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.
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Complete through the 340B OPAIS
https://340bopais.hrsa.gov/Must be completed by the authorizing official during the annual recertification period.
Filing Deadline
Annual. HRSA announces the recertification period (typically in the spring). Failure to recertify results in termination from the 340B program.
Processing during the recertification window. HRSA confirms recertification status within 2-4 weeks after the deadline.
HRSA will confirm your continued eligibility for 340B pricing. If recertification is not completed by the deadline, the entity will be removed from the program and must re-register.
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.
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 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.
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.
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 · 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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