ModifiedUnitedHealthcarePolicy CS176PAF

Autologous Cellular Therapy (for Pennsylvania Only)

This policy governs the medical necessity and coverage stance for autologous cellular therapy procedures and related services in the state of Pennsylvania for UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyAutologous Cellular Therapy (for Pennsylvania Only)

Policy CodePolicy CS176PAF

Change TypeContent updates to Supporting Information and Clinical Evidenceprior version archived

Effective DateNov 1, 2024

Next Review Date

Key ActionVerify the member's federal, state, or contractual benefit plan for any prior authorization requirements before requesting autologous cellular therapy services.

SourceLink

POLICY UPDATE CHANGES

Supporting Information and Clinical Evidence sections were updated to reflect the most current information and references.

Pennsylvania-onlygeographic applicability

CS176PAFpolicy identifier (payer)

Insufficient evidencecoverage rationale summary

Low-to-moderateevidence quality

Multiplecodes referenced

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Coverage Criteria for Autologous Cellular Therapy

inv-01: Not medically necessary (general)

Covered when ALL of the following are met:

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

Policy states unproven for all indications

inv-02: Summary of coverage-relevant evidence by indication

Coverage considerations derived from available evidence across indications

Knee osteoarthritis (intra-articular adipose or MSC products): Some randomized controlled trials (e.g., Garza et al.) report symptom improvement versus placebo up to 12 months, but trials are limited by small size, attrition, unblinding, heterogeneity of cell sources/preparations, and low-quality evidence; comparative effectiveness versus standard treatments is uncertain.

Further large, multicenter RCTs with standardized MSC/ADRC preparation, dose, and administration are recommended.

Peripheral arterial disease / critical limb ischemia: Meta-analyses and RCTs report possible improvements in ABI, TcPO2, ulcer healing, and reduced amputation in some studies, but pooled evidence is low-to-very-low quality with substantial heterogeneity and risk of bias; higher-quality trials are needed to confirm clinically meaningful benefit.

Larger randomized, double-blind, placebo-controlled multicenter trials with long-term follow-up are needed.

Tendon and ligament repair: Systematic reviews of trials for tendon disorders and rotator cuff/epicondylar injuries show mixed results with moderate-to-high risk of bias (level 3 evidence at best); evidence is insufficient to support routine clinical use and safety concerns remain.

Randomized trials with rigorous methodology and standardized protocols are required.

Scleroderma (hand disease): Available literature consists mainly of case series and small uncontrolled studies reporting some improvements in vascular and hand-related outcomes, but comparative data are lacking and evidence is inadequate to determine safety and efficacy.

Larger randomized comparative studies are needed.

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

Major professional society guidance does not endorse routine use of stem cell injections for hip, knee, or glenohumeral osteoarthritis. The AAOS states that injectable biologics such as stem cells cannot be recommended for glenohumeral joint OA and calls for better standardization and high-quality trials, and the VA/DoD guideline does not recommend stem cell injections for hip or knee OA citing limited evidence and the need for further evaluation versus standard care.

The European Society of Cardiology guideline states that angiogenic gene and stem cell therapies remain investigational with insufficient evidence and therefore are not indicated for patients with chronic limb‑threatening ischemia.

VA/DoD guidance does not recommend stem cell injections (including mesenchymal and adipose‑derived products) for hip or knee osteoarthritis and highlights limited research and the need for further comparative evaluation. The International Society for Stem Cell Research notes that MSC therapy remains in early experimental stages and that little evidence supports clear benefit.

Consistent with the evidence summaries and guideline statements, Autologous Cellular Therapy is considered unproven and not medically necessary for all indications and is therefore not covered.

The overall evidence base is limited by small trials, methodological concerns, and heterogeneity of preparations and protocols; given these limitations and guideline recommendations, routine clinical use of autologous cellular therapies for musculoskeletal conditions is not supported by current evidence.

Available studies are generally low quality and heterogeneous, with moderate-to-high risk of bias in many tendon and musculoskeletal trials and variable cell preparations and dosing. There is a lack of standardized manufacturing, concentration, and administration protocols, and long‑term randomized comparative data are sparse; therefore routine use is not supported.

Codes and Related Coding Notes

Applicable CPT/Unlisted codes referencedCPT

0263T	Intramuscular autologous bone marrow cell therapy; with preparation of harvested cells, multiple injections, one including ultrasound guidance, if performed; complete procedure including unilateral or bilateral bone marrow harvest leg;
0264T	Intramuscular autologous bone marrow cell therapy; with preparation of harvested cells, multiple injections, one including ultrasound guidance, if performed; complete procedure excluding bone marrow harvest leg;
0265T	Intramuscular autologous bone marrow cell therapy; with preparation of harvested cells, multiple injections; one including ultrasound guidance, if performed; unilateral or bilateral bone marrow harvest only for intramuscular autologous bone marrow cell therapy leg;
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.
27599	Unlisted procedure, femur or knee (when used to report LIPOGEMS)

No explicit codes in this part of the documentmixed

No codes listed

Regulatory notes (no specific CPT/HCPCS codes listed in this section)mixed

No codes listed

Follow-up durations in trials — key limitations

Typical trial sizeMost trials are small (many with 10–40 participants per arm; total treated cohorts often <500 across RCTs)

Follow-up durationFew trials report >1 year follow-up; most outcomes reported at 6–12 months with limited long-term data

Risk of biasMany RCTs and systematic reviews rate outcomes at high risk of bias due to randomization, attrition, and measurement concerns

Ankle-Brachial Index (ABI) — study endpoint

ABI improvement threshold> 0.1 increase in ankle-brachial index (ABI) at 6 months

Endpoint context

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior authorization and case-by-case review — Pennsylvania

This Medical Policy applies to Pennsylvania. Requests for services that do not meet criteria in the PARP will be evaluated on a case-by-case basis per Pennsylvania Code Title 55, Chapter 1101.

Verify that the member’s benefit plan is governed by Pennsylvania-specific rules before applying this policy.
If federal, state, or contractual requirements conflict with this policy, those requirements prevail.

Denial Risk

Coverage Denial Risk — ACT considered unproven

Autologous cellular therapies (ACT), including autologous mesenchymal stem cells, stromal vascular fraction, and microfragmented adipose tissue, are considered unproven and not medically necessary for all indications due to insufficient or low-quality evidence.

Background on Autologous Cellular Therapy

Autologous Cellular Therapy (ACT) uses a patient’s own stem or regenerative cells harvested from tissues such as adipose tissue or bone marrow, which may be processed and then reintroduced to the donor to attempt repair or regeneration of damaged tissue. The evidence base includes animal studies, case series, nonrandomized comparative trials and some randomized trials, but high‑quality long‑term randomized data are generally lacking.

Definitions and Abbreviations

Adipose-Derived Stem Cells (ASCs)

DefinitionAdipose-Derived Stem Cells (ASCs) are mesenchymal adult cells isolated from adipose tissue that can expand in vitro in an undifferentiated state and differentiate into multiple cell lineages.

Source and processingASCs are harvested from a patient’s adipose tissue (e.g., via liposuction) and may be processed for concentration or selection prior to reimplantation.

Therapeutic roleASCs are investigated for regenerative applications including musculoskeletal repair and osteoarthritis treatment.

Autologous Cellular Therapy — definition

DefinitionAutologous Cellular Therapy uses an individual’s own stem cells that can be cultured and expanded outside the body and then reintroduced into the donor.

Autologous source

Policy Summary

PayerUnitedHealthcare

PolicyAutologous Cellular Therapy (for Pennsylvania Only)

Policy CodePolicy CS176PAF

Change TypeContent updates to Supporting Information and Clinical Evidenceprior version archived

Effective DateNov 1, 2024

Next Review Date

Key ActionVerify the member's federal, state, or contractual benefit plan for any prior authorization requirements before requesting autologous cellular therapy services.

SourceLink

On This Page

Used as a primary endpoint in PAD trials comparing intra-arterial bone marrow mononuclear stem cell (BMSC) injection versus sham

Supporting outcomesABI change reported alongside clinical outcomes (ulcer size, rest pain, amputation rates) in PAD studies

Transcutaneous oxygen tension (TcPO2) — study endpoint

TcPO2 improvement threshold> 15% increase in transcutaneous oxygen tension (TcPO2) at 6 months

Measurement sitesTcPO2 evaluated at the mid- and lower foot in PAD trial endpoints

Clinical significanceTcPO2 improvement reported with concurrent hemodynamic and amputation outcome differences in some studies

High risk of denial — ACT is frequently considered experimental or investigational.

Requests should include high-quality supporting evidence (randomized controlled trials, validated outcome measures) to be considered.

Prefer established therapies (risk-factor management, exercise, pharmacotherapy) prior to ACT for osteoarthritis and PAD.

Prior Authorization

Prior Authorization Likely Required

Prior authorization is likely required for autologous cellular therapies. Confirm prior authorization and coverage requirements with the member’s plan before scheduling procedures.

Check member’s federal, state, and contractual benefit details to determine prior authorization requirements and coverage.
Document attempts to obtain prior authorization and any payer decisions in the medical record.

Documentation Required

Regulatory, Coding, and Documentation Note

Regulatory and coding considerations may affect coverage determinations. The FDA regulates human cells and tissues; some concentrated autologous MSC uses do not require FDA approval but may still be subject to regulation.

Listing of codes in this policy is for reference only and does not guarantee coverage or payment.
Confirm coding, billing, and FDA regulatory status when submitting claims; include procedure codes and all relevant documentation.
If a marketed product lacks FDA approval/clearance for the specific indication, include rationale and supporting evidence when requesting coverage consideration.

Documentation Required

Supporting Clinical Outcome Documentation

Clinical evidence for ACT is heterogeneous and generally low quality. When submitting requests include supporting clinical outcome documentation using validated measures.

Provide validated patient-reported outcomes (e.g., WOMAC for knee OA), imaging findings, and objective vascular measures (ABI, TcPO2) as applicable.
Include study design details if relying on published evidence (randomization, blinding, sample size, follow-up duration) and address limitations (risk of bias, attrition).
For PAD cases, document prior conventional therapies and objective limb status (ulcer size, Rutherford classification, prior revascularization attempts).

Note

Prefer Conventional and Established Therapies First

Prefer conventional therapy first — guidelines and systematic reviews emphasize standard care and note limited and inconsistent evidence for ACT.

For osteoarthritis: document prior use of conservative measures (physical therapy, weight loss, NSAIDs, intra-articular hyaluronic acid where applicable) and reason for considering ACT.
For PAD: document optimized medical therapy, exercise therapy, and prior revascularization attempts when applicable.

Denial Risk

Evidence-Related Denial Risk

Evidence limitations increase the risk of noncoverage decisions: many studies are small, nonrandomized, or have inconsistent methodologies and outcomes.

High risk of bias, heterogeneity, and low GRADE ratings are common in the ACT literature; include high-quality evidence to mitigate denial risk.
When evidence is limited, consider case-by-case review with comprehensive documentation of medical necessity and prior therapies.

Documentation Required

Verify Benefit Plan Requirements

Verify member benefit plan requirements and document findings when applying this policy. In case of conflict, federal/state/contractual requirements govern.

Record the benefit plan source (federal/state/contractual) and any exceptions considered under Pennsylvania law.
If coverage is granted despite typical noncoverage, retain written payer authorization and any utilization management notes in the chart.

Therapy sources include adipose tissue, bone marrow, peripheral blood, and other patient-derived tissues.

Intended useApplied experimentally across indications such as osteoarthritis, tendon/ligament repair, scleroderma, and peripheral arterial disease.

Autologous Adipose-Derived Regenerative Cellular Therapy (ADRC)

DefinitionAutologous Adipose-Derived Regenerative Cellular Therapy (ADRC) is a proposed treatment using adult stem cells extracted from a patient’s fat tissue and injected into targeted lesions of that same patient.

Processing noteADRC preparations may be processed in various ways prior to reinjection (e.g., isolation, concentration, enzymatic dissociation).

Clinical intentExplored for musculoskeletal and soft tissue conditions including knee OA and rotator cuff pathology.

Bone Marrow Mononuclear Stem Cells (BMMNC/BMSC)

DefinitionBone Marrow Mononuclear Stem Cells are a mixed population of blood cells, including stem and progenitor cells, derived from bone marrow and explored for cardiac and vascular repair.

CompositionIncludes heterogeneous mononuclear cells rather than a purified mesenchymal stem cell population.

Study useUsed in PAD and CLI trials delivered intra-arterially or intramuscularly to improve hemodynamic and wound outcomes.

Regenerative Medicine — definition

DefinitionRegenerative Medicine is the 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.

ScopeEncompasses stem cell therapies, tissue engineering, and production of artificial organs.

Clinical aimAims to restore structure and function in injured or diseased tissues through biologic interventions.

Abbreviations used in the evidence (SVF / MFAT / MSC / BMMNC)

SVFStromal vascular fraction (SVF) — adipose-derived heterogeneous cell fraction obtained after liposuction and processing

MFATMicrofragmented adipose tissue (MFAT) — adipose-derived product produced via mechanical processing (e.g., Lipogems)

MSC / BMMNCMSC = mesenchymal stem/stromal cells; BMMNC = bone marrow mononuclear cells — marrow- or blood-derived cellular products used across studies

Concentrated autologous mesenchymal stem cells (MSCs)

DefinitionConcentrated autologous mesenchymal stem cells (MSCs) are autologous MSCs obtained from the patient’s tissues (e.g., adipose or bone marrow) and concentrated for implantation or infusion.

FDA regulatory noteThe use of concentrated autologous MSCs does not require FDA approval, but FDA regulates human cells and tissues intended for implantation, transplantation, or infusion through CBER.

Clinical useThese concentrated MSC preparations are evaluated experimentally for indications such as musculoskeletal repair and vascular disease.