SpendMend Pharmacy 340B Compliance
SpendMend Pharmacy provides external 340B compliance program auditing while also assisting with regulatory oversight. We help your Covered Entity (CE) remain compliant with HRSA through annual reviews of your 340B programs.
We encourage you to let our expert team support you with mock HRSA audits and assist you with notices from CMS and manufacturers, while also providing you with corrective action planning. As part of our process, we mimic a HRSA audit to see how you’d do if you were facing an actual audit while also performing a comprehensive gap analysis of your 340B program.
The 340B Compliance Program
What We Do and What Your Covered Entity Will Receive:
340B Annual Audit
A comprehensive 340B program review including SME insights on compliance risk and gap analysis.
340B Maintenance Services
Remote program administration and guidance for sites who do not have 340B staff at their CE.
340B Management Services
Conversion of clinics (under the hospital) to maximize future 340B savings.
340B Support: 340B Staff Augmentation
Temporarily add 340B experts to your staff to help manage routine compliance tasks.
340B Support: Education
Onsite or remote 340B education and training focused on the CE’s specifications.
340B Support: HRSA Audit Support
One-on-one navigation and support during the HRSA audit and post HRSA audit support including a corrective action plan for any HRSA findings.
Why Is 340B Compliance Important?
The 340B Program requires drug manufacturers to sell outpatient drugs at a discount to CE’s. OPA and HRSA administer the program and oversee program compliance through annual audits, among other efforts.
If audits identify noncompliance issues, HRSA presents findings to CE’s and requires corrective action to continue in the 340B Program. Failure to maintain participation in the program can cost pharmacies a range of 20-50% on annual drug costs.:
Audit findings by HRSA over an 8-year span include the following 1,536 items:
Failures to maintain eligibility-related requirements (e.g., covered entities’ oversight of contract pharmacies).
Diversions of drugs to ineligible patients (e.g., patients’ health records are not maintained by the covered entity).
Duplicate discounts for prescribed drugs that may have been subject to both the 340B price and a Medicaid rebate.
Why Covered Entities Choose SpendMend
Pharmacy 340B Compliance
SpendMend Pharmacy 340B Compliance Overview
SpendMend By The Numbers