The Health Resources and Services Administration (HRSA) has clarified key details of its proposed pilot 340B Drug Pricing Program Rebate Model.
New frequently asked questions (FAQ) include details on the scope of applicable drugs, provide guidance on model development, and describe covered entities’ recourse for rebate claims that remain unpaid more than 10 days after filing.
When a manufacturer hasn’t paid an owed rebate, the FAQ directs covered entities to work with the manufacturer and its vendor before contacting HRSA via email. A manufacturer that is unable to resolve rebate reimbursement issues in a timely manner may be removed from the pilot program.
HRSA continues to accept comments on the proposed rebate model. After the association and other stakeholders sent a letter urging CMS to delay the comment deadline, HRSA extended the deadline to Sept. 8.
Contact Director of Policy Rob Nelb, MPH, at rnelb@essentialhospitals.org or 202.585.0127 with questions.
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