Georgia Section 340B Audit Counsel

Georgia Section 340B Audit Counsel

Our healthcare law firm represents Federally Qualified Health Centers and other Section 340B Program covered entities or their contracted pharmacies with responding to and defending against HRSA and drug manufacturer audits conducted pursuant to Section 340B. An important focus of our business and healthcare law practice is assisting healthcare providers in avoiding and solving legal problems. With respect to the Federal Section 340B Program for safety net providers, our Atlanta and Augusta-based law firm represents FQHCs and other Section 340B entities with respect to:

  • Assessing and evaluating compliance with Section 340B and related federal regulations;
  • Assessing and properly responding to an Audit Notice by HRSA or a drug manufacturer;
  • Addressing and advocating on behalf of FQHCs and other covered entities alleged to have engaged in diversion or duplicate discounts or other violations of Section 340B;
  • Preparing employees for onsite interviews by Section 340B auditors;
  • Advocating to the Office of Pharmacy Affairs in defense of alleged Section 340B violations;
  • Representation and advocacy in formal legal proceedings, including litigation, relating to a Section 340B Audit.

Our law firm’s offices are in Atlanta (404.685.1662) and Augusta (706.722.7886), Georgia and is rated “AV” by Martindale Hubbell (the highest rating) and “10” by AVVO (the highest rating). For involved healthcare matters, we often employ consultants, as a team of professionals, to address the needs of our client. We work with the best Section 340B consultants in the healthcare industry, with particular expertise in FQHC operations and contracted pharmacy arrangements. To schedule a consultation, you may email us at info@hamillittle.com.

Our Section 340B Team Protects Covered Entities

FQHCs and other HRSA-supported health centers and look-alikes, Ryan White Clinics and State AIDS Drug Assistance Programs, Medicare/Medicaid Disproportionate Share Hospitals, children’s services and other safety net providers, and their contracted pharmacies, may obtain substantial financial benefits from the Federal Government’s Section 340B Program. Generally speaking, the Federal Government intends that Section 340B Program drug savings and related financial benefits enable FQHCs and other so-called “safety net providers” to stretch scarce Federal Resources as far as possible to enable them to serve more patients with better, more comprehensive services. However, FQHCs and other covered entities must comply with Section 340B Program requirements or face removal from the program, substantial financial penalties (including the possibility of having to repay Section 340B discounts), or investigation by federal law enforcement agencies, including HRSA and CMS. Our law firm has experience representing and advocating for Section 340B covered entities in defense of a Section 340B audit.

Defending a Section 340B Audit the Right Way

The number of audits has increased recently to address problems and some alleged abuse of the Section 340B Program by covered entities. Generally, there are two types of Section 340B audits. The more common type is a HRSA audit. A less common type is a drug manufacturer audit. Either type of audit will begin with a letter or similar notification that the audit has been initiated pursuant to applicable federal law and regulations. The auditor, whether a government agency or a contracted entity (typically a large accounting firm), will have very broad legal authority to obtain extensive documentation regarding the covered entity’s treatment of individuals who received Section 340B drugs and contracted pharmacy arrangements. The auditors will typically engage in a comprehensive, meticulous review of the information and evidence obtained from the covered entity and/or its contracted pharmacy and evaluate, among other things:

  • The covered entity’s eligibility status;
  • The covered entity’s written policies, practices and procedures, including the procurement, inventory, distribution, dispensing and billing practices and patterns;
  • The covered entity’s internal controls (or lack of same);
  • Patient records;
  • Evidence of diversion;
  • Evidence of duplicate discounts.

Through the auditor, HRSA or the drug manufacturer will provide written audit results. The covered entity is entitled by law to an opportunity for notice and a hearing and may dispute the audit results. Often covered entities are required to take “corrective action” to address Section 340B violations, including refunding overpayments by way of improper Section 340B discounts based on an auditor’s determination that diversion or duplicate discounts occurred. OPA may remove a covered entity from the Section 340B Program under some circumstances where Section 340B is violated. The proper approach to defending a Section 340B audit will always be cooperative, comprehensive and highly meticulous.

We can help you

There are tremendous financial savings and advantages for FQHCs and other covered entities by participation in the Section 340B Program that warrant protection should your covered entity receive an audit notice from HRSA or a drug manufacturer. To schedule a consultation, you may reach our firm by email (info@hamillittle.com) or by calling our office nearest you (404) 685-1662 (Atlanta office) or (706) 722-7886 (Augusta office). Our staff will schedule your consultation.