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...]

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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...]

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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...]

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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...]

COMPLIANCE

Physician Referrals: New Rules Offer Some Stark Law Relief but Not Nearly Enough

Like most budget bills, the new federal Bipartisan Budget Act of 2018 includes a number of changes to Medicare fraud and enforcement requirements. One set of changes affects the current physician … [Read more...]

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New Laws: Very Quietly, Congress Doubles Penalties for Medicare Fraud & Abuse

Sneaky may be too strong a word. But what is fair to say is that the new hikes in federal health care fraud violation penalties have flown totally under the radar despite their obvious and immediate … [Read more...]


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