Platelet-Derived Growth Factors for Wound Healing Billing Codes

Description: 

A variety of growth factors have been found to play a role in wound healing.
Platelet-derived growth factor, epidermal growth factor, fibroblast growth
factors, transforming growth factor and Insulin-like growth factor are some of
the growth factors that have been investigated.  Topically applied
platelet-derived growth factors (PDGF) have been most extensively investigated
for clinical use in the treatment of wound healing.

A recombinant PDGF product, becaplermin gel, (Regranex® Gel) has been
approved by the US Food and Drug Administration (FDA) for the treatment of lower
extremity diabetic neuropathic ulcers, which extend into the subcutaneous
tissues, or beyond, and have adequate blood supply. Patients are typically
treated for 20 weeks or until complete wound healing occurs. Application of the
gel may be performed by the patient or caregiver in the home.

Autologous wound healing factors are derived from the patient’s own
blood. There are currently two autologous blood-derived preparations being
marketed in which blood drawn from the patient is centrifuged at high speeds to
create platelet rich plasma. Since these products are derived from the patient’s
own blood, they do not require FDA approval. The two available products that
have been investigated are marketed under the commercial names SafeBlood®
and Autologel™.

Services are covered: 

Becaplermin gel is considered a covered benefit when the following conditions
have been met:

• When used as an adjunct to standard wound care management
• When used for neuropathic diabetic ulcers extending into the
  subcutaneous tissue and the patient selection criteria listed below are met;
  • Adequate tissue oxygenation, as measured by a transcutaneous partial
    pressure of oxygen of 30 mmHg or greater, on the dorsum of the foot or
    at the margin of the ulcer.
  • Full-thickness ulcer (i.e., stage III or IV), extending through the
    dermis into the subcutaneous tissues.
  • Participation in a wound management program, which includes sharp
    debridement, pressure relief, and infection control.
• As a treatment of pressure ulcers extending into the subcutaneous tissue
  when the following patient selection criteria listed below are met;
  • Full-thickness ulcer (i.e., Stage III or IV), extending through
    dermis into subcutaneous tissues.
  • Ulcer in an anatomic location that can be offloaded for the duration
    of treatment
  • Albumin concentration >2.5g/dl
  • Total lymphocyte count > 1,000/mm3
  • Normal values for vitamins A and C

Services are not covered: 

• Becaplermin gel is considered investigational for any indication not
  listed above, including, but not limited to; ischemic ulcer, ulcer related
  to venous stasis, and ulcers not extending through the dermis into the
  subcutaneous tissue.
• Autologous platelet-derived growth factor products, including, but not
  limited to; SafeBlood® and Autologel™ are considered investigational in the
  treatment of chronic non-healing wounds.
• If the service is excluded from the member benefit certificate or it is
  determined to be not medically necessary.

Procedure Codes and Billing Guidelines: 

• To report physician services, use appropriate CPT* codes, Alpha Numeric
  (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
• Use alpha HCPCS code S0157 to report becaplermin gel.
• Use alpha HCPCS code S9055 to report other growth factor preparations to
  promote wound healing.  

References and Rationale: 
 

Wellmark’s policy is based on:

• The Medical Policy Reference Manual (MPRM) developed by the Blue Cross
  Blue Shield Association Health Management Systems, based on Technology
  Evaluation Center (TEC) criteria.
• A review of the medical literature and recommendations from the Medical
  Policy Advisory Council (MPAC), which assists Wellmark’s medical directors
  in the development of medical policies.  MPAC is comprised of practicing
  physicians from Iowa and South Dakota.
• 1999 TEC assessment concludes that treatment with becaplermin for
  chronic neuropathic diabetic ulcer improves patients health outcomes. There
  is insufficient evidence to support that this is helpful in the treatment of
  other type of ulcers.
• Wang HJ, Wan HL, Yang TS, Chen TM and Chang DM. Acceleration of skin
  graft healing by growth factor. Burns 1996;vol 22 (1): 10-14.
• Bello YM, Phillis TJ. Recent Advances in Wound Healing.
  JAMA 2000; 283,(6): 716-718. 
• Embil JM, Papp K, Sibbald G et al.  Recombinant human
  platelet-derived growth factor-BB (becaplermin) for healing chronic lower
  extremity diabetic ulcers: an open-label clinical evaluation of efficacy. 
  Wound Repair Regen.  2000 May-Jun;8(3):162-8.
• Bello YM, Phillis TJ. Recent Advances in Wound Healing. JAMA
  2000; 283,(6): 716-718.
• Stacey MC, Mata SD, Trengove NJ, Mather CA. Randomised
  double-blind placebo controlled trial of topical autologous platelet lysate
  in venous ulcer healing . Eur J Vasc Endovasc Surg.  2000
  Sep;20(3):296-301.
• Sanchez AR, Sheridan PJ, Kupp LI. Is platelet-rich plasma the perfect
  enhancement factor? A current review.  Int J Oral Maxillofac Implants. 
  2003 Jan-Feb;18(1):93-103.