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Proceedings of the ASHP Specialty Pharmacy State of Practice in Hospitals and Health Systems—Future Directions Summit, American Journal of Health-System Pharmacy, Volume 78, Issue 19, 1 October 2021, Pages 1800–1823, https://doi.org/10.1093/ajhp/zxab284
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February 1–4, 2021
Address correspondence to David Chen ([email protected]).
On February 2–5, 2021, over 150 pharmacists and other key stakeholders convened for the ASHP Specialty Pharmacy State of Practice in Hospitals and Health Systems — Future Directions summit to discuss key issues impacting specialty pharmacy practice in health systems and future directions. Summit participants ( Appendix A) also agreed upon recommendations to guide best practices and support sustainability and future growth of health-system specialty pharmacies (HSSPs). In order to stimulate thought-provoking and futuristic thinking by conference participants, the summit included 2 plenary sessions and 2 panel discussions led by thought leaders in the industry (Box 1). The plenary sessions were kicked off with an overview of the specialty pharmacy market and projected market trends. This was followed by a “state of the union” presentation guided by the first public release of survey results from the first ASHP National Survey of Health-System Specialty Pharmacy Practice. In addition to the survey results, insights and interpretation of results were shared to highlight possible best practices as well as gaps, which can also be viewed as potential areas of opportunity. The panel discussions held on the second day of the summit provided stakeholder perspectives, with a particular emphasis on value-based care delivery. The first panel focused on quality and outcomes evidence gained through research, which is needed to support a value-driven future. Panelists included a health-system specialty pharmacist and representatives from industry and academia. The second panel provided industry expert and payer stakeholder perspectives on the shift in the specialty drug industry to value-based payment and how HSSPs can support, and even lead, the creation of a high-performing, value-based model of care. These proceedings summarize session highlights, speaker insights, and key takeaways from the panelist discussions that provided context to the broader summit objectives, including development of recommendations for advancement of hospital and health-system pharmacy practice (Table 1).
Bill Roth
Founding Partner, Blue Fin Group
JoAnn Stubbings, BSPharm, MHCA
Clinical Associate Professor Emerita, Department of Pharmacy Practice, University of Illinois at Chicago College of Pharmacy
Lynnae Mahaney, BSPharm, MBA, FASHP (Moderator)
Senior Director, Pharmacy Accreditation, ASHP
Autumn D Zuckerman PharmD, BCPS, AAHIVP, CSP
Program Director, Health Outcomes and Research, Vanderbilt Specialty Pharmacy
Betsy Sleath, PhD, BSPharm, MS
Regional Associate Dean, Eastern North Carolina, and George H. Cocolas Distinguished Professor, Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy
Cameron James, PharmD, CGP, MHCI
Medical Affairs Executive Director, Genentech
Udobi Campbell, PharmD, MBA (Moderator)
Regional Director of Pharmacy, UNC Health
Gregory Dill, PharmD
Deputy Director for Innovation & Financial Management, Centers for Medicare & Medicaid Services
Cedric Terrell, PharmD, MHA
Chief Pharmacy Officer & Vice President, Health & Medical Management, Blue Cross Blue Shield of Massachusetts
. | DOMAIN 1 — Practice Model and Performance . |
---|---|
1 | Domain: 1. Practice Model and Performance Recommendation 1: Hospitals and health systems should support care models in which medications are procured and prepared by the health-system pharmacy for administration to the patient. Health system policies and procedures should (1) require that medications are obtained from a health-system-authorized and verified source, (2) adhere to state and federal regulations, (3) ensure the continuity of care, (4) validate medication integrity, and (5) ensure the secure and appropriate storage and management of such medications. |
2 | Domain: 1. Practice Model and Performance Recommendation 2: Hospital and health-system specialty pharmacy leaders should actively be involved in ensuring that ethical principles are applied to clinical and business decisions related to medication use. |
3 | Domain: 1. Practice Model and Performance Recommendation 3: Patient care documentation (e.g., patient contact, medication therapy problems, intervention tracking, and patient outcomes) should be standardized and functionally integrated into the electronic health record for continuity of care and reporting. |
4 | Domain: 1. Practice Model and Performance Recommendation 4: Specialty pharmacy team members should be integral to the care delivery and workflows in settings where specialty medications are prescribed to facilitate clinical decision-making, medication management, and care coordination (e.g., time to follow-up, prior authorization facilitation, documentation of medication therapy problems and their resolution, and financial assistance navigation). |
5 | Domain: 1. Practice Model and Performance Recommendation 5: Hospital and health-system specialty pharmacy leaders should develop and participate in internal and external specialty pharmacy benchmark reporting to assess, manage, and develop strategies to improve operational performance. |
6 | Domain: 1. Practice Model and Performance Recommendation 6: Organizations should allocate specialized staff, trained and competent in revenue cycle and contract management, to support specialty pharmacies in the optimization of financial performance, contract management, and compliance. |
7 | Domain: 1. Practice Model and Performance Recommendation 7: High-quality specialty pharmacy services must be patient-centered and span the entire continuum of care and involve/include collaboration among patients, caregivers, payers, pharmacy benefit managers (PBMs), manufacturers, and other healthcare professionals to establish consistent and sustainable models that support seamless transitions of care. |
8 | Domain: 1. Practice Model and Performance Recommendation 8: Hospital and health-system specialty pharmacists integrated into health-system specialty clinics should develop collaborative practice agreements, leverage pharmacist provider status, or utilize other protocols to optimize care delivery and decrease provider burden (subject to state and federal regulations). |
9 | Domain: 1. Practice Model and Performance Recommendation 9: Evidence-based, patient-specific care management criteria should be applied and documented by pharmacists for all patients prescribed specialty medications. Criteria should include patient-, drug-, and disease-specific assessments designed to achieve therapy goals and standardized outcome measures. |
10 | Domain: 1. Practice Model and Performance Recommendation 10: Health-system specialty pharmacy practices should collect, evaluate, and document key performance indicators in a standardized format and use these data to optimize operational performance and patient safety, including adequacy, efficiency, and effectiveness of the staffing model. These key performance indicators should be developed in collaboration with other hospitals and health systems to enable benchmarking. |
11 | Domain: 1. Practice Model and Performance Recommendation 11: The pharmacy enterprise must have oversight of the specialty pharmacy and dedicate resources to support specialty pharmacy business operations, regulatory compliance, contracts, licensure, accreditation, and internal policy review. |
12 | Domain: 1. Practice Model and Performance Recommendation 12: Specialty pharmacies should create advanced roles for pharmacy technicians and other support staff. These roles may include but are not limited to care coordination, prior authorization processing, coordinating patient-assistance programs, monitoring and reporting outcomes, monitoring accreditation and compliance requirements, conducting medication histories and synchronization, and providing patient management assessments. |
13 | Domain: 1. Practice Model and Performance Recommendation 13: Specialty pharmacists and pharmacy leaders should partner with organizational stakeholders to identify, develop, and implement population health models of care that optimize outcomes for patients and the healthcare organization. |
DOMAIN 2 — Patient Care Services and Access | |
14 | Domain: 2. Patient Care Services and Access Recommendation 14: Specialty pharmacists should collaborate with the healthcare team to optimize medication management and therapy outcomes through the development of evidence-based care plans. Elements of care plans should include but not be limited to (1) collection and documentation of patient-specific demographics; (2) inclusion of appropriate drug- or disease-specific patient assessments; (3) comprehensive review of the patient’s medication history and current medications; (4) documentation of all pharmacy case management activities, including education provided; and (5) patient-reported outcomes or clinical measures. |
15 | Domain: 2. Patient Care Services and Access Recommendation 15: Specialty pharmacy team members should coordinate and collaborate across the continuum of care to ensure patient access to appropriate specialty medications. |
16 | Domain: 2. Patient Care Services and Access Recommendation 16: Across the continuum of care, patients prescribed specialty drugs should have access to and be evaluated by health-system pharmacists who provide specialty pharmacy services or who are otherwise knowledgeable about the prescribed medication and disease state. |
17 | Domain: 2. Patient Care Services and Access Recommendation 17: Specialty pharmacy practices should offer telehealth and diverse patient engagement methods to optimize medication adherence and continuity of care. |
18 | Domain: 2. Patient Care Services and Access Recommendation 18: Hospital and health-system specialty pharmacy patient care should be structured as a medically integrated model in which the pharmacists’ role includes (1) assistance with determining the most appropriate and cost-effective treatment regimen; (2) pretreatment preparedness (e.g., immunization, lab testing, and imaging coordination); (3) ongoing monitoring for medication safety, compliance, medication reconciliation, and effectiveness; (4) ongoing patient interaction with frequent touchpoints, and (5) documentation that provides transparency in the patient journey for the provider. |
19 | Domain: 2. Patient Care Services and Access Recommendation 19: Patient consultation and education provided by the specialty pharmacist should be patient-centered, focus on patient engagement, and encompass expectations of therapy, including anticipated duration of treatment, expected outcome of treatment, anticipated time to therapeutic benefit, importance of adherence and persistence with therapy, management of adverse events, and other therapeutic and clinical goals. |
20 | Domain: 2. Patient Care Services and Access Recommendation 20: Specialty pharmacists should be proactively involved in treatment decisions and drug therapy selection, and decisions should include awareness and consideration of patient preferences, accessibility, expected outcomes, and the impact specialty drug therapy may have on patients, caregivers, providers, health system, and payers. |
21 | Domain: 2. Patient Care Services and Access Recommendation 21: Specialty pharmacists should collaborate with patients, families, the healthcare team, and other caregivers to ensure that treatment plans respect patients’ beliefs, values, and autonomy while addressing social determinants of health. |
22 | Domain: 2. Patient Care Services and Access Recommendation 22: Specialty pharmacists and pharmacy leaders should be involved in creating programs to reduce health disparities in our communities and advance health equity. |
23 | Domain: 2. Patient Care Services and Access Recommendation 23: The specialty pharmacy workforce should be knowledgeable and have the ability to identify and manage or refer patients to appropriate support services including but not limited to social work, nutrition services, and mental health services. |
24 | Domain: 2. Patient Care Services and Access Recommendation 24: Hospital and health-system specialty pharmacies should lead the provision or coordination of services to ensure timely access to specialty medications, such as real-time benefits investigation, prior authorization assistance, enrollment of eligible patients into financial assistance programs, and coordination of benefits that is managed at each transition of care across the continuum of care. |
25 | Domain: 2. Patient Care Services and Access Recommendation 25: Specialty pharmacies should support transparency, understanding, and proactive navigation of patient out-of-pocket costs of medications and any potential need for associated services (e.g., lab testing or other monitoring) so that patients understand the financial implications and monitoring commitments associated with their specialty medications. |
DOMAIN 3 — Workforce Competency, Credentials, and Culture | |
26 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 26: Foundational aspects of specialty pharmacy should be integrated into the curriculum of all schools and colleges of pharmacy and offered in experiential learning. |
27 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 27: Specialty pharmacy practice training should be incorporated into postgraduate year 1 residency standards. Residencies in specialty pharmacy practice should be offered as a new residency program distinct from a community pharmacy residency. |
28 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 28: Certified pharmacy technicians should be trained, utilized, and appropriately compensated for advanced specialty pharmacy support roles to ensure long-term career development. |
29 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 29: Hospital and health-system specialty pharmacies should leverage all members of the pharmacy workforce to practice at the top of their education and training. |
30 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 30: Hospital and health-system leaders, including specialty pharmacy leaders, will assess and enhance the diversity of their workforce; support a culture of diversity; and offer recurring training on diversity, equity, and inclusion to all members of their workforce. |
31 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 31: Specialty pharmacy leaders should collaborate with organization leaders to provide workforce training and prioritize opportunities to improve care of diverse patient populations (e.g., racial, gender, and cultural diversity). |
32 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 32: Organizations should encourage and support professional development and advancement of the specialty pharmacy workforce. Pharmacists, pharmacy technicians, and other staff who provide specialty pharmacy services should attain and maintain appropriate competency and applicable, advanced certifications or credentialing. |
33 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 33: Pharmacy technician certification and training courses should include education and competencies relevant to specialty pharmacy practice. |
34 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 34: Hospital and health-system specialty pharmacies should support the establishment of an advanced pharmacy technician certification in specialty pharmacy services. |
35 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 35: There should be an increase in the number of advanced training experiences in specialty pharmacy in ASHP-accredited residency positions to ensure that there is a sufficient number of appropriately trained pharmacists to meet the needs of patients, providers, health systems, and payers. |
36 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 36: Specialty pharmacy leaders should advocate for and support a culture of ongoing employee wellness and resilience, including programs that promote healthy coping measures. |
DOMAIN 4 — Safety, Quality, Outcomes, and Value | |
37 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 37: Hospital and health-system specialty pharmacies must define and operationalize clinical quality and safety goals that promote service optimization and minimize risk to patients. |
38 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 38: Hospital and health-system specialty pharmacy practices should support and lead health economics and outcomes research that identifies and mitigates care gaps and associated metrics to demonstrate the unique value of hospital and health-system specialty pharmacy services. |
39 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 39: As a critical component of a comprehensive quality management program, hospital and health-system specialty pharmacies should utilize quality measures to implement changes that improve processes and patient outcomes. |
40 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 40: Specialty pharmacies should standardize, analyze, and interpret both provider- and patient-reported data that include patient-reported outcomes, patient satisfaction, and patient experience and use these measures to create action plans to (1) improve the patient experience, (2) share externally for benchmarking, and (3) distinguish high-value services. |
41 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 41: The specialty pharmacy workforce should be trained and actively engaged in data-driven quality improvement and outcomes-based projects and initiatives. |
42 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 42: Hospital and health-system specialty pharmacies should collaborate with health plans to collect and monitor the total cost of care (e.g., medical plus medication costs) for patients and evaluate the relationship to health outcomes measures (e.g., patient safety, quality, and outcomes data). |
43 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 43: Specialty pharmacies should partner with health-system informatics, revenue cycle management, managed care, and data analytics teams to collect and report clinical and financial outcomes, including total costs of care. |
44 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 44: Specialty pharmacy practices should collaborate with key stakeholders to develop, incorporate, and validate standardized and evidence-based quality and outcome measures, including patient-reported outcomes that demonstrate and emphasize the value of specialty pharmacy. |
45 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 45: Hospital and health-system specialty pharmacy leaders should develop standardized measures that support strategies to demonstrate the impact of health-system specialty pharmacy, including but not limited to total cost of care and cost avoidance, impact on treatment decision-making, avoidance of adverse events, use of services, progression or regression of disease, and avoidable emergency visits and hospitalizations. |
46 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 46: Hospital and health-system specialty pharmacy leaders should work with payers and manufacturers to implement value-based contracts that prioritize both individual patient outcomes and total cost of care. |
DOMAIN 5 — Data and Technology | |
47 | Domain: 5. Data and Technology Recommendation 47: Health information technology used by specialty pharmacies should be interoperable to optimize patient care delivery, continuity of care, and timely collection, monitoring, and analysis of data for specialty pharmacy services. |
48 | Domain: 5. Data and Technology Recommendation 48: Hospital and health-system specialty pharmacists should assess and consider utilization of emerging patient care technologies (e.g., mobile applications, monitoring devices, digital wearables or ingestibles) that support optimal patient care and medication-use outcomes. |
49 | Domain: 5. Data and Technology Recommendation 49: Hospital and health-system specialty pharmacies should develop and utilize information systems that produce, integrate, and benchmark outcomes that demonstrate value to patients, payers, providers, and manufacturers. |
50 | Domain: 5. Data and Technology Recommendation 50: Technology solutions must support documentation and reporting of standard measures that attribute patient and population-based outcomes to pharmacists’ interventions in the specialty pharmacy setting. |
51 | Domain: 5. Data and Technology Recommendation 51: Hospital and health-system specialty pharmacists should work with manufacturers and payers for necessary sharing of patient information that is compliant with all applicable laws and regulations. Data sharing should facilitate network and medication access to allow health-system specialty pharmacies to provide more efficient and effective patient care processes. |
52 | Domain: 5. Data and Technology Recommendation 52: Innovative technology solutions that support patient outreach and patient-reported outcomes should be utilized to promote communication, engagement, clinical monitoring, and research. |
53 | Domain: 5. Data and Technology Recommendation 53: As permissible by law and institutional practices, collection and aggregation of de-identified data across stakeholders should be implemented to demonstrate value-based outcomes and continuously improve the quality of services. |
DOMAIN 6 — Business Development | |
54 | Domain: 6. Business Development Recommendation 54: Hospital and health-system specialty pharmacy services must be provided when clinically appropriate at the patient’s preferred site of care, without restrictions, to avoid compromising the quality of patient care or the medication distribution system. |
55 | Domain: 6. Business Development Recommendation 55: Accreditation standards and measures of performance should reflect critical practices necessary to achieve optimal patient outcomes and be equally applicable across all specialty pharmacy business models (e.g., health-system, small community, or big box mail-order pharmacies). |
56 | Domain: 6. Business Development Recommendation 56: Hospital and health-system specialty pharmacy leaders must develop relationships with the organization's payer contracting and managed care leaders to ensure that enterprise-wide pharmacy services are recognized as an integral component of the organization’s comprehensive healthcare delivery system. |
57 | Domain: 6. Business Development Recommendation 57: Hospital and health-system specialty pharmacists should advocate that specialty pharmacy accreditation, certification, and licensing organizations (1) include providers, key stakeholders, and patients in their accreditation and standards development processes and (2) adopt consistent standards for the medication-use process based on established evidence-based principles of patient safety and quality of care that, once adopted, are universally accepted for payer network access. |
58 | Domain: 6. Business Development Recommendation 58: Health system leaders should collaborate with health insurance plans to make coverage decisions in a way that preserves continuity of care between the patient and the care team and supports patient choice of pharmacy. |
59 | Domain: 6. Business Development Recommendation 59: Limited drug distribution strategies should only be used when established, transparent criteria are outlined, and pharmacy access must be based solely on the ability to meet these established criteria. Strategies should be designed to promote continuity of care; support population health management; preserve patients’ relationships with their healthcare providers, including pharmacists; and provide evidence that they are the least restrictive means while ensuring patient safety. |
60 | Domain: 6. Business Development Recommendation 60: Hospital and health-system specialty pharmacy leaders and their organizations must engage in comprehensive value-based care and payment models designed to ensure value for patients, communities, employers, manufacturers, and payers. |
61 | Domain: 6. Business Development Recommendation 61: Hospital and health-system specialty pharmacies should develop strategies with payers and manufacturers that promote access to and establish criteria for limited distribution networks, such as value-based contracting, cost management strategies, medication affordability assistance, and care coordination. |
62 | Domain: 6. Business Development Recommendation 62: Specialty pharmacy leaders should advocate for payers to be required to provide public transparency regarding formulary decisions and clinical coverage determination criteria and policies. |
63 | Domain: 6. Business Development Recommendation 63: Hospital and health-system pharmacy leaders should advocate for transparency in healthcare payer-provider networks and manufacturers’ participation requirements in which the criteria used to include, retain, or exclude providers are tied to best practices and patient care and are disclosed to all providers. |
DOMAIN 7 — Leadership, Research, and Advocacy | |
64 | Domain: 7. Leadership, Research, and Advocacy Recommendation 64: Hospital and health-system specialty pharmacists should lead efforts in health economics and outcomes research to demonstrate the value of integrated pharmacy care coordination. |
65 | Domain: 7. Leadership, Research, and Advocacy Recommendation 65: Hospital and health-system specialty pharmacies and their representing organizations should collaborate at the national level to document and advocate for the value of comprehensive, integrated specialty pharmacy programs. |
66 | Domain: 7. Leadership, Research, and Advocacy Recommendation 66: Health-system pharmacy leaders should advocate for 340B Drug Pricing Program stability and continued access in accordance with the intent of the program. Furthermore, leaders should collaborate with public and private payers to ensure optimization of benefits from the 340B program and related contract and reimbursement policies to ensure the nation’s uninsured, underinsured, underserved, and disadvantaged patients continue to have access to specialty pharmacy medications and disease management services. |
67 | Domain: 7. Leadership, Research, and Advocacy Recommendation 67: Hospital and health-system specialty pharmacists should be involved in the development and implementation by manufacturers, the FDA, or others establishing requirements related to medication access and engage in research on the impact of such requirements to ensure patient safety, access, and intended outcomes are achieved. |
68 | Domain: 7. Leadership, Research, and Advocacy Recommendation 68: At the community, state, and national levels, specialty pharmacy practitioners should participate in healthcare policy development to improve access to therapies that drive optimal health outcomes. |
69 | Domain: 7. Leadership, Research, and Advocacy Recommendation 69: Health-system pharmacy leaders should advocate for financial models for specialty pharmacy medications and services that take into consideration all costs associated with the safe, timely, and cost-effective provision, monitoring, and administration of specialty drugs and that reflect the potential impact on the total cost of care. |
70 | Domain: 7. Leadership, Research, and Advocacy Recommendation 70: Health-system leaders should demonstrate and share with key stakeholders the outcomes and value of an integrated specialty pharmacy. |
71 | Domain: 7. Leadership, Research, and Advocacy Recommendation 71: Hospital and health-system specialty pharmacy is an integral part of hospital and health-system pharmacy practice, and specialty pharmacists should strive to implement the recommendations delineated in the ASHP Practice Advancement Initiative 2030. |
. | DOMAIN 1 — Practice Model and Performance . |
---|---|
1 | Domain: 1. Practice Model and Performance Recommendation 1: Hospitals and health systems should support care models in which medications are procured and prepared by the health-system pharmacy for administration to the patient. Health system policies and procedures should (1) require that medications are obtained from a health-system-authorized and verified source, (2) adhere to state and federal regulations, (3) ensure the continuity of care, (4) validate medication integrity, and (5) ensure the secure and appropriate storage and management of such medications. |
2 | Domain: 1. Practice Model and Performance Recommendation 2: Hospital and health-system specialty pharmacy leaders should actively be involved in ensuring that ethical principles are applied to clinical and business decisions related to medication use. |
3 | Domain: 1. Practice Model and Performance Recommendation 3: Patient care documentation (e.g., patient contact, medication therapy problems, intervention tracking, and patient outcomes) should be standardized and functionally integrated into the electronic health record for continuity of care and reporting. |
4 | Domain: 1. Practice Model and Performance Recommendation 4: Specialty pharmacy team members should be integral to the care delivery and workflows in settings where specialty medications are prescribed to facilitate clinical decision-making, medication management, and care coordination (e.g., time to follow-up, prior authorization facilitation, documentation of medication therapy problems and their resolution, and financial assistance navigation). |
5 | Domain: 1. Practice Model and Performance Recommendation 5: Hospital and health-system specialty pharmacy leaders should develop and participate in internal and external specialty pharmacy benchmark reporting to assess, manage, and develop strategies to improve operational performance. |
6 | Domain: 1. Practice Model and Performance Recommendation 6: Organizations should allocate specialized staff, trained and competent in revenue cycle and contract management, to support specialty pharmacies in the optimization of financial performance, contract management, and compliance. |
7 | Domain: 1. Practice Model and Performance Recommendation 7: High-quality specialty pharmacy services must be patient-centered and span the entire continuum of care and involve/include collaboration among patients, caregivers, payers, pharmacy benefit managers (PBMs), manufacturers, and other healthcare professionals to establish consistent and sustainable models that support seamless transitions of care. |
8 | Domain: 1. Practice Model and Performance Recommendation 8: Hospital and health-system specialty pharmacists integrated into health-system specialty clinics should develop collaborative practice agreements, leverage pharmacist provider status, or utilize other protocols to optimize care delivery and decrease provider burden (subject to state and federal regulations). |
9 | Domain: 1. Practice Model and Performance Recommendation 9: Evidence-based, patient-specific care management criteria should be applied and documented by pharmacists for all patients prescribed specialty medications. Criteria should include patient-, drug-, and disease-specific assessments designed to achieve therapy goals and standardized outcome measures. |
10 | Domain: 1. Practice Model and Performance Recommendation 10: Health-system specialty pharmacy practices should collect, evaluate, and document key performance indicators in a standardized format and use these data to optimize operational performance and patient safety, including adequacy, efficiency, and effectiveness of the staffing model. These key performance indicators should be developed in collaboration with other hospitals and health systems to enable benchmarking. |
11 | Domain: 1. Practice Model and Performance Recommendation 11: The pharmacy enterprise must have oversight of the specialty pharmacy and dedicate resources to support specialty pharmacy business operations, regulatory compliance, contracts, licensure, accreditation, and internal policy review. |
12 | Domain: 1. Practice Model and Performance Recommendation 12: Specialty pharmacies should create advanced roles for pharmacy technicians and other support staff. These roles may include but are not limited to care coordination, prior authorization processing, coordinating patient-assistance programs, monitoring and reporting outcomes, monitoring accreditation and compliance requirements, conducting medication histories and synchronization, and providing patient management assessments. |
13 | Domain: 1. Practice Model and Performance Recommendation 13: Specialty pharmacists and pharmacy leaders should partner with organizational stakeholders to identify, develop, and implement population health models of care that optimize outcomes for patients and the healthcare organization. |
DOMAIN 2 — Patient Care Services and Access | |
14 | Domain: 2. Patient Care Services and Access Recommendation 14: Specialty pharmacists should collaborate with the healthcare team to optimize medication management and therapy outcomes through the development of evidence-based care plans. Elements of care plans should include but not be limited to (1) collection and documentation of patient-specific demographics; (2) inclusion of appropriate drug- or disease-specific patient assessments; (3) comprehensive review of the patient’s medication history and current medications; (4) documentation of all pharmacy case management activities, including education provided; and (5) patient-reported outcomes or clinical measures. |
15 | Domain: 2. Patient Care Services and Access Recommendation 15: Specialty pharmacy team members should coordinate and collaborate across the continuum of care to ensure patient access to appropriate specialty medications. |
16 | Domain: 2. Patient Care Services and Access Recommendation 16: Across the continuum of care, patients prescribed specialty drugs should have access to and be evaluated by health-system pharmacists who provide specialty pharmacy services or who are otherwise knowledgeable about the prescribed medication and disease state. |
17 | Domain: 2. Patient Care Services and Access Recommendation 17: Specialty pharmacy practices should offer telehealth and diverse patient engagement methods to optimize medication adherence and continuity of care. |
18 | Domain: 2. Patient Care Services and Access Recommendation 18: Hospital and health-system specialty pharmacy patient care should be structured as a medically integrated model in which the pharmacists’ role includes (1) assistance with determining the most appropriate and cost-effective treatment regimen; (2) pretreatment preparedness (e.g., immunization, lab testing, and imaging coordination); (3) ongoing monitoring for medication safety, compliance, medication reconciliation, and effectiveness; (4) ongoing patient interaction with frequent touchpoints, and (5) documentation that provides transparency in the patient journey for the provider. |
19 | Domain: 2. Patient Care Services and Access Recommendation 19: Patient consultation and education provided by the specialty pharmacist should be patient-centered, focus on patient engagement, and encompass expectations of therapy, including anticipated duration of treatment, expected outcome of treatment, anticipated time to therapeutic benefit, importance of adherence and persistence with therapy, management of adverse events, and other therapeutic and clinical goals. |
20 | Domain: 2. Patient Care Services and Access Recommendation 20: Specialty pharmacists should be proactively involved in treatment decisions and drug therapy selection, and decisions should include awareness and consideration of patient preferences, accessibility, expected outcomes, and the impact specialty drug therapy may have on patients, caregivers, providers, health system, and payers. |
21 | Domain: 2. Patient Care Services and Access Recommendation 21: Specialty pharmacists should collaborate with patients, families, the healthcare team, and other caregivers to ensure that treatment plans respect patients’ beliefs, values, and autonomy while addressing social determinants of health. |
22 | Domain: 2. Patient Care Services and Access Recommendation 22: Specialty pharmacists and pharmacy leaders should be involved in creating programs to reduce health disparities in our communities and advance health equity. |
23 | Domain: 2. Patient Care Services and Access Recommendation 23: The specialty pharmacy workforce should be knowledgeable and have the ability to identify and manage or refer patients to appropriate support services including but not limited to social work, nutrition services, and mental health services. |
24 | Domain: 2. Patient Care Services and Access Recommendation 24: Hospital and health-system specialty pharmacies should lead the provision or coordination of services to ensure timely access to specialty medications, such as real-time benefits investigation, prior authorization assistance, enrollment of eligible patients into financial assistance programs, and coordination of benefits that is managed at each transition of care across the continuum of care. |
25 | Domain: 2. Patient Care Services and Access Recommendation 25: Specialty pharmacies should support transparency, understanding, and proactive navigation of patient out-of-pocket costs of medications and any potential need for associated services (e.g., lab testing or other monitoring) so that patients understand the financial implications and monitoring commitments associated with their specialty medications. |
DOMAIN 3 — Workforce Competency, Credentials, and Culture | |
26 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 26: Foundational aspects of specialty pharmacy should be integrated into the curriculum of all schools and colleges of pharmacy and offered in experiential learning. |
27 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 27: Specialty pharmacy practice training should be incorporated into postgraduate year 1 residency standards. Residencies in specialty pharmacy practice should be offered as a new residency program distinct from a community pharmacy residency. |
28 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 28: Certified pharmacy technicians should be trained, utilized, and appropriately compensated for advanced specialty pharmacy support roles to ensure long-term career development. |
29 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 29: Hospital and health-system specialty pharmacies should leverage all members of the pharmacy workforce to practice at the top of their education and training. |
30 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 30: Hospital and health-system leaders, including specialty pharmacy leaders, will assess and enhance the diversity of their workforce; support a culture of diversity; and offer recurring training on diversity, equity, and inclusion to all members of their workforce. |
31 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 31: Specialty pharmacy leaders should collaborate with organization leaders to provide workforce training and prioritize opportunities to improve care of diverse patient populations (e.g., racial, gender, and cultural diversity). |
32 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 32: Organizations should encourage and support professional development and advancement of the specialty pharmacy workforce. Pharmacists, pharmacy technicians, and other staff who provide specialty pharmacy services should attain and maintain appropriate competency and applicable, advanced certifications or credentialing. |
33 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 33: Pharmacy technician certification and training courses should include education and competencies relevant to specialty pharmacy practice. |
34 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 34: Hospital and health-system specialty pharmacies should support the establishment of an advanced pharmacy technician certification in specialty pharmacy services. |
35 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 35: There should be an increase in the number of advanced training experiences in specialty pharmacy in ASHP-accredited residency positions to ensure that there is a sufficient number of appropriately trained pharmacists to meet the needs of patients, providers, health systems, and payers. |
36 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 36: Specialty pharmacy leaders should advocate for and support a culture of ongoing employee wellness and resilience, including programs that promote healthy coping measures. |
DOMAIN 4 — Safety, Quality, Outcomes, and Value | |
37 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 37: Hospital and health-system specialty pharmacies must define and operationalize clinical quality and safety goals that promote service optimization and minimize risk to patients. |
38 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 38: Hospital and health-system specialty pharmacy practices should support and lead health economics and outcomes research that identifies and mitigates care gaps and associated metrics to demonstrate the unique value of hospital and health-system specialty pharmacy services. |
39 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 39: As a critical component of a comprehensive quality management program, hospital and health-system specialty pharmacies should utilize quality measures to implement changes that improve processes and patient outcomes. |
40 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 40: Specialty pharmacies should standardize, analyze, and interpret both provider- and patient-reported data that include patient-reported outcomes, patient satisfaction, and patient experience and use these measures to create action plans to (1) improve the patient experience, (2) share externally for benchmarking, and (3) distinguish high-value services. |
41 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 41: The specialty pharmacy workforce should be trained and actively engaged in data-driven quality improvement and outcomes-based projects and initiatives. |
42 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 42: Hospital and health-system specialty pharmacies should collaborate with health plans to collect and monitor the total cost of care (e.g., medical plus medication costs) for patients and evaluate the relationship to health outcomes measures (e.g., patient safety, quality, and outcomes data). |
43 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 43: Specialty pharmacies should partner with health-system informatics, revenue cycle management, managed care, and data analytics teams to collect and report clinical and financial outcomes, including total costs of care. |
44 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 44: Specialty pharmacy practices should collaborate with key stakeholders to develop, incorporate, and validate standardized and evidence-based quality and outcome measures, including patient-reported outcomes that demonstrate and emphasize the value of specialty pharmacy. |
45 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 45: Hospital and health-system specialty pharmacy leaders should develop standardized measures that support strategies to demonstrate the impact of health-system specialty pharmacy, including but not limited to total cost of care and cost avoidance, impact on treatment decision-making, avoidance of adverse events, use of services, progression or regression of disease, and avoidable emergency visits and hospitalizations. |
46 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 46: Hospital and health-system specialty pharmacy leaders should work with payers and manufacturers to implement value-based contracts that prioritize both individual patient outcomes and total cost of care. |
DOMAIN 5 — Data and Technology | |
47 | Domain: 5. Data and Technology Recommendation 47: Health information technology used by specialty pharmacies should be interoperable to optimize patient care delivery, continuity of care, and timely collection, monitoring, and analysis of data for specialty pharmacy services. |
48 | Domain: 5. Data and Technology Recommendation 48: Hospital and health-system specialty pharmacists should assess and consider utilization of emerging patient care technologies (e.g., mobile applications, monitoring devices, digital wearables or ingestibles) that support optimal patient care and medication-use outcomes. |
49 | Domain: 5. Data and Technology Recommendation 49: Hospital and health-system specialty pharmacies should develop and utilize information systems that produce, integrate, and benchmark outcomes that demonstrate value to patients, payers, providers, and manufacturers. |
50 | Domain: 5. Data and Technology Recommendation 50: Technology solutions must support documentation and reporting of standard measures that attribute patient and population-based outcomes to pharmacists’ interventions in the specialty pharmacy setting. |
51 | Domain: 5. Data and Technology Recommendation 51: Hospital and health-system specialty pharmacists should work with manufacturers and payers for necessary sharing of patient information that is compliant with all applicable laws and regulations. Data sharing should facilitate network and medication access to allow health-system specialty pharmacies to provide more efficient and effective patient care processes. |
52 | Domain: 5. Data and Technology Recommendation 52: Innovative technology solutions that support patient outreach and patient-reported outcomes should be utilized to promote communication, engagement, clinical monitoring, and research. |
53 | Domain: 5. Data and Technology Recommendation 53: As permissible by law and institutional practices, collection and aggregation of de-identified data across stakeholders should be implemented to demonstrate value-based outcomes and continuously improve the quality of services. |
DOMAIN 6 — Business Development | |
54 | Domain: 6. Business Development Recommendation 54: Hospital and health-system specialty pharmacy services must be provided when clinically appropriate at the patient’s preferred site of care, without restrictions, to avoid compromising the quality of patient care or the medication distribution system. |
55 | Domain: 6. Business Development Recommendation 55: Accreditation standards and measures of performance should reflect critical practices necessary to achieve optimal patient outcomes and be equally applicable across all specialty pharmacy business models (e.g., health-system, small community, or big box mail-order pharmacies). |
56 | Domain: 6. Business Development Recommendation 56: Hospital and health-system specialty pharmacy leaders must develop relationships with the organization's payer contracting and managed care leaders to ensure that enterprise-wide pharmacy services are recognized as an integral component of the organization’s comprehensive healthcare delivery system. |
57 | Domain: 6. Business Development Recommendation 57: Hospital and health-system specialty pharmacists should advocate that specialty pharmacy accreditation, certification, and licensing organizations (1) include providers, key stakeholders, and patients in their accreditation and standards development processes and (2) adopt consistent standards for the medication-use process based on established evidence-based principles of patient safety and quality of care that, once adopted, are universally accepted for payer network access. |
58 | Domain: 6. Business Development Recommendation 58: Health system leaders should collaborate with health insurance plans to make coverage decisions in a way that preserves continuity of care between the patient and the care team and supports patient choice of pharmacy. |
59 | Domain: 6. Business Development Recommendation 59: Limited drug distribution strategies should only be used when established, transparent criteria are outlined, and pharmacy access must be based solely on the ability to meet these established criteria. Strategies should be designed to promote continuity of care; support population health management; preserve patients’ relationships with their healthcare providers, including pharmacists; and provide evidence that they are the least restrictive means while ensuring patient safety. |
60 | Domain: 6. Business Development Recommendation 60: Hospital and health-system specialty pharmacy leaders and their organizations must engage in comprehensive value-based care and payment models designed to ensure value for patients, communities, employers, manufacturers, and payers. |
61 | Domain: 6. Business Development Recommendation 61: Hospital and health-system specialty pharmacies should develop strategies with payers and manufacturers that promote access to and establish criteria for limited distribution networks, such as value-based contracting, cost management strategies, medication affordability assistance, and care coordination. |
62 | Domain: 6. Business Development Recommendation 62: Specialty pharmacy leaders should advocate for payers to be required to provide public transparency regarding formulary decisions and clinical coverage determination criteria and policies. |
63 | Domain: 6. Business Development Recommendation 63: Hospital and health-system pharmacy leaders should advocate for transparency in healthcare payer-provider networks and manufacturers’ participation requirements in which the criteria used to include, retain, or exclude providers are tied to best practices and patient care and are disclosed to all providers. |
DOMAIN 7 — Leadership, Research, and Advocacy | |
64 | Domain: 7. Leadership, Research, and Advocacy Recommendation 64: Hospital and health-system specialty pharmacists should lead efforts in health economics and outcomes research to demonstrate the value of integrated pharmacy care coordination. |
65 | Domain: 7. Leadership, Research, and Advocacy Recommendation 65: Hospital and health-system specialty pharmacies and their representing organizations should collaborate at the national level to document and advocate for the value of comprehensive, integrated specialty pharmacy programs. |
66 | Domain: 7. Leadership, Research, and Advocacy Recommendation 66: Health-system pharmacy leaders should advocate for 340B Drug Pricing Program stability and continued access in accordance with the intent of the program. Furthermore, leaders should collaborate with public and private payers to ensure optimization of benefits from the 340B program and related contract and reimbursement policies to ensure the nation’s uninsured, underinsured, underserved, and disadvantaged patients continue to have access to specialty pharmacy medications and disease management services. |
67 | Domain: 7. Leadership, Research, and Advocacy Recommendation 67: Hospital and health-system specialty pharmacists should be involved in the development and implementation by manufacturers, the FDA, or others establishing requirements related to medication access and engage in research on the impact of such requirements to ensure patient safety, access, and intended outcomes are achieved. |
68 | Domain: 7. Leadership, Research, and Advocacy Recommendation 68: At the community, state, and national levels, specialty pharmacy practitioners should participate in healthcare policy development to improve access to therapies that drive optimal health outcomes. |
69 | Domain: 7. Leadership, Research, and Advocacy Recommendation 69: Health-system pharmacy leaders should advocate for financial models for specialty pharmacy medications and services that take into consideration all costs associated with the safe, timely, and cost-effective provision, monitoring, and administration of specialty drugs and that reflect the potential impact on the total cost of care. |
70 | Domain: 7. Leadership, Research, and Advocacy Recommendation 70: Health-system leaders should demonstrate and share with key stakeholders the outcomes and value of an integrated specialty pharmacy. |
71 | Domain: 7. Leadership, Research, and Advocacy Recommendation 71: Hospital and health-system specialty pharmacy is an integral part of hospital and health-system pharmacy practice, and specialty pharmacists should strive to implement the recommendations delineated in the ASHP Practice Advancement Initiative 2030. |
. | DOMAIN 1 — Practice Model and Performance . |
---|---|
1 | Domain: 1. Practice Model and Performance Recommendation 1: Hospitals and health systems should support care models in which medications are procured and prepared by the health-system pharmacy for administration to the patient. Health system policies and procedures should (1) require that medications are obtained from a health-system-authorized and verified source, (2) adhere to state and federal regulations, (3) ensure the continuity of care, (4) validate medication integrity, and (5) ensure the secure and appropriate storage and management of such medications. |
2 | Domain: 1. Practice Model and Performance Recommendation 2: Hospital and health-system specialty pharmacy leaders should actively be involved in ensuring that ethical principles are applied to clinical and business decisions related to medication use. |
3 | Domain: 1. Practice Model and Performance Recommendation 3: Patient care documentation (e.g., patient contact, medication therapy problems, intervention tracking, and patient outcomes) should be standardized and functionally integrated into the electronic health record for continuity of care and reporting. |
4 | Domain: 1. Practice Model and Performance Recommendation 4: Specialty pharmacy team members should be integral to the care delivery and workflows in settings where specialty medications are prescribed to facilitate clinical decision-making, medication management, and care coordination (e.g., time to follow-up, prior authorization facilitation, documentation of medication therapy problems and their resolution, and financial assistance navigation). |
5 | Domain: 1. Practice Model and Performance Recommendation 5: Hospital and health-system specialty pharmacy leaders should develop and participate in internal and external specialty pharmacy benchmark reporting to assess, manage, and develop strategies to improve operational performance. |
6 | Domain: 1. Practice Model and Performance Recommendation 6: Organizations should allocate specialized staff, trained and competent in revenue cycle and contract management, to support specialty pharmacies in the optimization of financial performance, contract management, and compliance. |
7 | Domain: 1. Practice Model and Performance Recommendation 7: High-quality specialty pharmacy services must be patient-centered and span the entire continuum of care and involve/include collaboration among patients, caregivers, payers, pharmacy benefit managers (PBMs), manufacturers, and other healthcare professionals to establish consistent and sustainable models that support seamless transitions of care. |
8 | Domain: 1. Practice Model and Performance Recommendation 8: Hospital and health-system specialty pharmacists integrated into health-system specialty clinics should develop collaborative practice agreements, leverage pharmacist provider status, or utilize other protocols to optimize care delivery and decrease provider burden (subject to state and federal regulations). |
9 | Domain: 1. Practice Model and Performance Recommendation 9: Evidence-based, patient-specific care management criteria should be applied and documented by pharmacists for all patients prescribed specialty medications. Criteria should include patient-, drug-, and disease-specific assessments designed to achieve therapy goals and standardized outcome measures. |
10 | Domain: 1. Practice Model and Performance Recommendation 10: Health-system specialty pharmacy practices should collect, evaluate, and document key performance indicators in a standardized format and use these data to optimize operational performance and patient safety, including adequacy, efficiency, and effectiveness of the staffing model. These key performance indicators should be developed in collaboration with other hospitals and health systems to enable benchmarking. |
11 | Domain: 1. Practice Model and Performance Recommendation 11: The pharmacy enterprise must have oversight of the specialty pharmacy and dedicate resources to support specialty pharmacy business operations, regulatory compliance, contracts, licensure, accreditation, and internal policy review. |
12 | Domain: 1. Practice Model and Performance Recommendation 12: Specialty pharmacies should create advanced roles for pharmacy technicians and other support staff. These roles may include but are not limited to care coordination, prior authorization processing, coordinating patient-assistance programs, monitoring and reporting outcomes, monitoring accreditation and compliance requirements, conducting medication histories and synchronization, and providing patient management assessments. |
13 | Domain: 1. Practice Model and Performance Recommendation 13: Specialty pharmacists and pharmacy leaders should partner with organizational stakeholders to identify, develop, and implement population health models of care that optimize outcomes for patients and the healthcare organization. |
DOMAIN 2 — Patient Care Services and Access | |
14 | Domain: 2. Patient Care Services and Access Recommendation 14: Specialty pharmacists should collaborate with the healthcare team to optimize medication management and therapy outcomes through the development of evidence-based care plans. Elements of care plans should include but not be limited to (1) collection and documentation of patient-specific demographics; (2) inclusion of appropriate drug- or disease-specific patient assessments; (3) comprehensive review of the patient’s medication history and current medications; (4) documentation of all pharmacy case management activities, including education provided; and (5) patient-reported outcomes or clinical measures. |
15 | Domain: 2. Patient Care Services and Access Recommendation 15: Specialty pharmacy team members should coordinate and collaborate across the continuum of care to ensure patient access to appropriate specialty medications. |
16 | Domain: 2. Patient Care Services and Access Recommendation 16: Across the continuum of care, patients prescribed specialty drugs should have access to and be evaluated by health-system pharmacists who provide specialty pharmacy services or who are otherwise knowledgeable about the prescribed medication and disease state. |
17 | Domain: 2. Patient Care Services and Access Recommendation 17: Specialty pharmacy practices should offer telehealth and diverse patient engagement methods to optimize medication adherence and continuity of care. |
18 | Domain: 2. Patient Care Services and Access Recommendation 18: Hospital and health-system specialty pharmacy patient care should be structured as a medically integrated model in which the pharmacists’ role includes (1) assistance with determining the most appropriate and cost-effective treatment regimen; (2) pretreatment preparedness (e.g., immunization, lab testing, and imaging coordination); (3) ongoing monitoring for medication safety, compliance, medication reconciliation, and effectiveness; (4) ongoing patient interaction with frequent touchpoints, and (5) documentation that provides transparency in the patient journey for the provider. |
19 | Domain: 2. Patient Care Services and Access Recommendation 19: Patient consultation and education provided by the specialty pharmacist should be patient-centered, focus on patient engagement, and encompass expectations of therapy, including anticipated duration of treatment, expected outcome of treatment, anticipated time to therapeutic benefit, importance of adherence and persistence with therapy, management of adverse events, and other therapeutic and clinical goals. |
20 | Domain: 2. Patient Care Services and Access Recommendation 20: Specialty pharmacists should be proactively involved in treatment decisions and drug therapy selection, and decisions should include awareness and consideration of patient preferences, accessibility, expected outcomes, and the impact specialty drug therapy may have on patients, caregivers, providers, health system, and payers. |
21 | Domain: 2. Patient Care Services and Access Recommendation 21: Specialty pharmacists should collaborate with patients, families, the healthcare team, and other caregivers to ensure that treatment plans respect patients’ beliefs, values, and autonomy while addressing social determinants of health. |
22 | Domain: 2. Patient Care Services and Access Recommendation 22: Specialty pharmacists and pharmacy leaders should be involved in creating programs to reduce health disparities in our communities and advance health equity. |
23 | Domain: 2. Patient Care Services and Access Recommendation 23: The specialty pharmacy workforce should be knowledgeable and have the ability to identify and manage or refer patients to appropriate support services including but not limited to social work, nutrition services, and mental health services. |
24 | Domain: 2. Patient Care Services and Access Recommendation 24: Hospital and health-system specialty pharmacies should lead the provision or coordination of services to ensure timely access to specialty medications, such as real-time benefits investigation, prior authorization assistance, enrollment of eligible patients into financial assistance programs, and coordination of benefits that is managed at each transition of care across the continuum of care. |
25 | Domain: 2. Patient Care Services and Access Recommendation 25: Specialty pharmacies should support transparency, understanding, and proactive navigation of patient out-of-pocket costs of medications and any potential need for associated services (e.g., lab testing or other monitoring) so that patients understand the financial implications and monitoring commitments associated with their specialty medications. |
DOMAIN 3 — Workforce Competency, Credentials, and Culture | |
26 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 26: Foundational aspects of specialty pharmacy should be integrated into the curriculum of all schools and colleges of pharmacy and offered in experiential learning. |
27 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 27: Specialty pharmacy practice training should be incorporated into postgraduate year 1 residency standards. Residencies in specialty pharmacy practice should be offered as a new residency program distinct from a community pharmacy residency. |
28 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 28: Certified pharmacy technicians should be trained, utilized, and appropriately compensated for advanced specialty pharmacy support roles to ensure long-term career development. |
29 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 29: Hospital and health-system specialty pharmacies should leverage all members of the pharmacy workforce to practice at the top of their education and training. |
30 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 30: Hospital and health-system leaders, including specialty pharmacy leaders, will assess and enhance the diversity of their workforce; support a culture of diversity; and offer recurring training on diversity, equity, and inclusion to all members of their workforce. |
31 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 31: Specialty pharmacy leaders should collaborate with organization leaders to provide workforce training and prioritize opportunities to improve care of diverse patient populations (e.g., racial, gender, and cultural diversity). |
32 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 32: Organizations should encourage and support professional development and advancement of the specialty pharmacy workforce. Pharmacists, pharmacy technicians, and other staff who provide specialty pharmacy services should attain and maintain appropriate competency and applicable, advanced certifications or credentialing. |
33 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 33: Pharmacy technician certification and training courses should include education and competencies relevant to specialty pharmacy practice. |
34 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 34: Hospital and health-system specialty pharmacies should support the establishment of an advanced pharmacy technician certification in specialty pharmacy services. |
35 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 35: There should be an increase in the number of advanced training experiences in specialty pharmacy in ASHP-accredited residency positions to ensure that there is a sufficient number of appropriately trained pharmacists to meet the needs of patients, providers, health systems, and payers. |
36 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 36: Specialty pharmacy leaders should advocate for and support a culture of ongoing employee wellness and resilience, including programs that promote healthy coping measures. |
DOMAIN 4 — Safety, Quality, Outcomes, and Value | |
37 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 37: Hospital and health-system specialty pharmacies must define and operationalize clinical quality and safety goals that promote service optimization and minimize risk to patients. |
38 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 38: Hospital and health-system specialty pharmacy practices should support and lead health economics and outcomes research that identifies and mitigates care gaps and associated metrics to demonstrate the unique value of hospital and health-system specialty pharmacy services. |
39 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 39: As a critical component of a comprehensive quality management program, hospital and health-system specialty pharmacies should utilize quality measures to implement changes that improve processes and patient outcomes. |
40 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 40: Specialty pharmacies should standardize, analyze, and interpret both provider- and patient-reported data that include patient-reported outcomes, patient satisfaction, and patient experience and use these measures to create action plans to (1) improve the patient experience, (2) share externally for benchmarking, and (3) distinguish high-value services. |
41 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 41: The specialty pharmacy workforce should be trained and actively engaged in data-driven quality improvement and outcomes-based projects and initiatives. |
42 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 42: Hospital and health-system specialty pharmacies should collaborate with health plans to collect and monitor the total cost of care (e.g., medical plus medication costs) for patients and evaluate the relationship to health outcomes measures (e.g., patient safety, quality, and outcomes data). |
43 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 43: Specialty pharmacies should partner with health-system informatics, revenue cycle management, managed care, and data analytics teams to collect and report clinical and financial outcomes, including total costs of care. |
44 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 44: Specialty pharmacy practices should collaborate with key stakeholders to develop, incorporate, and validate standardized and evidence-based quality and outcome measures, including patient-reported outcomes that demonstrate and emphasize the value of specialty pharmacy. |
45 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 45: Hospital and health-system specialty pharmacy leaders should develop standardized measures that support strategies to demonstrate the impact of health-system specialty pharmacy, including but not limited to total cost of care and cost avoidance, impact on treatment decision-making, avoidance of adverse events, use of services, progression or regression of disease, and avoidable emergency visits and hospitalizations. |
46 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 46: Hospital and health-system specialty pharmacy leaders should work with payers and manufacturers to implement value-based contracts that prioritize both individual patient outcomes and total cost of care. |
DOMAIN 5 — Data and Technology | |
47 | Domain: 5. Data and Technology Recommendation 47: Health information technology used by specialty pharmacies should be interoperable to optimize patient care delivery, continuity of care, and timely collection, monitoring, and analysis of data for specialty pharmacy services. |
48 | Domain: 5. Data and Technology Recommendation 48: Hospital and health-system specialty pharmacists should assess and consider utilization of emerging patient care technologies (e.g., mobile applications, monitoring devices, digital wearables or ingestibles) that support optimal patient care and medication-use outcomes. |
49 | Domain: 5. Data and Technology Recommendation 49: Hospital and health-system specialty pharmacies should develop and utilize information systems that produce, integrate, and benchmark outcomes that demonstrate value to patients, payers, providers, and manufacturers. |
50 | Domain: 5. Data and Technology Recommendation 50: Technology solutions must support documentation and reporting of standard measures that attribute patient and population-based outcomes to pharmacists’ interventions in the specialty pharmacy setting. |
51 | Domain: 5. Data and Technology Recommendation 51: Hospital and health-system specialty pharmacists should work with manufacturers and payers for necessary sharing of patient information that is compliant with all applicable laws and regulations. Data sharing should facilitate network and medication access to allow health-system specialty pharmacies to provide more efficient and effective patient care processes. |
52 | Domain: 5. Data and Technology Recommendation 52: Innovative technology solutions that support patient outreach and patient-reported outcomes should be utilized to promote communication, engagement, clinical monitoring, and research. |
53 | Domain: 5. Data and Technology Recommendation 53: As permissible by law and institutional practices, collection and aggregation of de-identified data across stakeholders should be implemented to demonstrate value-based outcomes and continuously improve the quality of services. |
DOMAIN 6 — Business Development | |
54 | Domain: 6. Business Development Recommendation 54: Hospital and health-system specialty pharmacy services must be provided when clinically appropriate at the patient’s preferred site of care, without restrictions, to avoid compromising the quality of patient care or the medication distribution system. |
55 | Domain: 6. Business Development Recommendation 55: Accreditation standards and measures of performance should reflect critical practices necessary to achieve optimal patient outcomes and be equally applicable across all specialty pharmacy business models (e.g., health-system, small community, or big box mail-order pharmacies). |
56 | Domain: 6. Business Development Recommendation 56: Hospital and health-system specialty pharmacy leaders must develop relationships with the organization's payer contracting and managed care leaders to ensure that enterprise-wide pharmacy services are recognized as an integral component of the organization’s comprehensive healthcare delivery system. |
57 | Domain: 6. Business Development Recommendation 57: Hospital and health-system specialty pharmacists should advocate that specialty pharmacy accreditation, certification, and licensing organizations (1) include providers, key stakeholders, and patients in their accreditation and standards development processes and (2) adopt consistent standards for the medication-use process based on established evidence-based principles of patient safety and quality of care that, once adopted, are universally accepted for payer network access. |
58 | Domain: 6. Business Development Recommendation 58: Health system leaders should collaborate with health insurance plans to make coverage decisions in a way that preserves continuity of care between the patient and the care team and supports patient choice of pharmacy. |
59 | Domain: 6. Business Development Recommendation 59: Limited drug distribution strategies should only be used when established, transparent criteria are outlined, and pharmacy access must be based solely on the ability to meet these established criteria. Strategies should be designed to promote continuity of care; support population health management; preserve patients’ relationships with their healthcare providers, including pharmacists; and provide evidence that they are the least restrictive means while ensuring patient safety. |
60 | Domain: 6. Business Development Recommendation 60: Hospital and health-system specialty pharmacy leaders and their organizations must engage in comprehensive value-based care and payment models designed to ensure value for patients, communities, employers, manufacturers, and payers. |
61 | Domain: 6. Business Development Recommendation 61: Hospital and health-system specialty pharmacies should develop strategies with payers and manufacturers that promote access to and establish criteria for limited distribution networks, such as value-based contracting, cost management strategies, medication affordability assistance, and care coordination. |
62 | Domain: 6. Business Development Recommendation 62: Specialty pharmacy leaders should advocate for payers to be required to provide public transparency regarding formulary decisions and clinical coverage determination criteria and policies. |
63 | Domain: 6. Business Development Recommendation 63: Hospital and health-system pharmacy leaders should advocate for transparency in healthcare payer-provider networks and manufacturers’ participation requirements in which the criteria used to include, retain, or exclude providers are tied to best practices and patient care and are disclosed to all providers. |
DOMAIN 7 — Leadership, Research, and Advocacy | |
64 | Domain: 7. Leadership, Research, and Advocacy Recommendation 64: Hospital and health-system specialty pharmacists should lead efforts in health economics and outcomes research to demonstrate the value of integrated pharmacy care coordination. |
65 | Domain: 7. Leadership, Research, and Advocacy Recommendation 65: Hospital and health-system specialty pharmacies and their representing organizations should collaborate at the national level to document and advocate for the value of comprehensive, integrated specialty pharmacy programs. |
66 | Domain: 7. Leadership, Research, and Advocacy Recommendation 66: Health-system pharmacy leaders should advocate for 340B Drug Pricing Program stability and continued access in accordance with the intent of the program. Furthermore, leaders should collaborate with public and private payers to ensure optimization of benefits from the 340B program and related contract and reimbursement policies to ensure the nation’s uninsured, underinsured, underserved, and disadvantaged patients continue to have access to specialty pharmacy medications and disease management services. |
67 | Domain: 7. Leadership, Research, and Advocacy Recommendation 67: Hospital and health-system specialty pharmacists should be involved in the development and implementation by manufacturers, the FDA, or others establishing requirements related to medication access and engage in research on the impact of such requirements to ensure patient safety, access, and intended outcomes are achieved. |
68 | Domain: 7. Leadership, Research, and Advocacy Recommendation 68: At the community, state, and national levels, specialty pharmacy practitioners should participate in healthcare policy development to improve access to therapies that drive optimal health outcomes. |
69 | Domain: 7. Leadership, Research, and Advocacy Recommendation 69: Health-system pharmacy leaders should advocate for financial models for specialty pharmacy medications and services that take into consideration all costs associated with the safe, timely, and cost-effective provision, monitoring, and administration of specialty drugs and that reflect the potential impact on the total cost of care. |
70 | Domain: 7. Leadership, Research, and Advocacy Recommendation 70: Health-system leaders should demonstrate and share with key stakeholders the outcomes and value of an integrated specialty pharmacy. |
71 | Domain: 7. Leadership, Research, and Advocacy Recommendation 71: Hospital and health-system specialty pharmacy is an integral part of hospital and health-system pharmacy practice, and specialty pharmacists should strive to implement the recommendations delineated in the ASHP Practice Advancement Initiative 2030. |
. | DOMAIN 1 — Practice Model and Performance . |
---|---|
1 | Domain: 1. Practice Model and Performance Recommendation 1: Hospitals and health systems should support care models in which medications are procured and prepared by the health-system pharmacy for administration to the patient. Health system policies and procedures should (1) require that medications are obtained from a health-system-authorized and verified source, (2) adhere to state and federal regulations, (3) ensure the continuity of care, (4) validate medication integrity, and (5) ensure the secure and appropriate storage and management of such medications. |
2 | Domain: 1. Practice Model and Performance Recommendation 2: Hospital and health-system specialty pharmacy leaders should actively be involved in ensuring that ethical principles are applied to clinical and business decisions related to medication use. |
3 | Domain: 1. Practice Model and Performance Recommendation 3: Patient care documentation (e.g., patient contact, medication therapy problems, intervention tracking, and patient outcomes) should be standardized and functionally integrated into the electronic health record for continuity of care and reporting. |
4 | Domain: 1. Practice Model and Performance Recommendation 4: Specialty pharmacy team members should be integral to the care delivery and workflows in settings where specialty medications are prescribed to facilitate clinical decision-making, medication management, and care coordination (e.g., time to follow-up, prior authorization facilitation, documentation of medication therapy problems and their resolution, and financial assistance navigation). |
5 | Domain: 1. Practice Model and Performance Recommendation 5: Hospital and health-system specialty pharmacy leaders should develop and participate in internal and external specialty pharmacy benchmark reporting to assess, manage, and develop strategies to improve operational performance. |
6 | Domain: 1. Practice Model and Performance Recommendation 6: Organizations should allocate specialized staff, trained and competent in revenue cycle and contract management, to support specialty pharmacies in the optimization of financial performance, contract management, and compliance. |
7 | Domain: 1. Practice Model and Performance Recommendation 7: High-quality specialty pharmacy services must be patient-centered and span the entire continuum of care and involve/include collaboration among patients, caregivers, payers, pharmacy benefit managers (PBMs), manufacturers, and other healthcare professionals to establish consistent and sustainable models that support seamless transitions of care. |
8 | Domain: 1. Practice Model and Performance Recommendation 8: Hospital and health-system specialty pharmacists integrated into health-system specialty clinics should develop collaborative practice agreements, leverage pharmacist provider status, or utilize other protocols to optimize care delivery and decrease provider burden (subject to state and federal regulations). |
9 | Domain: 1. Practice Model and Performance Recommendation 9: Evidence-based, patient-specific care management criteria should be applied and documented by pharmacists for all patients prescribed specialty medications. Criteria should include patient-, drug-, and disease-specific assessments designed to achieve therapy goals and standardized outcome measures. |
10 | Domain: 1. Practice Model and Performance Recommendation 10: Health-system specialty pharmacy practices should collect, evaluate, and document key performance indicators in a standardized format and use these data to optimize operational performance and patient safety, including adequacy, efficiency, and effectiveness of the staffing model. These key performance indicators should be developed in collaboration with other hospitals and health systems to enable benchmarking. |
11 | Domain: 1. Practice Model and Performance Recommendation 11: The pharmacy enterprise must have oversight of the specialty pharmacy and dedicate resources to support specialty pharmacy business operations, regulatory compliance, contracts, licensure, accreditation, and internal policy review. |
12 | Domain: 1. Practice Model and Performance Recommendation 12: Specialty pharmacies should create advanced roles for pharmacy technicians and other support staff. These roles may include but are not limited to care coordination, prior authorization processing, coordinating patient-assistance programs, monitoring and reporting outcomes, monitoring accreditation and compliance requirements, conducting medication histories and synchronization, and providing patient management assessments. |
13 | Domain: 1. Practice Model and Performance Recommendation 13: Specialty pharmacists and pharmacy leaders should partner with organizational stakeholders to identify, develop, and implement population health models of care that optimize outcomes for patients and the healthcare organization. |
DOMAIN 2 — Patient Care Services and Access | |
14 | Domain: 2. Patient Care Services and Access Recommendation 14: Specialty pharmacists should collaborate with the healthcare team to optimize medication management and therapy outcomes through the development of evidence-based care plans. Elements of care plans should include but not be limited to (1) collection and documentation of patient-specific demographics; (2) inclusion of appropriate drug- or disease-specific patient assessments; (3) comprehensive review of the patient’s medication history and current medications; (4) documentation of all pharmacy case management activities, including education provided; and (5) patient-reported outcomes or clinical measures. |
15 | Domain: 2. Patient Care Services and Access Recommendation 15: Specialty pharmacy team members should coordinate and collaborate across the continuum of care to ensure patient access to appropriate specialty medications. |
16 | Domain: 2. Patient Care Services and Access Recommendation 16: Across the continuum of care, patients prescribed specialty drugs should have access to and be evaluated by health-system pharmacists who provide specialty pharmacy services or who are otherwise knowledgeable about the prescribed medication and disease state. |
17 | Domain: 2. Patient Care Services and Access Recommendation 17: Specialty pharmacy practices should offer telehealth and diverse patient engagement methods to optimize medication adherence and continuity of care. |
18 | Domain: 2. Patient Care Services and Access Recommendation 18: Hospital and health-system specialty pharmacy patient care should be structured as a medically integrated model in which the pharmacists’ role includes (1) assistance with determining the most appropriate and cost-effective treatment regimen; (2) pretreatment preparedness (e.g., immunization, lab testing, and imaging coordination); (3) ongoing monitoring for medication safety, compliance, medication reconciliation, and effectiveness; (4) ongoing patient interaction with frequent touchpoints, and (5) documentation that provides transparency in the patient journey for the provider. |
19 | Domain: 2. Patient Care Services and Access Recommendation 19: Patient consultation and education provided by the specialty pharmacist should be patient-centered, focus on patient engagement, and encompass expectations of therapy, including anticipated duration of treatment, expected outcome of treatment, anticipated time to therapeutic benefit, importance of adherence and persistence with therapy, management of adverse events, and other therapeutic and clinical goals. |
20 | Domain: 2. Patient Care Services and Access Recommendation 20: Specialty pharmacists should be proactively involved in treatment decisions and drug therapy selection, and decisions should include awareness and consideration of patient preferences, accessibility, expected outcomes, and the impact specialty drug therapy may have on patients, caregivers, providers, health system, and payers. |
21 | Domain: 2. Patient Care Services and Access Recommendation 21: Specialty pharmacists should collaborate with patients, families, the healthcare team, and other caregivers to ensure that treatment plans respect patients’ beliefs, values, and autonomy while addressing social determinants of health. |
22 | Domain: 2. Patient Care Services and Access Recommendation 22: Specialty pharmacists and pharmacy leaders should be involved in creating programs to reduce health disparities in our communities and advance health equity. |
23 | Domain: 2. Patient Care Services and Access Recommendation 23: The specialty pharmacy workforce should be knowledgeable and have the ability to identify and manage or refer patients to appropriate support services including but not limited to social work, nutrition services, and mental health services. |
24 | Domain: 2. Patient Care Services and Access Recommendation 24: Hospital and health-system specialty pharmacies should lead the provision or coordination of services to ensure timely access to specialty medications, such as real-time benefits investigation, prior authorization assistance, enrollment of eligible patients into financial assistance programs, and coordination of benefits that is managed at each transition of care across the continuum of care. |
25 | Domain: 2. Patient Care Services and Access Recommendation 25: Specialty pharmacies should support transparency, understanding, and proactive navigation of patient out-of-pocket costs of medications and any potential need for associated services (e.g., lab testing or other monitoring) so that patients understand the financial implications and monitoring commitments associated with their specialty medications. |
DOMAIN 3 — Workforce Competency, Credentials, and Culture | |
26 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 26: Foundational aspects of specialty pharmacy should be integrated into the curriculum of all schools and colleges of pharmacy and offered in experiential learning. |
27 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 27: Specialty pharmacy practice training should be incorporated into postgraduate year 1 residency standards. Residencies in specialty pharmacy practice should be offered as a new residency program distinct from a community pharmacy residency. |
28 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 28: Certified pharmacy technicians should be trained, utilized, and appropriately compensated for advanced specialty pharmacy support roles to ensure long-term career development. |
29 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 29: Hospital and health-system specialty pharmacies should leverage all members of the pharmacy workforce to practice at the top of their education and training. |
30 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 30: Hospital and health-system leaders, including specialty pharmacy leaders, will assess and enhance the diversity of their workforce; support a culture of diversity; and offer recurring training on diversity, equity, and inclusion to all members of their workforce. |
31 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 31: Specialty pharmacy leaders should collaborate with organization leaders to provide workforce training and prioritize opportunities to improve care of diverse patient populations (e.g., racial, gender, and cultural diversity). |
32 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 32: Organizations should encourage and support professional development and advancement of the specialty pharmacy workforce. Pharmacists, pharmacy technicians, and other staff who provide specialty pharmacy services should attain and maintain appropriate competency and applicable, advanced certifications or credentialing. |
33 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 33: Pharmacy technician certification and training courses should include education and competencies relevant to specialty pharmacy practice. |
34 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 34: Hospital and health-system specialty pharmacies should support the establishment of an advanced pharmacy technician certification in specialty pharmacy services. |
35 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 35: There should be an increase in the number of advanced training experiences in specialty pharmacy in ASHP-accredited residency positions to ensure that there is a sufficient number of appropriately trained pharmacists to meet the needs of patients, providers, health systems, and payers. |
36 | Domain: 3. Workforce Competency, Credentials, and Culture Recommendation 36: Specialty pharmacy leaders should advocate for and support a culture of ongoing employee wellness and resilience, including programs that promote healthy coping measures. |
DOMAIN 4 — Safety, Quality, Outcomes, and Value | |
37 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 37: Hospital and health-system specialty pharmacies must define and operationalize clinical quality and safety goals that promote service optimization and minimize risk to patients. |
38 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 38: Hospital and health-system specialty pharmacy practices should support and lead health economics and outcomes research that identifies and mitigates care gaps and associated metrics to demonstrate the unique value of hospital and health-system specialty pharmacy services. |
39 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 39: As a critical component of a comprehensive quality management program, hospital and health-system specialty pharmacies should utilize quality measures to implement changes that improve processes and patient outcomes. |
40 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 40: Specialty pharmacies should standardize, analyze, and interpret both provider- and patient-reported data that include patient-reported outcomes, patient satisfaction, and patient experience and use these measures to create action plans to (1) improve the patient experience, (2) share externally for benchmarking, and (3) distinguish high-value services. |
41 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 41: The specialty pharmacy workforce should be trained and actively engaged in data-driven quality improvement and outcomes-based projects and initiatives. |
42 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 42: Hospital and health-system specialty pharmacies should collaborate with health plans to collect and monitor the total cost of care (e.g., medical plus medication costs) for patients and evaluate the relationship to health outcomes measures (e.g., patient safety, quality, and outcomes data). |
43 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 43: Specialty pharmacies should partner with health-system informatics, revenue cycle management, managed care, and data analytics teams to collect and report clinical and financial outcomes, including total costs of care. |
44 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 44: Specialty pharmacy practices should collaborate with key stakeholders to develop, incorporate, and validate standardized and evidence-based quality and outcome measures, including patient-reported outcomes that demonstrate and emphasize the value of specialty pharmacy. |
45 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 45: Hospital and health-system specialty pharmacy leaders should develop standardized measures that support strategies to demonstrate the impact of health-system specialty pharmacy, including but not limited to total cost of care and cost avoidance, impact on treatment decision-making, avoidance of adverse events, use of services, progression or regression of disease, and avoidable emergency visits and hospitalizations. |
46 | Domain: 4. Safety, Quality, Outcomes, and Value Recommendation 46: Hospital and health-system specialty pharmacy leaders should work with payers and manufacturers to implement value-based contracts that prioritize both individual patient outcomes and total cost of care. |
DOMAIN 5 — Data and Technology | |
47 | Domain: 5. Data and Technology Recommendation 47: Health information technology used by specialty pharmacies should be interoperable to optimize patient care delivery, continuity of care, and timely collection, monitoring, and analysis of data for specialty pharmacy services. |
48 | Domain: 5. Data and Technology Recommendation 48: Hospital and health-system specialty pharmacists should assess and consider utilization of emerging patient care technologies (e.g., mobile applications, monitoring devices, digital wearables or ingestibles) that support optimal patient care and medication-use outcomes. |
49 | Domain: 5. Data and Technology Recommendation 49: Hospital and health-system specialty pharmacies should develop and utilize information systems that produce, integrate, and benchmark outcomes that demonstrate value to patients, payers, providers, and manufacturers. |
50 | Domain: 5. Data and Technology Recommendation 50: Technology solutions must support documentation and reporting of standard measures that attribute patient and population-based outcomes to pharmacists’ interventions in the specialty pharmacy setting. |
51 | Domain: 5. Data and Technology Recommendation 51: Hospital and health-system specialty pharmacists should work with manufacturers and payers for necessary sharing of patient information that is compliant with all applicable laws and regulations. Data sharing should facilitate network and medication access to allow health-system specialty pharmacies to provide more efficient and effective patient care processes. |
52 | Domain: 5. Data and Technology Recommendation 52: Innovative technology solutions that support patient outreach and patient-reported outcomes should be utilized to promote communication, engagement, clinical monitoring, and research. |
53 | Domain: 5. Data and Technology Recommendation 53: As permissible by law and institutional practices, collection and aggregation of de-identified data across stakeholders should be implemented to demonstrate value-based outcomes and continuously improve the quality of services. |
DOMAIN 6 — Business Development | |
54 | Domain: 6. Business Development Recommendation 54: Hospital and health-system specialty pharmacy services must be provided when clinically appropriate at the patient’s preferred site of care, without restrictions, to avoid compromising the quality of patient care or the medication distribution system. |
55 | Domain: 6. Business Development Recommendation 55: Accreditation standards and measures of performance should reflect critical practices necessary to achieve optimal patient outcomes and be equally applicable across all specialty pharmacy business models (e.g., health-system, small community, or big box mail-order pharmacies). |
56 | Domain: 6. Business Development Recommendation 56: Hospital and health-system specialty pharmacy leaders must develop relationships with the organization's payer contracting and managed care leaders to ensure that enterprise-wide pharmacy services are recognized as an integral component of the organization’s comprehensive healthcare delivery system. |
57 | Domain: 6. Business Development Recommendation 57: Hospital and health-system specialty pharmacists should advocate that specialty pharmacy accreditation, certification, and licensing organizations (1) include providers, key stakeholders, and patients in their accreditation and standards development processes and (2) adopt consistent standards for the medication-use process based on established evidence-based principles of patient safety and quality of care that, once adopted, are universally accepted for payer network access. |
58 | Domain: 6. Business Development Recommendation 58: Health system leaders should collaborate with health insurance plans to make coverage decisions in a way that preserves continuity of care between the patient and the care team and supports patient choice of pharmacy. |
59 | Domain: 6. Business Development Recommendation 59: Limited drug distribution strategies should only be used when established, transparent criteria are outlined, and pharmacy access must be based solely on the ability to meet these established criteria. Strategies should be designed to promote continuity of care; support population health management; preserve patients’ relationships with their healthcare providers, including pharmacists; and provide evidence that they are the least restrictive means while ensuring patient safety. |
60 | Domain: 6. Business Development Recommendation 60: Hospital and health-system specialty pharmacy leaders and their organizations must engage in comprehensive value-based care and payment models designed to ensure value for patients, communities, employers, manufacturers, and payers. |
61 | Domain: 6. Business Development Recommendation 61: Hospital and health-system specialty pharmacies should develop strategies with payers and manufacturers that promote access to and establish criteria for limited distribution networks, such as value-based contracting, cost management strategies, medication affordability assistance, and care coordination. |
62 | Domain: 6. Business Development Recommendation 62: Specialty pharmacy leaders should advocate for payers to be required to provide public transparency regarding formulary decisions and clinical coverage determination criteria and policies. |
63 | Domain: 6. Business Development Recommendation 63: Hospital and health-system pharmacy leaders should advocate for transparency in healthcare payer-provider networks and manufacturers’ participation requirements in which the criteria used to include, retain, or exclude providers are tied to best practices and patient care and are disclosed to all providers. |
DOMAIN 7 — Leadership, Research, and Advocacy | |
64 | Domain: 7. Leadership, Research, and Advocacy Recommendation 64: Hospital and health-system specialty pharmacists should lead efforts in health economics and outcomes research to demonstrate the value of integrated pharmacy care coordination. |
65 | Domain: 7. Leadership, Research, and Advocacy Recommendation 65: Hospital and health-system specialty pharmacies and their representing organizations should collaborate at the national level to document and advocate for the value of comprehensive, integrated specialty pharmacy programs. |
66 | Domain: 7. Leadership, Research, and Advocacy Recommendation 66: Health-system pharmacy leaders should advocate for 340B Drug Pricing Program stability and continued access in accordance with the intent of the program. Furthermore, leaders should collaborate with public and private payers to ensure optimization of benefits from the 340B program and related contract and reimbursement policies to ensure the nation’s uninsured, underinsured, underserved, and disadvantaged patients continue to have access to specialty pharmacy medications and disease management services. |
67 | Domain: 7. Leadership, Research, and Advocacy Recommendation 67: Hospital and health-system specialty pharmacists should be involved in the development and implementation by manufacturers, the FDA, or others establishing requirements related to medication access and engage in research on the impact of such requirements to ensure patient safety, access, and intended outcomes are achieved. |
68 | Domain: 7. Leadership, Research, and Advocacy Recommendation 68: At the community, state, and national levels, specialty pharmacy practitioners should participate in healthcare policy development to improve access to therapies that drive optimal health outcomes. |
69 | Domain: 7. Leadership, Research, and Advocacy Recommendation 69: Health-system pharmacy leaders should advocate for financial models for specialty pharmacy medications and services that take into consideration all costs associated with the safe, timely, and cost-effective provision, monitoring, and administration of specialty drugs and that reflect the potential impact on the total cost of care. |
70 | Domain: 7. Leadership, Research, and Advocacy Recommendation 70: Health-system leaders should demonstrate and share with key stakeholders the outcomes and value of an integrated specialty pharmacy. |
71 | Domain: 7. Leadership, Research, and Advocacy Recommendation 71: Hospital and health-system specialty pharmacy is an integral part of hospital and health-system pharmacy practice, and specialty pharmacists should strive to implement the recommendations delineated in the ASHP Practice Advancement Initiative 2030. |
Market overview and trends
In the first plenary session, futurist Bill Roth, founding partner of the Blue Fin Group, set the tone for the summit with an overview of the specialty pharmacy market and trends. Roth noted that historically, the specialty pharmacy market strategic focus was on creating the business model, optimizing purchasing, managing the drug spend, understanding network design, and generating revenue. For the summit, the focus was on outcomes. According to proprietary research conducted by the Blue Fin Group in 2019 and 2020, HSSPs are poised to drive desired outcomes; on average they have less than 5% prescription abandonment, 0 days time to fill, and 5% adherence loss, outperforming all others in the industry. HSSPs need to understand how to position this level of performance within a delivery system currently controlled by payers and, to some extent, manufacturers. By and large, the payers have set the rules of the game, but Roth believes HSSPs are learning to play the game. Industry consolidation and a subsequent increase in market share have strengthened the payer position; however, with the shift toward outcomes-based performance, HSSPs have the opportunity to reset the rules and “to be the board, not just one of the pieces.” Roth pointed to 3 strategic windows of opportunity driven in part by the Affordable Care Act: holding providers and systems accountable for outcomes, reimbursement reform with a shift from fee-for-service to value-based payments (and penalties), and requirements for more transparency. Strategically, then, HSSPs need to consider their services more broadly, across all settings, as a “holistic enterprise pharmacy,” with a focus on delivering outcomes.
Health-system specialty pharmacies need to consider their services more broadly, across all settings, as a “holistic enterprise pharmacy,” with a focus on delivering outcomes.
—Bill Roth, Blue Fin Group
From the payer point of view, alignment with the health system and providers is key in controlling costs, and payers are particularly focused on controlling the spend on cell and gene therapies and orphan and rare therapies in addition to the specialty medical and pharmacy benefit. Their shift to outcomes-based reimbursement is one opportunity for health systems to shift and, ultimately, define an outcomes-based model that aligns incentives. Also, with HSSPs, the level of integration (regionally) with health plans is strong, as is their performance on traditional patient journey optimization (eg, improving the abandonment rate, average time to fill, and adherence rates).1,2
Roth noted that while HSSPs are positioned to design and lead in an outcomes-based model, one challenge is that there is currently no standardization of metrics and currently reported metrics focus primarily on patient journey optimization, not outcomes. These service metrics are important to commercial business performance, but metrics must be developed to support outcomes reporting and value-based contracting. Looking at the bigger picture, a plan sponsor (such as a self-insured employer), is focused on retail prescriptions and the specialty drug spend, but as the ultrarare conditions spend (ie, expenditures for cell/gene therapies, orphan drugs, and drugs targeted to rare diseases) grows to account for more than two-thirds of the market, this is where the focus will shift, as well as the opportunity for impact. One advantage that can be leveraged by HSSPs is that they are the only channel that touches, or has the potential to touch, all of these areas.
For the most part, the HSSP business model has historically been more reactive than proactive, and tactical versus strategic. For example, many HSSPs are limited to dispensing employee prescriptions, with a focus on drug and payer access, and responding to manufacturer and payer requirements. Strategically, HSSP leaders need to consider external factors influencing their current business models and where they can align with stakeholders. For example, many HSSPs were developed to drive revenue associated with the federal 340B Drug Pricing Program, revenue that is likely to shrink over time. On the other hand, HSSPs have the opportunity to leverage their electronic health record (EHR) and physically embedded staff, which are the elements to produce a highly efficient and effective clinical care model that can drive outcomes and that will influence decisions by payers and manufacturers. To tell their story, HSSPs should look at outcomes as well as processes around high-priority therapies, those with the highest dollar impact, and more complex therapies. Available data (eg, data on care coordination, active therapeutic intervention, and comorbidities) can be used to show health plans what is being achieved, such as whether primary treatment endpoints are being met. All payers look at accreditation as an indicator of quality, so it may be a useful strategy to partner with specialty pharmacy accreditation bodies to align measures with the HSSP model for care delivery.
When developing business strategies, it is also important to recognize that payers have been moving toward vertical integration through inclusive ownership and managing of channels that control providers, pharmacies, and home infusion. The payer wants control and the revenues associated with a physical product dispense, which typically involves standalone specialty pharmacies that are not aligned with the complete patient journey. At best, a standalone specialty pharmacy can support only a prescription journey and not a patient journey. On the other hand, health systems view and manage the patient holistically and are effective at optimizing the patient journey. If manufacturers seek to enter meaningful value-based care agreements, they must consider the value that can be delivered by a more integrated HSSP model. While HSSPs stand to deliver against longitudinal therapy models better than any payers, they require the standards, benchmarks, and communication necessary to scale the required infrastructure.
Roth noted that one approach would be a hub-and-spoke information dissemination model whereby there is central thought leadership—perhaps by a council of strategic pharmacy corporate leaders—that creates standardized methodology and outcomes measurements, mechanisms for communication, and therapeutic area experts. Roth has worked with manufacturers directly in specialty and orphan/rare disease states that have seen as low as an 8% abandonment rate and an 8% adherence deficiency. This model creates a unified front, which elevates clinical practice and the patient experience, while taking a financial stewardship approach with the development of well-defined and measurable therapeutic outcomes. Through this model, health systems can deliver on the promise of proving their differentiation within the marketplace.
Roth had 5 key recommendations for moving forward with a unified approach: (1) standardize outcome and value metrics, considering alignment with stakeholders (plan sponsor and patients); (2) implement sharing of standardized peer-to-peer data; (3) create plans to mitigate reimbursement reform possibility (eg, 340B program changes); (4) actively engage with the health system’s payer team; and (5) promote performance to payers and manufacturers. One payer strategy that provides an example of this to consider is partnering with a large, self-insured employer. While national employers present more challenges, other large employers, such as a predominant plan in a region or state, have control over the design of their plans and network.
To summarize, there is considerable opportunity for HSSPs to offer a highly effective model for managing spend and ensuring optimal utilization of high-cost therapies, including the growing cell/gene and rare/orphan drug therapies. HSSPs are uniquely positioned in a vertically integrated market because they possess the full array of tools required to coordinate care and achieve therapeutic goals. If a central council of thought leaders drives industry standardization of processes and outcome measures that align with payer and manufacturer goals, HSSPs will be assured a place as preferred providers.
ASHP National Survey of Health-System Specialty Pharmacy Practice results
In the second plenary session of the summit, JoAnn Stubbings, BSPharm, MHCA, Clinical Associate Professor Emerita, Department of Pharmacy Practice, University of Illinois at Chicago College of Pharmacy, presented the preliminary results of the ASHP National Survey of Health-System Pharmacy Practice. The survey results provided timely context to the summit participants’ understanding of the issues facing HSSPs across the spectrum, as they describe the HSSP practice model and identify best practices and gaps that can inform the proposed summit recommendations. The results are interpretive and were open to debate and discussion among summit participants. A more detailed review of the survey results is now available.3 A review of the preliminary survey findings provided the audience with a sense of how the HSSP practice model is robust and unique, the extent to which HSSP services are integrated into health-system clinics, and methods to identify opportunities for improvement.
The survey was conducted in late 2020 and was completed by representatives of over 100 organizations. The survey questions addressed 8 domains: Health-System and Specialty Pharmacy Demographics; Workforce Staffing Levels, Training, and Credentials; Operations; Payer Access, Business Relationships, and Financial Management; Patient Care Services, Clinical Care, and Documentation; Quality, Outcomes, and Value; Staff Activities and Functions; and the Future of Specialty Pharmacy. The following sections highlight key survey findings as presented by Stubbings.
Demographics
Demographics indicate that HSSPs are well established and integrated into health systems, with the majority affiliated with a 340B-covered entity; many also dispense nonspecialty medications, and most are accredited. Most specialty pharmacies dispensed fewer than 30,000 specialty prescriptions per year and had gross revenue of less than $100 million in 2019—relatively small operations by industry standards. The top 5 therapeutic categories dispensed were consistent with industry trends and included agents targeting inflammatory conditions and hematology/oncology, hepatology, neurology, and infectious diseases. The HSSP business model is largely focused on the pharmacy benefit (versus medical benefit) claims, and less than 10% of HSSPs manage home infusion.
Workforce
Workforce domain responses indicate that most specialty pharmacies report through the pharmacy department, either to a chief pharmacy officer or to the ambulatory care pharmacy leadership. Specialty pharmacists and technicians are integrated into and dedicated to specific clinics, and pharmacists are involved in treatment decisions prior to the prescription being written. There are more hybrid, or mixed, practice models versus a generalist model (ie, all pharmacists are assigned to all clinics or disease states) or a specialist model (ie, pharmacists are assigned to a specific clinic or disease states). Stubbings considered the high level of integration a best practice. There do not seem to be consistent training or certification requirements for specialty pharmacists, which begs the question of whether training is keeping up with demands of the HSSP practice model. The advanced pharmacy practice experience (APPE) rotation for student pharmacists is the most common specialty pharmacy training offered by health systems, followed by an elective specialty pharmacy rotation in a postgraduate year 1 or postgraduate year 2 residency program. The majority of HSSPs perform patient care services related to documentation, monitoring, interventions, and patient assessments, most of which are required for accreditation. Less than half but still a notable percentage (about 30%) of specialty pharmacists are prescribing medications and ordering vaccines and laboratory tests. This indicates that there is an opportunity to expand services beyond those required for accreditation.
Operations
HSSPs are integrated operationally and clinically with their health system and have a local or regional reach that is, for the most part, payer agnostic. Although some payer contracts require licensure in all 50 states, most HSSPs have 1 to 5 licenses.
Payer access and business relationships
Over 80% of HSSPs have their own self-insured employee health plan, and HSSPs are most likely to be a preferred or sole provider of specialty medications. While this has resulted in a substantial fill rate (>50%) for employee prescriptions, there is room for improvement. This also points to the power of vertical integration within health systems and, consistent with Roth’s recommendations around payer alignment, suggests that other self-insured employers would also be interested in contracting with an HSSP to take advantage of that same integration for their employees.
HSSPs are less successful with network access for their own patients. Most HSSPs fill 50% or less of specialty prescriptions originating from their health system’s providers.
Although HSSPs have had moderate success in gaining access to limited-distribution contracts, there is significant opportunity to improve. The most frequent barriers cited include manufacturer refusal to engage and being blocked out by payers. To enhance access, HSSPs are actively helping patients to access their medications by managing a variety of patient assistance programs that save patients millions of dollars each year.
Patient care services, clinical care, and documentation
The top 5 clinical services provided by HSSPs are prior authorization support, adverse effect identification and management, providing medication refill reminders, offering copayment assistance programs, and adherence support. Although these are also the most common services required by accreditation organizations, some HSSPs are offering more advanced activities, although to a lesser extent. These types of advanced activities, such as comprehensive medication management services, conducting patient care visits with clinic-embedded pharmacists, and making dosage adjustments by protocol, are an opportunity for growth. Of the survey respondents, 40% stated that their specialty pharmacists operate under collaborative practice agreements, and 35% of respondents stated their organization has a credentialing and privileging process for pharmacists. HSSPs are positioned with highly skilled practitioners, likely with more training than pharmacists in other sectors of the market, particularly HSSPs with an integrated or hybrid clinical model. Stubbings proposed that specialty pharmacy residency training would further advance the level of practice. This will become even more important as value-based contracting and limited distribution networks will demand high-value outcomes. Most HSSPs do not seem to be billing for nondispensing services, but some are billing for services such as telehealth, medication therapy management services, and patient education, which indicates there is an opportunity to bill for more services. Likely distinguishing HSSPs from other specialty providers is that almost all have 2-way access to a patient’s EHR, considered now to be a best practice. Finally, most health systems allow “clear bagging” of specialty injectable medications and “white bagging” to a lesser extent, but “brown bagging” is mostly not allowed. Stubbings noted that clear bagging is an opportunity for HSSPs to build their business and expand into the medical benefit, since the HSSP will provide specialty injectable medications directly to its infusion clinics.
Quality, outcomes, and value
Having a quality improvement program is a best practice for HSSPs, and required elements are outlined in accreditation standards. However, there are differences in what is being measured. To show value, HSSPs most commonly measure patient and provider satisfaction, revenue, improved clinical outcomes, and safety. Process measures (eg, prescription volume, dispensing accuracy), financial measures (eg, financial assistance, cost savings), and clinical measures (eg, proportion of days covered, disease outcomes) were also commonly reported in the ASHP survey. Stubbings believes there is opportunity to measure and report additional clinical metrics and patient-reported outcomes to demonstrate value. HSSPs are also heavily involved in the prior authorization process. Almost half of HSSPs report an approval rate over 90%, a health-system best practice. The average HSSP has 13 pharmacist and 15 technician full-time equivalents (FTEs). On average, each pharmacist or technician FTE processes only up to 100 prescriptions per day and manages up to 50 patients per day, which speaks to the intensity of the service.
The future of specialty pharmacy
The survey respondents indicated that top challenges HSSPs expect to face in the next year are in the areas of access to payer networks, 340B Drug Pricing Program changes, shrinking reimbursement from payers, and access to limited-distribution drugs. Access to payer networks is critical to HSSP survival and is top of mind for everyone. Stubbings concurred and noted during the summit the need for a “big idea” to address this problem. The top opportunities for HSSP growth are driven by a natural growth that arises from introduction of new drugs that address new indications and that address new populations. This is consistent with survey responses that top opportunities for HSSP growth within the next 1 to 5 years are new populations, new therapeutic categories, and patient engagement through telehealth. There may also be an additional opportunity to redefine the specialty patient as high risk patient and include other drugs as well, because the integrated model is well suited to support a broader group of patients requiring complex medication therapies.
Patient satisfaction and level of service are consistently among the top 3 points of pride that HSSPs have been exceptionally successful in achieving. Payer contracting is the top priority in the HSSP strategic plan for next year, followed by reporting clinical outcomes, reporting capabilities, and expanded access to limited distribution drugs.
Based on her review of the survey results, Stubbings proposed that summit participants consider the following strategies as priorities to address gaps and opportunities:
Gain access to payer and limited distribution networks.
Expand the specialty practice model to include the medical benefit.
Implement advanced clinical services such as ordering prescriptions and telehealth, and bill for those services.
Require pharmacist credentialing and privileging to support advanced practice.
Develop specialty pharmacy residency training to support advanced practice.
Incorporate specialty pharmacy training into undergraduate experiential education.
Create a pharmacy technician career ladder (training, pathway, salary, education) to support advanced roles.
Expand measurement and reporting of performance metrics.
Demonstrate and disseminate outcomes and value.
In conclusion, the survey results provide evidence that the HSSP practice model is robust and unique and provided context and insights for summit participants as they considered recommendations for HSSP practice.
Value-Driven Future—Quality and Outcomes Evidence Through Research (Panel 1)
Session Moderator Lynnae Mahaney, BSPharm, MBA, FASHP, Senior Director, Pharmacy Accreditation, ASHP, led an in-depth discussion on implications of a values-driven future for specialty pharmacy and considerations for building quality and outcomes evidence through research. Mahaney described an urgent need for outcomes research and results sharing by HSSPs so that the excellence of care they provide can be validated in a market that requires quality, outcomes, and satisfaction to compete.
When the Institute of Medicine (since renamed the Academy of Medicine) published the reports To Err Is Human: Building A Safer Health System in 1999 and Crossing the Quality Chasm: A New Health System for the 21st Century in 2001, one of the standout findings was that only 55% of patients received recommended care.4 Since those reports, the US healthcare system has begun to shift focus from “payment for quantity” to “payment for quality,” driven in part by the Affordable Care Act, which directed the US Department of Health and Human Services to establish a National Quality Strategy to improve the delivery of healthcare services, patient health outcomes, and population health.5 The U.S. Healthcare Quality Strategy, known as the “Triple Aim,” strives to improve care and provide better outcomes at a lower cost. This has recently evolved into the “Quadruple Aim,” with an added goal of a better clinician experience. There are 6 priorities within the National Quality Strategy, all of which can be affected by HSSPs: (1) safer care; (2) patient-centered care; (3) effective communication and coordination of care; (4) effective prevention and treatment practices for the leading causes of mortality; (5) healthy living, including efforts to address social determinants of health; and (6) quality care that is affordable. Accountability for quality begins with clearly defined goals that can be measured and monitored and are recognized and utilized by all healthcare stakeholders. Furthermore, the consequences of achieving or falling short of these goals should be clear among all parties. Accountability measures for specialty pharmacies have historically been process oriented (eg, turnaround time and call center metrics), and these have been integrated into pharmacy network inclusion criteria and value-based payment contracts. In real-world practice, outcomes-based quality measurement for specialty diseases and medications may sound simple yet can be very difficult to implement, and few of the measures are standardized across the industry.
The Pharmacy Quality Alliance has developed standardized measures for certain specialty conditions, including medication adherence in multiple sclerosis, antiretrovirals, rheumatoid arthritis, and hepatitis C therapy completion.6 Though important, these measures are limited and foundational in assessing quality outcomes related to specialty medications. A value-driven future for specialty pharmacy is dependent on quality and outcome measures that are evidence-based, aligned across specialty pharmacy stakeholders, and widely communicated. To gain this alignment, it is essential to partner with internal and external collaborators to define critical elements necessary for meaningful and translatable outcomes-based research (ie, research to associate core process measures with desired outcomes). There is currently a paucity of validated measures that will translate to outcomes, including achievement of the expected therapeutic response or control of disease. Reduced utilization (eg, hospitalizations and emergency department visits), patient satisfaction, and quality-of-life measures are also commonly used value-based measures and are often used as surrogates for assessing disease control. Mahaney noted that outcomes reporting may also require use of a surrogate measure that can be correlated with a financial benefit (eg, work days lost).
Recently, there has been much interest in total cost of care (TCOC) measures as well. Measuring TCOC has been a challenge for health systems because of limited data available within the system itself and difficulty determining direct cost attribution. It would be necessary to partner with payers to assist with the data, as described in a report on a study by Soni et al7 wherein the researchers compared per-member per-month costs for patients within an accountable care organization who were served by an integrated specialty pharmacy versus a nonintegrated specialty pharmacy.
Research framework for health-system specialty pharmacy
The panelists for this session, representing unique points of view, included an HSSP pharmacist and external stakeholders from academia and industry and were asked to share their insights and suggested approaches for developing a research agenda for quality, outcomes, and value in specialty pharmacy practice.
The first panelist, Autumn Zuckerman, Program Director of Health Outcomes and Research with Vanderbilt Specialty Pharmacy, addressed the importance of outcomes-based research to demonstrate HSSP value in an evolving marketplace that demands the highest level of care for patients. A framework for specialty pharmacy outcomes research should reflect 3 goals: first and foremost, to gain knowledge to improve patient care (eg, what steps an organization is currently taking and can take to optimize specialty treatments, contain costs, and improve patient access, adherence, and outcomes); secondly, to create or support the value proposition for an intervention; and lastly, to contribute to a scientific body of knowledge (Table 2).
Patient Care . | Value Proposition . | Scientific Contribution . |
---|---|---|
• Optimize specialty treatments • Contain costs • Improve access, adherence, and outcomes | • Provide evidence of optimal patient care • Support value-based contracting | • Disseminate best practices • Improve understanding of specialty patients and outcomes |
Patient Care . | Value Proposition . | Scientific Contribution . |
---|---|---|
• Optimize specialty treatments • Contain costs • Improve access, adherence, and outcomes | • Provide evidence of optimal patient care • Support value-based contracting | • Disseminate best practices • Improve understanding of specialty patients and outcomes |
Patient Care . | Value Proposition . | Scientific Contribution . |
---|---|---|
• Optimize specialty treatments • Contain costs • Improve access, adherence, and outcomes | • Provide evidence of optimal patient care • Support value-based contracting | • Disseminate best practices • Improve understanding of specialty patients and outcomes |
Patient Care . | Value Proposition . | Scientific Contribution . |
---|---|---|
• Optimize specialty treatments • Contain costs • Improve access, adherence, and outcomes | • Provide evidence of optimal patient care • Support value-based contracting | • Disseminate best practices • Improve understanding of specialty patients and outcomes |
Zuckerman noted that it is critical for HSSPs to collect, aggregate, analyze, and report on the services that are provided to patients. HSSPs should evaluate the outcomes of these patient care services and disseminate findings. Three critical elements necessary for conducting effective outcomes research and results sharing are (1) identifying and standardizing outcome metrics that are recognized industry-wide; (2) implementing disease state monitoring capabilities that incorporate outcomes metrics and allow for real-time assessment of therapy response; and (3) identifying and utilizing resources to perform and communicate results of outcomes research. Each of these elements poses opportunities and challenges (Table 3).
. | Element . | ||
---|---|---|---|
. | Establish and standardize outcomes metrics . | Allow for real-time assessment of therapy response and data collection . | Identify and utilize resources to perform and communicate outcomes research . |
Needs | • Disease state–level metrics • Pharmacy-level metrics | • Build into normal clinical practices • Use real-time dashboards • Automate reporting | • Identify champion to determine strategy, oversee projects, and develop external messaging • Understand available resources and ways to optimize current capabilities without adding to burden on staff • Develop ROI for resources needed to perform and communicate outcomes research |
Challenges | • Standardization • Feasibility at site level • Understanding stakeholder needs | • Working with current technology and data source capabilities • Allocating resources to develop dashboards and reporting capabilities | • Asking for resources with “soft dollars” • Identifying and developing relationships with available resources • Lack of experience of current staff in performing and reporting research |
Opportunities | • Consistent measures are recognized across stakeholders • Provide clinically meaningful aggregation of data | • Reduce burden of data collection for research • More advanced study designs that impact patient outcomes • Tailoring patient care • Communicating value | • Establishing HSSP value in the marketplace • HSSP seen as attractive partner for external stakeholder collaboration |
. | Element . | ||
---|---|---|---|
. | Establish and standardize outcomes metrics . | Allow for real-time assessment of therapy response and data collection . | Identify and utilize resources to perform and communicate outcomes research . |
Needs | • Disease state–level metrics • Pharmacy-level metrics | • Build into normal clinical practices • Use real-time dashboards • Automate reporting | • Identify champion to determine strategy, oversee projects, and develop external messaging • Understand available resources and ways to optimize current capabilities without adding to burden on staff • Develop ROI for resources needed to perform and communicate outcomes research |
Challenges | • Standardization • Feasibility at site level • Understanding stakeholder needs | • Working with current technology and data source capabilities • Allocating resources to develop dashboards and reporting capabilities | • Asking for resources with “soft dollars” • Identifying and developing relationships with available resources • Lack of experience of current staff in performing and reporting research |
Opportunities | • Consistent measures are recognized across stakeholders • Provide clinically meaningful aggregation of data | • Reduce burden of data collection for research • More advanced study designs that impact patient outcomes • Tailoring patient care • Communicating value | • Establishing HSSP value in the marketplace • HSSP seen as attractive partner for external stakeholder collaboration |
Abbreviations: HSSP, health-system specialty pharmacy; ROI, return on investment.
. | Element . | ||
---|---|---|---|
. | Establish and standardize outcomes metrics . | Allow for real-time assessment of therapy response and data collection . | Identify and utilize resources to perform and communicate outcomes research . |
Needs | • Disease state–level metrics • Pharmacy-level metrics | • Build into normal clinical practices • Use real-time dashboards • Automate reporting | • Identify champion to determine strategy, oversee projects, and develop external messaging • Understand available resources and ways to optimize current capabilities without adding to burden on staff • Develop ROI for resources needed to perform and communicate outcomes research |
Challenges | • Standardization • Feasibility at site level • Understanding stakeholder needs | • Working with current technology and data source capabilities • Allocating resources to develop dashboards and reporting capabilities | • Asking for resources with “soft dollars” • Identifying and developing relationships with available resources • Lack of experience of current staff in performing and reporting research |
Opportunities | • Consistent measures are recognized across stakeholders • Provide clinically meaningful aggregation of data | • Reduce burden of data collection for research • More advanced study designs that impact patient outcomes • Tailoring patient care • Communicating value | • Establishing HSSP value in the marketplace • HSSP seen as attractive partner for external stakeholder collaboration |
. | Element . | ||
---|---|---|---|
. | Establish and standardize outcomes metrics . | Allow for real-time assessment of therapy response and data collection . | Identify and utilize resources to perform and communicate outcomes research . |
Needs | • Disease state–level metrics • Pharmacy-level metrics | • Build into normal clinical practices • Use real-time dashboards • Automate reporting | • Identify champion to determine strategy, oversee projects, and develop external messaging • Understand available resources and ways to optimize current capabilities without adding to burden on staff • Develop ROI for resources needed to perform and communicate outcomes research |
Challenges | • Standardization • Feasibility at site level • Understanding stakeholder needs | • Working with current technology and data source capabilities • Allocating resources to develop dashboards and reporting capabilities | • Asking for resources with “soft dollars” • Identifying and developing relationships with available resources • Lack of experience of current staff in performing and reporting research |
Opportunities | • Consistent measures are recognized across stakeholders • Provide clinically meaningful aggregation of data | • Reduce burden of data collection for research • More advanced study designs that impact patient outcomes • Tailoring patient care • Communicating value | • Establishing HSSP value in the marketplace • HSSP seen as attractive partner for external stakeholder collaboration |
Abbreviations: HSSP, health-system specialty pharmacy; ROI, return on investment.
Standardized outcome metrics would enable aggregation of data across HSSPs. Standardizing metrics is challenging for several reasons, as many specialty disease states have either several or no quantifiable outcomes that can be measured to assess patient response to therapy and, once metrics are developed, it may or may not be feasible for HSSPs to collect data to measure them. Finally, it can be a challenge for HSSPs to know what metrics are most important to demonstrate value to stakeholders.
In order to operationalize the use of the metrics, documentation of patient care activities and patient outcomes must be structured in a way that is readily extractable and, ideally, provides real-time outcomes monitoring capability to providers (eg, through dashboards). These data can be used to design care interventions and identify patients at risk for poor (or better) outcomes. Reporting patient outcomes provides invaluable information to payers and manufacturers and will support value-based contracting. Lastly, building and communicating the specialty pharmacy value story needs to be integrated into business expectations. HSSPs should identify a dedicated resource to determine a research strategy, including priorities; oversee projects; and communicate research results. Allocating resources to research activities can sometimes be justified by showing increased access to contracts and therefore translate to higher prescription capture rates and patient retention. Additional challenges and opportunities are also shown in Table 3.
To conclude her presentation, Zuckerman shared tactics to improve measuring of quality, outcome, and satisfaction metrics to support the unique value of HSSPs. These tactics build on the elements noted above that are critical to the research agenda. First, researchers should develop, validate, and standardize measures unique to HSSP practice. Second, HSSPs should determine the resources needed to perform metrics monitoring. Third, the plan and outcomes must be recognized as valuable by the HSSP leadership. Finally, HSSPs must collaborate with stakeholders to understand “value” from their perspective and then communicate the value demonstrated. Though this is not a comprehensive list of everything HSSPs and the field in general will need, it provides high-level guidance on creating a path forward.
Research collaboration: perspective from academia
Panelist Betsy Sleath, Regional Associate Dean of Eastern North Carolina and the George H. Cocolas Distinguished Professor in the Division of Pharmaceutical Outcomes and Policy at the University of North Carolina (UNC) Eshelman School of Pharmacy, provided the academic perspective on developing a research agenda to support value-based models and shared her recommendations for study design, measurement and data elements, analysis of data, and dissemination of findings. Sleath believes that the specialty pharmacy research agenda needs to be outcomes focused, designed to demonstrate the effectiveness of pharmacist interventions, and strengthened through partnerships. For example, UNC has a “Partnership in Patient Care” between the UNC Health system and the school of pharmacy, and one component is research. Some examples of ongoing research resulting from this partnership include development of a predictive model to guide pharmacist prioritization in the care of medically complex patient populations and a study of adherence to oral cancer therapies. Ideal partners (organizations or providers) are known for their expertise in the area to be studied and have a sufficient number of patients to meet the study’s inclusion criteria. For some patient populations, such as those being treated for a rare disease, it may be necessary to partner with other health systems (eg, through reliance agreements).
Identifying a specific research question and establishing the research team are the first steps in designing and conducting research. A multidisciplinary team, including learners, can help to facilitate the institutional review board approval process, refine the question(s), and identify the capability of the systems in place to gather the necessary data. Some areas of current HSSP research interest include patient-centered outcomes, health literacy and disparities, the impact of telehealth (eg, phone versus Internet interactions), risk-benefit communication about medications and the impact on outcomes, and improving training of the pharmacy workforce.
Once the research question is determined, outcome measures should be selected. Sleath emphasized that validated scales should be considered first, but there may be a cost associated with using them. If there is no validated measure, then one can be developed or a surrogate measure used. It is imperative that data management analysts be engaged early in the research to confirm their support and to guide decisions, such as deciding how many patients are required to achieve study results of the desired statistical power. Consider partnerships that can bring needed support; for example, industry can sometimes provide research expertise, such as analytics support. Finally, it is important to disseminate research findings through presentations and publications. This can occur internally (within the health system) or externally through dissemination of results to other stakeholders (eg, other health systems, professional organizations, health plans, government agencies, and patient advocacy groups).
Research collaboration: perspective from industry
The final panelist, Cameron James, PharmD, CGP, MHCI, Medical Affairs Executive Director for Genentech, Inc. (a member of the Roche Group), provided insights from industry on collaboration between industry and health systems. When looking for opportunities to collaborate, it is important to understand what potential partners value. For example, James noted that a key research priority of value to industry is gaining an understanding and evidence of how well drugs work in real-world circumstances (this might, eg, inform what changes might be made in clinical trials to better determine clinical efficacy). Understanding real-world evidence can also help to develop expectations for value-based agreements. Another priority is understanding whole-patient care and how complementary care (as is often provided by HSSPs) provides an opportunity to learn about symptom and adverse effect management that goes beyond dispensing and administering a drug. For example, what interventions impact the additions and subtractions to the value story (cost-impact or cost-benefit models)? By working together, a research team can tailor the research to uncover additional pieces of the value puzzle.
Value to industry partners can include differentiation of a therapy (through, eg, patient follow-up to determine which patients do better, cases where the drug works, and when “one size doesn’t fit all”). Also, industry partners may be interested in specific populations that are different, not often discussed in the literature, or hard to reach, or they may be interested in testing a population that reflects the population in which a therapy is used in real-world practice. Organizational characteristics that lend themselves to successful and meaningful research partnerships with industry include a clear mission and goals for the research, having a champion within the organization who can push the research agenda, and demonstrating a history of conducting research. It is also an advantage to have expertise (in a therapeutic or operational area) unique to the research question or population. Finally, there needs to be good capability (or a plan) to capture the data. Collaborations with industry start with aligning incentives and goals. Industry opportunities and current research priorities are often posted on a drug company’s website. Look for requests for proposals from industry and reach out to medical affairs liaisons, who can provide a wealth of information. Also, consider that drugs have life cycles and that information on new drug pipelines and patent expirations is readily available. Finally, HSSPs seeking to form partnerships should look beyond the financial element of an industry partnership and, as Sleath noted, also recognize that industry partners can provide research expertise and support.
James stressed that meaningful collaboration is critical to an outcomes-based research agenda and begins with self-evaluation: what the specialty pharmacy currently does and what is wanted from collaboration—evidence-based therapy guidance, money, resource support, publication, partnership, or all of the above. Consider the research capabilities, strengths, and weaknesses of the team and the direction of the health system as a whole, such as a history of publications in a certain area, being considered a center of excellence, or a team member’s being considered a national expert as part of the medical team. The goal is to foster long-term relationships and create a win-win for everyone.
Collaboration with industry and academic partners will enhance the ability of an HSSP to conduct meaningful and translatable research demonstrating its impact on patient outcomes. There is an opportunity to align stakeholder goals to develop meaningful metrics that reflect high performance and value. Effective partnerships will support outcomes research and dissemination of results that are necessary for an HSSP’s continued vitality and to differentiate its services in the market.
Stakeholder Perspectives to Support Value-Based Care with Specialty Pharmacy Practice (Panel 2)
Udobi Campbell, PharmD, MBA, Regional Director of Pharmacy, UNC Health, served as moderator for the panel discussion. Campbell introduced panelists Gregory Dill, PharmD, Deputy Director for Innovation & Financial Management, Centers for Medicare & Medicaid Services (CMS), and Cedric Terrell, PharmD, MHA, Chief Pharmacy Officer and Vice President Health & Medical Management, Blue Cross Blue Shield of Massachusetts (BCBSMA), to provide payer perspectives on how outcomes can be strategically connected to health system–based specialty pharmacies to demonstrate value. These leaders provided their insights into industry trends, including the industry’s high-priority economic drivers, and how to align with payers.
Government policy drives shift towards value-based care
Dill provided an overview of the “state of the union” of US healthcare, particularly a review of Medicare key cost drivers and what is being done to manage those costs.a In fiscal year (FY) 2019 CMS had spending that exceeded $1 trillion, or approximately 15% of total federal outlays; in 2020, this figure increased by over 16%. CMS spending now exceeds that of the Social Security program.8,9 The primary drivers of this shift are (1) healthcare inflation is growing faster than general inflation and (2) the increase in Medicare enrollment is at its fastest rate in history; by 2030, it is projected, there will be about 80 million Americans enrolled. Spending for drugs has also increased dramatically, from $17.6 billion in drugs (Part B, including specialty drugs) in 2011 to $28 billion in 2016. All of these factors merge to create a situation where expenditures are predicted to exceed income by 2026 for the Medicare Part A Trust Fund.10
While these trends are concerning, they also present an opportunity for HSSPs. When the risk of Medicare trust fund insolvency loomed in the past, Congress acted and, while it would be a politically questionable move, it is likely Congress will once again open the health policy window to address Medicare trust fund solvency. That window of opportunity is within the next few years, and health-system providers and advocacy strategists need to keep this “top-of-mind” to provide insights into solutions that support beneficiaries and the healthcare market. Another factor that will drive policy change is the high out-of-pocket expenses that Medicare beneficiaries are experiencing. In 2016, the average annual out-of-pocket spending was $5,460 per beneficiary, which exceeded 20% of the total average income for over a quarter of beneficiaries.11
When looking at how to address these cost increases, prescription drugs, including specialty drugs, are near the top of the list of expenditures. With drugs, issues involve both cost and access. Policy options are complex and wide-ranging. In order to address the cost problem, CMS is doing several things now within the current policy structure: (1) working to expand value-based payments and pay-for-performance models; (2) putting providers at risk; (3) implementing formulary structures (specialty tiers), which previously had been more often used by commercial payer plans; (4) working with manufacturers to close the “donut hole”; (5) considering how to apply competitive acquisition pricing to leverage market forces; and (6) considering the application of “most favored nation” law to require that drug pricing in the United States be equal to what other countries pay.
Dill also noted that CMS has promulgated requirements for drug spending and hospital price transparency as another strategy to allow patients to make more informed decisions. CMS has created Medicare Part D and B dashboards that are publicly available.12 The Part D Senior Savings Model for Part D drugs is another initiative to assist beneficiaries. The model’s goal is to make a stable, predictable copayment structure for beneficiaries across all benefit phases (deductible, initial coverage, coverage gap, and catastrophic). For example, the voluntary model has allowed Part D plans to provide broad access to multiple types of insulin, with a copay maximum of $35 for a 30-day supply in all phases of the Part D benefit.13 The Affordable Care Act has also allowed for experimentation with a number of other at-risk and value-based payment models. Physician and health plan quality measures have also been made transparent.
It is important that pharmacists understand what the quality measures are, making sure that pharmacists and all of the providers and entities that support the healthcare system can move the needle in the direction of achieving those quality measures. Medicare will also be launching more models that put providers and similarly situated entities at risk, such as the Medicare Shared Savings Program. It is important that all of the entities understand what defines value-based program success, then collaborate to get there. If an organization cannot drive quality, payment will be at risk.
To summarize, while Medicare solvency and cost challenges create a sense of urgency, they also present an opportunity for providers of all types to act now to develop strategies that support new models, particularly the shift from claims-based payment (ie, fee-for-service payment) to value-based payment (ie, paying for the best quality at a lower cost). All strategies must take into account outcomes and the beneficiary experience, particularly affordability and access to drug therapy.
Value-based payment: commercial payer perspective
BCBSMA’s Terrell provided a perspective of the evolution of value-based care from the view of a commercial payer responsible for a portfolio of approximately 2.5 million members. In 2019, healthcare expenditures accounted for almost 18% of the US gross domestic product, and 10% of that spending was associated with prescription drugs.14 Specialty drugs are driving steady increases in drug costs, and top categories include drugs used to treat multiple sclerosis, oncology disorders, and inflammatory conditions. The market is also seeing a shift to newer gene therapies that require expertise to deliver. However, gene therapies are more targeted and represent a one-time cost. However, the Food and Drug Administration could grant approval to 50 to 100 gene and cell therapies by 2025, with an associated projected cost of $13 billion in 2026.14
BCBSMA has approximately 1.4 million commercial pharmacy members and administers pharmacy benefits to both fully insured and self-insured accounts. Specialty drugs have a disproportionate impact on spending. In 2019, more than half of the Blue Cross total drug spend was for specialty drugs, but only 1.8% of the members received a specialty drug. Terrell noted that when considering strategies for managing specialty drug costs, it is important to understand the supply chain. For every $100 spent on prescription drugs, $41 goes to intermediaries in the supply chain, according to a 2017 report.15 Another study looked at costs in the pharmacy supply chain. The researchers noted that there is a multitude of players, which complicates addressing cost issues; and that when different models are tested, there is a need to consider how models benefit consumers, with the goal that they receive appropriate drug therapy.
Since 2009 the clinical management program at BCBSMA has aligned with value-based contracting since 2009, with a more global budget view versus fee-for-services. The Alternative Quality Contract (AQC) program initially emphasized prevention and gave flexibility to providers and health systems to implement innovative programs (eg, navigator-based and behavioral health programs). The impact of this program over time has shown that costs continue to come down. Overall savings associated with the value-based AQC program indicate phenomenal results with use of the improved patient care model and a slowing of healthcare spending by 12% (compared to spending growth in the New England region and the entire United States).
Terrell shared that commercial plans’ strategies for managing the specialty pharmacy drug spend include 3 main approaches: (1) site of care steerage (eg, benefit design, home infusion network); (2) utilization management (eg, medical policy, prior authorization, step therapy, quantity limits); and (3) clinical programs (eg, outcomes contracts, adherence goals, and quality measures). BCBSMA’s specialty network is comprised of national specialty and local provider-based pharmacies and is open to all willing providers as long as they meet predefined participation requirements based on drug access, accreditation, and oversight participation, for example. The pharmacies have performance incentives, and quarterly calls are held with each specialty pharmacy to review financial trends, operational activities, drug pipeline developments, and partnership opportunities. Quarterly dashboard reporting was added in 2019 to facilitate review of specialty medical and pharmacy prescription counts, BCBSMA liability, therapeutic category data, and drug utilization trends.
Utilization and inflation increases will continue to be the prime cost drivers in both pharmacy and medical benefits; therefore, additional strategies, such as building strong partnerships with physician and pharmacy benefit management partners, are needed in a value-based payment world. Earlier in this article, it was mentioned that the intermediaries drive cost into the supply chain system. BCBSMA is also exploring how to eliminate costs to intermediaries and possibly contract directly with manufacturers. The consumer experience is also a high priority, particularly looking at the way in which (and where) services are delivered.
To summarize, in order to manage the high cost of specialty drug therapies while ensuring quality and access, both commercial and government payers are exploring and implementing strategies to
Monitor the specialty drug pipeline and implement proactive utilization management strategies
Develop partnerships with provider organizations to drive alignment on preferred product selection
Explore direct-to-manufacturer contracting for utilization and outcomes-based agreements
Enter into risk-based agreements with pharmacies to move away from fee-for-service and toward pay for performance
Ensure touch points that improve the patient experience, compliance, and adherence to therapies
HSSPs are well positioned to partner with payers, align with these strategies, and demonstrate value to payer stakeholders.
Conclusion
The ASHP Specialty Pharmacy State of Practice in Hospitals and Health Systems — Future Directions Summit brought together thought leaders in the industry to discuss key issues impacting specialty pharmacy practice in health systems and provide insights and strategies needed to sustain and scale the high-value services they provide. There needs to be an understanding of the current market trends that are shaping the industry, a focus on outcomes research that aligns with stakeholder objectives and demonstrates the unique value HSSPs can provide, and the development and deployment of standardized measures that support value-based payment models.
Appendix A—Summit participants and observers
Summit Participants
Paul W. Abramowitz, PharmD, ScD (Hon), FASHP
Chief Executive Officer
ASHP
Bethesda, MD
Chad Alvarez, PharmD, MBA
Senior Director of Retail Pharmacy
Carilion Clinic
Roanoke, VA
Robert J. Anderson, PharmD
Oncology Pharmacist
Tuba City Regional Health Care Corporation
Tuba City, AZ
Zinkeng Asonganyi, PharmD
Director of Ambulatory Pharmacy Services
University of Texas Medical Branch
League City, TX
Sheena Babin, PharmD
Director Clinical Services and Business Development
Ochsner Health
New Orleans, LA
Heidi Barnett, PharmD, BCACP
Director of Specialty Pharmacy
Community Health Network
Indianapolis, IN
Shubha Bhat, PharmD, MS, BCACP
Clinical Pharmacist – Gastroenterology
Cleveland Clinic
Cleveland, OH
Jerry Buller, BSPharm, MMHC
Chief Pharmacy Officer
Trellis Rx
Lebanon, TN
Paul W. Bush, PharmD, MBA, BCPS, FASHP
Vice President, Resource Development and Consulting
ASHP
Bethesda, MD
Denali Cahoon, PharmD
Chief Operating Officer
Trellis Rx
Denver, CO
Udobi Campbell, PharmD, MBA
Executive Director of Pharmacy
University of North Carolina Hospitals
Chapel Hill, NC
Scott Canfield, PharmD, CSP
Assistant Director, Clinical Program Development
Johns Hopkins Home Care Group
Baltimore, MD
Karen Y. Chin, PharmD
Director – Kaiser Permanente National Specialty Pharmacy
Kaiser Permanente
San Francisco, CA
Julia M. Chisholm, PharmD, MBA, AAHIVP
Ambulatory Operations Pharmacy Manager
University of Missouri Health Care
Columbia, MO
Kristine Crawford, PharmD
Manager, Specialty Pharmacy
Virginia Mason Franciscan Health
Seattle, WA
Charles E. Daniels, BSPharm, PhD
Chief Pharmacy Officer
University of California San Diego
Associate Dean
San Diego, CA
Stephen J. Davis, PharmD, MS, FASHP
Director, Health System Strategy
Shields Health Solutions
Houston, TX
Michael DeCoske, PharmD, BCPS, FASHP
Assistant Vice President, Ambulatory Pharmacy
Baptist Health South Florida
Miami, FL
Richard Demers, BSPharm, MS, FASHP
Chief Administrative Officer, Ambulatory Pharmacy Solutions
Penn Medicine
Philadelphia, PA
Erica Diamantides, PharmD, MHA, BCPS
Specialty Pharmacy Manager
University of Washington (UW) Medicine
Seattle, WA
Gregory Dill, PharmD
Deputy Director for Innovation and Financial Management
Centers for Medicare and Medicaid Services
Baltimore, MD
Debbie Duckworth, PharmD, CSP
Senior Director, Specialty Pharmacy & Infusion Services
University of Kentucky HealthCare
Lexington, KY
Jillian Dura, PharmD
Assistant Director, Specialty Pharmacy
Cleveland Clinic
Cleveland, OH
Letrina Flowers, CPhT
Ambulatory Medication Access Coordinator
UChicago Medicine
Chicago, IL
Jorge J. Garcia, PharmD, MS, MHA, MBA, FACHE
Assistant Vice President, Pharmacy Services
Baptist Health South Florida
Miami, FL
Christopher A. Hatwig, BSPharm, MS, FASHP
President
Apexus LLC
Colleyville, TX
Rebecca Hluhanich, PharmD, AAHIVP
Senior Clinical Pharmacist: Hepatology and Infectious Diseases
UC Davis
Sacramento, CA
Travis Hunerdosse, PharmD, MBA
Director, Specialty Pharmacy Services
Northwestern Medicine
Strategy & Business Development
Chicago, IL
Clint Ivie, PharmD, MBA, CSP
Specialty Pharmacy Manager
Intermountain Healthcare
Taylorsville, UT
Cameron S. James, PharmD, MHCI, CGP
Medical Affairs Executive Director
Genentech
Nashville, TN
Tara N. Kelley, PharmD, MMHC, CSP
Executive Director, Vanderbilt Specialty Pharmacy
Vanderbilt University Medical Center
Nashville, TN
Paul R. Krogh, PharmD, MS, BCBS
System Director – Pharmacy Services
North Memorial Health
Minneapolis, MN
Andrea Lai, PharmD
Senior Director, Ambulatory Pharmacy Services
MaineHealth
Portland, ME
James Langley, PharmD, MS
Specialty Pharmacy Manager
UW Health
Madison, WI
Dylan Lindsay, PharmD, BCACP, CDCES
Clinical Pharmacy Specialist, Specialty Pharmacy Program Accreditation and Quality Management
University of Mississippi Medical Center
Jackson, MS
Lynnae Mahaney, BSPharm, MBA, FASHP
Senior Director, Pharmacy Accreditation
ASHP
Middleton, WI
Chelsea Mouser Maier, PharmD, CSP
Specialty Pharmacy Manager
UofL Health
Louisville, KY
Lubna Mazin, PharmD
PGY-2 Health-System Pharmacy Administration and Leadership Resident
Nationwide Children’s Hospital
Columbus, OH
Alex Mersch, PharmD, MBA, BCPS
Specialty Pharmacy Manager
University of Iowa Health Care
Iowa City, IA
Kimerly M. Metcalf, CPhT-Adv
Advanced Certified Pharmacy Technician
Unity Point Health
Cedar Falls, IA
Jennifer Morris, PharmD, BCPPS, FCCM
Assistant Director of Specialty Pharmacy – Clinical Services
Texas Children’s Hospital
Clinical Pharmacy Specialist – Dialysis
Texas Children’s Hospital
Houston, TX
Mel Nelson, PharmD, CSP
Regional Manager
Fairview Pharmacy Services
Minneapolis, MN
Melissa A. Ortega, PharmD, MS, FASHP
Pharmacy Director
Tufts Medical Center
Boston, MA
Steve Pate, BSPharm
Director, Outpatient Pharmacy Services
St. Jude Children’s Research Hospital
Memphis, TN
Sunil Patel, BSPharm, MHA
Sr National Director Pharmacy Continuity of Care
Ascension Health
St. Louis, MO
Tammy Pierce, BSPharm, MBA
Executive Director, Pharmacy Services
Providence St Joseph Health/Credena Health
Portland, OR
Brian Pinto, PharmD, MBA
Senior Principal
Cigna
Baltimore, MD
Laura H. Rang, BSPharm, MPH(c)
Specialty Pharmacy Manager
Children’s Hospital Colorado
Aurora, CO
Debi Reissman, PharmD
System Senior Pharmacist Specialist
Sharp HealthCare
San Diego, CA
LaTasha R. Riddick, PharmD, BCACP
Clinical Coordinator, Specialty Pharmacy
Johns Hopkins Home Care Group, Pharmacy Services
Baltimore, MD
Matthew H. Rim, PharmD, MS
Associate Director
University of Illinois Chicago
Chicago, IL
William Roth
Founding Partner
Blue Fin Group
St. Petersburg, FL
Dalia Saleh, PharmD
Director of Specialty Pharmacy, Mail Order, Central Fill and Compounding
Advocate Aurora Health
Milwaukee, WI
Jonathan Salud, CPhT
Pharmacy Technician III
Cedars-Sinai Medical Center
Los Angeles, CA
Matthew S. Saylor, PharmD, BCOP
Medical Affairs Director – Health Systems Oncology
Merck & Co, Inc.
Charlotte, NC
Denise L. Scarpelli, PharmD
Executive Director of Ambulatory Pharmacy and Business Development
University of Chicago
Chicago, IL
Bryan Schuessler, PharmD, MS
Director of Home Infusion and Specialty Pharmacy
Saint Luke’s Health System
Kansas City, MO
Mary Beth A. Seipel, PharmD
Ambulatory Clinical Lead Pharmacist, Neurology
Truman Medical Centers
Kansas City, MO
Yenia Silva, PharmD, MBA
Director of Community and Specialty Pharmacy
Memorial Healthcare System
Hollywood, FL
Betsy Lynn Sleath, BSPharm, PhD, FAPhA
Regional Associate Dean for Eastern North Carolina
UNC Eshelman School of Pharmacy
George H. Cocolas Distinguished Professor
Chapel Hill, NC
Dele Solaru, PharmD, MBA
Chief Pharmacy Officer
US Office of Personnel Management
Washington, DC
Patrick J. Sorgen, PharmD, CSP
Specialty Pharmacy Manager
Indiana University Health
Indianapolis, IN
Brian T. Spoelhof, PharmD, BCPS, BCCCP
Assistant Manager of Pharmacy – Medication Utilization Strategy
UVA Health
Charlottesville, VA
Scott Sterrett, PharmD
Director, Home Infusion & Specialty Pharmacy
Beaumont Health
Southfield, MI
Phillip Streit, PharmD
PBM National Clinical Pharmacy Specialist for Specialty Pharmacy
Department of Veterans Affairs
Hines, IL
JoAnn Stubbings, BSPharm, MHCA
Clinical Associate Professor Emerita
University of Illinois Chicago College of Pharmacy
Chicago, IL
Robert Taketomo, PharmD, MBA
President/CEO
Ventegra, Inc., a California Benefit Corporation
Glendale, CA
Julia C. Talley, BSPharm, CSP
Specialty Pharmacy Services Manager
University of Arkansas for Medical Sciences
Little Rock, AR
Kate Taucher, PharmD, MHA, BCOP
Ambulatory Oncology Clinical Specialist, PGY2 Oncology Residency Program Director
UCHealth Memorial Hospital
Medical Key Account Manager
G1 Therapeutics
Colorado Springs, CO
Karen C Thomas, PharmD, PhD
Pharmacy Supervisor
University of Utah Health
Salt Lake City, UT
Allison C. Trawinski, PharmD, MBA
Assistant Director of Specialty Pharmacy
UR Medicine – Strong Memorial Hospital
Residency Director for PGY1 Community and PGY2 Spec Admin and Leadership
Rochester, NY
Brantley M. Underwood, PharmD, MBA, CSP
Outpatient/Specialty Pharmacy Manager
Cookeville Regional Medical Center
Cookeville, TN
Robin Wanous-Williamson, RN, GERO-BC
Director of Pharmacy Program Development
Avera McKennan Hospital & University Health Center
Sioux Falls, SD
Angela Ward, BSPharm, MSB, FACHE
SVP – Specialty Services
AmerisourceBergen
Carrollton, TX
Timothy Weber, BSPharm, MBA
System Executive Director, Pharmacy
UNC Health
Durham, NC
Ian Willoughby, PharmD, MS, BCPS
Manager, Specialty Pharmacy Services
Lifespan Pharmacy
Providence, RI
Jennifer Young, PharmD, BCPS, CSP
Program Director II
Wake Forest Baptist Health
Winston Salem, NC
Autumn D. Zuckerman, PharmD, BCPS, AAHIVP, CSP
Program Director, Health Outcomes and Research
Vanderbilt University Medical Center
Nashville, TN
Summit Observers
Leigh A. Briscoe-Dwyer, PharmD, BCPS, FASHP
System Director of Pharmacy
United Health Services
Johnson City, NY
Kathryn Edwards
Marketing Director
Trellis Rx
Atlanta, GA
Amanda Fadden
Vice President, Service Quality Excellence
Trellis Rx
Minneapolis, MN
Toni Fera, PharmD
Senior Healthcare Consultant
Independent
Pittsburgh, PA
Barry C. Fuchs, PharmD, MBA, CSP
Vice President/General Manager
Trellis Rx
Minneapolis, MN
Erin C. Hendrick, PharmD, MS, FASHP
SVP, Health System Strategy
Shields Health Solutions
Atlanta, GA
Christine Hollenberg, MHA, CPHQ
Senior Director
AmerisourceBergen
Houston, TX
Thomas J. Johnson, PharmD, MBA, BCCCP, BCPS, FASHP, FCCM
Assistant Vice President – Hospital Pharmacy
Avera Health
Sioux Falls, SD
Jacob Jolly, PharmD, MMHC, CSP
Principal Consultant
Blue Fin Group
Nashville, TN
Christene M. Jolowsky, BSPharm, MS, FASHP
Senior Director of Pharmacy
Hennepin Healthcare
Minneapolis, MN
Nishaminy Kasbekar, PharmD, FASHP
Chief Pharmacy Officer
Penn Presbyterian Medical Center
Philadelphia, PA
Katie McMillen, PharmD, MPH, FACHE
Vice President
AmerisourceBergen
Carrollton, TX
Brandon Jay Newman, PharmD, MMHC, CSP
Vice President, Clinical Affairs
Trellis Rx
Atlanta, GA
Kathleen S. Pawlicki, BSPharm, MS, FASHP
Immediate Past President
ASHP
Royal Oak, MI
Andy Pulvermacher, PharmD
Senior Principal Consultant
Blue Fin Group
Madison, WI
Jeff Romano, BSPharm
VP Operations and Site Execution
Trellis Rx
Atlanta, GA
John Ryan, BSPharm
Vice President Service Solutions and Operations
AmerisourceBergen
Hopkinton, MA
Robert Scholz, MS, MBA
Senior Director, Acentrus Specialty
Vizient
Deerfield Beach, FL
Neil Smiley
Founder and CEO
Loopback Analytics
Dallas, TX
Cedric A. Terrell, PharmD, MHA
Chief Pharmacy Officer
Blue Cross Blue Shield of Massachusetts
VP Health & Medical Management
Boston, MA
Karen Tsai
Principle Strategy Manager
Genentech
South San Francisco, CA
Paul C. Walker, PharmD, FASHP
Clinical Professor and Assistant Dean, Experiential Education and Community Engagement
The University of Michigan College of Pharmacy
Ann Arbor, MI
Casey H. White, PharmD, MBA, BCCCP, BCNSP, BCPS, FASHP
Director of Pharmacy
Cookeville Regional Medical Center
Cookeville, TN
George Zula, BSPharm, MBA, CSP
Vice President, Acentrus Specialty
Apexus
Irving, TX
Footnotes
Panelist Gregory Dill provided the following statement regarding his presentation: “Dr. Dill’s presentation was prepared as a tool to assist providers and is not intended to grant rights or impose obligations. Although every reasonable effort has been made to assure the accuracy of the information within these pages, the ultimate responsibility for the correct submission of claims and response to any remittance advice lies with the provider of services. This publication is a general summary that explains certain aspects of the Medicare Program, but is not a legal document. The official Medicare Program provisions are contained in the relevant laws, regulations, and rulings. Medicare policy changes frequently, and links to the source documents have been provided within the document for your reference. The Centers for Medicare & Medicaid Services employees, agents, and staff make no representation, warranty, or guarantee that this compilation of Medicare information is error-free and will bear no responsibility or liability for the results or consequences of the use of this guide.”
Acknowledgments
Contract writer and consultant Toni Fera, PharmD, is acknowledged for drafting the manuscript of this article. She in turn acknowledges and thanks the authors of a series of 10 AJHP articles reporting the proceedings of the March 2014 ASHP–ASHP Foundation Ambulatory Care Summit (Am J Health-Syst Pharm. 2014;71:1345-1420), to which she referred for editorial guidance during manuscript preparation.
Disclosures
The authors have declared no potential conflicts of interest.
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