key: cord-0738921-zte4d0yo authors: Espinosa, Ashley Mains; Chisholm, Julia M; Kandah, Huda-Marie; Kumor, Lisa; Poirier, Michael; Taylor, Jennifer title: Expanding nonclinical roles in specialty pharmacy: How to grow a high-performance specialty pharmacy team date: 2021-03-11 journal: Am J Health Syst Pharm DOI: 10.1093/ajhp/zxab085 sha: bea858ad92fd7bbf6c6f89b64731f38ad4343f9e doc_id: 738921 cord_uid: zte4d0yo In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. considerations for the purpose and function of each role, key return on investment (ROI) metrics, key performance indicators (KPIs), and a list of ideal skills and behaviors to seek when recruiting and where to source or create a talent pipeline. The combination of roles and the timing of where to grow your specialty pharmacy team is wildly variable and unique to each organization. Often, specialty pharmacies will begin performing the basic functions of each role with existing staff, and the decision to dedicate a new resource is dependent on the workload and the need for a dedicated specialized skill set. Each specialty pharmacy is unique, not in the problems it faces but in the composition of resources used to support and expand operations. Roles may carry different titles and responsibilities and reflect a wide range of health-system specialty pharmacy program sizes. Resource justification, performance metrics, and managing the talent pipeline are universal challenges in the world of specialty pharmacy, yet each role fulfills an integral function and is explored herein. Workforce Development was committed to the goals of developing and delivering tools and resources to support and promote the success of health-system specialty pharmacy. Three distinct charges were given to the group: first, to identify and develop resources to support health-system specialty pharmacy workforce education, training, career development, and credentialing to support optimal specialty patient care; second, to identify and develop workforce resources for supporting and advancing innovative health-system specialty pharmacy practice models; and third, to advise on future M a n u s c r i p t health-system specialty pharmacy workforce education, training, career development, and credentialing to support practice model advancements. The SAG was broken into smaller working groups to focus on deliverables in several areas. A subgroup focused on emerging business roles in the specialty pharmacy workforce was created to explore and support growing specialty pharmacy operations. During the first part of the year, the emerging business roles subgroup members shared the organizational structure and scope of their respective specialty pharmacy operations and their organization's journey in specialty pharmacy. The group discussed similarities and differences and classified unique opportunities to help specialty pharmacy peers. Consensus was achieved in support of a virtual tool kit to help grow specialty pharmacies beyond the first few years of operations. The tool kit was considered a short-term deliverable and included a compilation of various job descriptions, organizational charts, and general business-related documents. A call for documents was shared with the entire SAG, and over 25 job descriptions from 26 organizations operating specialty pharmacies were provided. Once the job descriptions were aggregated, themes in the types of roles that each specialty pharmacy used emerged. Then the emerging business group began work on the long-term deliverable, a manuscript dedicated to understanding and supporting nonclinical resources. Results. Sample job descriptions, along with other very helpful resources, are posted in the online resource tool within ASHP's online Specialty Pharmacy Resource Center. 3 Job descriptions were categorized into 5 key areas, as summarized in Table 1 , and are published on the ASHP website. 4 The 5 areas are as business management and advanced technician roles, clinical and leadership roles, compliance and regulatory affairs roles, data analytics and information technology roles, and support roles. Advanced pharmacy technician roles: patient care focus. In specialty pharmacy, A c c e p t e d M a n u s c r i p t the role of a technician extends beyond the traditional roles of preparing and distributing medications to patients. For example, technicians in the specialty pharmacy setting may support the submission of prior authorization (PA) requests or enroll patients in patient assistance programs to ensure affordability of high-cost therapies. 4 Technicians may also perform outbound calls to patients to complete prescription refill assessments. Technicians desiring career advancement and a professional ladder for achievement are excellent additions to the specialty pharmacy team. All workgroup members reported that their organizations used advanced technician roles early in the specialty pharmacy journey. Expanding the number of advanced pharmacy technicians is highly dependent upon the patient care model and the specialty pharmacy's scope and volume. ROI justification for advanced pharmacy technicians can be supported by the common salary ratio of 4:1 resulting from having pharmacy technicians instead of a pharmacist perform clerical tasks, benefit investigation, and refill assessments. KPIs for advanced technicians include, but are not limited to, number of PAs completed, PA approval rate, number of refill assessments per month, and patient cost savings. Advanced pharmacy technician roles: non-patient care focus. Additionally, advanced technician roles exist outside of direct patient interactions. A 340B coordinator or analyst plays an essential role for a health system that participates in the 340B Drug Pricing Program. Positions dedicated to 340B program activities hold responsibility for auditing specialty pharmacy claims to ensure compliance with 340B program requirements. When a deficiency is identified, a 340B program coordinator may implement and oversee an action plan for correction. Self-audits may also include contract pharmacies and state Medicaid audits to prevent duplicate discounts. Reporting 340B program impact demonstrates the overall financial impact to the organization. Organizations support 340B operations differently, and use of a dedicated specialty 340B resource varied among subgroup members. ROI can be supported by incrementally increasing the number of specialty pharmacy claims audited for optimization. The ROI may be justified by ensuring maximum participation and use of 340B-covered products in qualified settings. Identifying 340B coverage opportunities in only a few ineligible claims a month pays for A c c e p t e d M a n u s c r i p t the position by generating revenue or saving on actual drug expense and quickly shows proof of concept for additional positions. KPIs may include number of claims audited, evaluation of program configurations, and monthly impact reports. A qualified candidate for such a role will demonstrate attention to detail and an inquisitive nature. An ideal candidate may have a bachelor's degree in business management or hospital administration, and 340B program knowledge or experience is always preferred. Many specialty programs prefer to provide on-the-job training and find a high school education combined with a desire to learn and be challenged in a new environment to be sufficient. A purchasing or inventory specialist is responsible for coordinating drug procurement and oversight of inventory and supply levels. The largest expense on specialty pharmacy operating statements, unlike those of most other health-system units, focuses on drug expense instead of labor expense. The role would maintain adequate inventory levels based on dispense history, ensure access to critical drugs, and ensure appropriate inventory practices such as stock rotation and minimizing expired medications. Additional responsibilities may include coordinating annual inventory, par level evaluation, and regular cycle counts to ensure accurate inventory counts. The specialist would also manage price updates, ensure maximum reimbursement, and track return credits and rebates. In the situation of drug recalls or shortages, this person would identify alternate product sources and selection. The inventory specialist would be expected to also evaluate the value and accuracy of inventory. Regular valuation and assessment would include ensuring the costs of purchases are consistent with organization-established standard costs. Reviewing and placing the drug order is a critical step, and a pharmacy technician is ideal for the role because using a pharmacist is not cost-effective. A c c e p t e d M a n u s c r i p t The justification for such a role would be to ensure increased profitability and greater cash flow through reduction in inventory carrying costs, reducing expired medications, sourcing medication replacement, accessing new drugs, and general supply expense oversight. Mitigating a small percentage of drug expense annually could significantly contribute to the ROI of the position. The ideal candidate would have experience with supply chain or purchasing within a healthcare or pharmacy setting. All specialty pharmacies begin procuring medications early in the journey, and the decision to dedicate a resource to purchasing is dependent on organizational structure and size. Business manager. Specialty pharmacy operations requires attention and oversight worthy of arguably the highest-grossing service line of the health system. A resource dedicated to specialty pharmacy business operations is becoming more of a critical role as pressures from declining reimbursement continue to challenge health systems' profitability. The business manager plays a key role in delivering financial analytics and assessment of the economic return of the program. Each specialty pharmacy relies on having an individual with the ability to gather specific data, provide detailed assumptions, and interpret the data to make sound strategic business decisions. Responsibilities for the business manager role include collaborating with key leaders; reviewing data analytics; focusing on revenue management; assessing thirdparty contracting and accreditation costs; maintaining facilities knowledge, regulatory awareness, and operations management skills; and maintaining insourcing/outsourcing capabilities. The ideal candidate possesses a strong business background and communication skills. Collaborating with organizational stakeholders and staff will be a critical skill for success. The job responsibilities would also include providing pro forma analyses, writing business cases, budget analysis, reviewing and monitoring profit and M a n u s c r i p t loss statements, and assessing new growth potential, financial viability, and opportunities for business acquisition. ROI assessments could include margin management through operational expense, payer contract negotiation evaluations, prescription capture rate assumptions, and evaluating services and supply contracts. Ultimately, working closely with the organization's key leaders to generate timely and accurate financial information, as well as engagement with the specialty pharmacy operations process, is critical to the ongoing success. A combination of a background in business and pharmacy experience are preferred experience qualities. Knowledge regarding facilities, infrastructure, operations, and logistics is essential for the position. Specifically, experience with financial planning regarding drug procurement, cash handling, claims reconciliation, and auditing may be a responsibility of this individual. Decisions to optimize inventory, space, and resources would be required of this individual. Business managers may be sourced from healthcare administration or business master's degree programs or other healthcare service lines, or consideration can be given to outsourcing consultative services. Although the functions of a business manager are necessary in the startup phase of specialty pharmacy, most subgroup members said they had dedicated a resource early in the specialty pharmacy journey. Compliance and regulatory affairs. One of the emerging roles within specialty pharmacy is that of accreditation and compliance officer. Obtaining 1 (or, in most instances, 2), accreditations is the standard of practice for specialty pharmacies, and the creation of an accreditation and compliance officer is essential for meeting the changing needs of specialty pharmacies. Accreditation is not required by regulatory bodies, but attaining and maintaining accreditation ensures the proper infrastructure is in place to meet payer and manufacturer requirements. In addition to accreditation standards, this role is also responsible for maintaining compliance with other regulatory bodies such as the state board of pharmacy, Centers for Medicare and Medicaid Services, USP, and various payers. Without constant program oversight, noncompliance with accreditation standards and regulatory bodies is probable, and noncompliance would be detrimental to the continued growth and success of the specialty pharmacy. The size and scope of specialty pharmacy operations will vary among organizations, and therefore not all subgroup members reported use of a dedicated resource for compliance and regulatory affairs. Pharmacy leaders provide critical strategy, forecasting, and guidance for operational goals in order to provide the highest level of fiduciary responsibility to pharmacy operations and the organization. Leadership roles represent more than management of employees; leaders unleash the potential of the team to set the strategy and accomplish results. Leaders of a specialty pharmacy are accountable for all aspects of the pharmacy, including clinical, operational, and financial performance. Leaders create and track metrics for internal and external stakeholders and navigate pharmacy accreditation decisions. Specialty pharmacy leaders lead projects to start services, expand services, and create the policies and procedures to guide compliant, quality, and meaningful work. The ROI for a leadership role is significant, as the role holds responsibility for providing direction and oversight for a highly skilled set of workers who bring additional ROI value. KPIs for the leader include employee turnover, development of new service lines or entry into new disease states, and accessing limited distribution drugs. When hiring a leader for a specialty pharmacy, the ideal skill set is exemplified by someone who is operationally savvy and understands pharmacy operations, including general retail and the unique elements of specialty. Someone who is entrepreneurial will help drive patient capture, scaling of operations, and smart growth while ensuring business viability. In regards to managing people, this individual needs to be able to manage specialized clinicians, technicians, project managers, and business, contracting, and finance-focused associates. As a specialty pharmacy program matures, delineation between a business manager and the department leader is common. Initially, the functions of clinical leadership, operational leadership, and purchasing A c c e p t e d M a n u s c r i p t and/or 340B program leadership may be shared, and as the program matures, separate types of leadership are needed. Finding an individual with all of these superlatives can prove challenging. Health-system pharmacy administration and leadership (HSPAL) residency programs train such individuals. Organizations may have experienced individuals with the right foundation to step into a similar or larger role. Internal candidates may be grown into a specialty pharmacy leader; however, a retail or acute care pharmacy manager will require significant cross training to thrive in the world of specialty pharmacy. Specialty pharmacy vendors or consultants may provide value on the needs and requirements of a specialty pharmacy and its team. Data analytics and information technology. The data analytics team plays a large and diverse role behind the scenes of specialty pharmacy. Some duties include collaboration with drug manufacturers for limited distribution drug access and with commercial payers. Furthermore, the data analytics team provides information to accrediting bodies and manufacturers. Continuously increasing technological efficiency-and, in turn, providing pharmacists more time for patient care-remains a primary goal. ROI can be demonstrated through financial savings through reduction of pharmacist or technician labor spent on data tasks; however, the key ROI is portrayed through the clinical value data analysts deliver to the pharmacy team. A robust data analytics team should allow pharmacists more time to focus on patient care. Therefore, ROI is collected through pharmacists' feedback regarding increased opportunity for clinically based care. When hiring an employee to serve as a data analyst, the most crucial requirement is a degree in technology, ideally with coding experience. Conversely, A c c e p t e d M a n u s c r i p t candidates usually have no background in the medical field, as this is not a job requirement. Aside from technology experience, the skills of innovation, self-teaching, and problem-solving are essential. The ability to work collaboratively with other data analysts from other departments and at a system level is also important. Depending on an organization's data infrastructure and governance, the resource may report through pharmacy leadership or may be supported through the larger system operations. Closing notes. In summary, each specialty pharmacy organization will look and feel different within each health system, and a successful specialty program requires contributions from a variety of nontraditional pharmacy team members. Not only are pharmacists and pharmacy technicians required in order to operate a pharmacy, but pharmacy leaders must also consider the nontraditional roles that make up the remainder of the pharmacy team. As the specialty pharmacy grows in terms of volumes, complexity, and additional disease states, consideration must be given to when to add additional team members, including additional leaders. Specialty pharmacies can benchmark the number of fulltime equivalents (FTEs) needed and develop a hiring timeline for startup or growth. Further analysis is needed to establish a benchmark comparison group for a specialty pharmacy and a timeline for hiring in a startup or existing specialty pharmacy. How does a health system grow a high-performance specialty pharmacy team? Regular program evaluation combined with data-driven decisions will guide programs throughout their growth journey. Programs must continuously adapt and consider rapid use of nontraditional roles as they grow. Consider the contributions from an advanced pharmacy technician functioning in the role of benefit investigator, medication assistance specialist, 340B program coordinator/analyst, education coordinator, and purchasing/inventory specialist. Evaluate how the roles of A c c e p t e d M a n u s c r i p t compliance/regulatory affairs, business oversight, leadership, and data analytics enhance and support specialty pharmacy operations. Not unlike a small startup, specialty pharmacies need to start small and change fast. The ability to expand and add incremental resources is critical to the success and sustainability of the specialty pharmacy. To best deploy pharmacists at the top of their license, nonclinical staff are essential to every specialty pharmacy operation. Efficiency takes precedent over total FTEs. Although the roles may seem novel within a single service line, a new approach to nonclinical roles in specialty pharmacy is one of the ways that specialty pharmacy is truly "special." The authors have declared no potential conflicts of interest. Strategic approach for improving the medication-use process in health systems: the high-performance pharmacy practice framework Leadership skills for a highperformance pharmacy practice Sample job descriptions for the specialty pharmacy workforce Pharmacy technician. Accessed Technicians/Advanced-Pharmacy-Technician-Roles/Prior-Authorization-Pharmacy-Technician A c c e p t e d M a n u s c r i p t