UDI2Claims: Planning a Pilot Project to Transmit Identifiers for Implanted Devices to the Insurance Claim.
Journal
Journal of patient safety
ISSN: 1549-8425
Titre abrégé: J Patient Saf
Pays: United States
ID NLM: 101233393
Informations de publication
Date de publication:
01 12 2021
01 12 2021
Historique:
pubmed:
28
11
2018
medline:
19
2
2022
entrez:
28
11
2018
Statut:
ppublish
Résumé
In response to problems with the current postmarket surveillance of medical devices, the U.S. Food and Drug Administration mandated device labelers to include a unique device identifier (UDI), composed of a device identifier (DI) and production identifier. Including the DI in insurance claims could be a potent method to monitor implanted devices, yet implementation has lagged because of questions of benefit and operational concerns. To illustrate the potential benefit of including DIs in claims, rates of 90-day adverse events after implantation using an electronic health record (EHR) were compared with the EHR plus claims, which capture utilization outside that EHR's health system. To explore operations, we planned a pilot project to transmit the DI of implanted devices from the point of care to the claim at two provider/payer pairs. By querying claims plus EHR, estimated rates of patients with potential adverse events were as much as 3.75 times higher. For our pilot, our multistakeholder team identified and resolved the following five challenges: (1) capturing the DI at the point of care; (2) selecting a location for the DI on the claim form; (3) transmitting the DI to the claim form; (4) analyzing the claim forms received by the payer; and (5) verifying the quality of the transmitted information. Including DIs on claims could allow more complete data capture of adverse events for implanted devices than the EHR data. We overcame challenges in transmitting the DI to the claim with attention to planning and multistakeholder involvement.
Sections du résumé
BACKGROUND
In response to problems with the current postmarket surveillance of medical devices, the U.S. Food and Drug Administration mandated device labelers to include a unique device identifier (UDI), composed of a device identifier (DI) and production identifier. Including the DI in insurance claims could be a potent method to monitor implanted devices, yet implementation has lagged because of questions of benefit and operational concerns.
METHODS
To illustrate the potential benefit of including DIs in claims, rates of 90-day adverse events after implantation using an electronic health record (EHR) were compared with the EHR plus claims, which capture utilization outside that EHR's health system. To explore operations, we planned a pilot project to transmit the DI of implanted devices from the point of care to the claim at two provider/payer pairs.
RESULTS
By querying claims plus EHR, estimated rates of patients with potential adverse events were as much as 3.75 times higher. For our pilot, our multistakeholder team identified and resolved the following five challenges: (1) capturing the DI at the point of care; (2) selecting a location for the DI on the claim form; (3) transmitting the DI to the claim form; (4) analyzing the claim forms received by the payer; and (5) verifying the quality of the transmitted information.
CONCLUSIONS
Including DIs on claims could allow more complete data capture of adverse events for implanted devices than the EHR data. We overcame challenges in transmitting the DI to the claim with attention to planning and multistakeholder involvement.
Identifiants
pubmed: 30480650
pii: 01209203-202112000-00012
doi: 10.1097/PTS.0000000000000543
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e708-e715Informations de copyright
Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.
Références
Norton MR, Yarlagadda R, Anderson GH. Catastrophic failure of the elite plus total hip replacement, with a hylamer acetabulum and zirconia ceramic femoral head. J Bone Joint Surg Br . 2002;84:631–635.
Graham J, Cooper S, Mackeen AD. How safety concerns about Essure reveal a path to better device tracking. Health Affairs Blog . 2015. Available at: https://www.healthaffairs.org/do/10.1377/hblog20151015.051219/full/ . Accessed October 10, 2018.
doi: 10.1377/hblog20151015.051219/full/
U.S. Food and Drug Administration. Essure permanent birth control: FDA activities. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452254.htm . Accessed December 30, 2015.
Bangalore S, Edelman ER, Bhatt DL. First-generation bioresorbable vascular scaffolds: disappearing stents or disappearing evidence? J Am Coll Cardiol . 2017;69:3067–3069.
Bangalore S, Toklu B, Bhatt DL. Outcomes with bioabsorbable vascular scaffolds versus everolimus eluting stents: insights from randomized trials. Int J Cardiol . 2012;2016:214–222.
US Senate HELP. Preventable tragedies: superbugs and how ineffective monitoring of medical device safety fails patients. Patty Murray, ranking member . 2016.
Ibrahim AM, Dimick JB. Monitoring medical devices: missed warning signs within existing data. JAMA . 2017;318:327–328.
Bhatt DL, Drozda JP, Shahian DM, et al. ACC/AHA/STS statement on the future of registries and the performance measurement enterprise: a report of the American College of Cardiology/American Heart Association task force on performance measures and the society of thoracic surgeons. J Am Coll Cardiol . 2015;66:2230–2245.
Institute of Medicine. Medical devices and the public’s health: the FDA 510(k) clearance process at 35 years. 2011:1–298.
Daniel G, Colvin H, Khaterzai S, McClellan M, Aurora P. Strengthening patient care: building an effective national medical device surveillance system. Washington, DC: The Brookings Institution; 2015.
U.S. Food and Drug Administration. Food and Drug Administration amendments act (FDAAA) of 2007; pub. L. No. 110–85 (2007).
Office of the National Coordinator for Health Information Technology. 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications. Fed Regist . 2015;80:62602–62759.
U.S. Food and Drug Administration. Compliance dates for UDI requirements. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/CompliancedatesforUDIRequirements/default.htm . Accessed November 10, 2015.
U.S. Food and Drug Administration. Global unique device identification database (GUDID). Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf . Accessed December 21, 2015.
U.S. Food and Drug Administration. Strengthening our national system for medical device post-market surveillance. Silver Spring, MD: Center For Devices And Radiological Health. 2013. Available at: https://www.fda.gov/downloads/medicaldevices/safety/cdrhpostmarketsurveillance/ucm348845.pdf . Accessed October 10, 2018.
Daniel G, McClellan M, Gardina S, Deak D, Bryan J, Streit C. Unique device identifiers (UDIs): a roadmap for effective implementation. Washington, DC: The Brookings Institution; 2014.
Drozda JP Jr, Roach J, Forsyth T, et al. Constructing the informatics and information technology foundations of a medical device evaluation system: a report from the FDA unique device identifier demonstration. J Am Med Inform Assoc . 2017;25:111–120.
Building UDI Into Longitudinal Data for Medical Device Evaluation (The BUILD Initiative). Medical Device Epidemiology Network. Available at: http://mdepinet.org/build/ . Accessed September 10, 2018.
Drozda JP, Dudley C, Helmering P, Roach J, Hutchison L. The mercy unique device identifier demonstration project: implementing point of use product identification in the cardiac catheterization laboratories of a regional health system. HealthCare . 2016;4:116–119.
Pew Charitable Trusts. Why insurance claims should include medical device identification. 2016. Available at: http://www.pewtrusts.org/~/media/assets/2016/02/why_insurance_claims_should_include_medical_device_id.pdf . Accessed October 10, 2018.
U.S. Food and Drug Administration. Medical device safety action plan: protecting patients, promoting public health. 2018. Available at: https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM604690.pdf . Accessed October 15, 2018.
Burton T. Medical device ID effort hits snag. Available at: http://www.wsj.com/articles/medical-device-id-effort-is-stalled-1426027440 . Accessed November 10, 2015.
MedPAC. June 2017 report to the congress: Medicare and the health care delivery system: Chapter 7 an overview of the medical device industry. Washington, DC: MedPAC. 2017;207–242.
Moscovitch B. Advisory committee recommends recording medical device ID in claims. Pew Charitable Trusts . 2017. Available at: https://www.pewtrusts.org/en/research-and-analysis/articles/2017/02/01/advisory-committee-recommends-recording-medical-device-ids-in-claims . Accessed October 10, 2018.
U.S. Food and Drug Administration. List of device recalls. Available at: https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/default.htm . Accessed May 08, 2018.
Strategic Marketplace Initiative, ed. UDI compliance initiative summary: introducing UDI labeling strategies for non-sterile implantable products into the surgical setting . Scituate, MA: SMI; 2015.