Implementing a System-Wide 340B Compliance Program...• Different resources, processes, vendor...
Transcript of Implementing a System-Wide 340B Compliance Program...• Different resources, processes, vendor...
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.
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.
Objectives
Intermountain HealthcareNonprofit system:22 Hospitals
Approximately 2500 licensed beds
24 Outpatient Pharmacies
Over 185 physician Clinics
6 enrolled covered entitiesIn process of enrolling 7th and 8th
Intermountain Healthcare
Divided into 5 Regions
Central Offices in Salt Lake City, Utah
1. Identify and discuss considerations associated with implementing a 340B compliance plan in a system with multiple covered entities.
Objectives
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 directly-applicable expertise
Pharmacy leaders often want to “own” drug management processes and practices
Compliance Plan: Central ManagementEach 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
Compliance Plan: Central ManagementAdvantages: 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
2. Identify and discuss one way to organize a centrally-managed 340B compliance plan.
Objectives
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
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
Contract PharmacyPolicy/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 computer-based training (CBT) Conferences, professional organizations (CE
presentations)
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
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) [email protected]