published studies are small, heterogeneous, and often uncontrolled. Core decompression may be considered only in selected cases or within clinical studies.

    inv-06: Coverage for core decompression (other joints) — Covered when ALL of the following are met

    Covered when ALL of the following are met

    Core decompression coverage criteria for non-hip joints: 1) Disease is early/pre‑collapse radiographic stage (eg Ficat/Arlet I–II or equivalent) confirmed by MRI; 2) Persistent or severe symptoms despite appropriate conservative management (eg protected weight‑bearing, orthoses, analgesics) or patient is an appropriate candidate for joint-preserving surgery; 3) Documentation of relevant risk factors and clinical course (eg corticosteroid use, immune disease) is provided; 4) Goal of treatment is joint preservation and patient is counseled that progression to collapse and arthroplasty remains possible.

    Evidence quality and expected outcomes vary by joint and study; consider enrollment in clinical trials when evidence is limited.

    inv-02: Experimental/investigational interventions — Not covered / considered experimental and investigational

    Not covered / considered experimental and investigational

    Experimental/investigational interventions: Core decompression for AVN of other joints (ankle, elbow, knee, mandibular condyle, shoulder), core decompression for late/post‑collapse (stage III or higher) hip AVN, post‑arthroscopic osteonecrosis, combined core decompression and intralesional autologous bone marrow–derived cell therapies, and adjunctive treatments including autologous bone marrow mononuclear cells/BMAC/BMSCs, platelet concentrates (PRP/PRF), bisphosphonates, BMPs (eg rhBMP‑2), demineralized bone matrix, erythropoietin, extracorporeal shockwave, growth factors, intraosseous ibandronate, laser therapy, mesenchymal stem cells, ozone therapy, parathyroid hormone, platelet‑rich fibrin, PRP combined with stem cells, PRP+MSCs+synthetic grafts, and synthetic bone graft substitutes (eg calcium sulphate and calcium phosphate) are considered experimental/investigational because effectiveness has not been established.

    List is not all-inclusive.

    The policy identifies combined procedures — specifically core decompression (CD) combined with bone marrow aspiration concentrate (BMAC) or intralesional autologous bone marrow–derived cell therapies — as experimental/investigational because effectiveness has not been established. The document also discusses CD with a range of biologic adjuncts (eg, PRP, MSCs, synthetic grafts) and emphasizes that evidence is heterogeneous across studies, with variable techniques, cell processing, scaffolds, and follow-up durations that limit definitive conclusions about benefit when CD is combined with cell therapies.

    When CD plus BMAC/BMDCT is considered clinically (eg, in a research or case‑by‑case context), prior authorization and documentation should specify the exact adjunct, cell source and processing, scaffold used (eg, tricalcium phosphate), and the clinical rationale, because pooled analyses suggest potential benefit but randomized, standardized evidence is limited and inconsistent.

    Multiple series and pooled analyses indicate that outcomes are substantially worse for late/post‑collapse disease (eg, ARCO/Steinberg/Ficat stage III–IV). Retrospective cohorts and small series report higher conversion rates to total hip arthroplasty (THA) and poorer survivorship in stage III–IV hips, and several authors consider late-stage disease an unfavorable indication or contraindication for core decompression.

    Randomized and controlled data are limited in advanced stages; available observational reports describe markedly lower survival and greater need for arthroplasty when decompression is performed after collapse, supporting the policy stance that CD is primarily applicable to early/pre‑collapse disease.

    Reports of CD combined with certain injectable synthetic bone graft substitutes (notably PRO‑DENSE, a calcium sulfate/calcium phosphate composite) showed a high early failure rate in ARCO stage IIC and IIIA femoral head lesions, with rapid graft resorption and conversion to THA in many cases. These findings indicate a failure signal for that specific synthetic graft combination in those stages and caution against routine use.

    In one prospective series, core decompression combined with autologous bone marrow concentrate and tricalcium phosphate did not prevent radiographic progression to collapse; median survival to any collapse was 7 months and median time to THA was 23 months. This trial concluded that the combined approach failed to halt radiographic progression in early-stage osteonecrosis of the hip.

    The evidence base is heterogeneous with many small observational series, variable adjunct techniques, inconsistent outcome measures, and limited long‑term randomized data. Network meta‑analyses and systematic reviews have often found no clear differences among CD variants and non‑operative care for conversion to THA or radiographic progression, and study quality ranges from very low to moderate. These limitations reduce confidence in broad coverage conclusions for adjunctive or novel CD techniques.

    Across multiple reports, patients with advanced or collapsed femoral head disease (eg Ficat/Arlet or ARCO stage III–IV) have markedly worse outcomes after core decompression, with lower survivorship and higher rates of conversion to arthroplasty compared with early‑stage disease. Several series show survival functions that differ significantly by stage, supporting the position that CD is less effective in advanced/collapsed stages.

    A randomized, double‑blind trial is cited reporting the inefficacy of autologous bone marrow concentrate in stage III osteonecrosis (Hauzeur et al.). In addition, a small randomized trial (Pepke et al.) of BMAC injection during CD (n=24) showed no short‑term difference in clinical or radiologic outcomes, underscoring that randomized evidence does not uniformly support benefit of autologous BMC in mid‑ to late‑stage disease.

    The policy lists several relevant billing and drug code references that relate to coverage and documentation: HCPCS/CPT and drug codes mentioned include S2325 (hip core decompression), P9020 (platelet rich plasma), and various bisphosphonate J‑codes (eg, J1740, J2430, J3489), as well as codes for synthetic grafts and related modalities. Providers should ensure coding aligns with the policy’s selection criteria and the documented indication.

    Available literature for core decompression of the knee, ankle, and shoulder is limited and of low quality. Reviews and evidence summaries conclude that there is currently insufficient high‑quality evidence to support routine coverage of CD for these non‑hip joints, and prospective randomized trials are needed before routine medical necessity can be established.

    Evidence for talar (ankle) AVN and other non‑hip joints is rated as very low to low quality in systematic reviews; small, heterogeneous studies and potential reporting bias limit interpretation, so no firm conclusions about effectiveness can be drawn for these sites.

    A small randomized controlled trial (Pepke et al.; n = 24) detected no short‑term benefit in bone regeneration or clinical outcomes from adding bone marrow concentrate injection during core decompression, reinforcing uncertainty about short‑term efficacy of BMC adjuncts in randomized data.

    The excerpted policy and evidence summaries do not present an explicit blanket statement labeling treatments as ‘not medically necessary’ in every context. Instead, they document heterogeneous results and limited high‑quality RCT data for many adjuncts and non‑hip indications, leading to cautious, evidence‑based language that some combinations and indications are considered experimental/investigational rather than universally denied.

    For humeral head osteonecrosis in patients with sickle cell disease, systematic reviews report low evidence quality and conclude that core decompression has not been confirmed to prevent or delay disease progression; the role of core decompression in this population therefore remains unproven and requires further high‑quality study.

    Coding — Procedure and Diagnosis Codes

    Related CPT/HCPCS codes (covered if selection criteria met or related)mixed
    0101TExtracorporeal shock wave involving musculoskeletal system, not otherwise specified, high energy.
    0232TInjection(s), platelet rich plasma, any site, including image guidance, harvesting and preparation when performed.
    0481TInjection(s), autologous white blood cell concentrate (autologous protein solution), any site, including image guidance, harvesting and preparation, when performed.
    38232Bone marrow harvesting for transplantation; autologous.
    20955Bone graft with microvascular anastomosis; fibula.
    27071Partial excision, wing of ilium, symphysis pubis, or greater trochanter of femur, (craterization, saucerization) (eg, osteomyelitis or bone abcess); deep (subfascial or intramuscular).
    27170Bone graft, femoral head, neck, intertrochanteric or subtrochanteric area (includes obtaining bone graft).
    38230Bone marrow harvesting for transplantation; allogenic.
    38241Hematopoietic progenitor cell (HPC); autologous transplantation.
    S2325Hip core decompression.
    HCPCS/CPT codes not covered for indications listedmixedNot Covered
    C1763Connective tissue, non-human (includes synthetic).
    J1436Injection, etidronate disodium, per 300 mg.
    J1740Injection, ibandronate sodium, 1 mg.
    J2430Injection, pamidronate disodium, per 30 mg.
    J3489Injection, zoledronic acid, 1 mg.
    P9020Platelet rich plasma, each unit.
    S8948Application of a modality (requiring constant provider attendance) to one or more areas; low-level laser; each 15 minutes.
    ICD-10 codes covered if selection criteria are metICD-10Covered
    M87.051 - M87.059Osteonecrosis of femur [early/pre-collapse (stage I or II; before X-ray changes are evident)]
    M87.151 - M87.159
    M87.251 - M87.256
    M87.351 - M87.353
    M87.851 - M87.859
    M90.551 - M90.559
    ICD-10 codes not covered for indications listedICD-10Not Covered
    M87.00 - M87.9Osteonecrosis of bone
    CPT codes related to intraosseous proceduresCPT
    36680Placement of needle for intraosseous infusion.
    Procedure/Diagnosis Codes (not specified in this section)mixed
    none specifiedDocument discusses interventions and adjuncts but does not list specific CPT/ICD codes in this excerpt
    Covered CPT CodesCPT
    No codes listed
    AVN stage for medical necessity
    AVN stage for medical necessityStage I or II (early/pre-collapse; before X‑ray changes are evident)
    ApplicabilityApplies to the hip (femoral head and/or neck) for joint‑preserving intent
    Exclusion noteLate/post‑collapse disease (stage III or higher) is considered experimental/investigational
    BMI as prognostic marker
    BMI threshold>= 30 kg/m2 — identified as an independent predictor of progression after CD
    Prognostic implicationObesity (BMI ≥30) associated with increased risk of radiographic progression and worse outcomes
    Documentation recommendationRecord BMI in prior authorization/clinical documentation to support prognosis assessment

    Provider Actions, Authorization & Documentation

    Prior Authorization

    Prior authorization required for HCPCS S2325

    Prior authorization is required for HCPCS S2325 (hip core decompression); coverage is contingent on meeting the policy's selection criteria for early/pre‑collapse (stage I or II) femoral head osteonecrosis.

    • HCPCS code: S2325 must be requested with PA documentation showing stage I–II disease and supporting clinical/imaging data.
    Prior Authorization

    Provide clinical justification: stage, size, and rationale

    Prior authorization requests should justify lesion stage, lesion size (MRI), and the clinical rationale for core decompression versus alternative nonoperative or joint‑preserving procedures.

    • Document MRI-based staging and lesion size (small/medium vs large).
    • Explain why conservative management is inadequate or why joint-preserving surgery is preferred.
    Prior Authorization

    PA appropriate for core decompression of other joints

    When core decompression is requested for non‑hip joints (knee, ankle, shoulder), prior authorization is appropriate to confirm early/pre‑collapse stage disease and persistent symptoms despite conservative care.

    • Confirm radiographic/MRI early-stage (eg Ficat/ARCO I–II equivalent) and document failed conservative management.
    • State intent for joint preservation and provide risk‑factor history.
    Prior Authorization

    Require evidence- and stage-based documentation for authorization

    Prior authorization should require documentation of indication (early/pre‑collapse ONFH), prior conservative therapy, and imaging staging because evidence and outcomes vary by disease stage and technique.

    • Include radiographic/MRI staging (Ficat/ARCO), symptom correlation, and record of prior nonoperative measures.
    • State planned adjuncts (if any) and intended operative technique.
    Prior Authorization

    Specify adjuncts and technique in PA requests

    Specify the exact adjunct(s) and surgical technique in the prior authorization (for example: CD + bone marrow–derived cells, CD + PRP, CD + synthetic grafting) because published studies differ by method, cell counts, and scaffolds.

    • List adjunct type (BMAC/BMDCT, PRP, autologous bone, synthetic graft such as CaSO4–CaPO4) and processing/source of biologics.
    • Describe backfilling material or advanced CD modifications if used.
    Prior Authorization

    Support PA with disease extent and adjunct rationale

    Prior authorization should be supported by documentation of early-stage disease, extent of necrosis (eg modified Kerboul angle or necrotic index), and a clear rationale for any adjunctive therapy given variable evidence of benefit.

    • Provide modified Kerboul angle or necrotic index and symptom severity (HHS/VAS).
    • If proposing cell-based adjuncts, include cell counts/CFU data when available.
    Note

    Administrative history present; no extra PA mandates in excerpt

    The document excerpts include administrative policy history but do not state additional explicit prior authorization requirements; reviewers should rely on the PA statements elsewhere in the policy for actionable requirements.

    • Policy history and review dates are administrative notes and do not add provider-facing PA steps.
    Step Therapy

    Attempt conservative (nonoperative) management first

    Attempt nonoperative measures prior to considering core decompression: rest/protected weight‑bearing, activity modification, NSAIDs/analgesics, orthoses, and pharmacotherapy such as bisphosphonates when appropriate.

    • Document duration and response to protected weight‑bearing or orthoses.
    • Record use and response to NSAIDs or bisphosphonate therapy if used.
    Step Therapy

    Consider conservative care or clinical trial for non‑hip joints

    For non‑hip joints, the policy advises considering conservative management or enrollment in clinical trials before approving core decompression due to limited and low‑quality evidence.

    • Document failed conservative care and consider trial enrollment where available.
    • Provide justification for proceeding to CD in non‑hip joints given evidence limitations.
    Step Therapy

    Conservative-first approach for talar/ankle AVN

    For talar/ankle AVN, conservative management (protected weight‑bearing, orthoses, and analgesics) is typically attempted first; core decompression is generally reserved for symptomatic pre‑collapse disease that does not respond.

    • Document initial protected weight‑bearing regimen and response.
    • If CD is proposed, include imaging showing pre‑collapse (stage II) disease.
    Step Therapy

    Use a stepwise decision process for CD ± cell therapy

    Consider a stepwise approach to selecting CD alone versus CD plus cell‑based therapy because trial and observational results are mixed and apparent benefit is greatest in early/pre‑collapse disease.

    • When proposing cell-based adjuncts, justify based on early-stage disease and cite available outcome data.
    • If cell therapy is requested, include details on cell source, counts, and processing.
    Note

    No explicit step therapy sequencing specified

    The excerpt does not provide an explicit mandated step therapy sequence; no formal sequencing requirement is stated in the policy text provided.

    • Providers should follow the documented conservative-first recommendations and PA requirements but no prescribed steps are listed in the excerpt.
    Note

    Consider evidence favoring CD + bone marrow–derived therapies

    Pooled analyses suggest CD combined with bone marrow–derived cell therapies reduces progression and conversion to arthroplasty compared with CD alone, but randomized data are limited; consider these findings when planning therapy and documenting justification.

    • Cite pooled ORs (eg OR 0.19 for progression; OR 0.20 for conversion) in rationale when applicable.
    • Note limitations: heterogeneity and need for larger RCTs.
    Note

    Identify adjuncts/alternatives and note investigational status

    Adjunctive and alternative treatments discussed in the policy include stem cells/BMAC, PRP, bisphosphonates, hyperbaric oxygen, extracorporeal shock wave therapy, and synthetic bone graft substitutes; providers should identify which adjunct is planned and be aware some are considered investigational.

    • If proposing adjuncts listed as investigational (eg MSCs, PRP, synthetic grafts), include supporting clinical rationale and literature if available.
    • Be aware certain adjuncts (eg PRO‑DENSE in ARCO IIC/IIIA) have reported high failure rates and may affect coverage.
    Billing Rule

    Ensure diagnosis and procedure coding align with policy

    Document diagnosis coding consistent with the listed ICD‑10 codes for femoral head osteonecrosis (eg M87.051‑M87.059) and include the HCPCS/CPT codes used (for hip core decompression, S2325) in claims and PA requests.

    • Use covered ICD‑10 codes for early/pre‑collapse femoral head osteonecrosis when selection criteria are met.
    • Include procedure code S2325 on authorization and claim submissions.
    Documentation Required

    Document radiographic/MRI stage and lesion size

    Document MRI and radiographic staging and report lesion size/location (eg modified Kerboul angle or necrotic index) and symptom status because outcomes are stage‑ and extent‑dependent.

    • Provide MRI-based stage (Ficat/ARCO) and quantify necrotic extent (modified Kerboul angle or necrotic index).
    • Include symptom measures (HHS, VAS) and correlation with imaging.
    Documentation Required

    Include radiographic/MRI staging, lesion details, and prior treatments

    Required clinical documentation for authorization should include radiographic and MRI staging (Ficat/Arlet or ARCO), lesion size/location, prior nonoperative measures, and key risk factors (eg corticosteroid use, immune disease).

    • Attach preoperative X‑rays and MRI reports and specify prior conservative treatments and duration.
    • List relevant comorbidities and risk factors influencing prognosis.
    Documentation Required

    Document follow‑up clinical and radiologic outcomes and adjunct details

    Capture clinical and radiologic follow‑up data when available (modified Harris Hip Score, MRI/XR findings, time to collapse, need for THA) and detail adjunctive materials used (BMAC source, scaffold type, cell counts) to support treatment outcomes.

    • Report pre‑ and post‑operative HHS, VAS, and imaging comparisons.
    • Document source/processing of biologics and implant/graft materials used.
    Documentation Required

    Include suggested operative and cellular documentation elements

    When reporting operative series or supporting documentation for adjunctive biologic procedures, include pre/post radiography/MRI, HHS, VAS, modified Kerboul angle, and cellular metrics such as nucleated cell counts and CFU assays where available.

    • Provide absolute nucleated cell counts/ml and CFU data if cell therapies were used.
    • Include objective imaging measures (modified Kerboul angle) and validated clinical scores.
    Documentation Required

    Provide study‑style clinical documentation elements (stage, BMI, follow‑up)

    Clinical studies documenting CD with biologic adjuvants typically report staging (Ficat/modified Kerboul), patient age, BMI, and follow‑up imaging; include these elements in authorization/supporting materials because BMI >=30 and older age predict progression.

    • Report patient demographics (age, BMI) and document BMI if ≥30.
    • Provide staging and follow‑up radiographic/MRI data.
    Note

    Policy history present; no extra documentation mandates here

    This portion of the document contains policy history and administrative notes; it does not specify additional provider-facing documentation requirements beyond those in the coverage and authorization sections.

    • Use the PA and documentation guidance elsewhere in the policy for provider requirements.
    Denial Risk

    Denial risk: CD for late/post‑collapse (stage III+) hips

    Core decompression for late/post‑collapse hip disease (stage III or higher) is considered experimental/investigational and is likely to be denied if submitted for coverage.

    • Do not submit PA for CD when imaging documents stage III or IV femoral head collapse without explicit medical rationale supported by evidence.
    • Coverage determinations will follow the policy's experimental/investigational stance for advanced stages.
    Denial Risk

    Denial risk for CD in non‑hip joints due to limited evidence

    Because evidence is insufficient for routine CD in joints other than the hip (knee, ankle, shoulder), requests for CD at these sites may trigger additional review or non‑coverage unless compelling documentation and trial enrollment justification are provided.

    • Provide evidence of early/pre‑collapse stage and failed conservative care for non‑hip joints.
    • Consider referring patients for clinical trial participation when appropriate.
    Denial Risk

    Adjunct graft failure may affect coverage (eg PRO‑DENSE)

    High failure rates have been reported when CD was combined with certain injectable synthetic grafts (eg PRO‑DENSE) in ARCO stage IIC and IIIA femoral head lesions; such combinations may be denied or unsupported by payers.

    • If proposing synthetic graft products, include evidence supporting their use for the specific ARCO/Ficat stage.
    • Be aware of reported early graft resorption and high conversion rates to THA with PRO‑DENSE in reported series.
    Documentation Required

    Document progression to collapse and subsequent interventions

    Document radiographic progression (collapse) and any subsequent interventions (repeat decompression, conversion to THA) because progression despite CD ± adjuncts is an expected outcome and relevant to treatment assessment.

    • Record time to collapse and dates/details of any subsequent hip arthroplasty.
    • Include imaging that documents progression and correlate with clinical scores.
    Note

    No other explicit administrative PA/denial triggers in excerpt

    The excerpted evidence summaries note lack of high‑quality randomized trials and heterogeneity across studies; there are no explicit administrative PA triggers or additional denial criteria stated in these chunks beyond the PA guidance above.

    • Rely on the policy's stated PA requirements (S2325, staging, documentation) for actionable steps.
    • Expect clinical discretion where evidence is limited.
    Denial Risk

    Stage‑related denial risk: higher for advanced disease

    Advanced-stage disease (stage III–IV) has substantially lower femoral head survivorship compared with early-stage disease; requests for CD in advanced stages carry higher denial risk and should include strong justification if submitted.

    • Document why CD is being considered in advanced stages and provide supporting evidence if available.
    • Be aware stage is an independent predictor of progression and failure.
    Note

    Policy history note — no provider actions implied

    Policy history and review dates are administrative information only and do not impose additional provider action requirements.

    • Use current PA and documentation guidance rather than policy history for submission requirements.

    Background & Epidemiology

    One randomized and several observational studies addressing CD with or without cell therapies for non‑hip joints or talar AVN have small sample sizes and limited follow‑up. Consequently, available data do not support routine use of CD for talar AVN or other joints, and conclusions are limited by the low quality and heterogeneity of existing studies.

    Definitions & Key Terms

    Ficat Classification stage II
    Ficat stage II definitionPresence of cysts is considered stage II per the Ficat Classification of AVN of the femoral head
    Clinical contextStage II is within the early/pre‑collapse window for which CD may be considered medically necessary
    Source noteFicat Classification referenced in policy note
    Core decompression — procedural definition
    Technical definitionSurgical removal of an 8–10 mm cylindrical core of bone from the antero‑lateral segment of the femoral head
    PurposeCreates an open cylindrical channel to relieve intraosseous pressure and may be optionally filled with vascularized or non‑vascularized bone graft
    ApproachLateral trochanteric approach to access the antero‑lateral femoral head
    Pre-collapse disease
    DefinitionPre‑collapse disease: AVN stages prior to femoral head collapse (commonly described as stages I and II)
    Clinical relevanceCore decompression is most effective in pre‑collapse stages to preserve the joint and delay THA
    Imaging requirementStage confirmation typically by MRI and radiographic staging (eg, Ficat/ARCO/Steinberg)
    Lesion size prognostic groups
    Prognostic groupsLesions are categorized as small, intermediate, or large based on necrotic extent on imaging
    Outcome correlationSmall and medium lesions have better hip‑preserving outcomes after CD than large lesions (higher THA conversion with larger lesions)
    DocumentationLesion size should be documented (MRI) for prior authorization and prognosis
    Pre-collapse disease definition (alternate)
    Alternate definitionPre‑collapse/early‑stage AVN refers to Ficat/Arlet stage I–II or ARCO pre‑collapse where structural femoral head collapse has not occurred
    Clinical implicationPatients in this category are the preferred candidates for core decompression
    Evidence noteMultiple series report best success rates in early-stage, small‑to‑medium lesions
    Definition of BMC/BMAC
    DefinitionBMC/BMAC: concentrated autologous bone marrow aspirate containing mesenchymal stem/progenitor cells (used as intralesional adjunct during CD)
    PurposeInstilled into the decompression tract to potentially enhance osteogenesis and reduce progression
    DocumentationCell source, concentration, and CFU/nucleated cell counts are often reported and should be documented
    Definition of APC/PRP/PRF
    DefinitionAPC/PRP/PRF: autologous blood‑derived platelet concentrates rich in platelets and growth factors applied to surgical sites to promote healing
    Use caseUsed alone or combined with stem cells during CD to potentially improve pain and function; evidence is preliminary
    Evidence noteCase series report improved outcomes but randomized data are limited; further study needed
    Advanced core decompression (ACD)
    DefinitionAdvanced core decompression (ACD): percutaneous removal of necrotic tissue with an expandable reamer followed by refilling the defect with injectable, hard‑setting composite CaSO4–CaPO4 bone graft substitute
    ModificationMay include impaction of autologous femoral neck bone into the defect (modified ACD) to improve outcomes
    Reported outcomesModified ACD with autologous bone reported 75.9% success (no collapse/conversion) in Steinberg stages 2a–2c in a cohort study
    CD + BMSCs / stem cell combination therapy
    DefinitionCD + BMSCs / stem cell combination therapy: core decompression followed by implantation/instillation of autologous bone marrow‑derived mesenchymal stem cells or bone marrow buffy coat into the decompression tract
    Intended effectAims to enhance bone regeneration, reduce collapse, and decrease conversion to THA compared to CD alone
    Evidence summarySystematic reviews and meta‑analyses report improved HHS, reduced necrotic area, lower progression and conversion rates with CD+cells versus CD alone, though study quality and heterogeneity vary
    PTH[1-34] (teriparatide)
    DefinitionPTH[1-34] (teriparatide): parathyroid hormone fragment studied in animal models as an adjunct to CD to stimulate bone formation and neovascularization
    Evidence statusPreclinical studies (eg, rabbit SAON model) show improved bone repair and vascularity after CD with intermittent PTH; clinical data lacking
    Research notePreliminary findings require validation in well‑designed clinical trials
    BMAC / BMDCT definitions
    DefinitionBMAC / BMDCT: concentrated autologous bone marrow preparations (bone marrow aspiration concentrate or bone marrow‑derived cell therapies) instilled into the CD tract to augment regeneration
    Clinical useUsed as an adjunct to CD with reported improvements in radiographic progression‑free survival and functional scores in some series/meta‑analyses
    Evidence caveatResults mixed across studies; predictors of outcome include BMI and extent of necrosis
    Modified Kerboul angle
    DefinitionModified Kerboul angle: imaging measure quantifying femoral head necrotic involvement used to assess prognosis and change after interventions
    Clinical useLower modified Kerboul angle (smaller necrotic extent) associated with better survivorship and less collapse after CD ± adjuncts
    Reported metricStudies report changes in modified Kerboul angle pre‑ and post‑treatment to evaluate treatment effect
    Adjunctive treatments
    Adjunctive treatments listedAutologous bone marrow concentrate/mesenchymal stem cells, PRP/APC/PRF, autologous bone grafting, synthetic bone graft substitutes (eg CaSO4–CaPO4), bisphosphonates, rhBMPs, extracorporeal shockwave therapy, hyperbaric oxygen, parathyroid hormone
    Evidence summaryAdjuncts have variable supporting evidence; some meta‑analyses show benefit for cell therapies, while others show heterogeneity and need for higher‑quality RCTs
    Coverage implicationMany adjuncts are considered investigational for general use; documentation of technique and materials is recommended when used

    Policy Revision History

    2008-04-25effective_date

    Policy effective date established.

    2023-10-04last_reviewLatest

    Policy last reviewed; review entry listed in policy history.