Compliance Services

340B Drug Pricing Program Services

Over the last 10 years, the number of locations participating in the 340B Drug Pricing Program (340B Program) has more than doubled, with much of that growth due to 340B Program expansion into contract pharmacy arrangements. This rapid growth has created concern as to whether the program is meeting its original purpose. Reports critical of the 340B Program’s oversight have been issued by the U.S. Government Accountability Office and the Office of Inspector General. In addition, the drug manufacturers are publicly voicing their complaints about the 340B Program’s operations.

HRSA audits are expected to grow in number as congressional members call for more oversight of the 340B Program.

In response to these reports, the Health Resources and Services Administration (HRSA) has stepped up efforts to monitor the 340B Program through recertification and audit efforts. HRSA audits are expected to grow in number as congressional members call for more oversight of the 340B Program.

Draffin Tucker understands the complexities and challenges facing the healthcare industry. In particular, our firm has the skills and experience to help address the numerous operational, financial, and compliance aspects of the 340B Program.

Recent client engagements include:

Complete 340B cost/benefit analyses
Assist with 340B registration and re-certifications
Evaluate 340B split-billing software systems
Perform ongoing compliance testing
Prepare for HRSA/manufacturer audits
Train hospital staff on 340B regulations and guidance

As part of the initial registration and re-certification processes, HRSA presently requires authorized officials of the covered entity to sign the following attestation: “. . . the covered entity is complying with all requirements and restrictions of Section 340B of the Public Health Service Act and any accompanying regulations or guidelines . . .”

Prior to signing this attestation, organizations should have reviewed their 340B programs and addressed any potential concerns. In our experience, common compliance issues include:

Erroneous data “feeds” into the software
System overrides and substitutions creating drug diversion
Improper NDC matching of dispenses to purchases
Ineligible patients passing to software
Inconsistent units of measure creating excess 340B purchases
Non-compliance with GPO prohibition
Improper billing to Medicaid agencies
Physician orders not supporting patient status

Draffin Tucker is here to help. We offer a variety of compliance solutions and other services that are tailored to meet your specific needs and concerns.

We can provide assistance with eligibility and enrollment, development of 340B policies and procedures, compliance testing, review of contract pharmacy arrangements, and mock HRSA audits.

Specific compliance testing may include: Medicaid registration, exclusions, and billing; group purchasing organization prohibition; patient eligibility; provider eligibility; and location eligibility.

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CONTACT OUR 340B COMPLIANCE EXPERTS.

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What is 340B?

The 340B Drug Pricing Program is a federal program that requires drug manufacturers participating in the Medicaid drug rebate program to provide outpatient drugs to enrolled “covered entities” at or below the statutorily-defined ceiling price. This requirement is described in Section 340B of the Public Health Service Act and codified at 42 USC 256b. The purpose of the 340B Program is to permit covered entities “to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” H.R. Rep. No. 102-384(II), at 12 (1992).

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