Leveraging Data Standardization in Specialty Pharmacy

Specialty pharmacy is a unique and complex sector of the health care industry. High cost pharmaceutical products are dispensed by specialty pharmacies to treat complex and often rare disease states. Data have a major impact on the industry for clinical and business reasons.

Among other strategies, specialty pharmacies may report data to pharmaceutical manufacturers and payers to gain access to limited distribution drugs (LDDs) and payer contracts. Without reporting data, specialty pharmacies may struggle to access LDDs, forcing patients to use preferred specialty pharmacies, driving business to their competitors.

Manufacturers, payers, and specialty pharmacies would benefit greatly from a robust data infrastructure allowing cleaner and faster reporting to stakeholders.

Specialty Pharmacy Data

Pharmaceutical companies use demographics, claims, and clinical data to improve research and development and sales strategies. Payers use the same data to ensure specialty medications are being prescribed and utilized appropriately.

Accreditation agencies, such as URAC and the Center for Pharmacy Practice Accreditation (CPPA), set data requirements in order to meet specialty pharmacy accreditation standards. Accreditation is becoming a quality standard for manufacturers and payers, and is among the criteria for specialty pharmacies to gain access to select LDDs and contracts.

Data requirements largely consist of patient and prescriber demographics details, claims and dispensing information, call center metrics, and clinical data. Anecdotal reports from specialty pharmacy leaders working closely with manufacturers and payers report that many of these stakeholders are unable to specifically identify additional data they are interested in; however, they know it is important.

Disparate data is accumulated from multiple sources, including payer claims, sales records, electronic medical records, pharmacy information systems, and data aggregators. These data are reported in many different formats, which produces a time and cost intensive scrubbing process to make it actionable.

Clinical data (ie, past medical history, family history, adverse drug event history, pharmacogenomics information, laboratory values, procedures, interventions, and outcomes) are difficult to obtain because of inconsistencies in legacy documentation practices and proprietary medical record systems that contain the information.

A standardized approach to documenting, storing, reporting, and exchanging specialty data would provide great benefits to all stakeholders in this high cost marketplace.

The Case for Standardization

Information technology standards provide a systematic, unified approach to ensure data are produced, managed, and reported consistently, ultimately leading to health information exchange capability. Most specialty pharmacy data today are administrative and lacks patient-specific clinical information.

Outlining clinical data standards would guide software vendors to develop solutions that allow the documentation, reporting, and exchange of clinical data consistently across the healthcare system. This would provide a true solution for population health analytics and value-based reimbursement.

All stakeholders would benefit from data standards. Manufacturers could use clinical data to study post-market adverse drug events and patient-specific outcome variations in relation to genomic profiles, providing enhanced insight into research and development efforts.

Hospitals, clinics, and pharmacies could study intervention and outcomes data across health systems and benchmark data to drive competition. Payers could use the same data to identify high quality providers for accountable care networks, design more precise risk modeling calculations, and gain greater insight into the care provided to beneficiaries.

Most importantly, this would be valuable to patients who would benefit from quality transparency, driving market competition, better quality, and lower cost health benefits, as well as faster-to-market, cutting edge treatments.

As the providers most closely tied to this industry, the professional pharmacy community should take this opportunity to provide guidance to the federal government on strategy to standardize data for specialty pharmacy disease states and outcomes. Aligning industry stakeholders would provide a consensus-driven process for identifying data elements and interoperability standards to create a robust data infrastructure for the health care system.

Standardization Efforts

A framework to accomplish this has been established through legislation and government regulations. The United States Department of Health and Human Services, and associated entities, including the Office of the National Coordinator and the Centers for Medicare and Medicaid Service are driving implementation of data standards.

Standard development organizations (SDOs), such as HL7 and NCPDP, have developed standards for documenting and exchanging electronic health information (eg, Consolidated Clinical Document Architecture or C-CDA, SCRIPT), including problem lists, allergies, medication lists, e-prescriptions, progress notes, and care plans.

Implementation efforts are being adopted due to financial incentive programs (eg meaningful use) that allows eligible hospitals and eligible providers to obtain additional funds for adopting certified electronic health record software and demonstrating data exchange capabilities.

Existing financial incentive programs do not specifically target specialty pharmacy providers or specialty pharmacy vendors. A strategy must be developed to incentivize adoption of electronic standards in this sector of the industry.

Current Landscape

There is still more work required to achieve a data environment to leverage data exchange health analytics. Several industry groups and CPPA, are identifying clinical data elements for common specialty pharmacy disease states, including hepatitis C, rheumatoid arthritis, and multiple sclerosis.

NCPDP recently held a stakeholder conference to discuss common interests and construct a consensus-driven data management strategy for specialty pharmacy. Accreditation agencies should align data requirement with standards developed by NCPDP and other SDOs.

Providers and vendors should work with SDOs and professional pharmacy associations represented by the Pharmacy HIT Collaborative to implement standards for interoperability and data exchange. The Pharmacy HIT Collaborative works closely with federal partners, SDOs, and pharmacy professionals. The collaborative has developed a process to publish documentation codes in form value sets that align with standards for interoperability and data exchange for clinical pharmacy.

Value sets provide a subset of standardized data elements needed for reporting and exchanging clinical information. The same process can also be leveraged for specialty pharmacy data.

Quality organizations, such as the Pharmacy Quality Alliance (PQA), should expand quality measures for specialty pharmacy. Quality measures allow payers and providers to quantify performance to set quality standards for the industry.

Setting quality benchmarks incentivizes providers to optimize treatment regimens and strategies to achieve the best possible patient outcomes. Quality measures bring data elements and standards full circle to measure the value of care provided.

A framework exists for the standard exchange and consistent reporting of health information. Other sectors of the health care system can follow this framework to leverage health data.

This is especially important for high cost, resource-intensive specialty pharmacy industry. Specialty pharmacy leaders should work closely with accreditation agencies, standard development organizations, vendors, the Pharmacy HIT Collaborative, and other stakeholders to develop a strategic plan for implementing data standards across the industry.

Proposed Actions

• NCPDP should work in concordance with other standard development organizations (eg, HL7) to develop technology standards for exchanging and reporting clinical information for specialty pharmacy disease states. Standards provide a framework for vendors and implementers to capture, report, and exchange clinical data for specialty disease states. Implementing standards will promote consistency in data management practices, regardless of where care is provided or what electronic system is utilized. Data can be leveraged by all stakeholders to improve outcomes and business performance.

• CPPA, URAC, and other accreditation agencies should incorporate technology and data standards within accreditation requirements. Accreditation requirements drive implementation. Financial incentive programs established by the federal government have facilitated the adoption of electronic health records, including standards, reporting, and exchange capabilities, but these programs have not specifically targeted the specialty pharmacy industry. Accreditation has become a benchmark for payers and manufacturers to identify well established, high quality specialty pharmacy providers. Incorporating data standards into accreditation requirements will drive vendors and providers to adopt standards that achieve interoperability and data consistency.

• Professional pharmacy associations, represented by the Pharmacy HIT Collaborative, should publish value sets and provide resources for implementing standards and data requirements. The Pharmacy HIT Collaborative has an established process to help guide vendors and providers to implement standards. The Pharmacy HIT Collaborative should develop value sets for specialty pharmacy and supporting documents to facilitate implementation.

• PQA and other quality organizations should develop quality measures for the specialty pharmacy industry. Quality measures use data elements to quantify value and establish performance benchmarks for the health care industry. Standards and data requirements provide the resources for calculating quality measures. Quality organizations can identify validated measures that guide providers to achieve better patient outcomes.