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Pharmacy and the 340B Program
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340B Audits

Covered entities that participate in the 340B Drug Pricing Program must ensure program integrity and maintain accurate records documenting compliance with all 340B Program requirements.

With the start of Fiscal Year 2016, the HRSA Office of Pharmacy Affairs (OPA) is providing some news and reminders to help facilitate covered entities through the auditing process and minimize operational burden.

Overview and Benefits

The 340B Drug Pricing Program requires drug manufacturers to provide outpatient drugs to eligible health care organizations/covered entities at significantly reduced prices.  The 340B Program enables covered entities to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.

Savings may be used to:

  • Reduce price of pharmaceuticals for patients
  • Expand services offered to patients
  • Provide services to more patients
  • Estimated $6 billion dollars in 340B drug purchases in 2011
  • Manufacturers that participate in Medicaid must also participate in the 340B Program

Eligible Federal Grantee Entities for 340B Program

  • Comprehensive Hemophilia Treatment Centers
  • Federally Qualified Health Centers
  • Urban/638 Health Center
  • Ryan White Programs
  • Sexually Transmitted Disease/Tuberculosis
  • Title X Family Planning

  

Health Center Site Visits Now Include 340B Questions

Community Health Centers preparing for HRSA Operational Site Visits (OSVs) to verify their compliance with the 19 Health Center Program requirements should be aware that those visits now include five questions on the 340B Drug Discount Program.  OSV reviewers are to ask the following but are not expected to review 340B documents/policies or patient records.  The questions are:
 
1.   Does the health center participate in the 340B drug pricing program? (if NO, the remaining questions are not required)
 
2.    Does the health center have written 340B policies, procedures, or other related documents? (if NO, proceed to question 4)
 
3.    If YES to #2, do the policies, procedures or other related documents address the following areas to assure that the individuals provided access to 340B drugs purchased by the health center meet all of the following?

 
a)   The health center has an established relationship with the individual, as documented by the health center maintaining records of the individual's health care;
 
b)    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 centers; i.e. 340B prescriptions are only made available to those who receive services that are either provided directly by the health center (Form 5A Column I or II) and/or through formal written referral arrangements (Form 5A Column III) consistent with approved scope of project; and 
 
c)     The prevention of duplicate discounts for patients covered under Medicaid? 
 
4.   Does the health center dispense 340B drugs to patients through a contract pharmacy services model?  If YES, please verify the following: 
 
a)   Does a written contract exist between the health center and contract pharmacy(ies);
 
b)    Does the health center have within its contract or in written policies and procedures how the contract pharmacy will ensure against diversion; 
 
c)     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.
 
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(ies)?
 
While the OSV reviewers are simply to ask the question and record the responses, responses could potentially trigger a 340B audit.  A comprehensive Community Health Center 340B Policy & Procedure Manual can be found online on the 340B University Tool Guide site.

340B Resources

HRSA's Presentation - The 3 P's of the 340B Drug Pricing Program:  Participation, Pricing and Program Integrity

HRSA's 340B Pharmacy Page

 

HRSA Site Visit Questions Regarding 340B Pharmacy


Community Health Center 340B Policy & Procedure Manual

340B Prime Vendor Program - The Prime Vendor Program (PVP) is a free federally sponsored program, managed by Apexus, Inc. The prime vendor program negotiates sub-ceiling, below 340b, pricing for drugs and pharmacy related items. All federally qualified health centers are eligible to become members of the PVP. The PVP saves members on the average an additional 16% on the cost of medication. It represents all 340b entities. The website provides additional resources beyond reports for medication pricing and site-specific saving opportunities. The Resource Center answer member questions regarding 340B regulations and best practices. The 340B University provides trainings through webinars, online tutorials, and seminars. Also, it provides tools, resources, and procedures to ensure integrity of the 340B program in different settings.

340B Peer-to-Peer Program - The 340B Peer-to-Peer Program was created by the HRSA Office of Pharmacy Affairs (OPA) and the American Pharmacists Association (APhA) to connect 340b entities with recognized high performing 340B entities. Recognized sites provide practical examples of excellence in 340B integrity and quality and serve as a resource for other 340B entities. Biweekly webinars help the Peers to communicate their expertise with stakeholders.  These webinars are live and open to the public.  They focus on improving 340B program integrity with topics such as patient eligibility, auditing, avoiding duplicate discounts, procurement, and many others. The webinars give perspectives from various entity types including but not limited to hospitals, community health centers, and hemophilia clinics. The webinars are live sessions that are recorded and posted to the website.

Mandatory 340B Recertification

An electronic recertification process is required for continued participation in the Health Resources and Services Administration's 340B Drug Pricing Program administered by the Office of Pharmacy Affairs (OPA).

It is extremely important that the 340B Program has accurate information on participating entities. Pharmaceutical manufacturers and distributors increasingly enforce the requirement for exact matches of information prior to providing access to 340B pricing.  In addition, entities that lose qualifying funding or that are no longer utilizing the 340B Program must be terminated from the program (through decertification during the recertification process, or through communication with the Office of Pharmacy Affairs at any other time during the year) to ensure program integrity.

It also is essential for the database to contain accurate information about whether or not Medicaid is billed for drugs purchased at 340B prices and, if so, what Medicaid numbers or NPI numbers are used for billing.  If the covered entity decides to purchase drugs for Medicaid OUTSIDE the 340B program (i.e. “carve out Medicaid from 340B”), then ALL drugs billed to that Medicaid provider number and or NPI must NOT be purchased under 340B, and those numbers should not be listed in the 340B database. If the covered entity decides to bill Medicaid FOR drugs purchased under 340B (“carve in") with a Medicaid provider number and or NPI, then ALL drugs billed to that number must be purchased under 340B, and that Medicaid provider number and or NPI must be listed in the 340B database. More information on Medicaid billing and the 340B Program is available online.  If further assistance is needed to understand this requirement, please contact the 340B Prime Vendor Program at 1-888-340-2787, or by sending an e-mail to ApexusAnswers@340bpvp.com.

A user manual for recertification is available online.

Please be aware that this user manual is generic and makes reference to the roles of an Approving Manager (AM) and a Program Manager (PM).  These specific roles may not apply for your recertification. 

If your organization has additional eligible sites that are not yet registered in the 340B Program database, please complete the online registration forms during the next open registration period (the first 15 days of each calendar quarter).  This activity is separate from the recertification of existing covered entity sites.

 

Stay Connected!

OACHC has a 340b Workgroup for Ohio FQHCs.  If you are interested in being a part of the working group email Julie DiRossi-King at jdirossi@ohiochc.org.

 

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