Only eligible entity types can participate: FQHCs, DSH hospitals, Ryan White clinics, and other specified federal grantees

340B pricing applies ONLY to outpatient drugs for eligible patients — inpatient use is not covered

Covered entities must maintain auditable records and prevent duplicate discounts with Medicaid

Financial Assistancehard

340B OPAIS Registration

340B OPAIS · HRSA Office of Pharmacy Affairs

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.

Form Details

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Where to Submit This Form

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https://340bopais.hrsa.gov/

Covered entities must register through the HRSA OPAIS system.

Filing Deadline

Register before purchasing 340B-priced drugs. Registration must be updated when changes occur to covered entity status, contract pharmacy arrangements, or authorized representatives.

Required Attachments

📎 Covered entity identification and grant/program information
📎 Authorizing official designation
📎 340B program contact information
📎 Contract pharmacy agreements (if applicable)
📎 Documentation of federal grant or program eligibility (FQHC, DSH hospital, etc.)

Processing Time

Initial registration: 2-4 weeks for HRSA review and approval. Changes and updates may take 1-2 weeks.

What Happens Next

Once registered, the covered entity can purchase outpatient drugs at 340B ceiling prices from participating manufacturers. HRSA will assign a 340B ID. Annual recertification is required.

Tips for This Form

✓ Only eligible entity types can participate: FQHCs, DSH hospitals, Ryan White clinics, and other specified federal grantees
✓ 340B pricing applies ONLY to outpatient drugs for eligible patients — inpatient use is not covered
✓ Covered entities must maintain auditable records and prevent duplicate discounts with Medicaid
✓ HRSA conducts audits — ensure your 340B program has robust compliance policies and software

More Financial Assistance Forms

Patient Assistance Program Enrollment

PAP Enrollment (manufacturer-specific) · Pharmaceutical Manufacturers (Pfizer, Lilly, Merck, J&J, AbbVie, etc.)

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.

Manufacturer Copay Card / Coupon Enrollment

Copay Card (manufacturer-specific) · Pharmaceutical Manufacturers

Enrollment for manufacturer copay reduction programs for commercially insured patients. NOT available to Medicare, Medicaid, or other federal program beneficiaries. Some insurers have accumulator adjustment programs that prevent copay card amounts from counting toward deductible.

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

Application for Extra Help (Low-Income Subsidy) with Medicare Part D prescription drug costs. Reduces premiums, deductibles, and copayments for qualifying beneficiaries. Can save an average of $5,300 per year.

PAP Attestation Form (CMS)

PAP Attestation · CMS

Attestation that the Patient Assistance Program operates outside the Part D benefit to ensure separateness. PAP assistance does not count toward True Out-of-Pocket costs (TrOOP).

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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 Office of Pharmacy Affairs 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.