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?
July 30, 2018
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
June 19, 2018
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
June 19, 2018
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
May 14, 2018
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
April 30, 2018
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
April 16, 2018
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
April 11, 2018
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...]
FOCUS ON
New Laws: Very Quietly, Congress Doubles Penalties for Medicare Fraud & Abuse
April 10, 2018
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...]
FOCUS ON
DOJ to Prosecutors: Show Tough Love to Whistleblowers with Weak Cases
March 19, 2018
A newly leaked internal Justice Department memo signals a new prosecution policy that may make it harder for whistleblowers to bring qui tam whistleblower lawsuits under the False Claims Act (FCA). … [Read more...]
