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Certified Pharmacy Policy Analyst (CPPA)
Official Examination Content Outline
This document provides the official content outline for the Certified Pharmacy Policy Analyst (CPPA) examination. The exam certifies that a candidate possesses the expertise to research, analyze, develop, and evaluate pharmacy-related policies, laws, and regulations, and to effectively communicate the impact of these policies on healthcare systems, providers, and patients.
Examination Specifications
| Name of Credential | Certified Pharmacy Policy Analyst (CPPA) |
|---|---|
| Certification-Issuing Body | The Council on Pharmacy Standards (CPS) |
| Designation Awarded | CPPA |
| Target Population | Pharmacists and professionals in managed care, government, health systems, and life sciences. |
| Examination Length | 120 multiple-choice items |
| Administration Time | 3.0 hours |
Examination Content Outline
The CPPA examination is weighted according to the six domains listed below, which cover the complete lifecycle of policy work and integrate modern competencies in data analytics, health equity, and technology.
| Domain 1: Policy Research and Environmental Analysis | 20% |
| Domain 2: Healthcare Economics and Financial Analysis | 20% |
| Domain 3: Policy Development and Implementation | 20% |
| Domain 4: Communication, Advocacy, and Evaluation | 15% |
| Domain 5: Health Equity, Ethics, and Global Policy | 15% |
| Domain 6: Emerging Technology and Digital Health Policy | 10% |
Domain 1: Policy Research and Environmental Analysis (20%)
Task 1: Monitor and interpret the legislative, regulatory, and judicial landscapes.
- Track proposed bills and regulations at federal and state levels impacting pharmacy.
- Analyze the implications of judicial decisions and legal precedents on healthcare policy.
- Interpret rules and guidance from key government agencies (e.g., FDA, CMS, DEA, HRSA).
- Differentiate between statutes, regulations, and agency sub-regulatory guidance.
- Utilize legislative tracking services and government publications to maintain situational awareness.
Task 2: Apply data analytics and real-world evidence (RWE) to inform policy research.
- Interpret research evidence from clinical trials, observational studies, and systematic reviews.
- Assess the validity and reliability of real-world data (RWD) sources, such as claims and EHRs.
- Evaluate how RWE is used by regulatory bodies for post-market surveillance and coverage decisions.
- Synthesize findings from multiple data sources to determine the weight of evidence on a policy question.
- Translate complex statistical concepts from data analyses into practical implications for policy.
Task 3: Conduct environmental scans and stakeholder analyses.
- Identify all key stakeholders and analyze their positions, influence, and interests.
- Perform situational analyses (e.g., SWOT) to evaluate the feasibility of policy proposals.
- Map the political, economic, and social forces influencing a policy issue.
- Gather qualitative intelligence through stakeholder interviews, surveys, and focus groups.
- Synthesize scan findings into a comprehensive report to inform strategic planning.
Task 4: Conduct policy simulation, forecasting, and risk analysis.
- Develop models to forecast the potential outcomes of a policy under different assumptions.
- Use scenario planning to stress-test proposed policies against various future states.
- Analyze and predict potential unintended consequences of policy interventions.
- Utilize forecasting methods to project future trends in drug spending, utilization, and access.
- Assess and formulate mitigation strategies for political, operational, and financial risks.
Task 5: Evaluate policies for specialty pharmaceuticals and novel therapies.
- Differentiate the regulatory pathways and market access challenges for biologics, biosimilars, and cell/gene therapies.
- Analyze the impact of the Orphan Drug Act on the development and pricing of rare disease treatments.
- Assess policies designed to encourage biosimilar uptake and market competition.
- Evaluate unique reimbursement and distribution models for high-cost therapies.
- Analyze the role of limited distribution networks and specialty pharmacies in managing access.
Task 6: Analyze the structure and function of U.S. healthcare systems.
- Differentiate between public and private payers, including Medicare, Medicaid, and commercial health plans.
- Map the pharmaceutical supply chain, including manufacturers, wholesalers, PBMs, and pharmacies.
- Evaluate the roles and interactions of integrated delivery networks, ACOs, and other care models.
- Assess how market consolidation impacts competition, cost, and access.
- Analyze the flow of payment and products for drugs covered under both the pharmacy and medical benefit.
Domain 2: Healthcare Economics and Financial Analysis (20%)
Task 1: Analyze drug pricing, reimbursement, and supply chain economics.
- Differentiate between drug pricing benchmarks (e.g., WAC, ASP, NADAC) and their use in payment calculations.
- Analyze the economic role and financial incentives of PBMs, wholesalers, and GPOs.
- Evaluate the impact of patents, market exclusivity, and generic/biosimilar competition on pricing.
- Assess the financial mechanisms of manufacturer rebates and DIR fees.
- Model the flow of funds for a prescription from payer to pharmacy.
Task 2: Develop budget and financial impact models.
- Construct models to forecast the financial impact of a legislative or regulatory change on an organization.
- Calculate the return on investment (ROI) for a proposed clinical program or policy intervention.
- Perform sensitivity analyses to test the robustness of financial projections against key assumptions.
- Differentiate between direct costs, indirect costs, and cost avoidance in a financial analysis.
- Present budget impact analyses in a clear, compelling format for executive decision-making.
Task 3: Evaluate the economic impact of utilization management strategies.
- Analyze the financial trade-offs between the administrative costs and savings generated by prior authorization.
- Assess the economic impact of formulary design, including tiered co-pays, preferred drug lists, and exclusions.
- Model the financial effects of step therapy, quantity limits, and site-of-care policies.
- Evaluate the role of utilization management in steering patients toward more cost-effective therapies.
- Quantify the potential for unintended costs arising from utilization management, such as non-adherence.
Task 4: Analyze value-based care models and payment reforms.
- Evaluate pharmacy’s role and financial incentives within ACOs, bundled payments, and medical homes.
- Analyze the structure and financial risk of outcomes-based contracts for pharmaceuticals.
- Assess how value assessment frameworks (e.g., ICER) influence payer negotiations and coverage policy.
- Differentiate payment models that reward value over volume in medication use.
- Model the financial implications for a pharmacy or health system participating in value-based payment arrangements.
Task 5: Apply pharmacoeconomic principles to policy decisions.
- Interpret the results of cost-effectiveness, cost-utility, and cost-benefit analyses.
- Evaluate the quality and relevance of economic evidence presented in formulary dossiers.
- Analyze an Incremental Cost-Effectiveness Ratio (ICER) and its implications for coverage decisions.
- Assess how pharmacoeconomic evidence is used in P&T committee deliberations.
- Differentiate between economic evaluations conducted from a payer, provider, or societal perspective.
Task 6: Assess the financial implications of the 340B Drug Pricing Program.
- Analyze the eligibility requirements and compliance obligations for 340B covered entities.
- Calculate the potential 340B savings and their impact on a covered entity’s budget.
- Evaluate the financial risks associated with duplicate discounts, diversion, and GPO prohibition violations.
- Analyze the financial impact of manufacturer restrictions and payer reimbursement policies on 340B programs.
- Assess how covered entities are required to use 340B savings to benefit patients.
Domain 3: Policy Development and Implementation (20%)
Task 1: Design evidence-based policy proposals and recommendations.
- Translate research findings, financial analyses, and environmental scans into a coherent policy proposal.
- Formulate clear, measurable, and achievable policy objectives.
- Draft policy language that is unambiguous and operationally feasible.
- Develop a compelling narrative and rationale to justify the proposed policy.
- Present policy options with a balanced analysis of the pros and cons of each.
Task 2: Develop clinical coverage policies and criteria.
- Translate evidence-based guidelines into objective, clinically sound coverage criteria.
- Design criteria for prior authorization and step therapy that balance access with appropriate use.
- Develop policies for formulary exceptions and medical necessity reviews.
- Establish a process for the transparent review and update of all clinical criteria.
- Ensure coverage policies comply with all applicable state and federal regulations (e.g., non-discrimination).
Task 3: Design operational workflows to support policy implementation.
- Map current and future state processes to translate policy into practice.
- Develop standard operating procedures (SOPs) that align with new policy requirements.
- Identify the technology, staffing, and training resources needed for successful implementation.
- Design workflows that are efficient, compliant, and minimize administrative burden.
- Incorporate quality assurance checkpoints and feedback loops into workflow designs.
Task 4: Apply implementation science frameworks to support policy adoption and sustainability.
- Select frameworks (e.g., RE-AIM, CFIR) to guide policy implementation and evaluation.
- Identify and address barriers and facilitators to the adoption of new policies in real-world settings.
- Design strategies to promote stakeholder buy-in and organizational readiness for change.
- Develop plans for scaling up successful policy interventions.
- Create monitoring systems to assess implementation fidelity and ensure long-term sustainability.
Task 5: Manage the policy lifecycle within an organization.
- Establish a systematic governance structure for policy review, approval, and maintenance.
- Maintain a centralized, version-controlled repository for all official policies.
- Develop a schedule and process for the periodic review and retirement of outdated policies.
- Ensure policies are updated in response to changes in regulations, evidence, or organizational goals.
- Track and document policy revisions to maintain a clear audit trail.
Task 6: Translate broad legislation into specific organizational policies.
- Conduct a gap analysis to identify discrepancies between new legal requirements and current practices.
- Develop or revise internal policies and procedures to ensure full compliance with new laws.
- Break down complex legal mandates into actionable requirements for different departments.
- Collaborate with legal and compliance departments to ensure accurate interpretation.
- Design a project plan for achieving and demonstrating compliance by established deadlines.
Domain 4: Communication, Advocacy, and Evaluation (15%)
Task 1: Communicate policy analysis to diverse stakeholders.
- Synthesize complex policy issues into concise policy briefs, white papers, and executive summaries.
- Develop and deliver compelling presentations tailored to different audiences (e.g., executives, clinicians, legislators).
- Translate complex regulatory and economic concepts into plain language.
- Utilize data visualization techniques to present quantitative information effectively.
- Facilitate meetings on contentious policy issues to build consensus and alignment.
Task 2: Design and execute strategic advocacy plans.
- Develop a strategy to influence legislative or regulatory outcomes based on organizational goals.
- Draft comment letters in response to proposed rules that are evidence-based and persuasive.
- Prepare materials for and participate in legislative visits and agency meetings.
- Build coalitions with other organizations to amplify advocacy efforts.
- Design grassroots advocacy campaigns to mobilize members or the public.
Task 3: Manage public relations, digital advocacy, and crisis communication.
- Prepare talking points, press releases, and background materials for media inquiries.
- Develop and execute social media campaigns to support advocacy goals and disseminate information.
- Formulate and deploy crisis communication plans for public health events like drug shortages or safety recalls.
- Monitor digital and traditional media to assess public sentiment and counter misinformation.
- Serve as or support a designated spokesperson on policy matters.
Task 4: Engage with professional associations and stakeholder groups.
- Represent the organization in the policy committees and workgroups of professional associations.
- Network with policy analysts from other organizations to gather intelligence and share best practices.
- Collaborate with patient advocacy groups on issues of mutual interest.
- Build and maintain relationships with key staff at government agencies and legislative offices.
- Contribute to the development of consensus-based policy statements and standards.
Task 5: Design and conduct program and policy evaluations.
- Develop an evaluation plan with clear, measurable research questions and objectives.
- Select appropriate metrics and key performance indicators (KPIs) to measure policy impact.
- Differentiate between process, outcome, and impact evaluation designs.
- Use mixed-methods approaches to assess a policy’s effectiveness and identify unintended consequences.
- Analyze evaluation data to draw evidence-based conclusions about a policy's success.
Task 6: Report on policy outcomes to inform future decisions.
- Develop specific, actionable recommendations based on evaluation findings.
- Write comprehensive evaluation reports summarizing the methodology, results, and conclusions.
- Present evaluation findings to leadership to guide decisions on continuing, modifying, or terminating policies.
- Disseminate evaluation results to external stakeholders to contribute to the broader evidence base.
- Integrate lessons learned from evaluations into the development of new policies.
Domain 5: Health Equity, Ethics, and Global Policy (15%)
Task 1: Analyze the impact of policy on health disparities.
- Use data to identify disparities in access, cost, and outcomes among different populations.
- Evaluate how social determinants of health (SDOH) interact with pharmacy policy.
- Assess the potential for a proposed policy to widen or narrow existing health disparities.
- Analyze policies specific to underserved and rural communities (e.g., FQHCs, Critical Access Hospitals).
- Recommend policy modifications to advance health equity and mitigate discriminatory effects.
Task 2: Apply ethical principles to pharmacy policy analysis.
- Analyze the ethical trade-offs between cost containment and patient autonomy or access.
- Evaluate the ethical implications of drug coverage decisions, rationing, and resource allocation.
- Assess the ethical considerations in policies related to drug pricing and affordability.
- Differentiate between legal compliance and ethical best practices in policy design.
- Apply principles of procedural justice to ensure fair and transparent policy-making processes.
Task 3: Evaluate global and comparative health policy frameworks.
- Compare the drug approval processes of the FDA and the European Medicines Agency (EMA).
- Analyze the role of global organizations (e.g., WHO, ICH) in setting international standards for drug quality, safety, and development.
- Assess the potential impact of international reference pricing on the U.S. pharmaceutical market.
- Evaluate policy lessons from international health technology assessment (HTA) bodies.
- Analyze the impact of global supply chains and trade agreements on domestic drug availability.
Task 4: Design policies to improve access in underserved communities.
- Develop strategies to address pharmacy deserts and workforce shortages in rural and urban areas.
- Evaluate the role of state and federal programs in supporting safety-net providers.
- Design culturally competent policies that address the needs of diverse patient populations.
- Assess the impact of patient assistance programs on medication access for low-income individuals.
- Analyze policies that support the integration of pharmacists into care teams in underserved settings.
Task 5: Resolve ethical dilemmas in policy case scenarios.
- Apply a structured ethical framework to a complex policy dilemma with competing values.
- Analyze conflicts between individual patient needs and population-level policy goals.
- Justify a policy recommendation by weighing competing ethical principles.
- Formulate strategies to mitigate the negative ethical consequences of a necessary but challenging policy.
- Mediate discussions among stakeholders with conflicting ethical viewpoints.
Task 6: Assess the impact of global public health crises on pharmacy policy.
- Analyze policy responses to pandemics, such as emergency use authorizations (EUAs) for diagnostics, vaccines, and therapeutics.
- Evaluate policies related to the Strategic National Stockpile and pharmaceutical supply chain resilience.
- Assess the role of international cooperation and organizations like the WHO in managing global health threats.
- Analyze how public health emergencies impact pharmacist scope of practice regulations.
- Evaluate the ethical challenges of resource allocation during a public health crisis.
Domain 6: Emerging Technology and Digital Health Policy (10%)
Task 1: Analyze policy and regulatory issues for digital health tools.
- Evaluate the regulatory framework for prescription digital therapeutics (PDTs) and software as a medical device (SaMD).
- Assess reimbursement and coverage policies for digital health technologies.
- Analyze the role of federal agencies (e.g., FDA, ONC, FTC) in regulating digital health.
- Evaluate policies governing data interoperability between pharmacy systems and other health IT.
- Assess how digital health tools can be used to support medication adherence and management.
Task 2: Evaluate policy for telepharmacy and technology-enabled care.
- Analyze state and federal regulations governing the provision of telepharmacy services.
- Assess payment parity and reimbursement policies for telehealth and telepharmacy.
- Evaluate policies related to pharmacist scope of practice in technology-enabled care models.
- Analyze the impact of telepharmacy on access to care in rural and underserved areas.
- Assess quality and safety standards for remote pharmacy services.
Task 3: Apply data privacy and security principles to health policy.
- Interpret the requirements of HIPAA, HITECH, and GDPR as they apply to pharmacy data.
- Analyze the privacy implications of using large-scale health datasets for policy research.
- Evaluate policies for data de-identification, anonymization, and secure data sharing.
- Assess the cybersecurity risks associated with interconnected digital health technologies.
- Develop policies to ensure the ethical and secure use of patient data in technology platforms.
Task 4: Assess policy for Artificial Intelligence (AI) in pharmacy.
- Analyze the regulatory considerations for clinical decision support (CDS) tools powered by AI.
- Evaluate the ethical implications of using algorithms in patient care, including the potential for bias.
- Assess policies needed to ensure the transparency, fairness, and validity of AI models used in healthcare.
- Analyze how AI and predictive analytics can be used to optimize medication use and identify at-risk patients.
- Evaluate the impact of AI on pharmacy workforce roles and responsibilities.
Task 5: Analyze policy frameworks for personalized medicine.
- Evaluate coverage and reimbursement policies for pharmacogenomic testing.
- Assess the regulatory oversight of laboratory-developed tests (LDTs) used in personalized medicine.
- Analyze the ethical, legal, and social implications (ELSI) of using genetic information in healthcare.
- Evaluate policies needed to integrate pharmacogenomic data into clinical workflows and EHRs.
- Assess data privacy concerns specific to genetic information.
Task 6: Design policies to foster responsible innovation.
- Analyze the impact of federal innovation models (e.g., from CMMI) on pharmacy practice.
- Develop policies that support pharmacist-led innovation in care delivery and payment.
- Evaluate policy frameworks that balance promoting rapid innovation with ensuring patient safety.
- Assess the role of public-private partnerships in advancing pharmacy innovation.
- Formulate strategies to overcome regulatory and reimbursement barriers to adopting new technologies.
