Frier Levitt attorneys Jesse Dresser, Arielle Miliambro, and Maria Stahl provide an in-depth overview of the 340B Drug Pricing Program and its intersection with innovative telehealth arrangements in our “340B & Telehealth: Regulatory Considerations” webinar. This presentation highlights the complex regulatory landscape and underscores the importance for stakeholders to stay informed about legal developments and proposed changes.
Key Takeaways:
- 340B Program and Patient Eligibility: Understand the criteria for hospital and non-hospital grantee Covered Entities and patient eligibility, including compliance with diversion prohibitions.
- Impact of Genesis Health Care Inc. v. Becerra: Learn about the ruling’s implications and HRSA’s continued enforcement of the 1996 Guidance on patient eligibility, and considerations when applied to telemedicine encounters.
- Proposed Legislative Changes: Follow pending legislation, including the SUSTAIN 340B Act, and explore the proposed changes to the definition of an “eligible patient” and how it may affect prescription-by-prescription eligibility.
- Contract Pharmacies: Gain insights into the impact of recent court decisions and state legislation on contract pharmacies, including manufacturer restrictions and 340B-specific reimbursement policies by PBMs.
- Non-Hospital Grantee Covered Entities and Regulatory Issues: Engage in a discussion regarding the increase in Non-Hospital Grantee Covered Entities and the accompanying regulatory considerations.
- Telehealth Considerations: Discover the critical aspects of telehealth regulations, including licensing status, practitioner-patient relationships, and prescribing limitations
- Kickback and Fee Splitting Implications: Understand how and when common 340B Telehealth models may trigger these federal and state rules.
- Innovative Models: Gain an overview of various innovative arrangements seeking to leverage telehealth resources to expand eligibility and access under the 340B program.