340B Compliance & Pharmacy Operations
Effectively Enhancing Pharmacy Operations
Advis has a proven track record of enhancing health system and grantee pharmacy operations, including within retail and inpatient pharmacy settings. Our overall objective is to deliver enhanced optimization to the pharmacy landscape in an area of increasing complexity and unparalleled regulatory oversight. Ultimately, our unique approach which brings in the expertise of attorneys, pharmacists, data scientist and 340B ACE certified consultants leads to improved compliance and optimized savings.
Pharmacy Operations and 340B 340B Program Experience
Advis has extensive experience in assisting clients with many aspects of the 340B program, including the enrollment and auditing processes. Advis assists 340B-covered entities and 340B contract pharmacies with the development of: HRSA-compliant inventory/dispensing methodologiesDispensing and invoicing of 340B drugsOngoing compliance initiatives340B compliance managementOur experience translates into an in-depth, sophisticated understanding of the program—expertise that can assist you in setting-up and operating a highly successful 340B program. Our focus not only helps to ensure compliance but also to help make operational decisions based on best practices and industry standards.
Increased scrutiny of 340B Programs From HRSA OPA
The Advis approach is unique in that it includes:
- A review of pharmacy and 340B strategies
- Infusion center assessment
- Retail pharmacy development and operations
- Credentialing and Enrollment services
- Contract Pharmacy optimization through development and improvement of existing
- Routine Auditing Compliance
- Referral Assessment services
- External annual audits
- A national leader in 340B compliance requirements and program optimization.
- External auditing
- HRSA audit support
- Contract/specialty pharmacy development
- Financial impact analysis
- Manufacturer Restriction
- Impact Analysis
- Third-Party Administrator RFP development and Implementation Assistance
- Strategic development
Compliance review - Staff training
- Cost Report Assessment
Advis is in a unique position to help you
Advis’ 340B consultants are acutely familiar with the benefits as well as the resulting 340B compliance obligations of the 340B program. We have been assisting various types of covered entities, including hospitals, FQHCs, community clinics, and contract pharmacies, with program compliance components, including Initial program feasibility, Registration, and implementation, Situational audits, Day-to-day compliance assistance operational assistance340B voluntary disclosures340B-Medicaid overpayments/repaymentsOnce up and running, we will continually apprise you of regulatory developments that could impact your program. We help to lay out courses of action to ensure your continuing compliance with regulations while minimizing additional administrative costs. On our expert team of 340B consultants, we also employ the insight of knowledgeable pharmacists who partner to guide your organization through every step of the 340B and pharmacy process.
Best Practice for an Effective 340B Compliance Audit
Many of the HRSA audits have resulted in the Covered Entity being levied with sanctions or repayments to manufacturers. The best way to prepare yourself for a HRSA audit is to ensure that you are adhering to a system of best practices and continuous improvements. Advis has developed these best practices, which include internal and external road maps designed to meet HRSA and manufacturer specific inquiries, and stands ready to assist with their implementation and maintenance.How can we help? Our 340B compliance audit program, developed to align with the actual audit process employed by HRSA, involves an assessment as well as remediation. Our teams work closely with you to identify the procedures that need to be put in place for compliance; then we strategize with you to develop processes to remediate and control flaws or weaknesses in the program. We analyze the efficiency of your program and look for ways to maximize your benefits further. Our reports are meant to be actionable, not merely an exercise to check a box during an audit. These reports result in a meaningful way to improve the 340B program at your covered entity.
Manufacturer Restriction Mitigation
In light of the increasing complexity surrounding the 340B program and the restrictions being imposed by the manufacturers, Advis is prepared to assist your team identify strategies to mitigate the restrictive measures being put in place that ensures a compliant and financially improved operations. How can we help? Our team of experts will review all contract pharmacy data and any eRx data that your team is able to present and identify the best way to employ the exceptions permitted by each manufacturer and prepare a full plan to help improve 340B savings, through designation improvement, retail pharmacy development, alternative operational strategies, or entity owned pharmacy development.
