Latest Review Date: May 2024

Category: Surgical

 

POLICY:

Recombinant platelet-derived growth factor (i.e., becaplermin) may be considered medically necessary when used as an adjunct to standard wound management for the following indications:

• Neuropathic diabetic ulcers extending into the subcutaneous tissue when all of the following criteria are met:
  • Adequate tissue oxygenation, (as measured by a transcutaneous partial pressure of oxygen of 30 mm Hg or greater on the foot dorsum or at the margin of the ulcer); AND
  • Full thickness ulcer (i.e., stage III or IV), extending through dermis into subcutaneous tissues; AND
  • Participation in a wound-management program, which includes sharp debridement, pressure relief, and infection control
  • Pressure ulcers extending into the subcutaneous tissue when all of the following criteria is met:
  • Full-thickness ulcer (stage III or IV), extending through dermis into the subcutaneous tissue; AND
  • Ulcer in an anatomic location that can be off-loaded for the duration of treatment; AND
  • Albumin concentration > 2.5 dL; AND
  • Total lymphocyte count > 1,000; AND
  • Normal values of vitamins A and C

Treatments are normally for 20 weeks or complete healing.

Other applications of recombinant platelet-derived growth factor (i.e., becaplermin) are considered investigational, including, but not limited to, ischemic ulcers, ulcers related to venous stasis, and ulcers not extending through the dermis into the subcutaneous tissue.

Autologous blood derived preparations (i.e., platelet rich plasma) are considered investigational, including but not limited to, use in the following:

• Treatment of acute or chronic wounds including surgical wounds, and non-healing ulcers
• All orthopedic indications including but not limited to the following situations and conditions:

•  Primary use (injection)
  • Achilles tendinopathy
  • Lateral epicondylitis
  • Plantar fasciitis
  • Osteochondral lesions
  • Osteoarthritis
  • Dupuytren’s contracture
  • Cartilage degeneration
  • Degenerative disc disease
• Adjunctive use in surgical procedures
  • ACL reconstruction
  • Hip fracture
  • Long-bone nonunion
  • Patellar tendon repair
  • Rotator cuff repair
  • Spinal fusion
  • Subacromial decompression surgery
  • Total knee arthroplasty

 

DESCRIPTION OF PROCEDURE OR SERVICE:

The use of blood-derived growth factors, including recombinant platelet-derived growth factors (PDGFs) and platelet-rich plasma (PRP), has been suggested as a treatment for wounds or other miscellaneous non-orthopedic conditions, including but not limited to, diabetic ulcers, pressure ulcers, venous stasis ulcers, and surgical and traumatic wounds.

A variety of growth factors have been found to play a role in wound healing, including platelet-derived growth factors, 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, osteoblasts), and vascular endothelial growth factors. Recombinant PDGF has also been extensively investigated for clinical use in wound healing.

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. In the operating room setting, PRP 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 factor, and thus PRP has been used in conjunction with bone-replacement grafting (using either autologous grafts or bovine-derived xenograft) in periodontal and maxillofacial surgeries. Alternatively, PRP may be injected directly into various tissues. Platelet rich plasma injections have been proposed as a primary treatment of miscellaneous conditions, such as epicondylitis, plantar fasciitis, and Dupuytren contracture.

PRP 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; Tisseel® (Baxter) and VITASEAL™ (Johnson & Johnson Surgical Technologies) 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.

Wound Closure Outcomes

This policy addresses the use of recombinant PDGF products and PRP for non-orthopedic indications, which include a number of wound closure-related indications.

For the purposes of this review, the primary end points of interest for studies of wound closure are as follows, consistent with guidance from the FDA for industry in developing products for treatment of chronic cutaneous ulcer and burn wounds:

1. Incidence of complete wound closure.
2. Time to complete wound closure (reflecting accelerated wound closure).
3. Incidence of complete wound closure following surgical wound closure.
4. Pain control.

KEY POINTS:

The most recent literature update was performed through February 13, 2024. 

Summary of Evidence

For individuals who have diabetic lower-extremity ulcers who receive recombinant PDGF, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life (QOL), and treatment-related morbidity. Results have shown improved rates of healing with use of recombinant PDGF for diabetic neuropathic ulcers and pressure ulcers. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have pressure ulcers who receive recombinant PDGF, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. Results have shown improved rates of healing with use of recombinant PDGF for pressure ulcers. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have venous stasis leg ulcers or acute surgical or traumatic wounds who receive recombinant PDGF, the evidence includes small RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. The level of evidence does not permit conclusions whether recombinant PDGF is effective in treating other wound types, including chronic venous ulcers or acute traumatic wounds. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have chronic wounds who receive PRP, the evidence includes meta-analyses of a number of small controlled trials. Relevant outcomes are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. In individuals with lower extremity diabetic ulcers, PRP demonstrated an improvement over the control groups in complete wound closure and healing time, but moderate to high risk of bias and imprecision preclude drawing conclusions on other important outcomes such as recurrence, infection, amputation, and quality of life. In individuals with venous ulcers, PRP did not demonstrate an improvement over the control groups in complete wound closure, recurrence, wound infection or quality of life, although imprecision likely precluded identifying differences on these outcomes. In individuals with pressure ulcers, although PRP reduced wound size, other important outcomes such as complete wound closure were not measured. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have acute surgical or traumatic wounds who receive PRP, the evidence includes systematic reviews and a number of small controlled trials. Relevant outcomes are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. Current results of trials using PRP are mixed and the studies are limited in both size and quality. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Primary Treatment for Tendinopathies

For individuals with tendinopathy who receive  platelet-rich plasma injections, the evidence includes multiple randomized controlled trials (RCTs) and systematic reviews with meta-analyses. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related morbidity. Findings from meta-analyses of RCTs have been mixed and have generally found that PRP did not have a statistically and/or clinically significant impact on symptoms (i.e., pain) or functional outcomes.Findings from subsequently published RCT failed to find improvement compared with placebo. The evidence is insufficient to determine the effects of the technology on health outcomes.

Primary Treatment for Non‒Tendon Soft Tissue Injury or Inflammation

For individuals with non-tendon soft tissue injury or inflammation (e.g., plantar fasciitis) who receive PRP injections, the evidence includes six small RCTs, multiple prospective observational studies, and systematic reviews. The relevant outcomes are symptoms, functional outcomes, health status measures, QOL, and treatment-related morbidity. The 2014 systematic review, which identified three RCTs on PRP for plantar fasciitis, did not pool study findings. Results among the six RCTs were inconsistent. The largest RCT showed that treatment using PRP compared with corticosteroid injection resulted in statistically improvement in pain and disability, but not quality of life. A 2023 systematic review found improved VAS scores with platelet-rich plasma compared to corticosteroid injections out to 6 months duration, but numerical differences between groups were small. Larger RCTs completed over a sufficient duration of time (i.e., 2 years) are still needed to address important uncertainties in efficacy and safety. The evidence is insufficient to determine the effects of the technology on health outcomes.

Primary Treatment for Osteochondral Lesions

For individuals with osteochondral lesions who receive PRP injections, the evidence includes an open-labeled quasi-randomized study. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related morbidity. The quasi-randomized study found a statistically significant greater impact on outcomes in the PRP group than in the group receiving hyaluronic acid. Limitations of the evidence base include lack of adequately randomized studies, lack of blinding, lack of sham controls, and comparison only to an intervention of uncertain efficacy. The evidence is insufficient to determine the effects of the technology on health outcomes.

Primary Treatment for Knee or Hip Osteoarthritis

For individuals with knee or hip OA who receive PRP injections, the evidence includes multiple RCTs and systematic reviews. The relevant outcomes are symptoms, functional outcomes, health status measures, QOL, and treatment-related morbidity. Most trials have compared PRP with hyaluronic acid for knee OA. Systematic reviews have generally found that PRP was more effective than placebo or hyaluronic acid in reducing pain and improving function. However,

systematic review authors have noted that their findings should be interpreted with caution due to important limitations including significant residual statistical heterogeneity, questionable clinical significance, and high risk of bias in study conduct. RCTs with a follow-up of at least 12 months published subsequent to the systematic reviews found statistically significantly greater 12-month reductions in pain and function outcomes, but these findings were also limited by important study conduct flaws including potential inadequate control for selection bias and unclear blinding. Also, benefits were not maintained at 5 years. Using hyaluronic acid as a comparator is questionable because the evidence demonstrating the benefit of hyaluronic acid treatment for OA is not robust. Two systematic reviews evaluating hip osteoarthritis did not report any statistically or clinically significant differences in pain or functional outcomes compared to hyaluronic acid, corticosteroids, or placebo. Additional studies comparing PRP with placebo and with alternatives other than hyaluronic acid are needed to determine the efficacy of PRP for knee and hip OA. Studies are also needed to determine the optimal protocol for delivering PRP. The evidence is insufficient to determine the effects of the technology on health outcomes.

Adjunct to Surgery

For individuals with anterior cruciate ligament reconstruction who receive platelet-rich plasma injections plus orthopedic surgery, the evidence includes several systematic reviews of multiple RCTs and prospective studies and a retrospective matched case-control study. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, morbid events, resource utilization, and treatment-related morbidity. In 2 systematic reviews that conducted a meta-analysis, adjunctive platelet-rich plasma treatment did not result in a significant effect on International Knee Documentation Committee (IKDC) scores, a patient-reported, knee-specific outcome measure that assesses pain and functional activity. One systematic review found improvements with platelet-rich plasma compared to controls in outcomes at 6 months, but these differences were determined to be clinically irrelevant with the exception of pain at 6 months which was improved with platelet-rich plasma. Individual trials have shown mixed results. A retrospective matched case-control study found no differences in knee function scores or time to return of activity between platelet-rich plasma and matched-control groups at 2 years; however, the platelet-rich plasma group demonstrated a higher rate of postoperative knee motion loss compared with the control group. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with hip fracture who receive platelet-rich plasma injections, the evidence includes 1 open-labeled RCT. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, morbid events, resource utilization, and treatment-related morbidity. The single open-label RCT failed to show any statistically significant reduction in the need for surgical revision with the addition of PRP treatment. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with long bone nonunion who receive platelet-rich plasma injections plus orthopedic surgery, the evidence includes three RCTs. The relevant outcomes are symptoms, functional outcomes, health status measures, QOL, morbid events, resource utilization, and treatment-related morbidity. One trial with a substantial risk of bias failed to show significant differences in patient-reported or clinician-assessed functional outcome scores between those who received PRP plus allogenic bone graft and those who received only allogenic bone graft. While the trial showed a statistically significant increase in the proportion of bones that healed in patients receiving PRP in a modified intention-to-treat analysis, the results did not differ in the intention-to-treat analysis. An RCT that compared platelet-rich plasma with recombinant human bone morphogenetic protein-7 (rhBMP-7), , also failed to show any clinical or radiologic benefits of PRP over morphogenetic protein. The third RCT reported no difference in the number of unions or time to union in patients receiving PRP injections s no treatment. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with rotator cuff repair who receive platelet-rich plasma injections plus orthopedic surgery, the evidence includes multiple RCTs and systematic reviews. The relevant outcomes are symptoms, functional outcomes, health status measures, QOL, morbid events, resource utilization, and treatment-related morbidity. Although systematic reviews consistently found significant reductions in pain with PRP at 12 months, important study conduct and relevance weaknesses limit interpretation of these findings. While the systematic reviews and meta-analyses generally failed to show a statistically and/or clinically significant impact on other outcomes, 1 meta-analysis found a statistically significant reduction in retear rate in a subgroup analysis of 4 RCTs that were at least 24 months in duration. The findings of a subsequently published 10-year follow-up of a small RCT failed to demonstrate the superiority of platelet-rich plasma over control for clinical and radiologic outcomes. The variability in platelet-rich plasma preparation techniques and platelet-rich plasma administration limits the generalizability of the available evidence. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with spinal fusion who receive platelet-rich plasma injections plus orthopedic surgery, the evidence includes two controlled prospective studies. The relevant outcomes are symptoms, functional outcomes, health status measures, QOL, morbid events, resource utilization, and treatment-related morbidity. The two studies failed to show any statistically significant differences in fusion rates between the PRP arm and the control arm. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals undergoing spinal fusion who receive platelet-rich plasma injections, the evidence includes a single small RCT and a few observational studies. Relevant outcomes include symptoms, functional outcomes, health status measures, quality of life, morbid events, resource utilization, and treatment related morbidity. Studies have generally failed to show a statistically and/or clinically significant impact on symptoms (ie, pain). The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with subacromial decompression surgery who receive platelet-rich plasma injections, the evidence includes 1 small RCT. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, morbid events, resource utilization, and treatment-related morbidity. A single small RCT failed to show reduced self-assessed or physician-assessed spinal instability with PRP injections. However, subjective pain, use of pain medications, and objective measures of range of motion showed clinically significant improvements with PRP. Larger trials are required to confirm these benefits. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with total knee arthroplasty who receive platelet-rich plasma injections, the evidence includes 1 small RCT. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, morbid events, resource utilization, and treatment-related morbidity. The RCT showed no significant differences between the PRP and untreated control groups in terms of bleeding, range of motion, swelling around the knee joint, muscle power recovery, pain, or Knee Society Score and Knee Injury and Osteoarthritis Outcome Score. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines And Position Statements

American College of Physicians

In 2015, the American College of Physicians (ACP) published guidelines on treatment of pressure ulcers. The guidelines noted that “although low quality evidence suggests that dressings containing PDGF [platelet-derived growth factors] promote healing, ACP supports the use of other dressings such as hydrocolloid and foam dressings, which are effective at promoting healing and cost less than PDGF dressings.”

Association for the Advancement of Wound Care

In 2010, the Association for the Advancement of Wound Care developed guidelines pressure ulcers and on venous ulcer:

• Pressure ulcer: growth factors are not indicated at this time (level C evidence – no RCTs available comparing growth factors with A-level dressings)
• Venous ulcer: platelet derived growth factor has shown no significant effects on venous ulcer healing or recurrence (level A evidence).

National Institute for Health and Care Excellence

In January 2016, NICE updated its guidance on the prevention and management of diabetic foot problems. The guidance states that neither autologous platelet-rich plasma gel nor platelet-derived growth factor should be offered in the treatment of diabetic foot ulcers.

American Academy of Orthopaedic Surgeons

The 2021, the American Academy of Orthopaedic Surgeons (AAOS) guidelines for the management of osteoarthritis of the knee made the following recommendation:

• "Platelet-rich plasma (PRP) may reduce pain and improve function in patients with symptomatic osteoarthritis of the knee. (Strength of Recommendation: Limited)" The variability of study findings was noted to have contributed to the low strength of recommendation rating.

In 2023, the AAOS updated evidence-based guidelines on the management of osteoarthritis of the hip. In the section on intra-articular injectables, the guidelines gave a moderate recommendation based on high-quality evidence supporting the use of intra-articular corticosteroids as an option to improve function and reduce pain in the short term for patients with osteoarthritis of the hip. There was also a strong recommendation based on high-quality evidence against the use of intra-articular hyaluronic acid, as it does not perform better than placebo in improving function, stiffness, and pain in patients with hip osteoarthritis. The guidelines did not mention any evidence or make recommendations related to the use of platelet-rich plasma for the treatment of osteoarthritis of the hip.

In 2019, the AAOS issued evidence-based guidelines on the management of rotator cuff injuries. The guideline noted the following recommendations related to the use of platelet-rich plasma in this setting:

• "There is limited evidence supporting the routine use of platelet-rich plasma for the treatment of cuff tendinopathy or partial tears (Strength of Recommendation: Limited)." The variability of study findings was noted to have contributed to the low strength of recommendation rating.
• "Strong evidence does not support biological augmentation of rotator cuff repair with platelet-derived products on improving patient reported outcomes; however, limited evidence supports the use of liquid platelet rich plasma in the context of decreasing re-tear rates (Strength of Recommendation: Strong)."
• "In the absence of reliable evidence, it is the consensus of the work group that we do not recommend the routine use of platelet rich plasma in the non-operative management of full-thickness rotator cuff tears. (Strength of Recommendation: Consensus)"

National Institute for Health and Care Excellence

In 2013, the U.K.’s National Institute for Health and Care Excellence (NICE) issued guidance on use of autologous blood injection for tendinopathy. NICE concluded that the current evidence on the safety and efficacy of autologous blood injection for tendinopathy is “inadequate” in quantity and quality. NICE recommended “this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.”

In 2013, NICE also issued guidance on use of autologous blood injection (with or without techniques for producing PRP) for plantar fasciitis. NICE concluded that the evidence on autologous blood injection for plantar fasciitis raised no major safety concerns but that the evidence on efficacy was “inadequate in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.” In addition, physicians should ensure that patients “understand the uncertainty about the procedure’s efficacy, [be] aware of alternative treatments” and be provided “with clear written information.”

In 2019, the NICE issued guidance on the use of PRP for OA of the knee. The NICE concluded that current evidence on PRP injections for OA of the knee raised “no major safety concerns”;however, the “evidence on efficacy is limited in quality. Therefore, NICE recommended that "this procedure should only be used with special arrangements for clinical governance, consent, and audit or research."

In 2019, the National Institute for Health and Care Excellence updated its guidance on the prevention and management of diabetic foot problems. The guidance stated that neither autologous platelet-rich plasma gel nor platelet-derived growth factors should be offered in the treatment of diabetic foot ulcers.

U.S. Preventive Services Task Force Recommendations

Not Applicable.

KEY WORDS:

Autologous platelet derived growth factors, autologous blood derived preparations, platelet-derived growth factors, PDGF, platelet rich plasma, PRP, autologous platelet gel, Autologel, SafeBlood, Medtronic Electromedic, Elmd-500 Autotransfusion system, Plasma Saver, Smart PreP, wound healing, platelet gel, platelet concentrate, autologous blood-derived products, platelet-derived wound healing formulas, epicondylitis, tennis elbow, plantar fasciitis, Dupuytren’s contracture, becaplermin, becaplermin gel, recombinant platelet-derived growth factor, VITASEAL, Aurix System, Aurix System, autoLog Autotransfusion system, SmartPRePÒ, Magellan Autologous Platelet Separator System, GPS II, GPS III

APPROVED BY GOVERNING BODIES:

In 1997, becaplermin gel (Regranex®, Smith & Nephew), a recombinant platelet-derived growth factor (PDGF) product, was approved by the U.S. Food and Drug Administration (FDA) for the following labeled indication:

"Regranex Gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. When used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control, Regranex Gel increases the complete healing of diabetic ulcers. The efficacy of Regranex Gel for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue or ischemic diabetic ulcers has not been evaluated...Regranex is not intended to be used in wounds that close by primary intention."

In 2008, the manufacturer added this black box warning to the labeling for Regranex:

“An increased rate of mortality secondary to malignancy was observed in patients treated with three or more tubes of REGRANEX Gel in a post-marketing retrospective cohort study. REGRANEX Gel should only be used when the benefits can be expected to outweigh the risks. REGRANEX Gel should be used with caution in patients with known malignancy.”

In 2018, the “Boxed Warning” and “Warnings and Precautions” were changed to remove “increased rate of cancer mortality” and “cancer mortality,” respectively.

Platelet-Rich Plasma

The U.S. Food and Drug Administration regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation (CFR) title 21, parts 1270 and 1271. Blood products such as platelet-rich plasma are included in these regulations. Under these regulations, certain products including blood products such as PRP are exempt and therefore, do not follow the traditional FDA regulatory pathway. To date, FDA has not attempted to regulate activated PRP.

A number of platelet-rich plasma preparation systems are available, many of which were cleared for marketing by the FDA through the 510(k) process for producing platelet-rich preparations intended to be mixed with bone graft materials to enhance the bone grafting properties in orthopedic practices. The use of platelet-rich plasma outside of this setting (e.g., an office injection) would be considered off-label. The Aurix System® (previously called AutoloGel™; Nuo Therapeutics) and SafeBlood® (SafeBlood Technologies) are 2 related but distinct autologous blood-derived preparations that can be used at the bedside for immediate application. Both AutoloGel™ and SafeBlood® have been specifically marketed for wound healing. Other devices may be used during surgery (e.g., autoLog® Autotransfusion system [Medtronic], the SmartPRePÒ [Harvest Technologies] device). The Magellan® Autologous Platelet Separator System (Isto Biologics) includes a disposable kit for use with the Magellan™ Autologous Platelet Separator portable tabletop centrifuge. GPS® II (BioMet Biologics), a gravitational platelet separation system, was cleared for marketing by the FDA through the 510(k) process for use as disposable separation tube for centrifugation and a dual cannula tip to mix the platelets and thrombin at the surgical site (GPS® III [Zimmer Biomet] is now available). Filtration or plasmapheresis may also be used to produce platelet-rich concentrates. The use of different devices and procedures can lead to variable concentrations of activated platelets and associated proteins, increasing variability between studies of clinical efficacy.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan. 

CURRENT CODING: 

CPT code:

0232T	Injection(s) platelet rich plasma, any tissue, 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
22899	Unlisted procedure, spine
27599	Unlisted procedure, femur or knee
29999	Unlisted procedure, arthroscopy
41899	Unlisted procedure, dentoalveolar structures
86999	Unlisted transfusion medicine procedure

NOTE: CPT code 20926-Tissue graft, other (DELETED 12/31/19) should not be billed for application of recombinant and autologous platelet derived growth factors.

HCPCS code:

D7921	Collection and application of autologous blood concentrate product
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
S0157	Becaplermin gel 0.01%, 0.5gm
S9055	Procuren or other growth factor preparation to promote wound healing

 

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27. Deng J, Yang M, Zhang X, et al. Efficacy and safety of autologous platelet-rich plasma for diabetic foot ulcer healing: a systematic review and meta-analysis of randomized controlled trials. J Orthop Surg Res. May 19 2023; 18(1): 370.
28. Driver VR, Hanft J, Fylling CP, et al. A prospective, randomized, controlled trial of autologous platelet-rich plasma gel for the treatment of diabetic foot ulcers. Ostomy Wound Manage. Jun 2006; 52(6): 68-70, 72, 74 passim.
29. Duymus TM, Mutlu S, Dernek B, et al. Choice of intra-articular injection in treatment of knee osteoarthritis: platelet-rich plasma, hyaluronic acid or ozone options. Knee Surg Sports Traumatol Arthrosc. Feb 2017; 25(2): 485-492.
30. Elksniņš-Finogejevs A, Vidal L, Peredistijs A. Intra-articular platelet-rich plasma vs corticosteroids in the treatment of moderate knee osteoarthritis: a single-center prospective randomized controlled study with a 1-year follow up. J Orthop Surg Res. Jul 10 2020; 15(1): 257.
31. Elsaid A, El-Said M, Emile S, et al. Randomized Controlled Trial on Autologous Platelet-Rich Plasma Versus Saline Dressing in Treatment of Non-healing Diabetic Foot Ulcers. World J Surg. Apr 2020; 44(4): 1294-1301.
32. Eppley BL, Woodell JE, Higgins J. Platelet quantification and growth factor analysis from platelet-rich plasma: implications for wound healing. Plast Reconstr Surg. Nov 2004; 114(6): 1502-8.
33. Eppley BL, Woodell JE, Higgins J. Platelet quantification and growth factor analysis from platelet-rich plasma: implications for wound healing. Plast Reconstr Surg. Nov 2004; 114(6): 1502-8.
34. Everts PA, Devilee RJ, Brown Mahoney C, et al. Exogenous application of platelet-leukocyte gel during open subacromial decompression contributes to improved patient outcome. A prospective randomized double-blind study. Eur Surg Res. 2008; 40(2): 203-10.
35. Figueroa D, Figueroa F, Calvo R, et al. Platelet-rich plasma use in anterior cruciate ligament surgery: systematic review of the literature. Arthroscopy. May 2015; 31(5): 981-8.
36. Franceschi F, Papalia R, Franceschetti E, et al. Platelet-rich plasma injections for chronic plantar fasciopathy: a systematic review. Br Med Bull. Dec 2014; 112(1): 83-95.
37. Freedman BM, Oplinger EH, Freedman IS. Topical becaplermin improves outcomes in work related fingertip injuries. J Trauma. Oct 2005; 59(4): 965-8.
38. Friese G, Herten M, Scherbaum WA. The use of autologous platelet concentrate activated by autologous thrombin (APC+) is effective and safe in the treatment of chronic diabetic foot ulcers-a randomized controlled trial. In: eds. Proceedings of the Fifth International Symposium on the Diabetic Foot, May September 12, 2007, Noordwijkerhout, The Netherlands. 2007.
39. Fu CJ, Sun JB, Bi ZG, et al. Evaluation of platelet-rich plasma and fibrin matrix to assist in healing and repair of rotator cuff injuries: a systematic review and meta-analysis. Clin Rehabil. Feb 2017; 31(2): 158-172.
40. Game F, Jeffcoate W, Tarnow L, et al. LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked, randomised controlled trial. Lancet Diabetes Endocrinol. Nov 2018; 6(11): 870-878.
41. Gazendam A, Ekhtiari S, Bozzo A, et al. Intra-articular saline injection is as effective as corticosteroids, platelet-rich plasma and hyaluronic acid for hip osteoarthritis pain: a systematic review and network meta-analysis of randomised controlled trials. Br J Sports Med. Mar 2021; 55(5): 256-261.
42. Griffin XL, Achten J, Parsons N, et al. Platelet-rich therapy in the treatment of patients with hip fractures: a single centre, parallel group, participant-blinded, randomised controlled trial. BMJ Open. Jun 25 2013; 3(6).
43. Griffin XL, Wallace D, Parsons N, et al. Platelet rich therapies for long bone healing in adults. Cochrane Database Syst Rev. Jul 11 2012; (7): CD009496.
44. Gude W, Hagan D, Abood F, et al. Aurix Gel Is an Effective Intervention for Chronic Diabetic Foot Ulcers: A Pragmatic Randomized Controlled Trial. Adv Skin Wound Care. Sep 2019; 32(9): 416-426.  
45. Gupta A, Channaveera C, Sethi S, et al. Efficacy of Intralesional Platelet-Rich Plasma in Diabetic Foot Ulcer. J Am Podiatr Med Assoc. May 01 2021; 111(3).
46. Habeeb T, AA E, H M. Platelet-rich plasma (PRP) bio-stimulant gel dressing in treating chronic non-healing leg and foot ulcers; cost and effectiveness. Randomized Controlled Clinical Trial. 2021.
47. Helmy Y, Farouk N, Ali Dahy A, et al. Objective assessment of Platelet-Rich Plasma (PRP) potentiality in the treatment of Chronic leg Ulcer: RCT on 80 patients with Venous ulcer. J Cosmet Dermatol. Oct 2021; 20(10): 3257-3263.
48. Hossam EM, Alserr AHK, Antonopoulos CN, et al. Autologous Platelet Rich Plasma Promotes the Healing of NonIschemic Diabetic Foot Ulcers. A Randomized Controlled Trial. Ann Vasc Surg. May 2022; 82: 165-171.
49. Hsu WK, Mishra A, Rodeo SR, et al. Platelet-rich plasma in orthopaedic applications: evidence-based recommendations for treatment. J Am Acad Orthop Surg. Dec 2013; 21(12): 739-48.
50. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
51. Jeong SH, Han SK, Kim WK. Treatment of diabetic foot ulcers using a blood bank platelet concentrate. Plast Reconstr Surg. Mar 2010; 125(3): 944-52.
52. Johal H, Khan M, Yung SP, et al. Impact of Platelet-Rich Plasma Use on Pain in Orthopaedic Surgery: A Systematic Review and Meta-analysis. Sports Health. 2019; 11(4): 355-366.
53. Johnson-Lynn S, Cooney A, Ferguson D, et al. A Feasibility Study Comparing Platelet-Rich Plasma Injection With Saline for the Treatment of Plantar Fasciitis Using a Prospective, Randomized Trial Design. Foot Ankle Spec. Apr 2019; 12(2): 153-158.
54. Kakagia DD, Kazakos KJ, Xarchas KC, et al. Synergistic action of protease-modulating matrix and autologous growth factors in healing of diabetic foot ulcers. A prospective randomized trial. J Diabetes Complications. 2007; 21(6): 387-91.
55. Kanchanatawan W, Arirachakaran A, Chaijenkij K, et al. Short-term outcomes of platelet-rich plasma injection for treatment of osteoarthritis of the knee. Knee Surg Sports Traumatol Arthrosc. May 2016; 24(5): 1665-77.
56. Karimi R, Afshar M, Salimian M, et al. The effect of platelet rich plasma dressing on healing diabetic foot ulcers. Nurs Midwifery Stud. 2016;5(3):e30314.
57. Kearney RS, Ji C, Warwick J, et al. Effect of Platelet-Rich Plasma Injection vs Sham Injection on Tendon Dysfunction in Patients With Chronic Midportion Achilles Tendinopathy: A Randomized Clinical Trial. JAMA. Jul 13 2021; 326(2): 137-144.
58. Kevy SV, Jacobson MS. Comparison of methods for point of care preparation of autologous platelet gel. J Extra Corpor Technol. Mar 2004; 36(1): 28-35.
59. Kevy SV, Jacobson MS. Comparison of methods for point of care preparation of autologous platelet gel. J Extra Corpor Technol. Mar 2004; 36(1): 28-35.
60. Kubota G, Kamoda H, Orita S, et al. Platelet-rich plasma enhances bone union in posterolateral lumbar fusion: A prospective randomized controlled trial. Spine J. Feb 2019; 19(2): e34-e40.
61. Lai LP, Stitik TP, Foye PM, et al. Use of Platelet-Rich Plasma in Intra-Articular Knee Injections for Osteoarthritis: A Systematic Review. PM R. Jun 2015; 7(6): 637-48.
62. Laudy AB, Bakker EW, Rekers M, et al. Efficacy of platelet-rich plasma injections in osteoarthritis of the knee: a systematic review and meta-analysis. Br J Sports Med. May 2015; 49(10): 657-72.
63. Li L, Chen D, Wang C, et al. Autologous platelet-rich gel for treatment of diabetic chronic refractory cutaneous ulcers: A prospective, randomized clinical trial. Wound Repair Regen. 2015; 23(4): 495-505.
64. Li L, Wang C, Wang Y, He LP, Yang YZ, Chen LH, et al. Impact of topical application of autologous platelet-rich gel on medical expenditure and length of stay in hospitals in diabetic patients with refractory cutaneous ulcers. Sichuan Da Xue Xue Bao Yi Xue Ban. 2012;43(5):7625
65. Li Y, Gao Y, Gao Y, et al. Autologous platelet-rich gel treatment for diabetic chronic cutaneous ulcers: A meta-analysis of randomized controlled trials. J Diabetes. May 2019; 11(5): 359-369.
66. Li Y, Li T, Li J, et al. Platelet-Rich Plasma Has Better Results for Retear Rate, Pain, and Outcome Than Platelet-Rich Fibrin After Rotator Cuff Repair: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Arthroscopy. Feb 2022; 38(2): 539-550.
67. Liao X, Liang JX, Li SH, et al. Allogeneic Platelet-Rich Plasma Therapy as an Effective and Safe Adjuvant Method for Chronic Wounds. J Surg Res. Feb 2020; 246: 284-291.
68. Liu GY, Deng XL, Sun Y, Wang MZ, Gao J, Gou J. Effect of autologous platelet-rich gel on the treatment of diabetic foot ulcers. J Xi'an Jiaotong Univ (Med Sci). 2016;37:264-267.
69. Lv ZT, Zhang JM, Pang ZY, et al. The efficacy of platelet rich plasma on anterior cruciate ligament reconstruction: a systematic review and meta-analysis. Platelets. Feb 17 2022; 33(2): 229-241.
70. Ma L. Clinical efficacy of autologous platelet rich gel in the treatment of diabetic foot and diabetic chronic cutaneous ulcer. Chin J Mod Drug Appl.2014;8:86-88
71. Margolis DJ, Bartus C, Hoffstad O, et al. Effectiveness of recombinant human platelet-derived growth factor for the treatment of diabetic neuropathic foot ulcers. Wound Repair Regen. 2005; 13(6): 531-6.
72. Martínez-Zapata MJ, Martí-Carvajal A, Solà I, et al. Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. Transfusion. Jan 2009; 49(1): 44-56.
73. Martinez-Zapata MJ, Martí-Carvajal AJ, Solà I, et al. Autologous platelet-rich plasma for treating chronic wounds. Cochrane Database Syst Rev. May 25 2016; 2016(5): CD006899.
74. Martinez-Zapata MJ, Martí-Carvajal AJ, Solà I, et al. Autologous platelet-rich plasma for treating chronic wounds. Cochrane Database Syst Rev. Oct 17 2012; 10: CD006899.
75. Masiello F, Pati I, Veropalumbo E, et al. Ultrasound-guided injection of platelet-rich plasma for tendinopathies: a systematic review and meta-analysis. Blood Transfus. Mar 2023; 21(2): 119-136.
76. Mazzucco L, Balbo V, Cattana E, et al. Not every PRP-gel is born equal. Evaluation of growth factor availability for tissues through four PRP-gel preparations: Fibrinet, RegenPRP-Kit, Plateltex and one manual procedure. Vox Sang. Aug 2009; 97(2): 110-8.
77. Mazzucco L, Balbo V, Cattana E, et al. Not every PRP-gel is born equal. Evaluation of growth factor availability for tissues through four PRP-gel preparations: Fibrinet, RegenPRP-Kit, Plateltex and one manual procedure. Vox Sang. Aug 2009; 97(2): 110-8.
78. Meamar R, Ghasemi-Mobarakeh L, Norouzi MR, et al. Improved wound healing of diabetic foot ulcers using human placenta-derived mesenchymal stem cells in gelatin electrospun nanofibrous scaffolds plus a platelet-rich plasma gel: A randomized clinical trial. Int Immunopharmacol. Dec 2021; 101(Pt B): 108282.
79. Meheux CJ, McCulloch PC, Lintner DM, et al. Efficacy of Intra-articular Platelet-Rich Plasma Injections in Knee Osteoarthritis: A Systematic Review. Arthroscopy. Mar 2016; 32(3): 495-505.
80. Mei-Dan O, Carmont MR, Laver L, et al. Platelet-rich plasma or hyaluronate in the management of osteochondral lesions of the talus. Am J Sports Med. Mar 2012; 40(3): 534-41.
81. Miłek T, Baranowski K, Zydlewski P, et al. Role of plasma growth factor in the healing of chronic ulcers of the lower legs and foot due to ischaemia in diabetic patients. Postepy Dermatol Alergol. Dec 2017; 34(6): 601-606.  
82. Miller LE, Parrish WR, Roides B, et al. Efficacy of platelet-rich plasma injections for symptomatic tendinopathy: systematic review and meta-analysis of randomised injection-controlled trials. BMJ Open Sport Exerc Med. 2017; 3(1): e000237.
83. Mohammadi Tofigh A, Tajik M. Comparing the standard surgical dressing with dehydrated amnion and platelet-derived growth factor dressings in the healing rate of diabetic foot ulcer: A randomized clinical trial. Diabetes Res Clin Pract. Mar 2022; 185: 109775.
84. Moraes VY, Lenza M, Tamaoki MJ, et al. Platelet-rich therapies for musculoskeletal soft tissue injuries. Cochrane Database Syst Rev. Apr 29 2014; 2014(4): CD010071.
85. Muthu S, Patel S, Gobbur A, et al. Platelet-rich plasma therapy ensures pain reduction in the management of lateral epicondylitis - a PRISMA-compliant network meta-analysis of randomized controlled trials. Expert Opin Biol Ther. Apr 2022; 22(4): 535-546.
86. National Institute for Health and Care Excellence (NICE). Autologous blood injection for tendinopathy [IPG438]. 2013; www.nice.org.uk/guidance/ipg438.
87. National Institute for Health and Care Excellence (NICE). Autologous blood injection for plantar fasciitis [IPG437]. 2013; www.nice.org.uk/guidance/ipg437.
88. National Institute for Health and Care Excellence (NICE). Platelet-rich plasma injections for knee osteoarthritis [IPG637]. 2019; www.nice.org.uk/guidance/ipg637.
89. Nin JR, Gasque GM, Azcárate AV, et al. Has platelet-rich plasma any role in anterior cruciate ligament allograft healing?. Arthroscopy. Nov 2009; 25(11): 1206-13.
90. Nouri F, Babaee M, Peydayesh P, et al. Comparison between the effects of ultrasound guided intra-articular injections of platelet-rich plasma (PRP), high molecular weight hyaluronic acid, and their combination in hip osteoarthritis: a randomized clinical trial. BMC Musculoskelet Disord. Sep 12 2022; 23(1): 856.
91. Peerbooms JC, Lodder P, den Oudsten BL, et al. Positive Effect of Platelet-Rich Plasma on Pain in Plantar Fasciitis: A Double-Blind Multicenter Randomized Controlled Trial. Am J Sports Med. Nov 2019; 47(13): 3238-3246.
92. Picard F, Hersant B, Bosc R, et al. The growing evidence for the use of platelet-rich plasma on diabetic chronic wounds: A review and a proposal for a new standard care. Wound Repair Regen. Sep 2015; 23(5): 638-43.
93. Qi KQ, ChenTJ PJL, Shang XL. The application of autologous platelet-rich gel in the treatment of diabetic foot ulcers. Chin J Diabetes. 2014;22: 1102-1105.
94. Qu S, Hu Z, Zhang Y, et al. Clinical Studies on Platelet-Rich Plasma Therapy for Chronic Cutaneous Ulcers: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Adv Wound Care (New Rochelle). Feb 2022; 11(2): 56-69.
95. Qu W, Wang Z, Hunt C, Morrow AS, Urtecho M, Amin M, Shah S, Hasan B, Abd-Rabu R, Ashmore Z, Kubrova E, Prokop LJ, Murad MH. Platelet-Rich Plasma for Wound Care in the Medicare Population. Technology Assessment Program Project ID 040-353-492. (Prepared by the Mayo Clinic Evidence-based Practice Center under Contract No. HHSA290201500013I.) Rockville, MD: Agency for Healthcare Research and Quality. www.ahrq.gov/sites/default/files/wysiwyg/research/findings/ta/prp/prp-wound-care.pdf.
96. Rainys D, Cepas A, Dambrauskaite K, et al. Effectiveness of autologous platelet-rich plasma gel in the treatment of hardto-heal leg ulcers: a randomised control trial. J Wound Care. Oct 02 2019; 28(10): 658-667.
97. Randelli PS, Stoppani CA, Santarsiero G, et al. Platelet-Rich Plasma in Arthroscopic Rotator Cuff Repair: Clinical and Radiological Results of a Prospective Randomized Controlled Trial Study at 10-Year Follow-Up. Arthroscopy. Jan 2022; 38(1): 51-61.
98. Rees RS, Robson MC, Smiell JM, et al. Becaplermin gel in the treatment of pressure ulcers: a phase II randomized, double-blind, placebo-controlled study. Wound Repair Regen. 1999; 7(3): 141-7.
99. Reyes-Sosa R, Lugo-Radillo A, Cruz-Santiago L, et al. Clinical comparison of platelet-rich plasma injection and daily celecoxib administration in the treatment of early knee osteoarthritis: a randomized clinical trial. J Appl Biomed. 2020;18(2-3):41-45.
100. Saad Setta H, Elshahat A, Elsherbiny K, et al. Platelet-rich plasma versus platelet-poor plasma in the management of chronic diabetic foot ulcers: a comparative study. Int Wound J. Jun 2011; 8(3): 307-12.
101. Saldalamacchia G, Lapice E, Cuomo V, et al. A controlled study of the use of autologous platelet gel for the treatment of diabetic foot ulcers. Nutr Metab Cardiovasc Dis. Dec 2004; 14(6): 395-6.
102. Samuel G, Menon J, Thimmaiah S, et al. Role of isolated percutaneous autologous platelet concentrate in delayed union of long bones. Eur J Orthop Surg Traumatol. Jul 2018; 28(5): 985-990.
103. Sdeek M, Sabry D, El-Sdeek H, et al. Intra-articular injection of Platelet rich plasma versus Hyaluronic acid for moderate knee osteoarthritis. A prospective, double-blind randomized controlled trial on 189 patients with follow-up for three years. Acta Orthop Belg. Dec 2021; 87(4): 729-734.
104. Senet P, Vicaut E, Beneton N, et al. Topical treatment of hypertensive leg ulcers with platelet-derived growth factor-BB: a randomized controlled trial. Arch Dermatol. Aug 2011; 147(8): 926-30.
105. Serra R, Grande R, Butrico L, et al. Skin grafting and topical application of platelet gel in the treatment of vascular lower extremity ulcers. Acta Phlebologica. 2014 01 Dec;15(3):129-36.
106. Seth I, Bulloch G, Seth N, et al. The role of corticosteroid injections in treating plantar fasciitis: A systematic review and meta-analysis. Foot (Edinb). Mar 2023; 54: 101970.
107. Shetty SH, Dhond A, Arora M, et al. Platelet-Rich Plasma Has Better Long-Term Results Than Corticosteroids or Placebo for Chronic Plantar Fasciitis: Randomized Control Trial. J Foot Ankle Surg. Jan 2019; 58(1): 42-46.
108. Shu H, Huang Z, Bai X, et al. The Application of Platelet-Rich Plasma for Patients Following Total Joint Replacement: A Meta-Analysis of Randomized Controlled Trials and Systematic Review. Front Surg. 2022; 9: 922637.
109. Singh SP, Kumar V, Pandey A, et al. Role of platelet-rich plasma in healing diabetic foot ulcers: a prospective study. J Wound Care. Sep 02 2018; 27(9): 550-556.
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POLICY HISTORY:

Medical Policy Group, May 2005 (3)

Medical Policy Group, June 2005

Medical Policy Group, July 2005 (2)

Medical Policy Administration Committee, July 2005

Available for comment August 6-September 19, 2005

Medical Policy Group, November 2006 (1)

Medical Policy Group, November 2007 (1)

Medical Policy Group, February 2009 (2)

Medical Policy Administration Committee, May 2009

Available for comment April 9-May 23, 2009

Medical Policy Group, April 2010 (1): Policy updated, Description, Key Points, Policy Update, Key Words

Medical Policy Administration Committee, May 2010

Available for comment May 7-June 17, 2010

Medical Policy Group, June 1010 (2)

Medical Policy Administration, June 2010

Available for comment June 18-August 2, 2010

Medical Policy Group, June 2011; Updated Key Points & References

Medical Policy Group, April 2012 (3): 2012 Updates-Key Points & References

Medical Policy Group, November 2012: Added Code D7921 effective 1/1/13.

Medical Policy Panel, April 2013

Medical Policy Group, April 2013 (1): Update to Title with addition of ‘recombinant’ and removal of ‘primary and miscellaneous’; Added HCPCS code G0460 with retro effective date of 08/02/2012; condensed Policy section with no change to coverage criteria; update to Key Points and References

Medical Policy Panel, May 2014

Medical Policy Group, June 2014 (1): Clarification to policy statements to further define what is not covered, no change to intent of policy or what is covered/non-covered; Update to Key Points and References

Medical Policy Panel, May 2015

Medical Policy Group, June 2015 (2): 2015 Updates to Title, Description, Key Points, Approved by Governing Bodies, Current coding: CPT code 86999 added, and References; policy statement updated to include a list of some of the conditions that are not covered for platelet-rich plasma; no change to intent.

Medical Policy Panel, January 2016

Medical Policy Group, January 2016 (2): 2016: Updates to Title, Key Points, Approved by Governing Bodies, and References; no change in policy statement.

Medical Policy Panel, April 2016:

Medical Policy Group, April 2016 (7): 2016 Updates to Key Points, References; no change in policy statement.

Medical Policy Panel, April 2017

Medical Policy Group, May 2017 (7): 2017 Updates to Description, Key Points, Approved by Governing Bodies & References. No change to policy statement.

Medical Policy Group, December 2017: Annual Coding Update 2018.  Added new CPT code 0481T effective 1/1/18 to the Current Coding section.

Medical Policy Panel, April 2019

Medical Policy Group, May 2019 (7): Updates to Key Points & References. No change to policy statement.

Medical Policy Panel, January 2020

Medical Policy Group, January 2020 (5): Updates to Description, Key Points, Approved by Governing Bodies, and References. No change to Policy Statement.

Medical Policy Panel, April 2020

Medical Policy Group, April 2020 (7): Updates to Key Points and References. No change to Policy Statement.

Medical Policy Panel, April 2021

Medical Policy Group, April 2021 (7): Updates to Key Points and References. Policy section updated to remove “not medically necessary” statements. No change in intent.

Medical Policy Panel, April 2022

Medical Policy Group, May 2022 (7): Updates to Key Points, Approved by Governing Bodies and References. No change in Policy Statement.

Medical Policy Panel, January 2023

Medical Policy Group, January 2023 (7): Review of literature related to Recombinant and Autologous Platelet-Derived Growth Factors for Wound Healing and Other Non-Orthopedic Conditions. Updates to Key Points, Approved by Governing Bodies and References. No change in Policy Statement.

Medical Policy Panel, April 2023

Medical Policy Group, May 2023  (7): Review of literature related to orthopedic applications of platelet-rich plasma. Updates to Description, Key Points, Benefit Application, Approved by Governing Bodies and References. Added Keywords: “VITASEAL, Aurix System, Aurix System, autoLog Autotransfusion system, SmartPRePÒ, Magellan Autologous Platelet Separator System, GPS II, GPS III.” No change in Policy Statement.

Medical Policy Panel, January 2024

Medical Policy Group, January 2024 (7): Review of literature related to Recombinant and Autologous Platelet-Derived Growth Factors for Wound Healing and Other Non-Orthopedic Conditions. Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, April 2024

Medical Policy Group, May 2024 (7): Review of literature related to orthopedic applications of platelet-rich plasma.Updates to Key Points. No new references added. No change in Policy Statement.

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.