At times it can seem like the Health Resources & Services Administration (HRSA) is frustratingly inflexible in its administration of the 340B Drug Pricing Program. In fact, a recent court ruling out of South Carolina suggests that HRSA may be too rigid in its definition of a patient eligible to receive discounted 340B medications. Yet the agency can be flexible with the program during public emergencies.
Declared public emergencies allow the HRSA to relax some of its rules in order to help safety net hospitals do an adequate job of meeting healthcare needs. The added flexibility is not intended to establish any sort of permanent changes as evidenced by the fact that the end of the COVID public emergency also brought an end to a waiver that made it easier for covered entities to register for 340B.
Flexibility in Hawaii
One of the more recent examples of HRSA flexibility with the 340B program occurred earlier this year in Hawaii. Immediately following the devastating fire on Maui, state officials declared a public health emergency. HRSA responded by allowing potentially eligible healthcare providers to immediately register for 340B participation rather than forcing them to wait until the next quarterly enrollment period.
Eligible providers include safety net hospitals, their satellite locations, and their institutional and contract pharmacies. Actual eligibility requirements have not been relaxed as a result of the emergency. The only thing that changed was the time frame under which eligible providers could register for the program.
While it is a small change, it is important, nonetheless. Healthcare facilities trying to help those affected by the fire need access to every tool available. Forcing them to wait until the next quarterly enrollment period would only hinder their ability to provide care for local residents.
Flexibility for Patients
The flexibility offered under the declared public emergency in Hawaii affected patients as well as healthcare providers. Under normal circumstances, HRSA’s definition of an eligible patient is pretty narrow. Not only that, but facilities also need to document patient eligibility before they can dispense discounted 340B drugs.
That all changes for as long as the public health emergency remains in effect. During the emergency, patients can self-certify that they are eligible without having to provide documentation. Dropping the documentation requirement accommodates local residents who may have lost everything in the fire.
340B Can Be Complicated at Times
These two examples of 340B program flexibility are good and beneficial, but they also highlight the reality that the program can be complicated at times. It can be so difficult to navigate that covered entities turn to third-party consultants to help them make sense of it all.
Ravin Consultants is one such 340B consulting firm. They help covered entities establish and maintain their 340B programs. They help with compliance issues, conduct mock audits, and provide 340B program management and optimization services. It is all necessary to ensure covered entities stay on track with the program.
Undoubtedly there are organizations in Hawaii who have turned to their consultants to help them understand the temporary changes now in effect. Once the public health emergency ends and things return to normal, consultants will still be there to help covered entities transition back to the normal way of doing things.
As for HRSA, their authority to administer the 340B Drug Pricing Program has been called into question by a federal court in South Carolina. While regulators and Congress grapple with that issue, HRSA still has the ability to be flexible when conditions warrant. During times of public emergency, they can relax the rules to get the most out of 340B.