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Date Printed: October 23, 2017: 02:12 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-10000-09

Original Effective Date: 12/15/02

Reviewed: 05/25/17

Revised: 10/01/17

Subject: Platelet-Derived Growth Factors and Autologous Blood-Derived Preparations (Platelet-Rich Plasma)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

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 type of transforming growth factor, and therefore PRP has been used in conjunction with bone-replacement grafting (using either autologous grafts or bovine-derived xenograft) in periodontal and maxillofacial surgeries.

Becaplermin gel (Regranex®), a recombinant (genetic recombination) PDGF product, has been approved by the U.S. Food and Drug Administration (FDA) for the following indications: “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.” In 2008, the manufacturer added the following black box warning to the labeling for Regranex: “An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of Regranex Gel in a postmarketing 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.”

POSITION STATEMENT:

Recombinant platelet-derived growth factor (i.e. becaplermin® gel) meets the definition of medical necessity when used as an adjunct to standard wound management for the following indications:

Candidates for becaplermin gel for the treatment of neuropathic diabetic ulcers extending into the subcutaneous tissue meet the definition of medical necessity when ALL of the following criteria are met:

Candidates for becaplermin gel for the treatment of pressure ulcers extending into the subcutaneous tissue meet the definition of medical necessity when ALL of the following criteria are met:

All other applications of becaplermin are considered experimental or investigational, including, but not limited to ischemic ulcers, ulcers related to venous stasis, and ulcers not extending through the dermis into the subcutaneous tissue. The evidence is insufficient to determine the effects of the technology on health outcomes.

The use of autologous blood-derived preparations (i.e. platelet-rich plasma) is considered experimental or investigational for the treatment of acute or chronic wounds, including surgical wounds and nonhealing ulcers. The evidence is insufficient to determine the effects of the technology on health outcomes.

Use of platelet-rich plasma is considered experimental or investigational for all indications. This includes, but is not limited to, use in the following situations:

Primary use (injection) for the following conditions:

Adjunctive use in the following surgical procedures:

The evidence is insufficient to determine the effects of the technology on health outcomes.

BILLING/CODING INFORMATION:

The following codes may be used to describe becaplermin and growth factor preparations:

CPT Coding:

0232T

Injection(s), platelet rich plasma, any site, including image guidance, harvesting and preparation when performed (investigational)

HCPCS Coding:

G0460

Autologous platelet rich plasma for chronic wounds/ulcers, including phlebotomy, centrifugation, and all other preparatory procedures and administration, per treatment (investigational)

P9020

Platelet rich plasma, each unit (investigational)

S0157

Becaplermin gel 0.01%, 0.5 gm

S9055

Procuren or other growth factor preparation to promote wound healing (investigational)

ICD-10 Diagnoses Codes That Support Medical Necessity for S0157:

E10.40 – E10.49
E10.610 - E10.638
E10.649 – E10.69

Type 1 diabetes mellitus with complications

E11.40 – E11.49
E11.610- E11.638
E11.649 – E11.69

Type 2 diabetes mellitus with complications

E13.40 – E13.49
E13.610 – E13.638
E13.65, E13.69

Other specified diabetes mellitus with complications

L89.000- L89.95

Pressure Ulcer

L97.112 – L97.118
L97.122 – L97.128
L97.212 – L97.218
L97.222 – L97.228
L97.312 – L97.318
L97.322 – L97.328
L97.412 – L97.418
L97.422 – L97.428
L97.512 – L97.518
L97.522 – L97.528
L97.801 – L97.929

Non-pressure chronic ulcer of lower limb, not elsewhere classified

L98.491 – L98.499

Non-pressure chronic ulcer of skin, not elsewhere classified

REIMBURSEMENT INFORMATION:

Refer to sections entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products:

The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Blood-Derived Products for Chronic Non-Healing Wounds (270.3) located at cms.gov.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

None applicable.

OTHER:

None applicable

REFERENCES:

  1. Agency for Healthcare Research and Quality (AHRQ), Guideline for Management of Wounds in Patients with Lower-Extremity Neuropathic Disease, last updated 12/08, accessed at guideline.gov on 08/06/09.
  2. Agency for Healthcare Research and Quality (AHRQ), Treatment of Pressure Ulcers, December 1994 accessed at ncbi.nlm.nih.gov on 09/02/08.
  3. Association for the Advancement of Wound Care (AAWC). AAWC Guideline: Pressure Ulcer, located at aawconline.org.
  4. Association for the Advancement of Wound Care (AAWC). AAWC Venous Ulcer Guideline, located at aawconline.org.
  5. Bloomgarden Z, The Diabetic Foot, The American Diabetes Association, Diabetes Care 31: 372-376, 2008 accessed at diabetes.org on 08/03/09.
  6. Blue Cross Blue Shield Association Medical Policy Reference Manual 2.01.16 Recombinant and Autologous Platelet-Derived Growth Factors for Wound Healing and Other Non‒Orthopedic Conditions, 01/17.
  7. Blue Cross Blue Shield Association Medical Policy Reference Manual 2.01.98 Orthopedic Applications of Platelet-Rich Plasma, 04/17.
  8. Blue Cross Blue Shield Association TEC Assessment “Becaplermin for Wound Healing” (06/99) – Tab 5.
  9. Blue Cross Blue Shield Association TEC Assessment “Growth Factors for Wound Healing” (12/92).
  10. Centers for Medicare & Medicaid Services (CMS), Decision Memo for Autologous Blood Derived Products for Chronic Non-Healing Wounds (CAG-00190R3), 08/02/12.
  11. Centers for Medicare & Medicaid Services (CMS), NCD for Blood-Derived Products for Chronic Non-Healing Wounds (270.3), accessed at cms.gov.
  12. ClinicalTrials.gov, Comparing the Efficacy and Safety of Two Dose Regimens of BioChaperone PDGF-BB to Becaplermin Gel for the Treatment of Diabetic Foot Ulcer, sponsored by Virchow Group, accessed 04/28/10.
  13. ClinicalTrials.gov, Efficacy of rhPDGF-BB in Healing Wounds Caused by Third Degree Thermal and Electrical Burns, sponsored by American Scitech International, accessed 04/28/10.
  14. Clinicaltrials.gov, the AutoloGel™ Post-Market Surveillance (TAPS) Program, sponsored by Cytomedix, CTI Clinical Trial and Consulting Services, accessed 04/28/10.
  15. Dougherty EJ, An Evidence-Based Model Comparing the Cost-Effectiveness of Platelet-Rich Plasma Gel to Alternative Therapies for Patients with Nonhealing Diabetic Foot Ulcers, Adv Skin Wound Care, 2008 Dec; 21(12): 568-75.
  16. Han SK, Kim DW, Jeong SH, et al, Potential Use of Blood Bank Platelet Concentrates to Accelerate Wound Healing of Diabetic Ulcers, Ann Plast Surg. 2007 Nov; 59(5): 532-7.
  17. Hom DB, Linzie BM, Huang TC, The Healing Effects of Autologous Platelet Gel on Acute Human Skin Wounds, Arch Facial Plast Surg. 2007 May-Jun; 9(3): 174-83.
  18. Kazakos K, Lyras DN, Verettas D, et al, The Use of Autologous PRP Gel as an Aid in the Management of Acute Trauma Wounds, Injury, 2008 Aug 12.
  19. Lacci KM, Dardik A, Platelet-Rich Plasma: Support for Its Use in Wound Healing, Yale J Biol Med, Mar 2010.
  20. Mishra A, Woodall J, Vieira A, Treatment of Tendon and Muscle Using Platelet-Rich Plasma, Clin Sports Med 28 pg 113-125, 08/07/08.
  21. National Institute for Health and Clinical Excellence (NICE). Diabetic foot problems: prevention and management [NG19]. 2016; accessed at nice.org.
  22. Papanas N, Maltezos E, Becaplermin Gel in the Treatment of Diabetic Neuropathic Foot Ulcers, Clin Interv Aging, 2008; 3(2): 233-40.
  23. Qaseem A, Humphrey LL, Forciea MA, et al. Treatment of pressure ulcers: a clinical practice guideline from the American College of Physicians. Ann Intern Med. Mar 03 2015;162(5):370-379.
  24. Rabago D, Best TM, Zgierska AE, et al, A Systematic Review of Four Injection Therapies for Lateral Epicondylosis: Prolotherapy, Polidocanol, Whole Blood and Platelet-Rich Plasma, Br J Sports Med, July 2009; 43(7): 471-81.
  25. U.S. Food and Drug Administration (FDA), Becaplermin (Marketed as Regranex) Information, June 6, 2008.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 05/25/17.

GUIDELINE UPDATE INFORMATION:

12/15/02

Reformat, review & revision of original Medical Coverage Guideline (11/91).

12/15/03

Scheduled review and revision of guideline; consisting of updated references.

12/15/04

Scheduled review and revision of guideline; consisting of updated references.

01/01/06

Scheduled review; maintain current coverage.

10/15/06

Scheduled review; maintain current coverage.

07/15/07

Scheduled review; current coverage maintained; reformatted guideline, references updated.

10/15/08

Annual review: position statements maintained; description section and references updated.

09/15/09

Annual review: position statements maintained; description section and references updated.

07/01/10

Annual review: position statements maintained; references updated. 3rd quarter HCPCS coding update: added CPT code 0232T.

10/15/10

Revision; related ICD-10 codes added.

01/01/11

Annual HCPCS coding update. Revised 0232T.

08/03/12

Revision; Medicare Program exception updated.

10/15/12

Coding section updated.

07/01/13

Quarterly HCPCS update. Added G0460. Revised Program Exception section.

10/01/15

Revision; ICD9 & ICD10 coding sections updated.

11/01/15

Revision: ICD-9 Codes deleted.

06/15/17

Revision; Guideline title, position statements, coding, and references updated.

10/01/17

Annual ICD-10 update. L97 code ranges updated.

Date Printed: October 23, 2017: 02:12 AM