340B Program
Counsel that delivers practical advice to both comply with 340B program requirements and optimize program performance
Capabilities at-a-glance
- A deep bench of 340B experience in an integrated, multi-office platform providing comprehensive, holistic support to our health care clients.
- A team whose various backgrounds enhance our 340B capabilities, including consulting, covered entity, pharmacy and wholesaler experience.
- Full range of 340B services delivered with national reach.
- Offering a practical focus on optimizing 340B outcomes based not only on our analysis of law and guidance, but also shaped by our experience serving on the front lines of 340B program developments.
Bringing experience and thought leadership to the 340B program space
As one of the premier pharmacy law groups in the country, Quarles maintains a thriving nationwide practice that guides clients through the complex world of the 340B drug pricing program. Our 340B team has represented nearly every type of stakeholder involved in the 340B pharmaceutical care delivery system, and we naturally leverage our larger pharmaceutical experience to ensure that any proposed actions or procedural changes are considered with the entire picture in mind. From providing hands-on assistance during each step of the formal 340B HRSA audit process to designing complex, compliant distribution models to maximize 340B capture, we consistently ensure our clients maintain 340B program compliance while simultaneously optimizing opportunities for 340B benefit realization.
Quarles’ 340B attorneys are thought leaders in the space, frequently publishing articles on cutting-edge strategies and presenting to national audiences on 340B developments. We also maintain a 340B program blog.
Serving 340B stakeholders of all shapes and sizes
We advise nearly all 340B stakeholders, including:
- Hospital-covered entities
- Grantee-covered entities (e.g., FQHCs, Ryan White clinics, STD clinics, etc.)
- Contract pharmacies (retail and specialty)
- Third-party administrators
- Wholesalers
- PBMs
- Pharmacy management companies
For covered entities, we routinely assist in complying with their reporting, enrollment, audit and other regulatory obligations related to the 340B program, ranging from general compliance with federal 340B requirements to more granular compliance with state-level Medicaid billing and general board of pharmacy regulations. On the pharmacy side, we frequently work with contract pharmacies to negotiate 340B contract pharmacy agreements that enable both covered entities and the contract pharmacies to obtain 340B program benefits and maintain program compliance. We also work with PBMs as they expand their pharmacy network and pharmacy services agreements to include the provision of 340B pharmacy services and navigate state-level restrictions on 340B program reimbursement.
Experience
- General regulatory compliance
- Assessment of 340B optimization strategies
- 340B HRSA audit preparation and on-site support
- Notice of Disagreements
- 340B policy and procedure drafting and maintenance
- Contract Pharmacy Services Agreement (CPSA) drafting and negotiation
- Alternative distribution model (ADM) strategies
- Navigation of manufacturer contract pharmacy pricing restrictions
Successes
Implementation of alternate distribution models (ADM)
Recent manufacturer restrictions on longstanding 340B contract pharmacy arrangements created difficulties for both covered entity and contract pharmacy clients in maintaining 340B revenue to continue providing a broad range of services for their most vulnerable patient populations. Our 340B team worked closely with both our contract pharmacy and covered entity clients to leverage our experience in the wholesaler space to enable the implementation of various ADMs. These ADMs included a variety of models such as:
- Helping covered entities set up their own wholesalers to ensure continued flow of 340B drugs within their systems.
- Working with contract pharmacies to identify relevant state law exceptions to “wholesaling” to enable them to efficiently transfer 340B drugs between contract pharmacy and covered entity sites.
- Assisting covered entities in scaling up their existing entity-owned pharmacy operations to enable them to maintain their 340B-capture.
PHE and post-PHE guidance for covered entities
The 340B program has been far from a quiet, settled space over the last few years. It has been the subject of high-profile litigation, temporary flexibilities during the COVID-19 pandemic, ongoing uncertainty into the Health Resources and Services Administration’s (HRSA) enforcement authority and proliferation of state level 340B-related laws. With all of this uncertainty and change, covered entities often struggle to comply with frequently shifting program guidance and are unsure how to best grow their 340B benefit within current program parameters. Our 340B team has helped many covered entity clients ensure both compliance with and optimization of their 340B programs, including:
- Growing entity-owned pharmacy networks to improve patient access to crucial medications while growing 340B benefit not impacted by manufacturer contract pharmacy restrictions, including the utilization of pharmacy management services agreements when appropriate.
- Post-Genesis decision, exploring updates to 340B eligible patient definitions that still comply with applicable HRSA guidance and enforcement trends.
- Tracking and consideration of state anti-PBM 340B discrimination laws to realize more favorable reimbursement on 340B medications while maintaining compliance with larger network requirements.
