ModifiedUnitedHealthcarePolicy CS176ID.C

Autologous Cellular Therapy (for Idaho Only)

Defines UnitedHealthcare's medical policy for autologous cellular therapy as applied to the state of Idaho (including Idaho Medicaid Plus), specifying coverage stance and applicable procedure codes and clinical evidence considerations.

Policy Summary

PayerUnitedHealthcare

PolicyAutologous Cellular Therapy (for Idaho Only)

Policy CodePolicy CS176ID.C

Change TypeAdded Category III CPT codesreference and references updated

Effective DateJun 1, 2026

Next Review Date

Key ActionVerify state-specific prior authorization and coverage requirements before submitting claims, because new CPT codes were added and some listed codes are not on the Idaho Medicaid Fee Schedule.

SourceLink

POLICY UPDATE CHANGES

Added CPT codes 0999T, 1000T, and 1001T to the policy's applicable codes.

Updated References section to reflect the most current information.

Idaho-onlyState application

Not medically necessaryCoverage stance summary

12IDs of CPT codes not on Idaho fee schedule

13 RCTsRCTs in KOA MSC reviews

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~13-20Document evidence chunks (partial)

Coverage Criteria and Rationale

General — Not medically necessary

Coverage Rationale

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

Applies statewide to Idaho plans covered by this policy.

Evidence-based coverage implications

Evidence synthesis conclusions and implications for coverage decisions

KOA - MSCs: Systematic reviews and meta-analyses report heterogeneous results: early-phase RCTs and cohort series often show structural/cartilage benefits on imaging (Gong et al. 2021) but pooled RCT data found no consistent clinically significant improvement in pain or function versus placebo and effects frequently did not exceed MCID; comparisons with hyaluronic acid show mixed superiority in some analyses but overall evidence is limited by heterogeneity, small sample sizes, and methodological limitations.

References: Gong et al. 2021; Dai et al. 2021; Prodromos et al. 2020.

KOA - SVF/MFAT: Some single RCT evidence (Garza et al. 2020) reported statistically and dose-dependent WOMAC improvements through 12 months with intra-articular SVF versus placebo, but trial limitations (unblinding after 6 months, attrition) and subsequent technology assessments (Hayes, ECRI) rate the overall quality as very low to inconsistent and call for larger, rigorous RCTs before routine clinical use.

References: Garza et al. 2020; Hayes assessments.

Peripheral arterial disease (PAD): Systematic reviews and meta-analyses of autologous cell therapy for PAD report improvements in surrogate and clinical endpoints (ABI, TcPO2, ulcer healing, reduced amputation rates in some analyses), but the body of evidence is low quality and heterogeneous with high risk of bias; higher-quality randomized trials are needed to confirm clinical benefit.

References: Gao et al. 2019; Rigato et al. 2017.

Tendon/ligament and musculoskeletal repair: Available RCTs and systematic reviews report mixed results with some trials showing improved patient-reported outcomes and tendon healing, but the trials have moderate-to-high risk of bias and overall evidence is insufficient to support routine clinical use; reviewers recommend further RCTs and caution against routine use due to unknown long-term safety.

References: van den Boom et al. 2020; Kon et al. 2021.

General coverage conclusion

Coverage stance and clinical summary based on available evidence and guideline statements:

Coverage summary: The clinical evidence is insufficient and of low-to-moderate quality for many applications of cellular therapies (MSCs, ADRCs, SVF) in musculoskeletal conditions and systemic sclerosis; professional society guidance and published guidelines generally do not recommend routine use; therefore coverage is limited and contingent on plan-specific, state, or contractual terms.

Drawn from multiple systematic reviews, RCTs, technology assessments, and guideline statements.

The policy lists multiple Category III CPT codes for reference (e.g., 0263T, 0264T, 0265T, 0489T, 0490T, 0565T, 0566T, 0717T, 0718T, 0999T, 1000T, 1001T). Codes marked with an asterisk are noted as not on the State of Idaho Medicaid Fee Schedule and therefore may not be covered by the State of Idaho Medicaid Program. Providers should verify Idaho Medicaid coverage and consult the Idaho Medicaid Provider Handbook for information on non-covered and excluded services before billing these codes.

Multiple technology assessments and systematic reviews identify substantial limitations in the evidence for microfragmented adipose tissue (MFAT), stromal vascular fraction (SVF), and many stem cell injections. Hayes characterized the overall body of evidence for MFAT as very low quality with a primary limitation being the lack of direct comparative trials. ECRI and trial authors similarly note heterogeneity in cell source, processing, dose, and number of injections, and call for larger, standardized randomized controlled trials to establish comparative effectiveness.

Professional society guidance does not endorse routine clinical use of stem cell injections for several musculoskeletal indications. The AAOS indicates injectable biologics such as stem cells cannot be recommended for glenohumeral osteoarthritis without better standardization and higher-quality evidence. The VA/DoD guideline does not recommend stem cell injections for hip or knee osteoarthritis. The ESC guideline advises that stem cell/gene therapy is not indicated for chronic limb-threatening ischemia due to insufficient evidence.

UnitedHealthcare considers Autologous Cellular Therapy (ACT) unproven and not medically necessary for all indications covered by this policy owing to insufficient evidence of efficacy. Claims for ACT services may be denied on this basis unless plan-specific, state, or contractual terms provide otherwise.

Pooled analyses of randomized trials for mesenchymal stem cell (MSC) injections in knee osteoarthritis have not demonstrated consistent, clinically meaningful improvement versus placebo. A 13‑RCT meta-analysis found no significant differences versus placebo for pain or function and reported treatment effects that did not exceed the minimum clinically important difference (MCID). Individual trials and assessments report mixed or modest benefits versus comparators such as hyaluronic acid, but heterogeneity and low-quality evidence limit confidence in routine clinical benefit.

Systematic review evidence for tendon disorders concludes available trials are at moderate-to-high risk of bias and provide at best low‑level evidence. The authors state that evidence-based recommendations cannot be made at this time and explicitly conclude that stem cell injections should not be used in clinical practice for tendon disorders given limited efficacy data and uncertainty about potentially serious adverse effects.

A systematic review of biologic agents to enhance ACL repair highlights the limited and heterogeneous literature (31 studies) and concludes that current evidence is lacking sound data to support use of biologic agents, including stem cell therapies, to improve ACL surgery outcomes.

Applicable Procedure and Billing Codes

Applicable CPT / Category III Codes (reference)CPT

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

Provider fee schedule notemixed

*	Codes labeled with an asterisk are not on the State of Idaho Medicaid Fee Schedule and therefore may not be covered by the State of Idaho Medicaid Program.

No explicit CPT/HCPCS/ICD-10 codes in this document segmentmixed

No codes listed

Applicable/State-fee-schedule-noted CPT CodesCPT

0999T	CPT code added to policy (unspecified in-text description)
1000T	CPT code added to policy (unspecified in-text description)
1001T	CPT code added to policy (unspecified in-text description)
0263T	CPT code noted as not on Idaho Medicaid Fee Schedule
0264T	CPT code noted as not on Idaho Medicaid Fee Schedule
0265T	CPT code noted as not on Idaho Medicaid Fee Schedule
0489T	CPT code noted as not on Idaho Medicaid Fee Schedule
0490T	CPT code noted as not on Idaho Medicaid Fee Schedule
0565T	CPT code noted as not on Idaho Medicaid Fee Schedule
0566T	CPT code noted as not on Idaho Medicaid Fee Schedule

1–10 of 12

1/2

Provider Actions, Authorization, and Documentation

Billing Rule

Applicable procedure codes — reference

Applicable procedure and diagnosis codes are provided for reference only. Inclusion of a code does not imply coverage or reimbursement. Benefit determination is governed by federal, state, or contractual requirements and applicable laws. Codes labeled with an asterisk (*) are not on the State of Idaho Medicaid Fee Schedule and therefore may not be covered by the State of Idaho Medicaid Program; for details see the Idaho Medicaid Provider Handbook: Non-Covered and Excluded Services.

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

Background

Autologous Cellular Therapy (ACT) uses an individual's own stem or regenerative cells (for example, adipose-derived or bone marrow–derived cells) that are harvested, processed, and reintroduced to treat conditions such as osteoarthritis, tendon injuries, peripheral arterial disease, and systemic sclerosis. The evidence base is early-stage and heterogeneous—comprising small RCTs, nonrandomized studies, and case series—with inconsistent clinical benefit across indications, which underlies the policy conclusion that ACT remains unproven for routine clinical use.

Definitions and Terminology

Adipose-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 (ASCs).

Common uses (investigational)Investigational intra-articular or soft-tissue injections for musculoskeletal conditions such as knee osteoarthritis and facial soft-tissue reconstruction in scleroderma.

Evidence summaryEarly-phase studies report structural/cartilage benefits on imaging in many small trials, but clinical benefit and long-term outcomes remain uncertain due to heterogeneity and methodological limitations.

Regulatory noteASC-based interventions may be subject to FDA regulation for human cells and tissues intended for implantation, transplantation, or infusion.

Autologous Adipose-Derived Regenerative Cellular Therapy

Typical processing

Policy Summary

PayerUnitedHealthcare

PolicyAutologous Cellular Therapy (for Idaho Only)

Policy CodePolicy CS176ID.C

Change TypeAdded Category III CPT codesreference and references updated

Effective DateJun 1, 2026

Next Review Date

SourceLink

On This Page

Prior Authorization

High-quality evidence required for approval

Prior authorization should require high-quality evidence demonstrating efficacy and safety. Approval decisions should be supported by randomized controlled trials or other high-quality comparative studies showing clinically meaningful improvements in prespecified outcomes relative to controls.

Prior Authorization

Verify prior authorization and state coverage

Verify that prior authorization has been obtained when required and confirm coverage under the member's specific benefit plan. In case of a conflict between this policy and federal, state, or contractual requirements, the federal/state/contractual requirements govern. UnitedHealthcare may use external criteria (e.g., InterQual) to assist in administering benefits.

Confirm prior authorization before service.
Review member contract and any applicable state mandates.

Denial Risk

State fee-schedule noncoverage may trigger denial

Some CPT codes listed in this policy are not included on the State of Idaho Medicaid Fee Schedule and therefore may not be covered by Idaho Medicaid. Presence of such a code in this policy may trigger denial for state-covered members; refer to the Idaho Medicaid Provider Handbook for non-covered and excluded services.

CPT codes not on Idaho Medicaid Fee Schedule: 0263T, 0264T, 0265T, 0489T, 0490T, 0565T, 0566T, 0717T, 0718T, 0999T, 1000T, 1001T

Billing Rule

Coding and benefit determination note

Listing of procedure and diagnosis codes in this policy does not guarantee coverage. Benefit coverage and coding determinations are made according to the member's plan, contract language, and applicable federal or state requirements.

Code listing is informational only — benefit and coding determinations are contractual.

Documentation Required

Required clinical outcome documentation

For any approved use, document high-quality clinical outcomes in the medical record. Required documentation includes randomized controlled trial reports or comparable evidence cited in the request (when applicable), patient-reported outcome measures (e.g., WOMAC, DASH, SANE, VAS), objective functional measures, and relevant imaging (e.g., MRI) pre- and post-treatment to demonstrate clinical benefit and any tissue healing or structural change.

Include copies/summaries of RCT evidence submitted for review.
Record baseline and follow-up PROMs (WOMAC, DASH, SANE, VAS) and objective findings.
Provide pre- and post-treatment imaging when available.

Note

Coverage decision guidance

Coverage determinations should follow federal, state, or contractual benefit requirements. In the absence of sufficient high-quality evidence demonstrating clinically meaningful benefit, services are considered unproven and not medically necessary and may be denied.

If evidence is insufficient or heterogeneous (lack of direct comparative RCTs, inconsistent results), denial may be appropriate.
Follow governing federal/state/contractual rules in case of conflict.

May involve same-visit processing (e.g., SVF) or mechanical/enzymatic processing to create microfragmented adipose tissue or cell concentrates (MFAT, ADRC).

Clinical evidenceSome RCTs (e.g., Garza et al. 2020) reported dose-dependent WOMAC improvements with same-visit SVF through 12 months, but health-technology assessments (Hayes) rate MFAT evidence as very low and note lack of direct comparative trials.

UncertaintiesHeterogeneity in processing methods, cell doses, and limited long-term outcomes limit conclusions about efficacy and safety.

Autologous Cellular Therapy

ScopeEncompasses autologous MSC preparations and other cell-based products derived from the patient for regenerative purposes.

Coverage stanceUnitedHealthcare considers autologous cellular therapy unproven and not medically necessary for all indications due to insufficient evidence of efficacy.

Regulatory contextSome concentrated autologous MSC preparations may not require FDA approval but remain subject to FDA regulation for human cells and tissues intended for implantation, transplantation, or infusion.

Bone Marrow Mononuclear Stem Cells

DefinitionA mixed population of blood cells, including stem and progenitor cells, obtained from bone marrow aspirate and explored for cardiac, vascular, and musculoskeletal repair.

ProcessingPercutaneous aspiration of autologous bone marrow followed by processing to concentrate mononuclear/cellular components (BMC).

Clinical evidenceRecent RCTs (e.g., Centeno et al. 2024) suggest improved patient-reported outcomes and imaging evidence of healing in some musculoskeletal applications, but study limitations and heterogeneity persist.

Common combinationsOften combined with platelet-rich products (PRP/PL) in clinical studies, complicating attribution of effect to BMC alone.

Regenerative Medicine

DefinitionBranch of medicine focused on regrowing, repairing, or replacing damaged or diseased cells, tissues, or organs using therapeutic stem cells, tissue engineering, and related technologies.

IncludesTherapeutic stem cells (autologous and allogeneic), cell products (e.g., SVF, BMC, MSC concentrates), tissue engineering, and artificial organ approaches.

Regulatory noteFDA regulates human cells and tissues intended for implantation, transplantation, or infusion through CBER; not all autologous MSC preparations require premarket FDA approval.

SVF (stromal vascular fraction)

DefinitionCellular fraction derived from adipose tissue obtained via liposuction and processed to create a heterogeneous cell mixture (SVF) for same-visit intra-articular or soft-tissue injection.

Clinical trial exampleGarza et al. (2020) used liposuction-derived SVF injected the same day and reported dose-dependent WOMAC improvements through 12 months versus placebo.

Evidence limitationsHealth technology assessments and systematic reviews note very low or inconsistent quality evidence for MFAT/SVF and call for larger, rigorous RCTs; imaging benefits may not align with clinical outcomes.

BMC (bone marrow concentrate)

DefinitionPercutaneously aspirated autologous bone marrow processed to concentrate mononuclear/cellular components for injection (BMC).

Typical useUsed in orthobiologic approaches for tendon, rotator cuff, and other musculoskeletal injuries; frequently paired with platelet products in studies.

Evidence noteRandomized trials report improved PROMs and imaging evidence of healing in some studies, but heterogeneity in protocols and combination therapies limits definitive conclusions.

MFAT (microfragmented adipose tissue)

DefinitionAutologous adipose tissue mechanically processed into a microfragmented product (e.g., Lipogems) used for intra-articular injection.

Evidence summaryHayes assessment (2022) found the overall quality of evidence for MFAT in knee OA to be very low, noting a lack of direct comparative trials and small observational studies.

Clinical roleUsed investigationally for knee osteoarthritis and other joint pathologies; comparative effectiveness versus alternatives remains uncertain.

Concentrated autologous mesenchymal stem cells (MSCs)

Regulatory contextConcentrated autologous MSCs do not always require FDA premarket approval but remain subject to FDA regulation for human cells and tissues intended for implantation, transplantation, or infusion.

Evidence characteristicsClinical studies of concentrated autologous MSCs are heterogeneous in source, processing, and dosing, limiting pooled conclusions about efficacy and safety.

ADRCs/SVF for systemic sclerosis and musculoskeletal disorders

DefinitionCell populations derived from adipose tissue (ADRCs/SVF) used experimentally for systemic sclerosis (scleroderma) and various musculoskeletal disorders.

Clinical trial evidenceThe STAR randomized trial (Khanna et al. 2023) enrolled 88 participants and showed feasibility and tolerability of ADRC finger injections but did not meet primary statistical significance for the full cohort; subgroup and some secondary endpoints suggested potential benefit.

Evidence limitationsOverall evidence for ADRCs/SVF in systemic sclerosis is limited (case series, small RCTs), with low-quality data and need for larger randomized comparative trials.