CurrentCignaPolicy 0507

Autologous platelet-derived growth factors (APDGF) / Platelet-rich plasma (PRP)

Cigna medical coverage policy regarding the use of autologous platelet-derived growth factors (APDGF), also referred to as platelet-rich plasma (PRP), for multiple conditions and indications. Defines coverage stance, lists specific indications considered experimental/investigational/unproven, provides background, FDA device context, and summarizes literature evidence.

Policy Summary

PayerCigna

PolicyAutologous platelet-derived growth factors (APDGF) / Platelet-rich plasma (PRP)

Policy CodePolicy 0507

Change TypeAnnual review — template/formatting updated; no clinical criteria changes

Effective DateOct 15, 2024

Next Review DateOct 15, 2025

Key ActionClaims submitted for codes 0232T or G0460 for services considered experimental/investigational/unproven will be denied as not covered; providers must bill with the most appropriate codes and review current Medicare NCD/LCD guidance.

POLICY UPDATE CHANGES

Annual review completed with no clinical policy statement changes.

Policy updated to new template and formatting standards during the 10/15/2023 annual review.

15+Specific Indications Listed as Unproven/Experimental

2024-10-15Policy Effective Date

2025-10-15Next Review Date

heterogeneousPRP preparation & protocols

2Codes Listed as Experimental/Unproven

0Material clinical changes in latest revision

Coverage Summary

Cigna medical coverage policy on autologous platelet-derived growth factors (APDGF), also known as platelet-rich plasma (PRP). The policy states the coverage stance as not covered for indications considered cosmetic/experimental and applies to multiple conditions and procedures. Effective date: 10/15/2024; next review date: 10/15/2025.

Policy Metadata

Policy Number0507

Effective Date2024-10-15

Next Review Date2025-10-15

Scope SummaryCigna medical coverage policy regarding use of autologous platelet-derived growth factors (APDGF/PRP) for multiple conditions; defines coverage stance, lists indications considered experimental/investigational/unproven, summarizes background, FDA device context, and literature evidence.

Coverage StanceExperimental, investigational, or unproven for ANY condition/indication (codes 0232T, G0460)

Medical Necessity / Coverage Determinations

Coverage Determination

The use of autologous platelet-derived growth factors (CPT Code 0232T; HCPCS Code G0460) is considered experimental, investigational, or unproven for ANY condition or indication, including but not limited to:

ALL of the following

anterior cruciate ligament (ACL) repair
bone graft supplementation, regeneration, substitution and/or healing (e.g., lumbar fusion, iliac crest bone graft to maxilla)
degenerative joint disease
epicondylitis

Not Covered / Experimental/Investigational

The policy states that use of autologous platelet-derived growth factors (APDGF/PRP) is considered experimental, investigational, or unproven for ANY condition or indication (see CPT Code 0232T and HCPCS Code G0460). Although systems/devices to prepare PRP have FDA 510(k) clearance as preparation systems, PRP products and preparations are heterogeneous with no standard production protocol and the literature is limited and inconsistent.

Illustrative examples of indications called out in the Coverage Determination (not exhaustive) include: anterior cruciate ligament (ACL) repair; bone graft supplementation/regeneration/substitution (e.g., lumbar fusion, iliac crest bone graft to maxilla); degenerative joint disease; epicondylitis; persistent epithelial defects of the cornea; fractures including long-bone nonunion; joint capsular injuries; muscle injuries and disorders; osteoarthritis of the knee; periodontal disease/gingival recession and dental surgery; plantar fasciitis; sinus augmentation procedures; soft tissue trauma (e.g., tendon and ligament ruptures); total knee arthroplasty; tendonitis; and wound healing (e.g., surgical wounds, chronic wounds, lower extremity ulcers).

Coding

Primary procedure codes referenced in policy statementmixedNot Covered

0232T	CPT Code listed for autologous platelet-derived growth factors / PRP
G0460	HCPCS Code listed for autologous platelet-derived growth factors / PRP

FDA-cleared device examples (informational)mixed

device	3C Patch System (Reapplix A/S)
device	Aeon CPKit (Aeon Biotherapeutics Corp.)
device	Arthrex Double Syringe (ACP) Kit (Arthrex, Inc.)
device	Aurix System (Nuo Therapeutics, Inc.)
device	Autologous Platelet Grafting (SafeBlood Technologies, Inc.)
device	Cascade Autologous Platelet System (MTF)
device	Fibrinet Autologous PRP System (Cascade Medical Enterprises)
device	GPS III (Zimmer Biomet)
device	PurePRP SupraPhysiologic Concentrating System (EmCyte Corporation)
device	SmartPReP 2 APC+ system (Terumo Corporation)

Considered Experimental/Investigational/Unproven CodesCPT|HCPCSExperimental

0232T	Injection(s), platelet rich plasma, any site, including image guidance, harvesting and preparation when performed
G0460	Autologous platelet rich plasma for nondiabetic chronic wounds/ulcers, including phlebotomy, centrifugation, and all other preparatory procedures, administration and dressings, per treatment

Provider Actions / Billing Impact

Denial Risk

Claims for APDGF/PRP

Claims submitted for services billed with these codes that are not accompanied by a covered diagnosis or that are for services considered experimental, investigational, or unproven will be denied as not covered.

Affected codes: 0232T, G0460
Claims will be denied when billed without a covered diagnosis or when for services considered experimental/investigational/unproven

Documentation Required

Use of most appropriate codes

When billing, providers must use the most appropriate codes as of the effective date of the submission; reimbursement is not allowed for services billed for conditions or diagnoses not covered under this Coverage Policy.

Background and Evidence Summary

Background: APDGF/PRP are autologous blood-derived products proposed to enhance healing by concentrating platelets and growth factors. Devices/systems to prepare PRP are cleared by FDA under the 510(k) process for preparing autologous platelet concentrates, and examples of cleared devices are listed in the policy. PRP preparations are heterogeneous with no standardized production protocol, leading to variable platelet/growth factor concentrations and inconsistent clinical results. The published literature is limited by small studies, heterogeneity of preparations and outcomes, conflicting results across indications, and concerns about potential theoretical risks (e.g., possible cancer-promoting effects from increased local growth factors).

Key Evidence Summary

Quality of evidenceHeterogeneous, small RCTs and observational studies with conflicting results; insufficient to establish safety and effectiveness for listed indications

Noted safety concernPotential theoretical risk of cancer-promoting effect from increased local growth factors

Shen et al. (2017)14 RCTs (n=1423): PRP reduced WOMAC pain and improved function at 3, 6, 12 months vs controls; no significant increase in adverse events; limitations include heterogeneity, moderate-high risk of bias, short follow-up

Medicare National / Local Coverage Determinations

Type	Number	Name	Effective Date
NCD	270.3	Blood-Derived Products for Chronic Non-Healing Wounds	2021-04-13
LCD	L36690	Wound Application of Cellular and/or Tissue Based Products (CTPs), Lower Extremities	2024-09-05

Definitions

Term	Definition
APDGF	Autologous platelet-derived growth factors, also referred to as platelet-rich plasma (PRP) and other synonyms such as platelet gel, PRGF, platelet releasate.
PRP	Platelet-rich plasma, an autologous blood-derived product with concentrated platelets and growth factors used for injections or topical application.
APC / APDGF	Autologous platelet concentrates / autologous platelet-derived growth factors — umbrella terms for platelet products used adjunctively in surgical or wound care contexts.
PRP (duplicate)	Platelet-rich plasma — autologous concentration of platelets purported to enhance healing; preparations vary widely in methodology and composition.
APDGF (duplicate)	Autologous platelet-derived growth factors / platelet gel — topical or injectable autologous products derived from patient's blood.

Revision History

10/15/2024annual_reviewLatest

Annual review completed on 10/15/2024; no clinical policy statement changes.

10/15/2023annual_review

Annual review completed on 10/15/2023; policy updated to new template and formatting standards with no changes to criteria.

Policy Summary

PayerCigna

PolicyAutologous platelet-derived growth factors (APDGF) / Platelet-rich plasma (PRP)

Policy CodePolicy 0507

Change TypeAnnual review — template/formatting updated; no clinical criteria changes

Effective DateOct 15, 2024

Next Review DateOct 15, 2025

On This Page

epithelial defects of the cornea, persistent

fractures, including long-bone nonunion

joint capsular injuries

muscle injuries and disorders

osteoarthritis of the knee

periodontal disease, gingival recession and dental surgery

sinus augmentation procedures

soft tissue trauma (e.g., tendon and ligament ruptures)

total knee arthroplasty

wound healing (e.g., surgical wounds; chronic wounds; lower extremity ulcers)

Considered Experimental/Investigational/Unproven

The following codes/procedures are considered experimental, investigational, or unproven:

ALL of the following

0232T: Injection(s), platelet rich plasma, any site, including image guidance, harvesting and preparation when performed
Listed as experimental/unproven
G0460: Autologous platelet rich plasma for nondiabetic chronic wounds/ulcers, including phlebotomy, centrifugation, and all other preparatory procedures, administration and dressings, per treatment
Listed as experimental/unproven

Use the appropriate procedure and HCPCS/CPT codes current as of the submission effective date
Reimbursement will not be provided for services billed for conditions or diagnoses not covered by this policy

Documentation Required

Refer to current Medicare Policy

Providers should review current Medicare National and Local Coverage Determinations for the most up-to-date coverage guidance and applicable effective dates.

See Medicare NCD 270.3 (Blood-Derived Products for Chronic Non-Healing Wounds, effective 4/13/2021)
See Medicare LCD L36690 (Wound Application of Cellular and/or Tissue Based Products, Lower Extremities, effective 9/5/2024)
Review Medicare determinations for current coverage guidance and effective dates

Meheux et al. (2016)

6 RCTs (739 patients): PRP better than hyaluronic acid on WOMAC at 3-6 and 6-12 months; limitations: heterogeneity, small samples, lack of blinding

An et al. (2021)Meta-analysis (6 RCTs + 2 NRCTs; 420 patients): PRP + bone graft not associated with higher radiographic healing rates for long-bone nonunion but associated with shorter healing time

Del Fabbro et al. (2018) Cochrane38 RCTs (n=1402 defects): APC + OFD or OFD+BG showed significant improvements for periodontal intraosseous defects; evidence very low quality overall

AHRQ (Qu et al. 2020 / 2021 TA)Moderate SOE that PRP increases complete wound closure in lower-extremity diabetic ulcers; insufficient evidence for venous or pressure ulcers

WSHCA / Technology Assessments & ReviewsTech assessments (WSHCA 2016, 2023; Mayo/AHRQ) and systematic reviews conclude safety/efficacy not well established; PRP unproven to be safer, more effective, or more cost-effective for knee/hip OA

Considered Experimental/Unproven Codes0232T and G0460 are listed as experimental/investigational/unproven in this policy