Orthopedic Applications of Stem-Cell Therapy (including allograft and bone substitute products used with autologous bone marrow)
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This policy governs coverage for mesenchymal stem cell therapies and related allograft or bone substitute products used with autologous bone marrow for orthopedic indications for members covered by Capital Bluecross programs to which this policy applies.
No material clinical or coverage changes in this revision.
Coverage Criteria and Policy Scope
Investigational / Not covered
Not covered (investigational) when used for orthopedic indications.
Supported by policy statement.
Supported by policy statement.
Supported by policy statement.
This policy does not address unprocessed allograft bone or products that do not require mixing with stem cells; example products are shown in Tables 1 and 2 for informational purposes. Regenexx is provided as an example of mesenchymal stem cell therapy, and AlloStem, Osteocel, Osteocel Plus, and Trinity Evolution are examples of demineralized bone matrix products reported to contain stem cells.
Procedure codes listed as investigational under this policy include: 0263T, 0264T, 0265T, 0489T, 0490T, 0565T, 0566T, and code 20999 when used for aspiration of bone marrow for the purpose of bone grafting outside of spine surgery and other therapeutic musculoskeletal applications (for example, Regenexx).
The available evidence for use of mesenchymal stem cells (MSCs) and MSC-containing allografts in orthopedic indications is limited in quantity and quality, with mixed findings across indications (eg, knee and hip osteoarthritis, cartilage and meniscal defects, joint fusion, osteonecrosis, and nonunion). Systematic reviews, randomized trials, and observational studies report uncertainties about optimal cell source and delivery methods; recent systematic reviews found little to no pain relief with intra-articular MSCs for knee OA and only limited, inconsistent evidence for hip OA. Although some phase 1/2 and industry-sponsored studies report positive findings (including higher fusion rates with cellular bone allografts), many of these are small, nonrandomized, or retrospective. Overall, the evidence is insufficient to demonstrate improved net health outcomes, and expanded MSC products for orthopedic applications are not FDA approved.
Use of mesenchymal stem cell therapies and related products for orthopedic conditions is considered investigational and not medically necessary/not covered under this policy. This includes: (1) mesenchymal stem cell therapy for all orthopedic applications; (2) allograft bone products containing viable stem cells (eg, DBM with stem cells); and (3) allograft or synthetic bone graft substitutes that must be combined with autologous blood or bone marrow. Claims for procedures coded with the listed investigational CPT codes are subject to denial rather than prior authorization.
Coding and Code Status
| K083033 | Vitoss Bioactive Foam Bone Graft Substitute (example 510(k) number) |
| K081558 | NanOss BVF-E (example 510(k) number) |
| K070751 | OrthoBlast II Demineralized bone matrix putty and paste (example 510(k) number) |
| K053218 | DBX Demineralized bone matrix putty, paste and mix (example 510(k) number) |
| K050789 | Formagraft Collagen Bone Graft Matrix (example 510(k) number) |
| K040419 | DynaGraft II Gel and Putty (example 510(k) number) |
| K071237 | CopiOs Bone Void Filler (example 510(k) number) |
| K062353 | Integra MOZAIK Osteoconductive Scaffold-Putty (example 510(k) number) |
| 0263T | Procedure code listed as investigational |
| 0264T | Procedure code listed as investigational |
| 0265T | Procedure code listed as investigational |
| 0489T | Procedure code listed as investigational |
| 0490T | Procedure code listed as investigational |
| 0565T | Procedure code listed as investigational |
| 0566T | Procedure code listed as investigational |
| 20999 | Use for aspiration of bone marrow for the purpose of bone grafting, other than spine surgery and other therapeutic musculoskeletal applications (e.g. Regenexx) |
Provider Actions, Prior Authorization and Billing Guidance
Prior authorization depends on program/product
This policy applies only to certain Capital Blue Cross programs and products and prior authorization requirements depend on the specific program or product; providers should confirm program applicability before requesting authorization.
- Applicable programs may vary (example: FEP PPO directs providers to the FEP Medical Policy Manual).
Investigational procedure codes are not eligible for authorization
Procedure codes listed as investigational in this policy are considered not covered and should be denied rather than processed through prior authorization; verify member benefits and eligibility for any coverage determinations.
Verify coding and member benefits prior to billing
Providers must check the policy and coding tables and verify member benefits; identification of a code in the policy does not denote coverage and final coverage/payment depends on member benefits and eligibility.
- Code lists may not be all-inclusive and are subject to change.
- Payment is subject to member benefit program terms, eligibility on date of service, and medical necessity determination.
Document medical necessity and member eligibility
Document clinical indications and medical necessity in the patient record when submitting claims or authorization requests; policy statements and coding do not guarantee coverage or payment.
- Include documentation that supports medical necessity as related to orthopedic indications.
- Maintain records showing benefit eligibility and date-of-service verification.
Check program/product-specific benefit variations
Confirm program- and product-specific benefit variations before proceeding; this policy is applicable only to certain Capital Blue Cross programs and products and some programs (eg, FEP PPO) reference alternative policy manuals.
- Refer to program-specific resources such as the FEP Medical Policy Manual for FEP PPO members.
Document medical necessity and verify eligibility
Providers should document the medical necessity rationale and verify member benefit eligibility at the time of service; policy language and coding do not guarantee coverage or payment.
- Final claim processing is determined by the member's benefit contract, eligibility, and medical necessity.
- Contact Provider Services or Member Services with questions about coverage.
MSC therapies and MSC-containing allografts are subject to denial
Mesenchymal stem cell therapy and allograft bone products containing viable stem cells, including DBM with stem cells, are considered investigational for all orthopedic applications and are therefore subject to denial.
- This includes MSC therapies and graft substitutes requiring mixing with autologous blood or bone marrow.
Claims for investigational procedures may be denied
Claims for procedures listed as investigational (see policy CPT list) may be denied; providers must verify member benefits and understand that these procedure codes are designated investigational and not covered.
Background and Rationale
Mesenchymal stem cells (MSCs) are multipotent stromal cells capable of differentiating into several mesenchymal lineages such as bone, cartilage, tendon, muscle, and fat. Bone marrow aspirate is a common MSC source but yields relatively low MSC numbers that decline with patient age. Successful tissue-engineering approaches typically require appropriate scaffolds, induction factors, and implantation techniques. FDA regulation of human cells, tissues, and cellular and tissue-based products depends on criteria such as minimal manipulation and homologous use; notably, the FDA does not consider stem cell use for orthopedic procedures to be homologous.
Definitions
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