DraftUnitedHealthcarePolicy SURGERY 116.7

Autologous Cellular Therapy

This policy addresses the medical necessity and coverage stance for autologous cellular therapy (including adipose- and bone marrow–derived cell therapies) across indications, focusing on orthopedic/musculoskeletal uses and related procedures for UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyAutologous Cellular Therapy

Policy CodePolicy SURGERY 116.7

Change TypeRemoved CPT codesupporting sections updated

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain and verify any required prior authorization per the member's benefit plan and payer processes before autologous cellular therapy procedures.

SourceLink

POLICY UPDATE CHANGES

CPT code 27599 was removed from the list of applicable codes.

Supporting Information, Clinical Evidence, and References sections were updated to reflect the most current information.

unprovencoverage stance for all indications

13+ RCTsrandomized trials summarized

31 studiesstudies in KOA review

Multiplerelated codes referenced

10/01/2025

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Coverage Criteria and Rationale

Not medically necessary — all indications

Covered when ALL of the following are met:

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

Policy-level determination based on the available evidence summarized in this document.

Evidence-based coverage considerations

Coverage considerations based on available evidence for different indications:

Knee osteoarthritis: Systematic reviews and meta-analyses of RCTs report mixed and generally modest effects of intra-articular autologous MSC/SVF/MFAT/BMC versus placebo or comparators; some trials show statistical improvement in PROMs but effects often do not exceed the minimum clinically important difference (MCID) and heterogeneity in dose, source, processing, and injection number limits conclusions; therefore evidence is insufficiently consistent to support routine coverage for KOA.evidence heterogeneity and lack of consistent MCID-exceeding benefit

Sources: Dai et al. (2021); Garza et al. (2020); ECRI, Hayes reviews.

Peripheral arterial disease (PAD/CLI): Meta-analyses of autologous cell therapies for PAD/critical limb ischemia report potential improvements in ulcer healing, ABI/TcPO2, pain-free walking distance, and reduced amputation rates in some trials, but included studies are heterogeneous, many have high risk of bias, and overall evidence quality is low; larger, high-quality RCTs with long-term follow-up are needed before definitive coverage conclusions.limited sample sizes, variable methods, inconsistent blinding

Sources: Gao et al./meta-analyses; Rigato et al. (2017); Pu et al.

Regeneration/repair of musculoskeletal tissue (tendons/ligaments/rotator cuff/ACL): Evidence includes small RCTs, cohort studies, and case series with mixed results; some trials report improved PROMs and imaging after BMC or MSC-based treatments, but moderate-to-high risk of bias and heterogeneity in study designs prevent conclusive recommendations for routine clinical use; further standardized RCTs are required.moderate-to-high risk of bias in many studies

Sources: Centeno et al. (2024); Kon et al. (2021); van den Boom et al. (2020).

Systemic sclerosis (scleroderma) hand dysfunction: Randomized placebo-controlled data (STAR trial) demonstrated feasibility and tolerability of ADRC hand injections with some endpoints suggesting benefit in subgroups (eg, diffuse cutaneous SSc) but primary endpoints were not statistically significant for the full cohort; findings are promising but insufficient to establish routine clinical benefit.promising but inconclusive trial results

Source: Khanna et al. (STAR trial, 2023).

General coverage rationale

Coverage stance informed by current evidence and guideline positions

Evidence summary AND guideline recommendations: Systematic reviews and clinical trials provide inconclusive or limited-quality evidence for autologous cellular therapies across indications (knee/shoulder osteoarthritis, tendon disorders, ACL, PAD, scleroderma). Multiple specialty guideline bodies and societies characterize MSC and other stem cell therapies as experimental, investigational, or not recommended for routine clinical use given insufficient high-quality evidence and lack of standardization.

Sources: AAOS position and 2020 glenohumeral OA guideline; VA/DoD OA guideline; ESC PAD guideline; ISSCR statements; systematic reviews by Kon et al. and van den Boom et al.

The presence of a procedure or diagnosis code in this policy is for reference only and does not imply coverage. Benefit coverage for any service described by a code is determined by the member-specific benefit plan document and applicable laws; inclusion of a code is not a guarantee of reimbursement or claim payment.

Systematic reviews of stem cell therapy for tendon disorders conclude that available trials have moderate-to-high risk of bias and that evidence is insufficient to support routine clinical use. The authors state that stem cell injections should not be used in clinical practice given limited knowledge about potentially serious adverse effects and the current absence of robust safety and efficacy data.

Major guideline bodies have not endorsed injectable stem cell biologics for joint or vascular indications. For example, the AAOS guideline for glenohumeral joint osteoarthritis states that injectable biologics (stem cells) cannot be recommended for treatment of glenohumeral OA. Similarly, VA/DoD guidance does not recommend stem cell injections for hip or knee OA, and the ESC indicates stem cell/gene therapies are not indicated for chronic limb‑threatening ischemia due to insufficient evidence.

Based on the totality of the available evidence, Autologous Cellular Therapy (ACT) is considered unproven and not medically necessary for all indications. This policy-level determination reflects inconsistent, limited, or low‑quality data across studied indications and the absence of consistent clinically meaningful benefit.

Evidence for knee osteoarthritis and many other musculoskeletal indications is heterogeneous and of variable quality. Systematic reviews and meta-analyses report mixed and generally modest effects of intra-articular MSC/SVF/MFAT/BMC versus placebo or alternatives, with several analyses finding improvements that often do not exceed the minimum clinically important difference. Trials are limited by small sizes, inconsistent cell sources and processing, variable dosing and injection protocols, and risk of bias, leading reviewers to conclude that the evidence is insufficiently consistent to support routine coverage.

Given the current evidence base and guideline positions, stem cell injections are not recommended for routine clinical practice for tendon disorders or for hip and knee osteoarthritis. Reviews and guideline statements cite limited, biased, or low‑quality evidence and call for larger, standardized randomized trials before these therapies can be recommended.

Applicable Procedure and Reference Codes

Referenced Category III/Procedure CodesCPT

0263T	Intramuscular autologous bone marrow cell therapy: with preparation of harvested cells, multiple injections, one including ultrasound guidance, if performed; complete procedure including unilateral or bilateral bone marrow harvest leg.
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.

Removed Applicable CPT CodesCPT

27599

Unlisted procedure, tibia and fibula (removed from applicable codes)

Average injected facial volume (scleroderma studies)

Average injected facial volume (mean)14.60 mL (range 3–27 mL)

Source study typeScleroderma clinical trial and case series reporting ADSVF/ADRC injections

Timepoints reportedOutcomes assessed at 6, 12 and up to 22–30 months in follow-up reports

Average number of lipotransfer procedures

Average number of lipotransfer procedures (mean)2.5 procedures (median 1.35; range 1–14)

ContextReported in scleroderma/adipose tissue intervention cohorts and case series

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Benefit Verification

Prior authorization may be required for autologous cellular therapies. Providers should verify member coverage and obtain any required prior authorization per the member's benefit plan prior to scheduling services.

Verify member-specific benefits and coverage details before providing services.
Obtain prior authorization when required by the member's plan or payer processes.

Prior Authorization

Prior Authorization Expected for Therapies with Heterogeneous Evidence

When evidence is heterogeneous or conflicting (for example, MSC, MFAT, SVF, or other autologous cell therapies with variable dose, source, processing, and administration), prior authorization is expected so the payer can review medical necessity on a case-by-case basis.

Expect prior authorization requests for therapies with heterogeneous evidence to include detailed documentation of cell source, processing method, dose, number of injections, and clinical rationale.
Provide comparisons to established nonsurgical or surgical therapies when available.

Background on Autologous Cellular Therapy

Autologous Cellular Therapy (ACT) refers to treatments that use a patient’s own stem or regenerative cells and, in this policy, encompasses adipose‑derived, bone marrow–derived, stromal vascular fraction (SVF), microfragmented adipose tissue (MFAT), and related autologous concentrates. ACT approaches vary in cell source, processing, dose, and administration; the published literature is dominated by early‑phase trials, small randomized studies, and observational reports with substantial heterogeneity. Because of the inconsistent and limited high‑quality evidence for efficacy and safety across indications, ACT is considered investigational for routine clinical use.

Definitions and Terminology

Adipose-Derived Stem Cells (ASCs)

TermAdipose-Derived Stem Cells (ASCs)

DefinitionMesenchymal adult cells isolated from adipose tissue that can expand in vitro in an undifferentiated state and differentiate into multiple cell lineages.

Typical useDescribed in studies as a source of autologous cells for regenerative injections

Autologous Cellular Therapy

TermAutologous Cellular Therapy

DefinitionA therapeutic intervention that uses an individual's stem cells, which can be cultured and expanded outside the body and reintroduced into the donor.

Policy Revision History

2025-10-01code_removalLatest

CPT code 27599 was removed from the list of applicable procedure codes.

2025-10-01archived_previous_version

Previous policy version SURGERY 116.6 was archived when this version took effect.

Policy Summary

PayerUnitedHealthcare

PolicyAutologous Cellular Therapy

Policy CodePolicy SURGERY 116.7

Change TypeRemoved CPT codesupporting sections updated

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain and verify any required prior authorization per the member's benefit plan and payer processes before autologous cellular therapy procedures.

SourceLink

On This Page

ImplicationMultiple procedures per patient were common in published series

Note

Consider Established Therapies First

Consider established, guideline-recommended therapies first. Comparative evidence with nonsurgical treatments is limited and inconsistent; established treatments should generally be attempted before experimental or unproven autologous cellular therapies.

Document prior trials of conservative care (e.g., physical therapy, pharmacologic management, intra-articular hyaluronic acid or corticosteroids) and rationale for considering cellular therapy.

Denial Risk

Denial Risk When Evidence Is Heterogeneous or Insufficient

Evidence heterogeneity and lack of standardized methods may lead to coverage uncertainty and potential claim denial. Therapies lacking sufficient evidence of efficacy are considered unproven and may be denied as not medically necessary.

Denials may be issued when submitted documentation does not demonstrate clinical benefit, standardized preparation/dosing, or when the member's benefit plan excludes experimental therapies.
Include robust clinical rationale and objective outcome measures when requesting coverage for cellular therapies.

Billing Rule

Coding and Benefit Documentation

Coding lists in this policy are for reference only. Inclusion of a code does not imply coverage or a right to reimbursement. Always reference the member-specific benefit plan to determine coverage and billing applicability.

Provide applicable procedure and diagnosis codes on prior authorization submissions as requested by the payer.
The member-specific benefit plan document governs coverage determinations in the event of a conflict with policy.

Documentation Required

Required Clinical Outcome Documentation

Required clinical outcome documentation should be included with authorization requests and claims when applicable. Objective measures reported in trials include WOMAC, VAS, PROMs, MRI findings, and adverse event reporting.

Submit baseline and follow-up objective outcome measures (e.g., WOMAC, VAS, PROMs) and imaging (MRI) when used to support medical necessity.
Include documentation of prior conservative treatments, indication, treatment protocol (cell source, processing, dose, number of injections), and any adverse events.

Note

Documentation and Benefit Reference

This policy is provided for informational purposes and does not replace the member-specific benefit plan document. The member-specific benefit plan governs coverage decisions and, where applicable, state or federal mandates may apply.

Use this policy to guide clinical review, but confirm benefit limitations, exclusions, and prior authorization requirements with the member's plan.
UnitedHealthcare may use external tools (e.g., InterQual) to assist in benefit administration.

Includes adipose- and bone marrow–derived cell therapies described in this policy

Autologous Adipose-Derived Regenerative Cellular Therapy

TermAutologous Adipose-Derived Regenerative Cellular Therapy

DefinitionTherapy using adult stem cells extracted from an individual's fat tissue and injected into a targeted lesion of the same individual; cells may be processed prior to reinjection.

ExamplesIncludes therapies referred to as ADRCs, SVF, MFAT in clinical reports

Bone Marrow Mononuclear Stem Cells

TermBone Marrow Mononuclear Stem Cells

DefinitionA mixed population of blood cells, including stem and progenitor cells, explored in studies of cardiac and vascular repair and used in orthobiologic applications.

PreparationOften obtained from autologous bone marrow aspirate and concentrated for injection

Regenerative Medicine

TermRegenerative Medicine

DefinitionThe branch of medicine that develops methods to regrow, repair, or replace damaged or diseased cells, organs, or tissues, including therapeutic stem cells, tissue engineering, and production of artificial organs.

RelevanceIncludes development and clinical use of autologous cellular therapies discussed in this policy

SVF (stromal vascular fraction)

TermSVF (stromal vascular fraction)

DefinitionA heterogeneous cell preparation obtained from lipoaspirate used for intra-articular or soft-tissue injection; in trials SVF is harvested by liposuction, processed the same visit, and injected as the cellular implant.

Clinical noteUsed in randomized trials for knee OA (eg, Garza et al.) and other indications

BMC (bone marrow concentrate)

TermBMC (bone marrow concentrate)

DefinitionAutologous concentrate from bone marrow often combined with platelet products (eg, PRP, platelet lysate) for orthobiologic treatments such as tendon repair or rotator cuff injections.

Clinical noteReported in randomized and controlled trials (eg, Centeno et al. 2024) for musculoskeletal repair

MFAT (microfragmented adipose tissue)

TermMFAT (microfragmented adipose tissue)

DefinitionAn autologous adipose-derived product (eg, Lipogems System) used in injections for osteoarthritis; evidence quality has been described as very low in assessments.

Evidence noteHayes and ECRI reports highlight limited comparative evidence and heterogeneity for MFAT in KOA

Concentrated autologous MSCs

TermConcentrated autologous MSCs

DefinitionAutologous mesenchymal stem cells concentrated from the patient; these products may not require FDA approval, though the FDA regulates human cells and tissues intended for implantation, transplantation, or infusion.

Regulatory noteFDA oversight applies to human cells and tissues via CBER; lack of FDA approval does not itself imply coverage eligibility

ADRCs (adipose-derived regenerative cells)

TermADRCs (adipose-derived regenerative cells)

DefinitionCells derived from autologous adipose tissue used for injection (eg, into fingers for systemic sclerosis); feasibility and tolerability have been demonstrated but efficacy is not definitively established.

Clinical evidenceSTAR randomized trial and open-label series report tolerability and some outcome improvements but not definitive statistical superiority across full cohorts