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Effective Date: 01/01/2013 |
Title: Bio-Engineered Soft Tissue Substitutes as Implants
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Revision Date: 01/01/2018
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Document: BI383:00
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CPT Code(s): 15777, Q4107, Q4113, Q4125
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Public Statement
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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.
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Medical Statement
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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:
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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) |
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Q4107 |
GRAFTJACKET, per sq cm |
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Q4113 |
GRAFTJACKET Express, injectable, 1 cc |
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Q4125 |
ARTHROFLEX, PER SQUARE CENTIMETER |
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Background
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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:
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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)
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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
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Reference
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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.
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Application to Products
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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.
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Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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