Featured Articles: Pharmacy and 340B

Best Practices for FQHC 340B Compliance

Tuesday, May 5, 2015   (0 Comments)
Share |




Authored by:

Cheryl Hetland, CliftonLarsonAllen 

Editor's Note: Kyla Delgado, Dan Frein, and Matt Borchardt of CliftonLaronAllen will be presenting on various fiscal issues at the Spring Primary Care Conference May 16-19 in Portland, OR

In 2014, Health Resources and Services Administration (HRSA) committed an additional $6 million to increase 340B Program integrity and oversight. The Office of Pharmacy Affairs (OPA) used the funds to establish a Program Performance and Quality branch of the agency to augment the already established operational and informatics branches. The additional branch will be responsible primarily for developing audit reports and recertifying 340B covered entities. What does that mean for covered entities? Covered entities can expect that additional resources will be deployed to expand the auditing capabilities of the OPA. OPA has stated that the goal is to double the number of audits performed during FY 2015. What areas of program compliance will be impacted? In the recently published OPA Program Integrity: FY 2014 Audit Results, it is evident that HRSA is focusing on diversion, duplicate discounts and 340B database records.


Best Practices for 340B Compliance

  • Register and maintain accurate information about the FQHC in the HRSA 340B database.
  • Understand state Medicaid agency 340B billing requirements for Medicaid and/or Medicaid managed care organizations regarding 340B covered entities to avoid potential duplicate discounts.
  • Verify that all Medicaid and National Provider Identifier (NPI) billing numbers, institutional information, and contract pharmacy arrangements for carve-in entities are accurately recorded in the HRSA Medicaid Exclusion File.
  • Develop and maintain comprehensive written 340B Program policies and procedures addressing key compliance elements:
  • HRSA 340B database registration and recertification
  • 340B prescription eligibility including patient, site and provider requirements
  • Prevention of 340B drug diversion
  • Prevention of duplicate discounts
  • 340B procurement and inventory management
  • Contract pharmacy compliance
  • Program auditing and monitoring
  • Develop a well-defined process to validate eligibility controls.
  • Service location
  • Patient status/responsibility of care
  • Entity – prescriber relationship
  • Service within scope of grant
  • Medicaid eligibility
  • Maintain a comprehensive list of health care professionals’ NPI numbers for distribution to the contract pharmacies and third party claims processors.
  • Maintain auditable records at both the covered entity and the contract pharmacy.
  • Develop and maintain concrete methodologies for routine self-audits of all aspects of the 340B process.
  • Ensure there is a written service agreement between the covered entity and any contract pharmacies.
  • Engage an outside vendor to perform an audit of the 340B Program. OPA expects covered entities to have an outside independent audit of contract pharmacy processes at least annually.
  • Implement immediate fixes to problems identified in the self-audit or independent audit process, and immediately report any material compliance breaches to HRSA.


NWRPCA welcomes and regularly publishes white papers and articles submitted by members, partners and associates with subject matter expertise. The appearance of any guest publication in our Health Center News database represents the views of the author and does not constitute endorsement by NWRPCA of the stated opinions or perspectives, nor does it suggest endorsement of the contributor's products or services.

Membership Software Powered by YourMembership  ::  Legal