340B Drug Pricing Program Assessment Supplement – Training for BPHC Consultants October 21, 2014 Michelle Herzog U.S. Department of Health and Human Services Health Resources and Services Administration Healthcare Systems Bureau Office of Pharmacy Affairs
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340B Drug Pricing Program Assessment Supplement – Training
for BPHC Consultants
October 21, 2014
Michelle Herzog U.S. Department of Health and Human Services Health Resources and Services Administration
Healthcare Systems Bureau Office of Pharmacy Affairs
• Verify the existence of appropriate documents • Consultants not expected to review patient
records or conduct any other type of sampling • The clinical consultant will be responsible to
address/ask the 340B questions. • The Team Lead will be responsible for ensuring
that the 340B questions have been answered electronically.
• The site visit report will not be able to be submitted until the 340B responses have been entered.
Question 1 & 2
1. Does the Health Center participate in the 340B drug pricing Program? YES/NO (if NO, completion of this supplement is not required)
2. Does the health center have written 340B policies, procedures, or other related documents? YES/NO (if No, Proceed to Question 4.)
Question 3
3. If Yes to #2, do the policies, procedures, or other related documents address the following areas: a. Assure that the individuals provided access to 340B drugs purchased by the health Center meet all of the following areas:
Question 3.a.i.
3.a.i The health center has an established relationship with the individual, as documented by the health center maintaining records of the individuals health care? YES/NO
Question 3.a.ii
3.a.ii The individual receives health care services from a health care professional who is either employed by the health center or under contractual or other arrangements (e.g., referral for consultation) such that responsibility for care provided remains with the health center; i.e., 340B prescriptions are only made available that receive services that are either provided directly by the health center (Form 5A Column I and/or II) and/or through formal written referral arrangements (Form 5A Column III) consistent with the approved scope of project YES/NO
Question 3.b
3.b. The prevention of Duplicate Discounts for patients covered under Medicaid? YES/NO
Question 4
4. Does the health center dispense 340B drugs to patients through a contract pharmacy services model? YES/NO (If NO is selected, click submit) If yes, please verify the following:
• Does a written contract exist between the health center and contract pharmacy(ies)? YES/NO
• Does the health center have within its contract or in written policies and procedures how the contract pharmacy will ensure against diversion? YES/NO
• Does the health center have, within its contract or in its written policies and procedures, a process that reflects how the contract pharmacy will ensure against duplicate discounts? YES/NO
Question 5
5. Does the health center attest that it provides oversight (e.g., annual audit or other mechanism) of the 340B drugs dispensed by the contract pharmacy? YES/NO Example Community Health Center (CHC) Comprehensive Policy and Procedure Manual can be found at: https://docs.340bpvp.com/documents/public/resourcecenter/340B_Tool_Guide.pdf
HRSA Prime Vendor Program (PVP) • Contract with Apexus • No cost to participate • http://www.340bpvp.com • [email protected] • 340B University – educational opportunity • Drug price negotiation services • Multiple wholesale distributor agreements • Favorable discounts on other pharmacy
• Showcases high performing 340B entities in order to provide practical examples of excellence in 340B integrity and quality
• Serves as a resource for other entities wishing to raise the standard of their 340B practices.
• All 340B entity types are encouraged to apply. • Qualified applications are evaluated on a rolling basis (limited spots are
available). • Applicants will be evaluated on 5 key areas:
o 340B program integrity o Providing access to affordable medications o Efficient business practices o Outcomes-driven clinical programs o Quality assurance programs
• Selected sites that will receive benefits such as off-site training, APhA association membership and access to other 340B events.
To apply, visit http://www.hrsa.gov/opa, click on the "Peer to Peer" tab on the right side of the screen and select "340B Peer to Peer Application.”