August 30, 2012—Health Resources and Services Administration (HRSA) program integrity audits of two hospitals’ 340B drug discount programs identified no occurrences of drug diversion to ineligible patients, duplicate discounts under Medicaid, or eligibility issues, the Drug Discount Monitor has learned.
Denver Health and Hospital Authority, an integrated public health system which operates one of Colorado’s largest disproportionate share hospitals, and Fort Logan Hospital, a 25-bed critical access hospital in central Kentucky, received their audit results from HRSA in August, officials at both institutions confirm.[ms-protect-content id=”2799″]
It is not known whether any of the 49 other 340B covered entities that were audited by HRSA this year have received their final audits reports as well. Denver Health and Fort Logan were both audited in February toward the start of the program integrity initiative. HRSA audited a total of 51 entities, most of them hospitals. It selected 46 on the basis of a risk profile and the remaining six on the basis of allegations of noncompliance. HRSA’s Office of Pharmacy Affairs (OPA) has said that will publish all of the audit findings on its Web site’s 340B program integrity page.
Pharmaceutical manufacturers, meanwhile, have begun their own audits to determine whether covered entities have either diverted drugs to non-qualified patients or have not implemented safeguards to protect against the payment of a Medicaid rebate and a 340B discount on the same product.
In an Aug. 21 letter that accompanied Fort Logan’s audit report, OPA Director Krista Pedley told hospital Chief Executive Officer Mike Jackson that “HRSA’s review of [the hospital’s] policies, procedures, and sample prescriptions did not indicate the occurrence of diversion, duplicate discounts, or eligibility issues.”
The hospital was audited on Feb. 28-29 by HRSA’s Office of Regional Operations. The review:
- confirmed the hospital’s eligibility;
- evaluated its drug procurement process;
- evaluated its inventory process;
- tested its dispensing process; and
- tested its prevention of duplicate discounts.
“Overall, it was determined that Fort Logan Hospital met all eligibility requirements … and had established policies and procedures to provide oversight of its utilization of the 340B program,” the report stated. HRSA said that each prescription it sampled met all patient eligibility requirements, that it found no evidence of drug diversion, that the hospital correctly reported it Medicaid billing practices in OPA’s Medicaid exclusion file, and that none of the tested prescription transactions demonstrated evidence of a duplicate discount.[/ms-protect-content]