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Exact Sciences Colon Cancer Test Gets Quick Results From CMS

This article was originally published in The Gray Sheet

Executive Summary

CMS granted the company a broad-based national coverage policy at breakneck speed and a positive preliminary payment decision to boot for the Cologuard DNA stool test. It is the first national coverage determination resulting from the FDA-CMS parallel review pilot.

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Pacts In Medtech, July/August 2018

Derived from Strategic Transactions, Informa's premium source for tracking life-sciences deals, the bimonthly Pacts In Medtech highlights notable technology alliances, R&D partnerships and commercial collaborations. In this edition, we look at industry pacts that were sealed in July and August 2018.

FDA Extends Parallel Review Program ‘Indefinitely’

The program, which allows select manufacturers to have their products reviewed simultaneously for FDA approval and Medicare coverage, has been in the pilot stage since 2011. Now it is formally in full implementation mode and the agencies are looking for more manufacturers to participate.

FDA-CMS Parallel Review Pilot Will Be Extended; Drugs Not The Focus

CMS remains open to the idea of using parallel review (or, less formal parallel advice) for prescription drugs, but the current and future focus of the pilot program is likely to stay on devices and diagnostics.

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