As specialty pharmaceuticals continue to dominate the growth of the US drug spend, more health care organizations are realizing the potential of entering the specialty pharmacy business. Not only can this afford health systems a unique opportunity to provide specialty pharmaceuticals to patients with minimal disruption to continuity of care, but it also represents a tremendous opportunity for business and financial growth. Although only 18% of health care systems currently operate a specialty pharmacy,¹ this percentage is expected to increase, as are the standards by which these specialty pharmacies are measured.

As a result, the specialty pharmacy accreditation business is brisk. With the number of specialty pharmacies growing, competition intensifies and accreditation becomes ever more vital for specialty pharmacies to demonstrate the quality of their business model to purchasers. Currently, of the 132 URAC (formerly known as the Utilization Review Accreditation Commission)-accredited specialty pharmacies, only 6 are health systems,² and one of those is the University of Illinois at Chicago Wood Street Pharmacy.

The pharmacy is part of the University of Illinois Hospital and Health Sciences System (UI Health), a nonprofit, 495-bed, academic health center located on the southwest side of Chicago. With 4,000 employees, over 60 outpatient clinics, and 12 federally qualified health centers, UI Health is the state’s only integrated health system and serves some of the area’s most vulnerable patients, with a high proportion of Medicaid, Medicare, and uninsured patients.

Getting Started
UI Health’s adventure into specialty pharmacy began in 2007 with one pharmacist and a single prescription. Now, 8 years later, the URAC-accredited specialty pharmacy has a staff of 10 FTEs and services over 400 patients. The decision to pursue accreditation was not made lightly; in fact, planning began 2 years before the ultimate onsite evaluation. Some of the most important considerations involved the proper allocation of staff and resources.

The first step was understanding the full scope and breadth of the project by becoming familiar with the accreditation standards, which are broken down into domains. URAC, for example, divides their standards into five modules: pharmacy core; customer service, communications, and disclosure; specialty drug management; pharmacy operations; and patient management, which translates, respectively, into: pharmacy oversight and administration; call center services; therapy management guidelines; dispensing operations; and the development and evaluation of the clinical management program.³

Performing a gap analysis builds familiarity with the standards and helps with getting organized. UI Health’s specialty pharmacy created a gap analysis tool that outlined the facility’s progress with each element of accreditation (see TABLE 1). The gap analysis tool served five main purposes:

• It indicated if the element was mandatory or weighted (Note that for certain accreditation bodies, all elements are mandatory.)
• Each element was described
• A numerical score was assigned indicating the progress on each element (1=element met with supporting documentation; 0.5=element met, but lacking documentation; 0=element not met)
• The documentation/policies and procedures currently in place to meet each standard were listed
• A list of additional information necessary to fill any identified gaps was compiled. The percentage of total elements met then can be tabulated for each module to help gauge readiness to start the accreditation process (see FIGURE 1). Be sure to allocate enough time for the gap analysis because it is useful only when performed in a thorough manner.

The second step is determining a strategic approach. Important questions to answer in this phase include:

• Should we hire a consultant to assist with the project? UI Health decided against hiring a consultant because the gap analysis results indicated that the workload was reasonable.
• Who will manage the project? At UI Health, the project manager was a clinical pharmacist, a member of the Specialty Pharmacy Services (SPS) team. The person who is chosen must be familiar with all operational and clinical components of the program and have strong managerial skills. The person also should be able to take time off from service to focus on project management.
• How will tasks be allocated to team members?
• How many pharmacies will be included in the scope of the accreditation? This impacts the cost of the accreditation application, as well as the business model of the specialty pharmacy. If you choose to accredit multiple sites, be sure the infrastructure is in place to case-manage patients remotely.
• Which model will be pursued: accredit then build or build then accredit? Both have pros and cons. UI Health followed the latter strategy; we chose to accredit a functioning specialty pharmacy. The specialty pharmacy was housed inside of the UI Chicago Wood Street Pharmacy—one of its seven outpatient pharmacies. In this model, accreditation becomes a roadmap to expand the services the pharmacy offers, which is less work than starting from scratch. Many of the dispensing, safety, and security policies and procedures were already in place. The downside is that allocating sufficient space and resources to the specialty pharmacy’s growing needs was an ongoing challenge.
• Which therapeutic categories will be included? UI Health’s specialty pharmacy was already managing Crohn’s disease/inflammatory bowel disease, hepatitis C/liver disease, multiple sclerosis, psoriatic arthritis, pulmonary arterial hypertension, rheumatoid arthritis, sarcoidosis, and sickle cell disease, so these were included in the scope of the accreditation. Facilities opting to pursue the accredit, then build model can choose which disease states make sense for their operation.

Constructing a Project Timeline
The moment an institution signs the accreditation contract, the institution is considered in process, and the clock starts ticking (see FIGURE 2). From that point, allow about 6 to 9 months until your document submission is due (ie, the desktop review [DTR]). After the online DTR submission, facilities typically receive a response from reviewers in 4 to 6 weeks. Many institutions go through multiple rounds of RFIs (requests for information), during which the reviewers request that additional information be submitted prior to continuance with the accreditation process. Typically, the reviewers are extremely helpful during this stage, which may take anywhere from a couple of weeks to a month, depending on the number of rounds of RFIs. Once all of the necessary documentation is submitted, reviewers will make arrangements to conduct an onsite evaluation of the specialty pharmacy. Expect the onsite visit to occur about 3 to 4 months after the date of your original DTR submission.

Despite the comprehensiveness of the gap analysis, once UI Health became in-process, an additional 2 months of planning was needed. This was handled largely by the director of the SPS team and the project lead during weekly meetings. At the end of that time, the director of the SPS team and the project lead presented the project, along with tentative deadlines, to the team. During the execution stage, a modified version of the gap analysis tool (see TABLE 2) was used to track progress, including the number of new policies and procedures that needed to be written or modified and the number of new documents, such as toolkits, training resources, etc, that had to be created, along with deadlines for completion of each standard. The project lead was responsible for updating the deadlines and maintaining the document on a shared drive so that it could be accessed by anyone on the SPS team at any time.

Assigning Tasks
To facilitate assigning and tracking the progress of tasks, the SPS team created a system involving colored folders; each module was assigned a color and each standard within that module received a folder that was labeled with the staff member designated to complete that standard. The initial process of assigning tasks to team members proved ineffective. After multiple deadlines were missed, those assigning tasks realized that ongoing, lengthy tasks, such as policy and procedure writing, should be consolidated to one or two people to maintain consistency, while smaller, self-limiting tasks, such as creating a training checklist, developing a resource library for patient-friendly resources, and writing a protocol for escalating clinical questions to the pharmacist, could be assigned to multiple team members. With more specific tasks—rather than whole standards—assigned to team members, the team worked more efficiently, and the project lead was better able to track progress.

Key Elements
As the project continued, key elements surfaced that required attention in order for the specialty pharmacy to obtain full accreditation status. Looking back, it is clear that these elements are crucial to the success of any specialty pharmacy accreditation.

1. Policies and procedures. The first element that any specialty pharmacy must address is developing policies and procedures. This can be particularly confusing for a health system, because often it is unclear when the institution’s existing policies and procedures are sufficient versus when the specialty pharmacy requires more specificity. Consultants may be helpful in this regard. Our team created a skeleton policy whose outline mirrored the URAC standards. Depending on the level of detail of each standard, the team either referenced an existing health system policy, wrote a new SPS policy, or referenced the health system policy but included an addendum specific to our SPS in order to meet the standard. This approach ensured that no time was wasted on unnecessary document creation.

2. Training and documentation. The specialty pharmacy must be able to document that employees have received training specific to the duties of their job (ie, processing, filling, prior authorizations, etc). Consider developing a checklist for each employee to sign that outlines all training levels, including institution training (emergency preparedness, infection control, etc), department training (attendance policy, performance review policy, etc), and SPS training (URAC training, processing, PA basics, telephone etiquette, etc).

3. Clinical patient management program. One of the most significant elements the team had to create and implement was the clinical patient management program. Designed by a senior clinical pharmacist, the program delineated the role and extent of reliance on the health system’s EMR and included what would be documented, where it would be documented, and if duplicate documentation would be required. The institution decided to leverage the EMR heavily for patient clinical information. Our call center utilizes three systems to ensure complete clinical coverage and refill management for the patient: the EMR, the prescription processing system, and the case management system.

Our clinical patient management program is performed in two locations. The first segment is conducted in the specialty clinics with embedded clinical pharmacists. Patients generally are initiated on treatment in the specialty clinics by the embedded clinical pharmacist, who is a member of the prescriber’s team. The clinical pharmacist also may conduct periodic specialty medication clinical treatment interventions when appropriate, according to therapy-specific recommendations. The clinical pharmacist then documents these interventions in the EMR. The second segment is conducted in the call center by the SPS pharmacists who perform ad hoc interventions when indicated, such as if medication safety, adherence, or tolerability issues are discovered during clinical assessments or during any other specialty pharmacy call center operation. The patient management program includes a treatment initiation session with the patient, either in the clinic or the pharmacy, ongoing refill management via monthly survey calls in the call center, and quarterly clinical assessments in the call center to ensure the medication is and remains safe, effective, and appropriate for the patient. When the SPS pharmacist working in the call center has a clinical interaction with the patient, the full note is entered into the EMR; only brief notes are entered in the case management system. The latter includes instructions to check the EMR for clinical details of the patient. By integrating the functions that occur in the specialty clinics and the call center, the facility is able to provide complete clinical management for its specialty pharmacy patients.

4. Marketing materials. URAC accreditation requires the creation of marketing materials. The specialty pharmacy at UI Health created an SPS Web page within the UI Health Web site along with a welcome packet for all new patients. The welcome packet includes a Welcome to SPS letter, an SPS brochure highlighting our services, a patient consent form, patient’s rights and responsibilities, information related to the patient’s medication and disease state, and materials that explain how to properly and safely dispose of medication. All of these materials were written in a patient-friendly manner at a patient-appropriate grade level, and required proof that the materials were tested. In addition, all of the materials were approved by our newly formed marketing committee.

5. Call center. Another crucial element of accreditation is the creation and implementation of a call center. The team replaced the existing phones with voice-over IP (VoIP) phones capable of tracking metrics, such as average hold time, average abandonment rate, and average speed of answer, which most accreditors require. UI Health’s specialty pharmacy call center houses two full-time, certified prior authorization technicians; two student pharmacists; one pharmacist; and many independent study and experiential pharmacy students from the college of pharmacy located across the street from the pharmacy. The functions of the call center include benefit verification, prior authorizations, medication access issues, refill management, and pharmacist escalations as needed during refill survey calls.

As previously noted, the specialty pharmacy was built inside of an existing pharmacy. It quickly became clear that the processing, labeling, and dispensing of specialty medications needed to be managed by a subgroup of the operational team to ensure compliance with the URAC operational standards. To address this need, the decision was made to dedicate one pharmacist and two full-time technicians to handle all the processing, filling, and dispensing of specialty medications within the outpatient pharmacy. A separate workspace was allocated for the specialty operational team, creating a pharmacy within a pharmacy to ensure that the proper procedures for specialty medications were followed. Because inventory storage and management policies must be clearly defined and followed, this was easier to coordinate once the specialty medications were separated from the rest of the outpatient inventory.

6. Quality management program and evaluation tool. A quality management program requires three key components: a quality committee that keeps detailed minutes of meetings, two ongoing quality improvement projects that have a direct impact on SPS, and a quality plan that outlines the annual SPS quality indicator goals. The clinical patient management evaluation tool must evaluate the clinical, financial, and health-related outcomes of the program and must be completed on an annual basis. For UI Health’s specialty pharmacy, this was one of the more difficult elements of the accreditation to create, because the patient management program was still under development. The solution was to create an assessment tool that measures all elements of the patient management program, as outlined in the standards. The regulations did not require that an assessment be complete; however, a tool needed to be in place that could be used after the initial year of the clinical patient management program implementation.

These elements—policies and procedures, training and documentation, clinical patient management program, marketing materials, call center, pharmacy operations, and a quality management program/evaluation tool—are by no means an exhaustive list of everything that is required to achieve accreditation, but developing these elements places the institution that much closer to success.

Tips for a Successful Onsite Visit
The last step of the accreditation process, which follows once documentation creation and submission is complete, is the onsite visit by the accrediting body. This normally takes 1 to 2 full days with multiple reviewers onsite. A detailed breakdown of what will occur will be provided a few months before the scheduled visit. Following are a few tips for success:

1. Mock interviews with staff are key. These interviews should be performed by a consultant, if feasible. If not, a few weeks prior to the official onsite visit, prepare mock interview questions for all involved parties by going through the standards and writing down pertinent questions for all levels of staff.
2. Be sure that all staff members, including clinical pharmacists, filling technicians, and prior authorization specialists, are well informed about the core components of the specialty pharmacy, and can competently discuss issues ranging from quality improvement projects to IT security.
3. Conduct mock audits of personnel files and patient management files. A random sample of both will be pulled during the visit. Be sure to comb through the required elements of the personnel files, in particular, as these are examined in detail by the accreditor.

Student pharmacists conducted mock audits on the specialty pharmacy’s patient management files to ensure that all elements of the patient management program (treatment initiation, refill surveys, and quarterly clinical assessments) were completed in a timely manner for each patient and that all outstanding issues were resolved.

The Fruits of Labor
After a grueling 2-year process, which launched with a gap analysis during the summer of 2013, the University of Illinois at Chicago Wood Street Pharmacy was accredited as a URAC specialty pharmacy on September 1, 2015. Opting to pursue specialty pharmacy accreditation is a monumental decision that should not be made lightly. Success requires the exertion and cooperation of a village of individuals, ranging from contracting staff, to the IT department, to the marketing team. Although the process may seem daunting, the result—a high-functioning specialty pharmacy that is committed to quality health care—is well worth the challenge.

Reference

1. Specialty Pharmacy. Biologics Supplement. Pharm Purch Prod. Nov 2015;50.
2. URAC. URAC Directory of Accredited Companies. https://www.urac.org/directory/DirectorySearch.aspx. Accessed October 5, 2015.
3. URAC. Standards and Measures at a Glance. https://www.urac.org/resource-center/research-publications/standards-and-measures-at-a-glance/#sp. Accessed October 5, 2015.  

Lisa Kumor, PharmD, is a clinical pharmacist within the specialty pharmacy services and clinical assistant professor at the University of Illinois Hospital and Health Sciences System, Chicago. Previously, she gained extensive experience in both clinical and operational management of specialty medications by working in the Walgreen Health System Pharmacies. Lisa obtained her BA degree in chemistry from Miami University, a PharmD from The Ohio State University College of Pharmacy, and completed a PGY1 community residency with University of Illinois at Chicago/Walgreen Co. Lisa served as project lead in the process of obtaining URAC Specialty Pharmacy Accreditation for the University of Illinois at Chicago Wood Street Pharmacy.

JoAnn Stubbings, BS Pharm, MHCA, is a clinical associate professor and manager of research and public policy in the ambulatory pharmacy and assistant director of specialty pharmacy services in the department of pharmacy practice at the University of Illinois Hospital and Health Sciences System, Chicago.