Orthopedic Applications of Stem Cell Therapy
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This policy governs coverage and coding for mesenchymal stem cell (MSC) therapies and related allograft/synthetic bone graft products for orthopedic uses for Blue Cross Blue Shield - Rhode Island members.
No material clinical or coverage changes in this revision.
Coverage Determinations
Coverage stance
Policy stance by product line
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This policy addresses coverage for mesenchymal stem cell (MSC) therapies and related allograft/synthetic bone graft products for orthopedic indications. For Medicare Advantage Plans, MSC therapy for all orthopedic applications — including use for repair or regeneration of musculoskeletal tissues — is not covered because the evidence is insufficient to demonstrate an improvement in net health outcome. Similarly, allograft bone products that claim to contain viable stem cells and allograft or synthetic bone graft substitutes that require combination with autologous blood or bone marrow for orthopedic uses are not covered for Medicare Advantage members.
The following CPT codes for autologous bone marrow and adipose-derived cellular therapies are identified as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products: 0263T, 0264T, 0265T, 0489T, 0490T, 0565T, 0566T. Each code corresponds to procedures for harvesting, preparation, implantation, or injection of autologous bone marrow– or adipose-derived cellular products as described in the CPT descriptors.
For Commercial Products, mesenchymal stem cell therapy for all orthopedic applications, and the specified allograft/synthetic graft product categories described in this policy, are considered not medically necessary because the available evidence is insufficient to determine an improvement in net health outcome.
Use of the listed CPT-coded procedures is considered not medically necessary for Commercial Products. The CPT codes include procedures for intramuscular autologous bone marrow cell therapy and autologous adipose-derived cellular implants/injections (0263T, 0264T, 0265T, 0489T, 0490T, 0565T, 0566T) and will be processed accordingly under this policy.
CPT / HCPCS Coding
| 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 |
| 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 Responsibilities & Billing Guidance
Prior authorization not applicable — listed CPT codes are not covered
Prior authorization is not applicable for the CPT codes listed in this policy because those codes are designated as not covered or not medically necessary.
Coverage and prior authorization — verify benefits for listed CPT codes
The CPT codes listed in this policy are identified as not covered for Medicare Advantage and not medically necessary for Commercial products; providers must verify member benefits and obtain prior authorization when required by the member's contract before delivering services.
Check member contract for coverage limitations
Benefits may vary between groups/contracts; refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for limitations when services are not covered or not medically necessary.
- When in doubt, contact the provider call center for member-specific benefit information
Verify member eligibility and subscriber agreement terms
Providers must follow the member-specific guidance in the subscriber agreement and verify eligibility; benefits and eligibility determinations supersede this policy and govern payment.
- Call the provider call center for member-specific benefits and eligibility questions
- Do not bill the member for services determined to be not medically necessary without prior written member agreement
Member benefit verification — consult benefit documents
Benefits can differ by contract; always refer to the member's Benefit Booklet, Evidence of Coverage or Subscriber Agreement for exact benefit limitations and covered services.
- Provider should confirm any limits or exclusions before performing services
Benefit verification — member agreements govern
Verify member benefits and eligibility prior to providing services; the member's subscriber agreement and employer agreement govern benefits and supersede this policy.
- For member-specific benefit questions, contact the provider call center
Coverage denial triggers — MSC therapies and certain allografts
Claims for mesenchymal stem cell (MSC) therapy for any orthopedic application, and for allograft bone products that contain viable stem cells or require combination with autologous blood or bone marrow, will be denied/not covered under this policy.
- Includes MSC therapies used for repair or regeneration of musculoskeletal tissue
- Includes allograft bone products containing viable stem cells and graft substitutes requiring autologous blood/bone marrow
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. MSCs are being investigated as cell-based therapies for repair or regeneration of bone, cartilage, ligaments, tendons, meniscus, and intervertebral discs. Sources of MSCs include bone marrow and adipose tissue; bone marrow harvest can cause donor-site morbidity and MSC yield declines with age. Overall, clinical evidence across orthopedic indications is generally low quality and mixed, with some trials showing no benefit and others reporting limited short-term improvements; no engineered or expanded MSC products are currently FDA-approved for orthopedic use.
Terms & Definitions
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