RetiredUnitedHealthcarePolicy CS176LA.E

Autologous Cellular Therapy (for Louisiana Only)

This policy governs the medical necessity and coverage stance for autologous cellular therapies (including adipose‑ and bone marrow‑derived products) for members in Louisiana and applies to providers submitting claims to UnitedHealthcare Community Plan in that state.

Policy Summary

PayerUnitedHealthcare

PolicyAutologous Cellular Therapy (for Louisiana Only)

Policy CodePolicy CS176LA.E

Change TypeRetired / Coding update

Effective DateFeb 1, 2026

Next Review Date

Key ActionSubmit prior authorization with appropriate clinical documentation when requesting coverage for autologous cellular therapies; listing of codes does not guarantee coverage.

SourceLink

POLICY UPDATE CHANGES

Policy retired effective April 1, 2026.

Application limited to the state of Louisiana.

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

Applicable CPT codes were updated to reflect annual edits and new temporary codes 0999T, 1000T, and 1001T were added.

Policy was retired for the Louisiana plan membership on April 1, 2026.

State-specificapplies to

All indicationscoverage stance

~20procedure codes listed

Multiple RCTs

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.

Coverage Criteria and Evidence Summary

Not medically necessary — all indications

Covered when ALL of the following are met

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

Policy conclusion based on available evidence including preliminary studies, case series, and limited RCTs; high‑quality long‑term RCTs are needed.

Evidence summaries by indication

Summary of evidence-based findings that drive coverage stance

Knee osteoarthritis evidence summary: Randomized trials and systematic reviews of intra-articular cell injections (MSC, SVF, MFAT) report heterogeneous results: imaging/cartilage structural improvements are frequently observed but clinical pain and function benefits are inconsistent versus placebo and often do not exceed minimum clinically important differences (MCIDs); comparisons with hyaluronic acid show mixed results. Small sample sizes, methodological heterogeneity, and risk of bias limit definitive conclusions.evidence inconsistent and low-to-moderate quality

Supports: chunks 18-24

Peripheral arterial disease / chronic limb-threat (PAD/CLI) evidence summary: Systematic reviews and pooled RCT data report potential improvements in ulcer healing, ABI, TcPO2, pain-free walking distance, and reduced overall amputation rates with autologous cell therapies in some trials; however, most studies have high risk of bias and overall evidence quality is low and heterogeneous, requiring larger high-quality RCTs.low-quality evidence

Supports: chunk 29

Musculoskeletal soft tissue (tendon/rotator cuff) evidence summary: Small RCTs and cohort studies of bone marrow concentrate and other cell products for tendon disorders and rotator cuff tears show some improved imaging and PROMs in controlled trials, but existing studies are small with moderate-to-high risk of bias and lack standardized cell preparations and protocols; evidence is insufficient to make routine clinical recommendations.insufficient high-quality evidence

Supports: chunks 31,35

Scleroderma (systemic sclerosis) evidence summary: Case series and one randomized double-blind placebo-controlled trial (STAR) demonstrate feasibility, tolerability, and some subgroup improvements (notably in diffuse cutaneous SSc) with ADRC therapy, but primary endpoints were not statistically significant for the full cohort; overall evidence is limited and promising but not definitive.promising but not definitive

Supports: chunks 36-39

General medical necessity / investigational stance

Coverage stance is based on available evidence and guideline positions

Evidence and guideline summary: Autologous adipose-derived and mesenchymal cell therapies are investigational or unproven for multiple indications due to limited, low-quality, and heterogeneous evidence; professional society guidance (AAOS) and evidence-based guidelines (VA/DoD) do not recommend stem cell injections for glenohumeral, hip, or knee osteoarthritis, and cardiovascular society guidance notes lack of indication for some limb-threatening ischemia scenarios. Trials demonstrate feasibility and some subgroup signals (e.g., dcSSc) but overall lack consistent statistical significance across primary endpoints.

Supports: chunks 36,37,40,42

The policy includes a list of applicable procedure codes for autologous cellular therapies. Several Category III/CPT entries in that list are annotated with an asterisk (*) in the source, indicating they are not on the State of Louisiana Medicaid Fee Schedule and therefore are not covered by the State of Louisiana Medicaid Program. Examples of asterisked codes in the document include 0263T, 0264T, 0265T, 0489T, 0490T, 0565T, 0566T, 0717T, and 0718T. Providers should note that inclusion of a code in the list is for reference only and does not guarantee coverage under the Louisiana plan if the code is not on the state fee schedule.

Use of stem cell injections for tendon disorders and other musculoskeletal indications is restricted in this policy because the published studies are heterogeneous, small, and at moderate-to-high risk of bias. A systematic review of tendon disorders found only low-level evidence (Level 3) with trials prone to bias and concluded that evidence-based recommendations for clinical practice cannot be made at this time and that stem cell injections should not be used in routine clinical practice given the lack of knowledge about potentially serious adverse effects. Similarly, assessments of autologous microfragmented adipose tissue (MFAT) for knee osteoarthritis note very low-quality evidence and a lack of direct comparative trials, supporting restriction of these procedures until higher-quality standardized data are available.

Professional society guidance relevant to peripheral arterial disease indicates that angiogenic gene and stem cell therapies remain investigational. The European Society of Cardiology guideline on peripheral arterial disease states that these approaches have insufficient evidence and specifically recommends that stem cell/gene therapy is not indicated for individuals with chronic limb‑threatening ischemia.

Based on the current evidence base, the policy concludes that Autologous Cellular Therapy is unproven and not medically necessary for all indications. This determination reflects insufficient high-quality, consistent data demonstrating clinical efficacy across indications and supports a noncoverage/investigational stance pending robust randomized comparative trials with standardized products and outcomes.

Randomized trials and systematic reviews of intra-articular mesenchymal stromal cell (MSC) injections and adipose-derived products for knee osteoarthritis report heterogeneous results. A pooled analysis of 13 RCTs found no significant difference versus placebo for pain and function measures and that observed treatment effects often did not exceed the minimum clinically important difference (MCID). Health-technology assessments and updated reviews of microfragmented adipose tissue (MFAT) likewise characterize the evidence as very low quality with a lack of direct comparative trials. Taken together, these findings indicate inconsistent clinical benefit for intra-articular MSC/ADRC/MFAT injections for knee osteoarthritis and do not support routine coverage.

Evidence for autologous adipose-derived regenerative cell therapies and expanded human mesenchymal stem/stromal cell (hMSC) products in systemic sclerosis (scleroderma) is limited and low quality. Published reports are dominated by case series without comparison groups and small studies; systematic reviews conclude that current data are insufficient to reach definitive conclusions about safety or efficacy. Although some case series and a small number of trials report subgroup improvements, overall the evidence is inadequate to support routine clinical use, and these uses are considered investigational/not medically necessary until larger randomized studies are available.

Applicable Procedure Codes and Related Notes

Applicable CPT/Category III codes (selected)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.

Additional Category III codesCPT

0999T	Autologous muscle cell therapy, harvesting of muscle progenitor cells, including ultrasound guidance, when performed.
1000T	Autologous muscle cell therapy, administration of muscle progenitor cells into the urethral sphincter, including cystoscopy and post-void residual ultrasound, when performed.
1001T	Autologous muscle cell therapy, injection of muscle progenitor cells into the external anal sphincter, including ultrasound guidance, when performed.

Codes referenced (not specified in this part)mixed

exact code

exact description from document

Updated Applicable CPT / Temporary CodesCPT

0999T	Temporary CPT code added per annual edits
1000T	Temporary CPT code added per annual edits
1001T	Temporary CPT code added per annual edits

Follow-up PROM timepoints

Primary recommended PROM follow-up intervals6 months, 12 months, and 48 weeks (reported in randomized trials and prospective studies for KOA and musculoskeletal indications)

Short-term assessment timepoint3 months (used as primary PROM comparison in some BMC vs exercise trials)

Additional follow-up reported2-year follow-up reported in some crossover/longitudinal orthobiologic studies for sustained effects

Number of lipotransfer procedures (facial SSc)

Mean number of proceduresMean 2.5 lipotransfer procedures

Range of procedures per patient

Prior Authorization, Documentation, and Billing Guidance

Billing Rule

Applicable codes and coverage implication

The following procedure and diagnosis codes are provided for reference only and do not guarantee coverage or reimbursement. Inclusion of a code in this policy does not imply that the service described is a covered benefit under applicable member contracts.

Codes are provided for billing reference; verify member benefits and state-specific coverage (e.g., Louisiana Medicaid exclusions).
Codes labeled with an asterisk (*) are not on the State of Louisiana Medicaid Fee Schedule and therefore are not covered by the State of Louisiana Medicaid Program.

Prior Authorization

Prior authorization recommended

Prior authorization is recommended for autologous cellular therapy procedures. Providers should submit the applicable CPT/HCPCS codes listed in this policy when requesting prior authorization to allow medical review of clinical justification and required documentation.

Background and Context

Autologous cellular therapies use a patient’s own cells (for example, cells derived from bone marrow, adipose tissue, or muscle) that are harvested, processed, and reintroduced to attempt tissue repair or regeneration. The literature includes animal studies, case series, and some randomized trials, but the overall evidence is early-stage, heterogeneous in cell types and processing methods, and limited in size and duration. Because of these methodological limitations and inconsistent clinical outcomes, the policy treats these interventions as investigational for routine clinical use.

Definitions and Terminology

Adipose‑Derived Stem Cells (ASCs)

DefinitionMesenchymal adult cells isolated from adipose tissue capable of in vitro expansion and differentiation

Primary source/referenceSi et al., 2019 (as cited in policy definitions)

Common uses describedInvestigational applications include intra‑articular injections and facial/hand grafting in SSc studies

Autologous Adipose‑Derived Regenerative Cellular Therapy

DefinitionTherapy using adult stem cells extracted from a person’s fat tissue and reinjected into targeted lesions of the same individual; may include processing prior to reinjection

Example applicationADRC therapy (Celution‑processed) used in scleroderma hand dysfunction and evaluated in STAR trial

Policy Revision History

2026-04-01retiredLatest

Policy retired for Louisiana plan membership; members disenrolled effective April 1, 2026.

2026-02-01coding_update

Applicable CPT codes updated to reflect annual edits and temporary codes 0999T, 1000T, and 1001T were added.

2026-02-01effective_date

Policy Summary

PayerUnitedHealthcare

PolicyAutologous Cellular Therapy (for Louisiana Only)

Policy CodePolicy CS176LA.E

Change TypeRetired / Coding update

Effective DateFeb 1, 2026

Next Review Date

Key ActionSubmit prior authorization with appropriate clinical documentation when requesting coverage for autologous cellular therapies; listing of codes does not guarantee coverage.

SourceLink

On This Page

Range 1–14 procedures

Typical inter-procedure intervalAverage interval between procedures ~5.3 months (median 6 months; range ~3–6.9 months)

Submit updated CPT codes 0999T, 1000T, and 1001T (added 02/01/2026) when applicable.
Include all relevant procedure codes from the policy (e.g., 0263T, 0264T, 0265T, 0489T, 0490T, 0565T, 0566T, 0717T, 0718T, 0999T–1001T).

Prior Authorization

Conservative therapy prerequisite

Conservative therapy must be attempted and documented prior to consideration of autologous cellular therapies for musculoskeletal conditions (e.g., knee osteoarthritis, tendon disorders). Documentation should demonstrate failure or inadequate response to standard nonoperative care.

Examples of conservative therapy: physical therapy, activity modification, weight management, NSAIDs/analgesics, intra-articular corticosteroid or hyaluronic acid injections when indicated, and structured exercise programs.
Document duration and objective measures of inadequate response (e.g., persistent pain scores, functional limitation) prior to authorization request.

Documentation Required

Low-quality or heterogeneous evidence — provider implication

The evidence base for many autologous cellular therapies is heterogeneous and of low to very low quality for several indications (e.g., knee osteoarthritis, rotator cuff, tendon disorders, MFAT). This uncertainty may affect medical necessity determinations and lead to denial when robust comparative evidence is lacking.

Low-quality, inconsistent, or small early-phase studies limit conclusions about efficacy and long-term outcomes.
Providers should be prepared for increased scrutiny of clinical rationale when evidence is inconsistent or derived primarily from observational studies or small RCTs.

Billing Rule

Coding and documentation note (codes for reference only)

Coding and documentation note: the list of codes in this policy is for reference only. Providers must submit the current CPT codes on claims and prior authorization forms and include supporting clinical documentation. Failure to submit updated or complete coding may delay review or result in claim denial.

Use the updated CPT codes effective 02/01/2026 when submitting requests or claims (0999T, 1000T, 1001T added).
Include code descriptions, laterality, and any relevant modifiers or ancillary procedure codes (e.g., ultrasound guidance) on submissions.

Documentation Required

Required clinical documentation for review

Required clinical documentation must be submitted with prior authorization requests to support medical necessity. Incomplete documentation may result in denial or delay.

Relevant clinical notes describing diagnosis, symptom duration, and prior conservative treatments tried and failed.
Objective assessments such as imaging (MRI, ultrasound) reports, physical exam findings, and validated patient-reported outcome measures (e.g., WOMAC, DASH, CHFS) with baseline scores.
Documentation of device or processing system used (if applicable) and detailed procedural plan including harvest site, cell processing, and injection site(s).

Documentation Required

Clinical baseline and outcomes documentation

Provide baseline and follow-up outcome documentation to demonstrate clinical response. Prior authorization and post-procedure medical review may request objective outcome data.

Baseline pain and function scores (e.g., VAS, WOMAC, DASH, CHFS) and the dates collected.
Follow-up outcome measures at defined intervals (e.g., 3, 6, 12 months) showing changes from baseline and any adverse events or complications.
Procedure-specific baseline findings (e.g., tendon tear size, cartilage defect characterization) and post-procedure imaging or functional assessments when available.

Processing noteMay include enzymatic dissociation, isolation, concentration, and preparation steps prior to injection

Autologous Cellular Therapy

DefinitionTherapeutic intervention using an individual’s stem cells cultured and/or expanded outside the body and reintroduced into the donor

ScopeEncompasses adipose‑ and bone marrow‑derived cellular products and expanded hMSCs as described in policy

Evidence stanceConsidered investigational/not medically necessary for all indications in this policy due to insufficient evidence

Bone Marrow Mononuclear Stem Cells

DefinitionA mixed population of blood cells including stem and progenitor cells explored for cardiac and vascular repair

Typical preparationOften concentrated as bone marrow concentrate (BMC) and sometimes combined with platelet products in orthobiologic studies

Clinical contextEvaluated in RCTs for musculoskeletal injuries (e.g., supraspinatus tears) with PROMs assessed at short- and mid-term follow-up

Regenerative Medicine

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

Included modalitiesTherapeutic stem cells, tissue engineering, and production of artificial organs as noted in policy definitions

Clinical implicationMany regenerative approaches remain investigational pending higher‑quality trials

SVF (stromal vascular fraction)

DefinitionStromal vascular fraction (SVF) obtained via liposuction and processed into a cellular implant for intra‑articular injection

Clinical trial exampleMultisite randomized trial (Garza et al., 2020) used SVF injected during same visit with WOMAC outcomes at 6 and 12 months

Evidence qualityResults show symptomatic improvement in some trials but heterogeneity and variable imaging outcomes limit conclusions

MFAT (microfragmented adipose tissue)

DefinitionMicrofragmented adipose tissue (MFAT), e.g., Lipogems system — an adipose‑derived cell product used for injection into osteoarthritic joints

Evidence summaryHayes assessment (2022) found overall quality of evidence for MFAT in KOA to be very low with lack of direct comparative trials

Device noteLipogems was the primary system studied in the reviewed observational reports

ADRC (adipose-derived regenerative cells)

DefinitionAdipose‑derived regenerative cells processed (e.g., Celution) and injected locally for scleroderma‑related hand dysfunction

Clinical trial exampleSTAR randomized double‑blind trial evaluated ADRC injections in SSc hand dysfunction (Khanna et al., 2023)

Evidence limitationsFeasibility and tolerability demonstrated but primary endpoints were not statistically significant for full cohort; subgroup signals noted

BMC (bone marrow concentrate)

DefinitionBone marrow concentrate (BMC) — an autologous orthobiologic containing marrow‑derived cells often combined with platelet products

Clinical useEvaluated in RCTs for musculoskeletal applications such as supraspinatus tears with PROM improvements reported in some trials

Preparation noteBMC typically involves harvest, concentration, and targeted injection under imaging guidance

ADRC/ADSVF — heterogeneous adipose-derived preparations

DefinitionHeterogeneous adipose‑derived preparations (ADRC/ADSVF) — mixed cell populations derived from autologous fat used for local injection

Evidence examplesIncluded in case series and small trials for SSc and KOA; open‑label follow‑ups report symptomatic improvements but lack controls

Processing heterogeneityMethods vary (enzymatic dissociation, mechanical processing, device‑specific protocols) contributing to low comparability across studies

Human mesenchymal stem/stromal cells (hMSC)

DefinitionHuman mesenchymal stem/stromal cells (hMSC) — expanded cell products derived from various sources reported in systemic sclerosis studies

Evidence summarySystematic review (Escobar‑Soto et al., 2021) included 11 articles (case series/case reports) totaling 101 individuals; concluded data are insufficient for definite conclusions

Clinical noteExpanded hMSCs were used in a subset of reported SSc patients; further RCTs with robust designs are needed

Policy effective date established as February 1, 2026 for the Louisiana-only policy period (Feb 1, 2026 – Mar 31, 2026).

coverage_stance_clarified

Coverage rationale states autologous cellular therapy is unproven and not medically necessary for all indications due to insufficient evidence of efficacy.