Moving UDI from Regulation to Value Within Hospitals and Beyond Karen Conway Executive Director, Industry Relations, GHX Terrie Reed, MDEpiNet Coordinating Center Duke Clinical Research Institute Slide 1
To learn how to comply with UDI? To learn what FDA and others will do with your data? To learn what you can do with the data? To get value beyond compliance for: Your organization Your trading partners For healthcare Slide 2
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The Impetus for the UDI Rule Preventable Medical Errors and Device Recalls Slide 4
Healthcare providers are demanding it! No Barcode, No Business Slide 5
It s all about Value Value in healthcare is a function of quality, efficiency, safety, and cost. Slide 6
There is almost a complete lack of understanding of how much it costs to deliver patient care, must less how those costs compare with the outcomes achieved. Robert Kaplan and Michael Porter The Big Idea: How to Solve the Cost Crisis in Health Care Slide 7
UDI Highlighting Multiple Uses of Product Data Point of Use Capture Shortages/Substitutions Anti-counterfeiting/diversion Disaster/terror preparation Operational (Supply Chain) Clinical Purchasing Inventory Management Logistics Demand Planning 8 Recalls/Adverse event reporting Comparative Effectiveness Clinical Financial Meaningful Use Contract Compliance Contract Price Accuracy Billing Reimbursement Understanding the Quality and Cost of Care Slide 8
Multiple Uses, Multiple Attributes, Multiple Sources Manufacturer Device Identifier Price Commercial Databases Physical Size Clinical Size UNSPSC GMDN HCPCS Financial Databases Clinically relevant attributes UDI UDI Clinical Databases Regulatory Databases Lot # Serial # Expiration Date Slide 9
ERP/EHR Item Master/ Charge Master Claims Transactions Manufacturers Supply Chain need (Item to be Master) the source as Source of truth of for Truth their for products. Providers Comparative Effectiveness Inventory Contracting Recalls Adverse Events Clinician and Patient Satisfaction Slide 10
UDI at the Center -U.S. FDA CDRH April 2013 Slide 11
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Current Requirements for Providers Electronic Code of Federal Regulations PART 803 MEDICAL DEVICE REPORTING 803.32 If I am a user facility, what information must I submit in my individual adverse event reports? You must include the following information in your report, if reasonably known to you, as described in 803.30(b).... 2) Outcomes attributed to the adverse event (e.g., death or serious injury) (c) Device information (Form 3500A, Block D). You must submit the following: (6) The unique device identifier (UDI) that appears on the device label or on the device package Slide 13
ONC and CMS Proposals (high level summary) Create a list of a patient s implantable devices in the EHR Parse the device identifier and production data, (e.g., lot, serial number, expiry date) from the UDI Link to the Global UDI Database (GUDID) to retrieve additional device information Add the UDI to the Common Clinical Data Set to enable the list of implanted devices to be exchanged as part of a patient s core medical history EHR Vendors Providers Physicians Mixed Reaction Slide 14
Attention on the Hill: UDI in Claims Congressman Bill Pascrell (NJ) announced during mark up of the medical device tax repeal bill that he is working with Congressman Kevin Brady, chairman of the Subcommittee on Health, Ways and Means Committee Congressman Pascrell asked HHS Secretary Burwell about UDI in claims. Secretary Burwell responded that that CMS and FDA are working together, and she will work with the committee. Slide 15
Think Beyond Regulation: Imagine what we could do with structured product data! Slide 16
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Value to Stakeholders Visibility to which products improve quality AND cost Less paperwork Less time looking for, counting supplies Confidence that she knows they can find her if there is a recall. Visibility to which product attributes improve quality AND cost Slide 19
Making Miracles Happen Slide 20
21 Manufacturer designs and markets product Demand and efficacy data available Product and clinical attribute efficacy understood; necessary actions taken Regulators and customers receive accurate information about product Visibility = Value Product data captured in registries Product Purchased/ Shipped/ Received Product consumption documented at point of use in EHR Slide 21
Device Evaluation Manufacturer Submits DI and Attributes to GUDID UDI into Supply Chain UDI scanned at Point of Use PATIENT, UDI and structured data linked in EHR Extract evaluation data from EHR Apply tested Methods for Evaluation and Analysis Make decisions for better patient care Slide 22
UDI role in device evaluation Foundation for structured device data capture and exchange (DDC&E) Provides common ID across device ecosystem Empowers patients and care providers Provides common registry reference terminology NOW Key to linking datasets that identify devices for research and device evaluation Slide 23
MDEpiNet Medical Device Epidemiology Network Initiative To develop national /international infrastructure and innovative methodological approaches for conducting robust studies and surveillance to improve medical device safety and effectiveness understanding throughout the device life cycle through Public Private Partnership Structure for Addressing Key Issues Slide 24
MDEpiNet Participants Academia Professional Societies Medical Device Manufacturers Standards Development Groups Hospitals Registry Developers Patients International Agencies Payers Government Slide 25
The DDC&E Challenge EASIER: Capture data best you can for a specific purpose HARDER: Capture structured data once and reuse across lifecycle.. Requires building partnerships and collaboration across organizations & systems to Define the data and promote interoperability MDEpiNet Slide 26
SMART Informatics Think Tank Specific, Measurable, Achievable, Results-Oriented, Time Bound Collaboration Think Tank Issue Working Group Issue: Structured device data capture & exchange (DDC&E) Brainstorm: 4 Use case areas, 18 DDC&E projects and links to innovative work Create: SMART Working Group 6 pilots and collaborative grant proposals Slide 27
SMART Think Tank Day 1 Medical Device Postmarket Plan Planning Board ONC HIT Plan FDA-ONC-Pew Meeting Capturing Structured Device Data -Point of Care -Device Other infrastructure projects Downstream device analysis Linking Patient to Device Extracting Structured Data for Analysis Slide 28
SMART Breakout - Day 2 Seek out collaborative partners Create SMART proposals that deliver immediate results that can be generalized find answers to well-articulated research questions are inclusive across the TPLC and empower relevant stakeholders reuse and leveraging existing national infrastructure efforts take advantage of EHR, patient reported, and claims-related data sources and reduce duplication by linking the patient and device Slide 29
SMART Working Group BUILD Building UDI Into Longitudinal Data for Surveillance & Research Leverage UDI as the index to connect data sources to identify devices for patients, clinicians, & others 1. Extend UDI implementation pilot 2. Medical device data capture and exchange: Leading practices & future directions 3. epulse Electrophysiology structured reporting Providing UDI for Leads and devices Using industry Standards to Electronic health records and CVIS systems Slide 30
SMART Working Group VANGUARD Initiative Venous Access: National Guidelines and Registry Development Link UDI to patient and create interoperable terminology to include ONC minimum data set and a venous access domainspecific data set Collaboration across the device ecosystem of multiple hospitals Include UDI and supplemental data, EHR minimum, registry data elements Populate and link registries for device evaluation Slide 31
Pilot Common Themes Collaborators Multiple Device Manufacturers Multiple Hospitals Supply Chain Clinicians Researchers Multiple Registries Letters of Support Systems Hospital IT System Coordinated Registry Network Structured Data EHR Core minimum data UDI Key device data Registry data Interoperable output from device Slide 32
EHR Core Data Set..advance the structured capture of data within an EHR for use within registries and other downstream uses of clinical data by defining and piloting a minimum data set that would always be captured within EHR Common MU Data Set + Supplemental Patient name Sex Date of birth Race Ethnicity Preferred language Smoking status Problems Medications Medication allergies Laboratory test(s) Lab value(s)/result(s) Vital signs Care plan field(s), including goals and instructions Procedures Care team members Immunizations Unique device identifier(s) for a patient s implantable device(s) Notes/narrative Slide 33
SMART Data Coordination Foster and disseminate lessons learned to make adoption and dissemination EASIER Leverage MDEpiNet Governance and Communication Promote interdependence between projects Do not reinvent existing standards Provide public access to all reference data - accessgudid Reuse tools and techniques Feedback loop between implementation and learning center Slide 34
SMART Data Coordination Future Pilot BUILD Pilot Learning Data Lab VANGUARD Initiative Core EHR data set across projects Data element access Structured data capture standards Best practices from data implementation issues/resolution Knowledge repository for standards implementation Link to Other Pilots Future Pilot Example: Drug Eluting Stent Attributes Slide 35
USE NOW even without UDI Slide 36
SMART Structured Data and Exchange Multi-Stakeholder/Multi-System collaboration to.. Manufacturer Submits DI and Attributes to GUDID UDI into Supply Chain UDI scanned at Point of Use PATIENT, UDI and structured data linked in EHR Extract evaluation data from EHR Apply tested Methods for Evaluation and Analysis Make decisions for better patient care..improve device evaluation & clinician/patient decision making Slide 37
Next Steps for SMART WG Funding for pilots Keep the momentum Find other projects Identify interested hospitals Create and demonstrate value for UDI Contact mdepinet@duke.dm.edu Slide 38