Recent and proposed changes to the policy environment directly affect market access for advanced diagnostics.
TORONTO (PRWEB) July 08, 2020
The precision medicine landscape has experienced significant evolution in the past ten years, evolving from single gene assays to complex next-generation sequencing panels. During this period, the access landscape has evolved significantly, emerging from a traditional access environment with relatively few inputs to an exceedingly complex environment, with policy initiatives playing an increasingly pivotal role.
Recent and proposed changes to the policy environment directly affect market access for advanced diagnostics. These changes include but are not limited to:
- Medicare’s date of service policy
- Medicare’s national coverage determination for next-generation sequencing
- Federal legislative initiatives, including the VALID Act and VITAL Act
- FDA guidance, including class-based companion diagnostic labeling
The experts from Boston Healthcare Associates routinely leverage their expertise in precision medicine and policy to support diagnostic and biopharmaceutical clients as they navigate the policy environment. In this webinar, participants will learn about the need for diagnostics policy monitoring and engagement to support development and access for precision medicines.
For more information or to register for this event, visit Implementing Precision Medicine: Diagnostics Policy Considerations for Biopharmaceutical Innovators.
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