Address every finding specifically — generic responses are likely to be rejected

Implement corrective actions immediately, do not wait for HRSA approval of the plan

Consider engaging 340B-specialized consultants or legal counsel for complex audit responses

Financial Assistancehard

340B Audit Corrective Action Plan

340B CAP · HRSA

Required within 60 days if HRSA audit findings are accepted. Documents corrective measures for compliance issues identified during program audit. Non-submission may result in removal from the 340B program.

Form Details

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Where to Submit This Form

🌐

Submit through the HRSA 340B OPAIS portal

https://340bopais.hrsa.gov/

Required in response to HRSA audit findings or self-disclosed violations.

📬

Mail to HRSA Office of Pharmacy Affairs

HRSA Office of Pharmacy Affairs 5600 Fishers Lane Rockville, MD 20857

Filing Deadline

Per HRSA's directive — typically 30-90 days after audit findings are issued. Specific deadlines are stated in the audit notification letter.

Required Attachments

📎 Detailed corrective action plan addressing each audit finding
📎 Root cause analysis for each identified violation
📎 Timeline for implementing corrective actions
📎 Evidence of corrective actions already taken
📎 Policies and procedures updated to prevent recurrence
📎 Repayment calculations for overcharges or duplicate discounts (if applicable)

Processing Time

HRSA reviews the corrective action plan within 30-60 days. Additional information or revisions may be requested. Final resolution can take 3-6 months.

What Happens Next

HRSA will review your corrective action plan and may accept it, request modifications, or require additional actions. Failure to adequately address findings can result in program termination. Manufacturers may be required to offer refunds or credits.

Tips for This Form

✓ Address every finding specifically — generic responses are likely to be rejected
✓ Implement corrective actions immediately, do not wait for HRSA approval of the plan
✓ Consider engaging 340B-specialized consultants or legal counsel for complex audit responses
✓ Self-disclosure of violations before an audit may result in more favorable treatment

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Application for free or reduced-cost medications for uninsured or underinsured patients. Requires income documentation and prescriber attestation. Each manufacturer has its own form and eligibility criteria.

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340B OPAIS Registration

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Online registration in the 340B Office of Pharmacy Affairs Information System. Required for covered entities (FQHCs, hospitals, etc.) before purchasing 340B-priced drugs. Requires supporting documentation for hospital classification.

340B Annual Recertification

340B Recertification · HRSA

Annual recertification of eligibility to participate in the 340B program. Failure to complete results in program termination. Authorizing Official must verify compliance with all program requirements.

State Pharmaceutical Assistance Program Application

SPAP Application (state-specific, e.g., NJ PAAD, NY EPIC, PA PACE) · State Pharmaceutical Assistance Programs

Application for state-funded prescription drug assistance. Eligibility typically based on age, income, and residency. Available in 20+ states. May coordinate with Medicare Part D for additional savings.

Extra Help / Low-Income Subsidy (LIS) Application

SSA-1020 · Social Security Administration

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Disclaimer: BeneFill™ provides form-filling assistance and informational guidance only. It is not affiliated with, endorsed by, or sponsored by the HRSA or any government agency. The information provided is for general informational purposes and does not constitute legal, medical, financial, or tax advice. Always verify form requirements and submission details directly with the issuing agency.