Medical Devices and IVDs

Purpose and Scope

• The purpose of the committee is to ensure clinical coding information standards for Medical devices and IVDs
• The MCC had published the first draft of a classification system for Medical Devices and In-Vitro Devices (IVDs) in September 2014 for public comment and then a second draft in 2015 for public comment by August 2015.Version 1 of the new guideline was published in July 2016 with an effective application date of August 2016.
• The sub-committee will address the validity of the proposed MCC classification system in terms of the regulatory and medical benefit management needs of the private sector and propose information standards for industry stakeholder consensus. Local SA guidelines, current industry practice and global best practice will be assessed for consensus driven agreement on information standards with a key focus on SA regulations and PMBs.
• A situational analysis of the private sector industry pertaining to MDs and IVDs is that several organizations, out of benefit and risk management necessity over the years, have developed or purchased surgical classification systems to identify surgical items and develop reimbursement rates for clinically or functionally similar products.