Autologous Cellular Therapy (for Kansas Only)

Coverage Summary

This policy is a Kansas-specific UnitedHealthcare medical policy for Autologous Cellular Therapy (ACT). Effective February 1, 2026, the policy scope is limited to the state of Kansas and defines the coverage position that ACT is unproven and not medically necessary for all indications due to insufficient evidence of efficacy.

Key policy quick facts

States applicableKansas (policy applies to Kansas only)

Procedure codes listed12 codes listed for reference (includes 0263T, 0264T, 0265T, 0489T, 0490T, 0565T, 0566T, 0717T, 0718T, 0999T, 1000T, 1001T)

Major clinical areas discussedPeripheral arterial disease (PAD)/critical limb ischemia; Musculoskeletal (knee OA, rotator cuff, tendons/ligaments); Scleroderma (systemic sclerosis)

CPT codes added (effective date)0999T, 1000T, 1001T (added effective 2026-02-01)

Guidelines / organizations citedAAOS, ACC/AHA, VA/DoD, ESC, ISSCR, FDA (informational only)

Coverage stance: not_covered_cosmetic — Autologous Cellular Therapy is unproven and not medically necessary for all indications.

Medical Necessity Determination

Policy statement regarding coverage:

ALL of the following

Autologous Cellular Therapy is unproven and not medically necessary for all indications due to insufficient evidence of efficacy.
Applies to the state of Kansas (policy only applies to Kansas).

Evidence-based conclusions / coverage implications

Policy summarizes evidence and guideline positions; coverage decisions depend on plan/federal/state contract and InterQual criteria; specific clinical coverage criteria not present in this part.

ALL of the following

Peripheral arterial disease / critical limb ischemia: For peripheral arterial disease / critical limb ischemia: systematic reviews/meta-analyses report reductions in amputation risk (37%), improved amputation-free survival (18%), and improved wound healing (59%) but overall evidence quality is low-moderate with heterogeneity and potential bias; higher-quality studies less likely to show benefit and authors recommend high-quality RCTs.

Procedure Codes (CPT)

Applicable CPT/Category III codes (listed for 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

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Applicable CPT codes (updated)CPT

0999T	As added to applicable CPT list per revision history (no description in part text)
1000T	As added to applicable CPT list per revision history (no description in part text)
1001T	As added to applicable CPT list per revision history (no description in part text)

Provider Actions & Billing Notes

Documentation Required

Reference and coding only

The listed procedure codes are provided for reference only and their inclusion does not imply coverage or guarantee payment. Benefit coverage is determined by federal, state, or contractual requirements.

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

Background, Evidence Summary & Definitions

Autologous Cellular Therapy (ACT) refers to treatments using a patient’s own cells (for example, bone marrow, adipose tissue, or muscle-derived cells) intended to promote repair or regeneration of damaged tissues. Proposed applications discussed in the policy include knee osteoarthritis, peripheral arterial disease/critical limb ischemia, musculoskeletal tissue repair (tendons, rotator cuff, ACL), and scleroderma.

The evidence base is heterogeneous and primarily consists of animal studies, case series, systematic reviews, and a limited number of randomized controlled trials. Studies vary in cell source, processing, dosing, delivery method, and outcome measures, which limits comparability. Systematic reviews and meta-analyses report some positive signals for select outcomes (for example, reductions in amputation risk and improved wound healing in PAD, and mixed functional/pain outcomes in musculoskeletal conditions), but overall the quality of evidence is low to very low with methodological limitations, heterogeneity, and risk of bias; higher-quality trials are less likely to show benefit. Larger, high-quality RCTs with standardized methods and long-term follow-up are needed to establish safety and efficacy before routine coverage can be recommended.

Evidence topic	Summary/value
Overall evidence quality
Low to very low; inconsistent and heterogeneous with limited long-term RCT data
KOA RCTs/systematic reviews
Mixed results; some trials/meta-analyses show limited or no superiority vs placebo; some show benefits vs hyaluronic acid; evidence downgraded for bias and inconsistency
PAD RCTs/meta-analyses
Some meta-analyses show improvements in ABI, TcPO2, ulcer healing and reduced amputation rate, but studies are small and heterogeneous; evidence low-certainty
Peripheral arterial disease - amputation risk reduction
37% risk reduction (systematic review/meta-analysis cited)
Peripheral arterial disease - amputation-free survival
18% improvement (meta-analysis cited)
Peripheral arterial disease - wound healing
59% improvement (meta-analysis cited)
Scleroderma STAR trial
Adipose-derived regenerative cells vs placebo: CHFS improvement 11.0±12.5 vs 8.9±10.5 at 48 weeks (p=0.299); dcSSc subgroup signals but not statistically significant overall
Rotator cuff RCT (Centeno 2024)
BMC group showed greater improvements in ΔDASH, ΔNPS, and SANE at 3 months vs exercise (p values 0.01, 0.004, <0.001); limitations include control design and mixed biologic components

Term	Definition
Adipose-Derived Stem Cells (ASCs)
Mesenchymal adult cells, isolated from adipose tissue that can expand in vitro in an undifferentiated state and have the capacity to differentiate into multiple cell lineages.
Autologous Adipose-Derived Regenerative Cellular Therapy
A therapy proposed to treat a wide array of conditions using adult stem cells extracted from an individual's fat tissue injected into a targeted lesion of the same individual; cells may be processed prior to reinjection.
Autologous Cellular Therapy
A therapeutic intervention that uses an individual's stem cells, which can be cultured and expanded outside the body, and reintroduced into the donor.
Bone Marrow Mononuclear Stem Cells
A mixed population of blood cells, including stem and progenitor cells, explored in cardiac and vascular repair studies.
Regenerative Medicine
Branch of medicine that develops methods to regrow, repair or replace damaged or diseased cells, organs, or tissues, including therapeutic stem cells and tissue engineering.
ADRC
Adipose-derived regenerative cellular
BMC
Bone marrow concentrate
MSC
Mesenchymal stem/stromal cell

Revision History

02/01/2026material_changeLatest

Applicable CPT/Category III codes updated to add 0999T, 1000T, and 1001T; billers instructed to use updated CPT code set effective 2026-02-01 per Policy History/Revision Information and provider actions.

02/01/2026archival

Administrative archival of prior policy version CS176KS.02 documented in Policy History/Revision Information.