TACHC The Heartbeat of Texas Community Health Centers

Retail Pharmacy Arrangements

It is possible to utilize the 340Better^sm program if your health center is contracting with a retail pharmacy (aka "bill to/ship to") for dispensing of 340B pharmaceuticals to the health center's patients. The retail pharmacy needs to be registered with the OPA (this is the health center’s responsibility to maintain). Below is a checklist of items that need to be completed when working with a contracted retail pharmacy.

Register the Contract Pharmacy

• When registering a Contract Retail Pharmacy, the OPA Registration Periods applies like when registering a health center site:

• Click here to complete the online registration process for contract pharmacy services. The contract retail pharmacy effective date may not precede the effective date for the health center.  Effective dates for the retail pharmacy will NOT be made retroactively.

• Click here to complete the TACHC 340Better Registration Form in order to utilize the 340Better pharmacy program. Complete the form for each health center site that is going to need a Cardinal account to receive pharmaceuticals.  Submit all completed TACHC 340Better Registration Forms to Lynn Ford or via fax at (512) 329-9189.
  
  

• Certification of the existence of a 340B contract pharmacy services arrangement will be done electronically. Previously, health centers needed to print out, complete, and mail back to OPA a form certifying that a contract pharmacy arrangement was in effect between the parties. The paper form needed to be physically signed by representatives of both the health center and the pharmacy. Under the new system, the health center’s 340B authorizing official will check a box on an electronic form confirming that he/she is fully authorized to bind both the health center and the pharmacy.
• Language has been added to this certification statement that the authorizing official will now click to accept instead of printing out, signing, and mailing back to OPA. In addition to the attestations of program compliance that were on the old paper form, the authorizing official must now certify that the contract arrangement “will be performed in accordance with OPA requirements and guidelines including, but not limited to, that the covered entity obtains sufficient information from the contractor to ensure compliance with applicable policy and legal requirements, and the health center has utilized an appropriate methodology to ensure compliance (e.g., through an independent audit or other mechanism).” Further, the official must now certify that the health center “has, and continues to bear, full responsibility and accountability for compliance with all 340B requirements, including but not limited to any 340B violations by the contract pharmacy. The health center agrees to notify the Office of Pharmacy Affairs, in writing, of any material changes in the contract arrangement and/or material breach by the covered entity of any of the foregoing.”
• The Drug Enforcement Agency (DEA) pharmacy registration database and the OPA 340B contract pharmacy database have been integrated. Now, when a 340B health center begins registering a contract pharmacy online, it will be prompted to search by DEA number for the pharmacy it wants to register. If the health center does not know the pharmacy’s DEA number, or if the pharmacy does not have a DEA number, the health center can still search for the pharmacy by name, city, zip code, and/or state.
• If a health center wants or needs to terminate a contract pharmacy arrangement, there will now be a direct link on the OPA database home page allowing it to do so online. Previously, a health center could terminate a contract pharmacy arrangement either (1) by submitting a change request form or (2) while online as an option during the process of registering a different pharmacy.
• Fields in the online contract pharmacy registration form requesting identifying information for the pharmacy under contract will now be auto-filled if the information already exists in the OPA database.

Guidelines

Updated guidelines for contracting with retail pharmacies became effective April 5, 2010.  This gives health centers new flexibility in offering patients access to pharmaceuticals. The guidelines:

• Clarify the requirements that must be met when utilizing contract pharmacy arrangements; and
• Provide health centers the option of utilizing more than one contract pharmacy per health center delivery site.

The OPA reminds the health centers that the guidelines outline the health center and contracted retail pharmacy responsibilities. Health centers along with contracted retail pharmacies are responsible for ensuring compliance with all 340B requirements to prevent diversion and duplicate discounts.

• Both parties must agree that they will not resell or transfer a 340B drug to any party but the health center's patients.
• Both must also establish an arrangement with the state Medicaid agency to prevent duplicate discounts.
• Both the health center and the contracted retail pharmacies must adhere to all federal, state and local laws.

Audit Requirements

• All health centers are required to maintain auditable records and it is the expectation of HRSA that most health centers will utilize independent audits as part of fulfilling their ongoing obligation of ensuring compliance.  However, HRSA leaves it up to the health centers to determine how to meet their compliance responsibilities.
• To the extent that any internal compliance activity or audit performed by a health center indicates that there has been a violation of 340B program requirements, it is HRSA's expectation that such finding be disclosed to HRSA along with the health center's plan to address the violation. Auditable records need to be maintained for a period of time that complies with all applicable federal, state and local requirements.