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Faster Access to Innovative Medical Products

This act aims to speed up the process of bringing new, breakthrough drugs and medical devices to market. This means citizens can gain quicker access to innovative therapies that may improve their health and quality of life. The changes affect both coding procedures and reimbursement decisions under the Medicare program.
Key points
Expedited coding for new medical products: Novel medical products designated as breakthrough therapies will receive codes faster, essential for billing.
Quicker coverage decisions: The decision-making process for covering innovative therapies under Medicare will be streamlined, reducing waiting times for access.
Enhanced agency coordination: The act mandates better collaboration between agencies approving drugs (FDA) and those deciding on their coverage (CMS) to facilitate innovation.
Reporting and transparency: A report will be published on challenges in coding, coverage, and payment processes, with recommendations for incorporating patient experience and shortening decision times.
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Additional Information
NOVEL Act of 2021
Print number: S 2416
Sponsor: Sen. Burr, Richard [R-NC]
Process start date: 2021-07-21