Federally Qualified Health Center (FQHC)

This checklist outlines compliance and operational considerations for new  340B-registered health centers and is a resource for existing health centers to review their program setups periodically. 

GETTING STARTED – Part I (Goal: complete within 3 weeks of registration start date) 

  • Confirm that your entity’s information is correct on the HRSA Office of Pharmacy Affairs Information System (OPAIS). 340Bopais.hrsa.gov 
  • Establish your entity-specific policy and procedure manual. See Community Health Center Sample 340B Policy and Procedure Manual. 340Bpvp.com/tools  
  • Contact your wholesaler to ensure that your 340B account is correctly set up to receive best pricing [Public Health  Service (PHS)/340B pricing and 340B Prime Vendor Program (PVP) contracts] after becoming active on OPAIS. 
  • Check with your internal legal department to ensure that all necessary contracts are reviewed and executed prior to starting any operations. 
  • Watch 340B University OnDemand for Health CentersTM. Register at Covered Entities; select FQHC; New User. 340Bpvp.com/ondemand 
  • Identify which drug inventory model works best for your entity – physical versus virtual versus physician/clinic administered medications. 340Bpvp.com/ondemand Module: 340B Drug Delivery Models 
  • Identify all areas where you use 340B drugs. See 340B Universe Mapping Template. 340Bpvp.com/tools 

GETTING STARTED – Part II (Goal: complete during the next 3–6 weeks) 

  • Identify and inform the individuals in your entity who need to be directly involved in your 340B program (e.g.,  compliance, purchasing, billing). See 340B FTE and Coordinator Job Description Template. 340Bpvp.com/tools 
  • Forward your purchasing individual’s contact information to 340B PVP Membership Services so we can keep that person up to date with the 340B PVP Contract Updates newsletter. apexus340bpvp@340bpvp.com 
  • Access your PVP pricing catalog through the secure PVP website portal. If you need assistance, please call  Apexus Answers. Watch navigation videos. 340Bpvp.com/website-tutorials and 340Bpvp.com/register/secure-website-access  
  • Review and consider enrollment in the 340B PVP vaccine program (must be signed into the PVP secure portal). 340Bpvp.com/vaccine 

NEXT STEPS (6 weeks–9 months) 

  • Create a material breach policy for your entity. See Establishing Material Breach Threshold Tool. 340Bpvp.com/tools 
  • Communicate your use of 340B savings to internal leadership using the Calculating 340B Net Financial Impact and Use of Savings Template. 340Bpvp.com/tools 
  • Review the 340B Prime Vendor education tools for additional resources. 340Bpvp.com/tools – Attend 340B University; see important dates. 340Bpvp.com/university 
  • Develop internal and external audit plans. 340Bpvp.com/tools 

ONGOING PROGRAM COMPLIANCE AND 340B PROGRAM OPTIMIZATION 

  • Recertify: HRSA requires you to recertify your entity annually. (View the HRSA recertification webinar and contact  a 340B specialist at Apexus Answers for additional assistance) 340Bopais.hrsa.gov 
  • Review annually: 340B compliance committee reviews policies and procedures for applicability and appropriateness

 

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