Sample 340B Policy & Procedures Manual Page 10
A Guide for Family Planning Entity Leaders
Apexus Answers Call Center | 340B Prime Vendor Program | 340B University | 888.340.2787 | www.340BPVP.com
© 2015 Apexus LLC. All rights reserved. Version 05122015
XIII. Appendix I: Contract Pharmacy Compliance Elements
HRSA has provided essential covered entity compliance elements as guidance for the contractual provisions
expected in all contract pharmacy arrangements.
Excerpt from: http://www.hrsa.gov/opa/programrequirements/federalregisternotices/contractpharmacyservices030510.pdf
(a) The covered entity will purchase the drug, maintain title to the drug and assume responsibility for
establishing its price, pursuant to the terms of an HHS grant (if applicable) and any applicable Federal, State
and local laws. A ‘‘ship to, bill to’’ procedure is used in which the covered entity purchases the drug; the
manufacturer/wholesaler must bill the covered entity for the drug that it purchased, but ships the drug directly
to the contract pharmacy. In cases where a covered entity has more than one site, it may choose between
having each site billed individually or designating a single covered entity billing address for all 340B drug
purchases.
(b) The agreement will specify the responsibility of the parties to provide comprehensive pharmacy services
(e.g., dispensing, recordkeeping, drug utilization review, formulary maintenance, patient profile, patient
counseling, and medication therapy management services and other clinical pharmacy services). Each
covered entity has the option of individually contracting for pharmacy services with a pharmacy(ies) of its
choice. Covered entities are not limited to providing comprehensive pharmacy services to any particular
location and may choose to provide them at multiple locations and/or ‘‘in-house.’’
(c) The covered entity will inform the patient of his or her freedom to choose a pharmacy provider. If the patient
does not elect to use the contracted service, the patient may obtain the prescription from the covered entity
and then obtain the drug(s) from the pharmacy provider of his or her choice. When a patient obtains a drug
from a pharmacy other than a covered entity’s contract pharmacy or the covered entity’s in-house pharmacy,
the manufacturer is not required to offer this drug at the 340B price.
(d) The contract pharmacy may provide other services to the covered entity or its patients at the option of the
covered entity (e.g., home care, delivery, reimbursement services). Regardless of the services provided by the
contract pharmacy, access to 340B pricing will always be restricted to patients of the covered entity.
(e) The contract pharmacy and the covered entity will adhere to all Federal, State, and local laws and
requirements. Both the covered entity and the contract pharmacy are aware of the potential for civil or criminal
penalties if either violates Federal or State law. [The Department reserves the right to take such action as may
be appropriate if it determines that such a violation has occurred.]
(f) The contract pharmacy will provide the covered entity with reports consistent with customary business
practices (e.g., quarterly billing statements, status reports of collections and receiving and dispensing records).
(g) The contract pharmacy, with the assistance of the covered entity, will establish and maintain a tracking
system suitable to prevent diversion of section 340B drugs to individuals who are not patients of the covered
entity. Customary business records may be used for this purpose. The covered entity will establish a process
for periodic comparison of its prescribing records with the contract pharmacy’s dispensing records to detect
potential irregularities.
(h) The covered entity and the contract pharmacy will develop a system to verify patient eligibility, as defined
by HRSA guidelines. The system should be subject to modification in the event of change in such guidelines.