UDI: Generating Value Beyond Compliance

Transcription

1 UDI: Generating Value Beyond Compliance Karen Conway, GHX Bill Mosser, Franciscan Missionaries of Our Lady Health System David Brooks, Medtronic June 7, 2017 Slide 1

2 2 UDI: What, When, How, Why? Why are we doing this? What do you have to do? By when? How can you derive value beyond compliance? For your organization? For your partners and customers? For patients? How does this change your approach to UDI? Slide 2

3 If you have been assigned to ensure UDI compliance for your organization, you might ask: Slide 3

4 From the Regulator s Perspective To protect patient safety But it is much more than that. Slide 4

5 Value in Understanding By promoting incorporation of UDIs into electronic health information, a vast quantity of untapped real-world data from clinical experience with devices housed in EHRs and other electronic information sources may become available for use in understanding the benefit-risk profiles of medical devices. Statement of Jeffrey Shuren, M.D., J.D. before the Committee on Health, Education, Labor and Pensions, April 28, Slide 5

6 UDI: A Systems View Source: FDA Strengthening Our National System For Medical Device Postmarket Surveillance April 2013 Slide 6

7 7 MDIC and Nest Slide 7

8 Case4Quality How do healthcare delivery organizations and value analysis teams evaluate medical device performance? What factors are critical to value? How do we ensure the data is accurate to generate valid results? How can real world performance data (from hospitals, registries and medical device reporting) inform better device design and development? Slide 8

9 9 Advamed Value Initiative Announced in May: AdvaMed s Value Framework Tools designed to objectively determine the value of medical technology and what evidence is necessary to support its use. It is not a formula for pricing a product, but will inform decisions about how to assess the value of a product in terms not just of its price but its overall cost and benefits. Scott Whitaker, CEO, Advamed Slide 9

10 The AHRMM Cost-Quality-Outcomes Movement In 2013, AHRMM launched the CQO Movement, a new way of approaching supply chain. Under the CQO movement, the supply chain can no longer focus exclusively on price, but rather the combination of product cost, the quality of care delivered, and the reimbursement outcomes to support healthcare s new valuebased models. Slide 10

11 11 Making quality a competitive advantage Increased sales Fewer internal product rejects Fewer warning letters and consent decrees Increased customer loyalty Improved brand perception Improved warranty approvals Higher valuation for acquisition targets Savings to industry 1.6 to 3% of sales = $6 to 11 billion/year in U.S.* Quality requires Investment. How can the FDA reward quality actors? * Jeff Shuren, Case for Quality Executive Forum, December 2016 Slide 11

12 Value to Multiple Stakeholders Less paperwork Less time looking for, counting supplies Visibility to which products improve quality AND cost and for which patients Confidence that she knows they can find her if there is a recall. Real world evidence (RWE) to: Better market and design products Achieve faster regulatory approvals Slide 12

13 .13 Today s Healthcare System Source: Institute of Medicine, Better Care at Lower Cost, Slide 13

14 .14 A Continuous Learning System 2. But only if it is captured and used by providers 3. And only if the information provided by manufacturers is usable (accurate and relevant) 1. UDI helps create Usable and Accessible Evidence (consistent, standardized) Slide 14

15 What Kind, Quality of Data Do You Want Used to Evaluate Your Products? Ensuring accurate and usable data in the Global UDI Database (GUDID) will be critical to healthcare providers effectively evaluating and sourcing products for quality. Slide 15

16 Challenge: Sharing Data in a Regulated and Material World DB2 Market /ecommerce Data US Providers DB1.CIN GDSN Datapool Group Purchasing Orgs Global Providers Product Data/ Product Changes Internal Processes / Approvals.SPL Regulatory Submissions FDA GUDID DB3 DB4.???.???.??? Future Global UDI Databases New Geographies One off processes are not sustainable Slide 16

17 17 How will they use the UDI in the healthcare delivery environment? How will they capture the UDI and related data? What data do they need to realize value? How will their use of UDI help you? Slide 17

18 Major Customers are Demanding It No Barcode, No Business Slide 18

19 19 It s What s Behind the Barcode Clinician documents supply and implant usage during case 50% Found Minimal clinician time to enter supply/implant Charging data seamlessly passes to billing 50% Not Found 29% of data needed found by research 21% of needed product data not found nor recorded for billing or the patient record Global Healthcare Exchange, LLC. All rights reserved. GHX proprietary information. Do not copy or distribute. Slide 19

20 Item Master as Source of Truth Supply Chain Orders Global UDI Database Item Master (Virtual) Inventory EHR Real world evidence Version Control is Important OR Information Systems Charge Master/ Patient Billing And many more Providers need to make sure their item master has data to feed multiple systems and processes Global Healthcare Exchange, LLC. All rights reserved. GHX proprietary information. Do not copy or distribute. Slide 20

21 21 Building the Provider Business Case Challenge: $3-5 million in unbillable OR usage/yr. due to missing supply data Solution: EHR System does real time call to virtual item master for product data >98 percent of products linked to detailed data in item master Helps provide access to data on products purchased, consumed, price paid, amount charged, reimbursement, outcomes and variation Slide 21

22 22 Product Data: Purpose Point of Use Capture Shortages/Substitutions Anti-counterfeiting Disaster/terror preparation Operational (Supply Chain) Clinical Purchasing Inventory Management Logistics Demand Planning Contract Compliance Contract Price Accuracy Recalls/Adverse event reporting Comparative Effectiveness Clinical Financial Billing Reimbursement Meaningful Use Slide 22

23 23 Product Data: What and Where Item Identifier Manufacturer Lot/Serial Number Expiry Date Clinically Relevant Attributes Physical/ Packaging Size Price HCPCS Codes Etc. Clinical Operational (Supply Chain) Clinical Financial ERP POU Systems Inventory Systems Recall Management Revenue Cycle Charge Master Surgical Systems Clinical Registries Claims Etc. Slide 23

24 24 UDI as the Common Code Commercial Databases UDI Financial Databases Clinical Databases Slide 24

25 What is the sound of trading partners talking? David Brooks Director of Engineering, Strategic Project Management Medtronic Bill Mosser Vice President, Supply Chain Franciscan Missionaries of Our Lady Health System Slide 25