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340B-participating hospitals will be required to recertify their enrollment in the 340B Program from August 6-September 10, 2014. If your hospital's Authorizing Official or 340B Primary Contact Person has not yet received log-in information to complete recertification, one will be sent in the coming weeks.
The Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) is required to annually recertify all participating 340B covered entities to ensure the covered entities are appropriately listed on the 340B database and that they remain compliant with the 340B Program requirements.
The following are some steps that all 340B participants should complete prior to recertification:
- Review the contact information listed on the OPA Database for the Authorizing Official and Primary Contact Person and confirm that they are correct - these are the individuals who the OPA will contact with recertification requests
- Review the OPA Database to verify that all of your enrolled sites' names and addresses are listed correctly.
- For Disproportionate Share Hospitals, Freestanding Cancer facilities, Children's Hospitals, Rural Referral Centers, and Sole Community Hospitals, review your most recently filed cost report to ensure that your hospital's DSH percentage meets the statutory minimums.
Murer also recommends that all covered entities use this time as an opportunity to review their participating hospitals' 340B program operations and assess regulatory compliance. In addition to assisting providers with the actual recertification process, Murer also conducts 340B program assessments and compliance reviews for hundreds of facilities nationwide.
Failure to appropriately recertify your covered entity during the open recertification period will result in termination from the 340B program. If you have received an OPA 340B recertification request, need assistance to ensure that your 340B program is meeting the regulatory requirements, or would like more information about the 340B Program or Murer's 340B assessments, please call or email us.
HRSA Rulemaking Authority Update
This week, HRSA revealed that it will be proposing a new interpretive rule regarding the 340B Orphan Drug Exclusion. While the rule itself does not affect all 340B covered entities, the change in rulemaking strategy by HRSA signals its intent to press forward with issuing guidance through the formal rulemaking process.
By promulgating the Orphan Drug Exclusion rule through interpretive rulemaking, HRSA can abide by a recent federal court opinion curtailing its rulemaking authority while still issuing new 340B guidance. This may signal HRSA's intent to press forward with developing the 340B Mega-Reg, which was originally expected to be released earlier this summer.
- MURER CONSULTANTS -
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