OSTEOARTHRITIS OF THE KNEE
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Defines medical necessity, limitations, and exclusions for diagnostic and therapeutic interventions for knee osteoarthritis, affecting providers delivering operative, interventional pain, and regenerative treatments.
Added partial and total knee arthroplasty as medically necessary treatment for knee OA when Turning Point criteria is met.
Added additional not medically necessary treatments, including Transcutaneous electrical nerve stimulation (TENS), Neuroablative therapies (e.g., cryoneurolysis), biomechanical shoe-based devices, implanted shock absorbers (e.g., MISHA®), synthetic cartilage implants, low-level laser therapy, and prolotherapy.
Genicular nerve radiofrequency ablation moved from not medically necessary to medically necessary when strict criteria are met. Prior Authorization required.
Removed a related policy that was retired (Autologous Chondrocyte Implant/Meniscal Allograft).
Removed outdated references.
New Policy scope section.
New Medical/Professional Society Guidelines section.
New Government Regulations section listing applicable CMS NCDs or LCDs.
New FDA/Regulatory sections.
Policy Language was added/removed/changed to better or more fully explain criteria.
Coverage Criteria and Determinations
Genicular nerve RFA — medically necessary criteria
Conventional thermal or cooled genicular nerve radiofrequency ablation (RFA) is considered medically necessary when ALL of the following criteria are met:
Applies to conventional thermal or cooled RFA only.
Operative and cartilage repair procedures — inclusions
Procedures specifically listed as medically necessary when performed according to applicable TurningPoint clinical criteria:
These procedures require adherence to TurningPoint clinical criteria where applicable.
Biomechanical shoe-based devices (AposHealth®)
Coverage stance:
Available data limited by methodological weaknesses and lack of appropriate comparators.
Cryotherapy / Cryoneurolysis
Coverage stance:
Sham-controlled trials and meta-analyses show inconsistent benefits and limited durability.
Custom-made lateral wedge insoles
Coverage stance:
May provide benefit for selected patients with medial compartment OA when combined with arch support.
Genicular artery embolization (GAE)
Coverage stance:
Ongoing sham-controlled trials (e.g., GENESIS-2) are noted.
Low-level laser therapy (LLLT)
Coverage stance:
Systematic reviews report short-term pain effects but inconsistent nonpain outcomes.
Medial knee implanted shock absorber (MISHA® / ISA)
Coverage stance:
Preserves future arthroplasty options but lacks guideline endorsement.
Osteochondral implant (CartiHeal Agili-C®)
Coverage stance:
Evidence derives from focal defect trials, not diffuse OA.
Prolotherapy
Coverage stance:
Variability in protocols and injectates limits conclusions.
Transcutaneous Electrical Nerve Stimulation (TENS) and related electrotherapies
Coverage stance:
Recent RCTs show no superiority over placebo.
Genicular nerve radiofrequency ablation (RFA) / Cooled RFA
Coverage stance and candidate selection:
Evidence certainty is low to very low; cooled RFA has not shown consistent superiority over conventional thermal RFA.
Genicular nerve RFA coverage criteria
Covered when ALL of the following are met
Diagnostic block-based enrichment is emphasized in clinical trials and guidance.
Conservative management examples include physical therapy, NSAIDs, and intra-articular corticosteroids.
Genicular Nerve RFA — medically necessary with criteria
Genicular nerve radiofrequency ablation coverage statement (summary):
Specific criteria are detailed elsewhere in the policy; prior authorization must document eligibility per policy requirements.
The policy explicitly identifies three procedural limitations related to genicular nerve radiofrequency ablation (RFA) that are considered not medically necessary: pulsed RFA of the genicular nerves; repeat genicular nerve RFA when there is no documented clinically meaningful benefit from a prior ablation; and genicular nerve RFA in individuals with end-stage knee osteoarthritis when knee arthroplasty is imminently planned. These exclusions are intended to prevent use of approaches with inferior evidence (pulsed RFA) and to avoid repeated or duplicative ablations when prior treatment has not provided clear clinical benefit or when definitive surgical management is imminent.
CartiHeal Agili-C® is a lesion-specific, resorbable osteochondral implant approved for focal articular cartilage and osteochondral defects. The policy clarifies that Agili-C is not indicated or supported for routine treatment of generalized knee osteoarthritis; its evidence base and regulatory labeling apply to contained, focal lesions and cannot be extrapolated to diffuse, whole-joint OA. Use of Agili-C for generalized OA is therefore considered investigational for the indications covered by this policy.
The document lists multiple procedures and technologies as not medically necessary or investigational for routine management of knee OA. Examples include certain orthobiologic injectable therapies (adipose-derived regenerative cell therapies, BMAC, PRP, and mesenchymal cell injections), peripheral nerve–targeted neuromodulation such as TENS, neuroablative therapies including cryoneurolysis (e.g., Iovera®), mechanical/external off-loading devices (e.g., AposHealth® and custom lateral wedge insoles), genicular artery embolization (GAE), medial knee implanted shock absorbers (MISHA®), synthetic cartilage implants (CartiHeal Agili-C®), low-level laser therapy (LLLT), and prolotherapy. Corresponding billing codes for many of these interventions are also identified as considered not medically necessary in the coding section.
The policy’s reference and evidence sections summarize existing bibliographic material about autologous therapies (adipose-derived injections, BMAC, PRP, and related mesenchymal cell approaches). These citations note heterogeneity in techniques, variable trial quality, and limited high-certainty evidence; however, the extracted bibliographic chunks do not by themselves state new, explicit coverage exclusions beyond those already summarized elsewhere in the policy text. The references provide supporting context for the policy’s investigational stance on these autologous biologic therapies.
This update explicitly adds several therapies to the list of treatments considered not medically necessary or investigational: Transcutaneous Electrical Nerve Stimulation (TENS), neuroablative therapies (e.g., cryoneurolysis), biomechanical shoe-based devices (AposHealth®), implanted shock absorbers (e.g., MISHA®), synthetic cartilage implants (CartiHeal Agili-C® for generalized OA), low-level laser therapy (LLLT), and prolotherapy. The policy cites randomized trials, systematic reviews, and guideline statements as the basis for classifying these as experimental, investigational, or not supported for routine clinical use.
In summary, the policy considers a broad set of interventions for knee osteoarthritis to be not medically necessary or investigational for routine care. This general list includes pulsed RFA, repeat ineffective genicular RFA, genicular RFA when arthroplasty is imminent, adipose-derived and other orthobiologic injectables (BMAC, PRP, MSCs), peripheral neuromodulation (TENS), neuroablative procedures (cryoneurolysis), biomechanical shoe-based devices and certain orthotics, genicular artery embolization (GAE), medial implanted shock absorbers (MISHA®), synthetic cartilage implants when used for generalized OA, low-level laser therapy (LLLT), and prolotherapy. The policy further cross-references specific CPT/HCPCS codes that are considered not medically necessary for these indications.
A more detailed listing of interventions classified as investigational or not medically necessary includes: AposHealth® (biomechanical footwear), cryoneurolysis/cryotherapy, genicular artery embolization (GAE), low-level laser therapy (LLLT), medial implanted shock absorbers (MISHA®), prolotherapy, and TENS/electrotherapies. For most of these modalities the policy cites limited, heterogeneous, or low-certainty evidence and notes lack of endorsement from major professional society guidelines, supporting their investigational classification.
The policy identifies a set of CPT/HCPCS and unlisted procedure codes to be considered in the context of the investigational or not medically necessary interventions. Representative codes listed as not medically necessary include 0232T (PRP injection), 0481T (autologous protein solution), 0552T (LLLT), 0565T/0566T (autologous adipose-derived cellular implants), 0737T (xenograft implantation), 20999 and 27599 (unlisted musculoskeletal procedures), 37242 (vascular embolization), 64640 (neurolytic peripheral nerve destruction), C8003 (medial knee implantable shock absorber), C9809 (cryoablation needle), E0720/L3649/L3000 (TENS/orthotic device codes), and M0076 (prolotherapy). These codes are flagged in the policy’s coding section as associated with treatments that are not supported for the indications covered here.
Some extracted reference chunks contain bibliographic discussion of autologous and cell-based therapies but do not themselves include explicit, standalone 'not medically necessary' coverage determinations; rather, they provide evidence summaries, technique descriptions, and citations that the policy uses to justify its overall investigational stance. Thus, while the literature is cited extensively, several reference chunks serve primarily as evidence context rather than direct exclusion language.
Prolotherapy and transcutaneous electrical nerve stimulation (TENS) are explicitly named among treatments considered not medically necessary in the policy text. The policy states that prolotherapy protocols are heterogeneous and that available trials show inconsistent, often short-term symptom benefits insufficient to support routine clinical use. Similarly, recent high-quality randomized evidence and guideline statements do not demonstrate clinically meaningful, durable benefit for TENS and related electrotherapies, supporting their classification as investigational or not medically necessary for knee OA.
Procedures discussed in the referenced RFA and interventional sections do not list additional explicit billing codes in these specific chunks; coding details for covered and not-medically-necessary procedures are provided elsewhere in the policy’s coding tables. For operational purposes the policy maps procedural descriptions to the coding section rather than embedding code lists within the narrative RFA discussion.
Coding and Billing
| 27438 | Arthroplasty, patella; with prosthesis |
| 27446 | Arthroplasty, knee, condyle and plateau; medial OR lateral compartment |
| 27447 | Arthroplasty, knee, condyle and plateau; medial AND lateral compartments with or without patella resurfacing (total knee arthroplasty) |
| 27486 | Revision of total knee arthroplasty, with or without allograft; 1 component |
| 27487 | Revision of total knee arthroplasty, with or without allograft; femoral and entire tibial component |
| 64454 | Injection(s), anesthetic agent(s) and/or steroid; genicular nerve branches, including imaging guidance, when performed. |
| 64624 | Destruction by neurolytic agent, genicular nerve branches including imaging guidance, when performed |
| 27412 | Autologous chondrocyte implantation, knee |
| J7330 | Autologous cultured chondrocytes, implant |
| 0232T | Injection(s), platelet rich plasma, any tissue, including image guidance, harvesting and preparation when performed |
| 0481T | Injection(s), autologous white blood cell concentrate (autologous protein solution), any site, including image guidance, harvesting and preparation, when performed |
| 0552T | Low-level laser therapy, dynamic photonic and dynamic thermokinetic energies, provided by a physician or other qualified health care professional |
| 0565T | Autologous cellular implant derived from adipose tissue for the treatment of osteoarthritis of the knees; tissue harvesting and cellular implant creation |
| 0566T | Autologous cellular implant derived from adipose tissue for the treatment of osteoarthritis of the knees; injection of cellular implant into knee joint including ultrasound guidance, unilateral |
| 0737T | Xenograft implantation into the articular surface |
| 20999 | Unlisted procedure, musculoskeletal system, general |
| 27599 | Unlisted procedure, femur or knee |
| 37242 | Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; arterial, other than hemorrhage or tumor (eg, congenital or acquired arterial malformations, arteriovenous malformations, arteriovenous fistulas, aneurysms, pseudoaneurysms) |
| 64640 | Destruction by neurolytic agent; other peripheral nerve or branch (e.g., Iovera) |
| No codes listed |
Provider Actions, Authorization, and Denial Triggers
Prior authorization required for genicular nerve RFA
Prior authorization is required when requesting conventional thermal or cooled genicular nerve radiofrequency ablation (RFA); the request must document that the member meets the policy's eligibility criteria (KL grade II–IV, chronic moderate-to-severe pain with functional impairment, ≥6 months conservative management, not an appropriate or electing to defer arthroplasty, and diagnostic genicular nerve block response ≥50% lasting ≥24 hours).
- Document imaging-confirmed Kellgren-Lawrence grade II–IV disease
- Document failure of ≥6 months of conservative management
- Document diagnostic genicular nerve block response (≥50% pain relief ≥24 hours)
- Confirm patient is not an imminent arthroplasty candidate or elects to defer arthroplasty
Confirm diagnostic genicular nerve block response
Prior authorization should include documentation that a diagnostic genicular nerve block demonstrating a clinically meaningful response (commonly defined as ≥50% pain relief) was performed prior to approving genicular nerve RFA.
- Include results of image-guided diagnostic genicular nerve block
- Specify magnitude and duration of pain relief observed after the block
Submit medical necessity justification with prior authorization
Providers must submit a prior authorization request per Priority Health procedures and include medical necessity justification and supporting documentation (use TurningPoint authorization criteria lookup when applicable).
- Submit medical necessity rationale and required supporting records
- Use Priority Health Provider Manual and TurningPoint Authorization Criteria Lookup
Authorization requirements for other therapies may vary
Some therapies described elsewhere in the policy do not have specified prior authorization requirements in the extracted reference material; check product-specific rules and the Priority Health Provider Manual for authorization details.
- Verify authorization requirements for non-RFA interventions in the Provider Manual
Genicular nerve RFA requires prior authorization and criteria
Genicular nerve radiofrequency ablation requires prior authorization and is covered only when the policy's strict coverage criteria are met; the policy was revised to change RFA from not medically necessary to medically necessary with criteria.
- Prior authorization is mandatory for genicular nerve RFA
- Coverage only when all specified eligibility criteria are documented
Document ≥6 months of conservative management
Prior authorization must demonstrate failure of at least 6 months of conservative management (examples include physical therapy, NSAIDs, and intra‑articular corticosteroid injections) before genicular nerve RFA is approved.
- Document duration and type of conservative therapies tried (e.g., PT, NSAIDs, intra‑articular corticosteroids)
- Indicate dates and clinical response to those therapies
RFA sequencing: conservative therapy → diagnostic block → RFA
Genicular nerve RFA is intended for patients who are not immediate candidates for arthroplasty and typically requires a prognostic diagnostic nerve block and sequencing after conservative therapy.
- Confirm patient is not an appropriate or imminent arthroplasty candidate or has elected to defer arthroplasty
- Ensure diagnostic genicular nerve block was performed as part of sequencing
Diagnostic genicular nerve block required before ablation
A diagnostic genicular nerve block is required as a prognostic step to confirm genicular-mediated nociceptive pain before proceeding to genicular nerve RFA.
- Perform image-guided diagnostic GNB targeting the intended genicular nerves
- Record pain relief magnitude and duration following the block
No additional step therapy requirements specified
The extracted reference material does not describe additional formal step therapy programs beyond the conservative management and diagnostic‑block sequencing required for RFA; check policy and benefits for any plan-specific step edits.
- No other formal step therapy requirements specified in these chunks
Required documentation for genicular nerve RFA
Documentation submitted for genicular nerve RFA must show imaging-confirmed Kellgren‑Lawrence grade II–IV disease, chronic moderate‑to‑severe pain causing functional impairment, failure of ≥6 months of conservative therapy, and diagnostic genicular nerve block demonstrating ≥50% pain relief lasting ≥24 hours.
- Include imaging report confirming KL grade II–IV
- Detail pain severity, functional impairment, and duration
- Provide records of conservative treatments and dates
- Attach diagnostic genicular nerve block procedure notes and pain relief metrics (magnitude and duration)
Document diagnostic block response and imaging guidance
To document RFA candidacy, include contemporaneous procedural records showing the diagnostic genicular nerve block response (commonly defined as ≥50% short‑term pain relief) and imaging guidance confirming the targeted nerves.
- Attach diagnostic GNB procedure note with percent pain relief and duration
- Document imaging modality and confirmation of needle placement
No documentation or administrative prior authorization risks denial
If no documentation or administrative prior authorization is provided to demonstrate that strict coverage criteria are met, requests for genicular nerve RFA risk denial.
- Absence of required documentation may lead to claim denial
- Ensure prior authorization includes all eligibility evidence to avoid administrative denials
Required documentation for RFA candidacy — failure may lead to denial
Providers must document failure of conservative management and positive diagnostic block response to support RFA candidacy; lack of these required elements will place the request at high risk for denial.
- Failure to show ≥6 months conservative therapy is a denial risk
- Failure to show diagnostic block ≥50% relief is a denial risk
Denial triggers: Not medically necessary RFA indications
Requests for procedures listed as Not Medically Necessary (for example, pulsed RFA, repeat genicular RFA without documented prior benefit, or genicular RFA when arthroplasty is imminently planned) may be denied.
- Pulsed RFA of genicular nerves is considered not medically necessary
- Repeat RFA without documented prior clinically meaningful benefit is not medically necessary
- RFA when arthroplasty is imminent is not medically necessary
Denial risk for investigational therapies
Interventions considered experimental, investigational, or unproven (e.g., AposHealth®, cryoneurolysis/cryotherapy, genicular artery embolization, medial knee implanted shock absorbers, Agili‑C for generalized OA) are at high risk for denial when requested as routine OA treatments.
- These therapies are classified as investigational and not supported for routine OA care
- Requests will likely be denied absent an approved individual case review
Experimental/investigational interventions require prior plan approval
Requests for interventions deemed experimental, investigational, or unproven will be denied unless an individual case review with prior plan approval is obtained and a Priority Health medical director or clinical pharmacist authorizes coverage.
- Submit case for individual plan review and prior approval to pursue investigational interventions
- Coverage exceptions require review and approval by plan medical leadership
Evidence and references available to support requests
This policy includes an evidence/reference list; providers may cite the listed references when supporting medical necessity requests, but references alone do not substitute for the required contemporaneous clinical documentation.
- Use cited randomized trials and guidelines to support rationale, but include member-specific clinical documentation in the authorization request
Genicular nerve RFA: prior authorization and denial risk
Requests for genicular nerve RFA may be denied if strict coverage criteria are not met; prior authorization is required and must include the documentation elements specified in the policy.
- Ensure all eligibility criteria evidence is included in the prior authorization to avoid denial
Denial risk: listed not medically necessary treatments
Treatments listed as not medically necessary in the policy (including transcutaneous electrical nerve stimulation, neuroablative therapies such as cryoneurolysis, biomechanical shoe-based devices, implanted shock absorbers, synthetic cartilage implants, low-level laser therapy, and prolotherapy) will be denied when requested for knee osteoarthritis.
- Do not submit prior authorization for interventions explicitly listed as not medically necessary unless requesting an individual case review
- Include supporting rationale and request prior plan approval if seeking exception
Background and Rationale
Knee osteoarthritis (OA) is a degenerative joint disorder characterized by activity-related knee pain, stiffness, swelling, and functional limitation. Radiographic severity is commonly classified using the Kellgren-Lawrence (KL) grading system, where KL grades II–IV represent definitive to severe disease and are used in this policy to define imaging eligibility for certain interventions. Core nonpharmacologic management—structured exercise, education, and weight management—forms the foundation of OA care, with pharmacologic therapies used as adjuncts. Genicular nerve procedures such as radiofrequency ablation are positioned as targeted, minimally invasive options for symptom relief in appropriately selected patients who have failed conservative therapy and are not immediate candidates for arthroplasty.
Definitions and Key Terms
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