Accreditation in Specialty Pharmacy: No Longer Optional

Specialty Pharmacy TimesMarch/April 2016
Volume 7
Issue 2

Payers prefer specialty pharmacies achieve third-party accreditation to confirm their commitment to quality.

IN OUR POSITION AS THE LEADING PUBLICATION IN SPECIALTY PHARMACY, along with our affiliated pharmacy associations, we have been battling with the media over some recent negative coverage on specialty.

The media has unfortunately lumped specialty services with specialty pharmacy, which has created widespread confusion as to the role of a true specialty pharmacy. A key point of differentiation is accreditation in specialty. Over the course of the last 5 to 7 years, one of the minimum standards in specialty pharmacy is having obtained 1 or more accreditation certifications.

If a pharmacy wants to have access to limited-distribution products and payer coverage, accreditation is near mandatory. It was recently announced that URAC was 1 of 2 approved accreditations for health plans as part of the Patient Protection and Affordable Care Act, better known as the Affordable Care Act (ACA).

URAC has some company in the space, however. The other 3 most commonly seen specialty pharmacy accreditation programs are from the Accreditation Commission for Health Care (ACHC;, The Joint Commission (, and Community Health Accreditation Program (

The most common accreditation for specialty pharmacy is URAC, followed by ACHC. URAC states that their accreditation programs are considered the premier choice in the industry, accounting for 64% of the votes for the program payers deem the “most important type of SP third-party accreditation.”

Make no mistake, accreditation makes a difference. The increased desire for discrete quality-management strategies is a good indication of the shift toward superior coordinated care.

This industrywide movement is cemented by the preference of payers that specialty pharmacies achieve third-party accreditation to confirm their commitment to quality, cost containment, and proper utilization of services.

According to the EMD Serono survey, “Healthcare purchasers are increasingly requesting that a specialty pharmacy become accredited by an independent third-party organization to validate the pharmacy’s commitment to quality management, patient safety and monitoring, and prescriber and consumer communications.”

When it comes to accreditation, and the quality measures it can achieve for industry stakeholders, it is worth examining the standards of an accreditation body to see how the diverse pieces of the puzzle fit together. To illustrate the full-service elements that accreditation necessitates for specialty pharmacies, we need to explore some of the patient-centered standards from URAC.

As background, the URAC Specialty Pharmacy accreditation standards cover a broad range of services that include drug handling, operations, and patient management. Providing a closer look at what the URAC standards for patient management require from a participating organization, we offer 4 examples within the patient management category. As these examples show, the onus rests on patient-centered quality measures.

The 4 primary elements of specialty drug accreditation (courtesy of, each of which contains their own standards for quality, are:

  • Customer Service, Communications, and Disclosure
  • Specialty Drug Management
  • Pharmacy Operations
  • Patient Management

Managed care health plans are mandating URAC Specialty Pharmacy accreditation for several reasons. One is due to the ACA mandate for health plans to have URAC Health Plan Accreditation.

There are accreditation standards specific to contractors. If you are providing specialty pharmacy services, then you will need to adhere to URAC standards as part of your contract agreement.

It also helps align their standards for accreditations with the organizations they partner with and align both quality goals and clinical oversight. Another reason health plans mandate URAC accreditation is because it helps to narrow their network of pharmacies.

Accreditation also helps ensure that the partnerships they have with specialty pharmacies have solid third-party validation of their operations and fosters continual improvement and regular updating of current best practices that help enhance operations and services. So, how does this affect a specialty pharmacy?

There are several managed care health plans that have recently mandated, in a request for proposals (RFPs), that specialty pharmacies have URAC specialty accreditation. This trend is growing throughout the United States, and if you don’t get prepared, you could get locked out of some large managed care health plans—that is, if you have not already been affected.

Accreditation holds an organization accountable on several levels. One way is by forcing an organization to review and implement new policies and procedures as the industry evolves.

Accreditation also guides an organization to continually improve its operations. This guidance can help your organization to become a leader in the specific services and products that are provided. Accreditation will also get you recognized by key decision makers and improve the influx of RFPs for potential access to limited-distribution products.

Ironically, we have yet to see the same standards around pharmacist certification in specialty, but that is likely one of the next must-haves in a specialty pharmacy’s repertoire.

Bottom line: if your organization is not accredited with any of the major players, you could lose out on future business growth opportunities.

We hope to see you in Las Vegas at the upcoming Armada Specialty Pharmacy Summit. We’ll have a Specialty Pharmacy Times booth, and many of our staff will be in attendance. (

We would love for you to visit and to hear your view of our publication and how we can make it even better. Managing Editor Davy James and Assistant Editor Lauren Santye will also be in attendance, looking for your feedback and potentially interviewing you on camera so we can post your interview on SPT

Specialty Pharmacy Times

is THE journal fully committed to setting the publication standard through peer-written and reviewed articles focusing on the “real world” of specialty pharmacy practice. We invite you to enjoy this issue and pass it on! We welcome your feedback on this topic and on any topics you would like us to cover in future editions of

Specialty Pharmacy Times

. Please reach out to me at We also encourage you and your colleagues to subscribe to this unique journal, receive the e-newsletter, and sign up for the free app by logging on to

DAN STEIBER, RPH, is founder of D2 Pharma Consulting LLC ( and is responsible for commercial operations; trade-supply chain strategy development, including 3PL selection; regulatory oversight, and “operationalizing” organizations. Mr. Steiber has served in several senior positions in pharmacy, distribution, and industry over the course of his 35-year career. Mr. Steiber is a licensed pharmacist in Texas, Washington, California, and Pennsylvania. He is affiliated with several professional associations and publications and is a frequent speaker on behalf of many professional organizations. Mr. Steiber graduated from Washington State University College of Pharmacy. He has participated in a variety of postgraduate programs in law and business development/marketing at Harvard University and Northwestern University. Mr. Steiber currently resides in Highland Village, Texas.

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