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Diagnostic Tests Laboratories

Baker Donelson

Precision Medicine Advances: Medicare Coverage of Next Generation Sequencing Testing

Baker Donelson on

Medicare recently released a new national coverage determination (NCD) that addresses certain diagnostic laboratory tests using Next Generation Sequencing (NGS) for patients with advanced cancer. NGS technology has made it...more

Akin Gump Strauss Hauer & Feld LLP

New CMS National Coverage Determination and FDA Regulatory Approach: the Next Generation for NGS Testing Policy?

• The new national Medicare coverage determination covers only FDA-authorized NGS tests with companion diagnostic indications, leaving NGS cancer tests without that specific indication to seek coverage from local Medicare...more

Mintz

What’s Lurking in Your Lab? Legal Risks for Hospital Laboratories

Mintz on

Most health-care lawyers are accustomed to monitoring the high profile areas of regulatory enforcement in health care. However, many hospital lawyers, whether in-house or outside counsel, are unaware of the potential...more

Foley & Lardner LLP

Is Next Generation Sequencing Ready for Personalized Medicine?

Foley & Lardner LLP on

Next generation sequencing (NGS) promises to transform the delivery of health care by providing in one test diagnostic and prognostic information that had previously only been available in multiple analyses. One application...more

McDermott Will & Emery

CMS Announces Plans to Modernize and Update the Clinical Laboratory Fee Schedule

McDermott Will & Emery on

On November 27, 2013, Centers for Medicare & Medicaid Services posted the final 2014 Medicare physician fee schedule and, in it, announced plans to change how and how much Medicare pays for clinical diagnostic laboratory...more

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