The Rise of Data and Accreditation in Specialty Pharmacy

Specialty pharmacies possess extensive clinical data in their databases, and their management of this information can be very rewarding, both clinically and financially.

This data must be handled very carefully to ensure its protection and proper utilization. One way to regulate handling of this data, and to prove the specialty pharmacy commitment to excellence, is through accreditation.

The accrediting bodies have extensive regulations and standards that must be followed and tested before placing their seal on any organization. The combination of specialty pharmacy data and specialty accreditations often can lead to multiple revenue streams, including exclusive contracts, limited distribution medications, and improved patient outcomes.

Specialty pharmacy patients contribute a wide-range of data that is valuable to many different stakeholders. Each stakeholder is primarily interested in the visibility of the data, and how it can add either clinical or financial value.

Every single touchpoint a specialty pharmacy has with a patient, from clinical assessments to the adjudication of the claim, adds valuable data. The majority of the data surrounding specialty pharmacies are concentrated on patient outcomes and care management.

Each specialty pharmacy must be able to quantify their data to justify the quality of care, as this data often can benchmark one specialty pharmacy against another. To ensure clinical performance, most specialty contracts have performance guarantees that must be met by each specialty pharmacy, or else the specialty pharmacy will be subject to fines and penalties.

For example, the proportion of days covered (PDC) rates is often used to measure a specialty pharmacy’s performance. PDC rates measure the percent of days that a patient has therapy on hand, versus the total amount of days of therapy possible.

The typical range is between mid-80% to mid-90%, depending on the disease state and how the contract is negotiated. The higher the PDC rates of the specialty pharmacy, the more attractive they are for exclusive contracts with health plans, which can add significant revenue and profit margin.

Health plans must treat their patients to have positive health outcomes, but they must keep overall spending as low as possible. They want to see how frequently the claims are being adjudicated to prove how compliant their patients are to therapy.

They do not want to waste resources on unnecessary or inappropriate treatments. Health plans often use compliance and drug data to make formulary decisions, and to renegotiate their drug pricing and rebates. What exactly does all of this data mean?

The short answer is increased revenue and profit margin. The extensive amount of information created and collected by a specialty pharmacy can be sold to organizations that aggregate scores of pharmacies data, and then ultimately sell it back to pharmaceutical companies, or any stakeholder willing to pay.

Pharmaceutical companies spend a lot of money and time on data produced by specialty pharmacies, and they often leverage superiority against each other when competing in a particular segment. Positive clinical data can generate increased access to limited distribution drugs that frequently require mandatory data collections, or REMS programs for a medication to be safely dispensed to a patient.

What about the accrediting bodies, what influence do they have on data and its utilization? First, the accrediting agencies ensure that what is documented, as to what a specialty pharmacy states they will do, actually happens.

URAC, which is considered one of the "gold standards" for specialty pharmacy accreditation, has extensive regulations and standards that must be met before they will accredit any organization. They have many mandatory standards, such as drug-drug interaction screening, defined call center performance metrics, dispensing accuracy, distribution accuracy, and turnaround time for prescriptions.

These standards ensure patient safety and improved clinical outcomes, and in the process creates more data, which fuels the specialty pharmacy data cascade. When a specialty pharmacy conducts a patient assessment that has either soft or hard cost savings, that data then can be used to negotiate additional contracts.

For example, if the specialty pharmacy can troubleshoot a faulty medication device that typically would have resulted in the patient getting a replacement at the expense of the health plan, then the savings can be calculated, and the data used as a marketing tool for the specialty pharmacy.

The combination of accreditation and data will be forever linked because of their complementary nature. The increased number of specialty pharmacies have made it harder to stand out of the crowd, and has shed more light on which accrediting bodies each specialty pharmacy possesses.

Each accreditation often has versions that get more detailed as they progress, and often require more data collection. This increased data collection then adds more value to each prescription and each patient, which in turn makes every prescriber and patient very attractive to competing specialty pharmacies.

The ultimate winners in the combination of data and accreditation are the patients and the health plans. The patients see improved clinical outcomes, and the health plans see decreased costs due to less inappropriate or unnecessary therapies.

The data required by accrediting bodies and managed by specialty pharmacies are growing, and must be managed properly for the data to grow in value. The number of specialty pharmacies is growing, and it is necessary to be able to benchmark one against another to see which can provide the most value to its stakeholders.

The disproportionate growth of specialty pharmacy has put a significant emphasis on reducing costs and increasing patient outcomes. As the accrediting standards get more detailed, more specialty pharmacy data will be produced, all of which can be purchased or sold.

About the Author

Anthony Mazzarese is a graduate of The University of Pittsburgh School of Pharmacy and is currently enrolled in the Masters of Science in Pharmacy Business Administration (MSPBA) program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines. He is the Pharmacist-In-Charge at Giant Eagle Specialty Pharmacy. His practice is focused on improving medication compliance and overall wellbeing in the areas of HIV, auto-immune disorders, oncology, and organ transplantation.