HIGHMARK COMMERCIAL MEDICAL POLICY - DELAWARE

 
 

Medical Policy:
S-180-012
Topic:
Recombinant and Autologous Platelet-Derived Growth Factors for Wound Healing and Other Non‒Orthopedic Conditions
Section:
Surgery
Effective Date:
October 14, 2019
Issued Date:
October 14, 2019
Last Revision Date:
September 2019
Annual Review:
September 2019
 
 

A variety of growth factors have been found to play a role in wound healing, including platelet-derived growth factors (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.

Autologous platelet concentrate suspended in plasma, also known as platelet-rich plasma (PRP), can be prepared from samples of centrifuged autologous blood.  PRP is distinguished from fibrin glues or sealants.

Policy Position

Recombinant platelet-derived growth factor (i.e., becaplermin [Regranex]) may be considered medically necessary when used as an adjunct to standard wound management when EITHER of the following criteria has been met:

  • Neuropathic diabetic ulcers extending into the subcutaneous tissue or beyond and have an adequate blood supply; or
  • Pressure ulcers extending into the subcutaneous tissue.

Becaplermin gel for treatment of neuropathic ulcers may be considered medically necessary when ALL of the following criteria are met:

  • Adequate tissue oxygenation of 30 mm Hg or greater measured by EITHER:
    • A transcutaneous partial pressure on the foot dorsum or at the margin of the ulcer; or
    • Toe photoplethysmography (PPG) with infrared reflectance technique; 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 (i.e., non-weight bearing), and infection control.

Becaplermin gel for the treatment of pressure ulcers may be considered medically necessary when ALL of the following criteria are met:

  • Full-thickness ulcer (i.e., Stage III or IV), extending through dermis into subcutaneous tissues; and
  • Ulcer in an anatomic location that can be off-loaded for the duration of treatment; and
  • Albumin concentration greater than 2.5 dL; and
  • Total lymphocyte count greater than 1,000; and
  • Normal values of vitamins A and C.

All other applications of recombinant platelet-derived growth factor (i.e., becaplermin [Regranex]) are considered experimental/investigational, and therefore, non-covered including, but not limited to, ischemic ulcers, ulcers related to venous stasis, and ulcers not extending through the dermis into the subcutaneous tissue. The safety and/or effectiveness cannot be established by review of the published peer-reviewed literature.

 

S0157

S9055

 

 

 

 

 




Use of autologous blood-derived preparations (i.e., injection of PRP) is considered experimental/investigational and therefore non-covered for ALL non-orthopedic conditions because the effectiveness cannot be established by published peer-reviewed literature. 

0232T

0481T

86999

G0460

P9020

 

 




Related Policies

Refer to Medical Policy S-265, Orthopedic Applications of Platelet-Rich Plasma, for additional information.

Refer to Medical Policy S-244, Fibrin Sealants, for additional information.


Covered Diagnosis Codes for Procedure Codes: S0157, S9055, 86999

E08.621

E08.622

E09.621

E09.622

E10.21

E10.40

E10.41

E10.42

E10.43

E10.49

E10.621

E10.622

E11.40

E11.41

E11.42

E11.43

E11.49

E11.621

E11.622

E13.621

E13.622

L89.43

L89.44

L89.93

L89.94

L89.003

L89.004

L89.013

L89.014

L89.023

L89.024

L89.103

L89.104

L89.113

L89.114

L89.123

L89.124

L89.133

L89.134

L89.143

L89.144

L89.153

L89.154

L89.203

L89.204

L89.213

L89.214

L89.223

L89.224

L89.303

L89.304

L89.313

L89.314

L89.323

L89.324

L89.503

L89.504

L89.513

L89.514

L89.523

L89.524

L89.603

L89.604

L89.613

L89.614

L89.623

L89.624

L89.813

L89.814

L89.893

L89.894

L89.94

L97.102

L97.103

L97.104

L97.105

L97.106

L97.108

L97.112

L97.113

L97.114

L97.115

L97.116

L97.118

L97.122

L97.123

L97.124

L97.125

L97.126

L97.128

L97.202

L97.203

L97.204

L97.205

L97.206

L97.208

L97.212

L97.213

L97.214

L97.215

L97.216

L97.218

L97.222

L97.223

L97.224

L97.225

L97.226

L97.228

L97.302

L97.303

L97.304

L97.305

L97.306

L97.308

L97.312

L97.313

L97.314

L97.315

L97.316

L97.318

L97.322

L97.323

L97.324

L97.325

L97.326

L97.328

L97.402

L97.403

L97.404

L97.405

L97.406

L97.408

L97.412

L97.413

L97.414

L97.415

L97.416

L97.418

L97.422

L97.423

L97.424

L97.425

L97.426

L97.428

L97.502

L97.503

L97.504

L97.505

L97.506

L97.508

L97.512

L97.513

L97.514

L97.515

L97.516

L97.518

L97.522

L97.523

L97.524

L97.525

L97.526

L97.528

L97.802

L97.803

L97.804

L97.805

L97.806

L97.808

L97.812

L97.813

L97.814

L97.815

L97.816

L97.818

L97.822

L97.823

L97.824

L97.825

L97.826

L97.828

L97.902

L97.903

L97.904

L97.905

L97.906

L97.908

L97.912

L97.913

L97.914

L97.915

L97.916

L97.918

L97.922

L97.923

L97.924

L97.925

L97.926

L97.928

L98.412

L98.413

L98.414

L98.415

L98.416

L98.418

L98.422

L98.423

L98.424

L98.425

L98.426

L98.428

L98.492

L98.493

L98.494

L98.495

L98.496

L98.498

 



Place of Service: Inpatient/Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Recombinant and autologous platelet-derived growth factors for wound healing and other non‒orthopedic conditions is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business



Links






This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract, and subject to the applicable laws of your state.


Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as: 
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as: 
    • Qualified interpreters
    • Information written in other languages

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

If you believe that the Claims Administrator/Insurer 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, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you. 

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: 

U.S. Department of Health and Human Services 
200 Independence Avenue, SW 
Room 509F, HHH Building 
Washington, D.C. 20201 
1-800-368-1019, 800-537-7697 (TDD) 

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. 

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans. 





Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer 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, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.