Implementing a System-Wide 340B Compliance Program So What Can Go Wrong?

Transcription

1 Implementing a System-Wide 340B Compliance Program One System s Perspective Presented by Richard Bucher, B.S. Pharm., J.D. Intermountain Healthcare, Utah So What Can Go Wrong? Diversion Many ways this is possible Duplicate Discounts Medicaid patients GPO Exclusion Disproportionate share hospitals (DSH), children s hospitals, and free-standing cancer hospitals Orphan Drug Exclusion Free-standing cancer hospitals, critical access hospitals(cah), rural referral centers, and sole community hospitals. Objectives 1. Identify and discuss considerations associated with implementing a 340B compliance plan in a system with multiple covered entities. 2. Identify and discuss one way to organize a centrally-managed 340B compliance plan. 1

2 Intermountain Healthcare Nonprofit system: 22 Hospitals Approximately 2500 licensed beds 24 Outpatient Pharmacies Over 185 physician Clinics 6 enrolled covered entities In process of enrolling 7th and 8th Intermountain Healthcare Divided into 5 Regions Central Offices in Salt Lake City, Utah Objectives 1. Identify and discuss considerations associated with implementing a 340B compliance plan in a system with multiple covered entities. 2

3 Compliance Plan Management Covered entity leadership Corporate leadership 340B Program champion Other stakeholders: pharmacy, compliance / regulatory, legal, accounting, supply chain, etc. Compliance Plan Management: Pharmacy Pharmacy is typically looked to as the expert Pharmacy probably has the most directlyapplicable expertise Pharmacy leaders often want to own drug management processes and practices Compliance Plan: Central Management Each covered entity is ultimately responsible Disadvantages: Operational disparity Different resources, processes, vendor solutions, and engagement levels System procedures may not work for all Reporting structure disparity Direct reporting through facility leadership 3

4 Compliance Plan: Central Management Advantages: Economies of scale Facilitates leveraging specific expertise Communication and idea sharing: Pharmacy to facility leadership Central pharmacy to corporate leadership Pharmacy to pharmacy Increased vendor negotiation and contract consistency Facility-independent oversight and auditing and centralized monitoring Intermountain: Compliance plan managed centrally by corporate pharmacy services Close collaboration with pharmacy directors Focus on updating and educating stakeholders throughout the system Communication, education, engagement, and diligence are key Objectives 2. Identify and discuss one way to organize a centrally-managed 340B compliance plan. 4

5 Organizing the Compliance Plan 7 OIG fundamental elements: Policies/procedures Accountability Education and training Monitoring and training Reporting and investigating Enforcement and discipline Response and prevention 1. Policies and Procedures Hospital Administered Medications Contract Pharmacy 5

6 Hospital Administered Medications : System-wide policy System-wide model procedure, each facility develops its own facility-specific procedure Hospital Administered Medications Policy/Procedure scope: Annual 340B recertification Diversion Duplicate discounts Purchasing restrictions (e.g., GPO, Orphan drugs, etc.) References system-wide audit guide Each site s responsibility to implement plan, policies/procedures, and audit guide Contract Pharmacy: System-wide policy and procedure for covered entities 6

7 Contract Pharmacy Policy/Procedure scope: Diversion Duplicate discounts Purchasing restrictions Written contract pharmacy agreements (including HRSA essential elements) Signed certification with OPA Multiple covered entity restriction Awareness of anti-kickback prohibitions References system-wide audit guide Each site s responsibility to implement plan, policies/procedures, and audit guide 2. Accountability Shared by pharmacy directors and corporate pharmacy services Policies, procedures, and the 340B compliance plan help establish this accountability Regular communication and updates to other applicable stakeholders helps extend accountability for certain requirements For example, updating regional compliance officers and leadership to ensure the addition of new clinics or other types of changes are communicated to corporate pharmacy services 3. Education and Training Pharmacy directors responsible for staff education as applicable Informational presentations and materials to various stakeholders Regularly-scheduled 340B user group Formal educational modules can be assigned to employees via system-wide computerbased training (CBT) Conferences, professional organizations (CE presentations) 7

8 4. Monitoring and Auditing Hospital Administered Medications: System-wide auditing guide Completed by both corporate pharmacy and pharmacy director 4. Monitoring and Auditing (Cont.) Contract Pharmacy: System-wide auditing guide Completed by both corporate pharmacy and pharmacy director 5. Reporting and Investigating Audit results are documented and stored in accordance with Intermountain s Document Management Policy Identified issues are fully investigated and analyzed Corrective action plans (CAPs) are identified Audit/investigation results and CAPs are communicated to appropriate stakeholders, including pharmacy directors and corporate pharmacy leadership 8

9 6. Enforcement and Discipline Intermountain policies /procedures and the 340B compliance plan provide accountability and a corresponding disciplinary process if needed Not needed so far, stakeholders have been engaged, cooperative, and responsive 7. Response and Prevention Accountable stakeholders are responsible for ensuring that CAPs are implemented Typically pharmacy directors and/or corporate pharmacy services CAPs may include operational changes, new or updated policies/procedures and/or auditing guides, credit-rebilling steps, disclosure steps, etc. Staying updated and informed about the changing 340B regulatory environment is key to being prepared and remaining compliant Contact Info Richard Bucher, B.S. Pharm., J.D. Intermountain Healthcare, Utah (801) rich.bucher@imail.org 9