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Introduction
The ASHP Accreditation Standard for Specialty Pharmacy Practice reflects contemporary best practice for specialty pharmacy. The accreditation process is designed to be easy to understand, flexible, and consultative in nature and can be tailored to different models of care. The accreditation focuses on optimal care delivery through evaluation of: Effective patient care plans to achieve desired medication therapy outcomes Patient-specific assessments and optimal collection, use, and documentation of information Inclusion of specialty drug-specific assessment and disease state-specific assessment requirements Comprehensive review of the patient’s medication history and medication list prior to each fill Documentation of all pharmacy case management activities Patient consultation and education Quality metrics and quality improvement plans This standard combines the Center for Pharmacy Practice Accreditation (CPPA) standards^1 with the support of ASHP’s pharmacy expertise and accreditation history. Successful accreditation signifies to payers, patients, and other healthcare providers that the pharmacy provides an advanced level of high- quality, safe, and efficient patient care in a predictable and measurable way.
Purpose of the Standard for Specialty Pharmacy Practice
Specialty pharmacy generally revolves around the provision of 1) high cost medications with 2) special handling procedures and 3) requiring complex patient care.^2 Specialty pharmaceuticals have at least four of the following characteristics: 3 Typically high in cost ($600 or more per month) (^1) Version III, February 27, 2019; Standards used with permission of Center for Pharmacy Practice Accreditation (CPPA) (^2) Blaser DA, Lewtas AJ, et al. How to define specialty pharmaceuticals—a systematic review. Am J Pharm Benefits. 2010;2(6):371-380. (^3) Distribution Management Association’s Center for Healthcare Supply Chain Research. Specialty Pharmaceuticals Facts, Figures and Trends in Healthcare. 2012. http://www.hcsupplychainresearch.org/projects/pdfs/2012-SpecPharm-ExecSummary.pdf. Accessed December 31, 2012.
Involve complex treatment regimens that require ongoing clinical monitoring and patient education Have special handling, storage, or delivery requirements Are generally biologically derived and available in injectable, infusible, or oral form Are dispensed to treat individuals with chronic and/or rare diseases Frequently have limited or exclusive product availability and distribution Treat therapeutic categories such as oncology, autoimmune/immune, or inflammatory conditions marked by long-term or severe symptoms, side effects, or increased fatality Prescription medications continue to be among the fastest growing elements of healthcare spending,^4 and the growth of the specialty medication spend continues to outpace traditional medication growth. In 2017 the specialty medication spend was 43.4% of the total non-discounted spend in the US. The majority of new active substances launched in 2017 were considered orphan.^5 By 2022 the spending on specialty medications, including orphan and precision, is expected to reach nearly $450B.^6 Under the pharmacy and medical benefits, the members who use specialty medications account for a much greater percentage of healthcare costs. Given these factors, it is imperative that pharmacy practices help optimize the clinically appropriate use of specialty medications. The ASHP Standard for Specialty Pharmacy Practice is designed to create a consensus around the practice of specialty pharmacy and guide the accreditation process. Specialty pharmacy practice is defined as a pharmacy practice created:
- To manage the medication access and handling requirements of specialty pharmaceuticals, including dispensing and distribution, and
- To provide clinical management services for patients with chronic, serious, life-threatening and/or rare diseases or conditions^7 receiving specialty medications aimed toward achieving the desired patient therapeutic and economic outcomes. While specialty pharmacy practice continues to evolve, best practices inclusive of patient management and support, product management, medication therapy management, healthcare provider relationships, manufacturer relationships, and continuous quality improvement should remain contiguous and be readily supported by its practitioners. Established standards help to guide, describe, and gain recognition for innovative, high quality, safe and effective specialty pharmacy practices. The development of a standards-based accreditation process is critical for continuous quality improvement, consistency, and “to ensure medication safety and effectiveness, and quality of medication use for desired health outcomes.”^8 This standard seeks to provide clarity to the key metrics (^4) Kacik A. Drug prices rise as pharma profit soars. www.modernhealth-care.com/article/20171228/NEWS/171229930 (accessed 2019 Feb 13). (^5) Medication use and spending in the US: A review of 2017 and outlook for 2022. April 2018. Accessed February 13, 2019. (^6) BFG Analysis on IMS 2016 Rx Sales, CMS Office of the Actuary. Accessed February 13, 2019. (^7) http://www.healthaffairs.org/healthpolicybriefs/brief.php?brief%20id= (^8) Nahata M, et al. The academy’s agenda for improving the safety use: report of the 2006–2007 Argus Commission. Am J Pharm Ed. 2007:71(6) Article S18.
Table of Contents
Introduction ………………………………….………………………………….……………………………………………………………. xx
Purpose of The Standard for Specialty Pharmacy Practice ……….………………………………….………… xx
Domain 1.0: Organizational Infrastructure ………………………………….………………………………….………… 1
1.1 The Specialty Pharmacy Practice has Appropriate Documents and Current Licensure
Required of the Specialty Pharmacy Practice…………………………………………………………………… 1
1.2 The Specialty Pharmacy Practice Has A) A Clear Organizational Structure Including a Mission Statement, B) A Policy and Procedure Process, and C) A Process for the Delegation of Organizational Oversight and Leadership to Allow for Safe and Effective
Delivery of Services………………………………………………………………………………………………….…..…. 2
1.3 The Specialty Pharmacy Practice Describes the Scope of Specialty Pharmacy Services
Offered………………………………………………………………………………………………..…………………………. 3
1.4 The specialty Pharmacy Practice Defines and Manages Internal and External
Delegated Services………………………………………………………………………………………………..………… 4
1.5 The Specialty Pharmacy Practice has Appropriate Professional and Support Staff to
Deliver Services……………………………………………………………………………………………………..……….. 5
1.6 The Specialty Pharmacy Practice Maintains a Structure to Ensure Appropriate Fiscal
Management………………………………………………………………………………………………………………….. 6
1.7 The Specialty Pharmacy Practice has Protocols for Medication Procurement, Storage, Preparation, and Distribution for Medication Integrity and Safe and Timely
Delivery…………………………………………………………………………………………………………………………… 7
1.8 The Specialty Pharmacy Practice has an Appropriate Environment to Maintain
Patient Privacy and Deliver Patient Care Services………………………………………………………….… 8
1.9 The Specialty Pharmacy Practice Uses Systems and Technology that Support Safe
Medication Distribution Processes and Facilitate Patient Safety……………………………………… 9
1.10 The Specialty Pharmacy Practice Uses Information Systems and Technology for
Documentation and Support of the Delivery of Patient Care Services…………..………………… 9
1.11 Specialty Pharmacy Practice Information Systems Provide Access to Appropriate Evidence-Based References and Clinical Decision Support Programs that Facilitate the
Delivery of Patient Care Services…………………………………………………………………………………….. 10
1.12 The Specialty Pharmacy Practice Supports the Interoperability of Information
Systems…………………………………………………………………………………………………………………………… 10
1.13 The Specialty Pharmacy Practice Ensures The Integrity, Security, and Privacy of
Patient Information and Other Data ………………………………………………………………………………. 11
1.14 The Specialty Pharmacy Practice Maintains Policies and Procedures to Ensure
Compliance With HIPAA and HITECH Regulations…………………………………………………………… 11
1.15 The Specialty Pharmacy Practice has a Contingency Plan in Order to Maintain
Patient Care Services During Unplanned Events……………………………………………………………… 12
Domain 2.0: Medication Access Support ………………………………….………………………………….…………….. 12
2.1 The Specialty Pharmacy Practice Provides Comprehensive Benefits Investigation, Prior Authorization Assistance, And Benefits Coordination on Behalf of The Patients it
Serves……………………………………………………………………………………………………………………………… 12
2.2 The Specialty Pharmacy Practice Implements Mechanisms to Support Patient Safety
and Compliance With Manufacturer and Payer Requirements……………….………………………. 13
2.3 The Specialty Pharmacy Practice Facilitates Patient Access to Care Through the
Transparent Provision of Financial Information to the Patient and Prescriber………………… 14
Domain 3.0: Clinical and Patient Management Services ………………………………….……………………… 15
3.1 The Specialty Pharmacy Practice Facilitates Coordinated Patient Management
Through Enrollment Communications to Patients And Prescribers…………………………………. 15
3.2 The Specialty Pharmacy Practice Communicates with Healthcare Providers to
Facilitate Coordination of Patient Care………………………………….………………………………….……. 15
3.3 The Specialty Pharmacy Practice Maintains Internal Policies And Procedures for
Collaboration with Other Pharmacy Providers Included in the Patient’s Care…………………. 16
3.4 The Specialty Pharmacy Practice Maintains A Comprehensive Patient Profile For All
Patients…………………………………………….………………………………….…………………………………………. 16
3.5 The Specialty Pharmacy Practice Provides Patient-Centered Consultation and
Education Regarding Expectations of Therapy………………………………….…………………………….. 17
3.6 The Specialty Pharmacy Practice Provides and Monitors Pharmacy Patient Case
Management Services………………………………….………………………………….……………………………… 18
3.7 The Specialty Pharmacy Practice Modifies Patient Case Management Based on
Patient-Specific Factors When Needed………………………………….……………………………………….. 20
3.8 The Specialty Pharmacy Practice Evaluates and Documents Competency and Facilitates Continuing Professional Development of Staff Involved in Patient Care
Service Delivery Based on the Complexity of Services and Needs of Patients………………….. 21
3.9 The Specialty Pharmacy Practice Maintains Consistent Procedures for Patient
Notification of Delays in Therapy and Interventions……………………………………………………….. 21
3.10 The Specialty Pharmacy Practice Prohibits the Use of Refill Protocols Whereby
Specialty Medications are Filled Without Direct Patient Contact…………………………………….. 21
Domain 4.0: Quality Improvement ………………………………….………………………………………………………….. 21
4.1 The Specialty Pharmacy Practice Reports and Evaluates Quality Outcomes and Quality Metrics to Assess the Effectiveness of Patient Care Services and Promote
Continuous Quality Improvement…………………………………………………………………………………… 21
4.2 The Specialty Pharmacy Practice Implements Continuous Quality Improvement
Projects Based on Quality Metric Reports…………………………………………………………..…………… 26
4.3 The Specialty Pharmacy Practice Provides Accurate Data Reports………………..…………… 27
Domain 1.0: Organizational infrastructure
The specialty pharmacy practice has an organizational infrastructure to support the
provision of specialty pharmacy care.
1.1 The specialty pharmacy practice has appropriate documents and current licensure required of the specialty pharmacy practice. NARRATIVE: It is expected for accreditation that the patient care, dispensing services, and support services provided by the specialty pharmacy practice and as described in their Scope of Services demonstrate compliance with applicable state and national regulatory requirements and/or standards established by a recognized organization appropriate for the services provided. The specialty pharmacy practice may or may not have a legal department or outside legal counsel to ensure necessary legal and regulatory compliance including resolution of conflict between state and federal laws and regulations. In order to provide pharmacy services beyond the borders of a pharmacy’s home state, out-of-state licensure and additional documentation may be applicable. Dispensing, wholesaling, infusion service provision and nursing services require individualized licensure with practice-specific oversight guiding individual practice authority. Maintaining an adequate and well-trained workforce is essential for high quality patient care and to reduce organizational risk. Regarding the staff of the specialty pharmacy practice, all pharmacists and nurses are licensed or registered and all technicians are licensed, registered, and/or certified, as required by state regulations. The specialty pharmacy practice has mechanisms for ensuring that all pharmacists and technicians are in good standing in all states where they are licensed/registered/ certified through verification of licensure, registration, certifications and continuing education requirements. 1.1.1 The pharmacy practice has a written code of conduct demonstrating the practice’s commitment to provision of ethical care and services. NARRATIVE:
- The specialty pharmacy practice has a written code of conduct that articulates the practice’s commitment to the provision of ethical care and services. The written code of conduct articulates the practice’s commitment to comply with all applicable statutory and regulatory requirements and includes expectations of its staff and professional pharmacy partners to act in an ethical and compliant manner and ramifications of failure to comply with these expectations, i.e. disciplinary actions.
- The code of conduct encourages employees, management, and board members or other governing body members to report violations of law and policy to the specialty pharmacy practice and/or to the board of pharmacy of the state and/or to law enforcement.
- The code of conduct is approved and reviewed periodically by the specialty pharmacy practice board of directors or senior management.
GOAL :
The specialty pharmacy implements sales and marketing practices, through policy implementation, orientation, and training of sales and marketing personnel, that support the practice’s expectations of its staff and professional pharmacy partners to act in an ethical and compliant manner. 1.1.2 The specialty pharmacy practice has a Compliance Program. NARRATIVE: The specialty pharmacy practice has a written compliance program implemented for the entire organization. The program includes the following elements:
- Written policies and procedures (SPP 1.1, SPP 1.1.1, SPP 1.1.2, SPP 1.5, SPP 1.6, SPP 1.7) address the organization’s commitment to compliance, risk areas for potential fraud (i.e. claims processing) and financial relationships with prescribers.
- A compliance officer and committee (SPP 1.1.2) are charged with the operation and monitoring of the compliance program and report directly to executive management.
- Training and education (SPP 1.1.1, SPP 1.1.2, SPP 1.5) include effective corporate compliance training on hire and annually.
- Lines of communication (SPP 1.1.1, SPP 1.1.2, SPP 1.2) assure effective communication of complaints and a means to protect complainants from retaliation.
- Enforcement and disciplinary guidelines (SPP 1.1.1, SPP 1.1.2) address response to allegations of compliance program infractions and enforce disciplinary action against employees who have violated laws and regulations.
- Auditing and monitoring (SPP 4.1) are used to monitor and ensure regulatory, contractual, and procedural compliance.
- Responses to detected offences and corrective action (SPP 1.5, SPP 4.1) address investigation and remediation of systemic compliance problems.^9 1.2 The specialty pharmacy practice has a) a clear organizational structure including a mission statement, b) a policy and procedure process, and c) a process for the delegation of organizational oversight and leadership to allow for safe and effective delivery of services. NARRATIVE: Specialty pharmacy practice requires a clear understanding of business relationships, internal reporting, and documented organizational structure. This organizational structure includes the direct and indirect reporting relationships within the organization and with service providers to whom specialty pharmacy practice roles are contractually delegated. Organizational structure documentation is inclusive of pharmacy ownership, management, reporting structure, and delegated authority to outside entities. A patient-centered mission statement that reflects the services provided to the patient is an essential guide for the specialty pharmacy practice and is posted in the practice setting to serve as a reminder to (^9) References: Compliance Resources, US DHHS, OIG. Available at: https://oig.hhs.gov/compliance/101/index.asp. Accessed 5/6/2018. Compliance Guidance, US DHHS. OIG. Available at: https://oig.hhs.gov/compliance/compliance-guidance/index.asp. Accessed 5/6/2018.
- Behavioral health
- Bleeding disorders
- Bone marrow transplantation
- Fertility and high-risk pregnancy
- Growth disorders
- Hepatology
- Hereditary angioedema (HAE)
- HIV
- Hypercholesterolemia
- Immune globulin therapy (IV or subcutaneous)
- Inflammatory conditions (includes rheumatology, dermatology, gastroenterology)
- Infusible oncology/hematology
- Osteoporosis
- Multiple sclerosis
- Oral oncology/hematology
- Pulmonary disorders (cystic fibrosis, pulmonary arterial hypertension)
- Renal failure
- Restricted distribution or orphan pharmaceutical-specific support programs
- Solid organ transplantation 1.4 The specialty pharmacy practice defines and manages internal and external delegated services. NARRATIVE: Delegated services may be provided by contracted internal organizational staff or by external contracted healthcare providers whose activities are under the control of the specialty pharmacy practice. These delegated roles do not supplant the requirement that specialty pharmacy practice staff be able to provide these delegated services when needed at the point of patient contact. Delegated roles are clearly defined, contractually documented, and of appropriate scope. Contracts include training and competency requirements of staff providing services. The specialty pharmacy practice is responsible for all aspects of delegated services. Delegated services, which may be services traditionally provided by a specialty pharmacy, are documented and integrated into the specialty pharmacy practice’s patient record. Contracts or service agreements for the delegated services and the performance of the delegated services are reviewed by the specialty pharmacy practice at regular intervals to ensure that services are appropriately provided and to ensure that delegation contracts and service agreements are current and accurate. Significant changes to delegated services contracts or agreements should be reported to ASHP. 1.5 The specialty pharmacy practice has appropriate professional and support staff to deliver services.
NARRATIVE:
The specialty pharmacy practice has appropriate staff management procedures to support overall operations and patient care. Effective staff management also aligns the roles of employees within the overall specialty pharmacy practice and assists in maintaining the integrity and consistency of the operations and patient care services. The specialty pharmacy practice has the following elements for effective staff management:
- Job descriptions for each category of staff that outline duties, functions, and responsibilities so that each employee understands precisely and in sufficient detail the tasks and functions that are expected and permitted by regulation in the course of performing his or her job or scope of service, and to whom the employee reports. The categories may include the pharmacist-in-charge, the pharmacy manager, the staff pharmacist, the pharmacy graduate intern, the pharmacy resident, the student pharmacist, the pharmacy technician, ancillary pharmacy staff, nurses, and other healthcare providers where applicable. The specialty pharmacy practice ensures that all employees are vigilant about performing only those tasks permitted by their category, are competent in their role, understand the practice’s policies and procedures, and know who to contact with concerns about their scope of practice. The specialty pharmacy practice has a defined scope of practice for pharmacists. The scope defines the necessary credentials and skill level for the specialty pharmacy practice. The pharmacist scope of practice is obtained through careful review of pharmacist qualifications, training, and demonstration of skills and allows for collaborative medication management, where practice setting allows. There is a written procedure for position description approval and frequency of update.
- Hiring procedures that include initial review of credentials. These procedures are standardized and documented in order to assess and maintain competent staff. Necessary education and training required for each position are documented and reviewed as part of the hiring process. Such practices include those related to ensuring all staff is compliant with the continuing education requirements of the relevant licensing or credentialing board. Other elements that should be included and documented as part of the hiring and ongoing process are employee background checks, review of OIG Medicare and Medicaid fraud registry, safety, infection control, HIPAA and patient privacy, malpractice insurance carriage for applicable positions, and applicable health factors for staff in direct patient contact. Specifically, the pharmacy practice has comprehensive TB screening, hepatitis B, and influenza vaccination programs for their employees who come in direct contact with patients. Other screenings and vaccinations may be applicable.
- Staff training and skills assessment as part of initial orientation as well as ongoing training to maintain job competency. This training will vary by job or profession but should include what staff needs to know to perform job duties and to have the most current knowledge required for job competency on an ongoing basis. Training also includes confidentiality of personal health information and organizational proprietary information, conflict of interest disclosures, and code of conduct policies.
- A performance appraisal system that includes an annual performance review aligned to the duties, responsibilities, and roles required for each staff member’s specific job description and defined measures of success including performance levels related to patient care programs. The specialty pharmacy practices recognize the power of performance evaluations and ensure that these
patient collections and accounting, billing units associated with specialty medications, and third-party audits to ensure financial integrity and timely access of medications for patients. 1.7 The specialty pharmacy practice has protocols for medication procurement, storage, preparation, and distribution for medication integrity and safe and timely delivery. NARRATIVE: Specialty pharmaceuticals routinely have specific handling requirements necessary for medication potency and integrity at the point of administration by the patient. Even in the absence of these special handling requirements, the significant costs associated with specialty medications require the specialty pharmacy practice to have the ability to reconcile delivery of medication to the patient. Because of the high percentage of specialty medication delivered via mail or courier service, diligence is exercised by the specialty pharmacy practice to protect and ensure safe delivery of medications to the patient. These policies and procedures include supply chain, storage, medication preparation, inventory control and delivery. The specific areas are the following: Supply chain: Due to the costs associated with specialty pharmacy therapy and the increasing risks associated with tertiary or “grey” market suppliers, specialty and non-specialty pharmaceuticals are sourced from licensed (minimum) and accredited (desired) distributors, wholesalers or manufacturers to ensure patient safety. This includes all branded and generic medications provided to patients under the care of the pharmacy provider. It is the responsibility of the applicant pharmacy to ensure that the specialty pharmacy practice stays current with established regulatory requirements governing supply chain and medication provision. The specialty pharmacy should ensure it has processes to prevent the dispensing of medications that have been adulterated, misbranded, are/or suspected of being counterfeit or fraudulent. Medication products should be visually inspected upon receipt and put into inventory. Additionally, inventory control should detect theft or diversion, and include investigating and reporting suspicious events to the appropriate agency, if warranted. Storage: Specialty pharmaceuticals have specific storage requirements and frequent requirements for inventory reporting. The specialty pharmacy practice ensures that medications are stored appropriately and pursuant to manufacturer requirements. The specialty pharmacy practice also demonstrates ability to identify storage temperatures, humidity conditions and have procedures for continuous temperature and humidity monitoring and detection of variances and excursions, as well as addressing ambient refrigerator or freezer storage conditions. Storage refers to both the act of medication storage and the ability to accurately reconcile medication inventory stored within the pharmacy location. The specialty pharmacy practice has mechanisms to track inventory levels and provide reporting via a reliable inventory tracking tool for internal auditing and reporting requirements. Appropriate physical storage conditions are ensured from the point of receipt from the medication source, storage at the pharmacy level, medication preparation at the site of dispensing, and throughout the delivery process of providing medication to the patient.
Medication recalls, outdated and returned medications: The specialty pharmacy practice has systems, policies, and procedures in place to appropriately manage medication recalls, outdated drugs, and returned medications. If the specialty pharmacy practice participates in a drug take-back program, it complies with applicable regulations as well as established policy and protocol. Medication preparation: During the process of medication preparation, storage and labeling, refrigerated medications are at risk of exposure to excessive temperatures if preventative safeguards are not in place. Generally, refrigerated medications should be at room temperature for a limited time, consistent with good handling practices, during medication preparation and labeling procedures. Pharmacy staff is protected from exposure to hazardous medications and other materials used in the preparation of the specialty medications. Medication delivery: Medication delivery represents the largest threat to overall medication stability as temperatures can vary widely based on different courier options. The threat of temperature fluctuation is greater for refrigerated medications but also exists for non-refrigerated medications. The specialty pharmacy practice ensures that medications are shipped by the most appropriate method to accommodate the storage requirements of the therapeutic agent being provided to the patient. While disposable temperature sensors and non-pharmacy-based packaging suppliers exist, it is the responsibility of the pharmacy to ensure that internal procedures are developed and appropriate for medication delivery including routine and seasonal temperature monitoring. The specialty pharmacy practice has internal policies and procedures to ensure that internal packaging protocols are appropriate for temperature integrity of packaged medications. Medications are packaged and shipped by an appropriate courier to ensure that the medication is maintained within the manufacturer’s or USP storage requirements while in transit through receipt of the package by the patient or patient caregiver. Hazardous Medications: The practice has procedures for handling, storage, preparation, and delivery of hazardous medications, including other hazardous materials and access to Safety Data Sheets. 1.8 The specialty pharmacy practice has an appropriate environment to maintain patient privacy and deliver patient care services. NARRATIVE: The specialty pharmacy practice provides patient care services in a setting that maintains privacy and confidentiality and provides the pharmacy staff access to relevant patient information. The specialty pharmacy practice has a procedure to make pharmacy staff members aware of privacy requirements and takes measures to secure patient information and protect patient privacy and confidentiality. The specialty pharmacy practice ensures that patients receive services, including services delivered telephonically, in a space that provides the level of privacy which reduces noise and visibility and is
The pharmacy practice has a system that reduces alert fatigue and provides the most clinically relevant information to the pharmacist regarding the patient’s medication therapy. In addition, the pharmacy practice ensures that this clinical information is available at the point of care, at the location where counseling occurs, and to the pharmacist who is performing the counseling. 1.11 Specialty pharmacy practice information systems provide access to appropriate evidence- based references and clinical decision support programs that facilitate the delivery of patient care services. NARRATIVE: Pharmacy information systems provide access to clinical decision support programs that include current drug interaction and adherence screening methodologies for guidance in up-to-date clinical decision- making efforts. The specialty pharmacy practice ensures that the software is readily available and routinely updated to assist the pharmacy staff in effective clinical decision-making. The specialty pharmacy practice establishes expectations for utilization of the most current references and the primary literature in the provision of patient care services. GOAL: The specialty pharmacy practice implements clinical decision support programs, as described by the Agency for Healthcare Research and Quality (AHRQ)^10 , that aid in guiding evidence-based decision- making. 1.12 The specialty pharmacy practice supports the interoperability^11 of information systems. NARRATIVE: Patient care is improved through the sharing of patient information among patient care providers. The specialty pharmacy practice implements strategies to facilitate the foundational exchange of medical and medication information. The exchange or transmission of data occurs via fax or telephone or other appropriate method and the practice is able to accept e-prescribing transmissions. This exchange is primarily for the purpose of sharing information between and among appropriate healthcare providers. GOAL: The specialty pharmacy practice explores strategies for and takes steps to implement technology to electronically interface with other healthcare entities to exchange and make use of information by means of electronic health records (EHR). 1.13 The specialty pharmacy practice ensures the integrity, security, and privacy of patient information and other data. (^10) References: What is Clinical Decision Support? Available at: http://www.himss.org/library/clinical-decision-support. Accessed 3/27/2018. Clinical Decision Support (CDS). AHRQ. Available at: https://healthit.ahrq.gov/ahrq-funded-projects/current-health-it-priorities/clinical- decision-support-cds. Accessed 3/27/2018. Clinical Decision Support (CDS), Chapter 1: “Approaching Decision Support in Medication Management”, Section 1 – Introduction. AHRQ. Available at: https://healthit.ahrq.gov/ahrq-funded-projects/current-health-it- priorities/clinical-decision-support-cds/chapter- 1 - approaching-clinical-decision/section- 1 - introduction. Accessed 3/27/2018. (^11) Interoperability means the ability of health information systems to work together within and across organizational boundaries in order to advance the effective delivery of healthcare for individuals and communities. Reference: www.himss.org/library/interoperability- standards/what-is. Accessed 3/27/
NARRATIVE
- The specialty pharmacy practice has policies and procedures to ensure information systems and technology are tested, validated, and updated on a routine basis.
- The specialty pharmacy practice information system utilizes the most recent National Council for Prescription Drug Programs standards or other appropriate standard(s), and the specialty pharmacy practice routinely receives updates to ensure use of current standards.
- Specialty pharmacy practice information systems have routine maintenance, validation, update, backup, cyber security, and data-retrieval systems.
- The specialty pharmacy practice has quality assurance mechanisms to monitor and respond to concerns with performance of pharmacy information systems and technology.
- Specialty pharmacy practice data are secure and protected from unauthorized access. The specialty pharmacy practice protects and secures the integrity and confidentiality of patient and transactional data. The specialty pharmacy practice has protocols to establish (provision) access to sensitive information including patient and human resource information, to revoke (deprovision) access when appropriate, and to periodically evaluate employee lists for properly continuing access at existing level. The specialty pharmacy practice ensures that the pharmacy information systems containing patient information meet or exceed security requirements of the Health Insurance Portability Accountability Act (HIPAA), the Payment Card Industry Data Security Standard, and other industry standards governing the protection of electronic protected health information. The specialty pharmacy practice ensures the maintenance of standard operating procedures including documentation of all staff with access to patient information. 1.14 The specialty pharmacy practice maintains policies and procedures to ensure compliance with HIPAA and HITECH regulations. NARRATIVE: Because data reporting and fee-for-service agreements are commonplace within the specialty pharmacy marketplace, it is imperative that specialty pharmacy practices ensure compliance with regulations protecting patient confidentiality. This preservation of patient confidentiality includes all aspects of pre- dispensing BI services, prior authorization (PA) services, dispensing services, and data reporting services. Specifically within fee-for-service data reporting (non-mandated by payer or manufacturer agreement) patients must be given the opportunity to opt-out of data reporting streams. The specialty pharmacy has a HIPAA policy in place for employees, vendors, and contractors and the policy includes names of privacy officers, crisis plan, provision of patient documentation, and destruction of protected health information. With any revisions to regulations governing privacy, such as the HITECH Act provisions and HIPAA requirements, specialty pharmacy practices ensure pharmacy staff is trained. Following privacy regulations, the pharmacy practice provides outbound phone calls and patient assessments to drive overall compliance rates and improve the outcomes of medication therapy. Equivalent services are provided to all patients as a standard of care service irrespective of fee-for- service agreements tied to particular medications within a therapeutic class.
to a third party. As with other delegated functions, delegation documentation is regularly reviewed for compliance and delegation relationships are fully disclosed, as needed. The specialty pharmacy practice conducts benefits coordination when providing BI and PA assistance services by coordinating information and involvement of the prescriber, other healthcare providers, and other sources of assistance, whenever possible. A major benefits coordination service provided by the specialty pharmacy practice to patients is identifying various sources of financial assistance (manufacturer-sponsored copay cards, manufacturer product assistance, and foundational assistance) and enrolling patients on their behalf after they authorize the service. The outcome of BI and PA services and benefits coordination (especially patient financial assistance) is communicated to the prescriber by an appropriate method of communication as a means of fostering collaborative patient management. 2.2 The specialty pharmacy practice implements mechanisms to support patient safety and compliance with manufacturer and payer requirements. NARRATIVE: Specialty pharmacy practice represents an area of pharmacy practice in which establishing relationships with pharmaceutical manufacturers and payers are integral for gaining/retaining access to specialty pharmaceuticals, providing care to patients, and facilitating patient safety from the time an order is initiated and for the duration of therapy. Specialty medications frequently have restricted distribution networks and require data reporting to manufacturers on dispensing volumes, inventory levels, and patient load. Payer reporting may include call center metrics, formulary and pharmacist interventions, copay compliance, patient adherence and persistence rates, plan cost avoidance, and other dispensing metrics. Manufacturers provide patient support services through reimbursement HUBS. The registration of patients with these HUB services and the integration of specialty pharmacy practice services with existing HUB services, when appropriate, are frequently required to ensure patient access to manufacturer-sponsored medication financial assistance. In addition, Risk Evaluation and Mitigation Systems (REMS) requirements are integrated into the specialty pharmacy practice in order to support manufacturers in maximizing patient medication safety. Data reporting is a critical component of specialty pharmacy. Data reporting is frequently required pursuant to inclusion in third-party payer contracts as a mechanism to support quality metrics, cost avoidance, and other measures to support specialty pharmacy network inclusion. Data reporting to pharmaceutical manufacturers is often required in order to gain access to limited distribution pharmaceuticals. Specialty pharmacy practices may be compensated for this and other non-dispensing- related activities as part of product/manufacturer-specific fee-for-service agreements. Specialty pharmacy practices can best meet these reporting requirements by having data/ information systems with the capabilities and capacity to generate and support such reporting.
2.3 The specialty pharmacy practice facilitates patient access to care through the transparent provision of financial information to the patient and prescriber. NARRATIVE: Patient acceptance of and long-term compliance with therapeutic regimens are critical for positive therapeutic outcomes from specialty medication therapies. Through a collaborative, patient-centric approach to patient enrollment and financial assessment and education, specialty pharmacists are uniquely qualified to enhance patient adherence and drive improved overall outcomes. As in Standard 2.1, prescribers are increasingly dependent on specialty pharmacy practices to provide support for their patients through benefits investigation (BI) and prior authorization (PA) services. Through these arrangements, the prescriber is often insulated from the true cost of therapy at the patient level and may be unaware of the overall cost of therapy when alternate therapy exists. Enrollment of patients in manufacturer-sponsored copay assistance programs and the selection of a preferred pharmacy provider shields patients from the true cost of care, and patients are often undereducated about the financial implications of therapy initiation. Manufacturer-sponsored programs often reduce or eliminate deductible phases of coverage, significant coinsurance, and specialty tier copay structures. These programs also protect the patient from adverse formulary agent selection, which could potentially lead to higher out-of-pocket costs if the patient were fully responsible for the costs of therapy. The collaborative approach to patient access to care through the transparent provision of financial information is multi-factorial and includes the following:
- Financial assessment and patient education: Through the BI and PA process, specialty pharmacy practice staff is able to fully understand the financial implications of therapy. Staff is fully able to manage patient assistance programs. Prior to enrolling patients in these programs, pharmacy staff will provide full information to patients about the sources of funding and any long-term implications of programmatic changes which could impact the financial responsibility of the patient.
- Manufacturer-sponsored programs: These programs provide a clear financial benefit to patients. Prior to enrolling patients in these programs, pharmacy staff will provide full information to patients about the sources of funding and any long-term implications of programmatic changes which could impact the financial responsibility of the patient. This information is also provided to prescribers as a means of keeping them abreast of patient therapy initiation and the financial responsibility of their patients when making therapy choices. Enrollment in these programs is not used as a means of shifting patients away from appropriate generic substitution without substantive reason that the generic medication cannot be used. In addition, specialty pharmacy staff ensures compliance with manufacturer-based patient financial support systems (copay cards, etc.). Acquisition cost of the pharmaceutical to the specialty pharmacy practice does not adversely influence patient utilization of nonpreferred/nonformulary options, which increase the cost of care to payers unless it can be documented that the patient has exhausted formulary options.
- Transparency in pharmacy choice: If, during the course of BI or PA, it is determined that the patient’s insurance mandates care through another pharmacy provider, it is an obligation of specialty pharmacy practice to assist the patient with navigating the care system to establish care
