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) 442-3256rich.bucher@imail.org