To amend the Public Health Service Act to revise and expand the section 340B program to improve the provision of discounts on drug purchases for certain safety net providers.
340B Program Revision and Expansion Act of 2004 - Amends the Public Health Service Act to include in the discount drug purchasing program those entities that receive funding under the Social Security Act for the provision of maternal and child care services, mental health services, and substance abuse services.
Allows otherwise qualified hospitals to purchase discounted drugs through group purchasing agreements and organizations.
Allows discounted drugs to be provided in an inpatient setting. (Currently, discounted drugs must be provided only on an outpatient basis.)
Allows covered entities to contract with multiple pharmacies to purchase covered drugs.
Requires the Secretary of Health and Human Services to prevent abuse and misuse of discounted prices by: (1) developing a system to verify the accuracy of information regarding covered entities that is listed on the Department of Health and Human Services web site; (2) establishing a third-party auditing system to regularly audit covered entities and ensure compliance with requirements of the discounted drug program; (3) conducting supplemental audits and implementing dispute resolution guidelines and other compliance programs; (4) issuing advisory opinions in response to questions by manufacturers or covered entities about the application of this program in specific factual circumstances; and (5) providing covered entities access through the Department's web site to the prices for covered drugs.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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