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 takes 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. Emily Cook and Sandy DiVarco explored:

• 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

Key takeaways include:

1. 340B does not override other laws. The 340B program does not exempt 340B hospital covered entities from complying with any federal or state laws governing the provision of hospital services. All applicable Medicare, Medicaid, and state licensure requirements must be met when providing Medication Therapy Management (MTM) services, regardless of the intent to use the MTM services to establish 340B patient eligibility. Review for compliance with 340B program requirements should occur only after review of all other applicable federal and state laws.
2. MTM services must meet hospital standards. Hospital-based MTM programs are hospital outpatient services—not pharmacy services—and must comply with Medicare Conditions of Participation (COPs), provider agreements, and standards of care. This includes proper clinical oversight, valid orders, and documentation in the hospital’s medical record.
3. Patient-centered, medically necessary care: MTM services must be tailored to individual clinical needs, not delivered as a “check-the-box” exercise or solely to expand 340B eligibility. Duplicative or unnecessary services, or those provided without patient awareness, risk noncompliance and regulatory scrutiny.
4. Respect for patient choice and access. Patients must have freedom to choose their MTM provider and pharmacy, and the ability to refuse services. Hospitals cannot require patients to use a specific pharmacy or mandate MTM as a condition for receiving medications, except where clinically justified.
5. Thorough compliance and risk assessment required: Establishing MTM programs demands careful attention to fraud and abuse laws, billing practices, cost reporting, and state-specific licensure. Involve hospital clinical leadership early, and do not focus solely on 340B requirements—compliance with all applicable laws is essential.