New Laws: Do-It-Yourself Kits Bring Lab Testing to the Home

Health care in the 21st century is moving toward consumerization of medicine, patient empowerment and increased price awareness resulting from higher out-of-pocket medical expenditures. The growth of … [Read more...]


Case of the Month: Foundation Medicine Faces Lawsuits from Shareholders & a Business Rival

Astart-up diagnostics firm on the precipice of a lab product breakthrough becomes a Wall Street darling. But, alas, the product fails to meet its lofty expectations. The firm's stock tanks and the … [Read more...]


Compliance Planning: OIG Switches from Semi-Annual to Monthly Work Plan Updates

When it comes to running a laboratory compliance plan, the semi-annual OIG Work Plan can be a big help to because it enables you to keep track of new enforcement initiatives and respond to emerging … [Read more...]


Labs to CMS: Push Back PAMA & Add Hospital Labs to CLFS Mix

The lab industry continues to wait nervously for word from CMS regarding PAMA. Demand 1: Fix the Fee Schedule Methodology The industry's paramount concern remains the formula CMS proposes to use to … [Read more...]


Global Markets: Local Joint Ventures Represent New Path into China Market

While the strategy of targeting the China market is nothing new, the tactics have evolved. Recognizing the need for a strong local presence, western firms are increasingly teaming with operators on … [Read more...]


New Fraud Takedown Shows that Coordinated Enforcement Remains Alive & Well under Trump

Last year at this time, the Justice Department announced the results of a nationwide takedown involving "the most defendants charged and largest alleged loss amount in Medicare Strike Force … [Read more...]


FDA Approves First NGS Oncology Companion Dx for Multiple Therapies

In May, the U.S. Food and Drug Agency (FDA), the agency known for its stinginess in approving new products, broke new ground by approving Merck's Keytruda (pembrolizumab) PD-1/PD-L1 inhibitor, a … [Read more...]


Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

Lab Tech and Account Rep Face Jail for Test Fee and Commissions Scheme. Case: A pair of Texans face criminal charges for allegedly conspiring to cheat Medicare of nearly $837,000 over a 6-month … [Read more...]


Proposed HOPPS Changes Would Allow Direct Billing of Molecular Pathology Tests & ADLTs

On July 13, the CMS proposed changes to Hospital Outpatient Prospective Payment System (HOPPS) rules for 2018. Here's a look at the three items that would affect laboratories that provide tests to … [Read more...]


Case of the Month: Theranos Settles with Walgreens

On June 21, less than a week before the eye-popping announcement about Walmart and Quest teaming up on a new retail venture, a case exemplifying just how badly arrangements between big labs and retail … [Read more...]