FDA Report Asserts Case Studies Support Need for More Oversight of LDTs

The U.S. Food and Drug Administration (FDA) released a 30-plus page report detailing case studies it says demonstrate the need for the FDA to abandon its policy of enforcement discretion and exercise … [Read more...]

AMP Offers Proposal for Regulation of Laboratory-Developed Tests

While the Food and Drug Administration’s proposed framework for regulating laboratory developed tests (LDTs) remains to be finalized, other stakeholders are proposing alternative oversight models. On … [Read more...]

Proposed Medicare Fee Schedule Changes Acknowledge Compliance Realities and Focus on Value

In the wake of the SGR's demise and the rise of alternative payment models, the Centers for Medicare and Medicaid Services' latest proposed revisions to the Medicare fee schedules support those … [Read more...]

CMS Releases New CLIA-Waived Tests, Billing Codes

CMS notified contractors of new CLIA-waived tests effective July 1, 2015. There are 7 newly waived complexity tests, the latest approved by the FDA. The tests, listed in the table below, all require … [Read more...]

CMS Offers Physicians and Providers Help Prepping for ICD-10

By Kelly A. Briganti, Editorial Director, G2 Intelligence With the transition to ICD-10 looming, the Centers for Medicare and Medicaid Services (CMS) and the American Medical Association issued a … [Read more...]

Proposed Legislation Aids Personalized Medicine Agenda

H.R. 6, the 21st Century Cures Act, has been presented to the House of Representatives by the Energy & Commerce Committee. “The nonpartisan legislation will help to modernize and personalize … [Read more...]

CMS Withdraws Memorandum, Seeks Public Comment on Blood Glucose Monitoring

The Centers for Medicare & Medicaid Services (CMS) has backed off on some of its CLIA mandates regarding blood glucose monitoring systems (BGMS) for off-label use. CMS issued a memorandum in … [Read more...]

CMS Releases New CLIA-Waived Tests, Billing Codes

CMS notified contractors of new CLIA-waived tests effective April 1, 2015. There are 30 newly waived complexity tests, the latest approved by the FDA—which are again dominated by drug testing related … [Read more...]

FDA Holds LDT Workshop Amid Flurry of Debate as Comment Period Nears End

During and surrounding two days of public comment at an FDA-sponsored workshop, various stakeholders sounded off on the LDT regulation debate. As we reported, just prior to the FDA workshop, the … [Read more...]

CMS Proposes Coverage Decision Regarding HIV Screening

The Centers for Medicare and Medicaid Services (CMS) proposes increased coverage of HIV screenings with changes to the Medicare National Coverage Determinations Manual, Section 210.7. The CMS … [Read more...]


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