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BIO Comments to CMS on Oregon Proposed 1115 Waiver Application

April 1, 2022

The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the Oregon Health Authority’s (OHA) proposed Oregon Health Plan §1115 Demonstration Waiver Application (Waiver Application), which among other things, would be a waiver of compliance with essential provisions of §1927 of the Social Security Act (SSA) to exclude drugs approved through the FDA’s accelerated approval pathway (AAP). We urge CMS to reject those provisions of the proposed waiver that would exacerbate health disparities and jeopardize patient access and care, especially for patients with rare and chronic diseases.

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BIO Comments to CMS on OHA Proposed 1115 Waiver Application
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In response to the 340B Request for Information issued by the Senate 340B Bipartisan Working Group, BIO submits detailed comments.