UDI TAC Meeting January 15, 2014

Transcription

1 UDI TAC Meeting January 15, 2014

2 UDI TAC Meeting Call in Information DIAL-IN: (605) ACCESS CODE: Please do NOT put this call on hold as we cannot mute your hold music Kindly MUTE your telephone if you are not speaking

3 Agenda 3:00pm 3:05pm Introductions Devin Jopp, Ed.D., President & CEO, WEDI 3:05pm 3:10pm Approaches to Device Postmarket Surveillance Josh Rising, MD, Director, Medical Devices, The Pew Charitable Trusts 3:10pm 3:20pm FDA s Vision for UDI Focusing on Claims Data Tom Gross, MD, Director, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, FDA 3:20pm 3:25pm ASC X12 Expectations Margaret Weiker, X12N Chair 3:25pm 5:00pm Questions and Discussion Devin Jopp, Ed.D. Moderator

4 UDI Background Facilitating the Transmission of UDI Background FDA issued the UDI final rule in September 2013 UDI will be the cornerstone to improved postmarket surveillance once it is in electronic health information The UDI Final Rule UDI consists of two parts: The Device Identifier (DI) corresponds to the manufacturer and model type The Production Identifier (PI) refers to other information, such as lot number September 2014 The labels of the highest risk devices will bear UDIs Challenge Determine the Best Option FDA cannot require UDI adoption by hospitals or health plans ASC X12 is considering a request to include UDI in claims transactions WEDI Foundation seeks feedback on the best options for UDI capture/transmission

5 Approaches to Device Postmarket Surveillance Josh Rising, MD, Director, Medical Devices, The Pew Charitable Trusts UDI capture in electronic health information is essential to improved device postmarket surveillance Adverse event reports Electronic health records Registries Claims and administrative transactions

6 Strengthening Our National System for Medical Device Postmarket Surveillance Focus on Unique Device Identification (and Claims Data) Thomas P. Gross, MD, MPH Director, Office of Surveillance and Biometrics Center for Devices and Radiological Health Pew/WEDI Unique Device Identifier Technical Advisory Committee Forum January 15,

7 Strengthening Our National System Taking the Next Steps

8 Proposed Specific Actions to Strengthen Device Postmarket Surveillance 1) Establish a UDI System and Promote the Incorporation of UDI into Electronic Health Information 2) Promote the Development of National and International Device Registries for Selected Products 3) Modernize Adverse Event Reporting and Analysis 4) Develop and Use New Methods for Evidence Generation, Synthesis, and Appraisal

9 Typical Information Available in Health Insurer Databases* MEMBERSHIP DATA Member identifier Date of birth Gender Date of enrollment Date of disenrollment Benefit plan number PHYSICIAN SERVICES Member identifier Provider identifier Date of service ICD-9-CM codes CPT-4 procedure codes HCPCS codes *Suzanne West, RTI International, Modified OUTPATIENT PHARMACY CLAIMS Member identifier Pharmacy identifier NDC code Generic code Drug strength Dosage form Quantity dispensed Days supply Prescribing physician ID Date filled NDC: National Drug Code HOSPITAL SERVICES Member identifier Provider identifier Date of admission Date of discharge DRG code ICD-9-CM codes Length of stay LABORATORY SERVICES Member identifier Provider identifier Date of service ICD-9-CM, CPT-4, and HCPCS codes

10 *Rich Platt, Mini-Sentinel

11 Devices and Claims Data At the procedure level, without device identification (e.g., coronary angioplasty) At the procedure level, with device group identification (e.g., insertion of vascular stent) At the manufacturer level (only when device is first on market and gets code, e.g., Cypher--first drugeluting coronary stent) At the UDI level to capture manufacturer, make, model

12 Multi-Payer Claims Database and Devices Pilot under auspices of ASPE and CMS to support comparative effectiveness studies CMS and Commercial Payer Data Device Projects (by device group) Total hip arthroplasty by articulating surface in patients with osteoarthritis Cardiac resynchronization therapy (CRT) defibrillators vs. implantable cardioverter defibrillators (ICDs) in patients with right and left bundle branch block

13 SafeRx and Devices CMS initiative launched with Part D to support safety surveillance Device Projects (by device group) Evaluation of adverse outcomes related to conventional tubal ligation and transcervical fallopian tube occlusive devices for female sterilization Evaluation of adverse outcomes related to negative pressure wound therapy in inpatient and outpatient settings

14 Mini-Sentinel and Devices Expansion of Sentinel to include devices required under the 2012 FDA Safety and Innovation Act (FDASIA) Current records accessible to Sentinel lack manufacturer or brand-specific device identifiers Device Uses utilization of hip arthroplasty devices by articulating surface (by device group) safety evaluation of robotically-assisted surgery (by manufacturer first on market)

15 Linking Registry with Claims Data UDI in registries and in claims can aid linkage process (matching using indirect identifiers) Registries linked to claims data provide a longitudinal profile of patient experience/device performance Registries will continue to be incorporated into Sentinel effort FDA has history of conducting linkage-based studies (e.g., endovascular vein-graft harvesting, transmyocardial revascularization, transcatheter aortic valve replacement)

16 Conclusions Device postmarket surveillance presents unique challenges Our use of claims data has been limited by lack of manufacturer-specific identifiers Incorporating UDI into electronic health information is key to expanding and strengthening device postmarket surveillance Claims data are an important national resource in this regard

17 ASC X12 Expectations Margaret Weiker, X12N Chair

18 Questions and Discussion Devin Jopp, Moderator

19 Polling Question #1 In which administrative transactions should UDI be included? Should UDI data be evaluated as part of the preauthorization process? Yes Optional No Additional Discussion Needed Should UDI data be included as a required data element? Yes Optional No Additional Discussion Needed

20 Polling Question #2 If UDI is included in the ASC X12 standard for a claim, should UDI be: Mandatory = required in all claims that include an implanted medical device Voluntary = optional for any provider and/or payer that deems benefit from including UDI in claims Voluntary in a Pilot = permitted to be included in the claim only by providers and payers participating in a voluntary pilot project

21 Polling Question #3 If UDI is included in a claim, what part of the UDI should be included? Only the DI (make and model) DI mandatory and optional PI (lot number, size, etc ) DI and PI mandatory

22 Polling Question #4 In what part of the claim should UDI be included? A new structured field in the claim header A new structured field in the claim line Repurpose an existing field such as what was used by Medi-Cal An attachment

23 Additional Points of Consideration UDI integration and interoperability among electronic health records, supply chain, and billing systems Using automated identification and data capture (AIDC) scanning equipment at multiple points in care delivery Necessary modifications within payer systems such as authorization, customer service, medical management, actuarial, and others to use the UDI Expanding health plan expertise to improve medical device coverage and analysis Using UDI data in safety management, medical device approval, case management, adverse event recognition, recall management, and elsewhere Including UDI fields in functionality in the necessary electronic systems

24 Second UDI TAC Meeting Save the date: February 11, :00pm 5:00pm EST Additional information forthcoming