Strategic Implications of UDI and Contract Administration

Transcription

1 What? Strategic Implications of UDI and Contract Administration 2014 Fall Conference Dec 9 11, 2014 OMNI Hotel, Chicago

2 Danny Adams President and CEO Distributor Data Solutions (DDS) Elizabeth Hilla Senior Vice President, Health Industry Distributors Association (HIDA) Executive Director, HIDA Educational Foundation Dennis Black Director, e-business BD Dennis Ellenmary Martin Chief Strategy Officer DUKAL Corporation Cameron Hall Director, Product Management ValueCentric, LLC Denise Odenkirk Senior Director, Industry Solutions GHX Kevin Neuman Vice President of Marketing and Operations Innovative Healthcare Corporation

3 Unique Device Identifier (UDI) = Device Identifier (DI) + Production Identifier (PI) Customer demands now for what they know UDI will require later. GS1 GLN and GTIN HIDA White Paper: Improving Pricing Accuracy: Best Practices in Contract Communications Guidelines for Manufacturers and Distributors Fifty Industry Manufacturer & Distributor Thought Leaders identified contract pricing and process as 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

4 5.4.1 Product Data 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 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.

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8 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

9 UDI Introduction Dennis Black Director, e-business BD

10 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.

11 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 and FDA GUDID Guidance for Industry dated June 27,

12 PI & DI: Using GTINs PI Production Information (Lot, Expiry, etc.) DI GTIN (Global Trade Item Number) Uniquely identifies the product. (This label is intended to depict GS1 standards. It is not yet compliant with UDI regulations.)

13 FDA UDI Rule Overview MARK 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 SUBMIT 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 COMPLY 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 UDI Final Rule Sept 24, 2013 GS1 US website: FDA UDI Website: and click on UDI Help Desk

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15 Issuing Agencies The UDI will be created and maintained by device labelers based on global standards managed by FDAaccredited Issuing Agencies. Issuing Agencies are: GS1 HIBC ICCBBA UDI Final Rule and FDA GUDID Guidance for Industry dated June 27,

16 Labeler Definition 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.

17 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, ). 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

18 General Exemptions 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. Source: Jay Crowley, Not IF but HOW FDA s Unique Device Identification (UDI) System The Final Regulation. September 23, 2013

19 FDA Global UDI Database (GUDID) 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. UDI Final Rule and FDA GUDID Guidance for Industry dated June 27,

20 Example of Elements from GUDID Presented by E Fields, FDA at GS1 Connect

21 Pricing Accuracy Elizabeth Hilla Senior Vice President Health Industry Distributors Association (HIDA) Executive Director, HIDA Educational Foundation

22 HIDA Pricing Accuracy Initiative Elizabeth B. Hilla Senior Vice President, HIDA Executive Director, HIDA Educational Foundation Copyright 2014 Health Industry Distributors Assn.

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24 Impact of All That Complexity Price mismatches Credits/rebills Rebate denials Supply chain FTEs Copyright 2014 Health Industry Distributors Assn.

25 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. Copyright 2014 Health Industry Distributors Assn.

26 White Paper Just Released! Copyright 2014 Health Industry Distributors Assn.

27 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 Copyright 2014 Health Industry Distributors Assn.

28 Standards for Contract Timing 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 Copyright 2014 Health Industry Distributors Assn.

29 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 Medical Center? Saint Mary s Hospital? Copyright 2014 Health Industry Distributors Assn. St. Mary s Surgical Center?

30 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? Copyright 2014 Health Industry Distributors Assn.

31 Other Benefits of Moving Now Instead of Waiting Ellenmary Martin Chief Strategy Officer DUKAL Corporation

32 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.

33 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

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

35 Open Discussion Questions Experiences Ideas Future HMMC Conference Workshops on these topics?