FOCUS ON

Medicare Reimbursement: 2019 CLFS Offers Some PAMA Relief But Not Nearly Enough

The battle between CMS and the lab industry over Medicare Part B pricing for lab tests is intensifying notwithstanding the ACLA's recent court loss and the supposed relief offered by the agency in its … [Read more...]

FOCUS ON

Industry Buzz: ACA Constitutionality Is Back in Play

After a series of court setbacks, Republicans challenging the constitutionality of Obamacare, aka, the Affordable Care Act (ACA) are back at it. And this time they may win. Beating a Dead Horse? The … [Read more...]

SPECIAL FOCUS

Cost Avoidance vs Cost Savings: What’s the Difference?

By Jennifer Dawson, MHA, DLM (ASCP)  bio As I work to spread awareness within the clinical laboratory community about the Cost of Poor Quality (COPQ) concept and its benefits as a method to … [Read more...]

FOCUS ON

FDA Says LOINC Coding of IVD Tests Is Voluntary, Not Mandatory

On June 15, the FDA issued a new guidance document clarifying the rules for laboratory coding of in vitro diagnostic tests. There are four key takeaways for IVD test makers and labs: 1. No Mandatory … [Read more...]

LITIGATION

Are Genetic Testing Labs Liable for Medical Malpractice?

Consumer-based genetic testing has become a $3 billion business with a seemingly limitless future. But the industry is also facing a legal threat to future growth: malpractice liability. In the past … [Read more...]

FOCUS ON

FDA Opens Door to Direct-to-Consumer Marketing of Genetic Tests—But Just a Crack

In a notice for public comment issued last November, the FDA raised eyebrows by floating a proposal that would make it easier to bring new genetic health risk (GHR) assessment tests to market. The … [Read more...]

FOCUS ON

Genomic Tests: Two New Assays Win FDA Breakthrough Device Designation

Earlier this month, the FDA finalized new rules designed to relax the regulatory obstacles faced by manufacturers in commercializing new genetic health risk assessment tests. And now an earlier … [Read more...]

FOCUS ON

New FDA Guidance Aims to Ease Approval for New NGS Tests—But It Probably Won’t Work

Test makers have long complained about the FDA's unwillingness to embrace technology and diagnostics advances. But on April 13, the agency took steps to address those concerns by issuing a pair of … [Read more...]

FOCUS ON

Emerging Tests: Medicare to Cover Next Gen-Sequencing Tests for Advanced Cancer

In the PAMA era, there are two salient trends in Medicare Part B lab reimbursements: Sharply lower prices for traditional tests; and Wider coverage of newly emerging tests, including some that … [Read more...]

SAFETY

Diagnostic danger in the lab: Time to reform how we process orders

By Oleg Bess, M.D.  bio I don't know about you, but I was stunned by the findings from a recent report published by Coverys, a national liability insurer, which I feel should put the entire … [Read more...]


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