Autologous Cellular Therapy (for Nebraska Only)

Coverage Summary

UnitedHealthcare Nebraska medical policy CS176NE.H (effective 2026-03-01) applies only to the State of Nebraska and defines the coverage stance for Autologous Cellular Therapy (ACT) including adipose- and bone marrow-derived therapies. This is a Nebraska-only policy and does not apply outside the state.

Coverage stance: Not covered — unproven / not medically necessary (cosmetic). Autologous Cellular Therapy is considered unproven and not medically necessary for all indications due to insufficient evidence of efficacy.

State-specific policyNebraska only

Procedure codes listed (count)12

New CPT codes added (count)3

Indications discussedPAD, musculoskeletal (KOA, tendon/rotator cuff, ACL), scleroderma (hands), osteoarthritis

Evidence qualityHeterogeneous; predominantly low to very low with preliminary studies, some RCTs and systematic reviews; higher-quality RCTs needed

Medical-Necessity Criteria

Coverage Rationale / Medical Necessity

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

Autologous Cellular Therapy (any indication described in policy) is considered unproven and not medically necessary due to insufficient evidence of efficacy.

General coverage interpretation

Policy assesses autologous cellular therapies; recommendations vary by indication based on evidence quality:

Use of autologous cell-based therapy or stem cell therapy for regeneration or repair of musculoskeletal tissue (tendons, ligaments, rotator cuff, ACL, tendon disorders) is investigational / insufficient high-quality evidence; randomized controlled trials needed.

Autologous cell therapy for peripheral arterial disease / critical limb ischemia: systematic reviews/meta-analyses show reduced risk of amputation and improved wound healing in many aggregated studies but limitations include low-moderate quality and heterogeneity; high-quality RCTs recommended.

Coding

Applicable/referenced procedure codes (listed for reference only)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.

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Applicable CPT / Policy Updated CodesCPT

0999T	Newly added code (policy update 03/01/2026)
1000T	Newly added code (policy update 03/01/2026)
1001T	Newly added code (policy update 03/01/2026)

Procedure and diagnosis codes listed in this policy are provided for reference purposes only and do not by themselves imply coverage or payment. CPT codes 0999T, 1000T, and 1001T were added effective 03/01/2026 (Policy History/Revision Information).

Provider Actions

Documentation Required

Reference justification of noncoverage

Document that autologous cellular therapies are considered unproven and not medically necessary for all indications per this Nebraska-only policy when submitting claims for the listed procedure codes.

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

Background and Evidence Summary

Autologous Cellular Therapy (ACT) encompasses a range of autologous, cell-based regenerative approaches including autologous adipose-derived regenerative cell therapies, bone marrow mononuclear stem cell implantation/concentrates, and other stem or progenitor cell–based interventions. Modalities described include injection of adipose-derived regenerative cells or stromal vascular fraction (SVF), autologous microfragmented adipose tissue products (eg, Lipogems), bone marrow aspirate concentrate (BMAC) or bone marrow mononuclear cell transplantation, and autologous muscle or muscle progenitor cell injections.

ACT has been proposed for indications such as knee osteoarthritis (KOA), peripheral arterial disease/critical limb ischemia (PAD/CLI), musculoskeletal repair (tendons, ligaments, rotator cuff, ACL, tendon disorders), and scleroderma-related hand dysfunction (including adipose-derived regenerative cell [ADRC] therapy for systemic sclerosis).

The published evidence base is mainly preliminary and heterogeneous — dominated by animal studies, case reports/series, observational studies, and some RCTs and systematic reviews/meta-analyses. While some trials and reviews report improvements in symptoms, function, wound healing, or surrogate measures (eg, ABI, TcPO2), overall study quality is variable and often low, with methodological limitations, inconsistent results, and short follow-up. High-quality randomized controlled trials with standardized methods and longer follow-up are needed to establish safety and efficacy across indications.

Evidence Item	Summary
Policy conclusion	Evidence insufficient; ACT considered unproven and not medically necessary for all indications.
KOA evidence summary	Multiple systematic reviews and RCTs with heterogeneous, generally low-to-very-low certainty evidence; mixed results with some trials showing limited or non‑clinically significant improvements and need for larger high‑quality RCTs.
PAD evidence summary	Small RCTs and systematic reviews report possible improvements in ABI, TcPO2, ulcer healing and reduced amputation rates but overall evidence quality low to very low; larger RCTs needed.
PAD meta-analysis (Rigato et al. 2017 & Cochrane 2022)	Rigato et al. (2017) pooled studies showed a 37% reduction in amputation risk, 18% improved amputation-free survival, and 59% improved wound healing; Cochrane (Moazzami et al. 2022) found very low- to low-certainty evidence and could not draw firm conclusions — overall limited by heterogeneity and study quality.
STAR trial	Randomized double-blind trial in systemic sclerosis (Khanna et al. 2023): ADRC group had numerically greater CHFS improvement at 48 weeks but not statistically significant for full cohort; dcSSc subgroup showed more promising results; treatment was well tolerated.
Centeno et al. 2024	Randomized crossover RCT for non-retracted supraspinatus tears: BMC + platelet products vs exercise showed significantly greater short-term PROM improvements at 3 months and sustained improvement through 2 years; limitations include small sample, exercise (not sham) control, and combined biologic therapies.

Glossary — key definitions: Adipose-Derived Stem Cells (ASCs): Mesenchymal adult cells isolated from adipose tissue that can expand in vitro and differentiate into multiple cell lineages. Autologous Adipose-Derived Regenerative Cellular Therapy: Therapy using adult stem cells extracted from a person’s fat tissue and injected into targeted lesions of the same person; cells may be processed prior to reinjection. Autologous Cellular Therapy: Therapeutic intervention using an individual’s stem cells that can be cultured/expanded outside the body and reintroduced into the donor. Bone Marrow Mononuclear Stem Cells (BMC/BMMNC): Mixed population of blood cells, including stem and progenitor cells explored for cardiac and vascular repair. Regenerative Medicine: Branch of medicine developing methods to regrow, repair, or replace damaged or diseased cells, organs, or tissues, including therapeutic stem cells and tissue engineering. Additional abbreviations: ADRC = adipose-derived regenerative cells/stromal vascular fraction; BMC = bone marrow concentrate (autologous); MSC = mesenchymal stem/stromal cells.

Revision History

03/01/2026policy_changeLatest

Added CPT codes 0999T,1000T,1001T to applicable codes list; archived previous policy version CS176NE.G (see Policy History/Revision Information).