Blue Cross Blue Shield of Minnesota Medical Policy


Medical Policy:
Stem Cell Therapy for Orthopedic Applications
Effective Date:
March 30, 2020
Issued Date:
May 3, 2021
Last Revision Date:
March 2020
Annual Review:
April 2021

This policy version was replaced May 2, 2022. To find the newest version, go to, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

Mesenchymal stem cells (MSCs) are progenitor cells located within the bone marrow, adipose (fat), and other tissues that have the potential to differentiate into a variety of tissue types, including various musculoskeletal tissues. MSC therapy involves the harvest and processing of these stem cells, with subsequent injection or infusion of the cells into specific anatomic sites in order to promote healing or regeneration of damaged tissue. Potential uses of MSC therapy for orthopedic applications include treatment of damaged bone, cartilage, ligaments, tendons and intervertebral discs. Concentrated autologous MSCs do not require approval from the U.S Food and Drug Administration (FDA). To date, no products using engineered or expanded MSCs have been approved by the FDA for orthopedic applications. However, several systems are used for autolgous infusion of concentrated MSCs primarily in musculoskeletal sugeries, including but not limited to Regenexx® and Lipogems® (Lipogems International).

Stem cells may also be administered by combining the cells with an allograft bone product, such as demineralized bone matrix (DBM), or a synthetic bone graft substitute. DBM is considered minimally processed tissue and does not require FDA approval. Some commercially available DBM products contain viable stem cells, whereas other DBM products or synthetic bone graft substitutes that have received 510(k) clearance from the FDA are intended to be mixed with bone marrow aspirate. Examples of these products are:

  • AlloStem® (AlloSource)
  • Map3® (rti surgical)
  • Osteocel Plus® (NuVasive)
  • Trinity Evolution Matrix™ (Orthofix)
  • Fusion Flex™ (Wright Medical)
  • Ignite® (Wright Medical)
  • CopiOs sponge or paste (Zimmer)
  • Collage™ Putty (Orthofix)
  • Vitoss® (Stryker)
  • nanOss® Bioactive 3D (rti surgical)

NOTE:  This policy does not address unprocessed allograft bone.


This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

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

Stem cell therapy is considered EXPERIMENTAL/INVESTIGATIVE for all orthopedic applications, including but not limited to use in repair or regeneration of musculoskeletal tissue, due to a lack of evidence demonstrating an impact on improved health outcomes. Stem cell therapy includes use of any of the following:

  • Mesenchymal stem cells (MSCs), including concentrated, engineered, or expanded MSCs;
  • Allograft bone products containing viable stem cells, including but not limited to demineralized bone matrix (DBM) with stem cells;
  • Allograft or synthetic bone graft substitutes that must be combined with autologous blood or bone marrow.

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Denial Statements

No additional statements.


Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.

Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.

Medicare products may provide different coverage for certain services, which may be addressed in different policies. For Medicare National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and/or Local Coverage Articles, please consult CMS, National Government Services, or CGS websites. 

Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.

Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. 

These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.


CPT® codes copyright American Medical Association® 2022. All rights reserved.

CDT codes copyright American Dental Association® 2022. All rights reserved.