Navigating MTM Regulations: Key Risks and Requirements for 340B Hospitals

Healthcare Policy Update
Dec 02, 2025
Article Background

What’s happening

For 340B hospitals, regulatory expectations are evolving, enforcement actions are intensifying, and the margin for error is shrinking. While regulators across state and federal programs are closely monitoring hospital 340B programs, hospitals offering medication therapy management (MTM) services need to understand and comply with numerous requirements — not just 340B rules.

Of interest

Our partners at McDermott Will & Schulte (MWS), one of healthcare’s most trusted and respected healthcare law firms, are hosting a webinar on regulatory provisions outside of the 340B statute and Health Resources and Services Administration (HRSA) guidance that are critical to understand for the compliant operation of a hospital MTM program. The program will explore:

How MTM services intersect with 340B compliance and why focusing on only HRSA audit risk can lead to trouble
Medicare and state law requirements that should be the first focus when developing a hospital MTM program — not the last
Why hospital MTM programs should not be operated as pharmacy programs
Questions to ask when developing a hospital MTM program

Why you should care

A non-compliant hospital MTM program can place a hospital at risk of having its Medicare participation terminated, its license terminated, or facing false claims act enforcement – among other enforcement actions. Hospital and health system leaders should stay informed to ensure compliance.

Looking to learn more?

Register here and tune in on December 9, 2025, at 12pm ET to learn more.