Developed in response to the needs of 340B pharmacies for regulatory compliance, network expansion, and operational management, Remy Healthcare provides a unique suite of custom services to help 340B pharmacies and clinics thrive.
What is the 340B Program?
Established in 1992 under the Public Health Service Act by the United States Congress, the 340B Program was created to help eligible vulnerable and underserved populations access prescription medication at significantly reduced prices through eligible healthcare organizations.
340B Eligible healthcare organizations, termed covered entities, include federally qualified health centers, designated hospitals serving a disproportionate share of low-income patients, and other community healthcare providers.
The 340B program requires drug manufacturers to provide outpatient drugs to covered entities at discounted prices, stretching federal resources and improving access to affordable medications for those in need.
Challenges Facing 340B Pharmacies
While 340B Pharmacies play a critical role in helping improve healthcare outcomes for underserved populations, successfully managing a 340B pharmacy poses a significant barrier due to complex regulations and the operational intricacies involved.
The costs and complexities are even more daunting for smaller, independent pharmacies. Fluctuating reimbursement rates, skyrocketing operational and contract pharmacy costs demand constant careful management to ensure compliance and optimize participation.
At Remy, we work hand-in-glove with 340B providers to help them overcome the challenges of the 340B pharmacy program.
Guided by our 38 years of service, we have found that most challenges facing 340B pharmacy programs boil down to 3 fundamental obstacles: regulatory, operational, and financial.
340B Regulations
340B pharmacies navigate a sea of stringent and ever-changing compliance requirements. While designed to ensure compliance and minimize abuse, these regulations demand meticulous record-keeping and are resource-intensive.
340B pharmacies contend with two major regulatory hurdles: ensuring compliance and passing audits, and navigating the changing regulatory landscape.
340B Compliance and HRSA Audits
Ensuring compliance with 340B program requirements, including eligibility criteria, patient eligibility verification, and diversion prevention measures, is crucial for continued involvement in the program. Pharmacies also face audits conducted by entities like the Health Resources and Services Administration (HRSA) or others to ensure compliance.
Passing these audits is, of course, critical. Still, many providers find the process resource-intensive and time-consuming, particularly if the team needs to gain experience handling HRSA audits.
Remy Healthcare makes the 340B compliance audit process stress-free with full-circle drug data management and reporting.
Changing Regulatory Landscape
The 340B program is subject to ever-evolving regulations, legislative changes, and potential policy shifts, including eligibility criteria, patient verification processes, and diversion prevention measures.
These changes pose a risk to pharmacy operations, reimbursement policies, and compliance requirements, requiring pharmacies to stay informed and adapt accordingly.
Remy’s 340B eligibility & registration expertise, coupled with market-leading compliance knowledge, ensures our clients are one step ahead of regulatory risks.
Operational Requirements
Best practices alone don’t just influence 340B pharmacy operations. Keeping operations current with regulatory compliance is also an ongoing battle. Two critical challenges we see- and help solve – are inventory management and integration with Electronic Health Records (EHR) Systems.
Inventory Management
Efficiently managing inventory can be a challenge for any pharmacy. However, managing inventory can be incredibly challenging for 340B pharmacies due to fluctuating patient demand, regulatory requirements, and the need to track and document 340B-eligible prescriptions separately from non-340B prescriptions.
Successful 340B inventory management requires careful oversight and strategic planning to minimize waste and maximize effectiveness. We pride ourselves on offering full-service management and compliance solutions to our clients.
Integration with Electronic Health Records (EHR) Systems
Integrating 340B program requirements into existing EHR systems and workflows can be complex, and many pharmacies require additional software solutions to accurately track and document 340 B-eligible prescriptions. But ever-changing regulations could mean a great solution yesterday is an expensive and outmoded burden today.
At Remy, our simple but robust 340B Drug Data Management and Reporting platform is designed to integrate into, not supplant, existing EHR systems. We specialize in Drug Data Management and Reporting personally tailored to your workflow, meaning lower cost, fewer headaches, and better results.
Maintaining Financial Stability
Maintaining financial sustainability, especially while participating in the 340B program, can be challenging due to fluctuating reimbursement rates, operational costs, and competition from larger pharmacy chains. This is especially true of smaller independent pharmacies, which may need more networks and contracts to compete with larger enterprises.
Reimbursement Issues
340B pharmacies often encounter challenges with reimbursement rates for medications purchased through the 340B program.
Reimbursement policies and rates can vary across payers and pharmacy benefit managers (PBMs), further complicating matters and making processing and management even more complex.
Remy’s 340B claims processing and reimbursement management help maximize reimbursements with minimal administrative burden.
Contract Pharmacy Arrangements
For those in the 340B space, developing a solid contract pharmacy network is critical.
Managing contract pharmacy relationships and ensuring compliance with 340B program rules and regulations can pose challenges for covered entities and their partner pharmacies, including inventory management, data reporting, and audit readiness issues.
Remy’s extensive 340B pharmacy network means we can source, negotiate, and manage contract pharmacy relationships that are secure, long-term, and mutually beneficial.
Due to these regulatory, operational, and financial challenges, too many 340B Pharmacies fail to live up to their potential, ultimately hindering their ability to provide crucial public health services to underserved communities.
“In today’s regulatory environment, 340B consultants can’t afford to be results-driven. You need to be results determined.”
Jacob Sacks, Founder & CEO Remy Healthcare
Support for 340B Entities
Despite 340B providers’ challenges, it is possible to succeed – and thrive – as a 340B entity.
Remy’s mission isn’t just to offer these solutions but to carefully tailor bespoke solutions that fit the exact needs of our clients. The result? Our 340B partner pharmacies become more efficient while optimizing patient services with ease.
Why a Personalized Approach to 340B Management Matters
The Remy process starts with a free assessment where we spend time getting to know your operation and the unique challenges it faces. Then, we pull a custom selection from our extensive range of services to craft the perfect solution that’s expertly tailored to your operation. Everything you need, nothing you don’t.
Unlike other 340B consultants, Remy Healthcare offers a collaborative approach and personal touch that ensures effective strategies for improved outcomes at lower costs, in addition to offering popular, bottom-line-boosting services that patients request:
Infusion Sites
Enhance patient-centered care and provide a broader range of comprehensive healthcare options with onsite infusion services. By offering infusion services onsite, clinics can offer convenient access to holistic treatments for patients with chronic conditions like rheumatoid arthritis or Crohn’s disease, reducing the need for patients to travel to separate infusion centers or hospitals.
Offering infusion clinics can financially benefit health clinics, diversifying revenue streams and potentially increasing patient volume. Infusion sites can attract new patients seeking specialized treatments and provide opportunities to bill for infusion-related services like medication administration and monitoring.
Remy infusion clinics provide comprehensive, patient-centered care while offering the potential for financial benefits and expanding service offerings.
Telemedicine
Avoid crowded waiting rooms while remotely offering consultations, diagnoses, and even treatment recommendations with Remy telemedicine. Our easy-to-use telemedicine platform empowers clinics to serve more patients conveniently and flexibly, enhancing continuity of care by facilitating regular check-ins and follow-up appointments.
Telemedicine can boost the clinic’s bottom line by reducing overhead costs like maintaining physical facilities and staffing while attracting new patients from expanded geographic areas seeking convenient virtual care options. Providers can conduct virtual appointments more efficiently, increasing patient throughput and optimizing provider schedules.
Remy’s telemedicine platform helps clinics increase access to care, improve patient convenience, enhance continuity of care, and realize potential cost savings, making it a valuable tool for modern healthcare providers.
Being a 340B Pharmacy in 2024
340B pharmacies face multifaceted and demanding challenges in their quest to provide underserved populations with quality healthcare options.
By offering personalized solutions tailored to each client’s unique needs, Remy Healthcare empowers pharmacies to overcome regulatory compliance issues, streamline operational processes, and achieve financial stability. With Remy Healthcare as a trusted partner, 340B pharmacies can confidently navigate the complexities of the program and continue to deliver essential healthcare services to those in need.
Thinking about your next step? Contact us today for a 100% free, no-obligation, personalized assessment.