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Focus on Reimbursement, Regulation and Innovation

Register now for ACLA’s 20th Annual Meeting, May 4-5, 2015 in Washington, DC.

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Boston Globe editorial: ‘FDA rules will do more harm’

A new Boston Globe editorial warns against proposed FDA guidance on laboratory developed tests.

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ACLA Warns Against Duplicative LDT Regulation at House Hearing

At a recent Energy and Commerce Health Subcommittee hearing, ACLA President Alan Mertz cautioned that duplicative regulation of LDTs would be harmful to innovation and patient access to diagnostic services.

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Academic Medical Center Labs to OMB: Don’t Stifle LDT Innovation

The nation’s leading academic medical center labs have joined together to warn against further FDA regulation of laboratory developed tests.

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The Protecting Access to Medicare Act of 2014

Big changes are coming to how Medicare pays for clinical lab services – here’s everything your lab needs to know about the new law. 

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Policy Issues

  • Reimbursement and Coverage

    Medicare cuts to clinical labs threaten jobs, stifle innovation, and put patient access to vital lab tests at risk.

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  • Laboratory Developed Tests

    FDA regulation of laboratory-developed tests (LDTs) is duplicative, outside of FDA jurisdiction, and would negatively impact patient access to vital lab tests.

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  • IOAS Exception

    Self-referral leads to over-utilization, mistreated patients, and billions of wasted Medicare dollars. It’s time to close the loophole.

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