SelectHealth Xclose Annular Repair Coverage

Not Covered — Investigational — SelectHealth Commercial and CHIP policy statement

Select Health Commercial and CHIP policy statement — Annular tissue repair systems (e.g., Xclose)

Select Health does NOT cover annular tissue repair systems, including the Xclose device, as there is a lack of published evidence demonstrating improved health outcomes compared to standard discectomy care. This meets the plan's definition of experimental/investigational.

Summary of Medical Information: A thorough search found no systematic reviews or peer-reviewed studies supporting the Xclose system or similar annular closure systems. Manufacturer-provided materials cited poster presentations and peripheral studies but no peer-reviewed evidence of superior patient outcomes.

An unpublished, single-blind, multicenter prospective comparative study provided to Select Health reported no difference in pain outcomes or statistically significant differences in re-surgery rates versus discectomy without annular closure. A post-hoc finding suggested a marginally significant reduction in reoperation rate for a subset of high-volume surgeons (p=0.049), but this was not a pre-specified outcome and is of uncertain generalizability given high dropout rates and other study limitations.

A Hayes review (June 2013) concluded insufficient published evidence to assess safety or impact on health outcomes or patient management for the Xclose Plus Tissue Repair System. Given the paucity and limitations of the evidence, annular tissue repair systems remain experimental/investigational.

Not Covered — Investigational — Anterolateral Ligament Reconstruction

Select Health Commercial and CHIP policy statement — Anterolateral ligament (ALL) reconstruction

Select Health does NOT cover anterolateral ligament reconstruction as part of knee reconstruction surgery; the procedure is considered unproven/experimental.

Summary of Medical Information: Limited published studies exist evaluating ALL repair in isolation or as part of ACL reconstruction. As of the cited review, only one systematic review and two primary articles were identified, with generally biomechanical or descriptive focus rather than patient-centered clinical outcomes.

Evidence limitations include non-randomized case series (e.g., Sonnery-Cottet et al.) where patients undergoing ACL+ALL repair were not randomized against ACL-only patients, preventing conclusions about incremental benefit of ALL repair. No meaningful evidence demonstrates clinical need or improved outcomes from routine ALL repair.

Artificial Disc Replacement — Coverage Criteria and Contraindications

Artificial intervertebral disc replacement — coverage dependent on FDA indication and criteria

Select Health covers artificial spinal disc replacements only for FDA-approved indications. All other uses are considered experimental/investigational.

Conditions necessary for coverage: Must meet all criteria for spinal fusion outlined in Select Health policy #622 and relevant lumbar or cervical criteria as specified.

Lumbar criteria include symptomatic degenerative disc disease at one or two levels with no isolated radicular compression syndromes (except at replacement level), and no listed contraindications.

Cervical criteria include symptomatic degenerative disc disease with radiculopathy with motor or sensory deficit or symptomatic myelopathy, coverage of FDA-approved discs for one- or two-level replacement, and no listed contraindications. Concurrent or planned one- to two-level cervical disc replacement without cervical fusion (or with planned fusion at adjacent levels) is considered medically necessary when criteria are met.

IDE Trial Success Definitions (Informational)

IDE trial success definitions and related evidence notes (informational)

IDE/PMA trial success criteria examples: improvement in ODI by ≥15% at 24 months versus baseline; no re-operation to remove/modify implant; improvement in SF-36; maintained or improved neurological status; radiographic success (no migration/subsidence >3 mm, no extensive radiolucency, maintained ROM, no loss of disc height >3 mm, no evidence of bony fusion).

Radiographic success definitions differ for fusion controls (e.g., evidence of solid fusion, <3 mm translation on flexion/extension).

Available randomized controlled trial data (e.g., ProDisc-L IDE) showed higher overall success at 24 months for ProDisc versus fusion (63.5% vs. 45.1%, p=0.0053) with mixed device-related adverse event profiles. Longer-term data remain limited and device-specific outcomes vary.

Evidence and Outcomes — Cervical Disc Replacement Summary

Evidence and outcomes — summarized evidence node for cervical devices

Randomized and controlled trials for cervical total disc replacement (TDR) show short-term (up to 48 months) improvements in clinical outcomes and comparable or improved safety versus ACDF for some devices, with maintenance of segmental ROM and lower subsequent surgery rates in some studies.

Device-specific summaries: Prestige ST IDE showed probabilities of equivalence/superiority at 24 months in Bayesian analyses; Mobi-C data through 48 months indicate greater improvement versus ACDF on some endpoints; M6-C IDE demonstrated noninferiority to ACDF with secondary advantages in pain, opioid use reduction, shorter operative times, and lower rates of subsequent surgery at 24 months. However, sample sizes are limited and longer-term published data beyond 3–4 years are sparse.

Hayes and other technology assessments note positive but limited evidence, small sample sizes, and lack of long-term data for many devices; ongoing trials may address some gaps.

Athletic Pubalgia Repair — Not Covered

Athletic pubalgia (sport's hernia) repair — coverage stance and billing note

Select Health does NOT cover athletic pubalgia (sports hernia) repair due to the ill-defined nature of the condition and lack of consensus on treatment approach; considered experimental/investigational.

Billing/Coding Information: Not covered – Investigational/Experimental/Unproven for this indication.

MACI Coverage (Commercial and CHIP) — Covered When ALL Criteria Met

MACI (matrix-induced autologous chondrocyte implantation) — limited coverage criteria

Select Health covers MACI in limited circumstances when ALL of the following are met:

- Age 15 to 55 years.

- BMI < 35.

- Documented disabling knee pain with significant symptoms (pain, swelling, catching) limiting daily activities.

- Focal articular cartilage defect down to but not through subchondral bone.

- Defect size at least 2 cm across (or approximately 3 cm² in total area).

AxiaLIF — Not Covered (Experimental/Investigational)

Axial Lumbar Interbody Fusion (AxiaLIF) — coverage stance and evidence summary

Select Health does NOT cover AxiaLIF. While short-term evidence suggests comparable safety and efficacy versus standard single-level fusion, long-term durability and cost-effectiveness data are lacking.

Evidence summary: Systematic reviews and primary studies provide short follow-up (12–34 months; mean ~21.7 months) with limited sample sizes. No head-to-head trials adequately comparing AxiaLIF to standard interbody fusion with long-term outcomes exist. NICE recommended limited use by specially trained surgeons given uncertainties. Reported outcomes include mean fusion rates and complication metrics, but generalizability and long-term conclusions are limited.

Electrical Bone Growth Stimulators — Coverage Criteria and Considerations

Electrical bone growth stimulators — coverage criteria (long-bone nonunion, congenital pseudoarthroses, degenerative hip post-osteotomy, spinal fusion adjuncts, failed fusion)

Select Health covers electrical bone growth stimulators only when specific criteria are met.

Long-bone nonunion (diaphyseal fractures): Covered when ALL of the following are met: the fracture resulted from trauma or surgery; predominantly of the shaft (diaphysis); fracture gap ≤ 1 cm; documented evidence of adequate fracture care (casting, immobilization, internal fixation); at least 3 months have passed since fracture or surgical treatment; serial radiographs over the preceding 3 months show no progression of healing; provider-submitted written interpretation documents lack of clinically significant healing between radiographs; the patient can be adequately immobilized and is likely to comply with non-weight bearing.

Congenital (infantile) pseudoarthroses: Non-invasive electrical stimulators may be used when criteria are met (fracture gap criteria, immobilization/compliance, documented conservative care).

Degenerative hip disease post-osteotomy: Non-invasive stimulation may be considered when immobilization/compliance and documented conservative care are present.

Evidence-based Coverage Considerations — Rationale

Evidence-based coverage considerations — summary and rationale

Quality of evidence for electrical stimulation is limited by difficulty conducting randomized, double-blind trials and heterogeneity in study designs and outcome measures. Systematic reviews and technology assessments yield mixed conclusions; some controlled data support use in specific high-risk spinal fusion populations, but overall clinical outcome data are inconsistent.

FDA labeling changes and expert panels have altered definitions of nonunion to focus on lack of progressive healing rather than fixed timeframes; Select Health aligns coverage to clinical indicators (radiographic nonprogression) rather than rigid time windows.

Given limited quantity and quality of evidence, Select Health restricts coverage of electrical bone growth stimulators to the indications and criteria outlined to protect program integrity and ensure appropriate use.

Computer-Assisted Orthopedic Surgeries — Coverage Rationale and Coding

Computer-Assisted Orthopedic Surgeries (CAS) — coverage stance and rationale

Select Health acknowledges improved prosthesis/component placement with computer-assisted techniques but does NOT find consistent evidence of improved patient-centered clinical outcomes (pain, function, range of motion, revision rates) or long-term benefit for most patients.

Systematic reviews and technology assessments (Hayes, BCBS TEC, Danish HTA) show improved technical alignment but limited/ inconsistent clinical outcome data; only small studies assess cost-effectiveness and long-term revision benefits.

Coding/Billing: Computer-assisted musculoskeletal navigation codes (e.g., 0054T, 0055T, 20985) are designated as Not covered: Investigational/Experimental/Unproven for these indications when used to seek additional reimbursement beyond standard procedure.

Core Decompression for Avascular Necrosis — Hip Covered (Early), Other Sites Not Covered

Core decompression for avascular necrosis (AVN) — hip covered in early stages; other sites not covered

Select Health covers core decompression of the hip for early (pre-collapse stages I and II by Ficat classification) avascular necrosis of the femoral head when clinically appropriate.

Select Health does NOT cover core decompression for late-stage hip AVN (post-collapse) or core decompression for AVN at other sites (humeral head, distal femur/femoral condyle, talus, mandibular condyle) as these are considered investigational due to limited and low-quality evidence.

Evidence summary: Studies suggest core decompression may be safe and may prevent or delay arthroplasty when performed in early hip AVN, with joint survival decreasing as baseline disease stage increases. Evidence for shoulder, knee, ankle, and mandibular condyle AVN is sparse, predominantly single-arm cohorts or small retrospective series with methodological limitations, preventing firm conclusions on safety and efficacy for these sites.

Cryoanalgesia / Cryosurgical Ablation — Not Covered (Investigational)

Cryoanalgesia / Iovera system and cryosurgical ablation of foot conditions — coverage stance and jurisdictional notes

Select Health does NOT cover Iovera (cryoneuroablation) for knee pain where there is insufficient published evidence to assess safety and impact on outcomes; Iovera is considered experimental/investigational for the commercial plan.

Medicare: Coverage is determined by CMS; if no CMS determination exists, Select Health Commercial policy applies.

Medicaid (Select Health Community Care): Policies typically align with Utah Medicaid and InterQual; refer to state resources for current coverage.

Select Health does NOT cover cryosurgical ablation of plantar fasciitis, Morton's neuroma, or other foot conditions (excluding warts) — considered investigational due to lack of evidence. Summary of medical information: Only two small Medline-identified studies (small case series and single case reports) exist for cryoablation of neuromas; evidence is inadequate and alcohol sclerosing injections may be more effective based on comparative reports.

Custom Components for Total Knee Replacement (TKA) — Not Covered

Custom components for total knee arthroplasty (TKA) — coverage stance and evidence summary

Select Health does NOT cover custom components for total knee arthroplasty. Current evidence does not demonstrate improved health outcomes compared to standard TKA; custom components are considered experimental/investigational.

Select Health does NOT provide additional reimbursement for custom components; they are considered part of the primary procedure and not eligible for separate payment.

Evidence summary: Systematic reviews and primary studies (including one RCT and several observational studies) report inconsistent effects on alignment and limited data on clinically relevant endpoints (revision rates, pain reduction, function). Cost-effectiveness analyses indicate routine use of custom cutting blocks is unlikely to be cost-effective unless revision rates are substantially reduced; current evidence is insufficient to show such benefit.

Billing Codes and Status

Not covered CPT CodesCPTNot Covered

22899

Unlisted procedure, spine

Not covered HCPCS CodesHCPCSNot Covered

L8699

Prosthetic implant; not otherwise specified

CPT codes listedCPT

29888	Arthroscopically aided anterior cruciate ligament repairlaugmentation or reconstruction
29999	Unlisted procedure, arthroscopy

HCPCS codesHCPCS

No codes listed

Covered lumbar CPT CodesCPTCovered

22857	Total disc arthroplasty, lumbar, interspace (other than for decompression), single interspace, lumbar
22860	Total disc arthroplasty, lumbar, second interspace (list separately in addition to code for primary procedure)
0163T	Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), each additional interspace, lumbar (List separately in addition to code for primary procedure)

Covered cervical CPT CodesCPTCovered

22856	Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation, single interspace, cervical
22858	Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation; second level, cervical

HCPCSHCPCS

No codes listed

Coding information (informational)mixed

No codes listed

Unlisted/laparoscopy CPT codes referencedCPT

49659	Unlisted laparoscopy procedure, hernioplasty, herniorrhaphy ; herniotomy
49999	Unlisted procedure, abdomen, peritoneum and omentum
49650	Laparoscopy, surgical, repair initial inguinal hernia

CPT codes for MACI-related proceduresCPTCovered

27412	Autologous chondrocyte implantation, knee articular surface defect; autografts
29870	Arthroscopy, knee, diagnostic, with or without synovial biopsy (separate procedure)

HCPCS codes for MACIHCPCSCovered

J7330	Autologous cultured chondrocytes, implant
S2112	Arthroscopy, knee, surgical for harvesting of cartilage (chondrocyte cells)

HCPCS CODESHCPCS

No codes listed

Not covered: Investigational/Experimental/Unproven CPT CODESCPTNot Covered

22586	Arthrodesis, pre-sacral interbody technique, including disc space preparation, discectomy, with posterior instrumentation, with image guidance, includes none when performed, L5-S1 interspace graft
22899	Unlisted procedure, spine

HCPCS CODESHCPCS

No codes listed

HCPCS / CPTmixed

No codes listed

CPT CodesCPT

20974	Electrical stimulation to aid bone healing; non-invasive (nonoperative)
20975	Electrical stimulation to aid bone healing; invasive (operative)

HCPCS CodesHCPCS

E0747	Osteogenesis stimulator; electrical noninvasive; other than spinal applications
E0748	Osteogenesis stimulator; electrical, non-invasive, spinal applications
E0749	Osteogenesis stimulator; electrical, surgically implanted

Not Covered / Investigational CPT CodesCPTNot Covered

0054T	Computer-assisted musculoskeletal surgical navigational orthopedic procedure, with image-guidance based on fluoroscopic images (List separately in addition to code for primary procedure)
0055T	Computer-assisted musculoskeletal surgical navigational orthopedic procedure, with image-guidance based on CT/MRI images (List separately in addition to code for primary procedure)
20985	Computer-assisted surgical navigational procedure for musculoskeletal procedures image-less (List separately in addition to code for primary procedure)

HCPCS CodesHCPCS

No codes listed

CPT unlisted procedure codesCPT

27299	Unlisted procedure, pelvis or hip joint
27599	Unlisted procedure, femur or knee
27899	Unlisted procedure, leg or ankle
29999	Unlisted procedure, arthroscopy

HCPCSHCPCS

S2325

Hip core decompression

CPT/HCPCS codes listedmixed

0440T	Ablation, percutaneous, cryoablation, includes imaging guidance; upper extremity distal/peripheral nerve
0441T	Ablation, percutaneous, cryoablation, includes imaging guidance; lower extremity distal/peripheral nerve
0442T	Ablation, percutaneous; cryoablation, includes imaging guidance; nerve plexus or other truncal nerve (eg, brachial plexus)
64600	Destruction by neurolytic agent, trigeminal nerve; supraorbital, infraorbital, mental, or inferior alveolar branch
64605	Destruction by neurolytic agent, trigeminal nerve; second and third division branches at foramen ovale
64610	Destruction by neurolytic agent, trigeminal nerve; second and third division branches at foramen ovale under radiologic monitoring
64620	Destruction by neurolytic agent, intercostal nerve
64632	Destruction by neurolytic agent, plantar common digital nerve
64633	Destruction by neurolytic agent; paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); cervical or thoracic, single facet joint
64634	Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); cervical or thoracic, each additional facet joint

1–10 of 13

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Procedure CPT codes (cryosurgical/neurolytic)CPT

0441T	Ablation, percutaneous, cryoablation, includes imaging guidance; lower extremity distal/peripheral nerve
28899	Unlisted procedure, foot or toes
64632	Destruction by neurolytic agent; plantar common digital nerve
64640	Destruction by neurolytic agent; other peripheral nerve or branch

HCPCS codes (custom TKA)HCPCS

C1776

Joint device (implantable)

inv-81: Clinical trial follow-up — 24 months

Clinical trial primary follow-up24 months (primary endpoint follow-up in pivotal randomized and IDE trials)

IDE study success timepoint24-month outcome assessments used for overall success and ODI improvement endpoints

Training/early-site enrollment contextEarly training cohorts and post-approval studies also reported 24-month outcomes

inv-82: DEXA T-score threshold — < -2.5

DEXA T-score contraindication thresholdDEXA bone mineral density T-score < -2.5 (defines osteoporosis contraindication)

ApplicationUsed as a contraindication to disc replacement procedures in policy (ProDisc-C and Mobi-C references)

Coverage impactPresence of T-score < -2.5 makes candidate ineligible and may trigger denial

inv-83: Defect size requirement for MACI — at least 2 centimeters across (~3 cm2)

Minimum defect size for MACICartilage defect is at least 2 centimeters across (or ~3 cm2 total area)

Defect depthFocal articular cartilage defect down to but not through the subchondral bone

Associated requirementsStable knee with intact meniscus and normal joint space on X-ray

inv-84: Age requirement for MACI — 15 to 55 years

Age window for MACI coverage15 to 55 years

Out-of-range policy stanceMACI considered experimental/investigational for ages below 15 and above 55

Benefit dependencyApplication of age criterion is dependent on member's individual benefit coverage

inv-85: BMI requirement for MACI — < 35

BMI eligibility for MACIBMI < 35

RationaleBMI threshold included among multiple patient selection criteria for MACI coverage

DocumentationBMI must be documented as part of coverage determination

inv-86: Radiographic non-progression window for nonunion — 3 months

Radiographic non-progression windowNo progression over a 3-month radiographic period (serial radiographs)

ContextUsed to define lack of healing when considering nonunion and prior to electrical bone growth stimulator coverage

Documentation requirementProvider must supply written interpretation stating no clinically significant evidence of healing between radiograph sets

inv-87: Time since fracture to consider nonunion — commonly ≥3 to 6 months (variable)

Common time-since-fracture references for nonunionReferences vary: commonly ≥3 months (some sources) and often ≥6 months for long bones; definitions vary across literature

Clinical interpretationMany clinicians consider 6 months for long-bone nonunion but radiographic non-progression over 3 months is commonly used by payers

Policy applicationAt least 3 months must have passed since fracture or surgical treatment before considering electrical bone growth stimulators per policy

Clinical Background and Definitions

Herniated disc material can protrude through a tear in the annulus and irritate adjacent nerve roots, producing radicular pain, numbness, or weakness. Standard operative management for symptomatic herniated disc is discectomy, typically leaving the annular defect to heal without device augmentation. The Xclose Tissue Repair System is described as a construct of non‑absorbable PET braided sutures with T‑anchor assemblies and a suture loop intended to re‑approximate annular tissue after discectomy; however, Select Health determined available published evidence is insufficient to demonstrate clinical benefit over standard discectomy, supporting the investigational stance noted above.

inv-151: Xclose — device name key value

Device nameXclose Tissue Repair System (Xclose)

Indication contextDesigned to close annular openings after discectomy to potentially reduce re‑herniation

Coverage stanceUse considered investigational/unproven in SelectHealth policy

inv-152: Device description — Xclose construct description

Construct descriptionTwo non-absorbable polyethylene terephthalate (PET) braided sutures with T-anchor assemblies connected by a smaller suture loop, provided sterile and preloaded on a disposable delivery instrument

FunctionSuture loop facilitates tightening to draw suture assemblies together and re-approximate annular tissue

Intended useClosure of annular defects after discectomy to reduce re-herniation risk

inv-153: Anterolateral ligament (ALL) definition

Anatomical definitionAnterolateral ligament (ALL): distinct structure originating at the lateral femoral epicondyle (just anterior to the LCL) and inserting on the anterolateral proximal tibia midway between Gerdy’s tubercle and fibular head

Functional hypothesisMay help control internal tibial rotation and influence the pivot-shift phenomenon after knee reconstruction

Evidence noteFunctional importance not established; studies assessing function are not available

inv-154: Symptomatic degenerative disc disease (DDD) definition

Clinical state definitionSymptomatic degenerative disc disease (DDD): symptomatic DDD specific to the treated level(s) required for candidacy for disc replacement

Associated findingsFor cervical: radiculopathy with motor or sensory deficit or symptomatic myelopathy may be required; lumbar: no isolated radicular compression except at replacement level

Coverage linkagePresence of symptomatic DDD at specified level(s) is a prerequisite for artificial disc replacement coverage

inv-155: Contraindication - Osteoporosis defined as DEXA T-score < -2.5

Osteoporosis contraindication definitionOsteoporosis defined as DEXA bone mineral density T-score < -2.5 — contraindicates disc replacement

Policy impactPresence of this finding excludes candidacy for artificial disc replacement (cited in ProDisc-C and Mobi-C sections)

DocumentationDEXA results should be part of preoperative assessment for disc replacement candidates

inv-156: Radiographic success (ProDisc IDE definitions)

Radiographic success (ProDisc IDE) — key elementsNo device migration/subsidence > 3 mm; limited radiolucency (<25% of interface length); maintained or improved ROM; no loss of disc height > 3 mm; no evidence of bony fusion

Outcome componentsRadiographic criteria combined with clinical endpoints (ODI improvement, no reoperation) define success

UseThese radiographic thresholds were used in ProDisc-L IDE trial definitions of success at 24 months

inv-157: Overall success (Prestige IDE definition)

Overall success (Prestige IDE) — key pointOverall subject success incorporated clinical improvement and absence of implant-related failures; Prestige IDE reported high probability of 24-month success (e.g., ~78.8% probability)

ComponentsIncluded functional measures, need for second surgery, and radiographic parameters in composite success definition

Comparative outcomePrestige group had lower second-surgery failure rates vs fusion controls in IDE analyses

inv-158: ACDF definition

ACDF definitionAnterior cervical discectomy and fusion (ACDF): standard operative comparator for cervical disc disease in cited trials

Role in studiesUsed as control treatment in randomized trials comparing cervical total disc replacement to fusion

Outcome contextACDF outcomes provide benchmark for device performance comparisons

inv-159: M6-C device key value

M6-C deviceM6-C artificial cervical disc — device evaluated in an IDE study with reported 24-month overall success (86.8%) and comparative outcomes vs ACDF

Study outcomesM6-C IDE reported improved pain, function, quality-of-life measures and reduced opioid use compared to ACDF at 24 months

Evidence levelProspective, non-randomized, concurrently controlled clinical trial across multiple US sites

inv-160: sports hernia definition

Sports hernia (athletic pubalgia) — concise definitionAthletic pubalgia (sports hernia): poorly standardized clinical entity causing chronic groin pain in athletes without a true hernia; diagnosis by history and physical exam

Typical presentationInsidious onset, overuse-related groin pain in athletes; initial treatment is conservative care (rest, NSAIDs, PT, injections)

Evidence noteSurgical approaches studied but evidence base limited; policy treats repair as investigational for commercial/CHIP

inv-161: Athletic pubalgia (sports hernia) definition

Athletic pubalgia definitionAthletic pubalgia (sports hernia): chronic groin pain in athletes related to musculotendinous injury; diagnosis is often elusive and management begins with conservative therapy

Treatment contextSurgery considered after failure of conservative measures; comparative evidence to nonoperative care is limited

Policy stanceSelectHealth considers athletic pubalgia repair investigational for Commercial/CHIP plans

inv-162: MACI definition

MACI definitionMatrix-induced autologous chondrocyte implantation (MACI): implantation of autologous cultured chondrocytes on a matrix to repair focal articular cartilage defects of the knee

Therapeutic goalAims to regenerate hyaline-like cartilage to restore joint surface integrity and function

Procedure contextConsidered in patients with symptomatic focal cartilage defects after failure of conservative and prior surgical repair attempts

inv-163: AxiaLIF procedure definition

AxiaLIF procedure definitionAxial Lumbar Interbody Fusion (AxiaLIF): anterior stabilization and interbody fusion via a retroperitoneal presacral approach using radial cutters, tissue extractors, and a TranS1 3D axial rod to prepare disc and insert implant/graft

Surgical approachRetroperitoneal presacral access with docking in sacrum and use of dilators to reach L5-S1 disc space

Device componentsMulti-component system including titanium implants and nitinol cutters for endplate preparation

inv-164: Oswestry Disability Index (ODI) definition

Oswestry Disability Index (ODI)Patient questionnaire measuring low back pain–related disability with categorical scoring (minimal to bedridden); used as outcome measure in trials (e.g., ODI improvement ≥15 points at 24 months as IDE success criterion)

Use in studiesODI change is a primary clinical endpoint in spinal device IDE trials

Scoring categoriesExamples: 0–20% minimal; 21–40% moderate; 41–60% severe; 61–80% crippled; 81–100% bedridden

inv-165: Nonunion definition (radiographic/time descriptions)

Nonunion definition (policy/literature)Generally described by lack of radiographic progression toward healing over a minimum 3-month period and/or elapsed time since injury often considered at least 6 months for long-bone fractures; definitions vary

Radiographic componentRepeated AP and lateral images showing no progressive healing over a 3-month period is commonly used by payers

Time-referent componentSome sources describe nonunion as lack of healing at 6–8 months; clinicians recognize variability by fracture type and patient factors

inv-166: Failed spinal fusion — definition

Failed spinal fusion definitionA spinal fusion not healed at a minimum of 6 months after the original surgery as evidenced by serial X-rays over a 3-month course

ApplicationNon-invasive electrical bone stimulation may be considered medically necessary for failed fusion defined by this criterion

Documentation neededSerial radiographs and provider interpretation documenting lack of clinically significant healing

inv-167: Nonunion (device labeling update)

Nonunion (device labeling update) — notePolicy acknowledges variation in labeling and literature; FDA/HCFA/orthopedic community discussions led to emphasizing radiographic non-progression rather than rigid timeframes

ImplicationTimeframes for nonunion definitions were reconsidered and labeling updated to reflect radiographic criteria

Clinical nuanceDefinitions remain heterogeneous across studies and device labels

inv-168: High-risk for pseudoarthrosis — definition and examples

High-risk for pseudoarthrosis — examplesIncludes previous failed fusion(s), multilevel fusion, Grade III or worse spondylolisthesis, current smoking, diabetes, renal disease, alcoholism

UsageThese risk factors are cited as indications for adjunctive electrical bone growth stimulation at time of fusion or up to 6 months post-op if progress is lacking

DocumentationRisk factor documentation should be provided when requesting stimulators as adjunct/prophylactic therapy

inv-169: CAS (computer-assisted surgery) definition

CAS definitionComputer-assisted surgery (CAS): intraoperative computer navigation (image-based or image-less) to guide component alignment and placement in orthopedic procedures

Typical applicationsUsed in TKA and THA to improve component placement and mechanical axis alignment

Policy noteImproves technical alignment but evidence of meaningful long-term clinical benefit is limited/inconsistent

inv-170: Outcome instruments (WOMAC/KSS/HSS/Oxford) definition

Outcome instruments — examplesWOMAC (pain, stiffness, function), KSS (Knee Score and Function Score), HSS, Oxford Knee Score (12-item), commonly used in orthopedic studies

Use caseOften employed to assess clinical outcomes in TKA/THA and other joint procedures where CAS or implant innovations are evaluated

Scoring notesOxford Knee Score items scored 1–5 with higher scores indicating worse outcome

inv-171: Core decompression of the hip — definition

Core decompression of the hip — definitionSurgical removal (coring) of necrotic bone from femoral head (8–10 mm cylindrical core) often filled with bone graft to relieve pressure and aid revascularization

ApproachLateral trochanteric approach with optional grafting (vascularized or non-vascularized) to promote revascularization or structural support

IndicationTypically employed before collapse of femoral head to delay or avoid reconstructive surgery

inv-172: Ficat stages reference

Ficat staging referenceFicat classification used to define early (pre-collapse = stage I–II) versus late (collapse/osteoarthritis = stage III–IV) AVN

Policy applicationCore decompression covered for early (pre-collapse, Ficat stage I–II) femoral head AVN; late stages considered investigational

Clinical implicationStaging is required to determine eligibility for core decompression coverage

inv-173: Ficat staging reference duplicate

Ficat staging (duplicate reference)Ficat classification: stage I–II = early/pre-collapse; later stages include collapse and osteoarthritis

UsageReferenced in policy as basis for core decompression coverage decisions

DocumentationRadiographic staging should be documented to support coverage determination

inv-174: iovera (key value)

iOvera system — key valueMyoscience iovera system: handheld cryoneuroablative device using closed-end Smart Tip needles and nitrous oxide for focused subdermal cooling and temporary peripheral nerve ablation

Indications notedIncludes relief of symptoms associated with osteoarthritis of the knee for up to 90 days and peripheral nerve lesioning applications

Policy stanceSelectHealth Commercial does not cover iOvera for knee pain due to insufficient published evidence

inv-175: cryoneedle/cryoablation key value

Cryoneedle/cryoablation — key valueCryogenic neuroablation: percutaneous application of a cold-generating probe (eg, cryoneedle) to ablate peripheral nerves or lesions for pain relief; procedures often performed in office setting with freeze–thaw cycles

Technique detailsTypical protocol: short activations with two 3-minute freeze cycles and 30-second thaw intervals; nerve stimulation used to confirm placement

Policy contextCryoablation for plantar fasciitis and Morton's neuroma considered investigational/not covered under Commercial plan

inv-176: Custom knee replacements key value

Custom knee replacements — key valueCustom knee replacements: patient-specific implants or off-the-shelf prostheses fit with patient-specific instruments/cutting jigs based on CT/MRI anatomy

TypesIncludes patient-specific cutting jigs, custom-made prostheses, and gender-specific customizations

Policy stanceSelectHealth Commercial does NOT cover custom components for total knee arthroplasty (considered investigational) and provides no additional reimbursement

OpenPayer

Annular Tissue Repair Systems (Xclose)

Coverage Criteria and Policy Stance

Prior Authorization, Documentation, and Billing Guidance

Billing Codes and Status

Clinical Background and Definitions

Policy Revision History