The 340B program was created by the congress in 1992 to assist the uninsured indigent patients to gain better access to the prescription medicines. In order to make this possible, the congress created a program that necessitates the pharmaceutical companies and manufacturers to provide the medications on discounts especially to the outpatients to the entities that served high numbers of the uninsured indigent patients. As originated, the 340B program provided discounts to the outpatient facilities and care centers serving the outpatients and the sole intent was to sustain the particular services to the targeted population. It is imperative to note that the 340B program was not targeted for the direct assistance of the poor as a program within the United States healthcare safety net. This program was supposed to allow only particular entities or the healthcare providers to stretch the federal resources to reach the patients who are more eligible and offer services that are more comprehensive. There is another implication of the patient care in that a financial incentive may be provided by the program to alter the care of the patients so that the patients who could have been treated as inpatients are treated as out patients thereby allowing the drugs bought on discount on the 340b program to be misused.
According to the reading, there is increasing evidence that suggests that the 340B program has diverged immensely from its original intent and thereby has led to the abuse of the program and the unintended and potentially harmful effects to the patients. In order to clarify the governmental intent of the 340B program, accountability, reform and transparency including oversight is needed to guarantee that the program meets its original intent. While the 340B program was intended to help the needy patients, it is the facilities that receive the discounts. There is no law obliging the healthcare providers to pass along the discounts provided by the program to the needy patients. The entities that are covered by the 340B program have access to the 340B pricing on most of the outpatient drugs and are able to provide the drugs to all of their patients without taking into consideration the patient income or the insurance. Therefore, there is no legislation that covers the needy patients. In order for the legislative intent of the program to be achieved, a greater oversight needs to be developed as the current oversight is insufficient.
Additionally, in order for the legislative intent of the 340B program to be clarified, there needs to be a clearer guidance on the definition of the term “patient’. Its current interpretation is ambiguous in the several cases provided, and it is up to the registered entities to decide so as to make the self-policing procedures and intents in the compliance. The sub regulatory guidance that has been issued recently allowed the covered entities to offer the 340B drugs through an unrestricted number of outside entities and thus the geographical proximity of the provision of the drugs is ambiguous. Therefore, for the entities that have their own in house pharmacies, there is need for the regulation in that it is difficult to distinguish between the inpatient and the outpatient drugs as all are viewed as the same patients.
The article has raised vital questions in the original intent of the programs goals and if the goals are being achieved. There exists opportunities to recalibrate the program so that the benefits are targeted to the indigent and uninsured patients who were the original target of the congress.
CCH Incorporated., & Wolters Kluwer (Firm). (2010). Law, explanation and analysis of the Patient Protection and Affordable Care Act: Including Reconciliation Act impact. Chicago, IL: Wolters Kluwer Law & Business.