Section 340B

With offices in Atlanta and Augusta, Georgia, our law firm represents Federally Qualified Health Centers (“FQHCs”) with regard to business and healthcare legal issues, including federal regulations. We help FQHCs properly utilize Section 340B.

Atlanta Georgia Healthcare Attorneys

The goal of the Section 340B Program is to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services. The Veteran’s Healthcare Act and Guidelines in Published in the Federal Register regulate the Section 340B Program. Our law firm assists covered entities regarding the following types of Section 340B issues:

Section 408
  • Eligibility for the Section 340 Program
  • Interpreting the law and guideless to ensure compliance
  • Definition of a Patient issues
  • Contract Pharmacy Guidelines
  • Manufacturer Audit Guidelines
  • Medicaid Carve Out
  • Drug Diversion
  • Duplicate Discounts
Why participate in the Section 340B Program?

We can help you properly obtain and utilize the following benefits of participation in the program:

  • Save patients money
  • Save payers money
  • Lower the cost of care
  • Increase patient choice
  • Generate more revenue
We advance and protect the financial interests of FQHCs and RHCs

Our law firm represents community health centers. The adage that “it’s better to be proactive than reactive” applies to participation in the Section 340B Program. The program is a great opportunity, but participation in the program carries serious responsibility. Any FQHC involved in the Section 340B Program is subject to audits by OPA or a manufacturer. It is critical that proper steps be taken to anticipate the possibility of the need to defend an audit. There are substantial adverse consequences for a covered entity’s failure to comply with the law, including liability for improper discounts, exclusion from the Section 340B Program, and other government penalties (e.g. the False Claims Act).

We have substantial experience and demonstrated interest in helping healthcare businesses succeed.

“Kevin Little [of Hamil Little] represented the Medical Association of Georgia and individual physicians in a matter addressing the abuses of the health insurance industry. Kevin was a pleasure to work with and brought forth legal theories to hold the health insurance industry accountable to physicians and patients. We received outstanding representation from Kevin.” *

Donald Palmisano, CEO and General Counsel, Medical Association of Georgia.

Our attorneys have extensive experience and hold Martindale Hubbell's AV rating, its highest rating. To schedule a consultation with our attorneys, email us at info@hamillittle.com or contact us at our office nearest you.

Section 340B Audits

The Veterans Healthcare Act of 1992 included “Section 340B,” which is a drug discount program that requires pharmaceutical manufacturers whose drugs are covered by Medicaid to provide discounts on outpatient covered drugs purchased by 340B covered entities. This program is administered by the Office of Pharmacy Affairs (“OPA”). Under the Section 340B program, “covered entities” may receive discounts for drugs that will be dispensed to covered patients. Retrospective procurement is used to realize the discounts. The intended purpose of the Section 340B program is to enable covered entities to stretch scarce federal resources to that more eligible patients can be served with comprehensive healthcare services. Typically the savings are 25-50% of a drugs average wholesale price. In 2010, there were approximately $6 billion in Section 340B purchases.

OPA and drug manufacturers have the right to conduct compliance audits of participating entities. Covered entities must allow such audits. A drug manufacturer can conduct an audit only if it has documentation that indicates there is reasonable cause. The records of the covered entity and of any organization working with the covered entity are subject to the audit. The audit rules provide for a dispute resolution mechanism that requires effort by the covered entity and manufacturer to attempt to resolve the dispute themselves. If that fails, the OPA will resolve the dispute.

Georgia Section 340B Law Firm

Our focus is helping healthcare providers succeed. To schedule a confidential consultation, email us at info@hamillittle.com or contact us at our office closest to you.

* DISCLAIMER: Any result this law firm or any lawyer of this law firm may achieve on behalf of one client in one matter does not necessarily indicate similar results can be obtained for other clients.