Strategic Implications of UDI and Contract Administration · 12/10/2014 · •Publish UDI plus required data attributes to the Global UDI Data Base (GUDID) •GDSN is one mechanism

What?

Strategic Implications of

UDI and

Contract Administration

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


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

our 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.





Distributor UDI Impact • In the current, soon to be in the past, distributors have a level

of 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 order for the distributor to stock and sell. Or find an alternative


UDI Introduction

Dennis Black

Director, e-Business

BD


UDI Requirements – Overview

• The following is a high level overview 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.


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 or 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


http://www.fda.gov/udi

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf


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.)


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”


http://www.gs1us.org/hcudi

http://www.fda.gov/gov


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





“Labeler means:

(1) Any person who causes a label to be applied to a device with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label; and

(2) Any person who causes the label of a device to be replaced or modified with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label, except that the addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label, is not a modification for the purposes of determining whether a person is a labeler.”

Labeler Definition


UDI Date Format

YYYY-MM-DD

• Dates on medical device labels for the user

o Must conform to a standard format consistent with international standards as year-month-day (for example, 2013-09-30). In the event of an expiration in particular month, the labeler may choose the last day of the month for the date field.

• Implementation Timeline - By UDI compliance date; if not – year 5

UDI Final Rule www.fda.gov/udi



General Exemptions

Source: Jay Crowley, “Not IF – but HOW… FDA’s Unique Device Identification (UDI) System –The Final Regulation.” September 23, 2013

Key Points:

• FDA listened to stakeholders in creating exemptions.

• FDA has not yet posted the exemptions that have granted post-UDI rule.

• Some general exemptions are complicated and will require additional discussion for a better understanding.


• Repository of key device information.

• Contains ONLY the DI, which serves as the primary key to obtain device information in the database and on the label. It also flags which PI attribute(s) are on the label.

• The data elements described in the UDI Final Rule are included in the GUDID, consistent with their label plus data used to develop and maintain the GUDID, as well integrate with internal FDA systems.

• Will be available to the public via the internet.

FDA Global UDI Database (GUDID)

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





Example of Elements from GUDID

Presented by E Fields, FDA at GS1 Connect 6 -11-2014


Pricing Accuracy

Elizabeth Hilla

Senior Vice President

Health Industry Distributors Association (HIDA)



HIDA Pricing Accuracy Initiative

Elizabeth B. Hilla Senior Vice President, HIDA


Copyright 2014 Health Industry Distributors Assn.

Impact of All That Complexity

• Price mismatches

• Credits/rebills

• Rebate denials

• Supply chain FTEs


3 Imperatives for Fixing the Contracting Process

• AUTOMATION:

– Push for 100% electronic transactions.

– Redesign any process that cannot be automated.

• STANDARDS:

– Standardize processes for information-sharing

– Support GS-1 standards adoption for customer and product identification.

• TIMELINESS:

– Commit to contract negotiation deadlines that allow timely notice and implementation of contract changes to all parties.


White Paper Just Released!


Standards for Contract Communications

• EDI 845: gold standard

• CSV file matched to 845 format

• Standard fields, definitions, and order

• Best practices for processing this information – Price Authorization Acknowledgment

– Manufacturers Price / Sales Catalog: EDI 832

– End User Sales Tracing: EDI 867

– Chargeback Reconciliation: EDI 849


• White paper recommendations specific timeframes for contract activation for:

– New GPO Contracts

– New Local Contracts

– GPO Price Tier Activation / Changes

– Extending a contract / award with or without changes

– Expiring a contract / award

Standards for Contract Timing


The Biggest Challenge: Standards for Customer Identification

We often don’t know who the customer is or what the product is

St. Mary’s Hospital? St. Mary’s

Surgical Center?

St. Mary Medical Center?

Saint Mary’s Hospital?


GS-1 Adoption Has Faced a Who-Goes-First Standoff

• Suppliers need to use GLNs and GTINs

• Providers need to “enumerate” their locations and maintain data

Provider Adoption

Supplier Adoption

Does UDI provide the impetus needed for all players to finally get this done?


Other Benefits of Moving Now Instead of Waiting

Ellenmary Martin

Chief Strategy Officer

DUKAL Corporation


Expanded Use of UDI

• Cost - Quality - Outcome

UDI will impact and support provider efforts in achieving C-Q-O

What is the true cost to deliver care?

Visibility to what is used where, when and how much.


Expanded Use of UDI

Supply Chain is in the middle of this:

Standardization – “the touchless order”

One Single Item Master vs. current state of multiple


Danny Adams President and CEO Distributor Data Solutions (DDS) Cameron Hall Director, Product Management ValueCentric, LLC Denise Odenkirk Senior Director, Industry Solutions GHX


• Open Discussion

• Questions

• Experiences

• Ideas

• Future HMMC Conference Workshops on these topics?
