CASP Module 16: Introduction to Compliance, Ethics & Legal Responsibilities
CASP Certification Program

Module 16: Compliance, Ethics & Legal Responsibilities

Navigating the Non-Clinical Pillars of Advanced Pharmacy Practice.

From Clinical Judgment to Principled Action: The Rules of the Road

Throughout this program, we have focused intensely on elevating your clinical acumen—mastering complex disease states, optimizing intricate therapies, and leveraging cutting-edge diagnostics and digital tools. You have honed your ability to make the best possible clinical decision for an individual patient based on the available evidence.

However, advanced practice operates within a complex web of external constraints and obligations that extend far beyond the purely clinical. Legal statutes, regulatory mandates, ethical principles, and payer policies create the essential “rules of the road” that govern our actions. Ignoring these non-clinical pillars is not an option; it invites legal jeopardy, professional sanctions, and potentially catastrophic harm to both patients and organizations.

This module shifts our focus from the microscopic details of patient care to the macroscopic framework of compliance, ethics, and law. We will dissect the key statutes that define fraud and abuse, explore ethical frameworks for navigating resource allocation dilemmas, reinforce the critical importance of information security, and examine the practical application of these principles in high-stakes scenarios. Mastering this material is not just about “checking boxes”; it is about building the foundation of integrity and principled action that underpins sustainable, trustworthy, and legally sound advanced practice.

Your Guide to the Legal & Ethical Landscape

This module provides a critical overview of the non-clinical frameworks essential for any advanced pharmacy practitioner.

Ethical Frameworks in High-Cost Therapy Decisions

Applying principles of justice, beneficence, and autonomy when navigating difficult choices about resource allocation and access to expensive treatments.

AKS, Stark Law, and OIG Enforcement Trends

A deep dive into the Anti-Kickback Statute and Stark Law, understanding prohibited referrals, safe harbors, and current areas of focus for the Office of Inspector General.

Fraud, Waste, and Abuse Prevention

Identifying red flags for FWA in pharmacy practice, implementing effective compliance programs, and understanding reporting obligations.

HIPAA, PHI, and Information Security

Reinforcing core HIPAA principles in the context of digital health, EHRs, and telepharmacy, focusing on practical security measures and breach prevention.

Conflict of Interest and Ethical Allocation

Navigating potential conflicts between professional duties, personal interests, and institutional pressures, particularly in resource-constrained environments.