Notice of Proposed Rulemaking (NPRM)
Definition
An NPRM is the formal mechanism by which federal agencies—including HRSA and CMS—propose new regulations affecting the 340B program. When an NPRM is published, interested parties including covered entities, manufacturers, patient advocates, and healthcare organizations can submit formal comments during the designated comment period.
In the 340B context, NPRMs have addressed topics such as the ceiling price and civil monetary penalty final rule, administrative dispute resolution procedures, and proposed changes to program administration. Covered entities that monitor NPRMs and participate in the comment process can influence the final shape of regulations that affect their programs.
Understanding the NPRM process helps covered entities stay ahead of regulatory changes and plan for implementation before new rules take effect.
Frequently Asked Questions
Why Notice of Proposed Rulemaking (NPRM) Matters
NPRMs signal upcoming regulatory changes that will affect 340B program operations. Covered entities that monitor and respond to NPRMs can prepare for implementation in advance and may have the opportunity to influence the final rule through the public comment process.
How Virtue 340B Uses It
Virtue 340B monitors NPRMs and regulatory developments affecting the 340B program to keep our clients informed and help them prepare for upcoming changes.