CurrentAetnaPolicy 0784

Blood and Adipose Product Injections for Selected Indications

Defines Aetna's clinical policy position that various blood- and adipose-derived product injections (e.g., autologous blood, PRP, ADRC, stem‑cell and related procedures) are considered experimental and investigational for a list of specified indications and outlines related CPT/HCPCS/ICD‑10 coding not covered. This part provides the 'Experimental and Investigational' coverage stance, related policies, code lists, and background evidence summaries.

Policy Summary

PayerAetna

PolicyBlood and Adipose Product Injections for Selected Indications

Policy CodePolicy 0784

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProviders should reference related Aetna CPBs (0207, 0235, 0411, 0649, 0934) when considering procedures that overlap with other therapies or adjuncts.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes identified in this update.

16+Procedures listed experimental

30+Codes listed (CPT/HCPCS/ICD-10)

multipleEvidence items cited

Coverage Summary

Scope: This policy defines Aetna's position that a range of autologous blood- and adipose-derived injections (including autologous blood, platelet-rich plasma [PRP], platelet-poor plasma, adipose-derived regenerative cell/ADRC and other autologous cell-based/stem-cell procedures) are considered experimental and investigational / not covered for the specified indications listed in the policy.

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Medical Necessity / Experimental Determinations

Experimental and Investigational

The following procedures are considered experimental and investigational because the effectiveness of these approaches has not been established:

Experimental and Investigational - listed procedures

Autologous blood injection for all indications including (not an all-inclusive list): cervical radiculopathy; chronic urticaria; lateral epicondylitis; lumbar radiculopathy; muscular injury; plantar fasciopathy; temporomandibular joint (TMJ) dislocation; tendinopathies (e.g., elbow, heel, knee, patella, and shoulder).
Platelet-poor plasma or platelet-rich plasma (PRP/PPP): Platelet-poor plasma or platelet-rich plasma injection for all indications including (not all-inclusive): Achilles tendon ruptures/Achilles tendinopathy; alopecia areata (androgenetic alopecia); ankle sprain; anterior cruciate ligament surgery; as adjunctive material to bone graft; avascular necrosis of the hip and the shoulder; carpometacarpal arthritis of the thumb; cerebral palsy; chronic wounds; Crohn's disease-related perianal fistula; discogenic low back pain; facial rejuvenation; gastrocnemius (calf) tear; greater trochanteric pain syndrome; hamstring injury; hip fractures; lumbar facet joint syndrome; osteoarthritis (e.g., hip, knee, TMJ); osteonecrosis of the jaw; plantar fasciitis; rotator cuff injuries; tendinopathies (elbow, heel, knee, shoulder); urethral stricture; vitiligo.
Autologous platelet gel for application following total knee arthroplasty and for diabetic foot ulcer.
Adipose-tissue-derived stem cells (Habeo cell therapy): Adipose-tissue-derived stem cells injection (Habeo cell therapy) for the treatment of chondromalacia patellae, knee osteoarthritis, scleroderma (systemic sclerosis) and all other indications.
Autologous adipose-derived regenerative cell (ADRC) therapy for the treatment of partial thickness rotator cuff tear.
Autologous cell-based therapy for CLI: Autologous cell-based therapy for critical lower limb ischemia.
Autologous fat for thumb CMC arthritis: Autologous fat for the treatment of carpometacarpal arthritis of the thumb.
Autologous interleukin-1 receptor antagonist blood products for knee osteoarthritis.
Autologous whole-blood or autologous serum for chronic urticaria: Autologous whole-blood or autologous serum acupoint injection therapy for chronic urticaria.
Bone marrow derived MSC administration: Bone marrow derived mesenchymal stromal cells administration for facet joint injections, and for the treatment of avascular necrosis of the shoulder, Crohn's disease and osteoarthritis.
Bone marrow plasma injection for the treatment of tendonopathies (e.g., elbow, heel, knee, shoulder) and all other indications.
Platelet-rich fibrin (PRF): Platelet-rich fibrin for intra-bony defects in chronic periodontitis and for rotator cuff tears.
PRP combined with stem cells (eg Regenexx): Platelet-rich plasma combined with stem cells (e.g., Regenexx) for all indications (see CPB 0411 - Bone and Tendon Graft Substitutes and Adjuncts).
Stem cell therapy for perianal fistulae: Stem cell therapy for the treatment of perianal fistulae.
Stromal vascular fraction with PRP for Crohn's: Stromal vascular fraction with platelet-rich plasma injection for treatment-refractory perianal fistulizing Crohn's disease.

Coding — CPT / HCPCS / ICD-10

CPT codes not covered for indications listed in the CPBCPTNot Covered

0232T	Injection(s), platelet rich plasma, any site, including image guidance, harvesting and preparation when performed.
0481T	Injection(s), autologous white blood cell concentrate (autologous protein solution), any site, including image guidance, harvesting and preparation, when performed.
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	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.
0748T	Injections of stem cell product into perianal perifistular soft tissue, including fistula preparation (eg, removal of setons, fistula curettage, closure of internal openings).
15771	Grafting of autologous fat harvested by liposuction technique to trunk, breasts, scalp, arms, and/or legs; 50 cc or less injectate.

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Other CPT codes related to the CPB (listed)CPT

0213T	Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with ultrasound guidance, cervical or thoracic; single level.
0214T	Second level (List separately in addition to code for primary procedure).
0215T	Third and any additional level(s).
0216T	Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with ultrasound guidance, lumbar or sacral; single level.
0217T	Second level (List separately in addition to code for primary procedure).
0218T	Third and any additional level(s).
20560	Needle insertion(s) without injection(s); 1 or 2 muscle(s).
20561	3 or more muscles.
38205	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogeneic.
38206	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; autologous.

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HCPCS codes not covered for indications listed in the CPBHCPCSNot Covered

G0460	Autologous platelet rich plasma for chronic wounds/ulcers, including phlebotomy, centrifugation, and all other preparatory procedures, administration and dressings, per treatment.
P9020	Platelet rich plasma, each unit.
S9055	Procuren or other growth factor preparation to promote wound healing.

ICD-10 codes listed (conditions for which injections are not covered)ICD-10Not Covered

E08.621	Diabetes mellitus due to underlying condition with foot ulcer.
E09.621	Drug or chemical induced diabetes mellitus with foot ulcer.
E10.621	Type 1 diabetes mellitus with foot ulcer.
E11.621	Type 2 diabetes mellitus with foot ulcer.
E13.621	Other specified diabetes mellitus with foot ulcer.
G80.0-G80.9	Cerebral palsy.
K05.30-K05.329	Chronic periodontitis.
K50.00-K50.919	Crohn's disease [regional enteritis].
K60.3	Anal fistula.
K60.4	Rectal fistula.

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Background and Evidence Summary

Clinical background and scope: The policy reviews autologous blood and platelet-based products for a wide range of conditions (tendinopathies — elbow/lateral epicondylitis, Achilles, patellar, rotator cuff; plantar fasciopathy; temporomandibular joint [TMJ] disorders; cervical and lumbar radiculopathy; chronic urticaria; osteoarthritis of hip and knee; diabetic foot ulcers; perianal Crohn's fistula; critical limb ischemia; alopecia; urethral stricture; and others).

Guideline context and evidence tenor: The document summarizes many small RCTs, cohort studies, systematic reviews and meta-analyses with mixed results — some positive RCTs (for example, PRP vs steroid in lateral epicondylitis) but many neutral or negative RCTs (e.g., Achilles, rotator cuff, knee OA) — and concludes that overall evidence is mixed and limited. Available guideline statements (ACOEM, NICE, Work Loss Data Institute) do not support routine use of autologous blood injections for tendinopathies; for some specific wound-care applications (eg, combined leucocyte/platelet/fibrin patches) guideline panels have conditional/weak recommendations where moderate evidence exists.

Study / Source	Design & n	Key finding
Suresh et al (2006)	Cohort n=20	Dry needling + autologous blood injection showed decreased VAS and Nirschl scores at follow-up (significant reductions).
Connell et al (2006)	Cohort n=35	Significant reductions in Nirschl and VAS for lateral epicondylitis at 6 months; sonographic improvements noted.
Kazemi et al (2010)	RCT n=60	Autologous blood superior to corticosteroid for short-term outcomes (4–8 weeks) on several pain/function measures.
Varshney et al (2017)	RCT n=83	PRP showed greater improvement than steroid at 6 months for elbow epicondylitis (VAS, MAYO); small sample and short follow-up noted.
Peerbooms et al (2010)	RCT n=100	PRP better than corticosteroid on VAS and DASH at 1 year for chronic lateral epicondylitis (p<0.001, p=0.005).
Meta-analyses (Sirico/Qian/Tsikopoulos etc.)	Systematic reviews / meta-analyses (various RCTs; lateral epicondylitis n~218 in Sirico)	Mixed results: corticosteroids superior short-term; autologous blood/PRP may be superior intermediate/long-term in some analyses; overall limited/low-quality evidence.
Mishra & Pavelko (2006)	Pilot cohort PRP n=15–20	PRP in chronic elbow tendinosis showed substantial long-term VAS improvements in uncontrolled cohort (up to ~25 months).
de Vos et al. (2010)	RCT n=54	PRP + eccentric exercises showed no greater improvement vs saline + exercises at 24 weeks (VISA-A difference -0.9; CI -12.4 to 10.6).
Kearney et al. (2021)	RCT n=240 (Achilles)	Single intratendinous PRP vs sham: 6‑mo VISA‑A 54.4 vs 53.4 (adjusted MD -2.7, 95% CI -8.8 to 3.3)—no benefit.
de Vos et al. 1‑yr follow-up / related Achilles trials	RCTs and systematic reviews (n small)	Multiple RCTs show no consistent benefit of PRP for Achilles tendinopathy; some short-term differences but no long-term advantage.
Sampson et al. (2010)	Pilot n=14 (knee OA)	Three PRP injections showed improvements in pain and function with no adverse events in small uncontrolled study.
Filardo et al. (2‑yr follow-up)	Cohort n=114 knees	Improvements at 12 months declined by 24 months; median duration of improvement ~9 months.
Griffin et al. (2013)	RCT ~n=200 (hip fracture)	No evidence of difference in revision surgery within 1 year between PRP and control.
Schepull et al. (2011)	RCT n=30 (Achilles rupture)	PRP not useful for Achilles tendon rupture; no significant benefit and possible detrimental effects on some scores.
Horstmann et al. (2011)	RCT n=40 (TKA, APG)	No significant clinically important effects in favor of autologous platelet gel; some subjective marginal differences only.
Martinez‑Zapata et al. (2016)	Meta-analysis 10 RCTs (442) – chronic wounds	Unclear if PRP improves chronic wound healing generally (RR 1.19, 95% CI 0.95–1.50); possible benefit for diabetic foot ulcers (RR 1.22, 95% CI 1.01–1.49).
Game et al. (Leucopatch RCT, 2018)	Multicenter RCT n=269 (DFU)	Healed within 20 weeks: 34% Leucopatch vs 22% standard care (OR 1.58; p=0.0235); no device-related AEs.
ADMIRE‑CD / darvadstrocel (phase 3 & follow-ups)	RCT and extensions (darvadstrocel n=25 in extension) / registries	Darvadstrocel associated with higher clinical remission rates for complex perianal fistulas vs control in trials and sustained remission up to 104 weeks in extensions/registries.
Hurd et al. (2020)	Pilot RCT UA‑ADRCs n=11 vs steroid n=5 (partial‑thickness rotator cuff)	UA‑ADRCs group showed improved ASES at 24 & 52 weeks vs corticosteroid; small open‑label pilot, no severe AEs.
Sanchez et al. (2012)	Case series n=40 (hip OA)	3 IA PRP injections: 57.5% had ≥30% pain reduction at 6 months; non‑controlled.
Osterman et al. (2015) lab study	In‑vitro co-culture	PRP preparations decreased inflammatory gene expression and nitric oxide production vs control, suggesting anti‑inflammatory effects.
Li et al. (2019) – PRF for intra‑bony defects	Meta‑analysis 12 trials	PRF adjunctive to open flap debridement improved probing depth, CAL gain, gingival marginal level and hard tissue parameters vs debridement alone.
Mao & Zhan (2018) – PRF for rotator cuff tears	Meta‑analysis 8 studies n=219	PRF did not improve overall clinical outcomes or reduce re‑tear rate (RR=1.30; p=0.082).
Masiello et al. (2023) – tendinopathies meta‑analysis	33 RCTs (2,025 subjects)	Generally no clear benefit of PRP vs controls across tendinopathies; evidence low/very low certainty.
Hamstring/hamstring RCTs (Hamilton 2015; Pas 2015)	RCTs/meta‑analyses (n up to 90 per trial)	Single PRP injection did not enhance return to play versus rehabilitation or control; meta‑analysis found no effect.
Bone marrow plasma / MSCs for tendinosis (Moon 2008; Duijvestein 2010)	Cohort/Phase I small studies (n~24; n=9–10)	Preliminary improvement in VAS and function reported; MSC infusions appeared feasible and safe in small early studies.
Autologous cell therapy for critical limb ischemia (Cochrane review)	7 RCTs (359 participants)	Mostly low/very low quality evidence; no clear differences in mortality or amputation rate; some signals favoring BM‑MSC for ulcer healing (single RCT).
Autologous IL‑1 receptor antagonist blood products (systematic review)	8 studies (3 RCTs, n=592)	Mixed improvements in pain/function for knee OA; AEs mostly mild/local; evidence limited (level IV).
AST/AWB for chronic spontaneous urticaria (meta-analysis)	8 trials (4 RCTs, n=529)	AST and AWB were not significantly more effective than placebo at end of treatment; no remarkable AEs.
Patellar tendinopathy / patella studies (James 2007, Di Matteo 2015)	Prospective cohort and systematic reviews (small RCTs)	Some RCTs support PRP/autologous blood for patellar tendinopathy; overall evidence limited and heterogeneous.
Rotator cuff tendinopathy (Kesikburun 2013; Fu 2017)	RCT n=40; meta‑analysis 11 studies	PRP no more effective than placebo at 1 year in RCT; meta‑analysis shows no difference in functional score or pain vs control.
Autologous platelet gel in TKA (Horstmann 2011)	RCT n=40	No clinically important benefit found for APG after TKA; further larger studies needed.
Bocanegra‑Perez et al. (2012) – jaw osteonecrosis	Case series n=8	PRP plus surgical debridement reported resolution in all patients at ~14‑month follow‑up; non‑controlled.
General systematic reviews / guidelines (NICE, ACOEM, Work Loss Data Institute)	Guideline reviews and systematic reviews	Guidelines do not support routine use of autologous blood/PRP for tendinopathies due to inadequate quantity/quality of evidence; call for more RCTs.
Kumar et al. (2013) – plantar fasciitis	Case series n=44 patients (50 heels)	Improvements in RM, VAS, AOFAS at 6 months; 64% satisfied; no complications reported; uncontrolled.
Leucopatch pilot/registry findings (Jorgensen, Londahl, Game)	Pilot cohorts and RCTs (n up to 269)	Pilot studies suggested safety; multicenter RCT (n=269) showed improved healing rates and shorter time‑to‑healing for Leucopatch vs standard care.
PRP for facial rejuvenation / alopecia (Trink 2013; de Oliveira 2023)	Pilot RCTs and meta‑analysis (small trials)	Some trials show increased hair regrowth/terminal hair density with PRP; facial rejuvenation studies show improved results but require larger RCTs.

Definitions from brief

PRPAutologous platelet-rich plasma — autologous platelet concentrate containing growth factors prepared from patient's blood

PPP/PRPLP/PRPHPPlatelet-poor plasma; PRPLP = PRP with low white blood cell and platelet concentrations; PRPHP = PRP with high platelet and white blood cell concentrations

APG/APCAutologous platelet gel / autologous platelet concentrate derived from patient's blood

MSC / BMSC / BM-MSCMesenchymal stromal/stem cells derived from bone marrow

ADSVF / ADSC / SVFAdipose-derived stromal vascular fraction / adipose-derived stem cells — cells harvested from lipoaspirate

AILBPAutologous interleukin-1 receptor antagonist blood-derived products (eg, autologous conditioned serum, autologous protein solution)

AWB / ASTAutologous whole blood injection / autologous serum therapy used for chronic spontaneous urticaria

Not Covered / Experimental (Scope Detail)

Indications and products/procedures considered experimental and investigational (policy list — readable operational rendering):

• Autologous whole-blood injections for all indications (examples listed: cervical radiculopathy; chronic urticaria; lateral epicondylitis; lumbar radiculopathy; muscular injury; plantar fasciopathy; TMJ dislocation; various tendinopathies).

• Platelet-poor plasma (PPP) and platelet-rich plasma (PRP) injections for all indications (examples listed: Achilles tendon rupture/tendinopathy; alopecia areata; ankle sprain; ACL surgery; adjunct to bone graft; avascular necrosis of hip/shoulder; thumb carpometacarpal arthritis; cerebral palsy; chronic wounds; Crohn’s perianal fistula; discogenic low back pain; facial rejuvenation; calf/hamstring tears; greater trochanteric pain syndrome; hip fractures; lumbar facet joint syndrome; osteoarthritis including hip, knee, TMJ; osteonecrosis of the jaw; plantar fasciitis; rotator cuff injuries; urethral stricture; vitiligo).

• Autologous platelet gel for: application following total knee arthroplasty; diabetic foot ulcer.

• Adipose-tissue-derived stem cell (Habeo) therapy for: chondromalacia patellae; knee osteoarthritis; scleroderma (systemic sclerosis) and other indications.

• Autologous adipose-derived regenerative cell (ADRC) therapy for: partial-thickness rotator cuff tear.

• Autologous cell-based therapies for: critical lower limb ischemia.

• Autologous fat injections for: carpometacarpal (CMC) arthritis of the thumb.

• Autologous interleukin-1 receptor antagonist blood products (eg, autologous conditioned serum / autologous protein solution) for: knee osteoarthritis.

• Autologous whole-blood or autologous serum acupoint injection therapy for: chronic urticaria.

• Bone marrow–derived mesenchymal stromal cell administration and bone marrow plasma injections for: facet joint injections; avascular necrosis of the shoulder; Crohn’s disease; osteoarthritis; tendonopathies.

• Platelet‑rich fibrin (PRF) for: intra‑bony defects in chronic periodontitis; rotator cuff tears.

• PRP combined with stem cells (eg, Regenexx) for all indications, and stem cell therapy for perianal fistulae including stromal vascular fraction (SVF) + PRP for treatment‑refractory perianal fistulizing Crohn’s disease.

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