By Curtis Rooney
The groundswell of change in the healthcare industry has been so widely reported and debated that many of its elements have become a familiar mantra in the collective consciousness, including:
- Federal payment cuts to hospitals and other healthcare providers
- Value-based (and bundled) payments
- Consolidation
- Increases in the number of insured patients
Although these elements of transformational change remain at the forefront of the conversation in the media, more subtle, under-the-radar changes in federal policy are leading to important alterations in the way the healthcare supply chain will work in the future. This evolution holds the promise of electronically bridging important aspects of the healthcare supply chain.
As recently as 2012, Mercy-ROi and Becton Dickinson issued a report entitled the Perfect Order, which contained a description of the ideal supply chain process. It included a graphic depiction of ideal electronic order-processing, from order placement to delivery and payment, from manufacturing plant to the patient bedside. Now, federal policy is slowly creating a similar, yet more evolved and expansive real-world process.
Unique Device Identification
The U.S. Food and Drug Administration has begun implementing the Unique Device Identification (UDI) system for medical devices. The FDA’s UDI implementation deadline for implantable, life-saving, and life-sustaining devices is September 2015. HSCA recently submitted comments to the FDA stating that it agreed that the UDI final rule should enable the identification of devices that are in the supply chain and are ultimately used in the clinical setting: “Once captured, the UDI will allow access to the data published in the Global Unique Device Identifier Database (GUDID), so that additional device information may also be recorded in the EHR.”
HSCA also expressed support for “a new 2015 certification criterion that requires EHR technology to be able to record and display UDIs in connection with patients’ implantable devices. The UDI recorded in the EHR will have been captured at the point of procurement and used to track the procurement through delivery and receipt, distribution within a hospital system, and storage as a staging area for in-patient use.”
Track & Trace
Title II of the recently enacted Drug Supply Chain Security Act of 2013 (DSCSA), often referred to as the Drug Quality and Safety Act (DQSA), includes the so-called “Track & Trace” provisions. DQSA creates a uniform national standard for drug supply chain security and establishes a lot-level tracking system for enhanced security with a ten-year transition period to a unit level system. It preempts state law (e.g., California) and maintains both floor and ceiling licensure standards for wholesale distributors and third-party-logistics providers, while preserving state authority for licensure issuance and fee collection. The FDA recently requested comments from supply chain stakeholders as part of its implementation of DQSA.
HSCA submitted comments highlighting the benefits of Track & Trace: “The new law may also positively affect the drug supply by making the process of tracking and tracing of pharmaceuticals more secure and less vulnerable to ‘gray market‘ activities. DSCSA will allow for the detection of illegitimate drugs (counterfeit, stolen, up-labeled, diverted, etc.) into the legitimate supply chain as early as possible, while also helping to identify those who participated in the introduction of the illegitimate product and to prosecute criminals efficiently by automatically generating solid evidence.”
HSCA maintains that effective implementation of DSCSA’s Track & Trace provisions holds the promise of linking all appropriate aspects of the healthcare supply chain and ultimately enhancing patient care.
Meaningful Use
The Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs are well known and provide financial incentives for the “meaningful use” of certified EHR technology to improve patient care. “Meaningful use” began in 2012. More recently, HSCA filed comments to the Office of the National Coordinator for Health Information Technology highlighting our GPO members’ support for GS1 standards and “end to end use” of Global Trade Item Numbers (GTINs), Global Location Numbers (GLNs), the Global Data Synchronisation Network (GDSN) and the FDA’s new Global Unique Device Identification Database (GUDID). HSCA’s comments also identified areas of interoperability between enterprise-wide technology systems that should be improved to ensure:
- The reliable, accurate capture of the UDI in the EHR as a routine protocol in the clinical setting.
- Effective recalls both for devices that have already been used as well as those that have been ordered, shipped, delivered and distributed into provider networks and clinical settings, which will allow affected patients to be identified and notified while also facilitating the identification of problem devices prior to use.
HSCA imagines a world in which EHRs connect the supply chain using UDI, Track & Trace serialization and related standards and protocols. To this end, we have promoted and recommended leveraging the GS1 US standards. GS1 standards offer unique Global Location Numbers (GLNs) for identifying locations in the supply chain, from manufacturer locations and operating rooms to provider “ship to” and “bill to” locations. GS1 standards also offer GTINs, which identify each product item as well as unique item numbers to classify packaging hierarchies where more than one “each” is packaged together; and support automatic identification and data capture (AIDC) technology, enabling GTINs for each product to be scanned into information systems, such as provider material management information systems and the EHR.
As healthcare reform shifts from volume- to value-based federal payment systems and negotiations move from price-driven to quality and performance measurements, changes in the supply chain will be utilized to provide meaningful data for these important conversations. Because a system with more detailed levels of data holds the potential to become more patient-centered, partnerships among non-traditional allies may become increasingly valuable. Unlike the revolution taking place in healthcare reform, the evolution now occurring in the supply chain will not be as politically driven, and it will not be televised.
Curtis Rooney is president of the Healthcare Supply Chain Association, www.supplychainassociation.org.