Get ready for a possible audit by self-auditing now, peer advisers tell entities during webinar.
April 27, 2012—340B providers should prepare for the possibility of an audit by taking stock of their policies and procedures for avoiding duplicate discounts and drug diversion, a hospital and health-center network recently test-audited by the Office of Pharmacy Affairs (OPA) counseled others during an April 25 webinar.
In addition to self-auditing, the 340B program managers advised webinar participants to review their listings in OPA's covered entity database for accuracy, educate their employees about 340B requirements, make sure that their state Medicaid office knows whether they carve their 340B drugs "in" or "out," and otherwise identify and resolve potential problems "before an audit is at your doorstep."
Patrick Barnes of Shands Jacksonville Medical Center in Jacksonville, Fla., and Bob Brown of CommUnityCare Health Center in Austin, Texas, shared what they learned as testing grounds for OPA's audit initiative, which got underway in January. They were joined by Donavan Smith of Wayne Community Health Center in rural south-central Utah, which has not been audited. All three are mentors in OPA's 340B Peer-to-Peer Network.
OPA reportedly will audit about 50 covered entities in 2012, with an initial focus on hospitals. Drug manufacturers are expected to begin seeking OPA approval to conduct their own audits as well. Although none has submitted an audit plan so far, "we might be seeing more of that in the future," OPA Public Health Analyst Thomas Pettin said.
In response to a participant's question, Pettin said OPA "is continuing to hone" its audit protocol and will not release it to the public "until it is further refined." Last December, OPA said it would make the protocol publicly available prior to the audits' commencement. Providers are anxious to see the protocol so they can know what to expect if they are chosen.
Brown of the Texas health-center network advised the webinar participants to "perform a few audits of specific prescription transactions" to be able to describe to an auditor the steps they take and data they use to ensure that 340B drugs go to eligible patients only. Covered entities that use contract pharmacies, he continued, should be able to reconcile the total quantity of any given 340B drug dispensed to patients with the total quantity of the same drug replenished to those pharmacies.
Barnes of Shands Jacksonville said hospitals with an outpatient pharmacy should examine how they identify patients that qualify for 340B medicines and the controls they use to make sure they are not filling prescriptions to those who are not qualified. Hospitals using split-billing software, he said, should verify that the quantity units that fill their accumulator match their ordering quantities.
Regarding drug diversion, Smith of the rural Utah center said providers should ask themselves if they have a clear and auditable way to identify eligible patients and a sound way to manage referrals for care provided outside their facility. And with respect to duplicate discounts, he said providers should review their billing practices for Medicaid and Medicaid managed care "to ensure you are in harmony with your OPA database records and state Medicaid billing policies."
The webinar recording and PowerPoint slides are available at http://www.healthcarecommunities.org/community.aspx?groupid=10 under the "Emerging Content" heading.The Peer-to-Peer Network is holding webinars on 340B contract pharmacy implementation and integrity on May 22 at 2:00 p.m. (Eastern) and on maintaining 340B program integrity in mixed-use settings on June 28 at 2:00 p.m. (Eastern). It plans to repeat the audit webinar on July 25 at 2:00 (Eastern). Visit http://www.healthcarecommunities.org/FAQs.aspx?id=11162 to register.