Coverage Policies

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Current policies effective through April 30, 2024.

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QualChoice reserves the right to alter, amend, change or supplement medical policies as needed. QualChoice reviews and authorizes services and substances. CPT and HCPCS codes are listed as a convenience and any absent, new or changed codes do not alter the intent of the policy.

INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 01/01/2013 Title: Bio-Engineered Soft Tissue Substitutes as Implants
Revision Date: 01/01/2018 Document: BI383:00
CPT Code(s): 15777, Q4107, Q4113, Q4125
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Many bio-engineered skin and soft tissue substitutes have been developed, derived from human tissue, non-human tissue, synthetics, and combinations of these.  These substitutes have a proven role in certain skin applications, such as full-thickness wounds, breast reconstruction, and repair of deep burns, and are covered for these uses; see BI382:00.

2)    Use of bio-engineered soft tissue substitutes as implants is considered investigational and experimental and is not covered for non-skin implants, including but not limited to any orthopedic procedures or hernia repair.


Medical Statement

The use of bio-engineered soft tissue substitutes in orthopedic procedures is considered investigational and experimental.  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.  This includes use to reinforce or repair rotator cuff injuries.

Codes Used in This Policy:

15777

Implantation of biologic implant (eg, acellular dermal matrix) for soft tissue reinforcement (eg, breast, trunk) (List separately in addition to code for primary procedure)

Q4107

GRAFTJACKET, per sq cm

Q4113

GRAFTJACKET Express, injectable, 1 cc

Q4125

ARTHROFLEX, PER SQUARE CENTIMETER


Background

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).  

 

In 2011, Barber et al. reported an industry-sponsored multi-center randomized controlled trial of augmentation with Graft Jacket acellular human dermal matrix for arthroscopic repair of large (>3 cm) rotator cuff tears involving 2 tendons.  Twenty-two patients were randomized to Graft Jacket 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 Graft Jacket 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 Graft Jacket 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 Graft Jacket group and 40% of repairs in the control group. However, no correlation was found between MRI findings and clinical outcomes. Rotator cuff re-tears occurred in 3 patients (14%) in the Graft Jacket 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 Optimizing 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, porcine 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 xenografts 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.”

 

Effective in 2012, there is a specific add-on CPT code for the use of these materials as an implant:

5777: 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


Reference

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

 

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

 

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

 

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

 

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

 

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.

 

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.

 

Addendum:

 

Effective 01/01/2018: Updated procedure codes for coverage of biologic implants.


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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