MEDICAL POLICY – 2.01.16 Recombinant and Autologous Platelet-Derived Growth Factors for Wound Healing and Other Non-Orthopedic Conditions BCBSA Ref. Policy: 2.01.16 Effective Date: April 1, 2020 Last Revised: March 19, 2020 Replaces: N/A

RELATED MEDICAL POLICIES: 2.01.26 Prolotherapy 2.01.98 Orthopedic Applications of Platelet-Rich Plasma 7.01.583 Amniotic Membrane and Amniotic Fluid 8.01.52 Orthopedic Applications of Stem Cell Therapy (Including Allografts and

Bone Substitutes Used with Autologous Bone Marrow) 8.01.55 Stem Cell Therapy for Peripheral Arterial Disease

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POLICY CRITERIA | DOCUMENTATION REQUIREMENTS | CODING RELATED INFORMATION | EVIDENCE REVIEW | REFERENCES | HISTORY

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Introduction

Special substances that are found in the blood may help cells to grow and divide. Some of these blood-derived growth factors, including some platelet-derived growth factors (PDGFs) and platelet-rich plasma (PRP), have been used to treat wounds and skin ulcers. Some of these growth factors have been made in the lab by manipulating genetic material such as DNA. These are called recombinant blood-derived growth factors. Other growth factors come from your own body. These are called autologous blood-derived growth factors. This policy discusses the use of recombinant and autologous blood-derived growth factors when treating wounds and skin ulcers.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.

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Policy Coverage Criteria

Treatment Medical Necessity Recombinant platelet-derived growth factor (ie, becaplermin)

Recombinant platelet-derived growth factor (ie, becaplermin ) may be considered medically necessary when used as an adjunct to standard wound management for the following indications (for information on patient selection criteria, see Additional Guidelines section below): • Neuropathic diabetic ulcers extending into the subcutaneous

tissue • Pressure ulcers extending into the subcutaneous tissue Other applications of recombinant platelet-derived growth factor (ie, becaplermin) are considered investigational, including but not limited to: • Ischemic ulcers • Venous stasis ulcers • Ulcers not extending through the dermis into the subcutaneous

tissue

Treatment Investigational Use of platelet-rich plasma (ie, autologous blood-derived preparations)

Use platelet-rich plasma (ie, autologous blood-derived preparations) is considered investigational for the treatment of acute or chronic wounds, including surgical wounds and nonhealing ulcers.

Additional Guidelines Becaplermin • Appropriate candidates for becaplermin gel for treatment of neuropathic ulcers should meet

ALL of the following criteria: o 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 o Full-thickness ulcer (ie, stage III or IV), extending through the dermis into subcutaneous

tissues

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Additional Guidelines AND o Participation in a wound management program, which includes sharp debridement,

pressure relief (ie, non-weight bearing), and infection control • Appropriate candidates for becaplermin gel for the treatment of pressure ulcers should meet

ALL of the following criteria: o Full-thickness ulcer (ie, stage III or IV), extending through the dermis into subcutaneous

tissues AND o Ulcer is in an anatomic location that can be off-loaded for the duration of treatment AND o Albumin concentration >2.5 dL AND o Total lymphocyte count >1,000/μL AND o Normal values of vitamins A and C

• Patients are typically treated once daily for up to 20 weeks or until completely healed. Application of the gel may be performed by the patient in the home

• Becaplermin is available in 2-g, 7.5-g, and 15-g tubes and is applied in a thin continuous layer, about 1/16 of an inch thick (ie, 1.6 mm or the thickness of a dime). The amount of the gel used will depend on the size of the ulcer, measured in square centimeters. However, an average-sized ulcer, measuring 3 cm2, treated for an average length of time of 85 days, will require a little more than one 15-g tube. If the ulcer is treated for the maximum length of time of 140 days, 2 of the 15-g tubes would be required.

Platelet-Rich Plasma (IE, Autologous Blood-Derived Preparations) • The American Medical Association’s Department of Coding instructs that placement of

platelet-rich plasma into an operative site is an inclusive component of the operative procedure performed and is not reported separately.

Documentation Requirements For recombinant platelet derived growth factor (ie, Regranex® [becaplermin]) to be used as an added treatment to standard wound management the following supporting documentation is required: • For neuropathic diabetic ulcers extending into the subcutaneous tissue (diabetic ulcers that

reach the innermost layer of skin):

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Documentation Requirements o Adequate tissue oxygenation as shown by a transcutaneous partial pressure of oxygen of

30 mm Hg or greater on the top of the foot or at the margin of the ulcer AND

o Full-thickness ulcer (stage III or IV) ulcer, extending through the dermis and into subcutaneous tissues

AND o Participation in a wound management program, which includes the cutting away of tissue,

pressure relief (that is, non-weight bearing), and infection control • For Pressure ulcers extending into the subcutaneous tissue (the innermost layer of skin):

o Full-thickness ulcer (stage III or IV), extending through the dermis and into subcutaneous tissues

AND o The wound is in a location where pressure can be relieved for the duration of treatment

AND o Albumin concentration greater than 2.5 dL

AND o Total lymphocyte count greater than 1,000/μL

AND o Normal values of vitamins A and C

Coding

Code Description CPT 0232T Injection(s), platelet rich plasma, any site, including image guidance, harvesting and

preparation when performed

86999 Unlisted transfusion medicine procedure

HCPCS 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%, 0.5 gm

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Code Description S9055 Procuren or other growth factor preparation to promote wound healing

(Please note that Procuren may no longer be available but this code is used to report other growth factor preparations that promote wound healing.)

Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).

Related Information

Benefit Application

Becaplermin is used as part of a program of wound management, as described in the Additional Guidelines. Use of becaplermin gel is potentially high, particularly if used for off-label indications, or if used outside the setting of adequate and diligent standard wound management.

Evidence Review

Description

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 of wounds or other miscellaneous non‒orthopedic conditions, including but not limited to diabetic ulcers, pressure ulcers, venous stasis ulcers, and surgical and traumatic wounds.

Background

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,

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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 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 factors, 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.

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 International) and Hemaseel® (Haemacure Corp.) 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 nonorthopedic indications, which include a number of wound closure-related indications.

For this policy, the primary end points of interest for studies of wound closure are as follows, consistent with guidance from the U.S. Food and Drug Administration (FDA) for the industry in developing products for the treatment of chronic cutaneous ulcer and burn wounds1:

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

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Summary of Evidence

Recombinant PDGFs

For individuals with diabetic lower-extremity ulcers who receive recombinant PDGF, the evidence includes randomized controlled trials (RCTs) and systematic reviews. The relevant outcomes are symptoms, change in disease status, morbid events, quality of life, 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 a meaningful improvement in the net health outcome.

For individuals with pressure ulcers who receive recombinant PDGF, the evidence includes RCTs and systematic reviews. The relevant outcomes are symptoms, change in disease status, morbid events, quality of life, 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 a meaningful improvement in the net health outcome.

For individuals with venous stasis leg ulcers or acute surgical or traumatic wounds who receive recombinant PDGF, the evidence includes small RCTs. The relevant outcomes are symptoms, change in disease status, morbid events, quality of life, 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 the effects of the technology on health outcomes.

Platelet-Rich Plasma

For individuals with chronic wounds or acute surgical or traumatic wounds who receive PRP, the evidence includes a number of small controlled trials. The relevant outcomes are symptoms, change in disease status, morbid events, quality of life, 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 the effects of the technology on health outcomes.

For individuals with chronic wounds who receive PRP, the evidence includes a number of small controlled trials. The 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 the effects of the technology on health outcomes.

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Ongoing and Unpublished Clinical Trials

Some larger studies that might influence this review are listed in Table 1.

Table 1. Summary of Key Clinical Trials

NCT No. Trial Name Planned Enrollment

Completion Date

Ongoing NCT02312596a A Prospective, Randomized Clinical Trial of PRP Concepts

Fibrin Bio-Matrix in Chronic Non-Healing Pressure Ulcers 250 Jul 2021

NCT02312570a A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Chronic Non-Healing Pressure Ulcers

250 Jul 2021

NCT02307448a Effectiveness of Autologous Platelet Rich Plasma in the Treatment of Chronic Non-Healing Wounds

1500 Dec 2020

NCT02402374a Randomized, Placebo-controlled, Blind-assessor Study to Evaluate the Safety and Efficacy of Autologous Platelet Rich Plasma Gel Prepared With the RegenKit-BCT Plus Family of Kits for the Treatment of Diabetic Foot Ulcer

192 Sept 2019

NCT02213952 Efficacy of Autologous Platelet-Rich Plasma in the Treatment of Vascular Ulcers in Primary Care: Clinical Trial Phase III

150 Dec 2017

Unpublished NCT02209662a A Multi-Center, Randomized Trial Comparing the

Effectiveness of APIC-PRP to Control, When Added to Standard of Care in the Treatment of Non-healing Diabetic Foot Ulcers

274 Dec 2015 (unknown)

NCT02071979a Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds (CMS)

1500 Jan 2018 (terminated; updated 01/16/18)

NCT: national clinical trial a Denotes industry-sponsored or cosponsored trial.

https://www.clinicaltrials.gov/ct2/show/NCT02312596?term=NCT02312596&rank=1https://clinicaltrials.gov/ct2/show/NCT02312570?term=02312570&rank=1https://www.clinicaltrials.gov/ct2/show/NCT02307448?term=NCT02307448&rank=1https://www.clinicaltrials.gov/ct2/show/NCT02402374?term=NCT02402374&rank=1https://www.clinicaltrials.gov/ct2/show/NCT02213952?term=NCT02213952&rank=1https://www.clinicaltrials.gov/ct2/show/NCT02209662?term=NCT02209662&rank=1https://www.clinicaltrials.gov/ct2/show/NCT02071979?term=NCT02071979&rank=1

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Practice Guidelines and Position Statements

American College of Physicians

The American College of Physicians (2015) published guidelines on treatment of pressure ulcers.33 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

The Association for the Advancement of Wound Care developed guideline recommendations for the management of pressure ulcers (2010)34 and venous ulcers (2015)35:

• Pressure ulcer: “Growth factors are not indicated for PU [pressure ulcers] at this time” (level C evidence – no RCTs available comparing growth factors with A-level dressings)34

• Venous ulcer: “Platelet derived growth factor has shown no significant effects on VU [venous ulcer] healing or recurrence” (level A evidence)35

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence (2016) updated its guidance on the prevention and management of diabetic foot problems.36 The guidance stated that neither autologous platelet-rich plasma (PRP) gel nor platelet-derived growth factors should be offered in the treatment of diabetic foot ulcers.

Medicare National Coverage

The Centers for Medicare & Medicaid Services (2012) revised its national coverage decision on autologous blood-derived products for chronic non-healing wounds.37,38 This revision replaces prior noncoverage decisions.39,40

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The Centers for Medicare & Medicaid Services covers autologous PRP only for patients who have chronic non-healing diabetic, pressure, and/or venous wounds and when all of the following conditions are met:

The patient is enrolled in a clinical research study that addresses the following questions using validated and reliable methods of evaluation…

The clinical research study must meet the requirements specified below to assess the effect of PRP for the treatment of chronic non-healing diabetic, pressure, and/or venous wounds. The clinical study must address:

Prospectively, do Medicare beneficiaries that have chronic non-healing diabetic, pressure, and/or venous wounds who receive well-defined optimal usual care, along with PRP therapy, experience clinically significant health outcomes compared to patients who receive well-defined optimal usual care for chronic non-healing diabetic, pressure, and/or venous wounds as indicated by addressing at least one of the following:

a. Complete wound healing

b. Ability to return to previous function and resumption of normal activities; or

c. Reduction of wound size or healing trajectory, which results in the patient’s ability to return to previous function and resumption of normal activities?

Regulatory Status

Regranex®

In 1997, becaplermin gel (Regranex®; Smith & Nephew), a recombinant PDGF product, was approved by the 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 débridement, pressure relief and infection control, REGRANEX Gel increases the complete healing of diabetic ulcers.

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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.

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 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.2

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.

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

References

1. U.S. Food and Drug Administration. Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds -- Developing Products for Treatment. Rockville, MD: Food and Drug Administration; 2006 June.

2. U.S. Food and Drug Administration (FDA). Tissue and Tissue Products. 2016; http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/ Accessed March 2020.

http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/

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3. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Becaplermin for wound healing. TEC Assessments. 1999;Volume 14:Tab 5.

4. Crovetti G, Martinelli G, Issi M, et al. Platelet gel for healing cutaneous chronic wounds. Transfus Apher Sci. Apr 2004;30(2):145-151. PMID 15062754

5. 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):1502-1508. PMID 15509939

6. 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. PMID 15095838

7. Castillo TN, Pouliot MA, Kim HJ, et al. Comparison of growth factor and platelet concentration from commercial platelet-rich plasma separation systems. Am J Sports Med. Feb 2011;39(2):266-271. PMID 21051428

8. 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):110-118. PMID 19392780

9. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Growth factors for wound healing. TEC Evaluations. 1992;7:352-377.

10. Zhao XH, Gu HF, Xu ZR, et al. Efficacy of topical recombinant human platelet-derived growth factor for treatment of diabetic lower-extremity ulcers: Systematic review and meta-analysis. Metabolism. Oct 2014;63(10):1304- 1313. PMID 25060693 NonOrthopedic Conditions

11. 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. Nov-Dec 2005;13(6):531-536. PMID 16283867

12. Sridharan K SG. Growth factors for diabetic foot ulcers: mixed treatment comparison analysis of randomized clinical trials. Br J Clin Pharmacol. 2018 Mar;84(3):434-444. doi: 10.1111/bcp.13470. Epub 2018 Jan 5. PMID: 29148070

13. 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. May-Jun 1999;7(3):141-147. PMID 10417749

14. 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):926-930. PMID 21482863

15. Freedman BM, Oplinger EH, Freedman IS. Topical becaplermin improves outcomes in work related fingertip injuries. J Trauma. Oct 2005;59(4):965-968. PMID 16374289

16. Martinez-Zapata MJ, Marti-Carvajal AJ, Sola I, et al. Autologous platelet-rich plasma for treating chronic wounds. Cochrane Database Syst Rev. Oct 17 2012;10:CD006899. PMID 23076929

17. Martinez-Zapata MJ, Marti-Carvajal AJ, Sola I, et al. Autologous platelet-rich plasma for treating chronic wounds. Cochrane Database Syst Rev. May 25 2016(5):CD006899. PMID 27223580

18. Martinez-Zapata MJ, Marti-Carvajal A, Sola 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. PMID 18954394

19. Carter MJ, Fylling CP, Parnell LK. Use of platelet-rich plasma gel on wound healing: a systematic review and meta-analysis. Eplasty. Oct 2011;11:e38. PMID 22028946

20. 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):638-643. PMID 26019054

21. Escamilla Cardenosa M, Dominguez-Maldonado G, Cordoba-Fernandez A. Efficacy and safety of the use of platelet-rich plasma to manage venous ulcers. J Tissue Viability. 2017 May;26(2):138-143. PMID 27955807

22. Del Pino-Sedeno T, Trujillo-Martin MM, Andia I, et al. Platelet-rich plasma for the treatment of diabetic foot ulcers: A meta-analysis. Wound Repair Regen, 2018 Dec 24;27(2). PMID 30575212

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23. 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, 2018 Sep 6;11(5). PMID 30182534

24. Zhou SF, Estrera AL, Loubser P, et al. Autologous platelet-rich plasma reduces transfusions during ascending aortic arch repair: a prospective, randomized, controlled trial. Ann Thorac Surg. Apr 2015;99(4):1282-1290. PMID 25661906

25. Serraino GF, Dominijanni A, Jiritano F, et al. Platelet-rich plasma inside the sternotomy wound reduces the incidence of sternal wound infections. Int Wound J. Jun 2015;12(3):260-264. PMID 23692143

26. El-Anwar MW, Nofal AA, Khalifa M, et al. Use of autologous platelet-rich plasma in complete cleft palate repair. Laryngoscope. Jul 2016;126(7):1524-1528. PMID 27075516

27. Sidman JD, Lander TA, Finkelstein M. Platelet-rich plasma for pediatric tonsillectomy patients. Laryngoscope. Oct 2008;118(10):1765-1767. PMID 18622315

28. Almdahl SM, Veel T, Halvorsen P, et al. Randomized prospective trial of saphenous vein harvest site infection after wound closure with and without topical application of autologous platelet-rich plasma. Eur J Cardiothorac Surg. Jan 2011;39(1):44-48. PMID 20634084

29. Alamdari DH AM, Rahim AN, et al. Efficacy and Safety of Pleurodesis Using Platelet-Rich Plasma and Fibrin Glue in Management of Postoperative Chylothorax After Esophagectomy. World J Surg. 2018;42(4):1046-1055. PMID: 28986682

30. 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. Aug 2009;40(8):801-805. PMID 18703188

31. Marck RE, Gardien KL, Stekelenburg CM, et al. The application of platelet-rich plasma in the treatment of deep dermal burns: A randomized, double-blind, intra-patient controlled study. Wound Repair Regen. Jul 2016;24(4):712-720. PMID 27169627

32. Yeung CY HP, Wei LG, Hsia LC, Dai LG, Fu KY, Dai NT. Efficacy of Lyophilised Platelet-Rich Plasma Powder on Healing Rate in Patients With Deep Second Degree Burn Injury: A Prospective Double-Blind Randomized Clinical Trial. Ann Plast Surg. 2018 Feb;80(2S Suppl 1):S66-S69. PMID: 29369904.

33. 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. PMID 25732279

34. Association for the Advancement of Wound Care (AAWC). Guideline of Pressure Ulcer Guidelines. Malvern, PA: AAWC; 2010.

35. Association for the Advancement of Wound Care (AAWC). International Consolidated Venous Ulcer Guideline (ICVUG). 2015; https://aawconline.memberclicks.net/assets/appendix%20c%20guideline%20icvug-textformatrecommendations-final%20v42%20changessaved18aug17.pdf. Accessed March 2020.

36. National Institute for Health and Clinical Excellence (NICE). Diabetic foot problems: prevention and management [NG19]. 2016; https://www.nice.org.uk/guidance/ng19. Accessed March 2020.

37. National coverage determination (NCD) for blood-derived products for chronic non-healing wounds (270.3). Centers for Medicare and Medicaid Services. Effective date of version August 2, 2012. https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=217&ncdver=5&NCAId=260&bc=ACAAAAAAQAAA&. Accessed March 2020.

38. Centers for Medicare & Medicaid Services. Decision Memo for Autologous Blood-Derived Products for Chronic Non-Healing Wounds (CAG-00190R3). 2012; https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=260. Accessed March 2020.

39. Centers for Medicare & Medicaid Services (CMS). CMS Manual System: Pub 100-3 Medicare National Coverage Determinations (Transmittal 127). 2010 Oct; https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R127NCD.pdf. Accessed March 2020.

40. Centers for Medicare & Medicaid Services. Decision Memo for Autologous Blood Derived Products for Chronic Non-Healing Wounds (CAG-00190R2). 2008; https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=208&bc=ACAAAAAAQCAA&. Accessed March 2020.

https://aawconline.memberclicks.net/assets/appendix%20c%20guideline%20icvug-textformatrecommendations-final%20v42%20changessaved18aug17.pdfhttps://aawconline.memberclicks.net/assets/appendix%20c%20guideline%20icvug-textformatrecommendations-final%20v42%20changessaved18aug17.pdfhttps://www.nice.org.uk/guidance/ng19https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=217&ncdver=5&NCAId=260&bc=ACAAAAAAQAAA&https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=217&ncdver=5&NCAId=260&bc=ACAAAAAAQAAA&https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=260https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=260https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R127NCD.pdfhttps://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R127NCD.pdfhttps://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=208&bc=ACAAAAAAQCAA&https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=208&bc=ACAAAAAAQCAA&

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History

Date Comments 05/05/97 Add to Medicine Section - New Policy

08/17/99 Replace Policy - Revised policy; addresses becaplermin gel.

10/08/02 Replace Policy - Policy reviewed with changes: new policy statement on becaplermin gel for treatment of pressure ulcers.

10/16/03 Replace Policy - Policy updated; no change in policy statement. Information regarding Autologel and SafeBlood provided. Title updated by removing Platelet and adding Blood.

01/11/05 Replace Policy - Policy updated focusing on autologous blood derived wound healing products; reference added; no change in policy statement.

01/10/06 Presented at January MPC - Policy revised; policy statement added regarding miscellaneous use of platelet-rich plasma as a primary procedure. Description and rationale now include discussion of platelet-rich plasma. MPC requested further research before adopting.

02/14/06 Replace Policy - Policy revised per MPC request of removing description regarding fibrin sealant and surgical indications (primary wound closure).

06/16/06 Update Scope and Disclaimer - No other changes

07/10/07 Replace Policy - Policy updated with literature search; references added; policy statement unchanged.

08/12/08 Replace Policy - Policy updated with literature search; no change to the policy statement.

01/13/09 Code Updates - Codes Q4102 and Q4103 added, effective 1/1/09.

10/13/09 Replace Policy - Policy updated with literature search; policy statement updated to include “acute” wounds for PRP. References added.

12/27/10 Codes Updated - CPT code 0232T added to policy; no other changes.

06/13/11 Replace Policy - Policy updated with literature search, reference numbers 11-14, 18, 19, 23, 24 added, policy statements unchanged. ICD-10 codes added to policy. CPT coding related to platelet-rich plasma also updated. Title changed to “Recombinant and Autologous Platelet-Derived Growth Factors as a Treatment of Wound Healing and Other Conditions.”

03/22/12 Minor update, Related Policies updated with 7.01.113 and 1.01.16.

06/26/12 Replace policy. Policy updated with literature search through February 2012, references added and reordered; some references removed; policy statements unchanged. Codes Q4102 and Q4103 removed; these do not apply to this policy and appear on 7.01.113.

Page | 15 of 16 ∞

Date Comments 07/25/12 Related Policies Update: 8.01.52 and 8.01.55 have been added.

08/24/12 Update Related Policies – Remove 1.01.16 as it was archived. Update coding section – ICD-10 codes are now effective 10/01/2014.

07/23/13 Replace policy. Policy updated with literature search through March 8, 2013; references added and reordered; policy statements unchanged.

03/17/14 Update Related Policies. Remove 7.01.100 as it was archived.

07/31/14 Annual Review. Policy updated with literature review through March, 2014. References 6, 19, 22-23, 26, 31, 36, and 48 added; others renumbered/removed. Policy statements unchanged. HCPCS code G0460 added to the policy.

09/23/14 Update Related Policies. Add 7.01.142.

07/14/15 Annual Review. Policy title changed to “Recombinant and Autologous Platelet-Derived Growth Factors as a Treatment of Wound Healing and Other Non‒Orthopedic Conditions.” Orthopedic applications of platelet-rich plasma (PRP) policy statements removed from this policy and placed in new Policy No. 2.01.98. Coding table in Policy Guidelines updated to match Coding section of policy. Policy updated with literature review through April 15, 2015; references 1 and 3 added. Policy statements removed as noted, others remain unchanged. CPT code 20926 removed; platelet-rich plasma is not considered a tissue graft. ICD-9 and ICD-10 codes removed; these were for informational purposes only.

09/01/15 Update Related Policies. Add 7.01.149

10/16/15 Update Related Policies. Remove 7.01.142.

04/01/16 Annual Review, approved March 8, 2016. Policy updated with literature review through October 29, 2015; references 16 and 18-19 added. Policy statements unchanged.

04/01/17 Annual Review, approved March 14, 2017. Policy updated with literature review through November 8, 2016; references 1, 16, 20, 23, and 27-31 added. Policy statements unchanged.

09/22/17 Policy moved to new format. No changes to policy statements.

04/01/18 Annual Review, approved March 20, 2018. Policy updated with literature review through November 2017; no new references added; notes 1-2, 29-30, and 32-34 updated. Policy statements unchanged.

03/01/19 Annual Review, approved February 25, 2019. Policy updated with literature review through October 2018; 12, 27, and 30 references added. Policy statements unchanged.

04/01/20 Annual Review, approved March 19, 2020. Policy updated with literature review through November 2019; references added. Policy statements unchanged.

08/01/20 Update related policies. 7.01.149 is now 7.01.583.

Page | 16 of 16 ∞

Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). ©2020 Premera All Rights Reserved.

Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

Discrimination is Against the Law

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If you need these services, contact the Civil Rights Coordinator.

If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator - Complaints and Appeals PO Box 91102, Seattle, WA 98111 Toll free 855-332-4535, Fax 425-918-5592, TTY 800-842-5357 Email AppealsDepartmentInquiries@Premera.com

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( ةالعربي :(. امةھ ماتولعم اإلشعار ھذا يحوي

خالل من ھاعلي صولحلا تريد لتيا التغطيةلل أو ةصحيلاكطيتتغ لىع اظلحفل نةعيم يخراوت في إجراء خاذتال تحتاج وقد .اإلشعار ھذا في

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037338 (07-2016)

https://www.hhs.gov/ocr/office/file/index.htmlhttps://ocrportal.hhs.gov/ocr/portal/lobby.jsfmailto:AppealsDepartmentInquiries@Premera.com

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ູຂໍ້

່

ສໍ ັ

ຈ

ໝ

ສິ

ັ

່

ວ

ຄ

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ມູຮັ

ູມີ ມຂໍ້

ភាសាែខមរ ( ): ឹ

រងរបស់

Premera Blue Cross ។ របែហលជាមាន កាលបរ ិ ឆ ំខានេនៅកងេសចក

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ជាមានព័ ៌ ៉ ងសំ ់អពី ់ ៉ ប់

នដំ ងេនះមានព័ ី

តមានយា ខាន ំ ទរមងែបបបទ ឬការរា

ណ ត៌មានយ៉ា ំ ់ តងសខាន។ េសចក

េចទស ់ ន ុ ត

ណងេនះ។ អ វការបេញញសមតភាព ដលកណតៃថ ចបាស

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នដ

ន

ី ន

ូ

អ

ូ

ជ

ជ

ំណឹងេនះរបែហល

នានា េដើ ីនងរកសាទុ ៉ បរងស់ ុ ់ ក ឬរបាក់ ំ

អ

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ធនកមានសិ ទទលព័ មានេនះ និ ំ យេនៅកុងភាសារបសទិ ួ ត៌ ងជ ននួ

ន

់ កេដាយម

អ

នអ

យេចញៃថល។ ួ

នអស

ន

ិ

លុ ើ ូ ូយេឡយ។ សមទ ទ រស័ព 800-722-1471 (TTY: 800-842-5357)។

Khmer

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ਪ ਜਾਬੀ (Punjabi): ਇਸ ਨ ਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ. ਇਸ ਨ ਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤੁਹਾਡੀ

ੰ

ੰ

ੇ ੇ ੇ ੱ ੂ ੋ ੈ ੋੋ ਂ ੁ ੇ ੱ ੋ ੇ ੱੱ ੁ ੱ ੂੁ ੱ ੇ ੱ ੇ ੍ਰ ੈ

ੋ ੰ ੂ ੱ ੁ ੋ ੋ ੈ ੰ

ੋ ੈ ੋ

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้

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Pусский (Russian): Настоящее уведомление содержит важную информацию. Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross. В настоящем уведомлении могут быть указаны ключевые даты. Вам, возможно, потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами. Вы имеете право на бесплатное получение этой информации и помощь на вашем языке. Звоните по телефону 800-722-1471 (TTY: 800-842-5357).

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Español ( ): Este Aviso contiene información importante. Es posible que este aviso contenga información importante acerca de su solicitud o cobertura a través de Premera Blue Cross. Es posible que haya fechas clave en este

tiene derecho a recibir esta información y ayuda en su idioma sin costo

aviso. Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura médica o ayuda con los costos. Usted

alguno. Llame al 800-722-1471 (TTY: 800-842-5357).

Spanish

Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471 (TTY: 800-842-5357).

ไทย (Thai): ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกน สขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตอง ดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอท มคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไม่มคาใชจาย โทร 800-722-1471 (TTY: 800-842-5357)

้ี ี ้ ู ํ ั ้ี ี ้ ู ่ี ํ ั ่ี ั ั ื ัุ ุ ่ ี ํ ี ุ ้ํ ิ ํ ่ี ่ ่ื ั ั ุ ุ ื ่ ื ่ีี ่ ้ ่ ุ ี ิ ิ ่ี ้ ั ้ ู ่ ื ้ี ุ ี ่ ้ ่

Український (Ukrainian): Це повідомлення містить важливу інформацію. Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross. Зверніть увагу на ключові дати, які можуть бути вказані у цьому повідомленні. Існує імовірність того, що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того, щоб зберегти Ваше медичне страхування або отримати фінансову допомогу. У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за номером телефону 800-722-1471 (TTY: 800-842-5357).

Tiếng Việt (Vietnamese): Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua chương trình Premera Blue Cross. Xin xem ngày quan trọng trong thông báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình miễn phí. Xin gọi số 800-722-1471 (TTY: 800-842-5357).