INFUSE for tibial shaft fractures — document intramedullary fixation and application within 14 days

Submit documentation that INFUSE use for tibial shaft fractures occurred within 14 days of the initial fracture and that fracture stabilization with intramedullary nail fixation and appropriate wound management were performed.

• Timing (within 14 days) and fixation method are explicit policy requirements for INFUSE tibial shaft fracture coverage.

Prior auth: INFUSE must match FDA‑labeled indications and policy criteria

Use INFUSE Bone Graft only in accordance with FDA‑labeled single‑level anterior/lateral lumbar interbody fusion indications and the policy’s stated criteria; prior authorization reviewers will expect device‑label concordant documentation.

• INFUSE is FDA‑approved for single‑level ALIF (L4–S1) after ≥6 months nonoperative treatment; coverage follows device labeling and policy criteria.
• Off‑label uses are considered investigational and may be denied.

Verify prior authorization for 510(k)‑cleared grafts/adjuncts; supply device labeling

Several grafts and adjunct devices have 510(k) clearances with specific intended uses; verify prior authorization and provide device labeling/indication when requesting coverage.

• Examples include PRP preparation devices (510(k)), Restore SIS for rotator cuff soft tissue reinforcement, and MIIG/Integra Mozaik OS putty for surgically treated osseous defects.
• Document manufacturer/FDA intended use when submitting authorization requests.

Recommend prior auth for bone void fillers proposed for nonunion/delayed healing

Prior authorization is recommended when bone void fillers or novel graft substitutes are proposed for delayed union/nonunion or large volumetric defects because evidence is limited and outcomes variable.

• Provide prior treatment history, duration of nonunion, infection history, and rationale for substitute versus autograft in authorization documentation.
• Products cleared for surgically treated osseous defects may not be supported for nonunion therapy.

Support clinical use of biologics and synthetics with evidence — supply during authorization

When requesting coverage for biologics or synthetic substitutes, include clinical evidence and rationale demonstrating expected benefit given mixed or limited fusion/outcome data.

• OP‑1, calcium phosphate/β‑TCP compounds, and novel cellular products require documented indication and supporting evidence for coverage consideration.

Prior auth expectation: cellular bone matrices — provide comparative evidence

Prior authorization for cellular bone matrices (e.g., Osteocel Plus) should request supporting clinical evidence because randomized controlled trial data of effectiveness versus autograft are lacking.

• Expect payers to request comparative data and intended use when cellular bone matrices are proposed as alternatives to autograft.

Consider prior auth for extensive/off‑label BMP use — document dose, levels, and rationale

Consider prior authorization for extensive or off‑label BMP use (for example, deformity fusions >8 levels); reviewers will weigh clinical rationale, dosing, levels treated, and cost versus expected benefit.

• Observational data show differing re‑operation rates and costs in extensive fusion cases; include dose/level rationale in requests.

i‑Factor: follow labeled use and device instructions; document per labeling

i‑Factor is labeled for single‑level cervical fusion (C3–C4 to C6–C7) in skeletally mature patients and must be used inside an allograft bone ring with supplemental anterior plate fixation per product labeling; prior authorization should reflect these device instructions.

• Do not use i‑Factor where contraindications apply (infection, absence of load‑bearing support, compromised organ function, metabolic disorders, or sensitivity to components).

Clinical evidence may inform prior authorization — include trial details

Clinical evidence presented in the policy may inform prior authorization decisions; when evidence is limited provide study-level data, expected outcomes, and comparator information in requests.

• Include relevant trial outcomes, fusion rates, follow‑up duration, and limitations when justifying non‑standard uses.

Prior auth expectations for synthetic spinal grafts — provide comparative evidence

When proposing synthetic spinal grafts for fusion, prior authorization reviewers will expect comparative data demonstrating fusion rates and complication profiles versus autograft/allograft.

• Comparative evidence for synthetic substitutes is limited and heterogeneous; document rationale and supporting data for patient‑specific coverage decisions.

Prior authorization — no explicit rules in this excerpt; verify with payer

This excerpt does not state explicit prior authorization rules for other listed items; verify payer‑specific rules when billing or seeking authorization.

• Absent explicit rules in the policy, follow standard Aetna prior authorization processes and cite CPB criteria where relevant.

Denial risk: appendix‑listed experimental/investigational products

Use of products explicitly listed as experimental/investigational in the appendix will trigger noncoverage per the policy; expect denials for those products when used for unsupported indications.

• The appendix enumerates numerous products considered not medically necessary due to insufficient evidence; providers should consult the appendix prior to use.

Ceracell Ortho Foam — document intended nonstructural posterolateral use and mixing with autograft

When Ceracell Ortho Foam is used for posterolateral spine applications mixed with autograft, documentation should indicate intended nonstructural void‑filling use and mixing with autograft in accordance with its 510(k) clearance.

• Document the planned mixing with autograft, the anatomic site, and that the defect is nonstructural per device clearance.

Prior authorization for appendix-listed medically necessary products — provide criteria-based justification

Products listed in the 'medically necessary when criteria are met' appendix remain subject to the policy’s coverage criteria and are likely to require prior authorization or provider justification per Aetna processes.

• Even appendix 'medically necessary' products require meeting the specific clinical criteria described in the CPB for coverage.

Step‑therapy and conservative sequencing — document failed standard care before investigational products

Providers should attempt standard conservative therapies and/or autograft/allograft options before using newer or investigational products; include documentation of failed standard care when requesting authorization.

• OP‑1 was labeled as an alternative only when autograft is unfeasible and other treatments have failed; similar sequencing principles apply to many investigational products.

Conservative‑first: document failed conservative care for rotator cuff prior to augmentation

Conservative management (rest, sling, NSAIDs, physical therapy, injections) is standard first‑line care for rotator cuff tears; document failure of conservative therapy before proposing biologic augmentation or implant use.

• Policy and background emphasize conservative‑first approach prior to surgical augmentation techniques.

Consider autograft or standard fixation before MSC/novel therapies — document prior attempts

Consideration should be given to autograft (iliac crest) or documented standard fixation/technique attempts prior to MSC‑based or novel graft substitutes; include documentation of prior attempts when seeking authorization.

• Autograft remains the gold standard; investigational MSC or novel substitutes require justification that standard options are unsuitable or have failed.

Anal fistula plug: first‑line for simple fistulas; document complexity and counsel on higher failure in Crohn’s

Anal fistula plug may be considered first‑line for simple fistulas and an alternative in selected complex fistulas, but providers must counsel patients about lower long‑term closure rates in complex/Crohn’s cases and document fistula type and prior treatments.

• Pooled closure in non‑Crohn's patients is ~54%; closure rates decline over time and are lower in complex or Crohn's disease patients.
• Document fistula complexity, Crohn's status, prior procedures, and expected outcomes.

Preferred sequencing for fusion adjuncts in long ASD fusions — document autograft/BMP rationale

For long fusions to the sacrum in adult spinal deformity, consider autograft (ICBG) or documented use of BMP with clear dose and level rationale; include this sequencing and justification in prior authorization requests.

• Observational data suggest BMP may improve fusion rates in long constructs, but safety and dosing considerations require explicit documentation.

Consider alternatives before rhBMP‑2; include comparative outcomes and cost rationale

Before using rhBMP‑2 for non‑labeled or alternative indications, consider established alternatives (e.g., OsteoAMP, V‑CBA) and provide comparative evidence of expected outcomes and costs when seeking authorization.

• Retrospective comparisons show alternatives may have similar fusion rates and lower supply costs; include such data if pursuing rhBMP‑2.

Conservative therapy prerequisite for i‑Factor (≥6 weeks) — document failures before use

i‑Factor’s labeled use requires failure of at least 6 weeks of conservative treatment for the cervical indication; use outside labeled indications requires clinical justification in the authorization request.

• Document prior conservative therapy duration and response when requesting coverage for i‑Factor outside labeled indications.

No explicit step‑therapy specified — document prior treatments when requesting coverage

No step‑therapy pathways are specified in these excerpts; where none are defined, follow standard prior authorization and medical necessity review and document prior treatments.

• Provide prior conservative and surgical treatment history to support requests for biologics or implants when explicit step therapy is not specified.

Consider established grafts/BMPs before novel cell‑based products — document comparative rationale

Evidence supports considering established grafts (autograft, allograft, DBM) and BMPs where indicated before newer cell‑based or synthetic peptide products; provide comparative rationale if proposing newer products.

• Newer cell‑based products have limited evidence; stepwise consideration of established options is advised.

Healos graft extender — document attempted autograft or justification when substituting ICBG

Healos (HA+collagen) used as a graft extender has mixed evidence on fusion rates versus autograft; if substituting for iliac crest bone graft, document attempted autograft or justify why autograft is not feasible.

• Some series show slower radiographic fusion with Healos+BMA compared to local iliac crest graft while clinical outcomes may be similar—document rationale when used.

Step‑therapy considerations for Tactoset — attempt conservative options first; document justification

Given limited evidence for Tactoset in some indications (e.g., subchondral bone marrow edema/percutaneous fixation and inadequate support after digital amputation), consider conservative steps first and provide justification and supporting data for Tactoset use.

• Where evidence is insufficient, prior authorization reviewers will expect documentation of failed conservative options and rationale for Tactoset use.

Required clinical documentation for INFUSE — alignment with CPB 0743 and implantation details

Authorization requests for INFUSE must include clinical documentation demonstrating the patient is skeletally mature, meets lumbar fusion criteria per CPB 0743, and that INFUSE implantation will be via an anterior or lateral approach; for tibial shaft fractures include intramedullary nail fixation and application within 14 days of fracture.

• Supply operative approach, fixation method, timing relative to fracture, and CPB 0743 concordant documentation when submitting prior authorization.

Safety documentation required for off‑label BMP‑2 use — document FDA safety notices and swelling risk mitigation

When BMP‑2 is used off‑label (e.g., anterior cervical spine), include FDA safety communications and documentation of awareness of increased risk of clinically relevant pre‑vertebral swelling and related safety measures in the record.

• Include documentation of informed consent addressing off‑label risks and any perioperative measures taken to mitigate swelling risk.

Document device labeling/intended use for 510(k) devices when requesting coverage

For devices cleared via 510(k), document device labeling and intended use when billing or requesting authorization to ensure proposed use matches cleared indications.

• Examples include Restore SIS (rotator cuff soft tissue reinforcement), Integra Mozaik OS (surgically treated osseous defects), and MIIG (injectable bone void filler).

Bone void filler documentation expectations — indicate defect type, fixation, prior treatments and infection history

When bone void fillers (e.g., MIIG, Integra Mozaik OS) are used, include indication, concurrent fixation or procedure, and rationale in documentation; for nonunions include prior treatments, duration, and infection history due to variable outcomes in the literature.

• Evidence lacks support for nonunion treatment with many fillers; detailed prior treatment history is essential for review.

Anal fistula plug: required clinical documentation elements — complexity, Crohn’s status, prior treatments, follow‑up

For anal fistula plug studies and clinical use, document fistula complexity, Crohn's disease status, prior treatments, follow‑up assessment of closure, and any plug extrusions; these elements informed the studies cited by the policy.

• Studies defined success as closure of external openings and absence of drainage/abscess; include similar follow‑up data in requests.

Procedure and imaging documentation for micronized allogeneic cartilage use

When using micronized allogeneic cartilage (BioCartilage) or similar products, document indication, prior conservative management, imaging (MRI) localization of the lesion, and intraoperative technique details given limited human outcome data.

• Provide MRI findings, lesion size/location, prior nonoperative therapy, and operative steps when seeking coverage or coding justification.

Imaging and fusion documentation expectations — schedule and fusion definition

Radiographic fusion assessment (x‑ray and/or CT) at standard postoperative intervals (approx. 1, 3, 6, 12, 18 months) and a clear definition of fusion (bridging across endplates or to interspace disc plugs) should be provided for fusion claims and prior authorizations.

• Blinded radiographic adjudication was used in comparative studies; include imaging schedule and fusion criteria in documentation.

CT documentation of bone bridging — include CT results when used to guide management

In trials assessing bone bridging (e.g., Fourman ankle study), CT at 3 months was used to quantify percent bone bridging; include CT documentation if fusion timing or device removal decisions are based on CT‑assessed bridging.

• Document CT‑assessed percent bridging and how it informed clinical decisions (e.g., frame removal or subsequent interventions).

Typical supporting‑study documentation: radiography and PRO measures — include when available

Supporting studies commonly required radiographic fusion assessment and patient‑reported outcome measures (VAS, NDI, SF‑36, ODI) with blinded adjudication; include similar outcome measures in documentation when available.

• Including PROs and blinded radiographic assessments strengthens prior authorization and coverage submissions for novel products.

Device trial documentation expectations (IDE studies) — levels, PROs, CT at 12/24 months

Registry or IDE device trials (e.g., OptiMesh) required documentation of instrumented fusion level, pre‑ and post‑op validated outcome measures, and CT imaging for fusion at 12 (and 24 if not fused) months; provide similar data when requesting coverage for devices studied under IDEs.

• Independent radiologist CT assessment and adjudicated adverse events were parts of IDE protocols; include equivalent imaging and outcome data where available.

Prior auth/documentation expectations for AGN1 LOEP — limited evidence; provide osteoporosis data and prior therapies

Clinical evidence supporting AGN1 LOEP is limited to a single small cohort; document patient T‑scores, prior osteoporosis treatments, and trial applicability if proposing AGN1 LOEP, and expect requests for higher‑quality evidence.

• Current evidence is insufficient to establish effectiveness; ongoing trials are recruiting but AGN1 remains investigational pending RCT data.

Billing/denial examples — CPT codes not covered for CPB indications (e.g., 0707T, 0547T)

Certain CPT/HCPCS codes are listed as not covered for indications in this CPB (for example, 0707T subchondroplasty and 0547T bone‑material microindentation testing); do not bill these codes for unsupported CPB indications.

• 0707T (subchondroplasty) is listed as not covered for indications in this CPB.
• 0547T (microindentation testing) is listed as not covered for indications in this CPB.

CMS non‑coverage alert: autologous PRP for certain wound indications — denial risk

CMS has issued a non‑coverage decision for autologous PRP for chronic non‑healing cutaneous wounds, acute surgical wounds when PRP is applied directly to the closed incision, and dehiscent wounds; expect payer denials consistent with CMS guidance.

• When proposing PRP for CMS‑noncovered indications, include clinical justification and expect denial based on CMS policy.

Bone void fillers for delayed union/nonunion — unsupported; potential denials

Use of bone void fillers for delayed union or nonunions is unsupported by sufficient evidence and may be denied when intended as treatment for delayed fracture healing or nonunion.

• ECRI and other assessments concluded there is no reliable evidence to support calcium sulfate or other bone void fillers for delayed fracture healing/nonunions.

AlloMatrix putty — documented high complication/infection rates; denial/documentation risk

AlloMatrix putty has been associated with high postoperative drainage and infection rates in nonunion series; providers should document infection risk and prior infection history if proposing its use and expect potential denial.

• In the Ziran series, over half developed postoperative drainage and many required reoperation for deep infection.

Evidence gap for cellular bone matrices — may trigger denial or request for comparative evidence

Evidence gaps for cellular bone matrices (e.g., Osteocel) may lead to denial or requests for comparative evidence when used as a replacement for standard allograft or autograft in procedures like ACDF.

• Matched‑cohort data showed lower 1‑year fusion rates for Osteocel in one series (87.7% vs 94.7%), prompting requests for higher‑level evidence.

Off‑label pediatric rhBMP use — documentation and denial risk

Off‑label pediatric use of rhBMP requires careful documentation; although some large administrative analyses did not show higher overall complication rates, certain infections were more common and long‑term growth/cancer risks were not assessed — expect payers to require detailed justification.

• Document indications, alternative options, and informed consent addressing off‑label pediatric concerns when requesting coverage.

i‑Factor contraindications — do not use when listed contraindications present

i‑Factor contraindications must be observed: do not use when acute/chronic infection is present at the operative site, load‑bearing structural support is absent, or in patients with compromised renal/hepatic function, metabolic disorders affecting healing, or known sensitivity to components.

• Prior authorization or chart documentation should confirm absence of these contraindications when i‑Factor is proposed.

Evidence limitations may affect coverage — provide robust supporting data

Because evidence is often limited (small samples, single‑center designs, or biased registries), coverage decisions may be affected — supply robust study details and address limitations when requesting authorization.

• Clearly state study design limitations and how proposed use differs from populations in cited studies when seeking coverage for novel products.

Synthetic grafts (PMMA/BOP) — higher risks reported; document comparative justification

Synthetic grafts such as PMMA and biocompatible osteoconductive polymer (BOP) have been associated with lower fusion rates and higher device‑related complications versus iliac crest bone graft in some studies; expect prior authorization scrutiny and need for comparative justification.

• Document comparative fusion and complication data when proposing synthetic grafts in place of accepted grafts.

SVF therapies — insufficient evidence; likely denial without strong data

Use of adipose‑derived stromal vascular fraction (SVF) cells lacks sufficient evidence for clinical indications; services based on insufficient evidence may be denied and prior authorization requests should include high‑level supporting data.

• Intraoperative isolation methods and small pilot studies exist, but clinical efficacy remains unproven—expect denials without robust trial evidence.

Xenograft implantation into articular surfaces — insufficient evidence; denial risk

Xenograft implantation into articular surfaces is unsupported by sufficient evidence and may be denied; do not propose xenograft articular implantation without compelling investigational trial data.

• Policy explicitly lists xenograft implantation into articular surfaces as investigational.

Denial risk for products listed as experimental/investigational in appendix

Use of products explicitly listed as 'experimental and investigational' in the appendix will trigger noncoverage per policy; verify the appendix before proposing a product and include comparative evidence if requesting exception.

• The appendix enumerates many products considered not medically necessary; exceptions require compelling, high‑quality evidence.