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Apexus works with more than 25,000 health care providers across the United States to lower their costs for purchasing outpatient pharmaceutical products, allowing them to stretch their resources to serve more low-income and uninsured patients. As the exclusive contract for the 340B Drug Pricing Program, managed by the Health Resources and Service Administration (HRSA), Apexus negotiates significant discounts for branded and generic pharmaceuticals while working with providers to help them comply with 340B regulations and guidance. Apexus works closely with HRSA's Office of Pharmacy Affairs to improve the integrity of the 340B program.
340B University Tools and Resources
The Apexus Compass
The GPO Prohibition and Compliant Contracting
As a condition of eligibility for 340B participation, disproportionate share hospitals (DSHs), children's hospitals, and free-standing cancer hospitals may not purchase covered outpatient drugs through a group purchasing organization (GPO) or group purchasing arrangement. These covered entities must attest to compliance with the GPO Prohibition during the annual 340B recertification process; this requirement is reviewed during HRSA 340B program audits. Because compliance with the GPO Prohibition is an eligibility requirement, covered entities found in violation of the GPO Prohibition will be considered ineligible and will be removed immediately from the 340B program. Covered entities may also be subject to repayment to manufacturers for the time period for which the violation occurred. Because findings related to GPO Prohibition violations are now appearing on the HRSA website, an inquiry trend to the Apexus Answers Call Center has been how to ensure that the contracting strategies of these types of hospitals do not conflict with HRSA policy.
In a published guideline, HRSA enables 340B covered entities to use purchasing agents; however, HRSA has also used this as an opportunity to distinguish a purchasing agent from a GPO. This provided additional details regarding what types of arrangements could constitute violations of the GPO Prohibition:
For purposes of the DSH/GPO prohibition only, a purchasing agent may be distinguished from and would not be considered operating as a GPO or other group purchasing arrangement if the following conditions are met:
The purchasing agent is not associated with a GPO or other purchasing arrangement.
No collective bargaining by a group of hospitals occurs.
The negotiations for PHS pricing are separate activities for each individual DSH.
A separate agreement with each DSH is executed.
As part of the agreement, there will be no sharing of pricing information.
All final decisions concerning product and price acceptance will be made by each individual DSH.
Based on this guidance, hospitals should be aware that they may not pool the collective volume for the negotiation and purchase of covered outpatient drugs for both 340B and non-340B hospitals, or multiple 340B hospitals each having a unique 340B parent ID. A hospital with one 340B ID number, however, may negotiate for covered outpatient drugs based on the volume of the 340B ID's parent and children associated with that 340B ID.
Problematic contracting scenarios include the following:
An individual DSH accessing contracts executed by an IDN in which it is a member
A wholesaler's generic source program (unless offered as a subcontracted solution to the Apexus Generics Source portfolio)
A manufacturer extending a discounted price to a group of covered entities (subject to the GPO Prohibition) through a wholesaler, other third party, or group purchasing arrangement that is not supported by an individual contract between the 340B covered entity and the manufacturer.
Apexus, as HRSA's contracted 340B Prime Vendor, is not considered a GPO and is permitted to perform such group purchasing functions on behalf of all entities that participate voluntarily in the Prime Vendor Program. The HRSA agreement enables Apexus to contract for outpatient covered drugs and other value-added products on behalf of participating covered entities. Apexus has implemented three types of contracting strategies that offer compliant savings opportunities for hospitals subject to the GPO Prohibition. The following three contract types may be loaded to the 340B and non-GPO/WAC accounts:
Apexus sub-WAC contracting was implemented in response to HRSA's clarification of the GPO Prohibition, and offers an efficient means for entities to receive savings on more than 7,500 brand and generic products. The savings generally approximate GPO pricing and bring value to the entities.
The Apexus Generic Portfolio (AGP) is subcontracted to wholesale distributors to provide discounts on non-contracted items, such as generic oral solids.
The Apexus Access Program (AAP) provides contracted savings on plasma products and offers a compliant approach for entities to receive savings on IVIG, Albumin and factor products.
In summary, the GPO Prohibition is a requirement for certain types of hospitals; Apexus has worked to put contracting strategies in place to provide savings to these entities. When a hospital or system does negotiate its own discounts on outpatient covered drugs on its own, each individual hospital must be able to produce a separate agreement with each manufacturer. Specific questions about the GPO Prohibition and contracting may be directed to the Apexus Answers Call Center.
HHS Spending Bill Contains 340B User Fee
June 24, 2015
HRSA Takes its First Steps on 340B Rules
June 22, 2015
AHA Responds to Report on 340B Program
June 9, 2015
340B Proposed Rule Clears White House Review
June 9, 2015
Final Medicare Shared Savings Program Rule Released
June 6, 2015
340B for Safety Net Providers
May 4, 2015
US House Committee 340B Hearing Video
March 31, 2015
Peer to Peer Webinar July 8 2015
July 8, 2015
19th Annual 340B Coalition Summer Conference
July 13, 2015
Peer to Peer Webinar July 22 2015
July 22, 2015
National Pharmacy Purchasing Association Conference
August 17, 2015
NACHC Community Health Institute and Expo
August 23, 2015
ASHP 2015 Midyear Clinical Meeting and Exhibition
December 6, 2015