DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

Orthopedic Applications of Stem Cell Therapy

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This policy governs coverage of mesenchymal stem cell therapies, viable stem cell-containing allograft bone products, and bone graft substitutes combined with autologous blood or bone marrow for orthopedic applications. It applies differently to Medicare Advantage and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyOrthopedic Applications of Stem Cell Therapy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 202754d

Last ReviewSep 16, 2026

Next Review DateN/A

Key ActionServices without a specific CPT code may be reported with CPT 20999, but coverage remains subject to the applicable coverage determination.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3Orthopedic stem cell therapy categories addressed as noncovered or not medically necessary

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DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

Orthopedic Applications of Stem Cell Therapy

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Sign up for all Blue Cross Blue Shield - Rhode Island policy alerts

Know when Blue Cross Blue Shield - Rhode Island releases new policies or updates existing guidance.

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Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyOrthopedic Applications of Stem Cell Therapy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 202754d

Last ReviewSep 16, 2026

Next Review DateN/A

Key ActionServices without a specific CPT code may be reported with CPT 20999, but coverage remains subject to the applicable coverage determination.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3Orthopedic stem cell therapy categories addressed as noncovered or not medically necessary

7Specific CPT codes listed as not covered or not medically necessary

4Orthopedic clinical application areas discussed in the evidence review

InsufficientEvidence determination regarding improvement in net health outcome

Not approvedFDA approval status of expanded MSC products for orthopedic applications

Orthopedic Stem Cell Therapy Coverage Criteria

Medicare Advantage Plans

For Medicare Advantage Plans, all of the following orthopedic applications are not covered.

Noncovered orthopedic stem cell therapy: The service is mesenchymal stem cell therapy for any orthopedic application, including repair or regeneration of musculoskeletal tissue; or an allograft bone product containing viable stem cells, including demineralized bone matrix with stem cells; or an allograft or synthetic bone graft substitute that must be combined with autologous blood or bone marrow.

The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Commercial Products

For Commercial Products, all of the following orthopedic applications are not medically necessary.

Not medically necessary orthopedic stem cell therapy: The service is mesenchymal stem cell therapy for any orthopedic application, including repair or regeneration of musculoskeletal tissue; or an allograft bone product containing viable stem cells, including demineralized bone matrix with stem cells; or an allograft or synthetic bone graft substitute that must be combined with autologous blood or bone marrow.

The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Specified orthopedic cellular therapy procedures

The following specific CPT codes are not covered for Medicare Advantage Plans and are not medically necessary for Commercial Products.

Specified orthopedic cellular therapy procedures: The service is reported with CPT 0263T, 0264T, 0265T, 0489T, 0490T, 0565T, or 0566T.

For Medicare Advantage Plans, these services are not covered. For Commercial Products, these services are not medically necessary.

For all orthopedic applications, mesenchymal stem cell therapy, viable stem cell-containing allograft bone products—including demineralized bone matrix with stem cells—and allograft or synthetic bone graft substitutes that must be combined with autologous blood or bone marrow are not covered for Medicare Advantage Plans and are not medically necessary for Commercial Products. The determination is based on insufficient evidence that these technologies improve the net health outcome.

The following CPT codes are not covered for Medicare Advantage Plans: 0263T, 0264T, 0265T, 0489T, 0490T, 0565T, and 0566T.

For Commercial Products, mesenchymal stem cell therapy for all orthopedic applications—including repair or regeneration of musculoskeletal tissue—is not medically necessary. Viable stem cell-containing allograft bone products, including demineralized bone matrix with stem cells, and allograft or synthetic bone graft substitutes requiring combination with autologous blood or bone marrow are also not medically necessary. The evidence is insufficient to determine that these technologies improve the net health outcome.

The following CPT codes are not medically necessary for Commercial Products: 0263T, 0264T, 0265T, 0489T, 0490T, 0565T, and 0566T.

Applicable Procedure Codes

Medicare Advantage Plans and Commercial Products: not covered or not medically necessaryCPTNot Covered

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

Unlisted CPT code; may be used for services addressed in this policy that do not have a specific CPT codeCPT

20999

Unlisted procedure, musculoskeletal system, general

Intramuscular autologous bone marrow cell therapyCPTNot Covered

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

Autologous adipose-derived regenerative cell therapy for sclerodermaCPTNot Covered

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

Autologous adipose-derived cellular implant for knee osteoarthritisCPTNot Covered

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

Unlisted musculoskeletal procedure; may be used for services addressed in this policy that do not have a specific CPT codeCPT

20999

Unlisted procedure, musculoskeletal system, general

Provider and Claims Guidance

Denial Risk

Medicare Advantage: Mesenchymal Stem Cell Therapy

For Medicare Advantage Plans, mesenchymal stem cell therapy for all orthopedic applications—including repair or regeneration of musculoskeletal tissue—is not covered because evidence is insufficient to determine improvement in the net health outcome.

Denial Risk

Medicare Advantage: Viable Stem Cell Allografts

For Medicare Advantage Plans, allograft bone products containing viable stem cells—including, but not limited to, demineralized bone matrix with stem cells—for all orthopedic applications are not covered because evidence is insufficient to determine improvement in the net health outcome.

Denial Risk

Medicare Advantage: Graft Substitutes Requiring Autologous Material

For Medicare Advantage Plans, allograft or synthetic bone graft substitutes that must be combined with autologous blood or bone marrow for all orthopedic applications are not covered because evidence is insufficient to determine improvement in the net health outcome.

Clinical Background

Mesenchymal stem cells are multipotent cells that can differentiate into musculoskeletal tissues, including bone, cartilage, tendon, ligaments, muscle, and fat. Their ability to develop into different tissue types is relevant to orthopedic cell-therapy and tissue-engineering approaches intended to support repair or regeneration of damaged musculoskeletal tissue.

Key Terms

Mesenchymal stem cells (MSCs)

DefinitionMultipotent cells, also called multipotent stromal cells, that can differentiate into various tissues including organs, trabecular bone, tendon, articular cartilage, ligaments, muscle, and fat.

Cell therapy

DefinitionThe application of mesenchymal stem cells directly to a musculoskeletal site.

Tissue engineering

DefinitionTechniques using mesenchymal stem cells and/or bioactive molecules such as growth factors with scaffold combinations to improve the efficiency of repair or regeneration of damaged musculoskeletal tissues.

Bone marrow aspirate

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyOrthopedic Applications of Stem Cell Therapy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 202754d

Last ReviewSep 16, 2026

Next Review DateN/A

Key ActionServices without a specific CPT code may be reported with CPT 20999, but coverage remains subject to the applicable coverage determination.

SourceLink

On This Page

Denial Risk

Commercial: Mesenchymal Stem Cell Therapy

For Commercial Products, mesenchymal stem cell therapy for all orthopedic applications—including repair or regeneration of musculoskeletal tissue—is not medically necessary because evidence is insufficient to determine improvement in the net health outcome.

Denial Risk

Commercial: Viable Stem Cell Allografts

For Commercial Products, allograft bone products containing viable stem cells—including, but not limited to, demineralized bone matrix with stem cells—for all orthopedic applications are not medically necessary because evidence is insufficient to determine improvement in the net health outcome.

Denial Risk

Commercial: Graft Substitutes Requiring Autologous Material

For Commercial Products, allograft or synthetic bone graft substitutes that must be combined with autologous blood or bone marrow for all orthopedic applications are not medically necessary because evidence is insufficient to determine improvement in the net health outcome.

Denial Risk

Specified Orthopedic Cellular Therapy Codes Are Excluded

The following specified orthopedic cellular therapy CPT codes are not covered for Medicare Advantage Plans and not medically necessary for Commercial Products.

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

Billing Rule

Unlisted Procedure Coding Does Not Establish Coverage

When no specific CPT code exists for a service addressed by this policy, CPT 20999 may be reported as an unlisted musculoskeletal procedure. Reporting an unlisted code does not establish coverage or medical necessity; the service remains subject to all applicable policy terms and the applicable Medicare Advantage or Commercial coverage consequence.

20999 — Unlisted procedure, musculoskeletal system, general

RoleThe most accessible and common source for isolating mesenchymal stem cells for treatment of musculoskeletal disease.

Harvesting considerationHarvesting mesenchymal stem cells from bone marrow requires a procedure that may result in donor-site morbidity.

Cell availabilityThe number of mesenchymal stem cells in bone marrow is low, and the number and differentiation capacity of bone marrow-derived mesenchymal stem cells decrease with age.