ModifiedBlue Cross Blue Shield of LouisianaPolicy MA-237

Implantable Shock Absorbers for Treatment of Knee Osteoarthritis

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This policy governs coverage of implantable shock absorber devices, including the MISHA Knee System, for treatment of knee osteoarthritis under Blue Advantage Medicare Advantage plans. These services are considered investigational and are not covered.

Policy Summary

PayerBlue Cross Blue Shield of Louisiana

PolicyImplantable Shock Absorbers for Treatment of Knee Osteoarthritis

Policy CodePolicy MA-237

Change TypeNew policy

Effective DateDec 1, 202623d

Last ReviewSep 15, 2026

Next Review DateSep 1, 2027

Key ActionObtain prior authorization for all codes listed in this policy.

SourceLink

POLICY UPDATE CHANGES

The policy was established as a new policy following Utilization Management Committee review and approval on September 15, 2026.

Not coveredCoverage status for implantable shock absorbers

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ModifiedBlue Cross Blue Shield of LouisianaPolicy MA-237

Implantable Shock Absorbers for Treatment of Knee Osteoarthritis

Customize your policy alerts

Sign up for blue cross blue shield - louisiana Policy MA-237 alerts

Get alerted when Policy MA-237 changes without checking for updates manually.

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Policy Summary

PayerBlue Cross Blue Shield of Louisiana

PolicyImplantable Shock Absorbers for Treatment of Knee Osteoarthritis

Policy CodePolicy MA-237

Change TypeNew policy

Effective DateDec 1, 202623d

Last ReviewSep 15, 2026

Next Review DateSep 1, 2027

Key ActionObtain prior authorization for all codes listed in this policy.

SourceLink

POLICY UPDATE CHANGES

The policy was established as a new policy following Utilization Management Committee review and approval on September 15, 2026.

Not coveredCoverage status for implantable shock absorbers

All listed codesPrior authorization requirement

90 daysTransition period for prior health plan authorization

2Procedure and supply code entries

Coverage Criteria

Not Covered as Investigational

Implantable shock absorbers, including the MISHA Knee System Implant, are not covered for the treatment of knee osteoarthritis because they are considered investigational. The available evidence is insufficient to determine that this technology improves net health outcomes.

NOT COVERED AS INVESTIGATIONAL

Use of implantable shock absorbers (e.g., MISHA Knee System Implant) as a treatment for knee osteoarthritis is considered investigational and is not covered.
The evidence is insufficient to determine that implantable shock absorbers improve the net health outcome. Available evidence is primarily from a single pivotal nonrandomized, open-label cohort with a historical control arm and a supporting qualitative systematic review of low-to-moderate certainty evidence. Longer-term and comparative evidence remains pending from the FDA-required post-market study (NCT06118892) and the ongoing MOTION randomized controlled trial (NCT06843980).

Blue Advantage does not cover investigational or experimental services, including any drug, device, procedure, or service provided under the investigational arm of a clinical trial or study unless mandated by the Centers for Medicare and Medicaid Services. Coverage is limited to routine services for Category A IDE studies and to devices and related services for Category B IDE studies when not supplied by the trial sponsor. Approved IDE studies are posted on www.cms.gov/medicare/coverage/evidence.

Coverage is not available for investigational medical treatments or procedures, drugs, devices, or biological products.

Coding

FDA Product Codemixed

QVV	FDA Product Code for the MISHA Knee System

Codes used to identify services associated with this policyCPT

27599

Unlisted procedure, femur or knee

Codes used to identify services associated with this policyHCPCS

C8003

Codes used to identify services associated with this policy; exact HCPCS description is not provided in the document excerpt

Codes used to identify services associated with this policyICD-10

All related Diagnoses

Provider Actions

Prior Authorization

Obtain prior authorization for all listed codes

All codes listed in this policy require prior authorization to support appropriate utilization and alignment with current clinical guidelines.

27599 — Unlisted procedure, femur or knee
C8003

Documentation Required

Document prior authorization for transition coverage

For an ongoing course of treatment authorized by a previous health plan, the member or provider must provide documentation of that authorization. Blue Advantage may honor the authorization for the same service under the same type of in-network benefit for a 90-day transition period, provided the service is otherwise covered under the Blue Advantage plan.

Submit documentation of the previous health plan’s authorization.
The 90-day transition applies to an ongoing course of treatment and the same service under the same type of in-network benefit.

Clinical Background

Knee osteoarthritis is a degenerative joint condition involving cartilage degradation, changes in the subchondral bone, synovial inflammation, osteophyte formation, and narrowing of the joint space. These changes can cause pain, stiffness, and functional limitation. Standard management may include exercise, physical therapy, weight management, analgesics, intra-articular injections, and off-loader bracing; surgical options for refractory disease include high tibial osteotomy and knee arthroplasty. Implantable shock absorbers are intended to reduce medial-compartment joint loading in patients who remain symptomatic after nonsurgical or surgical treatment and are not candidates for, or are unwilling to undergo, joint replacement.

Definitions

Osteoarthritis

TermOA

MeaningOsteoarthritis

Policy contextThe MISHA Knee System is indicated for medial compartment knee osteoarthritis in specified patients who continue to experience pain after nonsurgical or surgical treatment.

Implantable Shock Absorber

Device typeExtracapsular implantable shock absorber

MechanismIntended to reduce loads on the intra-articular medial joint surface to improve symptoms of osteoarthritis.

MISHA Knee System construction

Policy Summary

PayerBlue Cross Blue Shield of Louisiana

PolicyImplantable Shock Absorbers for Treatment of Knee Osteoarthritis

Policy CodePolicy MA-237

Change TypeNew policy

Effective DateDec 1, 202623d

Last ReviewSep 15, 2026

Next Review DateSep 1, 2027

Key ActionObtain prior authorization for all codes listed in this policy.

SourceLink

On This Page

Denial Risk

Investigational implantable shock absorbers are not covered

Coverage is denied when the service is an investigational medical treatment, procedure, drug, device, or biological product. Implantable shock absorbers, including the MISHA Knee System, are considered investigational for treatment of knee osteoarthritis.

Do not expect coverage for implantable shock absorbers used to treat knee osteoarthritis.
Blue Advantage does not cover investigational or experimental services, subject to applicable clinical-trial and CMS provisions.

A cylindrical polymer absorber fixed via titanium plates to the distal femur and proximal tibia.

Lateral kneeThe device is not intended to span the lateral knee.

NCT

AbbreviationNCT

MeaningNational clinical trial

ExampleNCT06118892 is a post-market evaluation of the MISHA Knee System for symptom relief in subjects with medial knee osteoarthritis.

Investigational

DefinitionA medical treatment, procedure, drug, device, or biological product is investigational when its effectiveness has not been clearly tested and it has not been incorporated into standard medical practice.

FDA considerationThe determination considers whether the product can be lawfully marketed without FDA approval and whether approval has been granted when the product is sought to be furnished.

Further evidenceA product may be investigational when further studies or clinical trials are needed to determine safety, effectiveness, comparative effectiveness, or improved health outcomes.

Evidence sourcesRelevant evidence may include technology evaluation centers, credible peer-reviewed medical literature, and federal regulations.

Medically Necessary

DefinitionHealth care services, treatment, procedures, equipment, drugs, devices, items, or supplies that a provider exercising prudent clinical judgment would provide to prevent, evaluate, diagnose, or treat an illness, injury, disease, or its symptoms.

Accepted practiceMust be in accordance with nationally accepted standards of medical practice.

Clinical appropriatenessMust be clinically appropriate in type, frequency, extent, level of care, site, and duration, and considered effective for the patient's illness, injury, or disease.

Cost and convenienceMust not be primarily for personal comfort or convenience and must not be more costly than an equally effective alternative.

InterQual

RoleInterQual criteria are used as a source of medical evidence to support medical necessity and level-of-care decisions.

BasisThe criteria are clinically based on best practice, clinical data, and medical literature, and are updated continually and released annually.

Utilization reviewInterQual criteria are a first-level screening tool to determine whether proposed services are clinically indicated and provided at the appropriate level or require further evaluation.

EscalationUtilization review staff perform the first-level screening; cases that do not meet the criteria are referred to the medical director.