Changes to healthcare aren't coming...they're here! Here's our take on healthcare changes that will have a big impact on the data management strategies at pharmaceutical organizations in 2015.
For the last few years we’ve gradually been made aware of some emerging initiatives and regulations that would impact the way Healthcare companies manage their data and information.Chances are you have either already (or are currently in the process of) addressing things like Global Trade Identification Number (GTIN) and Global Location Number (GLN) as part of the GS1 Healthcare standards and you somehow successfully managed your way over those hurdles.Now, as soon as we finally catch our breath and get some sort of rhythm going, we turn around and find out that topics like the “Sunshine Act”, “Drug Supply Chain Security Act (DSCSA)”, “FDA Unique Device Identifier (UDI)” and “Global Healthcare Exchange” have gone from “coming soon” to “needed now“.
Like most things that were defined as “coming soon”, we kept an eye on them, but spent the majority of our time working on more critical, time-sensitive projects and programs.If you’re like most organizations, when you explore what’s really involved to support these programs you quickly realize that you’re just not ready.The good news – and there is good news – is that the regulations and our understanding of the true information management impact has changed a lot in the past 6-12 months so it’s very likely that any early investment would not have been maximized anyway.At a minimum this is a good thing to tell your boss when he/she asks “where are with our ability to support UDI?”.
The really good news is that, if done properly, the changes to your information management program in support of these emerging regulations will also help enable other, more strategic goals – the ones that your executives really care about – the ones that drive revenue and/or decrease cost.For instance, the healthcare industry alone has over a half trillion dollars tied up in inventory … the techniques and systems used to address these regulations are some of the same methods we use to optimize inventory, decrease carrying costs and reduce obsolescence.
The first thing to consider is that the need to address these new regulations, coupled with the more strategic benefits, could be the infection point you need to kick start your information management program.If you’re like most organizations, the ability to support GTIN’s and GLN’s provided some visibility, but not enough to really extend the program in a meaningful way.In this case, your executive conversation will likely begin with “What do we have to do to comply with the new regulations?” … you need to convince them that “compliance is really just an output of a successful data governance program”.
Now, let’s take a look at what’s coming, what it means, and how we can address (and hopefully take advantage of) these information management triggers.
- The Sunshine Act requires manufacturers of drugs, medical devices, and biologicals to report certain payments given to physicians and teaching hospitals to be made public and searchable via federal databases.The law was adopted as part of the healthcare reform act in 2010, but the final regulations to implement and federal database website just went live in September of 2014.
- The Drug Supply Chain Security Act (DSCSA), signed into law by President Obama in November 2013, outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.Over the next 10 years, the system will facilitate the exchange of information at the individual package level about where a drug has been in the supply chain.Drug manufacturers, wholesale drug distributors, re-packagers, and many dispensers (primarily pharmacies) will be called on to work in cooperation with FDA to develop the new system over the next 10 years.
- The FDA Unique Device Identifier (UDI) system is designed to adequately identify medical devices through their distribution and use by including a unique device identifier in human and machine-readable form.The UDI system, which will be phased in over several years, will improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation.
- The Global Healthcare Exchange (GHX) is a healthcare collaboration network (100 supplier members and 300 hospital members) that provides business-to-business procurement solutions for the healthcare industry.Utilizing Internet-based technology, the company seamlessly integrates hospitals and suppliers to improve efficiencies and adding value throughout the supply chain.
What all these initiatives and regulations mean to data and information management organizations is the heightened need for data standardization, governance, improved information management processes, and tools to help capture and distribute this information, specifically:
- An increased emphasis on the quality of customer data (direct and indirect), as well as the complex relationship tracking (usually via multiple hierarchies)
- The ability to seamlessly capture additional product attributes (some provided by 3rd parties) and maintain them at the proper levels (e.g. material level, lot/batch level, device level, ..)
- Changes to the processes and methods in which we collect and govern product, customer, supplier and patient data
- Improvements to existing (and the introduction of new) tools that manage and distribute product, customer and supplier information internally and externally
- The need for clear (and often increased) ownership of data and accountability for its accuracy and completeness by the business and our partners
- The need to implement more robust reporting and analytics capabilities that handle deeper levels of customer and product data categorization
As you can clearly see, while it will have its challenges, our ability to properly address the new requirement healthcare requirements mandates that we introduce all of the core components of a successful information management program – data standards; robust processes; a framework for governance; and business ownership and accountability.If you haven’t already, turn these challenges into opportunity – one that allows you to turn the ‘project’ activities into a true information management ‘program’.