Purpose: This tool is used to provide feedback to HRSA on the 340B Rebate Model Pilot Program.
Instructions: Complete the form below to provide feedback on the 340B Rebate Model Pilot. HRSA is requesting feedback on:
- Administrative Burden on Stakeholders
Level of administrative effort required for covered entities (CEs), manufacturers, HRSA, and Medicaid programs during both implementation and ongoing maintenance.
- Financial Burden on Covered Entities
Financial impacts on CEs, including the timeliness and predictability of rebate payments.
- Alignment With HRSA Pilot and 340B Program Requirements
Rebate model implementation alignment with HRSA pilot and other 340B requirements, including number of denials and manufacturer alignment with- or implementation beyond- HRSA guidance.
- Impact on HRSA Integrity Framework
Affects on HRSA audit abilities and findings, impact on good faith inquiries (GFIs) and Administrative Dispute Resolution (ADR) processes.
- Impact on Patient Medication Access
Extent to which the rebate model facilitates, preserves, or restricts patient access to necessary medications.
- Effectiveness in Preventing or Eliminating Duplicate Discounts (DD)
Ability to prevent statutory and non-statutory duplicate discounts and the administrative burden connected to Medicaid Duplicate Discounts, Medicare MFP Duplicate Discounts, and Commercial Duplicate Discount Stacking.
Please provide feedback on each category separately. Additional documentation such as non-conforming claims or rebate reports and reasons may be submitted to aid in illustrating your feedback. Note: do not include PHI or PII in documentation.
HRSA may reach out to the person submitting this notification for additional information, however anonymous submissions are accepted.
Confirmation of submission and a copy of responses will be emailed to the contact information supplied. If you have any questions, contact Apexus Answers.
