CurrentCignaPolicy 0515

Miscellaneous Musculoskeletal Procedures

Cigna Medical Coverage Policy 0515 addresses coverage and medical necessity determinations for miscellaneous musculoskeletal procedures including articular cartilage repair (non-knee joints), ligament/meniscus reconstruction adjuncts, intra-articular injections, and other related procedures; provides determinations of medically necessary, not medically necessary, and experimental/investigational status for specified procedures and technologies.

Policy Summary

PayerCigna

PolicyMiscellaneous Musculoskeletal Procedures

Policy CodePolicy 0515

Change TypeAnnual & Focused revisions (adds/removals)

Effective DateApr 15, 2025

Next Review DateMar 15, 2026

Key ActionRefer to the Cigna 'Knee Surgery: Arthroscopic and Open Procedures' policy for knee-specific criteria and document rationale when using investigational therapies; verify revised coverage statements for healing response, thermal shrinkage and MISHA™.

SourceLink

POLICY UPDATE CHANGES

Revised policy statement for healing response microfracture technique.

Removed policy statement for subacromial balloon spacer.

Added policy statement for thermal shrinkage.

Added policy statement for medial knee implanted shock absorber.

Removed statements for focal resurfacing of knee joint and allograft bone substitutes for isolated facet fusion.

0515Policy number

4Material policy changes

LimitSteroid injection rule

De NovoMISHA™ FDA status

SeveralTechnologies deemed investigational

MultipleProcedure/code references

Coverage Summary

This is Cigna Medical Coverage Policy 0515 (effective 2025-04-15, status CURRENT). It addresses miscellaneous musculoskeletal procedures including articular cartilage repair, ligament/meniscus reconstruction adjuncts, intra‑articular injections, and thermal capsular shrinkage. The policy limits certain articular cartilage and related restorative procedures to knee‑specific indications where evidence and FDA indications exist (e.g., MACI for knee defects) and considers many applications outside the distal femur/patella and numerous novel implants/techniques (xenografts, synthetic resorbable polymers, minced juvenile cartilage, decellularized allografts, many meniscal scaffolds, subchondroplasty, in‑office arthroscopy, percutaneous ultrasonic ablation, thermal shrinkage, and medial knee implanted shock absorbers) as experimental, investigational or not medically necessary given insufficient evidence.

Policy header facts

Policy PayerCigna

Policy typeMedical Coverage Policy

Policy number0515

Effective date2025-04-15

Policy Summary

PayerCigna

PolicyMiscellaneous Musculoskeletal Procedures

Policy CodePolicy 0515

Change TypeAnnual & Focused revisions (adds/removals)

Effective DateApr 15, 2025

Next Review DateMar 15, 2026

SourceLink

On This Page

Medical-Necessity and Coverage Determinations

Articular Cartilage Repair - Not Medically Necessary

Each of the following procedures is considered not medically necessary for treatment of articular cartilage defects involving joints other than the distal femur and patellar articular cartilage within the knee:

Autologous chondrocyte implantation (e.g., Carticel®, MACI®)

Not medically necessary for joints other than knee

Osteochondral allograft transplantation

Not medically necessary for joints other than knee

Osteochondral autograft transplantation

Not medically necessary for joints other than knee

Articular Cartilage Repair - Experimental, Investigational or Unproven

Articular cartilage repair using ANY of the following, for any joint, is considered experimental, investigational or unproven:

Cartilage regeneration membrane (e.g., Chondro-Gide®)

Xenograft implantation into the articular surface

Synthetic resorbable polymers (e.g., PolyGraft™ BGS, TruFit® [cylindrical plug], TruGraft™ [granules])

Juvenile cartilage allograft tissue implantation, including minced cartilage (e.g., DeNovo® NT, DeNovo® ET™, BioCartilage®)

Decellularized osteochondral allograft implant (e.g., Chondrofix® Osteochondral Allograft)

Ligament/Meniscus Reconstruction - Medically Necessary

Ligament allograft materials are considered medically necessary when medical necessity has been established for the associated primary procedure:

Ligament allograft (e.g., anterior cruciate ligament allograft) materials

Covered when medical necessity for the associated primary procedure is established; refer to 'Knee Surgery: Arthroscopic and Open Procedures' for conditions of coverage

Ligament/Meniscus Reconstruction - Experimental, Investigational or Unproven

The following are considered experimental, investigational or unproven when used alone or as part of ligament or meniscus reconstruction/transplantation:

Bioactive scaffolds (e.g., collagen meniscal implants)

Bioresorbable porous polyurethane scaffold (e.g., meniscus implant)

Meniscal prosthesis

Tissue-engineered menisci

Xenografts

Intra-articular Joint Injections - Frequency Limits

Intra-articular corticosteroid injections for chronic osteoarthritic joint pain are not covered/reimbursable when administered more frequently than either limit:

More than four injections during a rolling 12 month year>4 per rolling 12 months

Not covered/reimbursable if exceeded

More than two injections on the same day>2 on same day

Not covered/reimbursable if exceeded

Other Procedures - Not Medically Necessary or Experimental

Specific other procedures are considered not medically necessary or experimental/investigational for any indication:

Healing response microfracture technique for intra-articular ligament injury

Considered not medically necessary due to insufficient evidence

Subchondroplasty for treatment of subchondral bone defect (e.g., ankle, shoulder, hip, knee, toe)

Considered experimental, investigational or unproven

In-office diagnostic arthroscopy (e.g., Mi-Eye2™, VisionScope®) of any upper or lower extremity joint for evaluation of joint pain/pathology

Experimental, investigational or unproven

Percutaneous ultrasonic ablation of soft tissue for musculoskeletal conditions (e.g., tendinosis, tendinopathy)

Experimental, investigational or unproven

Adjunctive Treatments for Ligament/Meniscus Reconstruction

Adjunctive treatments have insufficient evidence to support improvement in outcomes:

Autologous platelet-derived growth factors (e.g., centrifuged platelet aggregates) for ACL/PCL reconstruction using allograft tissue or meniscal transplant

Insufficient evidence to support improvement in health outcomes

Meniscal Regeneration/Transplantation and Meniscal Scaffolds

Coverage determined by evidence of safety/efficacy; current evidence insufficient for routine use:

Collagen meniscal implants and bioresorbable porous polyurethane scaffolds have insufficient high-quality evidence to support improved clinical outcomes; use is not recommended outside investigational/research settings

FDA status: Menaflex™ (collagen scaffold) received 510(k) clearance in 2008 but had clearance rescinded in 2010; Actifit® (polyurethane scaffold) has received FDA Breakthrough Designation but no full approval found

Systematic reviews and technology assessments (e.g., Kohli 2022; Veronesi 2021; CTAF/Tice 2010) concluded evidence insufficient, high failure rates, limited regenerative potential

Intra-articular Joint Injections (Corticosteroids and Viscosupplementation)

Clinical guidance and evidence-based recommendations summarized for steroid and hyaluronic injections:

Intra-articular corticosteroid injections provide short-term relief (generally ≤ 12 weeks) for knee and hip OA; recommended or conditionally recommended by multiple professional societies

Frequency considerations: generally accepted not to inject same joint more than every three months; EULAR suggests 3-4 injections per joint per year as general rule

Viscosupplementation (hyaluronate) may provide longer relief (>12 weeks) for knee OA; guidelines vary and some (e.g., VA/DoD) give weak suggestions for knee but against hip

Potential harms: concern for cartilage loss with repeated steroid injections; possible increased infection risk if corticosteroid injected prior to knee arthroplasty

Healing Response (Microfracture) Technique

Adjunctive microfracture to promote ligament healing:

Insufficient evidence to support improved health outcomes for ACL/PCL reconstruction or meniscal transplant when using healing response/microfracture; some studies show high revision rates

Reference to Cigna 'Knee Surgery: Arthroscopic and Open Procedures' policy for microfracture to treat chondral defects

Subchondroplasty

Treatment of subchondral bone defects via injection of bone void filler:

Current evidence consists primarily of case reports/series with short follow-up; evidence insufficient to support safety and efficacy and impact on net health outcomes is undetermined

Most evidence pertains to the knee; limited evidence for hip, shoulder, ankle

Percutaneous Ultrasonic Ablation (Tenex/TX System)

Minimally invasive ultrasonic tenotomy/tenotomy-like procedures for tendinopathies and fasciitis:

FDA cleared Tenex Health TX System via 510(k) (2016) for fragmentation/emulsification/aspiration of soft tissue; 510(k) does not require demonstration of effectiveness

Published evidence limited to small case series and case reports; systematic review limited by small studies and short follow-up; insufficient high-quality evidence to draw strong conclusions regarding safety and efficacy

In-Office Diagnostic Arthroscopy

Needle/endoscopic camera arthroscopy performed in office settings as alternative to MRI/standard arthroscopy:

Several FDA 510(k)-cleared devices exist (e.g., Mi-Eye2™, VisionScope); evidence is limited mainly to knee and is insufficient to establish impact on health outcomes or patient selection criteria

Further well-designed comparative studies are needed

Medial Knee Implanted Shock Absorber (MISHA™ Knee System)

Implanted subcutaneous shock absorber to unload medial knee compartment:

FDA granted De Novo marketing approval for MISHA™ Knee System (DEN220033) in April 2023 with indication for medial compartment knee OA in patients who failed other treatments and are unwilling/ineligible for total knee replacement

Peer-reviewed evidence limited to small retrospective case-control studies with short- to midterm follow-up; insufficient to draw conclusions about safety and efficacy compared to standard treatments

NICE previously concluded evidence inadequate and recommended use only in research context (2015 guidance for similar devices/shock absorbers)

Thermal Shrinkage (Arthroscopic Thermal Capsulorrhaphy / ETAC)

Use of radiofrequency/thermal energy to shrink collagen for joint capsule/ligament tightening:

FDA has cleared several thermal probe devices via 510(k) (e.g., Oratec ORA-50, VULCAN® EAS®, VAPR™ TC Electrode) as electrosurgical devices

Evidence across indications is limited, often shows high failure rates and complications (e.g., capsular necrosis, chondrolysis, nerve damage), and long-term durability not demonstrated

Overall evidence insufficient to support safety and efficacy; not recommended for many instability indications due to high failure/complication rates

Considered Not Medically Necessary - Articular cartilage repair outside distal femur/patella

Considered Not Medically Necessary when used to report treatment of articular cartilage defects involving joints other than the distal femur and patellar articular cartilage within the knee (e.g., ankle, elbow, shoulder):

Procedure codes reported for treatment of articular cartilage defects involving joints other than the distal femur and patellar articular cartilage within the knee are considered Not Medically Necessary

Applicable codes listed in code_groups

Considered Experimental/Investigational/Unproven - Xenograft and cartilage membrane products for articular cartilage repair

Note: considered Experimental/Investigational/Unproven when used to report xenograft implant and cartilage regeneration membrane products (e.g., ChondroGide®) for articular cartilage repair.

Use of xenograft implant and cartilage regeneration membrane products for articular cartilage repair is Experimental/Investigational/Unproven

Considered Experimental/Investigational/Unproven - Articular cartilage repair of any joint (specific code)

Code 0737T (Xenograft implantation into the articular surface) is considered Experimental/Investigational/Unproven when used to report articular cartilage repair of any joint

Bone Filler Materials - Experimental/Investigational/Unproven

Considered Experimental/Investigational/Unproven when used to report treatment of articular cartilage defects with listed materials and products:

ONE of the following products/uses: Synthetic resorbable polymers (e.g., PolyGraft™ BGS, TruFit® cylindrical plug, TruGraft™ granules)

Juvenile cartilage allograft tissue implantation (e.g., DeNovo® NT, DeNovo® ET™, BioCartilage®)

Decellularized osteochondral allograft implant (e.g., Chondrofix® Osteochondral Allograft)

When any of the above are used to report treatment of articular cartilage defects, the listed CPT/HCPCS codes are considered Experimental/Investigational/Unproven

See code_groups for exact codes

Ligament/Meniscus Reconstruction - Experimental/Investigational/Unproven when used alone or as part of reconstruction

Considered Experimental/Investigational/Unproven when bioactive scaffolds, bioresorbable porous polyurethane, meniscal prosthesis, tissue engineered menisci, or xenograft are used alone or as part of ligament/meniscus reconstruction/regeneration/transplantation:

Use of listed scaffolds, prostheses, xenografts for ligament/meniscus reconstruction is Experimental/Investigational/Unproven

Exception: Ligament allograft materials are considered Medically Necessary when medical necessity has been established for the associated primary procedure

Operational exception

Intra-articular corticosteroid injections - Frequency limitation (Not covered/reimbursable)

Intra-articular corticosteroid injections for chronic osteoarthritic joint pain are not covered/reimbursable when administered more frequently than either of the following:

More than four injections during a rolling 12-month year>4 per rolling 12 months

More than two injections on the same day>2 on same day

Applies to listed arthrocentesis/injection CPT codes

See code_groups for exact codes and descriptions

Considered Not Medically Necessary - Healing response technique

Use of code 29999 to report healing response technique is Considered Not Medically Necessary

Considered Experimental/Investigational/Unproven - Subchondroplasty of any bone defect

Subchondroplasty of any bone defect is Considered Experimental/Investigational/Unproven

Includes listed CPT/HCPCS codes and product codes

In-Office Diagnostic Arthroscopy - Experimental/Investigational/Unproven

Considered Experimental/Investigational/Unproven when used to report an in-office diagnostic arthroscopy of any upper or lower extremity joint for evaluation of joint pain and/or pathology (e.g., Mi-Eye2™, VisionScope®):

In-office diagnostic arthroscopy codes (29805,29860,29870,29999) are considered Experimental/Investigational/Unproven for evaluation of joint pain/pathology

Percutaneous Ultrasonic Ablation of Soft Tissue - Experimental/Investigational/Unproven

Percutaneous ablation of soft tissue for treatment of any musculoskeletal condition (e.g., tendinosis, tendinopathy) is Considered Experimental/Investigational/Unproven

Applies to listed unlisted procedure CPT codes

Miscellaneous Procedures - Experimental/Investigational/Unproven

Medial knee implanted shock absorber (e.g., MISHA™ Knee System) is Considered Experimental/Investigational/Unproven

C8003 listed

Arthroscopy with thermally-induced capsulorrhaphy for any joint capsule, ligament or tendon is Considered Experimental/Investigational/Unproven

29999 listed

Provider Actions & Billing Rules

Documentation Required

Refer to Knee Policy for Knee-Specific Criteria

Refer to the Cigna Medical Coverage Policy — Knee Surgery: Arthroscopic and Open Procedures for knee-specific medical necessity criteria. Clinicians should use that policy to determine coverage for articular cartilage repair, microfracture/healing response, ligament or meniscal primary procedures, and other knee-targeted technologies; this Miscellaneous Musculoskeletal Procedures policy does not replace knee-specific criteria.

Billing Rule

Intra-articular Corticosteroid Injection Frequency Limits

Intra-articular corticosteroid injections for chronic osteoarthritic joint pain have frequency limits and billing restrictions. These injections are not covered or reimbursable when administered more frequently than either of the following: four injections during a rolling 12-month period, or two injections on the same day. Deny or adjust payment when these conditions are exceeded. Prior authorization requirements may apply for specific products or added/removed technologies — verify plan-specific PA rules.

Affected CPT codes: 20600, 20604, 20605, 20606, 20610, 20611
Not covered if > 4 injections in any rolling 12-month period
Not covered if > 2 injections on the same day

Documentation Required

Refer to related Cigna policy for microfracture

For microfracture/healing response techniques, providers should reference the Cigna Medical Coverage Policy — Knee Surgery: Arthroscopic and Open Procedures for coverage guidance. Healing response microfracture technique for ligament injury is considered not medically necessary in this policy; when coding unlisted or procedure-specific services related to knee microfracture, reference the Knee Surgery policy.

Affected code: 29999
See: Knee Surgery: Arthroscopic and Open Procedures for knee-specific criteria and coding guidance

Documentation Required

Evidence/support documentation for investigational therapies

When proposing investigational or unproven therapies (e.g., cartilage regeneration membranes, xenografts, synthetic resorbable polymers, juvenile allografts, decellularized allografts, bioactive scaffolds, subchondroplasty, in-office diagnostic arthroscopy variants, percutaneous ultrasonic ablation, medial knee implanted shock absorbers, thermal shrinkage), document the clinical rationale and why standard therapies are not appropriate. These therapies are considered experimental, investigational or unproven and are likely to require preauthorization; anticipate denials when documentation is insufficient.

Clinician should document rationale for use and prior treatments tried
Therapies listed as experimental/investigational are likely subject to preauthorization or denial

Documentation Required

Use appropriate unlisted codes and product codes

Use appropriate unlisted procedure codes or product-specific codes when no specific CPT/HCPCS code exists for a device or technique. Submit full operative and product documentation to support medical necessity and pricing. Failure to use the correct unlisted or product code and to provide supporting documentation may result in claim denial or requests for additional information.

Examples: use unlisted CPT/HCPCS when no specific code applies; include device/product code and manufacturer details on the claim
Affected codes: 29999

Documentation Required

Be aware of revised coverage statements

Be aware that coverage statements for technologies may be revised as new evidence emerges or as technologies are added or removed. Changes to coverage may have prior authorization implications; providers should verify current criteria and PA requirements before scheduling procedures. When technologies are added or removed from this policy or related policies, prior authorization requirements and coding expectations may change.

Verify current medical necessity criteria and prior authorization rules for added or removed technologies
Policy revisions may affect PA implications — confirm plan-specific requirements

29999	Unlisted procedure, arthroscopy — mapped to many scaffold and implant applications
G0428	Collagen meniscal implant application (listed in crosswalk)
23929	Unlisted procedure, shoulder (listed for juvenile cartilage allograft/MACI applications)
24999	Unlisted procedure, forearm/hand (listed for juvenile cartilage allograft/MACI applications)
27299	Unlisted procedure, hip (listed for juvenile cartilage allograft/MACI applications)
27599	Unlisted procedure, femur/knee (listed for juvenile cartilage allograft)
27899	Unlisted procedure, tibia/ankle (listed for MACI applications)
28899	Unlisted procedure, foot/ankle (listed for juvenile cartilage allograft)

23929	Unlisted procedure, shoulder.
24999	Unlisted procedure, humerus or elbow.
25999	Unlisted procedure, forearm or wrist.
26989	Unlisted procedure, hands or fingers.
27299	Unlisted procedure, pelvis or hip joint.
27599	Unlisted procedure, femur or knee.
27899	Unlisted procedure, leg or ankle.
28103	CPT referenced in osteochondral autograft list.
28446	Open osteochondral autograft, talus (includes obtaining graft[s]).
28899	Unlisted procedure, foot or toes.

J7330	Autologous cultured chondrocytes, implant.
L8699	Prosthetic implant, not otherwise specified.
C1762	Connective tissue, human (includes fascia lata).
C1889	Implantable/insertable device, not otherwise classified.
C1781	Mesh (implantable).
G0428	Collagen meniscus implant procedure for filling meniscal defects (e.g., CMI, collagen scaffold, menaflex).
C8003	Implantation of medial knee extraarticular implantable shock absorber spanning the knee joint, open.
L8699 †	Prosthetic implant, not otherwise specified († noted in policy).

DEN220033	MISHA Knee System (FDA De Novo)
K994333	Oratec Interventions ORA-50 (510(k))
K082079	ReGen Collagen Scaffold (510(k))
K153299	Tenex Health TX System (510(k))
K002402	VAPR TC Electrode (510(k))
K991140	VULCAN EAS (510(k))

Evidence Item	Summary
MACI FDA indication	MACI approved for symptomatic full‑thickness cartilage defects of the knee; safety/effectiveness not established in other joints or in individuals >55
Chondrofix failure	Retrospective case series (Farr et al. 2016) reported 72% failure within two years (n=32) for decellularized osteochondral allograft Chondrofix
Allograft vs autograft talus meta-analysis	Migliorini et al. (2022) systematic review/meta‑analysis: autograft had better MOCART and AOFAS scores and lower revision and failure rates vs allograft for talus lesions
Systematic reviews conclusions	Multiple systematic reviews/assessments (e.g., Kohli 2022; Veronesi 2021; Nairn 2021) concluded evidence insufficient and high failure rates for meniscal scaffolds and subchondral procedures
Rodkey 2008 randomized trial	Prospective randomized trial (Rodkey et al. 2008, n=311) showed collagen meniscus implant safe and improved outcomes vs repeat partial meniscectomy at ~59 months, but overall evidence base remains limited
Thermal shrinkage failure rates	Prospective multicenter trial (Smith et al. 2008, n=64) reported failure rates: lax graft 78.9% and lax native ligament 38.1% after ACL thermal shrinkage
References listed	Extensive reference list (refs #137–275) covering arthroscopy, thermal shrinkage, subchondroplasty, meniscal implants, osteochondral procedures, and guidelines

OpenPayer

Miscellaneous Musculoskeletal Procedures

Coverage Summary

Medical-Necessity and Coverage Determinations

Coding Reference

Provider Actions & Billing Rules

Background and Evidence Summary

Definitions

Revision History