Spotlight on Issues -- 340B Drug Discount Program Under Fire
The 340B Drug Discount Program is a U.S. federal government program created in 1992 that requires drug manufacturers to provide outpatient drugs to eligible health care organizations and covered entities at significantly reduced prices. The program was originally designed to assist "covered entities" serving a high number of uninsured indigent patients to "provide direct clinical care to large numbers of uninsured Americans," (i.e., charitable institutions) by affording them access to discounts of 25-50 percent on prescription drugs.
Since 1992, the program has grown from a few hundred covered entities to more than 12,148 providers as of October 2016. Covered outpatient drugs include prescription drugs as well as over-the-counter ("OTC") products, and generally include any product bearing a National Drug Code (NDC). The 340B discounting obligation applies only to drugs that are used in an outpatient setting and neither vaccines nor orphan drugs are included.
BIO and BioNJ are concerned that the program lacks transparency and that drugs may not be getting to the patients intended by the program. These concerns have also been expressed by the Energy and Commerce Committee in an 80-page report that highlighted problems with the program and the concern over covered entities, mainly hospitals, abusing the program; and by the GAO and OIG in various studies, reports and testimony expressing concern over the lack of transparency in the program. BIO and BioNJ do not oppose the 340B program but we believe it could be improved through transparency and more stringent reporting requirements.
The Senate Health, Education, Labor and Pensions (HELP) Committee held the first of several planned hearings on the 340B program last week. To view the proceedings, click here.
BioNJ is addressing this issue with our Congressional delegation in meetings in Washington and in district offices. BioNJ holds in-district meetings with each Member at least once a year and meets with the delegation more frequently in Washington. If you would like to participate in a visit to your Congressional representative's district office, please contact Rebecca Perkins at [email protected] or 609-890-3185for more information
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