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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