BioEnthesis Biphasic Allograft
2021 Reimbursement Information
Indication for Use:
BioEnthesis is indicated to provide matrix for the repair or reconstruction of the bone of the enthesis within the rotator cuff. a biphasic allogenic, acellular, cancellous bone allograft that is placed inter-positionally between the decorticated humeral head and torn tendon(s) in, most commonly, a transosseous equivalent double row arthroscopic rotator cuff repair.
Rotator Cuff Coding
BioEnthesis is indicated to provide matrix for the repair or reconstruction of the bone of the enthesis within the rotator cuff. a biphasic allogenic, acellular, cancellous bone allograft that is placed inter-positionally between the decorticated humeral head and torn tendon(s) in, most commonly, a transosseous equivalent double row arthroscopic rotator cuff repair.
2020 Medicare National Payment Rates (rounded to nearest dollar)
Product Billing
BioEnthesis is billed as an allograft/implant. Coverage may depend on the payer contracts that the facility has, but reimbursement should be consistent with their current implant/allograft usage.

When the BioEnthesis Biphasic Allograft is used in concert with a rotator cuff repair procedure on a Medicare patient, the above facility procedure payment rates are relevant. To report the use and cost of BioEnthesis on the facility claim form, the following C code from the Healthcare Common Procedure Coding System (HCPCS) Level II code set may be appropriate:
C1762 Connective Tissue, human (note that connective tissue applies to tendon, ligament, bone, cartilage, integumentary systems, and connect or wraps all muscles, nerves, and tissue layers in the body)
Because BioEnthesis is intended to be used in concert with suture anchors, the following C code may be appropriate for use on the facility claim form as well:
Anchor for opposing bone-to-bone or soft tissue-to-bone (C1713) - Implantable pins and/or screws that are used to oppose soft tissue-to-bone, tendon-to-bone, or bone-to- bone. Screws oppose tissues via drilling as follows: soft tissue-to-bone, tendon-to-bone, or bone-to-bone fixation. Pins are inserted or drilled into bone, principally with the intent to facilitate stabilization or oppose bone-to-bone. This may include orthopedic plates with accompanying washers and nuts. This category also applies to synthetic bone substitutes that may be used to fill bony void or gaps (i.e., bone substitute implanted into a bony defect created from trauma or surgery).
Physician Dictation Example:
The following are sample dictations for stating the necessity of the allograft implant. Note: These are examples only, and not intended as direct guidance. All dictations are the responsibility of the physicians and must be applicable and accurate to individual's procedure.
Simple example

Implanted allograft between bone and soft tissue to repair and reconstruct the bone at the tendon enthesis

RCR

During the repair of the Rotator Cuff, BioEnthesis, an allograft tissue, was implanted at the bone-tendon junction interface to help in the repair and reconstruction of the bone within the enthesis, improve tendon healing, and reduce post-operative pain and inflammation.
These codes do not have assigned Medicare payment rates as the payment for this device categories expired. For Medicare, they will therefore be reported on the claims form to identify the technologies used and costs associated with these technologies. The use of these codes may be helpful in facilitating separate commercial payor payment for the implants.
References
    • 2020 AMA CPT Terminology and Payment Rates
    • 2020 CMS OPPS Final Rule
    • 2020 CMS ASC Final Rule
    • 2020 CMS APC Device Offset File
    • 2015 CMS Device Categories
    • BioEnthesis IFU
    The US reimbursement pathway for any medical intervention includes three associated but independent elements: coding, payment, and coverage. Each of these elements must be addressed to obtain consistent favorable reimbursement. Every reasonable effort has been made to ensure the accuracy of the information in this report. However, the ultimate responsibility for coding and claims submission lies with the provider of services (i.e., the physician, clinician, hospital, or other facility). Sparta Biopharma makes no representation, guarantee or warranty, expressed or implied, that this report is error-free or that the use of this information will prevent differences of opinion with third-party payers and will bear no responsibility or liability for the results or consequences of its use. The reimbursement information is provided given the current (March 2020) reimbursement climate for the procedures. This information is subject to change based on payor payment rate and market changes.