340B Compliance Consulting

INCompliance helps clients maintain enrollment in the 340B drug pricing program. Services include preparing clients for HRSA audits through audits and staff training, and developing and implementing policies and procedures that address all aspects of 340B compliance.


340B Consulting Services

The 340B Drug Pricing Program enables health care organizations (covered entities) that care for underserved populations to purchase covered outpatient drugs at significantly reduced prices from manufacturers participating in Medicaid. To receive these significant drug cost savings, covered entities must ensure compliance with program requirements, including maintaining auditable records of demonstrating compliance with all program requirements. Oversight of the program by HRSA includes audits that focus, among other areas, on potential diversion, duplicate discounts and 340B database records. The risk of non-compliance includes loss of eligibility and repayment of 340B discounts to manufacturers.

With a deep understanding of the hundreds of HRSA audits that have taken place over the past few years, as well as hands-on experience with covered entities, INCompliance attorney-consultants advise clients regarding their 340B programs. We give proactive advice to strengthen existing programs, identify areas for improvement and address identified issues. Importantly, we are known for our ability to assist health care entities in maintaining the compliance of their 340B program eligibility, while reducing the risks associated with a government audit.


When it comes to 340B compliance,

effective 340B policies and procedures include definitive roles and responsibilities for all employees and leaders who are involved in implementing and documenting the process. Our attorney-consultants clearly and effectively communicate the knowledge that employees need to fulfill their roles. . Our training programs teach employees the skills they need to perform their job duties in a compliant manner, and assist managers in establishing expectations and standards for their team members and ensuring those expectations are met and the standards are maintained over time.


INCompliance’s approach to 340B compliance

Our attorney-consultants follow best practices and current HRSA and Apexus guidance to provide clients with the tools and answers for continual and evolving compliance with the 340B program.

Policies and procedures

If a covered entity does not yet have policies and procedures in place, we can assist with the development and implementation of comprehensive policies and procedures that are compliant with 340B program requirements. Likewise, we can ensure that existing policies and procedures are up-to-date with the most recent program standards, as well as with industry benchmarks and best practices.


Industry experts recommend regular audits to ensure that 340B compliance programs meet HRSA requirements. In fact, some of the weaknesses of an existing program may only be exposed through this type of review and assessment. INCompliance has developed a detailed step by step audit process that reviews each element required in a 340B compliance program, and we assist clients in remedying problems identified through the audit process, before they face the high stakes of an actual government audit. Through our audits we can help ensure that the facility is following its policies and procedures; properly defining eligible patients, providers and settings and not diverting 340B drugs to ineligible patients; and properly capturing re-classification of patients from outpatient settings and emergency services to inpatient when they are admitted to a hospital.

Contract pharmacy oversight

In order to remain compliant with the 340B program, covered health care entities must verify that contract pharmacy arrangements are in place and comply with 340B requirements. These arrangements must also be properly listed in the Office of Pharmacy Affairs (OPA) database. INCompliance can help you make sure this process is properly monitored and effective oversight is in place.

Transaction review

Accurate documentation and an organized records system is one of the best defenses against 340B noncompliance. We can perform a review of a cover entity’s processing methodology for 340B information and assist in strengthening this process across each phase of a transaction.

Audit preparation

INCompliance works with in-house compliance teams to prepare our clients once HRSA sends notification of an impending audit. Our pre-audit preparation services include a review of policies and procedures, vendor contracts and HRSA enrollment documentation. Likewise, we perform mock audits and a thorough review of drug transaction records. We remain available to assist the client throughout the actual audit process, to ensure all potential issues are addressed and resolved with the auditor.

Audit of an FQHC

We advised a Federally Qualified Health Center (FQHC) through the pre-audit, audit and audit response portions of a HRSA audit to proactively identify issues before the audit, correct issues identified during the audit and minimize post-audit plans of correction.

DSH Audit

We performed an audit for a covered entity Disproportionate Share Hospital (DSH), which included the review of contract pharmacy relationships, patient eligibility determination methodology and transaction processing methodology. The engagement included a discussion of compliance questions and policy gaps with client in order to proactively strengthen all phases of its 340B program.

Covered Entity Counseling

Our attorney-consultants have counseled numerous types of covered entities on 340B compliance issues, and assisted them with the identification, analysis, self-disclosure and repayment process of 340B overpayments to HRSA and manufacturers in order to minimize the long-term effects on each organization.

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