The Path Ahead for Data Standardization in Specialty Pharmacy


Data standardization has been an ongoing problem in the specialty pharmacy field, affecting both patients and providers when approaching treatments.

Data standardization has been an ongoing problem in the specialty pharmacy field, affecting both patients and providers when approaching treatments, according to a virtual panel at the National Association of Specialty Pharmacy (NASP) Annual Meeting and Expo 2020. The panel outlined various challenges to data standardization as well as potential solutions available through further collaboration.

During the session on the push for data standardization, J.W. Hill, MBA-HCM, CNED​, executive vice president and general manager of National Council for Prescription Drug Programs (NCPDP); Lynn Pezzullo, RPh​, senior director of quality innovation at Pharmacy Quality Alliance​ (PQA); and Luis Rodriguez​, president of Keycentrix​, each explained their perspectives on the challenges and potential solutions available.

Hill explained that NCPDP is a standards development organization accredited by the American National Standards Institute (ANSI). Currently, NCPDP has approximately 1500 members who are volunteers falling into 3 segments—producer-provider, payer-processor, and general interest.

NCPDP became initially engaged in specialty pharmacy in 2018 after their board of trustees examined their current standard-making process and how they could better support initiatives specifically around specialty, with its unique process flows, according to Hill.

“As we evaluated what kind of task groups we wanted to support in our specialty space, we understood that there about 6 billion transactions prescribed annually. And, by the year 2024, there will be about $420 billion in drug spend,” Hill said. “So, we know that America is taking more drugs and we also know that Americans are taking more specialty drugs.”

However, Hill noted that specialty pharmacy has some unique challenges around processing and the patient journey. For this reason, NCPDP decided to launch the Specialty Pharmacy Data Exchange Task Group (SPDETG) in order to assess the reporting requirements, the documentation requirements, and the exchange requirements for all stakeholders within specialty, including specialty pharmacies, pharmacy benefit managers, data aggregators, hubs, and manufacturers.

The work of this task force helped to identify some of the unique challenges affecting workflow in the specialty pharmacy space. These challenges include the lack of a universal definition of specialty pharmacy; a lack of universal reimbursement, dispensing, or administration models; and the existence of a newly created category of medications called limited distributions drugs.

Pezzullo noted that she has participated in the SPDETG on a regular basis in order to support efforts to enhance specialty pharmacy workflow. She said that this has helped inform her understanding of the path forward regarding data standardization.

Additionally, Pezzullo said that PQA has been able to identify similar challenges on the path ahead to data standardization through testing their specialty pharmacy turnaround time (SP-TAT) measure​. This measure was established to assess the average number of days between a specialty pharmacy receiving a new prescription for a specialty medication and the prescription being ready for pick-up or scheduled for delivery​.

During the testing of SP-TAT, PQA found that the challenges to efficient turnaround time in specialty pharmacy included a lack of established, standardized performance metrics​; the desire for outcome measures​; highly variable, non-standardized data sources​; insufficient interoperability​; differing specialty pharmacy models​; and numerous dispensing and care management systems.

“Dispensing systems and care management systems are varied in what data they are able to capture, and how it’s captured. Additionally, many systems are configurable, which really is a benefit to meet individual specialty pharmacy needs, but also can pose a challenge when trying to define standardized data fields and data elements toward measurement,” Pezzullo said.

From a technology solutions perspective, Rodriguez noted that there are ways in which technology can help to make sure data moves and flows in the right direction. However, he noted there are also some challenges for technology stakeholders that hinder their engagement in the acceleration of these kinds of standards.

Rodriguez noted there are 3 main challenges to the adoption of any standard by a technology stakeholder. These include the incentives of a capitalist system that places a heightened importance on the role of supply and demand, the presence of unfunded mandates from non-legal entities, a lack of support from a strong member body that can push standards to the “optional zone,” and the existence of multiple standards bodies that can cause overlap for systems providers.

Rodriguez explained that although the presence of multiple standards bodies like NCPDP and PQA are valuable and important, they are not always in harmony with each other.

“They overlap and touch things, but they are not looking at the technology in harmony. They are very good clinicians, they are very good business operators, they are very good at understanding the payer landscape, and the patient landscape and journey. But sometimes, they run straight into a brick wall when it comes to understanding the feasibility of a technical deployment,” Rodriguez said. “When you have all of them very enthusiastic about their standard and the implication it has on health care and the patient, you can kind of be tossed in different directions, and that can be difficult.”

However, there are ways to overcomes these challenges, Rodriguez noted.

“Those challenges, they all can be overcome. It takes concerted effort, of course, it takes finding the right partners, finding the right body and the right network, and just being disciplined about that,” Rodriguez said.

In order to support efforts to improve data standardization, Pezzullo explained that PQA has established the data and interoperability advisory group (DIAG)​. Currently, the DIAG works to advise PQA on infrastructure and interoperability solutions to enable data sharing aligned with value-based pharmacy services​, considers current data standards that support development of prioritized pharmacy quality measures​, and identifies new data standards needed to support future measure development.

Additionally, Hill noted there were some transactions that could occur to enhance specialty pharmacy workflow. These would include SCRIPT, electronic prior authorization, and risk evaluation and mitigation strategies enhancements, as well as efforts to advance real-time benefits information.

Furthermore, Hill noted that it was important to engage in efforts to develop standardized reporting to support contractual arrangements between the manufacturers, specialty pharmacy, and other stakeholders​, as well as work on inventory reporting standards in conjunction with X12​.

“We do collaborate with PQA in determining how to solidify and be aligned with additional quality measures that support specialty processes,” Hill said. “We definitely need folks in NASP to help us move these initiatives forward.”


Hill JW, Pezzullo L, Rodriguez L. A Push for Data Standardization. Presented at: NASP Annual Meeting & Expo 2020; September 16, 2020; virtual.!/Lobby. Accessed September 16, 2020.

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