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HRSA Seeking Comment on 340B Audit Burden

The Health Resources and Services Administration (HRSA) is encouraging covered entities in the 340B Drug Pricing Program to comment on its proposal to collect information on the burden associated with guidelines for manufacturer audits of covered entities.

Manufacturers of covered outpatient drugs may audit covered entities only when there is reasonable cause that a covered entity violated the diversion or duplicate discount prohibition. Specifically, HRSA plans to collect information on these manufacturer audit guidelines:

  1. Manufacturers should notify the entity in writing when it believes a violation has occurred.
  2. Manufacturers should submit documentation to the Office of Pharmacy Affairs (OPA) as evidence of good faith of attempts to resolve a dispute.
  3. Manufacturers must submit an audit work plan to OPA.
  4. Manufacturers should submit the audit report to the OPA and informational copies to the U.S. Department of Health and Human Services Office of Inspector General.
  5. The covered entity should provide a written response to the audit report.

HRSA estimates the total annual burden to be 1,272 hours, in addition to 25 hours for record keeping, and is soliciting public comments in these areas:

  • the necessity and utility of the proposed information collection for the proper performance of the agency’s functions
  • the accuracy of the estimated burden
  • ways to enhance the quality, utility, and clarity of the information collected
  • the use of automated collection techniques or other forms of information technology to minimize the information collection burden

Comments are due to HRSA by Feb. 22, 2016. Contact Director of Policy Erin O’Malley at or 202.585.0127 with questions.


About the Author

Shahid Zaman is a senior policy analyst at America's Essential Hospitals.

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