Autologous Cellular Therapy

Coverage Summary

Scope: This policy (CS176.F) addresses Autologous Cellular Therapy (ACT) — therapies using a patient’s own cells (adipose-derived, bone marrow–derived, stromal vascular fraction/ADRC, etc.) and related devices (e.g., Lipogems) for indications across orthopedic/musculoskeletal, vascular, and rheumatologic conditions. The policy states that ACT is unproven and not medically necessary for all indications because the published evidence is preliminary, heterogeneous, and insufficient to establish efficacy and long-term safety.

Overview: Specific indication areas discussed include knee osteoarthritis (KOA), peripheral arterial disease/critical limb ischemia (PAD/CLI), musculoskeletal tissue regeneration (tendons, ligaments, rotator cuff), and scleroderma of the hands. The evidence base is characterized by small, heterogeneous, often nonrandomized or low-quality studies; randomized controlled trials with adequate sample size and long-term follow-up are required before ACT can be considered medically necessary. Note: as of the 06/01/2025 revision, this Medical Policy does not apply to the states of Idaho and Kansas (refer to state-specific policy versions).

Policy at-a-glance

Policy NumberCS176.F

Effective DateOctober 1, 2024

StatusCURRENT

Primary SubjectAutologous Cellular Therapy

Overall evidence certainty described in policyLow

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:

ALL of the following

Autologous Cellular Therapy (ACT) is considered unproven and not medically necessary for all indications because the published evidence is preliminary, heterogeneous, and insufficient to establish efficacy and long-term safety.
Specific indications discussed in the evidence include knee osteoarthritis, peripheral arterial disease/critical limb ischemia, musculoskeletal tissue regeneration (tendons, ligaments, rotator cuff), and scleroderma of the hands; available studies are small, heterogeneous, and often nonrandomized or low quality.
Randomized controlled trials with adequate sample size and long-term follow-up are required before ACT can be considered medically necessary for these indications.

Not Medically Necessary / Experimental

Policy stance: The policy conclusion is that Autologous Cellular Therapy (ACT) is unproven and not medically necessary for all indications because evidence is preliminary, inconsistent, and of low quality. The document explicitly requires adequately powered randomized controlled trials with long-term follow-up before ACT could be considered medically necessary.

Key indication-level conclusions: across multiple areas the policy finds insufficient evidence or not recommended use — for example, knee osteoarthritis (limited, inconsistent/low- to very low-certainty evidence), peripheral arterial disease/critical limb ischemia (very low- to low-certainty or heterogeneous trial results), musculoskeletal repair including tendon and rotator cuff disorders (small trials, moderate-to-high risk of bias), and scleroderma (case series/case reports only). Guideline bodies cited (AAOS, VA/DoD, ESC, ACC/AHA) either do not recommend or find evidence insufficient to support routine use of stem cell/ACT therapies.

Referenced Procedure / CPT / HCPCS Codes

Referenced Procedure/HCPCS/CPT CodesCPT

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 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 specific billing codes listed in this partmixed

No codes listed

Provider Actions / Prior Authorization & Documentation

Prior Authorization

Prior authorization implication

The listed CPT/HCPCS codes are provided for reference only. Inclusion of a code in this policy does not imply that the procedure is covered or reimbursable. Providers must confirm benefit coverage and any prior authorization requirements with the member's federal, state, or contractual plan before submitting claims or scheduling services.

0263T
0264T
0265T
0489T
0490T
0565T
0566T
0717T
0718T
27599
Confirm benefit coverage and authorization requirements per applicable federal, state, or contractual rules before providing services.

Background and Definitions

Background: Autologous Cellular Therapy (ACT) uses a patient’s own cells (for example adipose-derived stem cells/ADRCs, bone marrow mononuclear cells/BMMNCs, mesenchymal stem/stromal cells) to attempt tissue repair or regeneration. Devices and proprietary processes (for example, Lipogems) produce microfragmented or minimally manipulated adipose tissue or cell concentrates for same-day injection or implantation. ACT is being investigated across orthopedic, vascular, and rheumatologic applications.

State of the evidence: The published literature is heterogeneous with varied cell sources, preparation methods, doses, routes of administration, and outcome measures. Most studies are preliminary (animal studies, case reports/series) or small clinical trials; available human comparative trials are few and often nonrandomized or have methodological limitations. As a result, the evidence base does not yet support routine clinical use.

Glossary (brief)

Evidence Summary

Evidence synthesis — key takeaways: Overall the evidence across indications is low to very low certainty, heterogeneous, and at risk of bias. Hayes HTA (2024) concluded low-quality evidence for adipose-derived stem cell therapy for knee OA with limited, inconsistent improvements versus placebo or hyaluronic acid and recommended additional RCTs with long-term follow-up. Cochrane review for critical limb ischemia (Moazzami et al., 2022) found very low- to low-certainty evidence and was unable to support intramuscular BMMNC transplantation for CLI.

Meta-analyses and PAD: Some RCTs and meta-analyses in peripheral arterial disease report improvements in ABI, TcPO2, ulcer healing and reduced amputation rates, but the pooled evidence is heterogeneous and graded low quality; authors call for larger, well-designed RCTs. For PAD, systematic reviews report possible benefits in some hemodynamic and wound outcomes but inconsistent high-quality evidence.

Tendon and rotator cuff: Systematic reviews and pooled evaluations found mixed results; available RCTs and observational studies are small and at moderate-to-high risk of bias. Authors concluded evidence is insufficient to recommend stem cell injections in routine clinical practice for tendon disorders or rotator cuff repair.

Scleroderma: Evidence is limited to case series and case reports (e.g., 11 articles, 101 patients) with primarily level 4 evidence; small uncontrolled studies show possible improvements but are inadequate for definitive conclusions and randomized trials are needed.

Guidelines and expert bodies: Multiple guideline statements (AAOS, VA/DoD, ESC, ACC/AHA, ISSCR) either do not recommend ACT or indicate insufficient evidence; ESC recommends stem cell/gene angiogenic therapy is not indicated for chronic limb-threatening ischemia. Overall, guideline consensus aligns with the policy’s conclusion that evidence is insufficient to support routine clinical use.

Revision History

2024-10-01supporting information updated

Updated Clinical Evidence and References; prior version archived

2025-06-01materialLatest

Application Idaho and Kansas Added; policy does not apply to Idaho and Kansas