1. The Institution and HTC 340B Program Relationship

2. Critical Knowledge for your 340B Program
Understand your organizational structure and relationships
Be proactive in cultivating internal relationships with key personnel
Understand responsibilities of key personnel
Educate
Ask for support

3. Can you answer the following?
Where does your HTC reside within the larger institution? What are the relationships? (Obtain a copy of organizational chart(s) if possible. These relationships can be complex.)
Who signs the HRSA MCHB grant and in which department does it reside?
Who does pre-grant management and post grant management?
Who prepares your MCHB program income report annually for your 340B program?
Who is the authorizing official that certifies compliance with the 340B regulations annually on the OPA website?
Who has final decision making authority for the 340B program related to its operation and contracts?

4. Can you answer the following?
How are you registered on the OPA website? As an HM hemophilia treatment center designation, DSH or Children’s hospital?
For state Medicaid patients are drugs purchased at the 340B price (carve in) or at a commercial price (carve out)?
Do you utilize an in-house pharmacy, blood bank, or contract pharmacy to dispense 340B factor products?
Who at the HTC is responsible for the 340B program or who at the HTC is the liaison with your institution’s personnel responsible for the program?
Who is responsible for contracting with insurance companies or PBMs on behalf of the institution?
Do the insurance contracts require factor to be billed under the medical benefit, pharmacy benefit or both?
Who does the billing for the 340B drugs?

5. Sample Organization Chart
Chairman Dept. of Medicine
Hospital Administration
CFO/Finance
Network Mgmt./
Contracting
Hospital OP Pharmacy
DoM Administrator
Grant Management
HTC
340B SPRx Contract Pharmacy
Physician Organization
HTC Physician
Billing Staff

6. Key Personnel
Compile a list of all key personnel and their contact information
Division Administrator
Grant Manager
Authorizing Official
HTC 340B Administrator/Liaison
CFO
Legal/ Compliance Officer
Network Manager/Contracting
Pharmacy/Blood Bank/Contract Pharmacy Manager
Billing Manager or Contracted Billing Agency

7. What your institution needs to know
Do personnel understand if you are an HM status
the hemophilia treatment center model, the MCHB grant and the right it conveys to the HTC to be a covered entity under the 340B drug pricing program.
the 340B regulation regarding diversion of drug and the prohibition against duplicate discounts.
the additional requirements that must be met as a grantee participating in the 340B drug pricing program related to reporting and restriction of program income.

8. Meet with your Key Personnel Contacts
Ask and understand what their role is in the oversight, management and reporting related to the 340B drug pricing program.
Document each person’s role.
Review overall roles addressing gaps in needed oversight, management or reporting.
Create a plan to address and bridge the gaps.

9. Network Management and Contracting Team
Understand if the institution is an in network provider and do they have in network vendor status with insurers, so that 340B drug can be purchased and billed on behalf of the hemophilia treatment center
Ensure open communication between billing, contract management and HTC personnel
Share with them specific examples of patients you cannot currently service due to not being in network
previously served but now cut out of network
never in network

10. Ask for Help!
Ask for assistance in understanding your organizational structure from the department administrator, legal counsel and CFO/finance staff.
Ask the grants management/finance staff how they calculate program income and restrict funds.
Ask for assistance from your network management/contracting team to assist you in understanding how contracts are developed to promote inclusion of the 340B drug program.
Ask your Regional Coordinator for assistance
Ask the Hemophilia Alliance for assistance

11. Be Proactive!
Make understanding your organizational structure a priority.
Commit to determining who the key personnel are that impact your 340B drug program.
Engage with your internal team.
Ask for assistance and support.