Growth Factors in Wound Healing (becaplermin and PRP)
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Defines BCBSNC coverage and medical necessity criteria for recombinant platelet-derived growth factor (becaplermin) and states investigational stance for autologous platelet-rich plasma (PRP) for wound healing and related musculoskeletal uses, affecting providers treating members with wounds or musculoskeletal conditions.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: Becaplermin (recombinant PDGF) — Medically Necessary indications
Covered when ALL of the following are met for each indication group
Individuals are typically treated once daily for up to 20 weeks or until complete healing; application of the gel may be performed by the patient at home.
inv-02: Not covered / Investigational uses
List of specific surgical adjunct uses provided in policy.
inv-03: Long bone nonunion
Summary conclusions for PRP in long bone nonunion
From policy summary.
inv-04: Rotator cuff repair and spinal fusion
Summary conclusions for PRP in rotator cuff repair and spinal fusion
Includes subgroup meta-analysis finding and subsequent long-term follow-up.
From policy summary.
inv-05: Subacromial decompression and total knee arthroplasty
Summary conclusions for other orthopedic procedures
From policy summary.
From policy summary.
This policy does not address the use of fibrin sealants (fibrin glues). Fibrin glues are created from platelet-poor plasma and are used as surgical adjuncts to promote local hemostasis; commercially available products (for example, Tisseel® and VITASEAL™) are derived from pooled donor plasma. Autologous fibrin sealants, made from platelet-poor plasma, are also outside the scope of this policy.
Use of autologous blood-derived preparations (commonly referred to as platelet-rich plasma (PRP)) is considered investigational when used as a primary procedure for various miscellaneous conditions. Examples historically listed in the policy include epicondylitis (tennis elbow), plantar fasciitis, and Dupuytren’s contracture; the policy notes that PRP is investigational for primary procedures and other similar uses.
Autologous platelet-rich plasma (PRP) treatments for the wound and musculoskeletal indications listed in this policy are considered investigational and therefore not medically necessary. The policy specifies investigational status for PRP as treatment of acute or chronic wounds (including surgical wounds and non-healing ulcers), as an adjunct in multiple surgical procedures (including ACL reconstruction, rotator cuff repair, spinal fusion, long-bone nonunion, subacromial decompression, and total knee arthroplasty), and as primary injection therapy for conditions such as tendinopathy, plantar fasciitis, osteoarthritis, and Dupuytren’s contracture. The policy’s clinical summaries for specific procedures (for example, long-bone nonunion; rotator cuff repair; spinal fusion; subacromial decompression; total knee arthroplasty) conclude the evidence is insufficient to determine net health benefit.
Inclusion of a code in the billing/coding section of this policy does not guarantee reimbursement. Medical necessity must be determined on a case-by-case basis, and BCBSNC may request medical records and supporting documentation to make that determination. Letters of support or explanation can be helpful but are not sufficient unless they include all specific information needed for a medical necessity review.
Coding
| 0232T | Note: should not be reported with 20550-20551, 20600, 20604, 20605, 20606, 20610, 76942, 77002, 77012, 77021, 86965 (as listed in policy). |
Provider Actions and Documentation Requirements
Prior authorization required for becaplermin
Prior authorization is required when using recombinant platelet-derived growth factor (becaplermin) as an adjunct to standard wound management for covered neuropathic diabetic or pressure ulcers; requests must meet the medical necessity criteria specified in the policy (adequate TcPO2, full‑thickness Stage III/IV ulcer extending into subcutaneous tissue, participation in a wound‑management program, and other criteria as applicable).
Applicable codes — inclusion does not guarantee reimbursement
The listed CPT/HCPCS/therapy codes are provided for applicability only; inclusion does not guarantee reimbursement and BCBSNC may request medical records to determine medical necessity.
Confirm participation in wound‑management program
Before initiating becaplermin, providers must confirm the member has participated in a wound‑management program that includes sharp debridement, pressure relief (non‑weight‑bearing/off‑loading), and infection control.
- Sharp debridement
- Pressure relief/off‑loading (non‑weight‑bearing)
- Infection control
Include all required clinical elements with requests
Ensure all required clinical elements are present in the prior authorization and medical record to support medical necessity for becaplermin; missing elements may delay or result in denial.
Required clinical documentation for medical necessity
Document ulcer characteristics and relevant physiologic and laboratory values: full‑thickness Stage III or IV ulcer extending into subcutaneous tissue; transcutaneous PO2 ≥ 30 mm Hg at the foot dorsum or ulcer margin; participation in a wound‑management program; and for pressure ulcers, albumin > 2.5 g/dL, total lymphocyte count > 1,000/μL, and normal vitamins A and C.
Provide full medical records when requested
BCBSNC may request medical records to determine medical necessity; when records are requested, letters of support or explanation can be helpful but are not sufficient unless all specific information needed for the determination is included in the documentation.
Denial triggers — PRP and noncovered PDGF uses
Denials may occur for use of PRP or other noncovered applications of recombinant PDGF (becaplermin), including ischemic ulcers, venous stasis ulcers, and ulcers that do not extend through the dermis into subcutaneous tissue.
- Use of autologous platelet‑rich plasma (PRP) for wound or surgical indications is considered investigational
- Recombinant PDGF for ischemic ulcers, venous stasis ulcers, or ulcers not extending into subcutaneous tissue is investigational
Medical necessity may be requested for billed codes
Inclusion of a code in the billing/coding section does not guarantee reimbursement; BCBSNC may request medical records to determine medical necessity for submitted codes.
Background
Growth factors, including platelet-derived growth factor (PDGF) and factors released from platelets, play roles in wound healing. Becaplermin (recombinant PDGF) is a recombinant PDGF gel that is FDA-approved for treatment of lower-extremity diabetic neuropathic ulcers that extend into subcutaneous tissue when used as an adjunct to standard wound care, and the policy cites supporting evidence that becaplermin can improve healing rates in appropriate patients.
Definitions
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