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Is your hospital MTM program compliant? Federal and state requirements beyond 340B

Is your hospital MTM program compliant? Federal and state requirements beyond 340B

Overview


Regulators across state and federal programs are closely monitoring hospital 340B programs and hospitals offering medication therapy management (MTM) services need to understand and comply with numerous requirements not just 340B rules. For health system executives and in-house counsel, the stakes are high: regulatory expectations are evolving, enforcement actions are intensifying, and the margin for error is shrinking. 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.

This webinar will take you inside the 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. We’ll 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

Continuing legal education (CLE) credit is pending. McDermott Will & Schulte LLP is an approved provider and can provide credit in California, Illinois, and New York. McDermott Will & Schulte is a sponsor and will apply for credit in Delaware, Florida, Georgia, Tennessee, Texas, and Virginia when lawyers licensed in these jurisdictions are in attendance. We can issue reciprocal credit for lawyers licensed in Connecticut and New Jersey. For all other jurisdictions not listed, attendees will be provided with a Universal Certificate of Attendance that they may use to self-apply for CLE credit in their state of admission. Attendees should contact their state’s CLE board for current rules, regulations, and guidance.

REGISTRATION INFORMATION

Tuesday, December 9, 2025
12:00 – 1:00 pm ET

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