Life Sciences Blog

Does UDI matter when it comes to Reimbursements?

by | Jan 15, 2019

Is your supply chain process prepared for reimbursement scenarios? Traditional Class I, II, III medical devices and even some ‘specialty’ accessories (like unique packaging mechanisms) need a product data management strategy that includes reimbursement considerations to avoid risk and maximize market share.
There are three key planning aspects that medical device manufacturers must review carefully with a deep-dive into specific case criteria:

Does the product fit in existing insurance ‘coding’ for claim forms or is a new code required? Insurance coding is a standardized mechanism that identifies the services provided to patients and includes devices, drugs, diagnoses, lab tests, procedures and supplies. The coding may apply differently depending upon the treatment conditions of the patient care, such as inpatient or outpatient, physician office or ASC (Ambulatory Service Care). These various scenarios impact the procedures that drive coding and subsequently, payments.

Is the product meeting the conditions for ‘coverage,’ meaning it meets program benefits for a specific medical use (either limited or broadly). Does it meet the criteria for payment of the service or procedure? The optimal utilization of a product or service is that it meets universal coverage from all insurers in the proper patient care setting. Limited coverage will likely result in less positive market impact.
When a new medical device is brought to market, payors want to understand clinical data in the form of multi-year studies (minimally 2-year). The data should support the superiority of the device as it relates to the existing standard of care and improvement in patient function, not necessarily degrees of pain.
Ultimately, payors want to limit their exposure and private insurers will likely want to cover the narrowest population possible. For purposes of a supporting clinical study, covering the widest possible population is advised. You could encounter restrictions that remove a significant portion of patients who might otherwise be covered. Added contraindications related to failure of a previous treatment could impact the available size of market for a device, subsequently impacting reimbursement scenarios.

Are all the payment scenarios mapped out to understand how the various ‘payors’ make decisions concerning coverage? Analysis of patient demographics and indications for use is a necessary component of reimbursement strategy. Medicare and Medicaid policies may drive different payment decisions versus a private insurance company. For any scenario, there are important nuances and exceptions to note. It is of utmost importance to understand how hospitals and health providers view cost drivers and include those economic data points in any supporting analysis.

What other medical device data could drive future impacts to all of the above criteria?

UDI data and the subsequent step of membership in a global data pool are creating benefits for the entire product lifecycle and supply chain. In 2007, Congress began requiring the Food and Drug Administration (FDA) establish a unique device identification (UDI) system. Data-driven analysis from UDI information placed into the Global Unique Device Identification Database (GUDID) is now helping researchers monitor and compare device safety and quality. Both manufacturers and their downstream stakeholders can now make more informed decisions that ultimately affect product improvements, cost modeling, post-market surveillance, and patient outcomes. For a few years now, influential organizations have been advocating adding device identifiers to claim forms. Eventually, UDI data may become a necessary component in claim forms. The case for standardization and centralization of medical device data continues to drive change. With streamlined processes for master data management, positive efficiencies are gained throughout the product lifecycle. The ultimate achievement is improved outcomes for healthcare around the globe.

When it comes to trusted guidance for product management solutions, Reed Tech can become a valuable asset to your team. We are industry experts in UDI data submissions in SPL (Structured Product Language) and can help you efficiently maintain records throughout the product lifecycle.

Contact Reed Tech today for any questions regarding medical device product management and syndication. We are here to help. Email us: or call 215-682-8269

For more information, see: – Compliance Dates for UDI Requirements

Centers for Medicare & Medicaid Services – List of Device Category Code for Present or Previous Pass-Through Payment and Related Definitions


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