Pharmacy Outlook: Lee Ann Stember, NCPDP

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Lee Ann Stember

Through value-based arrangements (VBAs) and speed to standards development, NCPDP is taking bold steps to help power a new health care paradigm focused on improving patient health outcomes and reducing costs. It’s a paradigm that changes the dynamics between payors, providers and patients. It changes the way health care services are coordinated, managed, delivered and consumed; the definition of value and criterion for health improvement; how health care services and products, including medications, are paid for; and intensifies the need for data and communication. The move toward VBAs and personalized medicine can bring better alignment in providing higher-quality care to improve patient outcomes while reducing the total cost of care. It also exposes the nonmedical factors that affect health outcomes, enabling greater visibility into the real-world challenges to health, wellness and the policies, systems and social factors that play a big role in determining health risk and outcomes.

NCPDP’s charge remains the same: to standardize the exchange of health care information to improve outcomes. NCPDP’s Three Year Strategic Plan has a specific goal to increase the speed at which NCPDP can deliver new or enhanced standards to the industry. The strategic plan also includes priority goals for VBAs, precision medicine and tactics for social determinants of health (SDOH). While the goals are focused on standards and interoperability, they all support the expanded role of pharmacists as valuable patient care providers.

We have to bring standards to the industry faster

NCPDP has been asked by representatives from across the industry, including government agencies, to deliver industry standards and guidance faster. It is widely recognized that standards are vital to the interoperability and data sharing requirements of a learning health care ecosystem. The urgency has heightened in recent years to keep pace with changes and advancements in technology and solutions that can improve health care delivery. Accordingly, speed to standards creation is a top priority goal in NCPDP’s Three Year Strategic Plan.

NCPDP convened a subcommittee to examine the life cycle of a standard from the point it has been developed until it has moved through the regulatory process. The subcommittee’s analysis provides details on the process flows and time lines that are under NCPDP’s control and those that fall under the control of regulatory agencies and other industry influences. Importantly, the NCPDP time line also takes into account the consensus process steps that NCPDP requires, which are all driven by ANSI requirements.

The results of the analysis are eye opening. It reveals that it takes approximately four and a half years to realize industry use of a new version of a Medicare Modernization Act (MMA)-approved NCPDP Standard. For a new version of a Health Insurance Portability and Accountability Act (HIPAA)-approved NCPDP Standard, the time frame increases to six years. NCPDP’s internal development process takes between seven and 13 months of that four and a half to six-year time frame, depending upon how the balloting process progresses.

Finding ways to fast-track the NCPDP process is within our scope and power to streamline. The remaining time required for regulatory processes and industry implementation is largely out of our control, but the absence of regulatory requirements does not preclude the industry from adopting and implementing new or enhanced standards more quickly to take advantage of the workflow efficiencies, patient safety measures or data access and transparency made possible by a standard.

Completion of the analysis is a milestone achievement that informs NCPDP’s next steps to accelerate the speed at which we develop new standards and new transactions or enhancements for existing standards. We will be looking for opportunities to streamline our internal processes, while also adhering to ANSI requirements and the rigorous integrity of our consensus-building process. We will also work with regulatory agencies on an ad hoc basis to collaborate on ways to support their innovative approaches to moving health care improvements forward faster.

In addition, our decision last year to migrate the NCPDP Telecommunication Standard to a JavaScript Object Notation (JSON) format, supports our goal to increase speed to standards creation. The move modernizes and enhances the extensibility of the real-time pharmacy claims standard and facilitates access to data via application programming interfaces (APIs). With JSON, we will be able to add data elements without a version change — a capability we need to support the rapid pace of change in health care.

Supporting VBAs — from discovery to define and design

A prominent objective in NCPDP’s Three Year Strategic Plan is to ensure that VBAs can achieve the goal of enhanced patient health outcomes. It’s a lofty goal considering the vast variability among VBAs in terms of design, formulas, measures and metrics, participants, incentives and more, to reduce the total cost of care and improve the patient’s health. However, there are common data elements that NCPDP can explore standardizing to support data access and reporting requirements in VBAs.

Last year NCPDP’s VBA subcommittee completed its discovery work on VBAs, informed by stakeholder action group meetings, interviews, educational forums and other activities. The subcommittee is now moving into documentation of data elements around data collection, analysis and reporting, to support collaboration, transparency and clinical interventions by pharmacists and other providers who are part of a value-based contract. It’s not as straightforward as billing for a transaction such as dispensing of a product or billing for a service. The services can span diagnosis to treatment; patient response to therapy; changing therapy; monitoring or managing disease progression; monitoring side effects, complications or adverse events, and more. VBAs also require data access and sharing across a variety of participants who have different work flows and siloed EMR/EHR, pharmacy and practice management systems. Progress will be incremental, and by activating our efforts in support of VBAs now, NCPDP can keep pace with innovative strategies and continue to build upon that interoperability to support a future when VBAs have proven their value and are more robustly deployed.

Precision medicine’s personalized health care utopia

Equally important as VBAs and accelerating its standards development process is NCPDP’s goal to standardize precision medicine information. While precision medicine may seem far off, this utopian future of health care can mean that one day people will benefit from receiving highly personalized, individualized care as part of their routine medical appointments. Precision medicine takes a whole-person approach to care, including an individual’s environment, lifestyle and genetic makeup. It relies heavily on data collected by patients and health care providers, including relevant multi-omics data. Managing access, use and sharing of the data is critical. A patient’s health data must be easily shared among the patient, their health care providers, researchers and others, as necessary. NCPDP is exploring opportunities to support the data access and interoperability requirements of precision medicine, with more to report on its work in 2022.

The impact of health inequities on health outcomes

A key lever in VBAs and precision medicine are important data on SDOH. The Centers for Disease Control and Prevention (CDC) defines SDOH as “conditions in the places where people live, learn, work and play that affect a wide range of health and quality-of-life risks and outcomes.”

As high as 80% of health outcomes are based on nonmedical factors such as education, unemployment, food insecurity, discrimination, income, housing, working conditions, access to health services and early childhood development. Data on SDOH is important in both precision medicine and VBAs. As trusted, accessible (local) care providers, pharmacists are in a good position to collect and report SDOH data, to benefit both VBAs and precision medicine initiatives, in addition to expanding into other vital patient care services.

An important note on the integrity of the patient record

In any care delivery model, particularly with new collaborations in VBAs and precision medicine initiatives, or even capturing SDOH data, accurate patient identification and the integrity of the patient record maintained and shared with other care providers is paramount. Leveraging NCPDP’s UPI, powered by Experian Health UIM and NCPDP Standards, will help preserve patient data integrity, and the UPI can be appended to the patient record shared by all care providers in a VBA or precision medicine initiative.

Support the work to develop standards for the future

This year marks NCPDP’s 45th anniversary and for all that this organization has accomplished, inspired by the continuing legacy of its entrepreneurial founders who were focused on solving industry challenges, it is only the beginning. NCPDP’s bold and aggressive pursuit of transparency, interoperability, work flow-enabled efficiencies and standards and solutions for the common good is evolving. NCPDP welcomes all industry stakeholders to participate in task groups supporting VBAs, precision medicine and SDOH. Greater industry participation helps speed the development of needed standards. Join us as we expand to support the specific clinical, data sharing and reporting needs of innovative models and approaches to care and help pave the way for better health care tomorrow.

Lee Ann Stember is the president, CEO of National Council for Prescription Drug Programs.



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