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News Briefs: Dx Bill Reintroduced; FDA Questions Guided Therapeutics’ LuViva; Study Milestones

Rep. Leonard Lance reintroduced a bill in the House to address flaws in Medicare’s reimbursement system for diagnostics. Guided Therapeutics receives more questions from FDA on the PMA for its LuViva cervical scan. Study news from InSightec, Direct Flow Medical and PLC Systems. More news.

Rep. Leonard Lance, R-N.J., reintroduced a bill Sept. 12 designed to address flaws in Medicare’s reimbursement system for diagnostics, including molecular and genetic assays. The bipartisan Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network (MODDERN) Cures Act would reform payment for new tests by setting new criteria incorporating elements of market value, and it “takes into account the contribution of diagnostics to health care outcomes,” explained Andrew Fish, executive director of AdvaMedDx, which supports the legislation. According to Rep. Lance, it will also advance creative solutions for developing companion diagnostic tests for new drugs. Lance introduced the same bill in Nov. 2011. (See Also see "News In Brief" - Medtech Insight, 5 December, 2011..)

The bill calls on HHS to set up an advanced diagnostics education council, composed of heads of 10 federal health care agencies, including FDA and CMS; seven members with expertise...

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