Coverage Policy Manual
Policy #: 2003057
Category: Surgery
Initiated: July 2003
Last Review: June 2018
  Soft Tissue Substitutes, Orthobiologic Implant

Description:
This policy originally addressed the implantation of Restore® in the process of shoulder repair.  There are now a number of implants being used for soft tissue reinforcement in orthopedic procedures as well as breast reconstruction, abdominal and urologic procedures.  This policy will address only orthopedic applications.  
 
Bio-engineered skin and soft tissue substitutes may be derived from human tissue (autologous or allogeneic), non-human tissue (xenographic), synthetic materials, or a composite of these materials.  Bio-engineered skin and soft tissue substitutes are being evaluated for a variety of conditions, including breast reconstruction and to aid healing of lower extremity ulcers and severe burns.  Acellular dermal matrix products are also being evaluated in the repair of a variety of soft tissues.
 
Bio-engineered skin and soft tissue substitutes may be either acellular or cellular.  Acellular products (i.e., cadaveric human dermis with cellular material removed) contain a matrix or scaffold composed of materials such as collagen, hyaluronic acid, and fibronectin.  Cellular products contain living, cells such as fibroblasts and keratinocytes within a matrix.  The cells contained within the matrix may be autologous, allogeneic, or derived from other species (e.g., bovine, porcine).  
 
Acellular dermal matrix products from human skin tissue are regarded as minimally processed and not significantly changed in structure from the natural material; the FDA classifies it as banked human tissue and therefore does not require FDA approval. DermaMatrix (Synthes) is an acellular dermal matrix (allograft) derived from donated human skin tissue. DermaMatrix Acellular Dermis is processed by the Musculoskeletal Transplant Foundation® (MTF®).
 
GraftJacket™ Matrix (Wright Medical Technology, Arlington, TN)  is an acellular regenerative tissue matrix that has been processed from screened donated human skin supplied from U.S. tissue banks.  The allograft is minimally processed to remove the epidermal and dermal cells, while preserving dermal structure.  
 
PriMatrix (TEI Biosciences) is a xenogeneic acellular dermal matrix processed from fetal bovine dermis. It is indicated through the U.S. Food and Drug Administration’s (FDA) 510(k) process for partial and full-thickness wounds; diabetic, pressure, and venous stasis ulcers; surgical wounds; and tunneling, draining, and traumatic wounds.
 
OASIS™ Wound Matrix (Cook Biotech) is a xenogeneic collagen scaffold derived from porcine small intestinal mucosa. It was cleared by the FDA’s 510(k) process in 2000 for the management of partial- and full-thickness wounds including pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled undermined wounds, surgical wounds, trauma wounds, and draining wounds.
 
The “Restore” orthobiologic soft tissue implant, manufactured by DePuy, Inc., received FDA 510(k) approval for marketing in December 2000.  DePuy, Inc. is a Johnson & Johnson company. The implant is a device manufactured from 10 plies of Small Intestine Submucosa (SIS), derived from porcine small intestine, and is composed of predominately water and collagen.  According to the FDA, the implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.  The device is intended to act as a resorbable scaffold that initially has sufficient strength to assist with a soft tissue repair, but then resorbs and is replaced by the patient’s own tissue.  The device is also intended for reinforcement of the soft tissues which are repaired by suture of suture anchors, limited to the supraspinatus, during rotator cuff repair surgery.
 
Effective in 2012, there is a specific add-on CPT code for the use of these materials as an implant:
 
15777: Implantation of biologic implant (e.g., acellular dermal matrix) for soft tissue reinforcement (e.g., breast, trunk) (List separately in addition to code for primary procedure)
 
There are also HCPCS modifiers to indicate whether the skin substitute is or is not used as a graft (i.e., surface use vs. use as an implant):
 
   JC: Skin substitute used as a graft
   JD: Skin substitute not used as a graft
 
Related Policy:
2012009_Skin and Soft Tissue Substitutes, Bio-Engineered
 
 

Policy/
Coverage:
Effective June 2012
The use of bio-engineered soft tissue substitutes in orthopedic procedures, including but not limited to those listed in this policy, does not meet Primary Coverage Criteria that there be evidence of effectiveness.  Some of these devices are being studied in ongoing trials, many have never been compared to standard therapy and there are no reports of improved long-term health outcomes.
 
For contracts without Primary Coverage Criteria the use of bio-engineered soft tissue substitutes in orthopedic procedures, including but not limited to those listed in this policy, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
 
Effective prior to June 2012
For member benefit contracts which require that for a drug, device, treatment or service to be covered, that drug, device, treatment, or service must meet Primary Coverage Criteria. The Restore® Orthobiologic Implant to reinforce or repair rotator cuff injuries is not covered because this use is being studied in clinical trials to determine effectiveness. All other uses of the Restore Orthobiologic Implant are not covered because of lack of scientific evidence of effectiveness.  
 
For contracts without Primary Coverage Criteria, the use of the Restore® Orthobiologic Implant to reinforce or repair the supraspinatus tendon injuries in rotator cuff tears or for use in other indications is considered investigational.  Investigational services are an exclusion in the member benefit certificate.

Rationale:
Member benefit contracts exclude coverage of procedures being studied in Phase I, II or III trials or otherwise under study to determine effectiveness.
 
2009 Update
A search of the Medline database was conducted for the time period of August 2005 through February 2009.  In 2007, Walton et al, compared data from patients receiving Restore® implants during rotator cuff repair with data from patients undergoing conventional rotator cuff repair.  Four patients who had received a Restore® implant experienced a severe local inflammatory reaction necessitating surgical irrigation and debridement and removal of the implant.  Two years after surgical repair, patients that received the Restore® implant did not show any benefits over the control group.  The authors “do not recommend use of the Restore® Orthobiologic Implant in its present form” (Walton et al, 2007).
 
Additionally, in a study conducted by Malcarney et al, four out of 25 patients implanted with the Restore® Orthobiologic Implant experienced overt inflammatory reactions requiring open irrigation and debridement (Malcarney et al, 2005).
 
There is a Phase IV, prospective, randomized controlled trial ongoing at this time in subjects undergoing rotator cuff repair with or without the Restore® orthobiologic implant.  The only published articles found on the implant of the Restore® orthobiologic implant for indications other than the repair of rotator cuff injuries were done on animals. Presently there is a lack of scientific evidence indicating the safety and effectiveness of the Restore® Orthobiologic Implant for rotator cuff repair or other indications.
 
2012 Update
Tendon Repair
GraftJacket
In 2012, Barber et al. reported an industry-sponsored multi-center randomized controlled trial of augmentation with GraftJacket acellular human dermal matrix for arthroscopic repair of large (>3 cm) rotator cuff tears involving 2 tendons.  Twenty-two patients were randomized to GraftJacket augmentation and 20 patients were randomized to no augmentation. At a mean follow-up of 24 months (range, 12 to 38 months) the American Shoulder and Elbow Surgeons (ASES) score improved from 48.5 to 98.9 in the GraftJacket group and from 46.0 to 94.8 in the control group (p=0.035). The Constant score improved from 41 to 91.9 in the GraftJacket group and from 45.8 to 85.3 in the control group (p=0.008). The University of California, Los Angeles score was not significantly different between the groups. Gadolinium-enhanced magnetic resonance imaging (MRI) scans showed intact cuffs in 85% of repairs in the GraftJacket group and 40% of repairs in the control group. However, no correlation was found between MRI findings and clinical outcomes. Rotator cuff retears occurred in 3 patients (14%) in the GraftJacket group and 9 patients (45%) in the control group. Although these results are promising, additional study with a larger number of patients is needed.
 
In 2012 (Pedowitz et al.) a summary of AAOS Clinical Practice Guideline recommendations for Opimizing the Management of Rotator Cuff Problems was published.  This article included the following statements:
  • Non-crosslinked, porcine small intestine submucosal xenografts
We suggest surgeons not use a non-crosslinked, procine small intestine submucosal xenograft patch to treat patients with rotator cuff tears (strength of recommendation: Moderate)
 
  • Allografts and xenografts:
 We cannot recommend for or against the use of soft tissue allografts or other exenografts to treat  patients with rotator cuff tears (strength of recommendation: Inconclusive)
 
Cheung et al., in a 2010 review article, concluded many of the new and promising application of biologic augmentation have not yet been rigorously tested in humans.  They suggested further human subject research to incorporate multicenter prospective trials comparing the addition of extracellular matrices, allograft, or growth factors to a standard repair.  “Further studies in this regard will define the role of biologic augmentation in rotator cuff repair and protocols for surgical technique and clinical application.”
 
2013 Update
A literature search was conducted through May 2013. There was no new literature identified that would prompt a change in the coverage statement.
 
One study was identified assessing the use of Graft Jacket allograft acellular human dermal matrix in the surgical repair of hip abductors (Rao, 2012). Twelve patients diagnosed with hip abductor avulsions were enrolled in this prospective study. Outcome measures include pain scoring, gait evaluation, Trendelenberg test, and the Harris hip score. A significant improvement in pain score, limp, gait and abductor strength was noticed. The Trendelenberg test became negative in all but one case. At the mean follow-up of 22 months Harris hip scores improved from 34.05 to 81.26. Larger, randomized trials are needed to evaluate the impact of this treatment on health outcomes.
 
A search of the clinicaltrials.gov website identified an ongoing clinical trial (NCT01025037) evaluating the use of Conexa Reconstructive Tissue Matrix in rotator cuff repair. Conexa is a surgical mesh deried from procine dermis and processed to produce an acellular dermal matrix. The study is expected to enroll 61 patients with an estimated completion date of January 2014.
  
2015 Update
A literature search conducted through May 2015 did not reveal any new information that would prompt a change in the coverage statement.  
 
2016 Update
A literature search conducted through May 2016 did not reveal any new information that would prompt a change in the coverage statement.  
 
2017 Update
A literature search conducted through May 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Bryant and colleagues published a randomized clinical trial  pilot study to compare the effectiveness of rotator cuff repair with or without augmentation using porcine small intestine submucosa for patients with moderate to large rotator cuff tears (Bryant, 2016). There were 62 patients with moderate and large cuff tears randomized to repair alone (control) or augmentation with SIS (Restore Orthobiologic Implant; DePuy, Warsaw, IN, USA). Primary outcome was repair failure using magnetic resonance arthrography. Randomization occurred on completion of the repair. Patients and assessors were blind to group. Assessments occurred preoperatively and postoperatively at 2 and 6 weeks and 3, 6, 12, and 24 months.
 
There were 62 patients randomized (34 SIS, 28 control). Patient demographics, rotator cuff tear characteristics, and repair details were similar between groups. At 1 year, risk of failure was 52.9% (18/34) in the SIS group and 65.4% (17/26) in the control group for a risk difference of 12% (80% confidence interval, -7% to 32%) or relative risk of 0.81 (95% confidence interval, 0.53-1.24, P = .33) in favor of SIS. At 1 and 2 years, the mean difference between groups for patient-reported outcomes was small and consistent with chance but did not exclude the possibility of a clinically important difference. There was no statistically significant difference (P = .50) between the SIS group (59.6 ± 38.9; range, 3-112) and the control group (52.7 ± 38.6; range, 5-112) in number of days to being narcotic and pain free (<20 mm on a 100-mm visual analog scale). Evidence did not support that SIS-augmented rotator cuff repair provides superior outcomes in patients with moderate rotator cuff tears.
 
2018 Update
A literature search conducted through May 2018 did not reveal any new information that would prompt a change in the coverage statement.  

CPT/HCPCS:
15777Implantation of biologic implant (eg, acellular dermal matrix) for soft tissue reinforcement (ie, breast, trunk) (List separately in addition to code for primary procedure)
Q4107GRAFTJACKET, per sq cm
Q4113GRAFTJACKET XPRESS, injectable, 1cc
Q4125Arthroflex, per sq cm

References: Badylak S, Arnoczky S, Plouhar P, et al.(1999) Naturally Occurring Extracellular Matrix as Scaffold for Musculoskeletal Repair. Clinical Orthopaedics and Related Research Number 367S, pp. S333-S343; 1999.

Badylak SF, Tullius R, Kokini K, et al.(1995) The Use of Xenogenic Small Intestinal Submucosa as a Biomaterial for Achille's Tendon Repair in a Dog Model. Jnl biomedical Materials Research 1995; Vol 29, 977-985.

Barber FA, Burns JP, et al.(2011) A prospective, randomized evaluation of acellular human dermal matrix augmentation for athroscopic rotator cuff repair. Arthroscopy, 2012; 28:8-15 [Epub Oct 5, 2011].

Bryant D, Holtby R, Willits K, et al.(2016) A randomized clinical trial to compare the effectiveness of rotator cuff repair with or without augmentation using porcine small intestine submucosa for patients with moderate to large rotator cuff tears: a pilot study. J Shoulder Elbow Surg. 2016 Oct;25(10):1623-33

Cheung EV, Luz Silverio BA, Sperling JW.(2010) Strategies in biologic augmentation of rotator cuff repair. Clin Orthop Relat Res, 2010; 468:476-1484.

ClinicalTrials.gov. Pilot study to evaluate the Restore orthobiologic implant in rotator cuff tear repair. Available at www.clinicaltrials.gov.. Accessed March 18, 2009.

Cobb MA, Badylak SF, Janas W, et al.(1999) Porcine Small Intestinal Submucosa s a Dural Substitute. Elsevier Science 1999.

Cook JL, Tomlinson JL, Kreeger JM, et al.(1999) Induction of Meniscal Regeneration in Dogs Using a Novel Biomaterial. The Am J Sports Medicine 1999; Vol 27, No 5.

Dejardin LM, Arnoczky SP, Ewers BJ, et al.(2001) Tissue-Engineered Rotator Cuff Tendon Using Porcine Small Intestine Submucosa: Histologic and Mechanical evaluation in Dogs. The Am J Sports Med 2001; Vol 29, No 2.

Malcarney HL, Bonar F, Murrel GA.(2005) Early inflammatory reaction after rotator cuff repair with a porcine small intestine submucosal implant: a report of 4 cases. Am J Sports Med 2005; 33(6):907-11.

Pedowitz RA, Yamaguchi K, et al.(2012) AAOS Clinical Practice Guideline on Optomizing the management of rotator cuff problems. J Bone Joint Surg AM, 2012;94:163-7.

Rao BM, Kamal TT, Vafaye J, et al.(2012) Surgical repair of hip abductors. A new technique using Graft Jacket allograft acellular human dermal matrix. Int Orthop. 2012 Oct;36(10):2049-53.

Sarikaya A, Record R, Wu CC, et al.(2002) Antimicrobial Activity Associated with Extracellular Matriaces. Tissue Engineering, 2002; 8(1).

Suckow MA, Voytik-Harbvin SL, Terril LA, et al.(1999) Enhanced Bone Regeneration Using Porcine Small Intestinal Submucosa. Jnl Inves Surgery 1999; 12:277-287.

Walton JR, Bowman NK, Khatib Y, et al.(2007) Restore orthobiologicimplant: not recommended for augmentation of rotator cuff repairs. J Bone Joint Surg Am. 2007 Apr;89(4): 786-91.

Zheng MH, Chen J, Kirilak Y, et al.(2005) Porcine small intestine submucosa (SIS) is not an acellular collagenous matrix and contains porcine DNA: possible implications in human implantation. J Biomed Mater Res B Appl Biomater 2005; 73(1):61-7.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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