SpendMend Pharmacy - 340B Compliance
340B program participation comes with complex regulatory and audit requirements that must be managed carefully to maintain compliance
SpendMend Pharmacy 340B Compliance
SpendMend Pharmacy provides external 340B 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 the 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

A 340B annual audit with monthly 340B program compliance support from a 340B SME.

340B Management Services

Remote program administration and guidance for sites who do not have 340B staff at their CE.

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.

Getting Started
To begin the project, we work with you to pull your initial data set. We then provide an in-depth assessment of your environment and tailor our services to your specific needs. All our work is performed with the goal of limiting the time required from you and your staff. Pricing is based on the complexity and size of your facility.
Why Covered Entities Choose SpendMend
Pharmacy 340B Compliance

Ensure compliance with HRSA guidelines.

Benefit from a combined 250 years of 340B compliance and optimization experience.

Gain insight on best practices from leading pharmacies across the country.

Expand 340B compliance to include industry leading 340B optimization.

340B subject matter experts who have all come from covered entities help CEs identify real solutions for compliance gaps.

With over 300 active clients across the country and in every 340B CE type, our team can share best practices and solutions used for almost every situation in the industry.
SpendMend Pharmacy 340B Compliance Overview
SpendMend By The Numbers








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