Title: Provision of Pharmacy Services

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  Prescriptions dispensed for individuals not qualifying as a patient as defined by the 340B Drug Discount Program will be filled using alternate inventory purchased at a non-340B price.
  
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  The general public may be eligible for discounted pricing as long as such discounts are not in violation of third party payer agreements or in violation of local, state, or federal regulations.
  
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  The general public will be eligible for all available services (with the exception of 340B discount pricing) including patient counseling, health education, and MTM
  

Upon registration on the OPA database as a participant in the 340B Program, entities agree to abide by specific statutory requirements and prohibitions.

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  XHC uses any savings generated from 340B in accordance with 340B Program intent
  
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  XHC. meets all 340B Program eligibility requirements.
  
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    XHC listing as a covered entity in the Office of Pharmacy Affairs (OPA) Database covered entity listing is complete, accurate, and correct.
    
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    XHC receives a grant or designation consistent with that conferring 340B eligibility.
    
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  XHC complies with all requirements and restrictions of Section 340B of the Public Health Service Act and any accompanying regulations or guidelines including, but not limited to, the prohibition against duplicate discounts/rebates under Medicaid, and the prohibition against transferring drugs purchased under 340B to anyone other than a patient of the entity. [REFERENCE: Public Law 102-585, Section 602, 340B Guidelines, 340B Policy Releases]
  
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  XHC maintains auditable records demonstrating compliance with the 340B requirement described in the preceding bullet.
  

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  XHC identifies eligible prescriptions to be those in which: a.) the prescribing provider is employed or under contractual or other arrangements with XHC; b.) the individual receives a health care service (within the scope of grant/designation for which 340B status was conferred) from this professional such that the responsibility for care remains with the health center; and c.) XHC maintains records of the individual’s health care.
  
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  XHC “carves-out” Medicaid from 340B eligibility and maintains information consistent to this in the OPA Medicaid Exclusion Database.
  
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  XHC has systems/mechanisms and internal controls in place to reasonably ensure ongoing compliance with all 340B requirements.
  
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  XHC conducts routine compliance audits under the direction of the Director of Pharmacy Services. Audit results are reported to the Corporate Compliance Officer.
  
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  XHC provides comprehensive orientation to the 340B program for new pharmacy staff and conducts regular and ongoing updates and continuing education.
  
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  XHC conducts corporate wide training on the 340B program to maximize the value to patients served at all medical sites.
  
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  XHC has procedures in place to protect the patient’s right to use the pharmacy of their choice.
  
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  XHC may choose to uses contract pharmacy services, in which case the contract pharmacy arrangement is performed in accordance with OPA requirements and guidelines including, but not limited to:
  
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    XHC obtains sufficient information from the contractor to ensure compliance with applicable policy and legal requirements, and XHC has utilized an appropriate methodology to ensure compliance including an annual independent audit of the contract pharmacy arrangement.
    
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    Signed Contract Pharmacy Services Agreement(s) complies with 12 contract pharmacy essential compliance elements (http://www.hrsa.gov/opa/programrequirements/federalregisternotices/contractpharmacyservices030510.pdf
    
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  XHC acknowledges its responsibility to contact OPA as soon as reasonably possible if there is any change in 340B eligibility or material breach by the XHC of any of the foregoing policies.
  
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  XHC acknowledges that if there is a breach of the 340B requirements, XHC may be liable to the manufacturer of the covered outpatient drug that is the subject of the violation, and depending upon the circumstances, may be subject to the payment of interest and/or removal from the list of eligible 340B entities.
  
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  XHC elects to receive information about the 340B Program from trusted sources, including, but not limited to:
  

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  The Office of Pharmacy Affairs (OPA)
  
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  The 340B Prime Vendor Program, managed by Apexus
  
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  Any OPA contractors
  

These policies apply to all XHC pharmacy services in which pharmaceuticals purchased under the 340B Drug Pricing Program are dispensed and/or administered.

The following XHC Staff are engaged with 340B program compliance.

1. 
   Chief Executive Officer
   

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  Responsible as the principal officer in charge for the compliance and administration of the program
  
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  Responsible for attesting to the compliance of the program in form of recertification
  

2. 
   Chief Financial Officer
   

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  Responsible for financial management and allocation of savings to support the non-profit mission of XHC
  

3. 
   Chief Pharmacy Officer/Director of Pharmacy
   

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  Accountable agent for 340B compliance
  
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  Agent of the CEO responsible to administer the 340B program to fully implement and optimize appropriate savings and ensure current policy statements and procedures are in place to maintain program compliance
  

4. 
   Corporate Compliance Officer or Director of Internal Audit
   

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  Collaborates with the Director of Pharmacy Services on the internal audit plan of the compliance of the 340B program
  
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  Includes information on compliance with the 340B program requirements as part of quarterly compliance report to the XHC Board of Directors.
  

5. 
   Chief IT Officer/Pharmacy Informatics Person
   

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  Support the Pharmacy software selection of tracking software to manage the 340B program
  
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  Define process and access to data for compliant identification of eligible patients
  
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  Archive the data so as to be available to auditors when audited
  

Board Approved Revision: 3/24/14

Board Review/no revisions: 3/30/15

Date of Next Scheduled Board Review: 3/30/16