Orthopedic Applications of Stem Cell Therapy — Mesenchymal Stem Cell (MSC) Therapies
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This policy governs coverage and medical necessity determinations for mesenchymal stem cell (MSC) therapies and stem cell–containing allograft/synthetic bone graft products for orthopedic and musculoskeletal indications for Blue Cross Blue Shield - Rhode Island members.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity
Overall coverage stance
Policy coverage stance varies by product type and purchaser:
This policy distinguishes between concentrated autologous MSCs and expanded or engineered MSC products. Concentrated autologous MSC preparations (cells concentrated from the patient’s own tissue at the point of care) do not require premarket approval by the U.S. Food and Drug Administration. In contrast, expanded or engineered MSC products intended for orthopedic applications have not been approved by the FDA and are treated differently in the regulatory assessment and evidence review.
Because products using expanded or engineered MSCs lack FDA approval for orthopedic uses, they are subject to greater regulatory and clinical-evidence scrutiny; the policy notes that no engineered or expanded MSC products for orthopedic applications have FDA approval and that evidence across modalities is insufficient to demonstrate improved net health outcome.
Coverage and payment for MSC therapies are governed by the member’s subscriber agreement or employer agreement. This medical policy is informational and does not guarantee payment; determinations of benefits and eligibility are made according to the member’s specific benefit documents, which supersede the policy.
Providers should verify member-specific benefits and obtain any required authorizations as specified by the subscriber or employer contract prior to delivering services.
For Commercial products, mesenchymal stem cell therapy for all orthopedic applications, including use for repair or regeneration of musculoskeletal tissue, is considered not medically necessary because the evidence is insufficient to show an improvement in net health outcome.
Specific CPT-coded MSC procedures are likewise designated not medically necessary / not covered for the applicable product lines (see coding section for the list of CPT codes such as 0263T, 0264T, 0265T, 0489T, 0490T, 0565T, 0566T).
If a service is determined to be not medically necessary or is a non-covered benefit under the member’s plan, providers may not charge the member unless the member was informed in advance and provided written agreement to accept financial responsibility for the service.
This policy is informational and not a guarantee of payment; providers should consult the member’s Benefit Booklet, Evidence of Coverage, or Subscriber Agreement and contact the provider call center for member-specific benefit and eligibility information.
Procedure and Billing Codes
| 0263T | Intramuscular autologous bone marrow cell therapy, with preparation of harvested cells, multiple injections, one leg, including ultrasound guidance, if performed; complete procedure including unilateral or bilateral bone marrow harvest |
| 0264T | Intramuscular autologous bone marrow cell therapy, with preparation of harvested cells, multiple injections, one leg, including ultrasound guidance, if performed; complete procedure excluding bone marrow harvest |
| 0265T | Intramuscular autologous bone marrow cell therapy, with preparation of harvested cells, multiple injections, one leg, including ultrasound guidance, if performed; unilateral or bilateral bone marrow harvest only for intramuscular autologous bone marrow cell therapy |
| 0489T | Autologous adipose-derived regenerative cell therapy for scleroderma in the hands; adipose tissue harvesting, isolation and preparation of harvested cells including incubation with cell dissociation enzymes, removal of non-viable cells and debris, determination of concentration and dilution of regenerative cells |
| 0490T | Autologous adipose-derived regenerative cell therapy for scleroderma in the hands; multiple injections in one or both hands |
| 0565T | Autologous cellular implant derived from adipose tissue for the treatment of osteoarthritis of the knees; tissue harvesting and cellular implant creation |
| 0566T | Autologous cellular implant derived from adipose tissue for the treatment of osteoarthritis of the knees; injection of cellular implant into knee joint including ultrasound guidance, unilateral |
Provider Requirements and Administrative Actions
Prior authorization not applicable
Prior authorization is not applicable for mesenchymal stem cell (MSC) therapies and related CPT-coded procedures per this policy.
Benefits and policy subject to member agreement
BCBSRI may review and revise this policy at any time; benefits and eligibility are determined by the member's subscriber agreement, member certificate, or employer agreement and those documents supersede this medical policy.
No step therapy specified — verify contract
No step therapy requirements are specified in this policy; coverage and benefit requirements may vary between groups/contracts.
Administrative note — informational policy and provider contact
This policy is provided for informational purposes and not a guarantee of payment; for member-specific benefit details or authorization requirements, contact the provider call center.
Refer to member benefit documents
Providers must refer to the appropriate Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for limitations of benefits and coverage when services are not covered or not medically necessary.
Verify member benefits with provider call center
Verify member-specific benefits and eligibility with the provider call center; member-specific benefit documents supersede this medical policy.
High denial risk for MSC orthopedic procedures
Mesenchymal stem cell therapy for all orthopedic applications and the listed CPT procedures are not covered for Medicare Advantage plans and are not medically necessary for Commercial products — performing these services risks claim denial.
Member financial liability rules for non-covered or NMN services
If services are determined to be not medically necessary or are non-covered benefits, providers may not charge the member unless the member was informed in advance and agreed in writing to assume financial responsibility.
- Follow participation agreement provisions for member charges.
- Obtain written member agreement before charging for non-covered or not medically necessary services.
Clinical Background
Mesenchymal stem cells (MSCs) are multipotent stromal cells capable of differentiating into musculoskeletal tissues such as bone, cartilage, tendon, ligament, muscle, and fat. They are found in vascular niches of bone marrow, synovium, adipose tissue, and muscle and are being investigated as a means to promote repair or regeneration in orthopedics.
MSC-based approaches vary by source and processing: therapies may use concentrated autologous cells obtained at the point of care, or they may use expanded or engineered cell products. Clinical trials and reviews show mixed results across indications; overall the evidence is limited and of variable quality, and expanded MSC products for orthopedic uses are not FDA-approved.
Commercial products marketed as containing viable stem cells (for example certain demineralized bone matrix or allograft combinations) exist, and some devices or grafts are designed to be combined with autologous bone marrow aspirate, but available evidence does not clearly demonstrate improved clinical outcomes for orthopedic applications.
Key Terms and Product Definitions
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