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ACLA Commends FDA Decision Not to Release Final LDT Guidance

Looks Forward to Continuing to Work with Congress and the Incoming Administration on Reform that Puts Patients First

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Key Lawmakers Support the FDA’s Decision to Delay Final Guidance on Laboratory-Developed Tests

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ACLA/AdvaMedDx West Coast Diagnostics Summit

November 10th, 2016

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ACLA sends letter to OIRA regarding LDT Guidance

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Senate Health Leadership Reacts to FDA Laboratory Developed Test (LDT) Oversight

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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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