By Bruce Stanley
It starts within your own organization
Many of us in healthcare have experienced well-intentioned initiatives over a generation trying to “fix” the complexity of our healthcare operational systems and the transactional/financial processes. I’ve worked with many technically savvy individuals who tell me, “This looks easy. One more tweak and we’ll be there.” The more candid professionals freely admit that this is actually hard work.
Looking back, some of us might remember the EHCR initiative of the late 90s, which was intended to revolutionize and streamline contracting. HINs were the Holy Grail of contract simplification. Today we have new buzzwords, like GLN, GTIN, UDI and so on.
So why, after so many years, are we still talking about data and process standardization and alignment? Because no one person, group or company owns the complete data set.
As a practitioner and consultant, I find the successful implementations often occur when the organizational leader asks questions like, “What does success look like for us? What can we do in our local site to support the industry initiative?”
What often surfaces as an “aha” moment is the realization that organizations can take simple steps to ease the pain. These steps center around how companies create clarity with their own sensible and sustainable internal business rules, processes and financial reporting.
Simple is better
As companies begin their organizational homework, they start to see the workings of their own supply chain processes, and they see what amazing things could happen if they modified them, regardless of any industry standard. Taking simple steps to make their own life easier and more manageable are key to getting off on the right foot. Examples include SKU rationalization, price streamlining, contract choice management and selection, feasible direct distribution and value-based data.
Astute leaders realize that implementing simplification rules won’t happen by accident or by dictum, but only when they fix and organize their companies with stronger and more understandable internal platforms. They know that in order to understand how an organization actually operates, one needs to “flip it on its edge” and then ask a million questions – many of which aren’t easily answered. They view their organizations from different perspectives, i.e. staff skill sets, business rules, actual practices, exceptions, financial reconciliation and all the rest.
Asking the right questions about the organization can be much more valuable than the answers at this point. They might include:
- How does our operational and financial data work?
- Why do we do this transaction the legacy way?
- How is the ownership of all data managed and why?
- How could financial reconciliation work?
- Who should own what parts of what data?
- What other industries would you mirror, if any?
- Could we better align timing and terminology?
Fortunately, organizations such as GS1 and the Health Industry Distributors Association are immensely helpful in setting the stage for our industry. This momentum helps our own organizations build the platform with stronger data understanding, so that once and for all we can align and drive towards pristine data in healthcare.
Having data accuracy close enough isn’t good enough any longer. Data needs to be – and can be – perfect. When it’s not, nothing works right. Pristine data alignment is in your organization’s control and no one else’s.
It all comes down to heavy lifting. It’s always easy and certainly less effective to suggest to someone else to “make your transactions timely or use our technology and follow these standards.” The bottom line is, despite the help of industry standards, the burden remains with each company to make those standards its own.
Bruce Stanley is a supply chain and contracting operations consultant, and an adjunct professor at Endicott College’s MBA program, teaching global supply chain, contracting and healthcare informatics and regulations. In 2011, he co-founded The Stanley East Consulting Group, in Ipswich, Mass., a consulting practice specializing in supply chain, contracting, order fulfillment and project management for small and medium-sized companies, startups, and companies in transition or divestiture. Earlier, he served as senior director, contracting operations, for Becton Dickinson.
UDI and direct marking
The Food and Drug Administration in November issued final guidance on direct marking of the unique device identifier (UDI) on devices. By law, a device must be directly marked with a UDI when the device is intended to be used more than once and intended to be reprocessed before each use. However, “intended to be used more than once” and “intended to be reprocessed” were not defined in the UDI regulations.
The November guidance provides FDA’s interpretation of these terms, clarifies when direct marking of devices with a UDI is required, provides recommendations for how labelers should comply with the UDI direct marking requirements, and clarifies the criteria for exceptions to the direct marking requirement.
See the Federal Register, Nov. 17, 2017, https://www.federalregister.gov/documents/2017/11/17/2017-24992/unique-device-identification-direct-marking-of-devices-guidance-for-industry-and-food-and-drug
Add device identifier to claims forms, groups urge CMS
Adding a device identifier (part of the unique device identifier, or UDI) to medical claims forms would provide better data on product performance and detect device failures sooner than current methods, according to a number of medical and healthcare organizations. The organizations – including Geisinger, Intermountain Healthcare, Premier, the American College of Cardiology and the American Medical Group Association — made the recommendation in a Nov. 15 letter to Seema Verma, administrator of the Centers for Medicare & Medicaid Services.
In November, the Office of the Inspector General reported that the failure and recall of just seven cardiac implants cost CMS $1.5 billion in follow-up care to patients affected by the faulty products, and Medicare beneficiaries an additional $140 million in out-of-pocket expenses. “Given the limited scope of the investigation, the costs to both taxpayers and patients is assuredly higher when considering other products, including hip and knee implants,” according to the letter-writers.
To address the issue, OIG recommended adding device identifiers to claims to indicate the brand and model of device used. (The device identifier is a fixed portion of a UDI that identifies the labeler and the specific version or model of a device.)
“Claims data … could supplement other data sources – such as registries – to provide more robust data on product performance and detect device failures sooner, which is important to both prevent problems sooner and provide assurances to organizations that participate in alternative payment models that the products they use are high quality,” according to the letter-writers.
As a tool for postmarket surveillance, “claims data could provide longitudinal information (such as revision surgery to remove an implant) on patient outcomes from thousands – even millions –of patients in ways that other data sources may not be able to provide,” they write. “Adding the device identifier will provide claims with information on the brand and model of device, so that researchers – including within some of our organizations—can evaluate the quality of specific devices.”