Currentsierra health and lifePolicy 2026T0612L

Autologous Cellular Therapy

Defines UnitedHealthcare Commercial and Individual Exchange coverage position on autologous cellular therapies (including adipose-derived, bone marrow-derived, stromal vascular fraction, BMAC, muscle progenitor therapy) across musculoskeletal, vascular, and other indications; lists applicable procedure codes and summarizes evidence and rationale for noncoverage.

Policy Summary

Payersierra health and life

PolicyAutologous Cellular Therapy

Policy CodePolicy 2026T0612L

Change TypeTemplate update / CPT code edits

Effective DateJan 1, 2026

Next Review Date

Key ActionBefore using this policy, check the member specific benefit plan document and any applicable federal or state mandates; member plan governs in event of conflict.

SourceLink

POLICY UPDATE CHANGES

Created shared policy version to support application to Oxford plan membership and updated applicable CPT codes to reflect annual edits; added 0999T, 1000T, and 1001T.

1Coverage Position (Unproven/Not Medically Necessary)

12Procedure Codes Listed

MultipleCovered Indications

LowEvidence Quality

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Coverage Summary

Defines UnitedHealthcare Commercial and Individual Exchange coverage position on Autologous Cellular Therapy (including adipose-derived, bone marrow-derived, stromal vascular fraction, BMAC, muscle progenitor therapy) across musculoskeletal, vascular, and other indications; lists applicable procedure codes and summarizes evidence and rationale for noncoverage. Policy number: 2026T0612L; effective date: January 1, 2026. Position: unproven / not medically necessary (not covered) for all indications (see policy rationale and evidence summary).

Policy Number2026T0612L

Effective DateJanuary 1, 2026

Payersierra health and life

ScopeDefines UnitedHealthcare Commercial and Individual Exchange coverage position on autologous cellular therapies (including adipose-derived, bone marrow-derived, stromal vascular fraction, BMAC, muscle progenitor therapy) across musculoskeletal, vascular, and other indications; lists applicable procedure codes and summarizes evidence and rationale for noncoverage.

Policy statement: Autologous Cellular Therapy is unproven and not medically necessary for all indications due to insufficient evidence of efficacy.

Medical Necessity / Coverage Rationale

Coverage Rationale

Policy statement:

Autologous Cellular Therapy is unproven and not medically necessary for all indications due to insufficient evidence of efficacy.

Evidence-based conclusions and coverage implications (narrative)

Summarized findings from systematic reviews, RCTs, and society guidelines regarding autologous cellular therapies:

Peripheral arterial disease/critical limb ischemia: systematic review/meta-analysis showed reduced risk of amputation (37%), improved amputation-free survival (18%), and improved wound healing (59%), but higher-quality studies were less likely to show benefit and authors recommend high-quality RCTs.

Musculoskeletal repair (rotator cuff, tendons, ACL): evidence is limited and heterogeneous; some RCTs (e.g., Centeno 2024) showed short-term PROM improvement with BMC + platelet products vs exercise, but limitations exist and further RCTs are needed.

Applicable Codes

Applicable CPT/HCPCS Codes (listed for reference)mixed

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.
0717T	Autologous adipose-derived regenerative cell (ADRC) therapy for partial thickness rotator cuff tear; adipose tissue harvesting, isolation and preparation of harvested cells, including incubation with cell dissociation enzymes, filtration, washing and concentration of ADRCs.
0718T	Autologous adipose-derived regenerative cell (ADRC) therapy for partial thickness rotator cuff tear; injection into supraspinatus tendon including ultrasound guidance, unilateral.
0999T	Autologous muscle cell therapy, harvesting of muscle progenitor cells, including ultrasound guidance, when performed.

1–10 of 12

1/2

Updated Applicable CPT Codes (annual edits noted)CPT

0999T
1000T
1001T

List of applicable procedure and diagnosis codes provided for reference only; inclusion of a code does not imply coverage or guarantee reimbursement—benefit coverage is determined by the member-specific plan and applicable law.

Provider Actions & Billing Notes

Documentation Required

Reference codes and benefit determination

List of applicable procedure and diagnosis codes provided for reference only; inclusion of a code does not imply coverage or guarantee reimbursement—benefit coverage determined by member-specific plan and applicable law.

0263T
0264T
0265T
0489T
0490T
0565T
0566T
0717T
0718T
0999T
1000T
1001T

Documentation Required

Reference member-specific benefit plan

Background & Evidence Summary

Autologous Cellular Therapy (ACT) uses a patient’s own stem or progenitor cells (for example adipose-derived cells, bone marrow–derived cells, stromal vascular fraction, BMAC, muscle progenitor cells) for regenerative purposes. The evidence base is primarily early-phase studies, case series, some randomized trials, and systematic reviews with heterogeneous methods and methodological limitations; hematopoietic stem cell transplantation is the only well-established stem cell therapy in clinical practice.

Overall evidenceInsufficient/low to very low certainty for most indications; studies heterogeneous with methodological limitations; some small RCTs and systematic reviews show inconsistent or modest benefits for knee OA and PAD but not definitive clinical efficacy.

Knee OsteoarthritisSystematic reviews and RCTs provide mixed results; some trials and meta-analyses show modest or transient pain/function improvements versus controls but effects often do not exceed MCID; evidence rated low to very low certainty.

Peripheral Arterial Disease / CLIMeta-analyses and systematic reviews report reduced amputation risk (~37%), improved amputation-free survival (~18%), and improved wound healing (~59%) in pooled analyses, but higher-quality studies less likely to show benefit and overall evidence quality low and inconsistent.

Rigato 2017 (PAD)

Definitions

Term	Definition
Adipose-Derived Stem Cells (ASCs)	Mesenchymal adult cells, isolated from adipose tissue that can expand in vitro in an undifferentiated state and have the capacity to differentiate into multiple cell lineages.
Autologous Cellular Therapy	A therapeutic intervention that uses an individual's stem cells, which can be cultured and expanded outside the body, and reintroduced into the donor.
Autologous Adipose-Derived Regenerative Cellular Therapy	Therapy using adult stem cells extracted from an individual's fat tissue injected into targeted lesion of the same individual; cells sometimes processed prior to reinjection.
Bone Marrow Mononuclear Stem Cells	A mixed population of blood cells, including stem and progenitor cells, explored in studies of cardiac and vascular repair.
Regenerative Medicine	Branch of medicine developing methods to regrow, repair or replace damaged or diseased cells, organs, or tissues, including therapeutic stem cells and tissue engineering.
ADRC	Adipose-derived regenerative cellular therapy (autologous adipose-derived cells).
BMC	Bone marrow concentrate (autologous).

Revision History

01/01/2026revisedLatest

Created shared policy version to support application to Oxford plan membership and updated applicable CPT codes to reflect annual edits; added 0999T, 1000T, and 1001T.

Policy Summary

Payersierra health and life

PolicyAutologous Cellular Therapy

Policy CodePolicy 2026T0612L

Change TypeTemplate update / CPT code edits

Effective DateJan 1, 2026

Next Review Date

Key ActionBefore using this policy, check the member specific benefit plan document and any applicable federal or state mandates; member plan governs in event of conflict.

SourceLink

On This Page

Tendon disorders: systematic reviews report mixed results; available trials at moderate-to-high risk of bias; Level 3 evidence insufficient to recommend routine clinical use; authors caution against clinical use given unknown serious adverse effects.

Osteoarthritis: mixed randomized trial results; some systematic reviews find no difference from placebo for intra-articular MSCs; insufficient evidence for definitive coverage.

Scleroderma / systemic sclerosis: evidence limited to case series and small RCT STAR trial (Khanna 2023) showed feasibility and some signals in dcSSc subgroup but not statistically significant for full cohort; larger RCTs needed.

Regulatory note: Concentrated autologous MSCs do not require FDA approval but FDA regulates human cells/tissues intended for implantation/transplantation/infusion (informational only).

Society guidance: AAOS does not recommend stem cells for glenohumeral OA; ACC/AHA and VA/DoD do not recommend or reference stem cell therapy for PAD or hip/knee OA; ESC recommends stem cell/gene therapy is not indicated for chronic limb-threatening ischemia; ISSCR considers MSC therapy experimental.

Before using this policy, check the member specific benefit plan document and any applicable federal or state mandates; member plan governs in event of conflict.

Documentation Required

Use of objective evidence for Medicare Advantage

In the absence of an NCD or LCD, Medicare Advantage Organizations may create coverage determinations using objective evidence-based rationale; this policy may be applied to MA plans where applicable.

Billing Rule

Policy application to Oxford membership

Template update created shared policy version to support application to Oxford plan membership; applicable CPT code list updated.

0999T
1000T
1001T
Note: Template update (01/01/2026) applies this policy to Oxford membership and includes the added CPT codes.

Meta-analysis found reduced amputation risk 37%; improved amputation-free survival 18%; improved wound healing 59%; noted higher-quality studies less likely to show benefit.

Centeno 2024 (rotator cuff)Randomized controlled crossover trial: BMC plus platelet products showed superior PROMs at 3 months versus exercise and sustained improvement through 2-year follow-up; study limited by small sample and control design.

Khanna STAR 2023 (scleroderma)Randomized double-blind placebo-controlled STAR trial: no statistically significant difference in primary CHFS for full cohort; diffuse cutaneous subgroup showed promising signals; ADRC treatment well tolerated.

Regulatory and society guidance: concentrated autologous mesenchymal stem cells do not require FDA approval, but the FDA regulates human cells and tissues intended for implantation/transplantation/infusion (informational). Professional societies and guideline panels consider MSC therapy experimental or do not recommend it for routine use: ISSCR states MSC therapy remains in early experimental stages; AAOS does not recommend stem cells for glenohumeral OA and emphasizes the need for high-quality evidence; ESC recommends stem cell/gene therapy is not indicated for chronic limb‑threatening ischemia; ACC/AHA and VA/DoD guidelines do not recommend or do not reference stem cell therapy for PAD or hip/knee OA.