The window for 340B recertification is just around the corner so now is the perfect time to review the recertification process. The 340B statute requires HRSA to recertify all 340B covered entities annually and that period begins August 5th and ends September 9th. Currently listed authorizing officials and primary contacts will receive recertification notification emails August 3rd.
ALL covered entities registered for the 340B drug pricing program AS OF JULY 1, 2015 without a future termination date will be required to recertify. FAILURE TO COMPLETE THE RECERTIFICATION PROCESS WILL RESULT IN THE REMOVAL FROM THE 340B PROGRAM and while 5 weeks seems like ample time, we would suggest starting the process as soon as possible, and even before the recertification window begins, to account for uncontrollable factors such as hospital officials on vacation or heavy website traffic slowing the submission process (P.S. think tax time on April 15th).
Updates Since Last Year
There are two updates that have been made to the recertification process this year:
- The authorizing official can be updated electronically
- Eligibility criteria will automatically populate with Medicare Cost Report data where available
Recertification Process Basics
There are two parts to the recertification process:
- Verifying covered entity information is correct in the OPA database
- Attesting that the covered entity is complying with ALL 340B requirements
The OPA database can be found at: http://opanet.hrsa.gov/opa
Seems fairly simple, right? Did we mention that there may be research involved in these two tasks and that ALL registered child site information must be verified as well? Remember when we said 5 weeks seemed like plenty of time? As we examine each of the parts to the recertification process, it will become apparent that time may not be on your side if you wait to start the process...
Verifying OPA Database Information
As previously mentioned, information for the covered entity and all child sites will need to be verified in the OPA database. You will need to confirm the following:
- Authorizing official information
- Primary contact information
- Addresses (main, billing, shipping)
- Hospital type (nonprofit, proprietary, governmental, etc.)
- Ownership status
- DSH percentage (auto-populated with Medicare Cost Report data if available)
- Cost reporting period (auto-populated with Medicare Cost Report data if available)
- Medicaid information for hospital and ALL registered child sites (NPI or Medicaid provider numbers, billing numbers, carve-in/carve-out decision)
- Orphan drug information for CAH, RRC, SCH and cancer hospitals and ALL registered child sites (opt-in/opt-out decision)
- Child site eligibility
- Changes can be made electronically during the recertification process but know that the OPA may ask follow up questions if certain revisions are made and/or require documentation for the change.
Attestation of 340B Compliance
After all OPA database information is verified, the authorizing official will be ask to attest to 340B compliance. There are 8 attestation statements:
- Accuracy of 340B database information
- Covered entity meets ALL eligibility requirements
- Covered entity will comply will ALL requirements/restrictions
- Auditable records are maintained
- Mechanisms to ensure ongoing compliance are in place
- Contract pharmacy compliance in accordance with OPA guidance and requirements
- Responsibility for self-disclosure of material changes or breach
- Potential liability to the manufacturer or removal from 340B program if material breach occurs
If there is any doubt on whether the authorizing official can attest to even one of these statements above, please seek legal counsel.
The decertification process can also be time consuming as the previously covered entity will need to address the following questions:
- Termination effective date
- Brief description for reason of termination and how effective date was determined
- Last 340B purchase date with the impending decertified 340B ID
Whew! Overwhelmed yet? Our next post will provide helpful tips to make the recertification process smoother for covered entities. We'll give you a hint - START NOW! Be on the lookout...
Southwest Consulting Associates’ 340B Audit and Compliance team can assist you with the recertification process if needed. Please contact us at 972-732-8100 or email us at 340B@southwestconsulting.net.
We’ve got more to write on the recertification process and 340B compliance in general including 340B external audits, 340B compliance reviews, 340B program requirements, 340B audit results, etc. Don’t miss out on future articles delving deeper into the 340B program!