Strategic Im plications of UDI and Contract Adm inistration 2014 - - PowerPoint PPT Presentation

What?

Strategic Im plications

• f

UDI and Contract Adm inistration

2014 Fall Conference Dec 9 – 11, 2014 OMNI Hotel, Chicago

Elizabeth Hilla Senior Vice President, Health Industry Distributors Association (HIDA) Executive Director, HIDA Educational Foundation Ellenmary Martin Chief Strategy Officer DUKAL Corporation Denise Odenkirk Senior Director, Industry Solutions GHX

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago

Danny Adams President and CEO Distributor Data Solutions (DDS) Dennis Black Director, e-Business BD Dennis Cameron Hall Director, Product Management ValueCentric, LLC

Kevin Neuman Vice President of Marketing and Operations Innovative Healthcare Corporation

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago HIDA White Paper:

Improving Pricing Accuracy: Best Practices in Contract Communications Guidelines for Manufacturers and Distributors

Unique Device Identifier (UDI) =

• Device Identifier (DI)

+

• Production Identifier (PI)

Customer demands now for what they know UDI will require later . Fifty Industry Manufacturer & Distributor Thought

• ur biggest problem and must be solved.

UDI and Contracting /Pricing share process adaptations that are similar and simultaneous. They are both driven by long overdue efficiencies and GS1 standards, customer demands and now FDA regulations. Solutions are both strategic and IT deliverables contract pricing and process as Leaders identified GS1 GLN and GTIN

• 5.4.1 Product Data.
• 5.4.1.1

Access to GTINs and GDSN Certified Data Pool. Supplier must (i) assign a GTIN to identify each Product at all applicable levels of packaging (e.g. case, box, each) and (ii) permit KPS and Kaiser Permanente to access all product attributes related to the Products using the services of a GS1 Global Data Synchronization Network (“GDSN”) Certified Data Pool Provider. Supplier represents and warrants that as of the Effective Date: (a) it has assigned a GTIN to all levels of packaging for all Products; (b) it has enrolled with a certified GDSN data pool; and (c) upon KPS’ or Kaiser Permanente’s request, it will participate in compliance testing to demonstrate that its data submissions conform to the GTIN requirements. If Supplier cannot comply with this Section 5.4.1 as of the Effective Date, then Supplier, KPS, and Kaiser Permanente must mutually agree upon (A) a clearly defined interim plan to facilitate the transmission of GTINs to KPS and the Customers, and (B) a timeline to become compliant.

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago

Distributor UDI Impact

• In the current, soon to be in the past, distributors have a level
• f product recall customer service responsibility to the

customer but charged the manufacturer for the effort to identify and inform their customers and advise the manufacturer.

• UDI holds the manufacturer 100% responsible with none for

the distributor by using the UDI labels and GUDID to identify the manufacturer.

• Not only manufacturers, distributors as well are being asked

by their healthcare provider customers to have the products they stock carry UDI like labeled products. Manufacturers that do not UDI label will be pressured by distribution to do so in

• rder for the distributor to stock and sell. Or find an

alternative

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago

UDI Introduction

Dennis Black Director, e-Business BD

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago

UDI Requirements – Overview

• The following is a high level
• verview of the FDA UDI Regulation.
• You will not be an expert on UDI

after this review and should review the Federal Register for a complete review of the regulation and consult your legal counsel.

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago

What is the FDA UDI?

Appearing in two forms*:

• Easily readable plain-text, and
• Automatic identification and data capture or AIDC technology

Composed of two parts:

• Device Identifier or DI - mandatory, fixed, identifies the labeler and the specific version
• r model of a device; and
• Production Identifier(s) or PI – conditional, variable identifies one or more of the

following when included on the label of a device:

 lot or batch number  serial number  expiration date  date manufactured  for an HCT/P (Human Cell, Tissue or Cellular or Tissue-Based Product) regulated as a device, the International Council for Commonality in Blood Banking Automation (ICCBBA).

For all exceptions refer to UDI Final Rule www.fda.gov/udi and FDA GUDID Guidance for Industry dated June 27, 2014 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago

PI & DI: Using GTINs

DI

GTIN (Global Trade Item Number) Uniquely identifies the product.

PI

Production Information (Lot, Expiry, etc.)

(This label is intended to depict GS1 standards. It is not yet compliant with UDI regulations.)

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago

FDA UDI Rule Overview

• Label with AIDC (barcode)
• UDI=Device Identifier(DI)+Production Identifier(PI)
• UDI=GTIN + Standardized Production Data
• Label plain-text ISO format date YYYY-MM-DD

MARK

• Publish UDI plus required data attributes to the Global

UDI Data Base (GUDID)

• GDSN is one mechanism to publish that data once to

both the FDA and customers

SUBMIT

• Year 1 (2014):Class III and devices licensed under PHS Act
• Year 2 (2015):Class II/I implants and life-supporting/sustaining
• Year 3 (2016):Remainder of Class II
• Year 5 (2018):Class I
• For Direct Marking- Compliance dates are extended by 2 years except for FDASIA

implants and life-supporting/sustaining

COMPLY

UDI Final Rule Sept 24, 2013 GS1 US website: www.gs1us.org/hcudi FDA UDI Website: www.fda.gov/gov and click on “UDI Help Desk”

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago

Issuing Agencies

• The UDI will be created and maintained by device

labelers based on global standards managed by FDA- accredited Issuing Agencies.

• Issuing Agencies are:
• GS1
• HIBC
• ICCBBA

UDI Final Rule www.fda.gov/udi and FDA GUDID Guidance for Industry dated June 27, 2014 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago