September 12, 2014—The Health Resources and Services Administration has outlined the steps providers should follow to inform it when a “material breach” of 340B program compliance has occurred. [ms-protect-content id=”2799″]
The list appears in HRSA’s September 340B Program Update on the Office of Pharmacy Affairs website. “We are working to standardize the self-disclosure process, and highlight best practices to assist covered entities in this effort,” HRSA wrote. Providers “should take steps to inform HRSA while they move to correct” a material breach of 340B program compliance.
These are the steps in the process:
1. Covered Entity Reports Issue to HRSA (including the following information)
- 340B identification number
- the violation that occurred
- scope of the problem
- a corrective action plan to fix the problem moving forward
- a strategy to inform affected manufacturers (if applicable)
- a plan for financial remedy if repayment is owed
2. Covered Entity Works With Manufacturer
- covered entity and the manufacturer work out any necessary financial remedy in good faith
3. HRSA Reviews Self-Disclosure (including)
- violation information
- corrective action plan, ensuring that it fully addresses issues causing the violation
- repayment plan and/or completion of plan
- completion of contact to all affected manufacturers
Note: HRSA staff will follow-up with the covered entity authorizing official if any of the requested information is missing from the self-disclosure submitted
4. HRSA Closes Self-Disclosure
- When all criteria under step #3 are met, the covered entity receives written communication that the matter is closed
HRSA suggests that providers use a set of sample documents, available on the 340B Prime Vendor website, for self-reporting program noncompliance to OPA and drug manufacturers.
“Covered entities are able to most efficiently and effectively resolve their compliance issue if they provide an immediate remedy to correct the material breach, propose a plan for periodic assessment and continuous monitoring, and outline a clear method to determine when the [corrective action plan] is completed,” the September program update concludes. “Successful covered entities have also routinely identified an implementation date, entity contact person, and clarified an internal 340B communication/education strategy.” [/ms-protect-content]