CurrentUnitedHealthcarePolicy CS176LA.E

Autologous Cellular Therapy (for Louisiana Only)

UnitedHealthcare Community Plan medical policy (Louisiana only) defining coverage stance and evidence summary for autologous cellular therapies (including adipose-derived, bone marrow–derived, muscle progenitor therapies) across indications such as knee osteoarthritis, peripheral arterial disease, musculoskeletal repair, and others. Includes definitions, applicable CPT/T proprietary codes, and clinical evidence synthesis.

Policy Summary

PayerUnitedHealthcare

PolicyAutologous Cellular Therapy (for Louisiana Only)

Policy CodePolicy CS176LA.E

Change TypeCPT code updates; archival of prior version

Effective DateFeb 1, 2026

Next Review Date

Key ActionWhen billing or documenting services in Louisiana, follow state-specific coverage determinations and the LA Medicaid fee schedule and report applicable CPT/temporary codes (including newly added 0999T, 1000T, 1001T) per payer guidance.

POLICY UPDATE CHANGES

Updated list of applicable CPT codes to reflect annual edits; added 0999T, 1000T, and 1001T.

Archived previous policy version CS176LA.D.

1Policy stance

12Procedure codes listed

MultipleIndications evaluated

Low–moderateOverall quality of evidence

InsufficientEvidence to support routine coverage

3New temporary CPT codes added

Coverage Summary

UnitedHealthcare Community Plan medical policy CS176LA.E applies only to the state of Louisiana and addresses autologous cellular therapies (ACT) including adipose-derived, bone marrow–derived, and muscle progenitor cell therapies. The policy reviews use of these therapies across several indications including knee osteoarthritis, peripheral arterial disease/critical limb ischemia, musculoskeletal repair (rotator cuff, ACL), tendon disorders, and scleroderma and lists applicable CPT and temporary codes for reference.

The high-level coverage stance is that Autologous Cellular Therapy is unproven and not medically necessary for routine use across evaluated indications due to insufficient evidence of efficacy; state-specific applicability and code-level guidance (including LA Medicaid fee schedule exclusions) are provided in the policy.

Policy key values

Policy stanceNot covered / Insufficient evidence (Autologous Cellular Therapy is unproven and not medically necessary for all indications)

Evidence qualityLow–moderate (overall low to very low certainty; heterogeneous studies with methodological limitations)

Procedure codes listed0263T, 0264T, 0265T, 0489T, 0490T, 0565T, 0566T, 0717T, 0718T, 0999T, 1000T, 1001T

New temporary CPT codes added0999T, 1000T, 1001T

Effective dateFebruary 1, 2026

Medical Necessity & Coverage Rationale

Coverage Rationale / Medical Necessity

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

General evidence-based coverage assessment

Coverage determinations are based on available peer-reviewed evidence and guideline statements; conclusions vary by indication but generally indicate insufficient evidence for routine coverage.

PAD/CLI evidence summary: For peripheral arterial disease / critical limb ischemia: systematic reviews/meta-analyses and RCTs show some improvements (reduced amputation risk, improved wound healing, improved hemodynamics) but evidence is limited by small trials, heterogeneity, and low-to-very-low certainty; high-quality RCTs are needed.

Musculoskeletal regeneration/repair: For regeneration/repair of musculoskeletal tissue (tendons, ligaments, rotator cuff, ACL): evidence is limited, mixed, or low quality; some RCTs and case series report improvements but lack of standardization and trial heterogeneity prevent firm conclusions and further RCTs are needed.

Not Covered / Experimental Therapies

Autologous cellular therapies (including adipose-, bone marrow-, and muscle-derived cell treatments) are considered unproven and not medically necessary / not covered for routine use for the indications evaluated in this Louisiana-only policy because of insufficient and low-certainty evidence.

The policy includes a list of applicable CPT codes for reference; codes marked with an asterisk (*) are not on the Louisiana Medicaid Fee Schedule and therefore are not covered by LA Medicaid (see listed procedure codes and policy history for added temporary codes 0999T, 1000T, 1001T).

Applicable CPT / Temporary Codes

Listed procedure codes (reference only)CPTNot Covered

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

Applicable CPT / Temporary Codes (updated)CPT

0999T	Category III temporary code (added per policy history)
1000T	Category III temporary code (added per policy history)
1001T	Category III temporary code (added per policy history)

Provider Actions & Billing Guidance

Documentation Required

State-specific applicability

Affected CPT codes: 0263T, 0264T, 0265T, 0489T, 0490T, 0565T, 0566T, 0717T, 0718T, 0999T, 1000T, 1001T. Note: codes marked with an asterisk in the policy are not on the Louisiana Medicaid Fee Schedule and are therefore not covered by LA Medicaid. This policy applies only to the state of Louisiana.

Listed procedure codes: 0263T, 0264T, 0265T, 0489T, 0490T, 0565T, 0566T, 0717T, 0718T, 0999T, 1000T, 1001T
Codes with an asterisk (*) are not on the LA Medicaid Fee Schedule and therefore not covered by LA Medicaid

Documentation Required

Reference contractual and regulatory coverage terms

When applying this policy, reference and follow federal, state, or contractual requirements for benefit plan coverage, as they may differ from this standard policy. In the event of a conflict, federal/state/contractual requirements govern.

Background & Evidence Summary

Autologous Cellular Therapy (ACT) encompasses treatments that use a patient’s own stem or progenitor cells (for example, adipose-derived cells, bone marrow–derived cells, or muscle progenitor cells) for regenerative or reparative purposes. Techniques include harvesting, isolation or concentration, and re‑administration of cells to targeted tissues (e.g., intra-articular, intramuscular, or intratendinous injections) and may involve adjunctive biomaterials or growth factors.

The evidence base for ACT is evolving but heterogeneous: published data include animal studies, case series, some randomized controlled trials, and multiple systematic reviews/meta-analyses. Studies vary widely in cell source, processing methods, dosing, route of administration, and outcome measures, limiting the ability to draw definitive conclusions about efficacy and safety.

Evidence highlights

Overall evidence certaintyLow to very low; heterogeneous studies with methodological limitations; RCTs limited and mixed results

Knee osteoarthritis summaryMultiple systematic reviews and RCTs show inconsistent, generally low-quality evidence; some trials show symptom improvement but often not exceeding MCID or superior to placebo

PAD/CLI summarySmall RCTs and meta-analyses show some improvements (amputation, wound healing, hemodynamics) but limited by small studies, heterogeneity, and low-certainty evidence

Revision History

2026-02-01material_changeLatest

Summary of Changes: Applicable Codes updated — Updated list of applicable CPT codes to reflect annual edits; added 0999T, 1000T, and 1001T.

2026-02-01administrative

Supporting Information: Archived previous policy version CS176LA.D.

Policy Summary

PayerUnitedHealthcare

PolicyAutologous Cellular Therapy (for Louisiana Only)

Policy CodePolicy CS176LA.E

Change TypeCPT code updates; archival of prior version

Effective DateFeb 1, 2026

Next Review Date

On This Page

Tendon disorders: For tendon disorders: available trials are moderate-to-high risk of bias; evidence (Level 3) suggests possible efficacy but is insufficient to make clinical practice recommendations; stem cell injections should not be used in clinical practice given unknown potentially serious adverse effects.

Osteoarthritis (knee/hip): For osteoarthritis (knee/hip): multiple systematic reviews and guidelines (VA/DoD, AAOS) do not recommend stem cell injections; RCT evidence is mixed and overall low to very low certainty, with effects often not exceeding MCID and heterogeneity in cell source, dose, and methods.

Scleroderma/systemic sclerosis: For scleroderma/systemic sclerosis: evidence is limited to case series and small trials; randomized trial (STAR) showed numerically greater but not statistically significant improvement in primary hand-function outcome for full cohort with some signals in diffuse cutaneous subgroup; evidence insufficient to conclude effectiveness.

Regulatory context: concentrated autologous mesenchymal stem cells do not require FDA approval; FDA regulates human cells and tissues for implantation/infusion but FDA status is informational and not a basis for coverage decisions.

Note

Use of third-party clinical criteria

UnitedHealthcare may use external third-party tools (for example, InterQual) to assist in administering health benefits; coverage decisions may reference such criteria.

Billing Rule

Updated CPT code applicability

Newly added temporary CPT codes: 0999T, 1000T, 1001T. Report these applicable CPT/temporary codes per annual CPT edits and payer billing guidance. Prior policy version CS176LA.D has been archived for reference.

Temporary codes added: 0999T, 1000T, 1001T
Report and bill per annual CPT edits and payer-specific billing guidance
Prior policy CS176LA.D archived (see policy history)

Rigato meta-analysis resultCell therapy reduced amputation risk by 37%, amputation-free survival improved 18%, wound healing improved 59%; higher-quality studies less likely to show benefit

Centeno 2024 RCT noteBMC for supraspinatus tears showed significantly greater PROM improvements at 3 months sustained to 2 years versus exercise; limitations include control design and missing data

STAR trial scleroderma noteADRCs showed numerically greater CHFS improvement but not statistically significant for full cohort; dcSSc subgroup had nominal signals; feasible and tolerated

van den Boom 2020 tendon reviewEight trials (289 individuals) with moderate-high risk of bias; evidence insufficient and recommendation against clinical use due to unknown potentially serious adverse effects

Definitions: Adipose-Derived Stem Cells (ASCs) — mesenchymal adult cells isolated from adipose tissue capable of in vitro expansion and multilineage differentiation; ADRC — adipose-derived regenerative cells or stromal vascular fraction from autologous fat; Autologous Cellular Therapy (ACT) — use of an individual’s stem cells that may be cultured/expanded ex vivo and reintroduced into the donor; BMC/BMC (bone marrow concentrate) — autologous bone marrow products used for orthobiologic injections; MSC — mesenchymal stem/stromal cells derived from bone marrow, adipose, or other sources; Regenerative Medicine — the field developing methods to regrow, repair, or replace damaged tissues including therapeutic stem cells and tissue engineering.