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NuShield®

NuShield®

0

CLINICAL

Indications

  • Adhesion barrier, wound covering, acts as an adjunct to soft tissue healing
  • Direct application, wrapping or suturing around tendons, on-lay graft

FDA

Regulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/Ps. Among other criteria, HCT/Ps are required to be minimally manipulated and intended for homologous use. Homologous use means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor. [1]  In the case of amniotic membranes, homologous use include serving as a selective barrier, protection and covering of a wound. 

How supplied

NuShield®: 2cmx3cm, 4cmx4cm, 4cmx6cm, 6cmx6cm. Disk: 1.6cm.: Q4160

CODING, COVERAGE AND REIMBURSEMENT

This section currently focuses primarily on Medicare. It may be expanded in the future to include information on private insurers as well. 

Medicare hospital outpatient prospective payment system (OPPS) cost category assignment:

  • CY 2019: high cost

Frequency of replacement allowed by Medicare:



Medicare Administrative Contractor (MAC) Frequency of replacement if requirements met
Novitas Solutions, Inc. 10 units in 12 weeks
CGS Administrators, LLC 10 units in 12 weeks
Palmetto 10 units in 12 weeks
First Coast Service Options, Inc. (FCSO)

1 type of product per 12 weeks, fewest repeat applications and amount of product is expected

Noridian

Wisconsin Physicians Service Insurance Corporation (WPS)

National Government Services, Inc. (NGS)

Carrier discretion

More details on requirements, medical necessity and documentation in specific Medicare Local Coverage Determinations (if available). See section on Coding, Coverage and Reimbursement in topic "Cellular and/or Tissue Products". 

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NOTE: This is a controlled document. This document is not a substitute for proper training, experience, and exercising of professional judgment. While every effort has been made to ensure the accuracy of the contents, neither the authors nor the Wound Reference, Inc. give any guarantee as to the accuracy of the information contained in them nor accept any liability, with respect to loss, damage, injury or expense arising from any such errors or omissions in the contents of the work.
Topic 332 Version 1.0