HRSA Omnibus-Mega Guidance Case Study

Decent Essays
Before we get started on the how to benefit from the 340B Mega Guidance, let's review some of the basics.
What is 340B?
According to HRSA (Health Resources and Services Administration, and simply put, the 340B drug pricing program is a requirement placed on drug manufacturers to provide outpatient drugs, at reduced prices, to health care organizations and covered entities that comply with eligibility requirements. This program helps covered entities to reach more eligible patients by stretching their federal resources as much as possible. 340B helps low income patients receive the medications they need at a price they can pay.
340B Drug Pricing Omnibus Guidance
The Health and Services Administration has published the 340B Drug Pricing Omnibus
…show more content…
Compliance and abuse
The HRSA Omnibus - Mega Guidance is primarily focused on compliance and abuse prevention. This can be a positive measure, but also has outreaching effects on federally qualified health centers (FQHC).
Clarification of patient eligibility
Many critics of the 340B program complained that the program is too broad in scope and that the eligibility of patients was too vague. The mega-guidance document proposes that patients now must meet six conditions of requirements instead of the current three conditions that must be met in order to be eligible for discounted drugs.
Clarification of provider credentials
Under the current 340B program, a provider is required to have privileges or credentials with a 340B facility. The mega guidance document recommends that the provider must be employed by the 340B member organization.
Outpatient status
Currently, patients are able to receive prescriptions as they are being discharged from the hospital. The mega guidance document contends that drug discounts are available on a true outpatient basis

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