Printer Friendly Version
Printer Friendly Version
Printer Friendly Version
A.2.01.16
The use of blood-derived growth factors, including recombinant platelet-derived growth factors and platelet-rich plasma, 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.
Wound Healing Treatment
A variety of growth factors have been found to play a role in wound healing, including platelet-derived growth factor (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. Recombinant PDGF also has 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 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 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.
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; Tisseel® (Baxter International) and Hemaseel® (Haemacure Corp.) are examples of commercially available fibrin sealants. Autologus fibrin sealants can also 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 PRP for non-orthopedic indications, which include a number of wound closure-related indications.
For the purposes of this policy, the primary end points of interest for the study of wound closure are as follows, consistent with guidance from the U.S. Food and Drug Administration for the industry in developing products for the treatment of chronic cutaneous ulcer and burn wounds:
Incidence of complete wound closure;
Time to complete wound closure (reflecting accelerated wound closure);
Incidence of complete wound closure following surgical wound closure;
Pain control.
Platelet-Rich Plasma
The FDA regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation, Title 21, parts 1270 and 1271. Blood products such as platelet-rich plasma (PRP) 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, the FDA has not attempted to regulate activated PRP.
Numerous PRP preparation systems have been cleared for marketing by the FDA through the 510(k) process. These devices are intended to concentrate patient plasma at the point of care during bone grafting procedures. The use of different devices and procedures can lead to variable concentrations of active platelets and associated proteins, increasing variability between studies of clinical efficacy.
Related medical policies -
Use of platelet-rich plasma (ie, autologous blood-derived preparations) is considered investigational for the treatment of acute or chronic wounds, including surgical wounds and non-healing ulcers.
None
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
4/1993: Approved by Medical Policy Advisory Committee (MPAC) as Growth Factors for Wound Healing. ICD-9 diagnosis 707.1 added
5/2000: Comprehensive revision with medically necessary indications approved by MPAC; policy renamed
2/11/2002: Investigational definition added
5/2/2002: Type of Service and Place of Service deleted
11/2002: Reviewed by MPAC; indications expanded to include venous stasis and pressure ulcers, FEP exception added, Sources updated, Code Reference updated, 707.1 5th digit added, ICD-9 diagnosis 459.81, 707.0 added covered codes, HCPCS S0157 added covered codes, non-covered table added, HCPCS S9055 added non-covered codes
9/2/2003: Code Reference section updated, ICD-9 diagnosis code range 250.60-250.63, 250.80-250.83 listed separately
10/20/2004: Code Reference section updated, ICD-9 diagnosis code 707.0 deleted effective 9/30/2004, ICD-9 diagnosis code 707.0 5th digit effective 10/1/2004
5/18/2006: Policy revised. Revisions approved by Medical Policy Advisory Committee (MPAC)
6/26/2006: Code reference section updated, ICD-9 diagnosis codes 440.23, 440.24, 454.0, 454.2, 459.81 deleted from medical policy.
1/25/2007: Policy description reviewed and updated. Name of policy changed from Platelet-Derived Growth Factors for Wound Healing to Recombinant and Autologous Platelet-Derived Growth Factors as a Primary Treatment of Wound Healing and Other Miscellaneous Conditions
5/9/2007: Policy reviewed, no changes
7/10/2008: Policy reviewed, statement concerning black box warning added to description
9/17/2008: Annual ICD-9 updates effective 10-1-2008 applied
3/19/2010: Description section was updated to include language about the Magellan® Autologous Platelet Separator System and BioMet Biologics platelet separation system (GPSII); Policy Statement section was revised for clarity; Code Reference section was revised to remove ICD-9 diagnosis codes 249.60 - 249.61, 250.60 - 250.63 and descriptions were revised for ICD-9 diagnosis codes 707.23 and 707.24.
06/21/2011: Policy reviewed; no changes.
05/09/2012: Policy reviewed; no changes.
08/07/2013: Policy reviewed; no changes to policy statement. Deleted outdated references from the Sources section.
07/22/2014: Policy title changed from "Recombinant and Autologous Platelet-Derived Growth Factors as a Primary Treatment of Wound Healing and Other Miscellaneous Conditions" to "Recombinant and Autologous Platelet-Derived Growth Factors as a Treatment of Wound Healing and Other Conditions." Policy description updated. Medically necessary policy statement revised to remove "When used according to the FDA-labeled indication; i.e.," from the list of indications and add "Pressure ulcers extending into the subcutaneous tissue." Investigational policy statements regarding autologous blood-derived preparations revised to state that the use of autologous blood-derived preparations (ie, platelet-rich plasma) is considered investigational. This includes, but is not limited to, use in the following situations: treatment of acute or chronic wounds including non-healing ulcers; adjunctive use in surgical procedures; primary use (injection) for other conditions such as epicondylitis (ie, tennis elbow), plantar fasciitis, or Dupuyten contracture.
09/01/2015: Code Reference section updated for ICD-10.
09/17/2015: Policy title changed from "Recombinant and Autologous Platelet-Derived Growth Factors as a Treatment of Wound Healing and Other Conditions" to "Recombinant and Autologous Platelet-Derived Growth Factors as a Treatment of Wound Healing and Other Non-Orthopedic Conditions." Policy description and policy sections updated to remove orthopedic applications of platelet-rich plasma from the policy. Policy description also updated regarding PRP preparation systems and to add a link to the Orthopedic Applications of Platelet-Rich Plasma medical policy. Investigational policy statement revised to state that the use of autologous blood-derived preparations (i.e. platelet-rich plasma) is considered investigational for the treatment of acute or chronic wounds, including surgical wounds and non-healing ulcers. Removed the following statements: This includes, but is not limited to, use in the following situations: Adjunctive use in surgical procedures; Primary use (injection) for other conditions such as epicondylitis (i.e. tennis elbow), plantar fasciitis, or Dupuytren's contracture. Policy Guidelines section updated to add medically necessary and investigative definitions.
03/07/2016: Policy title changed from "Recombinant and Autologous Platelet-Derived Growth Factors as a Treatment of Wound Healing and Other Non-Orthopedic Conditions" to "Recombinant and Autologous Platelet-Derived Growth Factors for Wound Healing and Other Non-Orthopedic Conditions." Policy description updated. Policy statements unchanged.
06/01/2016: Policy number A.2.01.16 added.
01/26/2017: Policy description updated regarding wound closure outcomes and FDA regulation. Policy statements unchanged.
01/30/2018: Policy description updated regarding devices. Policy statements unchanged.
08/01/2019: Policy statements unchanged. Code Reference section updated to expand the ICD-10 diagnosis code ranges to include ICD-10 codes L97.105, L97.106, L97.115, L97.116, L97.125, L97.126, L97.205, L97.206, L97.215, L97.216, L97.225, L97.226, L97.305, L97.306, L97.315, L97.316, L97.325, L97.326, L97.405, L97.406, L97.415, L97.416, L97.425, L97.426, L97.505, L97.506, L97.515, L97.516, L97.525, L97.526, L97.805, L97.806, L97.815, L97.816, L97.825, L97.826, L97.905, L97.906, L97.915, L97.916, L97.925, L97.926, L98.415, L98.416, L98.425, L98.426, L98.495, and L98.496. Added HCPCS code G0460 as investigational.
02/07/2020: Policy description updated. Policy statements unchanged.
12/15/2021: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Code Reference section updated to add new HCPCS code G0465 and to revise code description for HCPCS code G0460, effective 01/01/2022.
02/07/2022: Policy reviewed; no changes.
03/23/2023: Policy reviewed. Policy description updated regarding Regranex. Policy section updated to change "patients" to "individuals" and "ulcers related to venous stasis" to "venous stasis ulcers." Added "recombinant platelet-derived growth factor" to investigational statement for consistency with the first policy statement. Policy Guidelines updated regarding becaplermin.
07/01/2023: Code Reference section updated to revise code descriptions for HCPCS codes G0460 and G0465.
03/15/2024: Policy archived. Please refer to the Regranex medical policy.
08/13/2026: Policy reactivated. Policy description updated with minor changes. Added related medical policies. Policy section revised to remove statements regarding recombinant platelet-derived growth factors. Policy Guidelines updated. Code Reference section revised to add CPT code 0232T and HCPCS codes P9020 and S0157 as investigational.
Blue Cross Blue Shield Association policy # 2.01.16
This may not be a comprehensive list of procedure codes applicable to this policy.
Investigational Codes
Code Number | Description |
CPT-4 | |
0232T | Harvest and injections of platelet rich plasma using imaging guidance |
HCPCS | |
G0460 | Autologous platelet rich plasma or other blood-derived product for non-diabetic chronic wounds/ulcers, including as applicable phlebotomy, centrifugation or mixing, and all other preparatory procedures, administration and dressings, per treatment |
G0465 | Autologous platelet rich plasma (PRP) or other blood-derived product for diabetic chronic wounds/ulcers, using an FDA-cleared device for this indication, (includes as applicable administration, dressings, phlebotomy, centrifugation or mixing, and all other preparatory procedures, per treatment) |
P9020 | Platelet rich plasma, each unit |
ICD-10 Procedure | |
ICD-10 Diagnosis |