February 22, 2013—One of the four audits of 340B covered entities being conducted by drug manufacturers has reached the final report stage, the Health Resources and Services Administration (HRSA) said yesterday.
HRSA, responding to questions about a Federal Register notice yesterday regarding 340B audits and dispute resolution, said it has received six audit work plans from manufacturers, only four of which have proceeded to audits.[ms-protect-content id=”2799″] “At this time, HRSA has received only one final audit report from a manufacturer which is still under review by HRSA,” the agency said. “None of the other manufacturer audits have been finalized.”
HRSA itself audited 51 covered entities in 2012 and reportedly plans to audit hundreds more this year. Covered entities lack authority to audit manufacturers.
HRSA did not disclose the findings of the completed manufacturer audit of a 340B provider. Under HRSA’s 1996 guidelines for audits by manufacturers, the entity under investigation must provide its response to the manufacturer within 30 days of receiving the final report. If the entity disputes the auditor’s findings, the matter moves next to HRSA’s informal dispute resolution process. If the entity or the manufacturer disagrees with the three-person dispute-resolution panel’s determination, the entity or manufacturer may appeal to an appeals officer appointed by the HRSA Administrator.
HRSA’s Feb. 21 public notice was required under a paperwork-reduction law. Periodically over the years since it published the 1996 audit guidance, it has needed to obtain Office of Management and Budget (OMB) re-approval for its estimates of the reporting and recordkeeping requirements of the audit and associated dispute-resolution guidelines.
In yesterday’s filing, HRSA said it anticipates that about 10 drug manufacturers per year will initiate proceedings that could lead to an audit of a 340B covered entity.
In eight out of 10 cases, HRSA indicates that it expects that efforts at good-faith resolution will be unsuccessful and that manufacturers will submit audit work plans for review. Of those eight, it projects that six will actually proceed to an audit.
HRSA estimates that for these 10 instances combined, the entire process will require a total of 628 hours of work by manufacturers and covered entities alike. The breakdown for each step in the process, per instance, is as follows:
- Good faith resolution: 40 hours
- Audit notification of entity: 4 hours
- Audit work plan: 10 hours
- Audit report: 10 hours
- Entity response: 8 hours
In addition, HRSA anticipates it will receive 10 requests per year to activate its 340B dispute resolution process. HRSA established the informal voluntary dispute resolution mechanism in 1996, along with the manufacturer audit process, but it has been invoked only three times.
Congress authorized the creation of a 340B mandatory administrative dispute resolution process in the Affordable Care Act but HRSA has not created one yet.
HRSA is accepting comments on its new reporting-requirement estimates through March 14. They can be submitted to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to (202) 395–5806. Direct all correspondence to the ‘‘attention of the desk officer for HRSA.’’[/ms-protect-content]