Medical Policy
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
Limits
Intentially left empty
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.