CurrentUnitedHealthcarePolicy 2026T0612L

Autologous Cellular Therapy – Commercial and Individual Exchange Medical Policy

Defines UnitedHealthcare Commercial and Individual Exchange medical policy position on autologous cellular therapy (ACT) including adipose-derived, bone marrow-derived, and other autologous stem/cellular interventions for a range of indications (orthopedic/knee osteoarthritis, peripheral arterial disease, musculoskeletal repair, scleroderma, rotator cuff, muscle therapies). Provides definitions, clinical evidence summary, and lists applicable procedure codes for reference.

Policy Summary

PayerUnitedHealthcare

PolicyAutologous Cellular Therapy – Commercial and Individual Exchange Medical Policy

Policy CodePolicy 2026T0612L

Change TypeRevised (template and CPT code updates)

Effective DateJan 1, 2026

Next Review Date

Key ActionBefore applying this policy, check the member specific benefit plan document and any applicable federal or state mandates; the member specific 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; added 0999T, 1000T, and 1001T.

1Coverage stance (not medically necessary)

12Procedure codes listed

3Major clinical areas discussed (KOA, PAD, musculoskeletal)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Policy/template update (2026-01-01)

0FDA-approved autologous MSC indications cited

Coverage Summary

Policy statement: Autologous Cellular Therapy (ACT) is unproven and not medically necessary for all indications due to insufficient evidence of efficacy. This policy (Policy Number 2026T0612L) is effective 2026-01-01. Benefit determination depends on the member-specific benefit plan document and any applicable federal or state mandates; listing of procedure codes in this policy is for reference only and does not imply coverage or guarantee reimbursement. Providers should consult the member-specific plan and applicable mandates before applying this policy.

Policy-level key values

Overall evidence qualityInsufficient; low to very low certainty with heterogeneous methods

Coverage stanceNot medically necessary / unproven for all indications

Procedure codes listed (count)12 codes: 0263T, 0264T, 0265T, 0489T, 0490T, 0565T, 0566T, 0717T, 0718T, 0999T, 1000T, 1001T

Major clinical areas discussedKnee osteoarthritis (KOA); Peripheral arterial disease (PAD)/PVD; Musculoskeletal repair (rotator cuff/tendons)

Policy template / code update dateTemplate update effective January 1, 2026; added CPT 0999T, 1000T, 1001T; archived prior versions

Medical-Necessity Criteria

Coverage Rationale

Policy statement

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

General Coverage Determination

Policy summarizes evidence and guideline positions; specific coverage decisions depend on member benefit plan and applicable mandates.

Autologous cellular therapies are considered experimental/investigational or of insufficient evidence for many indications due to limited, low-quality, heterogeneous studies and need for RCTs.

Coverage determination requires review of member specific benefit plan document and applicable federal/state mandates; in absence of Medicare NCD/LCD, Medicare Advantage Organizations may create their own determinations.

Clinical Areas & Evidence Summaries

Peripheral Arterial Disease / Critical Limb Ischemia

Summary of evidence from systematic reviews and RCTs:

Systematic reviews/meta-analyses (e.g., Rigato 2017, Gao 2019) show reduced amputation risk and improved wound healing but note lower-quality studies more likely to show benefit; high-quality RCTs needed.

ESC guideline (2018) states stem cell/gene therapy is not indicated for chronic limb-threatening ischemia.

Regeneration/Repair of Musculoskeletal Tissue (rotator cuff, tendons, ACL, osteoarthritis)

Evidence and guideline statements:

Evidence is mixed: some RCTs and systematic reviews show potential benefit (e.g., Centeno 2024 BMC for rotator cuff), while others show no difference from placebo (e.g., knee OA reviews); overall lack of standardization and heterogeneous methods limit conclusions.

Coding

Applicable CPT / Category III (listed procedure) codes referencedCPT

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) - inclusion for reference only and does not imply coverage; see provider_actions for billing and coverage determinationCPT

0999T
1000T
1001T

Provider Actions

Documentation Required

Benefit determination per member-specific plan

Listing of codes is for reference only; benefit coverage is determined by the member specific benefit plan document and applicable laws; inclusion of a code does not imply coverage or guarantee reimbursement.

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

Documentation Required

Refer to member-specific benefit plan and mandates

Background

Autologous Cellular Therapy (ACT) uses an individual’s own stem or regenerative cells (for example, adipose-derived cells, bone marrow–derived cells, or muscle progenitor cells) to attempt tissue repair or regeneration. The published evidence base is primarily early-phase animal and human studies, case series, observational studies, some randomized controlled trials, and multiple systematic reviews and meta-analyses. Available studies are heterogeneous in cell source, processing, dosing, and outcome measures, and many trials are small or at risk of bias; therefore firm conclusions about safety and effectiveness for most indications cannot be drawn. Hematopoietic stem cell transplantation is noted as the only well-established clinical stem cell therapy in practice.

Definitions / Glossary

Adipose-Derived Stem Cells (ASCs)Mesenchymal adult cells from adipose tissue that can expand in vitro and differentiate into multiple lineages

Autologous Cellular TherapyUse of an individual's stem cells, cultured/expanded ex vivo and reintroduced into the donor

Autologous Adipose-Derived Regenerative Cellular Therapy (ADRC)Therapy using adult stem cells from a person’s fat tissue injected into targeted lesions; cells may be processed prior to reinjection

Bone Marrow Mononuclear Stem Cells (BMC/BMMNC)

Revision History

2026-01-01template_updateLatest

Template update; archived prior policy versions 2025T0612K and SURGERY 116.7; added CPT codes 0999T,1000T,1001T. Created shared policy version to support application to Oxford plan membership and updated applicable CPT codes; added 0999T, 1000T, and 1001T.

Policy Summary

PayerUnitedHealthcare

PolicyAutologous Cellular Therapy – Commercial and Individual Exchange Medical Policy

Policy CodePolicy 2026T0612L

Change TypeRevised (template and CPT code updates)

Effective DateJan 1, 2026

Next Review Date

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

SourceLink

On This Page

AAOS does not recommend injectable biologics such as stem cells for glenohumeral joint OA (2020). VA/DoD guideline (2020) does not recommend stem cell injections for hip/knee OA.

Systematic reviews for tendon disorders report limited/moderate evidence with risk of bias; authors advise against routine clinical use due to unknown serious adverse effects.

Scleroderma (systemic sclerosis)

Evidence summaries for adipose-derived/regenerative cell therapies:

Evidence limited primarily to case series and small trials; STAR RCT (Khanna 2023) showed numerical but not statistically significant improvement overall, with some promising results in diffuse cutaneous SSc subgroup; larger RCTs required.

Systematic reviews conclude data insufficient to make definitive safety/efficacy conclusions; further well-designed studies needed.

Regulatory / FDA note

Informational only:

Concentrated autologous MSCs do not require FDA approval; FDA regulates human cells and tissues intended for implantation/transplantation/infusion through CBER.

Evidence highlights

Overall evidence qualityInsufficient/low to very low; heterogeneity and need for larger high-quality RCTs

KOA RCT/meta-analysis findingsMixed results—some RCTs and meta-analyses show limited or no superiority to placebo; low certainty and inconsistent clinical significance

PAD findingsSome RCTs/meta-analyses report improved ABI, TcPO2, ulcer healing and reduced amputation rates but evidence limited by study quality and heterogeneity

Rigato et al. (2017)Meta-analysis: 37% reduced amputation risk; 18% improved amputation-free survival; 59% improved wound healing; higher-quality studies less likely to show benefit

Centeno et al. (2024)BMC + platelet products showed greater short-term PROM improvements vs exercise for supraspinatus tears with sustained 2-year improvement; limited by small size and control design

Khanna et al. (STAR trial)ADRC vs placebo in systemic sclerosis: numerically greater CHFS improvement not statistically significant overall; subgroup signals in diffuse cutaneous SSc

Centeno note (2024) / musculoskeletalPromising RCT-level results for rotator cuff BMC but additional RCTs needed

Guideline positions (ESC/AAOS/VA-DoD)ESC: stem cell/gene therapy not indicated for chronic limb-threatening ischemia; AAOS and VA/DoD do not recommend routine stem cell injections for specified orthopedic OA indications

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

Billing Rule

Use updated CPT codes

Report applicable procedures using the updated list of CPT codes including newly added 0999T, 1000T, and 1001T as reflected in policy revision.

0999T
1000T
1001T

Documentation Required

Use evidence-based rationale for MAO determinations

In absence of Medicare NCD/LCD, Medicare Advantage Organizations may create their own coverage determinations using objective evidence-based rationale; document rationale if applying to MA members.

Recommend documenting the evidence-based rationale when applying determinations to Medicare Advantage members.

Mixed population of blood cells including stem/progenitor cells used in cardiac/vascular repair studies

Regenerative MedicineBranch of medicine developing methods to regrow, repair or replace damaged cells, organs, or tissues including stem cells and tissue engineering

ADRC (term)Adipose-derived regenerative cells / stromal vascular fraction from adipose tissue

BMCBone marrow concentrate (autologous bone marrow-derived cells sometimes combined with platelet products)

MSCMesenchymal stem/stromal cells