Coverage Policy Manual
Policy #: 2009049
Category: Surgery
Initiated: December 2009
Last Review: February 2019
  Platelet-Rich Plasma (Autologous Growth Factors), Orthopedic Applications

Description:
Platelet-derived growth factors (PDGF) are frequently used as an adjunct to surgery, including but not limited to their use in periodontal, plastic/reconstructive, or orthopedic procedures; adjunctive use of PDGF is considered outside the scope of this policy. This policy only discusses use of blood-derived growth factors as a primary treatment.
 
A variety of growth factors have been found to play a role in wound healing, including platelet-derived growth factors (PDGF), epidermal growth factor, fibroblast growth factors, transforming growth factors, and insulin-like growth factors. Autologous platelets are a rich source of PDGF, transforming growth factors (that function as a mitogen for fibroblasts, smooth muscle cells, and osteoblasts), and vascular endothelial growth factors.
 
Autologous platelet concentrate suspended in plasma, also known as platelet-rich plasma (PRP), can be prepared from samples of centrifuged autologous blood. Exposure to a solution of thrombin and calcium chloride degranulates platelets, releasing the various growth factors and results in the polymerization of fibrin from fibrinogen, creating a platelet gel. The platelet gel can then be applied to wounds or may be used as an adjunct to surgery to promote hemostasis and accelerate healing. Alternatively, platelet-rich plasma may be injected directly into the tissue. Injection of platelet-rich plasma for tendon and ligament pain is theoretically related to prolotherapy, the injection of chemical irritants that are intended to stimulate inflammatory responses and induce release of endogenous growth factors.  Platelet-rich plasma is distinguished from fibrin glues or sealants, which have been used for many years as a surgical adjunct to promote local hemostasis at incision sites. Fibrin glue is created from platelet-poor plasma, and consists primarily of fibrinogen. Commercial fibrin glues are created from pooled homologous human donors; Tissel (Baxter) and Hemaseal are examples of commercially available fibrin sealants. Autologous fibrin sealants can be created from platelet-poor plasma. This policy does not address the use of fibrin sealants.
 
A number of commercially available centrifugation devices are used for the preparation of platelet-rich plasma. For example, AutoloGel™ (Cytomedix) and SafeBlood® (SafeBlood Technologies) are two related but distinct autologous blood-derived preparations that can be prepared at the bedside for immediate application. Both Autologel and SafeBlood have been specifically marketed for wound healing. Other devices may be used in the operating room setting, such as Medtronic Electromedic, Elmd-500 Autotransfusion system, the Plasma Saver device, or the Smart PreP device. In the operating room setting, platelet-rich plasma has been investigated as an adjunct to a variety of periodontal, reconstructive, and orthopedic procedures. For example, bone morphogenetic proteins are a type of transforming growth factors, and thus platelet-rich plasma has been used in conjunction with bone-replacement grafting (using either autologous grafts or bovine-derived xenograft) in periodontal and maxillofacial surgeries. In addition, platelet-rich plasma has also been proposed as a primary treatment of miscellaneous conditions, such as epicondylitis, plantar fasciitis, and Dupuytren’s contracture.
 
The use of autologous conditioned serum (ACS), a preparation of whole blood exposed to glass beads, produces a serum enriched in anti-inflammatory cytokines and some growth factors, is being tested in animals.  
 
No specific CPT codes describe the preparation of autologous blood-derived products. The use of CPT code 20926 (tissue graft, other) to describe the overall procedure is not appropriate.

Policy/
Coverage:
Autologous blood-derived preparations (i.e., platelet-rich plasma) for the adjunctive or primary treatment of orthopedic conditions including, but not limited to, epicondylitis (i.e., tennis elbow), plantar fasciitis, or Dupuytren’s contracture, do not meet primary coverage criteria.  The use of platelet rich plasma is the subject of ongoing trials.  Concerns about the use of platelet rich plasma are expressed in current medical literature because of the lack of good clinical trials.  
 
For members with contracts without primary coverage criteria, the use of autologous blood-derived preparations (i.e., platelet-rich plasma) for the adjunctive or primary treatment of orthopedic conditions is considered investigational for orthopedic conditions including, but not limited to, epicondylitis (i.e., tennis elbow), plantar fasciitis, or Dupuytren’s contracture.  Investigational procedures are an exclusion in the member benefit certificate.
 

Rationale:
One abstract was identified from a 2005 meeting presentation that described the use of percutaneous injection of PRP as a treatment of lateral epicondylitis in a prospective controlled study of 20 patients; a full report was published by Mishra and Pavelko in 2006.  Criteria for participation included elbow epicondylar pain for longer than 3 months and at least 60 of 100 on a VAS with failure of conservative therapy (a standardized stretching and strengthening protocol, and some combination of non-steroidal medication, bracing, or corticosteroid injections). Twenty (15%) of the 140 patients evaluated met the inclusion/exclusion criteria. Fifteen patients were treated with PRP and 5 patients were injected only with bupivacaine with epinephrine into the skin, subcutaneous tissue and directly into the area of maximum tenderness. Either 2–3 mL PRP or 2–3 mL bupivacaine with epinephrine was injected into the common extensor or flexor tendon using a single skin portal with 5 penetrations of the tendon (peppering technique). Although drawing of 55 mL of blood in control patients (to conceal the treatment allocation) was not permitted by the institutional review board, participants were informed that the needling alone was expected to improve symptoms. All participants were given a standardized post-treatment stretching and strengthening program. At 4 weeks after the procedure, PRP-treated patients reported a mean 46% improvement (80 to 43) in VAS pain scores and a 42% improvement (50 to 71) in Mayo elbow scores. Control patients reported a mean 17% improvement (86 to 71) in VAS and 20% improvement (50 to 60) in Mayo elbow scores. The PRP-treated patients continued to improve over follow-up. At a mean of 26 months’ follow-up PRP-treated patients reported a 93% reduction in pain compared with before the procedure. Follow-up was limited in the control patients as 3 of 5 (60%) had either sought treatment outside of the protocol or had formally withdrawn from the study by 8 weeks. No complications were noted in either group at any time. Mishra and colleagues (2009) report that a double-blind prospective trial with 230 patients had been initiated in the United States using this protocol.
 
Nin (2009) reported results in 100 patients undergoing arthroscopic patellar tendon allograft ACL reconstruction, 50 received platelet-enriched gel (PDGF) inside the graft and tibial tunnel, 50 did not.  At 2-years follow-up there was no discernable clinical or biomedical effect.  There was no statistically significant difference for inflammatory parameters in the two groups.
 
Hall and colleagues (2009) cautioned that minimal clinical evidence is currently available yet the use of platelet-rich plasma has increased.  “Many controlled clinical trials are under way, but clinical use should be approached cautiously until high-level clinical evidence supporting platelet-rich efficacy is available.”
 
Foster and colleagues (2009) states the use of autologous products is a rapidly growing field of orthopedics focusing on manipulating growth factors and secretory proteins to maximize healing of bone and soft tissue.  “Despite their clinical use, many of these products have not been studied using rigorous scientific standards.”  “Before adopting PRP into a sports medicine practice, it is important to assess the evidence in the literature that supports its safety and efficacy.”  The authors state there are significant questions to be addressed:
    • The differential effects on acutely injured tendon versus the degenerative tendon since underlying cellular and molecular processes are quite different between the two medical conditions
    • The timing of the PRP injection in the treatment of the acutely injured tendon, ligament or muscle
    • The best time for PRP injection and the effect of serial injections
    • The kinetics of cytokine release from various PRP preparations
    • The effect of local tissue pH on PRP activity as there are some preliminary data that cytokine release from PRP is pH dependent.
 
Harnack (2009) reported 22 patients with contralateral bony defects that were randomized to beta-TCP (Cerasorb) in combination with PRP or alone.  In early healing parameters and at 6 months PRP did not improve results achieved with beta-TCP in the treatment of intrabony defects.  
 
One trial, industry sponsored, was completed in 2009 but results have not yet been published:
NCT00757289 compares PRP with corticosteroid injection for treatment of tennis elbow.
There are other ongoing trials involving PRP in total knee replacement, in rotator cuff repair, in meniscus repair, medial retinaculum tear, Achilles tendon tear, MCL tear, periodontal regeneration and bone augmentation in post-extraction sockets.  
 
In Jan 2010 de Vos and colleagues reported a single center study of 54 randomized patients with chronic tendinopathy 2 to 7 cm above the Achilles tendon insertion.  All had eccentric exercises and PRP injection (n=27) or saline injection (n-27).  Pain score and activity level were completed at baseline and 6, 12, & 24 weeks utilizing the validated Victorian Institute of Sports Assessment-Achilles (VISA-A).  At 24 weeks the mean VISA-A improved 21.7 points in the PRP group (95% CI,13 - 30.5) and by 20.5 points in the placebo group (95% CI, 11.6 - 29.4).  There were no significant differences in secondary outcomes of patient satisfaction and return to sports activity between the two groups. (NCT00761423)
 
2012 Update
A search of the MEDLINE database through September 2012 did not reveal any new information that would prompt a change in the coverage statement.
 
A search of the clinicaltrials.gov website identified 17 clinical trials assessing the use of platelet-rich plasma for orthopedic applications. Several of these trials are listed as completed but do not have study results or publications provided. The following studies are listed as ongoing:
 
NCT01670578-Platelet-rich Plasma vs Viscosupplementation in the Treatment of knee Articular Degenerative Pathology . Randomized, double-blind trial of PRP vs hyaluronic acid. Single site study conducted in Italy. Estimated completion date 2013.
 
NCT00826098-Platelet Rich Plasma (PRP) in Total Knee Replacement. Sponsored by Exactech. Randomized, single-blind, single-center study.
 
NCT01238302-Arthroscopic Rotator Cuff Repair with Platelet-Rich Plasma in Large Massive Tears.  Estimated study completion date October 2012. Conventional arthroscopic rotator cuff repair vs conventional repair plus PRP.
 
NCT01458665- Arthroscopic Rotator Cuff Repair with Platelet-Rich Plasma in Medium to Large Rotator Cuff Tears. Estimated study completion date October 2013. Conventional arthroscopic rotator cuff repair vs conventional repair plus PRP.
 
NCT01458691- Intra-articular Injection of Allogeneic Platelet Rich Plasma (PRP) for Adhesive Capsulitis.  Randomized, Double-blind, Placebo-controlled trial. Estimated completion date December 2013.
 
NCT00961597- Assessment of Outcome of Meniscus Repair with or without Platelet Rich Plasma. Non-randomized, open-label trial sponsored by the Cincinnati Sportsmedicine Research and Education Foundation. Scheduled completion date December 2011.
 
NCT01152658- Partial Tear of Supraspinatus and Treatment with Plasma Rich in Growth Factors (PRGF). Sponsored by the Meir Medical Center. Phase 1, Randomized, double-blind trial. Estimated completion date May 2012.
 
2014 Update
A search of the MEDLINE database through March 2014  did not reveal any new information that would prompt a change in the coverage statement.
 
A search of the clinicaltrials.gov website revealed of the identified clinical trials in 2012, two have completed (NCT00826098 and NCT01238302) but no results have been published; one clinical trial (NCT01152658) was withdrawn and is no longer active. There are four ongoing clinical trials from those listed in 2012:
 
NCT01670578-Platelet-rich Plasma vs Viscosupplementation in the Treatment of knee Articular Degenerative Pathology . Randomized, double-blind trial of PRP vs hyaluronic acid. Single site study conducted in Italy. Estimated completion date 2013.
 
NCT01458665- Arthroscopic Rotator Cuff Repair with Platelet-Rich Plasma in Medium to Large Rotator Cuff Tears. Estimated study completion date October 2013. Conventional arthroscopic rotator cuff repair vs conventional repair plus PRP.
 
NCT01458691- Intra-articular Injection of Allogeneic Platelet Rich Plasma (PRP) for Adhesive Capsulitis.  Randomized, Double-blind, Placebo-controlled trial. Estimated completion date December 2013.
 
NCT00961597- Assessment of Outcome of Meniscus Repair with or without Platelet Rich Plasma. Non-randomized, open-label trial sponsored by the Cincinnati Sportsmedicine Research and Education Foundation. Scheduled completion date December 2011
 
2016 Update
A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement.
 
2017 Update
 A search of the MEDLINE database did not reveal any new literature that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
 
PRP as a Primary Treatment of Tendinopathies
In 2016, Tsikopoulos et al published a systematic review that compared PRP to placebo or dry needling in patients with tendinopathy lasting at least 6 weeks (Tsikopoulos, 2016). Minimum length of follow-up was 6 months. The primary outcome of interest was pain intensity; the secondary outcome was functional disability. Five RCTs met the reviewers’ eligibility criteria. Two RCTs addressed lateral epicondylitis, 2 rotator cuff tendinopathy, and 2 patellar tendinopathy. Three studies had a saline control group and 2 compared PRP with dry needling. In a pooled analysis of all 5 trials, there was no statistically significant difference in pain intensity at 2 to 3 months with PRP or placebo/dry needling (standardized mean difference [SMD], -0.29; 95% confidence interval [CI], -0.60 to 0.02). The between-groups difference in pain intensity was statistically significant at 6 months in a pooled analysis of the 4 studies (SMD = -0.48; 95% CI, -0.86 to -0.10). The authors noted that the difference between groups in pain relief at 6 months was not clinically significant. Three studies reported functional disability levels at 3 months and a meta-analysis of these studies found significantly greater decrease in function in the PRP group (SMD = -0.47; 95% CI, -0.85 to -0.09). Functional disability 6 months postintervention was not addressed in this review.
 
A 2015 systematic review by Balasubramaniam et al included RCTs on PRP for tendinopathy (Balasubramaniam, 2015). In contrast to the Tsikopoulos et al (2016) review, the authors did not limit study inclusion criteria by type of control intervention or postintervention length of follow-up. The authors included 4 of the 5 RCTs in the Tsikopoulos et al review and 5 additional RCTs (total of 9). There were 4 trials on epicondylitis, 2 on rotator cuff tendinopathy, 2 on patellar tendinopathy, and 1 on Achilles tendinopathy. Comparison interventions included placebo (n=3), dry needling (n=2), autologous blood (n=2), extracorporeal shock wave therapy (n=1), and corticosteroid injections (n=2). (One study included both placebo and corticosteroid control groups.) The authors did not pool study findings due to a high level of heterogeneity among studies. In their qualitative analysis of the literature by anatomic site of tendinopathy, they concluded that 1 study on PRP for Achilles tendinopathy was insufficient to draw conclusions about efficacy. Findings of studies of other anatomic sites were mixed. Some studies showed statistically significantly greater benefit of PRP than controls on outcomes and some did not, or some studies found statistically significantly better outcomes at some time points but not others.
 
Knee Osteoarthritis
One placebo-controlled trial, Patel et al (2013) was identified (Patel, 2013). The RCT included 78 patients with bilateral knee osteoarthritis. Patients were randomized to receive a single injection of PRP, 2 injections of PRP, or a single saline placebo injection. There was statistically significantly greater improvement in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 1, 3 and 6 months in the active treatment groups combined compared with the placebo group (p<0.01). The difference in WOMAC scores between patients who received 1 or 2 injections of PRP did not differ significantly.
 
ACL Reconstruction
A 2015 qualitative systematic review by Figueroa et al included 11 RCTs or prospective cohort studies with a combined total of 516 patients (Figueroa, 2015). Four studies found significantly faster graft maturation while 3 found no significant difference. One study showed faster tunnel healing while 5 showed no benefit. One study showed better clinical outcomes and 5 showed no improvement in clinical outcomes when using PRP.
 
2018 Update
A literature search conducted through January 2018 revealed no new information that would prompt a change in the coverage statement.
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
PRP as a Primary Treatment for Tendinopathy
Several systematic reviews have evaluated PRP for treating mixed tendinopathies. They include trials on tendinopathies of the Achilles, rotator cuff, patella, and/or lateral epicondyle (tennis elbow). Recent (ie, 2014 to present) systematic reviews of RCTs and/or nonrandomized studies are described next. Miller et al conducted a systematic review and meta-analysis on PRP for symptomatic tendinopathy and included only RCTs with injection controls (Miller, 2017). The literature search, conducted through November 2016, identified 16 RCTs, with 18 groups (some studies included >1 tendinopathy site) for inclusion (total N=1018 patients). The Cochrane Collaboration tool was used to assess the risk of bias: 5 studies had an uncertain risk of bias, and 11 studies had a high risk of bias. The median sample size was 35 patients. Tendinopathy sites were lateral epicondylar (12 groups), rotator cuff (3 groups), Achilles (2 groups), and patellar (1 group). Preparation of PRP differed across trials as did the number of injections, with most studies administering 1injection and a few administering 2 injections. Eight of the 18 groups reported statistically significant lower pain scores using PRP compared with control and the other ten reported no differences in pain scores between trial arms. A meta-analysis reported a standard mean difference (SMD) in pain scores favoring PRP over control (0.47; 95% confidence interval [CI], 0.21 to 0.72; I2=67%).
 
PRP as a Primary Treatment of Knee or Hip Osteoarthritis
Xu et al acid (8 trials) or placebo (2 trials) for the treatment of knee OA (Xu 2017). Risk of bias was assessed using Cochrane criteria. Four studies were assessed as having low quality, 3 as moderate quality, and 3 as high quality. Meta-analyses including 7 of the trials comparing PRP with hyaluronic acid showed that PRP significantly improved Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) or International Knee Documentation Committee (IKDC) scores compared with HA at 6-month follow-up; however, when meta-analyses included only the 2 high-quality RCTs, there was not a significant difference between PRP and hyaluronic acid. (Note that WOMAC evaluates 3 domains: pain, scored from 0-20; stiffness, scored from 0-8; and physical function, scored from 0-68. Higher scores represent greater pain and stiffness as well as worsened physical capability. The IKDC is a patient-reported, knee-specific outcome measure that measures pain and functional activity.) In the meta-analysis comparing PRP with placebo, a third trial was included, which had four treatment groups, two of which were PRP and placebo. This analysis showed that PRP significantly improved WOMAC or IKDC scores compared with placebo; however, only one of the trials was considered high quality and that trial only enrolled 30 patients. All meta-analyses showed high heterogeneity among trials (I2≥90%).
 
Long Bone Nonunion
The trial study by Dallari et al, which was included in the Cochrane review, compared PRP plus allogenic bone graft with allogenic bone graft alone in patients undergoing corrective osteotomy for medial compartment osteoarthrosis of the knee (Dallari, 2007). According to Cochrane reviewers, the risk of bias in this study was substantial. Results showed no significant differences in patient-reported or clinician-assessed functional outcome scores between groups at 1 year. However, the proportion of bones united at 1 year was statistically significantly higher in the PRP plus allogenic bone graft arm (8/9) compared with the allogenic bone graft alone arm (3/9; relative risk, 2.67; 95% CI, 1.03 to 6.91). This benefit, however, was not statistically significant when assuming poor outcomes for participants who were lost to follow-up (8/11 vs 3/10; relative risk, 2.42; 95% CI, 0.88 to 6.68).
 
Samuel et al conducted a controlled trial in which patients with delayed unions (15-30 weeks old) were randomized to 2 PRP injections at the fracture site at baseline and 3 weeks (n=23) or no treatment (n=17) (Samuel, 2017).https://www.evidencepositioningsystem.com/_w_1985646703e69442087b4411f05a9ef225be82b4b8f87d49/ The delayed unions were in the tibia (n=29), femur (n=8), forearm (n=2), and the humerus (n=1). The main outcome was long bone union, defined as no pain or tenderness on weight bearing, no abnormal mobility, and bridging at three or more cortices in x-ray. Examinations were conducted every 6 weeks for 36 weeks or until union. Percent union did not differ significantly between the 2 groups (78% in the PRP group vs 59% in the control group). Time to union also did not differ significantly (15.3 weeks for the PRP group vs13.1 weeks for the control group).
 
Rotator Cuff Repair
Chen et al conducted a systematic review and meta-analysis on the efficacy of PFP for tendon and ligament healing (Chen, 2017). The literature search, conducted through April 2017, identified 37 articles for qualitative synthesis, 21 of which reported VAS outcomes and were used in a meta-analysis. Of the 21 studies, 8 enrolled patients undergoing rotator cuff repair. Patients in the PRP group experienced significant reductions in VAS pain compared with the control group at both short-term (6 months) follow-up (-0.5; 95% CI, -0.7 to -0.1) and long-term (≥1 year) follow-up (-0.5; 95% CI, -1.0 to -0.1). While findings were encouraging, reviewers warned that there was extensive variability in both the way PRP was prepared and how the PRP injections were administered.
 
Ebert et al (2017) published an RCT after the systematic reviews discussed above comparing rotator cuff repair alone with rotator cuff repair plus PRP treatment (Ebert, 2017). Patients were randomized to 2 ultrasound-guided injections of PRP to the tendon repair site at 7 and 14 days after arthroscopic supraspinatus repair (n=27) or not (n=28). Outcomes of interest included Oxford Shoulder Score, Quick Disabilities of the Arm, Shoulder and Hand questionnaire, and VAS score for pain. At a mean follow-up of 3.5 years, there were no statistically significant differences in any of the outcomes of interest. There was also no difference in re-tear rates, with 2 patients in each trial group experiencing symptomatic re-tears.
 
Practice Guidelines and Position Statements
 
American Academy of Orthopaedic Surgeons
AAOS issued evidence-based guidelines on the management of OA of the hip (AAOS, 2017). In the section on intra-articular injectables, the guidelines stated that there is strong evidence supporting the use of intra-articular corticosteroids to improve function and reduce pain in the short term for patients with OA of the hip. There was also strong evidence that the use of intra-articular hyaluronic acid does not perform better than placebo in improving function, stiffness, and pain in patients with hip OA. The guidelines also noted that there were no high-quality studies comparing PRP with placebo for the treatment of OA of the hip.

CPT/HCPCS:
0232TInjection(s), platelet rich plasma, any site, including image guidance, harvesting and preparation when performed

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American Academy of Orthopaedic Surgeons A.(2018) Management of Osteoarthritis of the Hip - Evidence-Based Clinical Practice Guideline. 2017; https://www.aaos.org/uploadedFiles/PreProduction/Quality/Guidelines_and_Reviews/OA%20Hip%20CPG_1.5.18.pdf. Accessed February 15, 2018.

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Patel S, Dhillon MS, Aggarwal S, et al.(2016) Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. Am J Sports Med. Feb 2013;41(2):356-364. PMID 23299850

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Reider B.(2009) Proceed with caution. (editorial) Am J Sports Med, 2009; 37(11):2099-2101.

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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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