The summer meeting of the 340B Coalition provided useful and timely information on important considerations for 340B Covered Entities. Gene Harber, 340B ACE, and Monika Filip-Prescher, 340B ACE, cover three Key Takeaways that impact CEs and are important to understand.
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Audit Trends and Takeaways from Diversion and Duplicate Discount Findings
When it comes to maintaining a compliant 340B Program, it is important to focus on the fundamentals: eligible location, eligible provider and eligible payor. In several of the audit-focused sessions, presenters noted that post-COVID19 changes that previously allowed retail prescriptions outside registered locations have led to HRSA findings primarily in 340B drug dispensations at contract pharmacies lacking medical record support or prescribed by ineligible providers. HRSA emphasized that the patient must have been seen in a provider-based location of the hospital at some point (as defined by the Covered Entity’s policies and procedures) prior to receiving a prescription for retail drugs written outside the hospital. The patient definition requirements, including the involvement of a credentialed or employed health professional, must still be met. HRSA is also identifying more duplicate discounts, complicated by growing child site registrations. Self-audit best practices involve incorporating measures into policies and procedures manuals, conducting self-audits tailored to carve-in and carve-out decisions and scrutinizing outliers and “one-offs,” especially in retail pharmacies. Overall, comprehensive policies, regular self-audits and stakeholder involvement are crucial for compliance, accuracy and preventing duplicate discounts.
Contract Pharmacy Restrictions
Currently, 24 drug manufacturers have restricted access to 340B drugs purchased at contract pharmacies. Maureen Testoni, President and Chief Executive Officer at 340B Health, indicated in her opening remarks that the estimated loss of revenue to all Covered Entities due to these restrictions is $8.4 billion in 2023. In order to retain some of that revenue, it is critical that Covered Entities stay updated on all manufacturer restrictions and changes, which is labor-intensive and complicated. It is critical to review prescription data to make informed decisions on single pharmacy designations and submit those designations before the deadlines imposed by the manufacturers. Other ways that some Covered Entities are dealing with manufacturer restrictions is through alternate distribution models to deliver drugs to their contract pharmacies. If any of these critical revenue-retaining measures apply to you, Visante can assist with the analysis and exploration of 340B ESP™ support and/or alternate distribution models.
The bill sponsored by Rep. Doris Matsui was one of the hot topics during the Summer Conference Meeting. This bill focuses solely on the Covered Entity’s perspective and does not address other 340B issues. The proposed bill aims to bring contract pharmacy back to its pre-2020 state for all Covered Entities and prohibit manufacturers from imposing conditions. It also establishes civil monetary penalties (CMPs) for manufacturers’ contract pharmacy violations. Other acts, such as the PROTECT 340B Act and Rep. Larry Bucshon’s 340B hospital reporting bill, tackle these concerns but face opposition from hospital groups. The bill’s chances of becoming law are uncertain, but it may have a better chance as an amendment to a must-pass bill or as part of the reauthorization of federal funding for community health centers. The outcome of ongoing lawsuits related to the 340B program may also influence congressional action on this matter.
Learn more about How to Navigate 340B Complexities in our recent Guide.