Healthcare standards make a trip to the real world


One of the most promising aspects of healthcare’s move to value is the ability to garner more real world evidence (RWE)to better understand how well medical devices work in day-to-day clinical practice, as opposed to relying only on clinical trials. Unlike pharmaceuticals, clinical trials for medical devices are often site-specific and involve a relatively small number of patients that fit specific clinical criteria. Once on the market, those same medical devices can be used to care for a wide range of patients, many outside the parameters of the original studies. As a result, those sourcing products for use in clinical care delivery may be leery of whether the results are generalizable to broader populations. Now, with the growing prevalence of unique device identifiers (UDIs) for medical devices, the increased adoption of electronic health records (EHRs) that can hold UDIs, and the increasing number and quality of clinical registries, the use of registry-based randomized clinical trials (rRCTs) is becoming a reality.

U.S. hospital adoption of meaningful use-certified EHRs topped 95 percent in 2016, and the major EHR vendors have announced that they have met (or will soon meet) the 2015 stage 3 meaningful use requirements that their systems are able to hold a list of a patient’s implantable devices using UDIs. While new federal rules published in August give hospitals flexibility next year regarding whether their EHRs meet the 2014 or 2015 requirements, they still have to be able to share UDIs for their implantable devices as part of the Common Clinical Data Set (CCDS). As for registries, not all currently meet the same clinical quality standards but progress is being made to improve how data is collected, including the use of UDIs to identify the devices used in patient care and link to data about those products.

Much of this work is being done under the auspices of the Medical Device Epidemiological Network (MDEpiNet), which has a number of projects underway to explore what it takes to capture device usage using UDIs in various electronic health information systems and to leverage the structured data aspects of UDI to be able to share data across the medical device ecosystem. As an example, the PASSION project, which is focused on national registries for cardiovascular devices, is researching the infrastructure needed to ensure the reliability and cost efficiency of registry-based clinical trials. The AHRMM Learning UDI Community (LUC), meanwhile, has a work group looking at the flow of device usage data from EHRs into registries, which to date is still highly manual.

Currently, most healthcare delivery organizations routinely capture information on products purchased in their enterprise resource planning (ERP) or material management information systems (MMIS), while fewer do so for supply consumption. That is changing as providers realize accurate clinical supply documentation is necessary to 1) fully charge for product usage and 2) calculate the total cost of care delivery, which will be increasingly important for value based payment programs such as bundled payments.

Data capture in EHRs is facilitated by the use of point-of-use scanning technology and content management solutions that ensure product data in EHRs is fully up to date and complete. But data entry into registries is still highly manual, increasing the risk of incomplete and/or inaccurate documentation. A better solution is the ability to feed scanned data incorporating UDIs directly from the EHR into registries.

Seems simple enough, but achieving this vision requires both technology system and process changes, along with good data governance. Any proposal to implement such changes will require a business case to be made, a job that supply chain is best suited to handle in my opinion. That’s because the value of incorporating UDIs into systems and processes can achieve benefits for multiple stakeholders; and understanding that value across the enterprise can better justify investments rather than just focusing on the value that can be achieved in one area. More than any other function in healthcare, supply chain sees the problem and need from multiple perspectives — clinical, supply chain and operational.

A foundational business case begins with the growing need for a hospital to understand the relationship between what supplies are used in a procedure, how much was paid for those products, if and how much the hospital charged for those products, and how much the hospital is reimbursed for the procedures in which those products are used. An added benefit is the ability to identify where there is variation in product usage and to tie that to both clinical and financial outcomes. For example, does using a specific product reduce procedure time, hospital acquired conditions, or length of stay? Does it make a difference in the hospitals’ profit margin for performing specific procedures? Answers to these kinds of questions can help determine when, for example, use of a higher priced product is warranted. With the move to more population-based healthcare and precision medicine, hospitals are recognizing that variation in product usage can and should be based on the needs of specific patients.

This is where the potential for RWE becomes most evident. If data can be collected and reported accurately, completely, and with the right controls and context, the use of rRCTs can provide a much more robust data set for better clinical decision making and treatment based on specific patient needs. But that potential can only be realized through greater standardization in data and processes. As I told an expert panel on the use of real world evidence earlier this year, the opportunities to utilize RWE to determine what delivers the best value in healthcare are exciting, but without the infrastructure and business case to support it, it’s like talking about all the cool things we are going to do on our summer vacation, without first determining how to get there, where to stay, if you need a passport or if you speak the same language, and how to pay for the trip. Supply chain can help not only answering these questions but also in making the necessary arrangements. Let me know how your journey goes.