Orthopedic Applications of Stem-Cell Therapy

Policy ID: S-225-014

Section: Surgery

Effective Date: September 01, 2019

Revised Date: June 06, 2023

Revision Effective Date: September 02, 2024

Last Reviewed: July 16, 2024

Applies To: Commercial and Medicaid Expansion

Description

Mesenchymal stem cells (MSCs) have the capability to differentiate into the variety of tissue types, including musculoskeletal tissues. MSCs are associated with the blood vessels within bone marrow, synovium, fat, and muscle, where they can be mobilized for endogenous repair as occurs with healing of bone fractures. Stimulation of endogenous MSCs is the basis of procedures such as bone marrow stimulation (i.e., microfracture) and harvesting/grafting of autologous bone for fusion.

MSCs may also be referred to as bone marrow aspirate or adipose derived stem cells.

Note: Currently, there are no products using engineered or expanded MSCs that have been approved by the FDA for orthopedic applications.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Policy Application

All claims submitted under this policy's section will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

ALL the following orthopedic applications involving the mixing or use of MSCs or viable bone marrow are considered experimental investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature (not an all-inclusive list).

Mesenchymal stem cell therapy including use in repair or regeneration of musculoskeletal tissue:
- Non-surgical injection treatments, including but not limited to:
  - Regennex® Procedure; or
- Allograft bone products containing viable stem cells, including but not limited to demineralized bone matrix (DBM) with stem cells, including but not limited to:
  - Allostem® (Allosource); or
  - Allsync with Biosurge ^{TM
    
    _{Kit;
    
    or}}
  - ^{_Allosync
    TM
    
    _{Pure;
    
    or}}
  - ^{_{Map3® (RTI Surgical);
    
    or}}
  - ^{_{Osteocel Plus® (NuVasive);
    
    or}}
  - ^{_{Stryker BIO}
    4
    
    _{Viable Bone Matrix® (Orthofix);
    
    or}}
  - ^{_{Trinity Evolution Matrix
    
    ®
    (Orthofix);
    
    or}}
  - ^{_{Vivigen Bone Matrix;
    
    or}}
- Allograft or synthetic bone graft substitutes that must be combined with autologous blood or bone marrow, including but not limited to:
  - Allograft Bone Substitute DBX ^{TM
    
    _{;
    
    or}}
  - CopiOs ^_® Bone Void Filler; or
  - _{DBX
    
    ^®
    Demineralized bone matrix putty, paste and mix;
    
    or}
  - _{Formagraft
    
    ^TM
    Collagen Bone Graft Matrix;
    
    or}
  - _{Fusion Flex
    
    ^®
    ;
    
    or}
  - _{Ignite
    
    ^®
    ;
    
    or}
  - _{Integra MOZIAK
    
    ^TM
    Osteoconducitive Scaffold-Putty;
    
    or}
  - _{Vitoss
    
    ^®
    Bioactive Foam Bone Graft Substitute.}

Procedure Codes

38206

38230

38232

38241

A4694

L8699

Diagnosis Codes

Not Applicable

Professional Statements and Societal Positions Guidelines

American Association of Orthopedic Surgeons - 2020

A 2020 guideline from American Association of Orthopaedic Surgeons on the management of glenohumeral joint OA, endorsed by several other societies, states that injectable biologics such as stem cells cannot be recommended in the treatment glenohumeral joint OA. There was a consensus from the panel that better standardization and high-quality evidence from clinical trials is needed to provide definitive evidence on the efficacy of biologics in glenohumeral OA. The strength of evidence was rated as no reliable scientific evidence to determine benefits and harms.

American Association of Neurological Surgeons - 2014

The American Association of Neurological Surgeons guidelines on fusion procedures for degenerative disease of the lumbar spine relevant to this evidence review have indicated that 'The use of demineralized bone matrix (DBM) as a bone graft extender is an option for 1- and 2-level instrumented posterolateral fusions. Demineralized Bone Matrix: Grade C (poor level of evidence).

American College of Rhematology/Arthritis Foundation - 2019

Stem cell injections are strongly recommended against in individuals with knee and/or hip OA.

There is a concern regarding the heterogeneity and lack of standardization in available preparations of stem cell injections, as well as techniques used. This treatment has not been evaluated in hand OA and, therefore, no recommendation is made with regard to OA of the hand

ND Committee Review

Internal Medical Policy Committee 3-16-2020 Annual Review

Internal Medical Policy Committee 3-17-2020 Annual Review

Internal Medical Policy Committee 3-23-2022 Revision

Updated criteria, and
Updated Professional Statement.

Internal Medi cal Policy Committee 3-23-2023 Annual Review- no changes in criteria

Internal Medical Policy Committee 7-26-2023 Revision with Coding - Effective July 03, 2023

Removed procedure codes 20932, 20933, 20934
Added two (2) new procedure codes A4694, L8699
Added this statement 'MSCs may also be referred to as bone marrow aspirate or adipose derived stem cells.'

Internal Medical Policy Committee 7-16-2024 Annual Review-no changes in criteria

Added coverage statement; and
Added Policy Application

Links

Refernces (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.