ModifiedUnitedHealthcarePolicy CS176NM.D

Autologous Cellular Therapy (for New Mexico Only)

This policy governs the medical necessity and coverage stance for autologous cellular therapy interventions in New Mexico and applies to UnitedHealthcare members and their providers in that state.

Policy Summary

PayerUnitedHealthcare

PolicyAutologous Cellular Therapy (for New Mexico Only)

Policy CodePolicy CS176NM.D

Change TypeUpdated CPT code list

Effective DateFeb 1, 2026

Next Review Date

Key ActionEnsure prior authorization and claims use the updated CPT codes (0999T, 1000T, 1001T) where required by the plan.

SourceLink

POLICY UPDATE CHANGES

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

1state-specific (NM)

unprovencoverage conclusion

13RCTs for knee OA

88STAR trial participants

Coverage Criteria and Rationale

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inv-02: Evidence sufficiency and required trial quality

Summary of evidence-based coverage considerations (interpretive — not policy language):

General evidence requirements for coverage of cell-based therapies

Indication-specific evidence examples: Examples from the literature: MSC trials in knee OA show consistent imaging/structural effects but pooled RCT data do not demonstrate clinically important pain/function benefit versus placebo in some meta-analyses (Dai et al.; Gong et al.); Garza et al. SVF randomized trial reported dose-dependent WOMAC improvements versus placebo at 6 and 12 months; MFAT evidence consists primarily of small uncontrolled observational studies (Hayes) limiting comparative conclusions; PAD meta-analyses of RCTs report improvements in ABI, TcPO2, ulcer healing and lower amputation rates but included trials are heterogeneous and often at high risk of bias (Gao et al.); tendon/rotator cuff trials and systematic reviews show mixed results with risk of bias and insufficient evidence for routine use (Centeno; van den Boom); STAR ADRC trial in systemic sclerosis showed tolerability and numerical improvements but not statistically significant for the full cohort (Khanna et al.).
These examples illustrate the types of outcomes and study limitations that should be addressed by future trials.

inv-03: Scleroderma / Systemic sclerosis

Coverage stance is driven by available evidence summaries and RCTs/case series findings

Scleroderma - evidence summary: Available evidence for ADRC/ADSVF/MSC therapies in systemic sclerosis is limited and consists mainly of case series and small randomized trials with inconsistent outcomes; the STAR randomized, double-blind, placebo-controlled trial (Khanna et al., 2023) showed feasibility and tolerability and numerically greater improvement in hand function for ADRC-treated participants but did not achieve statistical significance for the primary endpoint in the full cohort; systematic reviews conclude current data are insufficient to draw definitive conclusions and larger randomized studies are needed.

References: STAR trial (Khanna 2023); systematic reviews (Escobar-Soto 2021; Almadori 2024); phase-1/series data (Daumas 2017).

inv-04: Guideline limitations (OA, PAD)

Specialty guideline positions relevant to orthopedic and vascular indications

Orthopedics and peripheral vascular guideline stance: Relevant specialty guidelines do not support routine use of stem cell or other autologous cellular injections for common orthopedic or vascular indications: AAOS (2020) does not recommend injectable biologics such as stem cells for glenohumeral osteoarthritis and calls for better standardization and high-quality trials; the VA/DoD (2020) guideline does not recommend stem cell injections for hip or knee osteoarthritis due to limited research; the ESC (2018) indicates angiogenic gene and stem cell therapies are investigational and not indicated for chronic limb-threatening ischemia; ISSCR (2024) characterizes MSC therapy as early experimental with little definitive evidence.

These guideline positions inform expectation for conservative stepwise care and the need for robust evidence before coverage.

Applicable Procedure and CPT Codes

Applicable Procedure 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

Applicable CPT codes (updated)CPT

0999T	Added applicable CPT code (per policy history)
1000T	Added applicable CPT code (per policy history)
1001T	Added applicable CPT code (per policy history)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization may be required for cell-based and autologous cellular therapies. Given heterogeneity in products and limited, low-quality comparative evidence for many indications (e.g., KOA, MFAT, SVF, PAD, scleroderma), providers should obtain prior authorization before scheduling procedures to avoid claim denials.

Prior authorization required for autologous cellular therapies and related injections/procedures.
Verify medical necessity against contract, benefit plan, and this policy prior to service.
Failure to obtain prior authorization may result in denial or delayed payment.

Billing Rule

Updated Applicable CPT Codes — Use Current Codes for PA and Claims

Use the current CPT codes when requesting prior authorization and submitting claims. The policy's applicable CPT code list was updated to include 0999T, 1000T, and 1001T (02/01/2026). Listing of codes in the policy is for reference and does not guarantee coverage.

Confirm appropriate CPT (and HCPCS/diagnosis) codes prior to authorization submission.
Include updated codes (e.g., 0999T, 1000T, 1001T) where clinically applicable.
Incorrect or outdated codes may cause claim processing issues or denials.

Note

FDA / Regulatory Compliance Risk

Providers must be aware of FDA and other regulatory considerations for human cells, tissues, and cellular and tissue-based products (HCT/Ps). Some concentrated autologous MSC products and certain cell-manipulation processes may be subject to additional FDA regulation; regulatory status does not by itself determine coverage.

Review FDA guidance and device/biologic labeling and ensure procedures comply with applicable regulations.
Document product processing details (e.g., degree of manipulation, culture/expansion, enzymes used) to support clinical review and regulatory compliance.
FDA approval alone is not a basis for coverage; conversely, lack of FDA approval for a particular preparation may affect risk assessment and payer determination.

Billing Rule

Coding Mismatch Risk — Verify Codes and Documentation

Coding accuracy is required. Failure to use up-to-date or correct CPT codes (including newly added 0999T, 1000T, 1001T or legacy procedure codes) can lead to processing delays or claim denials.

Ensure coding reflects the exact procedure performed (harvest only, injection only, combined procedures, laterality).
If proprietary or temporary codes (Category III) apply, document clinical rationale and link to prior authorization.
Coordinate with billing/coding teams to map device- or vendor-specific codes to payer-accepted codes before claim submission.

Documentation Required

Required Clinical Documentation Elements

Required clinical documentation should be submitted with prior authorization requests and maintained in the medical record; include objective baseline and follow-up data to support medical necessity determinations.

Clinical indication and relevant history (duration, prior treatments).
Documentation of conservative therapy trial(s) and response (see step-therapy prerequisite).
Physical exam findings and pertinent imaging (e.g., MRI, radiographs) with report dates.
Procedure details: harvest site, processing method, cell type/concentration, number of cells injected, laterality, guidance used.
Validated patient-reported outcome measures (PROMs) and baseline scores (e.g., WOMAC, VAS, CHFS) and planned follow-up assessment schedule.
Adverse events or complications reporting and monitoring plan.

Step Therapy

Conservative Therapy Prerequisite Before Cellular Therapies

Conservative, standard nonoperative therapies should be attempted and documented before considering autologous cellular therapies for conditions such as knee or hip osteoarthritis.

Document trial and failure or intolerance of guideline-recommended conservative measures (e.g., activity modification, physical therapy, weight loss, analgesics, intra-articular hyaluronic acid where appropriate).
Specify duration and objective response to each conservative therapy.
When specialty guidelines explicitly discourage stem-cell injections (e.g., AAOS, VA/DoD), document rationale for proceeding and prior discussions of risks/benefits.

Definitions and Terminology

Adipose-Derived Stem Cells (ASCs) — definition

DefinitionMesenchymal 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.

Primary source tissueAdipose (fat) tissue, obtained by liposuction or surgical harvest.

Key propertiesIn vitro expansion capability and multilineage differentiation potential (per Si et al., 2019).

Autologous Adipose-Derived Regenerative Cellular Therapy — definition

Autologous natureCells are harvested from and returned to the same patient (autologous).

ProcessingMay include isolation and other processing steps prior to reinjection (per Si et al., 2019).

Autologous Cellular Therapy — definition

ApplicationsIncludes adipose-derived, bone marrow–derived, and other autologous cell sources used investigationally for tissue repair/regeneration.

Regulatory noteAutologous sourcing does not by itself establish efficacy; evidence remains insufficient for most indications according to policy.

Bone Marrow Mononuclear Stem Cells — definition

DefinitionA mixed population of blood cells from bone marrow, including stem and progenitor cells, explored in studies of cardiac and vascular repair.

Typical useInvestigational applications include peripheral arterial disease and other vascular indications.

CompositionContains multiple mononuclear cell types rather than a purified single stem-cell population.

Regenerative Medicine — definition

DefinitionThe branch of medicine developing methods to regrow, repair, or replace damaged or diseased cells, organs, or tissues, including therapeutic stem cells, tissue engineering, and production of artificial organs.

ScopeEncompasses stem cell therapies, regenerative cellular products, and tissue-engineering approaches used investigationally or clinically.

ObjectiveAim is restoration of structure and function through biologic or engineered interventions.

SVF / MFAT / BMC / ADRC — commonly referenced cellular products

SVF / MFAT / BMC / ADRC — definitionCellular products derived from adipose tissue (stromal vascular fraction, microfragmented adipose tissue), bone marrow concentrate, or processed adipose-derived regenerative cells used as injectate or implant for tissue repair/regeneration.

ExamplesSVF (stromal vascular fraction), MFAT (microfragmented adipose tissue), BMC (bone marrow concentrate), ADRC (adipose-derived regenerative cells).

Clinical contextUsed in investigational injections or implants for musculoskeletal conditions such as knee OA, tendon/ligament repair, and other indications.

MSC — mesenchymal stem/stromal cell definition

DefinitionMesenchymal stem/stromal cells derived from bone marrow, adipose, peripheral blood, umbilical cord, or placenta used for intra-articular injections aiming to improve cartilage and subchondral bone in osteoarthritis and other regenerative purposes.

Evidence noteSystematic reviews/meta-analyses of RCTs report mixed clinical benefit for MSCs in knee OA; structural MRI benefits are more consistent than patient-reported symptom improvements.

SourcesBoth autologous and allogeneic MSCs have been studied (bone marrow, adipose, umbilical cord, placenta).

ADRC / ADSVF — autologous adipose-derived regenerative cells definition

DefinitionAutologous adipose-derived regenerative cells (ADRC) or adipose-derived stromal vascular fraction (ADSVF): cell populations harvested from adipose tissue and used for local injection.

Use in sclerodermaADRC/ADSVF therapies have been evaluated for scleroderma (hands/facial grafting) but evidence is limited to small case series and few RCTs; larger studies are needed.

Regulatory contextUse of concentrated autologous MSCs does not require FDA approval but human cells/tissues are regulated by the FDA CBER when intended for implantation, transplantation, or infusion.

MSC / hMSC — mesenchymal stromal/stem cell definition (ISSCR context)

DefinitionMesenchymal stromal/stem cells (including human MSCs, hMSCs) used experimentally for regenerative purposes; characterized by ISSCR as remaining in early experimental stages with little definitive evidence of benefit.

Evidence statusSystematic reviews note insufficient data to reach definitive conclusions for systemic sclerosis and other indications; trials are often small and low quality.

ImplicationClinical use remains investigational for many indications pending larger, high-quality RCTs and standardized cell-processing protocols.

OpenPayer

Autologous Cellular Therapy (for New Mexico Only)

Coverage Criteria and Rationale

Applicable Procedure and CPT Codes

Provider Actions, Prior Authorization, and Documentation

Background and Scope

Definitions and Terminology